"Notes" "VAERS ID" "VAERS ID Code" "Symptoms" "Symptoms Code" "Age" "Age Code" Adverse Event Description "0921175-1" "0921175-1" "BODY TEMPERATURE INCREASED" "10005911" "65-79 years" "65-79" "Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38, T 101.4," "0921175-1" "0921175-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38, T 101.4," "0922977-1" "0922977-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Fever, RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100 mg daily" "0922977-1" "0922977-1" "RESPIRATORY DEPRESSION" "10038678" "65-79 years" "65-79" "Fever, RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100 mg daily" "0922977-1" "0922977-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Fever, RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100 mg daily" "0932346-1" "0932346-1" "DEATH" "10011906" "65-79 years" "65-79" "1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased" "0932346-1" "0932346-1" "DIZZINESS" "10013573" "65-79 years" "65-79" "1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased" "0932346-1" "0932346-1" "HEADACHE" "10019211" "65-79 years" "65-79" "1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased" "0932346-1" "0932346-1" "PYREXIA" "10037660" "65-79 years" "65-79" "1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased" "0932346-1" "0932346-1" "RESPIRATORY ARREST" "10038669" "65-79 years" "65-79" "1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased" "0932346-1" "0932346-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever, dizziness, headache 1/10/21 0250 was found not breathing. EMS performed CPR and patient deceased" "0940955-1" "0940955-1" "AUTOPSY" "10050117" "65-79 years" "65-79" ""Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown"" "0940955-1" "0940955-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" ""Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown"" "0940955-1" "0940955-1" "DEATH" "10011906" "65-79 years" "65-79" ""Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown"" "0940955-1" "0940955-1" "PULSE ABSENT" "10037469" "65-79 years" "65-79" ""Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown"" "0940955-1" "0940955-1" "RESPIRATORY ARREST" "10038669" "65-79 years" "65-79" ""Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown"" "0940955-1" "0940955-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" ""Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association (""Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown"" "0944282-1" "0944282-1" "CARDIO-RESPIRATORY ARREST" "10007617" "65-79 years" "65-79" "resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type two diabetes mellitus), CHF(congestive heart failure), open wound, wound infection, heart failure. Allergies to medications, food, or other products: none. Concomitant medications included unspecified products (List of any other medications the patient received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: Yes. Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender's Comments: The old patient had diabetes mellitus, congestive heart failure, open wound complicated by infection, all these pre-existing medical conditions contribute to the patient death. More information including complete medical history, concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired" "0944282-1" "0944282-1" "DEATH" "10011906" "65-79 years" "65-79" "resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type two diabetes mellitus), CHF(congestive heart failure), open wound, wound infection, heart failure. Allergies to medications, food, or other products: none. Concomitant medications included unspecified products (List of any other medications the patient received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Serious: Yes. Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender's Comments: The old patient had diabetes mellitus, congestive heart failure, open wound complicated by infection, all these pre-existing medical conditions contribute to the patient death. More information including complete medical history, concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired" "0952704-1" "0952704-1" "ABDOMINAL PAIN UPPER" "10000087" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "ABNORMAL BEHAVIOUR" "10061422" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "AGITATION" "10001497" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "ANXIETY" "10002855" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "COMPLETED SUICIDE" "10010144" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "CONFUSIONAL STATE" "10010305" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "DEMENTIA" "10012267" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "PANIC DISORDER" "10033666" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "TREMOR" "10044565" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0952704-1" "0952704-1" "VACCINATION COMPLICATION" "10046861" "65-79 years" "65-79" "Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home." "0953754-1" "0953754-1" "DEATH" "10011906" "65-79 years" "65-79" "patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pneumonia" "0953754-1" "0953754-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pneumonia" "0956962-1" "0956962-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "COVID 19 vaccine, unknown which company Chronically ill in a skilled nursing facility found diaphoretic, hypotensive, hypoxia to 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have been related to vaccine date of vaccination 1/6/20 hx covid 19 PNA in April 2020" "0956962-1" "0956962-1" "DEATH" "10011906" "65-79 years" "65-79" "COVID 19 vaccine, unknown which company Chronically ill in a skilled nursing facility found diaphoretic, hypotensive, hypoxia to 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have been related to vaccine date of vaccination 1/6/20 hx covid 19 PNA in April 2020" "0956962-1" "0956962-1" "HYPERHIDROSIS" "10020642" "65-79 years" "65-79" "COVID 19 vaccine, unknown which company Chronically ill in a skilled nursing facility found diaphoretic, hypotensive, hypoxia to 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have been related to vaccine date of vaccination 1/6/20 hx covid 19 PNA in April 2020" "0956962-1" "0956962-1" "HYPOTENSION" "10021097" "65-79 years" "65-79" "COVID 19 vaccine, unknown which company Chronically ill in a skilled nursing facility found diaphoretic, hypotensive, hypoxia to 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have been related to vaccine date of vaccination 1/6/20 hx covid 19 PNA in April 2020" "0956962-1" "0956962-1" "HYPOXIA" "10021143" "65-79 years" "65-79" "COVID 19 vaccine, unknown which company Chronically ill in a skilled nursing facility found diaphoretic, hypotensive, hypoxia to 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have been related to vaccine date of vaccination 1/6/20 hx covid 19 PNA in April 2020" "0964795-1" "0964795-1" "BLOOD CULTURE NEGATIVE" "10005486" "65-79 years" "65-79" "Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination. No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care." "0964795-1" "0964795-1" "COMPUTERISED TOMOGRAM HEAD NORMAL" "10072167" "65-79 years" "65-79" "Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination. No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care." "0964795-1" "0964795-1" "DIARRHOEA" "10012735" "65-79 years" "65-79" "Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination. No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care." "0964795-1" "0964795-1" "MENTAL STATUS CHANGES" "10048294" "65-79 years" "65-79" "Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination. No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care." "0964795-1" "0964795-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination. No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care." "0964795-1" "0964795-1" "WHITE BLOOD CELL COUNT NORMAL" "10047944" "65-79 years" "65-79" "Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination. No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care." "0966844-1" "0966844-1" "DEATH" "10011906" "65-79 years" "65-79" ""Patient is reported to have died at home, the day after his COVID test. Family member states that he did good the afternoon and evening after his COVID-19 injection, but that he started not feeling good the next day. The patient ""was having palpitations"". The family tried to convince him to go to the Emergency Room, but he refused. Patient died at home."" "0966844-1" "0966844-1" "FEELING ABNORMAL" "10016322" "65-79 years" "65-79" ""Patient is reported to have died at home, the day after his COVID test. Family member states that he did good the afternoon and evening after his COVID-19 injection, but that he started not feeling good the next day. The patient ""was having palpitations"". The family tried to convince him to go to the Emergency Room, but he refused. Patient died at home."" "0966844-1" "0966844-1" "PALPITATIONS" "10033557" "65-79 years" "65-79" ""Patient is reported to have died at home, the day after his COVID test. Family member states that he did good the afternoon and evening after his COVID-19 injection, but that he started not feeling good the next day. The patient ""was having palpitations"". The family tried to convince him to go to the Emergency Room, but he refused. Patient died at home."" "0970412-1" "0970412-1" "CARDIO-RESPIRATORY DISTRESS" "10049874" "65-79 years" "65-79" "Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed." "0970412-1" "0970412-1" "DEATH" "10011906" "65-79 years" "65-79" "Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed." "0970412-1" "0970412-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed." "0970412-1" "0970412-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed." "0970412-1" "0970412-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed." "0970412-1" "0970412-1" "GENERAL PHYSICAL CONDITION ABNORMAL" "10058911" "65-79 years" "65-79" "Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed." "0970412-1" "0970412-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed." "0970495-1" "0970495-1" "SUDDEN CARDIAC DEATH" "10049418" "65-79 years" "65-79" "Patient expired three days after receiving first dose of Moderna COVID-19 vaccine. The death certificate states cause of death is sudden cardiac arrest." "0975023-1" "0975023-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01)." "0975023-1" "0975023-1" "DEATH" "10011906" "65-79 years" "65-79" "CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01)." "0975023-1" "0975023-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01)." "0975023-1" "0975023-1" "INFLUENZA A VIRUS TEST NEGATIVE" "10070417" "65-79 years" "65-79" "CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01)." "0975023-1" "0975023-1" "INFLUENZA B VIRUS TEST" "10071544" "65-79 years" "65-79" "CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01)." "0975023-1" "0975023-1" "INFLUENZA VIRUS TEST NEGATIVE" "10070718" "65-79 years" "65-79" "CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01)." "0975023-1" "0975023-1" "RESPIRATORY SYNCYTIAL VIRUS TEST NEGATIVE" "10068564" "65-79 years" "65-79" "CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01)." "0975023-1" "0975023-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01)." "0975023-1" "0975023-1" "SYNCOPE" "10042772" "65-79 years" "65-79" "CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01)." "0982472-1" "0982472-1" "DEATH" "10011906" "65-79 years" "65-79" "Worsening respiratory failure 1/20/2021 death 1/27/2021" "0982472-1" "0982472-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Worsening respiratory failure 1/20/2021 death 1/27/2021" "0982495-1" "0982495-1" "DEATH" "10011906" "65-79 years" "65-79" "Client's sister called crying and said the family just found out yesterday that Client had died some time last week. The last time any family talked to him was on the 19th of January, missed calls show on the phone on the 21st. His last internet search was sternum pain. . She will also call the Agency and report this. The vaccine isn't in Registery at this time, do I don't know the lot number but she said he was due back in one month. She said he was very healthy and ran triathalons." "0985205-1" "0985205-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient was feeling dizzy and under the weather after the vaccination. The following day he died in his sleep during a nap." "0985205-1" "0985205-1" "DIZZINESS" "10013573" "65-79 years" "65-79" "Patient was feeling dizzy and under the weather after the vaccination. The following day he died in his sleep during a nap." "0985205-1" "0985205-1" "MALAISE" "10025482" "65-79 years" "65-79" "Patient was feeling dizzy and under the weather after the vaccination. The following day he died in his sleep during a nap." "0986869-1" "0986869-1" "RESPIRATORY DISTRESS" "10038687" "65-79 years" "65-79" "Patient noted with respiratory distress on 1/10/2021, transferred to hospital via 911." "0992347-1" "0992347-1" "DEATH" "10011906" "65-79 years" "65-79" "Death" "0995649-1" "0995649-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Cardiac arrest; Patient transported by EMS to hospital 11:00pm on 01/29/2021. Patient received vaccine on 01/25/2021. Patient expired 01/30/2021 within the hour into the new day after midnight on 01/30/2021. Patient was feeling well prior to and any chronic health conditions were well controlled. Sudden cardiac arrest 4 days after receiving the vaccine. Details given by patients husband/POA." "0995649-1" "0995649-1" "DEATH" "10011906" "65-79 years" "65-79" "Cardiac arrest; Patient transported by EMS to hospital 11:00pm on 01/29/2021. Patient received vaccine on 01/25/2021. Patient expired 01/30/2021 within the hour into the new day after midnight on 01/30/2021. Patient was feeling well prior to and any chronic health conditions were well controlled. Sudden cardiac arrest 4 days after receiving the vaccine. Details given by patients husband/POA." "0996959-1" "0996959-1" "DEATH" "10011906" "65-79 years" "65-79" "Vaccine was administered Thursday and my father Died early Monday morning unexpectedly" "0997783-1" "0997783-1" "DEATH" "10011906" "65-79 years" "65-79" "patient passed away subsequent to receiving dose on 02/01. Staff does not have reason to believe vaccine was involved." "0998637-1" "0998637-1" "ARRHYTHMIA" "10003119" "65-79 years" "65-79" "Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest." "0998637-1" "0998637-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest." "0998637-1" "0998637-1" "IRREGULAR BREATHING" "10076213" "65-79 years" "65-79" "Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest." "0998637-1" "0998637-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest." "0998637-1" "0998637-1" "SOMNOLENCE" "10041349" "65-79 years" "65-79" "Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest." "1009991-1" "1009991-1" "CIRCULATORY COLLAPSE" "10009192" "65-79 years" "65-79" "73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department" "1009991-1" "1009991-1" "DEATH" "10011906" "65-79 years" "65-79" "73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department" "1009991-1" "1009991-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department" "1009991-1" "1009991-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department" "1009991-1" "1009991-1" "PHARYNGEAL SWELLING" "10082270" "65-79 years" "65-79" "73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department" "1009991-1" "1009991-1" "PULSE ABSENT" "10037469" "65-79 years" "65-79" "73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department" "1009991-1" "1009991-1" "RESPIRATION ABNORMAL" "10038647" "65-79 years" "65-79" "73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department" "1009991-1" "1009991-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department" "1009991-1" "1009991-1" "SYNCOPE" "10042772" "65-79 years" "65-79" "73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department" "1009991-1" "1009991-1" "VENTRICULAR FIBRILLATION" "10047290" "65-79 years" "65-79" "73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building 10:47 CPR initiated 10:49 medical team/EMS found no pulse, agonal respirations, ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling; 11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department" "1011149-1" "1011149-1" "ARRHYTHMIA" "10003119" "65-79 years" "65-79" "Developed heart arrhythmia and was unable to be revived." "1011149-1" "1011149-1" "DEATH" "10011906" "65-79 years" "65-79" "Developed heart arrhythmia and was unable to be revived." "1011440-1" "1011440-1" "DEATH" "10011906" "65-79 years" "65-79" "unanticipated death" "1013087-1" "1013087-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient received vaccine on 1/23/2021 and death occurred on 1/30/2021." "1016111-1" "1016111-1" "CEREBROVASCULAR ACCIDENT" "10008190" "65-79 years" "65-79" "her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke between 4 and 6pm. She died within 6 to 7 hours later." "1016111-1" "1016111-1" "DEATH" "10011906" "65-79 years" "65-79" "her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke between 4 and 6pm. She died within 6 to 7 hours later." "1016111-1" "1016111-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" "her arm was sore but no other adverse reactions until Saturday, Feburary 6th 2021 she had stroke between 4 and 6pm. She died within 6 to 7 hours later." "1017011-1" "1017011-1" "DEATH" "10011906" "65-79 years" "65-79" "Resident expired 01/26/21 at 5:25am." "1020002-1" "1020002-1" "DEATH" "10011906" "65-79 years" "65-79" "Given First Moderna covid vacc 1/19/2021. Doing well on multiple contacts from health care providers, then 2/5/2021 was driving, pulled over to the side of the road into a yard, got out of the car and told an observer that he could not breathe, collapsed face down in the snow, EMS called, unable to revive him." "1020002-1" "1020002-1" "RESPIRATORY ARREST" "10038669" "65-79 years" "65-79" "Given First Moderna covid vacc 1/19/2021. Doing well on multiple contacts from health care providers, then 2/5/2021 was driving, pulled over to the side of the road into a yard, got out of the car and told an observer that he could not breathe, collapsed face down in the snow, EMS called, unable to revive him." "1020002-1" "1020002-1" "SYNCOPE" "10042772" "65-79 years" "65-79" "Given First Moderna covid vacc 1/19/2021. Doing well on multiple contacts from health care providers, then 2/5/2021 was driving, pulled over to the side of the road into a yard, got out of the car and told an observer that he could not breathe, collapsed face down in the snow, EMS called, unable to revive him." "1020018-1" "1020018-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient reported to be unresponsive on the morning after receiving his second dose of Moderna COVID-19 vaccine. Patient had expired during the night." "1020018-1" "1020018-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Patient reported to be unresponsive on the morning after receiving his second dose of Moderna COVID-19 vaccine. Patient had expired during the night." "1020079-1" "1020079-1" "COUGH" "10011224" "65-79 years" "65-79" "Received Moderna covid vaccination 1/14/2021. 1/16/2021 received report of cough and difficulty breathing. Proceeded to hospital and was diagnosed Covid+ on testing. Continued to decline, died 1/31/2021." "1020079-1" "1020079-1" "COVID-19" "10084268" "65-79 years" "65-79" "Received Moderna covid vaccination 1/14/2021. 1/16/2021 received report of cough and difficulty breathing. Proceeded to hospital and was diagnosed Covid+ on testing. Continued to decline, died 1/31/2021." "1020079-1" "1020079-1" "DEATH" "10011906" "65-79 years" "65-79" "Received Moderna covid vaccination 1/14/2021. 1/16/2021 received report of cough and difficulty breathing. Proceeded to hospital and was diagnosed Covid+ on testing. Continued to decline, died 1/31/2021." "1020079-1" "1020079-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Received Moderna covid vaccination 1/14/2021. 1/16/2021 received report of cough and difficulty breathing. Proceeded to hospital and was diagnosed Covid+ on testing. Continued to decline, died 1/31/2021." "1020079-1" "1020079-1" "GENERAL PHYSICAL HEALTH DETERIORATION" "10049438" "65-79 years" "65-79" "Received Moderna covid vaccination 1/14/2021. 1/16/2021 received report of cough and difficulty breathing. Proceeded to hospital and was diagnosed Covid+ on testing. Continued to decline, died 1/31/2021." "1020079-1" "1020079-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Received Moderna covid vaccination 1/14/2021. 1/16/2021 received report of cough and difficulty breathing. Proceeded to hospital and was diagnosed Covid+ on testing. Continued to decline, died 1/31/2021." "1026752-1" "1026752-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Developed vomiting, seizure and cardiac arrest, V Fib" "1026752-1" "1026752-1" "SEIZURE" "10039906" "65-79 years" "65-79" "Developed vomiting, seizure and cardiac arrest, V Fib" "1026752-1" "1026752-1" "VENTRICULAR FIBRILLATION" "10047290" "65-79 years" "65-79" "Developed vomiting, seizure and cardiac arrest, V Fib" "1026752-1" "1026752-1" "VOMITING" "10047700" "65-79 years" "65-79" "Developed vomiting, seizure and cardiac arrest, V Fib" "1029412-1" "1029412-1" "DEATH" "10011906" "65-79 years" "65-79" "Death" "1029514-1" "1029514-1" "DEATH" "10011906" "65-79 years" "65-79" "patient deceased" "1035850-1" "1035850-1" "CEREBROVASCULAR ACCIDENT" "10008190" "65-79 years" "65-79" "Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered." "1035850-1" "1035850-1" "COMPUTERISED TOMOGRAM" "10010234" "65-79 years" "65-79" "Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered." "1035850-1" "1035850-1" "ECHOCARDIOGRAM" "10014113" "65-79 years" "65-79" "Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered." "1035850-1" "1035850-1" "LABORATORY TEST" "10059938" "65-79 years" "65-79" "Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered." "1035850-1" "1035850-1" "MAGNETIC RESONANCE IMAGING" "10078223" "65-79 years" "65-79" "Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered." "1035850-1" "1035850-1" "NEUROLOGICAL SYMPTOM" "10060860" "65-79 years" "65-79" "Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered." "1035850-1" "1035850-1" "THROMBOSIS" "10043607" "65-79 years" "65-79" "Patient woke up on the morning of 2/6 with symptoms of a stroke. Rushed to hospital where clot found in brain. Recovered from initial stroke but then had another major stroke on 2/8 and never recovered." "1035950-1" "1035950-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient found deceased at home on 2/15/2021. There was no known cause of death with no significant medical history." "1036047-1" "1036047-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Short version The patient has long-standing health issues. The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021. CPR and treatment was begun and he was transported to the ED. He was pronounced dead in the ED at 0846. Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest. 911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive. Patient was noted by family to be pulseless and CPR was started right away. Patient received two doses of epi by police were on scene first (AED defibrillation x2) and six doses of epi (plus 6 more AED shocks) by EMS when they arrived. Patient had CPR performed for 45 minutes prior to arriving at the hospital. On route, patient had episodes of paced rhythm and V. fib. Patient received one amp of bicarb and one amp of calcium en route. Patient also received 300 mg of amiodarone en route. Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED." "1036047-1" "1036047-1" "CARDIAC ASSISTANCE DEVICE USER" "10053686" "65-79 years" "65-79" "Short version The patient has long-standing health issues. The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021. CPR and treatment was begun and he was transported to the ED. He was pronounced dead in the ED at 0846. Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest. 911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive. Patient was noted by family to be pulseless and CPR was started right away. Patient received two doses of epi by police were on scene first (AED defibrillation x2) and six doses of epi (plus 6 more AED shocks) by EMS when they arrived. Patient had CPR performed for 45 minutes prior to arriving at the hospital. On route, patient had episodes of paced rhythm and V. fib. Patient received one amp of bicarb and one amp of calcium en route. Patient also received 300 mg of amiodarone en route. Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED." "1036047-1" "1036047-1" "DEATH" "10011906" "65-79 years" "65-79" "Short version The patient has long-standing health issues. The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021. CPR and treatment was begun and he was transported to the ED. He was pronounced dead in the ED at 0846. Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest. 911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive. Patient was noted by family to be pulseless and CPR was started right away. Patient received two doses of epi by police were on scene first (AED defibrillation x2) and six doses of epi (plus 6 more AED shocks) by EMS when they arrived. Patient had CPR performed for 45 minutes prior to arriving at the hospital. On route, patient had episodes of paced rhythm and V. fib. Patient received one amp of bicarb and one amp of calcium en route. Patient also received 300 mg of amiodarone en route. Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED." "1036047-1" "1036047-1" "PULSE ABSENT" "10037469" "65-79 years" "65-79" "Short version The patient has long-standing health issues. The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021. CPR and treatment was begun and he was transported to the ED. He was pronounced dead in the ED at 0846. Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest. 911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive. Patient was noted by family to be pulseless and CPR was started right away. Patient received two doses of epi by police were on scene first (AED defibrillation x2) and six doses of epi (plus 6 more AED shocks) by EMS when they arrived. Patient had CPR performed for 45 minutes prior to arriving at the hospital. On route, patient had episodes of paced rhythm and V. fib. Patient received one amp of bicarb and one amp of calcium en route. Patient also received 300 mg of amiodarone en route. Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED." "1036047-1" "1036047-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "Short version The patient has long-standing health issues. The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021. CPR and treatment was begun and he was transported to the ED. He was pronounced dead in the ED at 0846. Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest. 911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive. Patient was noted by family to be pulseless and CPR was started right away. Patient received two doses of epi by police were on scene first (AED defibrillation x2) and six doses of epi (plus 6 more AED shocks) by EMS when they arrived. Patient had CPR performed for 45 minutes prior to arriving at the hospital. On route, patient had episodes of paced rhythm and V. fib. Patient received one amp of bicarb and one amp of calcium en route. Patient also received 300 mg of amiodarone en route. Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED." "1036047-1" "1036047-1" "SEIZURE LIKE PHENOMENA" "10071048" "65-79 years" "65-79" "Short version The patient has long-standing health issues. The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021. CPR and treatment was begun and he was transported to the ED. He was pronounced dead in the ED at 0846. Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest. 911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive. Patient was noted by family to be pulseless and CPR was started right away. Patient received two doses of epi by police were on scene first (AED defibrillation x2) and six doses of epi (plus 6 more AED shocks) by EMS when they arrived. Patient had CPR performed for 45 minutes prior to arriving at the hospital. On route, patient had episodes of paced rhythm and V. fib. Patient received one amp of bicarb and one amp of calcium en route. Patient also received 300 mg of amiodarone en route. Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED." "1036047-1" "1036047-1" "SYNCOPE" "10042772" "65-79 years" "65-79" "Short version The patient has long-standing health issues. The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021. CPR and treatment was begun and he was transported to the ED. He was pronounced dead in the ED at 0846. Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest. 911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive. Patient was noted by family to be pulseless and CPR was started right away. Patient received two doses of epi by police were on scene first (AED defibrillation x2) and six doses of epi (plus 6 more AED shocks) by EMS when they arrived. Patient had CPR performed for 45 minutes prior to arriving at the hospital. On route, patient had episodes of paced rhythm and V. fib. Patient received one amp of bicarb and one amp of calcium en route. Patient also received 300 mg of amiodarone en route. Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED." "1036047-1" "1036047-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Short version The patient has long-standing health issues. The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021. CPR and treatment was begun and he was transported to the ED. He was pronounced dead in the ED at 0846. Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest. 911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive. Patient was noted by family to be pulseless and CPR was started right away. Patient received two doses of epi by police were on scene first (AED defibrillation x2) and six doses of epi (plus 6 more AED shocks) by EMS when they arrived. Patient had CPR performed for 45 minutes prior to arriving at the hospital. On route, patient had episodes of paced rhythm and V. fib. Patient received one amp of bicarb and one amp of calcium en route. Patient also received 300 mg of amiodarone en route. Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED." "1037878-1" "1037878-1" "DEATH" "10011906" "65-79 years" "65-79" "Is patient deceased: Yes; Low pulse; This is a spontaneous report from two contactable nurses reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140 expiration date Mar2021) intramuscular on 22Dec2020 at 10:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home. Patient age at time of vaccination was 70 years. Patient's Medical History included ongoing Type 2 Diabetes Mellitus Without Complication onset date: admission 22Oct2020, ongoing morbid obesity due to excess calories onset date: admission 22Oct2020, cardiac disorder, essential hypertension, hypertension, schizophrenia, hyperlipidemia, benign prostatic hyperplasia (BPH), Gastrooesophageal reflux disease (GERD), depression, hypothyroid, epilepsy, pain, dry eyes, anxiety, restlessness, 17Jan2020 Slid out of chair to floor, no injury, on 27Jan2020, 28Jan2020, 29Jan2020 diarrhea noted. Concomitant medications included acetylsalicylic acid (ASPIRIN EC) for Cardiac Health, atenolol (ATENOLOL) for Essential Hypertension, atorvastatin calcium (ATORVASTATIN CALCIUM) for hyperlipidemia, finasteride (FINASTERIDE) for benign prostatic hyperplasia, tamsulosin hydrochloride (FLOMAX) benign prostatic hyperplasia, insulin glargine (LANTUS) for diabetes mellitus, lithium carbonate (LITHIUM CARBONATE) for Schizophrenia, losartan potassium (LOSARTAN POTASSIUM) for hypertension, lurasidone hydrochloride (LURASIDONE HYDROCHLORIDE) for Schizophrenia, omeprazole (OMEPRAZOLE) for gastrooesophageal reflux disease, sertraline hcl (SERTRALINE HCL) for depression, levothyroxine sodium (SYNTHROID) for hypothyroid, ergocalciferol (VIT D) for supplement, haloperidol (HALOPERIDOL) for Schizophrenia, levetiracetam (KEPPRA) for epilepsy, paracetamol (TYLENOL EXTRA-STRENGTH) for pain, propylene glycol (ARTIFICIAL TEARS) for dry eyes, lorazepam (ATIVAN) for a anxiety or restlessness. As antipyretic use was reported Tylenol ES (500 mg) Tab, 2 Tabs by Mouth Routine use three times a day given at time of vaccination and after. It was reported the patient was Covid+. He was tested on 21Dec2020 and was not admitted to hospital. Event Onset Date was reported as 24Dec2020 (clarification pending). On 30Dec2020 the patient was started on O2 at 2L for low pulse. O2 was increased over time to eventually O2 at 8L on 03Jan2021. Morphine Sulfate was started on 03Jan2021 at 5 mg sl/by mouth every 2 hours as needed for pain or airhunger. The patient deceased on 03Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The AEs did not require a visit to Emergency Room or Physician Office. Outcome of Low pulse was unknown.; Sender's Comments: Based on the information available the events Death (unknown cause) and Heart rate decreased are attributed to patient's multiple underlying medical conditions including Type 2 Diabetes Mellitus, morbid obesity, cardiac disorder, hypertension, epilepsy etc. However, based solely on a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the above mentioned events cannot be completely excluded. The case will be reevaluated should additional information, including the cause of death, become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Is patient deceased: Yes" "1037878-1" "1037878-1" "HEART RATE" "10019299" "65-79 years" "65-79" "Is patient deceased: Yes; Low pulse; This is a spontaneous report from two contactable nurses reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140 expiration date Mar2021) intramuscular on 22Dec2020 at 10:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home. Patient age at time of vaccination was 70 years. Patient's Medical History included ongoing Type 2 Diabetes Mellitus Without Complication onset date: admission 22Oct2020, ongoing morbid obesity due to excess calories onset date: admission 22Oct2020, cardiac disorder, essential hypertension, hypertension, schizophrenia, hyperlipidemia, benign prostatic hyperplasia (BPH), Gastrooesophageal reflux disease (GERD), depression, hypothyroid, epilepsy, pain, dry eyes, anxiety, restlessness, 17Jan2020 Slid out of chair to floor, no injury, on 27Jan2020, 28Jan2020, 29Jan2020 diarrhea noted. Concomitant medications included acetylsalicylic acid (ASPIRIN EC) for Cardiac Health, atenolol (ATENOLOL) for Essential Hypertension, atorvastatin calcium (ATORVASTATIN CALCIUM) for hyperlipidemia, finasteride (FINASTERIDE) for benign prostatic hyperplasia, tamsulosin hydrochloride (FLOMAX) benign prostatic hyperplasia, insulin glargine (LANTUS) for diabetes mellitus, lithium carbonate (LITHIUM CARBONATE) for Schizophrenia, losartan potassium (LOSARTAN POTASSIUM) for hypertension, lurasidone hydrochloride (LURASIDONE HYDROCHLORIDE) for Schizophrenia, omeprazole (OMEPRAZOLE) for gastrooesophageal reflux disease, sertraline hcl (SERTRALINE HCL) for depression, levothyroxine sodium (SYNTHROID) for hypothyroid, ergocalciferol (VIT D) for supplement, haloperidol (HALOPERIDOL) for Schizophrenia, levetiracetam (KEPPRA) for epilepsy, paracetamol (TYLENOL EXTRA-STRENGTH) for pain, propylene glycol (ARTIFICIAL TEARS) for dry eyes, lorazepam (ATIVAN) for a anxiety or restlessness. As antipyretic use was reported Tylenol ES (500 mg) Tab, 2 Tabs by Mouth Routine use three times a day given at time of vaccination and after. It was reported the patient was Covid+. He was tested on 21Dec2020 and was not admitted to hospital. Event Onset Date was reported as 24Dec2020 (clarification pending). On 30Dec2020 the patient was started on O2 at 2L for low pulse. O2 was increased over time to eventually O2 at 8L on 03Jan2021. Morphine Sulfate was started on 03Jan2021 at 5 mg sl/by mouth every 2 hours as needed for pain or airhunger. The patient deceased on 03Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The AEs did not require a visit to Emergency Room or Physician Office. Outcome of Low pulse was unknown.; Sender's Comments: Based on the information available the events Death (unknown cause) and Heart rate decreased are attributed to patient's multiple underlying medical conditions including Type 2 Diabetes Mellitus, morbid obesity, cardiac disorder, hypertension, epilepsy etc. However, based solely on a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the above mentioned events cannot be completely excluded. The case will be reevaluated should additional information, including the cause of death, become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Is patient deceased: Yes" "1037878-1" "1037878-1" "HEART RATE DECREASED" "10019301" "65-79 years" "65-79" "Is patient deceased: Yes; Low pulse; This is a spontaneous report from two contactable nurses reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140 expiration date Mar2021) intramuscular on 22Dec2020 at 10:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home. Patient age at time of vaccination was 70 years. Patient's Medical History included ongoing Type 2 Diabetes Mellitus Without Complication onset date: admission 22Oct2020, ongoing morbid obesity due to excess calories onset date: admission 22Oct2020, cardiac disorder, essential hypertension, hypertension, schizophrenia, hyperlipidemia, benign prostatic hyperplasia (BPH), Gastrooesophageal reflux disease (GERD), depression, hypothyroid, epilepsy, pain, dry eyes, anxiety, restlessness, 17Jan2020 Slid out of chair to floor, no injury, on 27Jan2020, 28Jan2020, 29Jan2020 diarrhea noted. Concomitant medications included acetylsalicylic acid (ASPIRIN EC) for Cardiac Health, atenolol (ATENOLOL) for Essential Hypertension, atorvastatin calcium (ATORVASTATIN CALCIUM) for hyperlipidemia, finasteride (FINASTERIDE) for benign prostatic hyperplasia, tamsulosin hydrochloride (FLOMAX) benign prostatic hyperplasia, insulin glargine (LANTUS) for diabetes mellitus, lithium carbonate (LITHIUM CARBONATE) for Schizophrenia, losartan potassium (LOSARTAN POTASSIUM) for hypertension, lurasidone hydrochloride (LURASIDONE HYDROCHLORIDE) for Schizophrenia, omeprazole (OMEPRAZOLE) for gastrooesophageal reflux disease, sertraline hcl (SERTRALINE HCL) for depression, levothyroxine sodium (SYNTHROID) for hypothyroid, ergocalciferol (VIT D) for supplement, haloperidol (HALOPERIDOL) for Schizophrenia, levetiracetam (KEPPRA) for epilepsy, paracetamol (TYLENOL EXTRA-STRENGTH) for pain, propylene glycol (ARTIFICIAL TEARS) for dry eyes, lorazepam (ATIVAN) for a anxiety or restlessness. As antipyretic use was reported Tylenol ES (500 mg) Tab, 2 Tabs by Mouth Routine use three times a day given at time of vaccination and after. It was reported the patient was Covid+. He was tested on 21Dec2020 and was not admitted to hospital. Event Onset Date was reported as 24Dec2020 (clarification pending). On 30Dec2020 the patient was started on O2 at 2L for low pulse. O2 was increased over time to eventually O2 at 8L on 03Jan2021. Morphine Sulfate was started on 03Jan2021 at 5 mg sl/by mouth every 2 hours as needed for pain or airhunger. The patient deceased on 03Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The AEs did not require a visit to Emergency Room or Physician Office. Outcome of Low pulse was unknown.; Sender's Comments: Based on the information available the events Death (unknown cause) and Heart rate decreased are attributed to patient's multiple underlying medical conditions including Type 2 Diabetes Mellitus, morbid obesity, cardiac disorder, hypertension, epilepsy etc. However, based solely on a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the above mentioned events cannot be completely excluded. The case will be reevaluated should additional information, including the cause of death, become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Is patient deceased: Yes" "1037878-1" "1037878-1" "OXYGEN SATURATION" "10033316" "65-79 years" "65-79" "Is patient deceased: Yes; Low pulse; This is a spontaneous report from two contactable nurses reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140 expiration date Mar2021) intramuscular on 22Dec2020 at 10:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home. Patient age at time of vaccination was 70 years. Patient's Medical History included ongoing Type 2 Diabetes Mellitus Without Complication onset date: admission 22Oct2020, ongoing morbid obesity due to excess calories onset date: admission 22Oct2020, cardiac disorder, essential hypertension, hypertension, schizophrenia, hyperlipidemia, benign prostatic hyperplasia (BPH), Gastrooesophageal reflux disease (GERD), depression, hypothyroid, epilepsy, pain, dry eyes, anxiety, restlessness, 17Jan2020 Slid out of chair to floor, no injury, on 27Jan2020, 28Jan2020, 29Jan2020 diarrhea noted. Concomitant medications included acetylsalicylic acid (ASPIRIN EC) for Cardiac Health, atenolol (ATENOLOL) for Essential Hypertension, atorvastatin calcium (ATORVASTATIN CALCIUM) for hyperlipidemia, finasteride (FINASTERIDE) for benign prostatic hyperplasia, tamsulosin hydrochloride (FLOMAX) benign prostatic hyperplasia, insulin glargine (LANTUS) for diabetes mellitus, lithium carbonate (LITHIUM CARBONATE) for Schizophrenia, losartan potassium (LOSARTAN POTASSIUM) for hypertension, lurasidone hydrochloride (LURASIDONE HYDROCHLORIDE) for Schizophrenia, omeprazole (OMEPRAZOLE) for gastrooesophageal reflux disease, sertraline hcl (SERTRALINE HCL) for depression, levothyroxine sodium (SYNTHROID) for hypothyroid, ergocalciferol (VIT D) for supplement, haloperidol (HALOPERIDOL) for Schizophrenia, levetiracetam (KEPPRA) for epilepsy, paracetamol (TYLENOL EXTRA-STRENGTH) for pain, propylene glycol (ARTIFICIAL TEARS) for dry eyes, lorazepam (ATIVAN) for a anxiety or restlessness. As antipyretic use was reported Tylenol ES (500 mg) Tab, 2 Tabs by Mouth Routine use three times a day given at time of vaccination and after. It was reported the patient was Covid+. He was tested on 21Dec2020 and was not admitted to hospital. Event Onset Date was reported as 24Dec2020 (clarification pending). On 30Dec2020 the patient was started on O2 at 2L for low pulse. O2 was increased over time to eventually O2 at 8L on 03Jan2021. Morphine Sulfate was started on 03Jan2021 at 5 mg sl/by mouth every 2 hours as needed for pain or airhunger. The patient deceased on 03Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The AEs did not require a visit to Emergency Room or Physician Office. Outcome of Low pulse was unknown.; Sender's Comments: Based on the information available the events Death (unknown cause) and Heart rate decreased are attributed to patient's multiple underlying medical conditions including Type 2 Diabetes Mellitus, morbid obesity, cardiac disorder, hypertension, epilepsy etc. However, based solely on a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the above mentioned events cannot be completely excluded. The case will be reevaluated should additional information, including the cause of death, become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Is patient deceased: Yes" "1037878-1" "1037878-1" "SARS-COV-2 TEST" "10084354" "65-79 years" "65-79" "Is patient deceased: Yes; Low pulse; This is a spontaneous report from two contactable nurses reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140 expiration date Mar2021) intramuscular on 22Dec2020 at 10:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home. Patient age at time of vaccination was 70 years. Patient's Medical History included ongoing Type 2 Diabetes Mellitus Without Complication onset date: admission 22Oct2020, ongoing morbid obesity due to excess calories onset date: admission 22Oct2020, cardiac disorder, essential hypertension, hypertension, schizophrenia, hyperlipidemia, benign prostatic hyperplasia (BPH), Gastrooesophageal reflux disease (GERD), depression, hypothyroid, epilepsy, pain, dry eyes, anxiety, restlessness, 17Jan2020 Slid out of chair to floor, no injury, on 27Jan2020, 28Jan2020, 29Jan2020 diarrhea noted. Concomitant medications included acetylsalicylic acid (ASPIRIN EC) for Cardiac Health, atenolol (ATENOLOL) for Essential Hypertension, atorvastatin calcium (ATORVASTATIN CALCIUM) for hyperlipidemia, finasteride (FINASTERIDE) for benign prostatic hyperplasia, tamsulosin hydrochloride (FLOMAX) benign prostatic hyperplasia, insulin glargine (LANTUS) for diabetes mellitus, lithium carbonate (LITHIUM CARBONATE) for Schizophrenia, losartan potassium (LOSARTAN POTASSIUM) for hypertension, lurasidone hydrochloride (LURASIDONE HYDROCHLORIDE) for Schizophrenia, omeprazole (OMEPRAZOLE) for gastrooesophageal reflux disease, sertraline hcl (SERTRALINE HCL) for depression, levothyroxine sodium (SYNTHROID) for hypothyroid, ergocalciferol (VIT D) for supplement, haloperidol (HALOPERIDOL) for Schizophrenia, levetiracetam (KEPPRA) for epilepsy, paracetamol (TYLENOL EXTRA-STRENGTH) for pain, propylene glycol (ARTIFICIAL TEARS) for dry eyes, lorazepam (ATIVAN) for a anxiety or restlessness. As antipyretic use was reported Tylenol ES (500 mg) Tab, 2 Tabs by Mouth Routine use three times a day given at time of vaccination and after. It was reported the patient was Covid+. He was tested on 21Dec2020 and was not admitted to hospital. Event Onset Date was reported as 24Dec2020 (clarification pending). On 30Dec2020 the patient was started on O2 at 2L for low pulse. O2 was increased over time to eventually O2 at 8L on 03Jan2021. Morphine Sulfate was started on 03Jan2021 at 5 mg sl/by mouth every 2 hours as needed for pain or airhunger. The patient deceased on 03Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The AEs did not require a visit to Emergency Room or Physician Office. Outcome of Low pulse was unknown.; Sender's Comments: Based on the information available the events Death (unknown cause) and Heart rate decreased are attributed to patient's multiple underlying medical conditions including Type 2 Diabetes Mellitus, morbid obesity, cardiac disorder, hypertension, epilepsy etc. However, based solely on a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the above mentioned events cannot be completely excluded. The case will be reevaluated should additional information, including the cause of death, become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Is patient deceased: Yes" "1040005-1" "1040005-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient was found unresponsive and had passed away." "1040005-1" "1040005-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Patient was found unresponsive and had passed away." "1041789-1" "1041789-1" "ARTERIOSCLEROSIS" "10003210" "65-79 years" "65-79" "As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD." "1041789-1" "1041789-1" "ARTERIOSCLEROSIS CORONARY ARTERY" "10003211" "65-79 years" "65-79" "As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD." "1041789-1" "1041789-1" "CHILLS" "10008531" "65-79 years" "65-79" "As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD." "1041789-1" "1041789-1" "CHRONIC OBSTRUCTIVE PULMONARY DISEASE" "10009033" "65-79 years" "65-79" "As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD." "1041789-1" "1041789-1" "DEATH" "10011906" "65-79 years" "65-79" "As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD." "1041789-1" "1041789-1" "LUNG NEOPLASM MALIGNANT" "10058467" "65-79 years" "65-79" "As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD." "1042351-1" "1042351-1" "DEATH" "10011906" "65-79 years" "65-79" "death" "1046230-1" "1046230-1" "DEATH" "10011906" "65-79 years" "65-79" "Death. My father-in-law was found unexpectedly deceased in his home Saturday morning. He worked the previous day." "1046347-1" "1046347-1" "DEATH" "10011906" "65-79 years" "65-79" "When family members came to receive the second dose of their COVID vaccine, they informed us that the above patient had passed away." "1052820-1" "1052820-1" "DEATH" "10011906" "65-79 years" "65-79" "Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia. The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries. She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years." "1052820-1" "1052820-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia. The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries. She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years." "1052820-1" "1052820-1" "HIP FRACTURE" "10020100" "65-79 years" "65-79" "Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia. The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries. She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years." "1052820-1" "1052820-1" "HIP SURGERY" "10051060" "65-79 years" "65-79" "Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia. The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries. She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years." "1052820-1" "1052820-1" "PNEUMONIA BACTERIAL" "10060946" "65-79 years" "65-79" "Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia. The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries. She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years." "1052820-1" "1052820-1" "POOR PERIPHERAL CIRCULATION" "10036155" "65-79 years" "65-79" "Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia. The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries. She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years." "1052820-1" "1052820-1" "STENT PLACEMENT" "10048561" "65-79 years" "65-79" "Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia. The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries. She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years." "1052820-1" "1052820-1" "SURGERY" "10042609" "65-79 years" "65-79" "Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia. The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries. She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years." "1053393-1" "1053393-1" "ASTHENIA" "10003549" "65-79 years" "65-79" ""Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and ""losing stamina"". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later."" "1053393-1" "1053393-1" "DEATH" "10011906" "65-79 years" "65-79" ""Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and ""losing stamina"". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later."" "1053393-1" "1053393-1" "DIZZINESS" "10013573" "65-79 years" "65-79" ""Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and ""losing stamina"". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later."" "1053393-1" "1053393-1" "FATIGUE" "10016256" "65-79 years" "65-79" ""Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and ""losing stamina"". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later."" "1053393-1" "1053393-1" "MALAISE" "10025482" "65-79 years" "65-79" ""Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and ""losing stamina"". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later."" "1053393-1" "1053393-1" "PAIN" "10033371" "65-79 years" "65-79" ""Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and ""losing stamina"". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later."" "1054966-1" "1054966-1" "ABDOMINAL PAIN" "10000081" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "ANGIOGRAM PULMONARY NORMAL" "10002442" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "APNOEIC ATTACK" "10002977" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "BLOOD CREATINE" "10005461" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "BLOOD CREATINE PHOSPHOKINASE INCREASED" "10005470" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "BLOOD POTASSIUM NORMAL" "10005726" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "BLOOD UREA INCREASED" "10005851" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "CARDIAC FAILURE CONGESTIVE" "10007559" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "COMPUTERISED TOMOGRAM HEAD NORMAL" "10072167" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "CSF GLUCOSE INCREASED" "10050763" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "CSF PROTEIN INCREASED" "10011575" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "DEHYDRATION" "10012174" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "FIBRIN D DIMER INCREASED" "10016581" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "GLOMERULAR FILTRATION RATE DECREASED" "10018358" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "HYPOPHAGIA" "10063743" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "PROTEIN TOTAL INCREASED" "10037016" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1054966-1" "1054966-1" "TENDERNESS" "10043224" "65-79 years" "65-79" "Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration" "1055203-1" "1055203-1" "BLOOD LACTIC ACID INCREASED" "10005635" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "BRAIN NATRIURETIC PEPTIDE INCREASED" "10053405" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "C-REACTIVE PROTEIN INCREASED" "10006825" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "CLOSTRIDIUM DIFFICILE COLITIS" "10009657" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "COLITIS" "10009887" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL" "10057798" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "COMPUTERISED TOMOGRAM THORAX ABNORMAL" "10057799" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "COUGH" "10011224" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "DEATH" "10011906" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "FULL BLOOD COUNT ABNORMAL" "10017412" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "METABOLIC FUNCTION TEST ABNORMAL" "10061286" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1055203-1" "1055203-1" "SEPSIS" "10040047" "65-79 years" "65-79" "Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632." "1057828-1" "1057828-1" "SUDDEN DEATH" "10042434" "65-79 years" "65-79" "Patient unexpectedly died on 2/17 after 14 days of receiving first dose of COVID-19 vaccine. EMS presumed it could be from possible myocardial infarction." "1058793-1" "1058793-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt had only complained of a sore arm after receiving the vaccine- pt died on 2/25/21 from what they feel was a massive heart attack- unsure if related to vaccine at all" "1058793-1" "1058793-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" "Pt had only complained of a sore arm after receiving the vaccine- pt died on 2/25/21 from what they feel was a massive heart attack- unsure if related to vaccine at all" "1060833-1" "1060833-1" "DEATH" "10011906" "65-79 years" "65-79" "Severe headache, nausea and vomiting" "1060833-1" "1060833-1" "HEADACHE" "10019211" "65-79 years" "65-79" "Severe headache, nausea and vomiting" "1060833-1" "1060833-1" "NAUSEA" "10028813" "65-79 years" "65-79" "Severe headache, nausea and vomiting" "1060833-1" "1060833-1" "VOMITING" "10047700" "65-79 years" "65-79" "Severe headache, nausea and vomiting" "1065543-1" "1065543-1" "DEATH" "10011906" "65-79 years" "65-79" "It was reported to staff that this gentleman suffered thrombocytopenia following his vaccine, a platelet infusion was done and he expired on 2-14-21" "1065543-1" "1065543-1" "PLATELET TRANSFUSION" "10035543" "65-79 years" "65-79" "It was reported to staff that this gentleman suffered thrombocytopenia following his vaccine, a platelet infusion was done and he expired on 2-14-21" "1065543-1" "1065543-1" "THROMBOCYTOPENIA" "10043554" "65-79 years" "65-79" "It was reported to staff that this gentleman suffered thrombocytopenia following his vaccine, a platelet infusion was done and he expired on 2-14-21" "1075296-1" "1075296-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient was found dead this morning." "1075608-1" "1075608-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient waited 15 mins after covid vaccination on Wednesday 3/3, cleared by EMT to leave. I was notified by nurse at the senior building where patient resides that she had expired Thursday evening at home. Paramedics were called. No other additional information." "1076188-1" "1076188-1" "ACUTE KIDNEY INJURY" "10069339" "65-79 years" "65-79" "Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death" "1076188-1" "1076188-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death" "1076188-1" "1076188-1" "DEATH" "10011906" "65-79 years" "65-79" "Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death" "1076188-1" "1076188-1" "ISCHAEMIC HEPATITIS" "10023025" "65-79 years" "65-79" "Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death" "1076188-1" "1076188-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death" "1076188-1" "1076188-1" "SHOCK" "10040560" "65-79 years" "65-79" "Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death" "1078002-1" "1078002-1" "CHILLS" "10008531" "65-79 years" "65-79" "Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m." "1078002-1" "1078002-1" "COUGH" "10011224" "65-79 years" "65-79" "Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m." "1078002-1" "1078002-1" "DEATH" "10011906" "65-79 years" "65-79" "Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m." "1078002-1" "1078002-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m." "1078002-1" "1078002-1" "HEADACHE" "10019211" "65-79 years" "65-79" "Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m." "1078002-1" "1078002-1" "PAIN" "10033371" "65-79 years" "65-79" "Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m." "1078002-1" "1078002-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m." "1081416-1" "1081416-1" "BRAIN HERNIATION" "10006126" "65-79 years" "65-79" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1081416-1" "1081416-1" "CEREBRAL HAEMORRHAGE" "10008111" "65-79 years" "65-79" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1081416-1" "1081416-1" "CEREBRAL MASS EFFECT" "10067086" "65-79 years" "65-79" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1081416-1" "1081416-1" "COMA" "10010071" "65-79 years" "65-79" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1081416-1" "1081416-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1081416-1" "1081416-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1081416-1" "1081416-1" "HYPERTENSION" "10020772" "65-79 years" "65-79" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1081416-1" "1081416-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1081416-1" "1081416-1" "SUBARACHNOID HAEMORRHAGE" "10042316" "65-79 years" "65-79" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1081416-1" "1081416-1" "SUBDURAL HAEMATOMA" "10042361" "65-79 years" "65-79" "Pt. presented to ED via EMS for emergent coma. EMS intubated patient in field due to respiratory failure. Pt. was severely hypertensive with nearly total loss of brainstem reflexes. Patient had known L MCA cerebral aneurysm with appointment to undergo intervention to address in the near future. NCCT reported massive multifocal brain hemorrhage, SAH, SDH, and parenchymal hemmorhage with midline shift and subfalcine herniation. Due to dismal/poor prognosis, family requested withdrawal of support approximately 4 hours after presentation and patient expired shortly thereafter." "1087885-1" "1087885-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient was found deceased in garage one day post vaccination" "1088956-1" "1088956-1" "COVID-19" "10084268" "65-79 years" "65-79" "Tested positive and had symptoms for Covid-19 . Admitted to hospital on 2/14/21 in the icu and died in 2/28/21" "1088956-1" "1088956-1" "DEATH" "10011906" "65-79 years" "65-79" "Tested positive and had symptoms for Covid-19 . Admitted to hospital on 2/14/21 in the icu and died in 2/28/21" "1088956-1" "1088956-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "Tested positive and had symptoms for Covid-19 . Admitted to hospital on 2/14/21 in the icu and died in 2/28/21" "1088956-1" "1088956-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Tested positive and had symptoms for Covid-19 . Admitted to hospital on 2/14/21 in the icu and died in 2/28/21" "1090240-1" "1090240-1" "BLOOD PRESSURE MEASUREMENT" "10076581" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "BODY TEMPERATURE" "10005906" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "CHEST X-RAY" "10008498" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "DEHYDRATION" "10012174" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "HEART RATE" "10019299" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "HYPOTENSION" "10021097" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "HYPOXIA" "10021143" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "INVESTIGATION" "10062026" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "OXYGEN SATURATION" "10033316" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "PHYSICAL EXAMINATION" "10034986" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "PULMONARY EMBOLISM" "10037377" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "RENAL FAILURE" "10038435" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "RESPIRATORY ARREST" "10038669" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "SARS-COV-2 TEST" "10084354" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "THROMBOSIS" "10043607" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1090240-1" "1090240-1" "VENTRICULAR TACHYCARDIA" "10047302" "65-79 years" "65-79" "Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus" "1094490-1" "1094490-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Patient was vaccinated with her second dose on Wednesday, February 24th. A family member contacted us to let us know she was sitting in a casino exactly one week later and passed out, going into cardiac arrest. The patient did pass away." "1094490-1" "1094490-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient was vaccinated with her second dose on Wednesday, February 24th. A family member contacted us to let us know she was sitting in a casino exactly one week later and passed out, going into cardiac arrest. The patient did pass away." "1094490-1" "1094490-1" "LOSS OF CONSCIOUSNESS" "10024855" "65-79 years" "65-79" "Patient was vaccinated with her second dose on Wednesday, February 24th. A family member contacted us to let us know she was sitting in a casino exactly one week later and passed out, going into cardiac arrest. The patient did pass away." "1095238-1" "1095238-1" "CARDIAC FAILURE CONGESTIVE" "10007559" "65-79 years" "65-79" "Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047." "1095238-1" "1095238-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047." "1095238-1" "1095238-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047." "1095238-1" "1095238-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047." "1095238-1" "1095238-1" "OEDEMA" "10030095" "65-79 years" "65-79" "Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047." "1095238-1" "1095238-1" "OXYGEN SATURATION DECREASED" "10033318" "65-79 years" "65-79" "Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047." "1095238-1" "1095238-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047." "1095238-1" "1095238-1" "TACHYCARDIA" "10043071" "65-79 years" "65-79" "Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047." "1095238-1" "1095238-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047." "1098856-1" "1098856-1" "BLOOD TEST" "10061726" "65-79 years" "65-79" "Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm." "1098856-1" "1098856-1" "CEREBRAL HAEMORRHAGE" "10008111" "65-79 years" "65-79" "Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm." "1098856-1" "1098856-1" "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "65-79 years" "65-79" "Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm." "1098856-1" "1098856-1" "DEATH" "10011906" "65-79 years" "65-79" "Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm." "1098856-1" "1098856-1" "HEADACHE" "10019211" "65-79 years" "65-79" "Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm." "1098856-1" "1098856-1" "INCOHERENT" "10021630" "65-79 years" "65-79" "Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm." "1098856-1" "1098856-1" "VOMITING" "10047700" "65-79 years" "65-79" "Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm." "1102082-1" "1102082-1" "ACUTE MYOCARDIAL INFARCTION" "10000891" "65-79 years" "65-79" "Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia" "1102082-1" "1102082-1" "CACHEXIA" "10006895" "65-79 years" "65-79" "Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia" "1102082-1" "1102082-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia" "1102082-1" "1102082-1" "DEMENTIA" "10012267" "65-79 years" "65-79" "Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia" "1102082-1" "1102082-1" "DYSPHAGIA" "10013950" "65-79 years" "65-79" "Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia" "1102082-1" "1102082-1" "ELECTROLYTE IMBALANCE" "10014418" "65-79 years" "65-79" "Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia" "1102082-1" "1102082-1" "ODYNOPHAGIA" "10030094" "65-79 years" "65-79" "Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia" "1102082-1" "1102082-1" "ULTRASOUND SCAN" "10045434" "65-79 years" "65-79" "Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia" "1102082-1" "1102082-1" "X-RAY" "10048064" "65-79 years" "65-79" "Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia" "1103813-1" "1103813-1" "ABDOMINAL DISTENSION" "10000060" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "ACUTE KIDNEY INJURY" "10069339" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "CHEST PAIN" "10008479" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "DEHYDRATION" "10012174" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "ECHOCARDIOGRAM NORMAL" "10014115" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "ELECTROCARDIOGRAM NORMAL" "10014373" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "HAEMOGLOBIN NORMAL" "10018890" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "INFLUENZA VIRUS TEST NEGATIVE" "10070718" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "INTERNATIONAL NORMALISED RATIO NORMAL" "10022596" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "NAUSEA" "10028813" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "PAIN" "10033371" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "PLATELET COUNT NORMAL" "10035530" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "PROTHROMBIN TIME NORMAL" "10037062" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "RENAL FAILURE" "10038435" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "ULTRASOUND KIDNEY NORMAL" "10045423" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "URINE ANALYSIS NORMAL" "10061578" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "VOMITING" "10047700" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1103813-1" "1103813-1" "WHITE BLOOD CELL COUNT NORMAL" "10047944" "65-79 years" "65-79" "Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis." "1104364-1" "1104364-1" "DEATH" "10011906" "65-79 years" "65-79" "Death within 24 hours of receiving vaccine" "1108609-1" "1108609-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient was found unresponsive the morning of March 14, 2021. She was pronounced dead at 5:33 AM. The medical examiner quoted natural cause of death." "1108609-1" "1108609-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Patient was found unresponsive the morning of March 14, 2021. She was pronounced dead at 5:33 AM. The medical examiner quoted natural cause of death." "1111546-1" "1111546-1" "ABDOMINAL DISTENSION" "10000060" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "BLOOD PRESSURE DECREASED" "10005734" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "CHOKING" "10008589" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "CHOKING SENSATION" "10008590" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "COLD SWEAT" "10009866" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "COUGH" "10011224" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "DEHYDRATION" "10012174" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "FEEDING DISORDER" "10061148" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "FEELING ABNORMAL" "10016322" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "FLUID INTAKE REDUCED" "10056291" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "GASTROINTESTINAL PAIN" "10017999" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "LETHARGY" "10024264" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "PAIN" "10033371" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "PRODUCTIVE COUGH" "10036790" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1111546-1" "1111546-1" "RESPIRATORY ARREST" "10038669" "65-79 years" "65-79" ""One week post vaccine, caller's mother started to feel ""phlegm-y"", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14."" "1112370-1" "1112370-1" "ANGIOGRAM" "10061637" "65-79 years" "65-79" "The patient got the Moderna vaccine on 3/2/2021. On 3/3/2021 he suffered a dissection of the ascending thoracic aorta and died." "1112370-1" "1112370-1" "AORTIC DISSECTION" "10002895" "65-79 years" "65-79" "The patient got the Moderna vaccine on 3/2/2021. On 3/3/2021 he suffered a dissection of the ascending thoracic aorta and died." "1112370-1" "1112370-1" "BLOOD TEST" "10061726" "65-79 years" "65-79" "The patient got the Moderna vaccine on 3/2/2021. On 3/3/2021 he suffered a dissection of the ascending thoracic aorta and died." "1112370-1" "1112370-1" "COMPUTERISED TOMOGRAM ABDOMEN" "10053876" "65-79 years" "65-79" "The patient got the Moderna vaccine on 3/2/2021. On 3/3/2021 he suffered a dissection of the ascending thoracic aorta and died." "1112370-1" "1112370-1" "DEATH" "10011906" "65-79 years" "65-79" "The patient got the Moderna vaccine on 3/2/2021. On 3/3/2021 he suffered a dissection of the ascending thoracic aorta and died." "1117316-1" "1117316-1" "DEATH" "10011906" "65-79 years" "65-79" "Sister in law called on 3-19-2021 to report that had died a day after receiving his Moderna vaccine. She stated he was found in his driveway and was unable to be resuscitated after being rushed to the hospital." "1123329-1" "1123329-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Presented to Emergency department in cardiac arrest. Pt's family reports patient complaining of indigestion throughout the night. Awakened this morning but returned to bed. Family noted his breathing became loud and then stopped. EMS called. Patient in PEA arrest when they arrived. Patient's family reports he received COVID-19 vaccine day before via facility. I have notified the vaccine clinic and received the Lot number of the vaccine use when I called." "1123329-1" "1123329-1" "DYSPEPSIA" "10013946" "65-79 years" "65-79" "Presented to Emergency department in cardiac arrest. Pt's family reports patient complaining of indigestion throughout the night. Awakened this morning but returned to bed. Family noted his breathing became loud and then stopped. EMS called. Patient in PEA arrest when they arrived. Patient's family reports he received COVID-19 vaccine day before via facility. I have notified the vaccine clinic and received the Lot number of the vaccine use when I called." "1123329-1" "1123329-1" "INFLUENZA VIRUS TEST NEGATIVE" "10070718" "65-79 years" "65-79" "Presented to Emergency department in cardiac arrest. Pt's family reports patient complaining of indigestion throughout the night. Awakened this morning but returned to bed. Family noted his breathing became loud and then stopped. EMS called. Patient in PEA arrest when they arrived. Patient's family reports he received COVID-19 vaccine day before via facility. I have notified the vaccine clinic and received the Lot number of the vaccine use when I called." "1123329-1" "1123329-1" "PULSELESS ELECTRICAL ACTIVITY" "10058151" "65-79 years" "65-79" "Presented to Emergency department in cardiac arrest. Pt's family reports patient complaining of indigestion throughout the night. Awakened this morning but returned to bed. Family noted his breathing became loud and then stopped. EMS called. Patient in PEA arrest when they arrived. Patient's family reports he received COVID-19 vaccine day before via facility. I have notified the vaccine clinic and received the Lot number of the vaccine use when I called." "1123329-1" "1123329-1" "RESPIRATION ABNORMAL" "10038647" "65-79 years" "65-79" "Presented to Emergency department in cardiac arrest. Pt's family reports patient complaining of indigestion throughout the night. Awakened this morning but returned to bed. Family noted his breathing became loud and then stopped. EMS called. Patient in PEA arrest when they arrived. Patient's family reports he received COVID-19 vaccine day before via facility. I have notified the vaccine clinic and received the Lot number of the vaccine use when I called." "1123329-1" "1123329-1" "RESPIRATORY ARREST" "10038669" "65-79 years" "65-79" "Presented to Emergency department in cardiac arrest. Pt's family reports patient complaining of indigestion throughout the night. Awakened this morning but returned to bed. Family noted his breathing became loud and then stopped. EMS called. Patient in PEA arrest when they arrived. Patient's family reports he received COVID-19 vaccine day before via facility. I have notified the vaccine clinic and received the Lot number of the vaccine use when I called." "1123329-1" "1123329-1" "RESPIRATORY SYNCYTIAL VIRUS TEST NEGATIVE" "10068564" "65-79 years" "65-79" "Presented to Emergency department in cardiac arrest. Pt's family reports patient complaining of indigestion throughout the night. Awakened this morning but returned to bed. Family noted his breathing became loud and then stopped. EMS called. Patient in PEA arrest when they arrived. Patient's family reports he received COVID-19 vaccine day before via facility. I have notified the vaccine clinic and received the Lot number of the vaccine use when I called." "1123329-1" "1123329-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "Presented to Emergency department in cardiac arrest. Pt's family reports patient complaining of indigestion throughout the night. Awakened this morning but returned to bed. Family noted his breathing became loud and then stopped. EMS called. Patient in PEA arrest when they arrived. Patient's family reports he received COVID-19 vaccine day before via facility. I have notified the vaccine clinic and received the Lot number of the vaccine use when I called." "1127245-1" "1127245-1" "DEATH" "10011906" "65-79 years" "65-79" "Vaccine given Dec 27th 2020, patient couldn?t swallow eat or drink the next day, patients family notified Dec 29th 2020 and patient passed away on Dec 30, 2020 at 1 pm EST." "1127245-1" "1127245-1" "DYSPHAGIA" "10013950" "65-79 years" "65-79" "Vaccine given Dec 27th 2020, patient couldn?t swallow eat or drink the next day, patients family notified Dec 29th 2020 and patient passed away on Dec 30, 2020 at 1 pm EST." "1127245-1" "1127245-1" "FEEDING DISORDER" "10061148" "65-79 years" "65-79" "Vaccine given Dec 27th 2020, patient couldn?t swallow eat or drink the next day, patients family notified Dec 29th 2020 and patient passed away on Dec 30, 2020 at 1 pm EST." "1127866-1" "1127866-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient died in his sleep the night of getting dose 1 COVID -19 he had a massive heart attack and died" "1127866-1" "1127866-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "Patient died in his sleep the night of getting dose 1 COVID -19 he had a massive heart attack and died" "1129993-1" "1129993-1" "ABDOMINAL DISCOMFORT" "10000059" "65-79 years" "65-79" "Family stated she felt fine after shot. Had upset stomach night before her death. Took tums. Died in sleep." "1129993-1" "1129993-1" "DEATH" "10011906" "65-79 years" "65-79" "Family stated she felt fine after shot. Had upset stomach night before her death. Took tums. Died in sleep." "1132159-1" "1132159-1" "DEATH" "10011906" "65-79 years" "65-79" "Death, adverse event occurred outside of the hospital and outside of observation window. Event was reported via employee to hospital." "1132313-1" "1132313-1" "BODY TEMPERATURE INCREASED" "10005911" "65-79 years" "65-79" ""Patient got vaccine dose #2 on 3/23/21 (Tues) approx 10am. Per family reports patient went to hospital 3/24/21 (Wed) for unspecified pain and temp of 102f. Family states a ""scan"" was done and came back with nothing. P was treated for UTI and sent home. Patient was reportedly laying down at home about 8:15 or 8:30am complaining of a bad headache. Patient was found later that am deceased in her bed."" "1132313-1" "1132313-1" "DEATH" "10011906" "65-79 years" "65-79" ""Patient got vaccine dose #2 on 3/23/21 (Tues) approx 10am. Per family reports patient went to hospital 3/24/21 (Wed) for unspecified pain and temp of 102f. Family states a ""scan"" was done and came back with nothing. P was treated for UTI and sent home. Patient was reportedly laying down at home about 8:15 or 8:30am complaining of a bad headache. Patient was found later that am deceased in her bed."" "1132313-1" "1132313-1" "HEADACHE" "10019211" "65-79 years" "65-79" ""Patient got vaccine dose #2 on 3/23/21 (Tues) approx 10am. Per family reports patient went to hospital 3/24/21 (Wed) for unspecified pain and temp of 102f. Family states a ""scan"" was done and came back with nothing. P was treated for UTI and sent home. Patient was reportedly laying down at home about 8:15 or 8:30am complaining of a bad headache. Patient was found later that am deceased in her bed."" "1132313-1" "1132313-1" "PAIN" "10033371" "65-79 years" "65-79" ""Patient got vaccine dose #2 on 3/23/21 (Tues) approx 10am. Per family reports patient went to hospital 3/24/21 (Wed) for unspecified pain and temp of 102f. Family states a ""scan"" was done and came back with nothing. P was treated for UTI and sent home. Patient was reportedly laying down at home about 8:15 or 8:30am complaining of a bad headache. Patient was found later that am deceased in her bed."" "1132313-1" "1132313-1" "SCAN NORMAL" "10061505" "65-79 years" "65-79" ""Patient got vaccine dose #2 on 3/23/21 (Tues) approx 10am. Per family reports patient went to hospital 3/24/21 (Wed) for unspecified pain and temp of 102f. Family states a ""scan"" was done and came back with nothing. P was treated for UTI and sent home. Patient was reportedly laying down at home about 8:15 or 8:30am complaining of a bad headache. Patient was found later that am deceased in her bed."" "1132313-1" "1132313-1" "URINARY TRACT INFECTION" "10046571" "65-79 years" "65-79" ""Patient got vaccine dose #2 on 3/23/21 (Tues) approx 10am. Per family reports patient went to hospital 3/24/21 (Wed) for unspecified pain and temp of 102f. Family states a ""scan"" was done and came back with nothing. P was treated for UTI and sent home. Patient was reportedly laying down at home about 8:15 or 8:30am complaining of a bad headache. Patient was found later that am deceased in her bed."" "1132800-1" "1132800-1" "DEATH" "10011906" "65-79 years" "65-79" "Wife found husband dead two days after2nd dose. This Health Department was made aware of the death by the the Kidney Center. The patient failed to show up for a scheduled dialysis appointment on 03/24/2022. The clinic obtained information of the passing from the wife. The patient received his SECOND dose of COVID-19 vaccine on 3/22/21, reported feeling ill 3/23/21 and then passing on 3/24/21. The clinic called the health department to report the death of the patient on 3/24/2021." "1132800-1" "1132800-1" "MALAISE" "10025482" "65-79 years" "65-79" "Wife found husband dead two days after2nd dose. This Health Department was made aware of the death by the the Kidney Center. The patient failed to show up for a scheduled dialysis appointment on 03/24/2022. The clinic obtained information of the passing from the wife. The patient received his SECOND dose of COVID-19 vaccine on 3/22/21, reported feeling ill 3/23/21 and then passing on 3/24/21. The clinic called the health department to report the death of the patient on 3/24/2021." "1136004-1" "1136004-1" "DEATH" "10011906" "65-79 years" "65-79" "Patients representative notified pharmacy today to cancel patients second appointment as the patient had died this morning due to a staff infection in hospital. Representative did state they did not believe it was related to vaccination as patient has been having difficult time with underlying conditions (pulmonary fibrosis and atrial fibrillation)." "1136479-1" "1136479-1" "ABDOMINAL DISCOMFORT" "10000059" "65-79 years" "65-79" "PATIENT HAD THE FOLLOWING SYMTOMS AFTER RECEVING THE PFIZER COVID VACCINATION. MORNING OF MARCH 23RD HE WAS NOT WELL AND STATED HOME FROM WORK. SYMTOMS WERE AN UPSET STOMACH, UPPER BACK SORENESS, AND SORENESS OF ARM. DURING THE AFTERNOON HE TOLD HIS WIFE HE NEEDED TO LAY DOWN AND NEVER REGAINED CONCIOUSNESS BEFORE AND AFTER EMS WAS CALLED @7PM. SPECIFIC DETAILS OF EMERGENCY MEDICAL CARE CAN BE GATHERED FROM THE HOSPITAL. UPON VISITING PATIENT AT POST MORTUM, STAFF NURSE INFORMED ME THEY WORKED ON HIM FOR OVER AN HOUR BUT THEY NEVER GOT A PULSE. FURTHER DETAILS SUCH AS LOCATATION OF VACCINE ADMINISTRATION MAY BE GATHERED BY THIS AGENCY FROM HIS WIDOW." "1136479-1" "1136479-1" "BACK PAIN" "10003988" "65-79 years" "65-79" "PATIENT HAD THE FOLLOWING SYMTOMS AFTER RECEVING THE PFIZER COVID VACCINATION. MORNING OF MARCH 23RD HE WAS NOT WELL AND STATED HOME FROM WORK. SYMTOMS WERE AN UPSET STOMACH, UPPER BACK SORENESS, AND SORENESS OF ARM. DURING THE AFTERNOON HE TOLD HIS WIFE HE NEEDED TO LAY DOWN AND NEVER REGAINED CONCIOUSNESS BEFORE AND AFTER EMS WAS CALLED @7PM. SPECIFIC DETAILS OF EMERGENCY MEDICAL CARE CAN BE GATHERED FROM THE HOSPITAL. UPON VISITING PATIENT AT POST MORTUM, STAFF NURSE INFORMED ME THEY WORKED ON HIM FOR OVER AN HOUR BUT THEY NEVER GOT A PULSE. FURTHER DETAILS SUCH AS LOCATATION OF VACCINE ADMINISTRATION MAY BE GATHERED BY THIS AGENCY FROM HIS WIDOW." "1136479-1" "1136479-1" "LOSS OF CONSCIOUSNESS" "10024855" "65-79 years" "65-79" "PATIENT HAD THE FOLLOWING SYMTOMS AFTER RECEVING THE PFIZER COVID VACCINATION. MORNING OF MARCH 23RD HE WAS NOT WELL AND STATED HOME FROM WORK. SYMTOMS WERE AN UPSET STOMACH, UPPER BACK SORENESS, AND SORENESS OF ARM. DURING THE AFTERNOON HE TOLD HIS WIFE HE NEEDED TO LAY DOWN AND NEVER REGAINED CONCIOUSNESS BEFORE AND AFTER EMS WAS CALLED @7PM. SPECIFIC DETAILS OF EMERGENCY MEDICAL CARE CAN BE GATHERED FROM THE HOSPITAL. UPON VISITING PATIENT AT POST MORTUM, STAFF NURSE INFORMED ME THEY WORKED ON HIM FOR OVER AN HOUR BUT THEY NEVER GOT A PULSE. FURTHER DETAILS SUCH AS LOCATATION OF VACCINE ADMINISTRATION MAY BE GATHERED BY THIS AGENCY FROM HIS WIDOW." "1136479-1" "1136479-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" "PATIENT HAD THE FOLLOWING SYMTOMS AFTER RECEVING THE PFIZER COVID VACCINATION. MORNING OF MARCH 23RD HE WAS NOT WELL AND STATED HOME FROM WORK. SYMTOMS WERE AN UPSET STOMACH, UPPER BACK SORENESS, AND SORENESS OF ARM. DURING THE AFTERNOON HE TOLD HIS WIFE HE NEEDED TO LAY DOWN AND NEVER REGAINED CONCIOUSNESS BEFORE AND AFTER EMS WAS CALLED @7PM. SPECIFIC DETAILS OF EMERGENCY MEDICAL CARE CAN BE GATHERED FROM THE HOSPITAL. UPON VISITING PATIENT AT POST MORTUM, STAFF NURSE INFORMED ME THEY WORKED ON HIM FOR OVER AN HOUR BUT THEY NEVER GOT A PULSE. FURTHER DETAILS SUCH AS LOCATATION OF VACCINE ADMINISTRATION MAY BE GATHERED BY THIS AGENCY FROM HIS WIDOW." "1136479-1" "1136479-1" "PULSE ABSENT" "10037469" "65-79 years" "65-79" "PATIENT HAD THE FOLLOWING SYMTOMS AFTER RECEVING THE PFIZER COVID VACCINATION. MORNING OF MARCH 23RD HE WAS NOT WELL AND STATED HOME FROM WORK. SYMTOMS WERE AN UPSET STOMACH, UPPER BACK SORENESS, AND SORENESS OF ARM. DURING THE AFTERNOON HE TOLD HIS WIFE HE NEEDED TO LAY DOWN AND NEVER REGAINED CONCIOUSNESS BEFORE AND AFTER EMS WAS CALLED @7PM. SPECIFIC DETAILS OF EMERGENCY MEDICAL CARE CAN BE GATHERED FROM THE HOSPITAL. UPON VISITING PATIENT AT POST MORTUM, STAFF NURSE INFORMED ME THEY WORKED ON HIM FOR OVER AN HOUR BUT THEY NEVER GOT A PULSE. FURTHER DETAILS SUCH AS LOCATATION OF VACCINE ADMINISTRATION MAY BE GATHERED BY THIS AGENCY FROM HIS WIDOW." "1136657-1" "1136657-1" "CEREBROVASCULAR ACCIDENT" "10008190" "65-79 years" "65-79" "NA 74 y/o several comorbidities. Stroke" "1138403-1" "1138403-1" "DEATH" "10011906" "65-79 years" "65-79" "patient showed no signs or symptoms after but was found deceased the following day." "1139029-1" "1139029-1" "CONFUSIONAL STATE" "10010305" "65-79 years" "65-79" "Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM." "1139029-1" "1139029-1" "DEATH" "10011906" "65-79 years" "65-79" "Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM." "1139029-1" "1139029-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM." "1139029-1" "1139029-1" "HEPATIC ENZYME INCREASED" "10060795" "65-79 years" "65-79" "Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM." "1139029-1" "1139029-1" "HEPATIC FAILURE" "10019663" "65-79 years" "65-79" "Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM." "1139029-1" "1139029-1" "HEPATIC LESION" "10061998" "65-79 years" "65-79" "Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM." "1139029-1" "1139029-1" "LUNG DISORDER" "10025082" "65-79 years" "65-79" "Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM." "1139029-1" "1139029-1" "RENAL FAILURE" "10038435" "65-79 years" "65-79" "Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM." "1139029-1" "1139029-1" "SCAN ABNORMAL" "10061499" "65-79 years" "65-79" "Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM." "1139039-1" "1139039-1" "ACUTE KIDNEY INJURY" "10069339" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "ACUTE MYOCARDIAL INFARCTION" "10000891" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "DEATH" "10011906" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "ELECTROCARDIOGRAM ABNORMAL" "10014363" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "ELECTROCARDIOGRAM ST SEGMENT DEPRESSION" "10014391" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "FATIGUE" "10016256" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "HYPERKALAEMIA" "10020646" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "HYPOPHAGIA" "10063743" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "ILLNESS" "10080284" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "MYALGIA" "10028411" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "PYREXIA" "10037660" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "SEPTIC SHOCK" "10040070" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139039-1" "1139039-1" "TROPONIN" "10061576" "65-79 years" "65-79" "According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation." "1139677-1" "1139677-1" "DEATH" "10011906" "65-79 years" "65-79" "Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25." "1139677-1" "1139677-1" "ESCHERICHIA BACTERAEMIA" "10054258" "65-79 years" "65-79" "Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25." "1139677-1" "1139677-1" "HEPATIC CIRRHOSIS" "10019641" "65-79 years" "65-79" "Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25." "1139677-1" "1139677-1" "HEPATIC FAILURE" "10019663" "65-79 years" "65-79" "Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25." "1139677-1" "1139677-1" "JAUNDICE" "10023126" "65-79 years" "65-79" "Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25." "1139677-1" "1139677-1" "LABORATORY TEST ABNORMAL" "10023547" "65-79 years" "65-79" "Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25." "1139677-1" "1139677-1" "RENAL FAILURE" "10038435" "65-79 years" "65-79" "Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25." "1139677-1" "1139677-1" "SOMNOLENCE" "10041349" "65-79 years" "65-79" "Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25." "1139677-1" "1139677-1" "WEIGHT INCREASED" "10047899" "65-79 years" "65-79" "Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25." "1142965-1" "1142965-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "Following the vaccination, individual ate lunch and then returned home. Later found deceased in chair in home ~8 hours after vaccine. No known symptoms. However no one was at home with individual for prolonged period of time during this time frame." "1142965-1" "1142965-1" "DEATH" "10011906" "65-79 years" "65-79" "Following the vaccination, individual ate lunch and then returned home. Later found deceased in chair in home ~8 hours after vaccine. No known symptoms. However no one was at home with individual for prolonged period of time during this time frame." "1143912-1" "1143912-1" "ANGIOGRAM" "10061637" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "BILEVEL POSITIVE AIRWAY PRESSURE" "10064530" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "BLOOD CULTURE" "10005485" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "BRAIN NATRIURETIC PEPTIDE INCREASED" "10053405" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "BRONCHOSCOPY" "10006479" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "CARDIAC FAILURE ACUTE" "10007556" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "CHEST X-RAY" "10008498" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "COMPUTERISED TOMOGRAM ABNORMAL" "10010235" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "COMPUTERISED TOMOGRAM HEAD" "10054003" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "CULTURE URINE" "10011638" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "DEATH" "10011906" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "DIARRHOEA" "10012735" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "DIFFERENTIAL WHITE BLOOD CELL COUNT" "10012784" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "FIBRIN D DIMER" "10016577" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "FULL BLOOD COUNT" "10017411" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "HYPOTENSION" "10021097" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "INTERNATIONAL NORMALISED RATIO" "10022591" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "LIPASE" "10050659" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "METABOLIC FUNCTION TEST" "10062191" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "NAUSEA" "10028813" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "PNEUMONITIS" "10035742" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "POLYURIA" "10036142" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "RED BLOOD CELL SEDIMENTATION RATE" "10049184" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "SARS-COV-2 ANTIBODY TEST" "10084501" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "SARS-COV-2 TEST" "10084354" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "SCAN WITH CONTRAST" "10059696" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1143912-1" "1143912-1" "TROPONIN" "10061576" "65-79 years" "65-79" "Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again." "1144235-1" "1144235-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient deceased on 3/23/2021." "1145183-1" "1145183-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "25 hours after receiving Covid vaccine, patient began seizing and went into cardiac arrest. Daughter began CPR and continued until EMS arrived. Patient subsequently passed away at Hospital." "1145183-1" "1145183-1" "DEATH" "10011906" "65-79 years" "65-79" "25 hours after receiving Covid vaccine, patient began seizing and went into cardiac arrest. Daughter began CPR and continued until EMS arrived. Patient subsequently passed away at Hospital." "1145183-1" "1145183-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "25 hours after receiving Covid vaccine, patient began seizing and went into cardiac arrest. Daughter began CPR and continued until EMS arrived. Patient subsequently passed away at Hospital." "1145183-1" "1145183-1" "SEIZURE" "10039906" "65-79 years" "65-79" "25 hours after receiving Covid vaccine, patient began seizing and went into cardiac arrest. Daughter began CPR and continued until EMS arrived. Patient subsequently passed away at Hospital." "1146141-1" "1146141-1" "DEATH" "10011906" "65-79 years" "65-79" "My mother didn't feel well after the 2nd shot. She died in her bathtub overnight 3/12 into 3/13" "1146141-1" "1146141-1" "MALAISE" "10025482" "65-79 years" "65-79" "My mother didn't feel well after the 2nd shot. She died in her bathtub overnight 3/12 into 3/13" "1146940-1" "1146940-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient died on March 7th 2021 exactly one week after she received the vaccine. The only symptoms she exhibited was pain at the injection site." "1146940-1" "1146940-1" "INJECTION SITE PAIN" "10022086" "65-79 years" "65-79" "Patient died on March 7th 2021 exactly one week after she received the vaccine. The only symptoms she exhibited was pain at the injection site." "1148390-1" "1148390-1" "DEATH" "10011906" "65-79 years" "65-79" "Diarrhea, Pulmonary embolism resulting in death" "1148390-1" "1148390-1" "DIARRHOEA" "10012735" "65-79 years" "65-79" "Diarrhea, Pulmonary embolism resulting in death" "1148390-1" "1148390-1" "PULMONARY EMBOLISM" "10037377" "65-79 years" "65-79" "Diarrhea, Pulmonary embolism resulting in death" "1149704-1" "1149704-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient received Moderna vaccine on 3/12 and passed away on 3/14. Patient had multiple chronic and acute conditions and was in overall poor health." "1152698-1" "1152698-1" "CEREBROVASCULAR ACCIDENT" "10008190" "65-79 years" "65-79" "stroke -venous thrombosis" "1152698-1" "1152698-1" "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "65-79 years" "65-79" "stroke -venous thrombosis" "1152698-1" "1152698-1" "HAEMORRHAGE INTRACRANIAL" "10018985" "65-79 years" "65-79" "stroke -venous thrombosis" "1152698-1" "1152698-1" "VENOUS THROMBOSIS" "10047249" "65-79 years" "65-79" "stroke -venous thrombosis" "1156352-1" "1156352-1" "BRAIN DEATH" "10049054" "65-79 years" "65-79" ""Patient's wife returned for second Pfizer CoVid vaccine on 4/1/2021 she told the vaccinator, that her husband, died two days after he received the first Pfizer vaccine. Date of Death - 03/13/2021. Wife states that husband had a ""massive stroke."" EEG indicated no brain activity and it was decided to remove him from life support."" "1156352-1" "1156352-1" "CEREBROVASCULAR ACCIDENT" "10008190" "65-79 years" "65-79" ""Patient's wife returned for second Pfizer CoVid vaccine on 4/1/2021 she told the vaccinator, that her husband, died two days after he received the first Pfizer vaccine. Date of Death - 03/13/2021. Wife states that husband had a ""massive stroke."" EEG indicated no brain activity and it was decided to remove him from life support."" "1156352-1" "1156352-1" "DEATH" "10011906" "65-79 years" "65-79" ""Patient's wife returned for second Pfizer CoVid vaccine on 4/1/2021 she told the vaccinator, that her husband, died two days after he received the first Pfizer vaccine. Date of Death - 03/13/2021. Wife states that husband had a ""massive stroke."" EEG indicated no brain activity and it was decided to remove him from life support."" "1156352-1" "1156352-1" "ELECTROENCEPHALOGRAM ABNORMAL" "10014408" "65-79 years" "65-79" ""Patient's wife returned for second Pfizer CoVid vaccine on 4/1/2021 she told the vaccinator, that her husband, died two days after he received the first Pfizer vaccine. Date of Death - 03/13/2021. Wife states that husband had a ""massive stroke."" EEG indicated no brain activity and it was decided to remove him from life support."" "1156352-1" "1156352-1" "WITHDRAWAL OF LIFE SUPPORT" "10067595" "65-79 years" "65-79" ""Patient's wife returned for second Pfizer CoVid vaccine on 4/1/2021 she told the vaccinator, that her husband, died two days after he received the first Pfizer vaccine. Date of Death - 03/13/2021. Wife states that husband had a ""massive stroke."" EEG indicated no brain activity and it was decided to remove him from life support."" "1156579-1" "1156579-1" "CHEMOTHERAPY" "10061758" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "CHILLS" "10008531" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "COUGH" "10011224" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "COVID-19" "10084268" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "ELECTROCARDIOGRAM NORMAL" "10014373" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "LUNG OPACITY" "10081792" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1156579-1" "1156579-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Per Hospital medical records patient was admitted to hospital 3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever, chills, dyspnea, anorexia." "1159365-1" "1159365-1" "CEREBRAL HAEMORRHAGE" "10008111" "65-79 years" "65-79" "My father received his second dose of the moderna vaccine on 3/27/2021. Around 5PM he started to feel unwell and went to lay down. My mom found him unresponsive at 10PM and called an ambulance. She was told at the hospital that he had a massive brain bleed. He passed away the following morning around 10AM." "1159365-1" "1159365-1" "DEATH" "10011906" "65-79 years" "65-79" "My father received his second dose of the moderna vaccine on 3/27/2021. Around 5PM he started to feel unwell and went to lay down. My mom found him unresponsive at 10PM and called an ambulance. She was told at the hospital that he had a massive brain bleed. He passed away the following morning around 10AM." "1159365-1" "1159365-1" "MALAISE" "10025482" "65-79 years" "65-79" "My father received his second dose of the moderna vaccine on 3/27/2021. Around 5PM he started to feel unwell and went to lay down. My mom found him unresponsive at 10PM and called an ambulance. She was told at the hospital that he had a massive brain bleed. He passed away the following morning around 10AM." "1159365-1" "1159365-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "My father received his second dose of the moderna vaccine on 3/27/2021. Around 5PM he started to feel unwell and went to lay down. My mom found him unresponsive at 10PM and called an ambulance. She was told at the hospital that he had a massive brain bleed. He passed away the following morning around 10AM." "1163843-1" "1163843-1" "DEATH" "10011906" "65-79 years" "65-79" "It was reported that patient died on 3/14/2021. This may have had nothing to do with the vaccine." "1165014-1" "1165014-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "My dad had the first shot of the covid vaccine and less then 24 hours later he went into cardiac arrest. He spent 10 days in ICU and we had to remove him from life support and he survived another 6 days suffering until he past in April 3rd" "1165014-1" "1165014-1" "DEATH" "10011906" "65-79 years" "65-79" "My dad had the first shot of the covid vaccine and less then 24 hours later he went into cardiac arrest. He spent 10 days in ICU and we had to remove him from life support and he survived another 6 days suffering until he past in April 3rd" "1165014-1" "1165014-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "My dad had the first shot of the covid vaccine and less then 24 hours later he went into cardiac arrest. He spent 10 days in ICU and we had to remove him from life support and he survived another 6 days suffering until he past in April 3rd" "1165014-1" "1165014-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "My dad had the first shot of the covid vaccine and less then 24 hours later he went into cardiac arrest. He spent 10 days in ICU and we had to remove him from life support and he survived another 6 days suffering until he past in April 3rd" "1173602-1" "1173602-1" "DEATH" "10011906" "65-79 years" "65-79" "Passed away on the sleep; A spontaneous report was received from a pharmacist concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine and passed way on the sleep/death. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (lot number: 024M20A) on 23 Jan 2021. On 23 Mar 2021, patient received second of two planned doses of mRNA-1273 (lot number: 047A21A) intramuscularly for COVID-19 prophylaxis. On an unknown date in Mar 2021, the patient passed away on the sleep. The patient received both scheduled doses of mRNA-1273 prior to the event therefore, action taken with the drug in response to the event was not applicable. The patient died on the sleep on an unspecified date in Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: This case concerns a 73-years-old, male patient, who died. The cause of death was unknown. Plans for an autopsy were unknown. Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death" "1179434-1" "1179434-1" "APHASIA" "10002948" "65-79 years" "65-79" "She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital." "1179434-1" "1179434-1" "BLOOD GLUCOSE INCREASED" "10005557" "65-79 years" "65-79" "She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital." "1179434-1" "1179434-1" "FEELING ABNORMAL" "10016322" "65-79 years" "65-79" "She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital." "1179434-1" "1179434-1" "INFLUENZA LIKE ILLNESS" "10022004" "65-79 years" "65-79" "She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital." "1179434-1" "1179434-1" "MYDRIASIS" "10028521" "65-79 years" "65-79" "She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital." "1179434-1" "1179434-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital." "1179434-1" "1179434-1" "NAUSEA" "10028813" "65-79 years" "65-79" "She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital." "1179434-1" "1179434-1" "PAIN" "10033371" "65-79 years" "65-79" "She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital." "1179434-1" "1179434-1" "PALLOR" "10033546" "65-79 years" "65-79" "She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital." "1196401-1" "1196401-1" "CHILLS" "10008531" "65-79 years" "65-79" "My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot." "1196401-1" "1196401-1" "DEATH" "10011906" "65-79 years" "65-79" "My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot." "1196401-1" "1196401-1" "DIARRHOEA" "10012735" "65-79 years" "65-79" "My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot." "1196401-1" "1196401-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot." "1196401-1" "1196401-1" "LOSS OF CONSCIOUSNESS" "10024855" "65-79 years" "65-79" "My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot." "1196401-1" "1196401-1" "MALAISE" "10025482" "65-79 years" "65-79" "My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot." "1196401-1" "1196401-1" "PAIN" "10033371" "65-79 years" "65-79" "My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot." "1196401-1" "1196401-1" "PYREXIA" "10037660" "65-79 years" "65-79" "My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot." "1196401-1" "1196401-1" "VOMITING" "10047700" "65-79 years" "65-79" "My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot." "1198737-1" "1198737-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient passed away on 4/1/21. 4 days after getting his second moderna vaccine. He was is good health" "1198939-1" "1198939-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "Per Medical Examiner, fourteen hours after receiving vaccine presenting symptoms were fatigue and muscle aches, went to Hospital Emergency Room and was released. Six hours later family stated symptoms had worsened, fever, shortness of breath and fatigue, admitted to Medical Center, diagnosed with sepsis and died within 48 hours of vaccination, deceased 4/7/2021, cause of death neutropenic sepsis with multi-lobar pneumonia, autopsy scheduled 4/13/2021." "1198939-1" "1198939-1" "DEATH" "10011906" "65-79 years" "65-79" "Per Medical Examiner, fourteen hours after receiving vaccine presenting symptoms were fatigue and muscle aches, went to Hospital Emergency Room and was released. Six hours later family stated symptoms had worsened, fever, shortness of breath and fatigue, admitted to Medical Center, diagnosed with sepsis and died within 48 hours of vaccination, deceased 4/7/2021, cause of death neutropenic sepsis with multi-lobar pneumonia, autopsy scheduled 4/13/2021." "1198939-1" "1198939-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Per Medical Examiner, fourteen hours after receiving vaccine presenting symptoms were fatigue and muscle aches, went to Hospital Emergency Room and was released. Six hours later family stated symptoms had worsened, fever, shortness of breath and fatigue, admitted to Medical Center, diagnosed with sepsis and died within 48 hours of vaccination, deceased 4/7/2021, cause of death neutropenic sepsis with multi-lobar pneumonia, autopsy scheduled 4/13/2021." "1198939-1" "1198939-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Per Medical Examiner, fourteen hours after receiving vaccine presenting symptoms were fatigue and muscle aches, went to Hospital Emergency Room and was released. Six hours later family stated symptoms had worsened, fever, shortness of breath and fatigue, admitted to Medical Center, diagnosed with sepsis and died within 48 hours of vaccination, deceased 4/7/2021, cause of death neutropenic sepsis with multi-lobar pneumonia, autopsy scheduled 4/13/2021." "1198939-1" "1198939-1" "MYALGIA" "10028411" "65-79 years" "65-79" "Per Medical Examiner, fourteen hours after receiving vaccine presenting symptoms were fatigue and muscle aches, went to Hospital Emergency Room and was released. Six hours later family stated symptoms had worsened, fever, shortness of breath and fatigue, admitted to Medical Center, diagnosed with sepsis and died within 48 hours of vaccination, deceased 4/7/2021, cause of death neutropenic sepsis with multi-lobar pneumonia, autopsy scheduled 4/13/2021." "1198939-1" "1198939-1" "NEUTROPENIC SEPSIS" "10049151" "65-79 years" "65-79" "Per Medical Examiner, fourteen hours after receiving vaccine presenting symptoms were fatigue and muscle aches, went to Hospital Emergency Room and was released. Six hours later family stated symptoms had worsened, fever, shortness of breath and fatigue, admitted to Medical Center, diagnosed with sepsis and died within 48 hours of vaccination, deceased 4/7/2021, cause of death neutropenic sepsis with multi-lobar pneumonia, autopsy scheduled 4/13/2021." "1198939-1" "1198939-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "Per Medical Examiner, fourteen hours after receiving vaccine presenting symptoms were fatigue and muscle aches, went to Hospital Emergency Room and was released. Six hours later family stated symptoms had worsened, fever, shortness of breath and fatigue, admitted to Medical Center, diagnosed with sepsis and died within 48 hours of vaccination, deceased 4/7/2021, cause of death neutropenic sepsis with multi-lobar pneumonia, autopsy scheduled 4/13/2021." "1198939-1" "1198939-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Per Medical Examiner, fourteen hours after receiving vaccine presenting symptoms were fatigue and muscle aches, went to Hospital Emergency Room and was released. Six hours later family stated symptoms had worsened, fever, shortness of breath and fatigue, admitted to Medical Center, diagnosed with sepsis and died within 48 hours of vaccination, deceased 4/7/2021, cause of death neutropenic sepsis with multi-lobar pneumonia, autopsy scheduled 4/13/2021." "1201182-1" "1201182-1" "SUDDEN DEATH" "10042434" "65-79 years" "65-79" "Sudden death - found by paramedics" "1203240-1" "1203240-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "My husband had fever of 102.6 the morning after he received the vaccine. He continued to run high fever. He had gi symptoms with diarrhea. He was up all Saturday night with generalized body aching and diarrhea. On Sunday night he coded in the bathroom at home. CPR was started when EMS arrived he was in full cardiac arrest. He was coded for 1 hour without any return of heart function. I found my husband on the bathroom floor on that Sunday night about 1140pm performed CPR and activated 911." "1203240-1" "1203240-1" "CARDIO-RESPIRATORY ARREST" "10007617" "65-79 years" "65-79" "My husband had fever of 102.6 the morning after he received the vaccine. He continued to run high fever. He had gi symptoms with diarrhea. He was up all Saturday night with generalized body aching and diarrhea. On Sunday night he coded in the bathroom at home. CPR was started when EMS arrived he was in full cardiac arrest. He was coded for 1 hour without any return of heart function. I found my husband on the bathroom floor on that Sunday night about 1140pm performed CPR and activated 911." "1203240-1" "1203240-1" "DIARRHOEA" "10012735" "65-79 years" "65-79" "My husband had fever of 102.6 the morning after he received the vaccine. He continued to run high fever. He had gi symptoms with diarrhea. He was up all Saturday night with generalized body aching and diarrhea. On Sunday night he coded in the bathroom at home. CPR was started when EMS arrived he was in full cardiac arrest. He was coded for 1 hour without any return of heart function. I found my husband on the bathroom floor on that Sunday night about 1140pm performed CPR and activated 911." "1203240-1" "1203240-1" "GASTROINTESTINAL DISORDER" "10017944" "65-79 years" "65-79" "My husband had fever of 102.6 the morning after he received the vaccine. He continued to run high fever. He had gi symptoms with diarrhea. He was up all Saturday night with generalized body aching and diarrhea. On Sunday night he coded in the bathroom at home. CPR was started when EMS arrived he was in full cardiac arrest. He was coded for 1 hour without any return of heart function. I found my husband on the bathroom floor on that Sunday night about 1140pm performed CPR and activated 911." "1203240-1" "1203240-1" "PAIN" "10033371" "65-79 years" "65-79" "My husband had fever of 102.6 the morning after he received the vaccine. He continued to run high fever. He had gi symptoms with diarrhea. He was up all Saturday night with generalized body aching and diarrhea. On Sunday night he coded in the bathroom at home. CPR was started when EMS arrived he was in full cardiac arrest. He was coded for 1 hour without any return of heart function. I found my husband on the bathroom floor on that Sunday night about 1140pm performed CPR and activated 911." "1203240-1" "1203240-1" "PYREXIA" "10037660" "65-79 years" "65-79" "My husband had fever of 102.6 the morning after he received the vaccine. He continued to run high fever. He had gi symptoms with diarrhea. He was up all Saturday night with generalized body aching and diarrhea. On Sunday night he coded in the bathroom at home. CPR was started when EMS arrived he was in full cardiac arrest. He was coded for 1 hour without any return of heart function. I found my husband on the bathroom floor on that Sunday night about 1140pm performed CPR and activated 911." "1203240-1" "1203240-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "My husband had fever of 102.6 the morning after he received the vaccine. He continued to run high fever. He had gi symptoms with diarrhea. He was up all Saturday night with generalized body aching and diarrhea. On Sunday night he coded in the bathroom at home. CPR was started when EMS arrived he was in full cardiac arrest. He was coded for 1 hour without any return of heart function. I found my husband on the bathroom floor on that Sunday night about 1140pm performed CPR and activated 911." "1203575-1" "1203575-1" "ACUTE RESPIRATORY DISTRESS SYNDROME" "10001052" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "BACTERIAL TEST POSITIVE" "10059421" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "CONVALESCENT PLASMA TRANSFUSION" "10084817" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "COVID-19" "10084268" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "CYTOMEGALOVIRUS VIRAEMIA" "10058854" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "ENTEROBACTER BACTERAEMIA" "10058857" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "ENTEROBACTER TEST POSITIVE" "10070023" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "INFLUENZA VIRUS TEST NEGATIVE" "10070718" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "PROCALCITONIN INCREASED" "10067081" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "SARS-COV-2 ANTIBODY TEST" "10084501" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1203575-1" "1203575-1" "SHOCK" "10040560" "65-79 years" "65-79" "Patient contracted COVID-19 after receiving 2 COVID-19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is still an inpatient currently. Patient admitted with hypoxic respiratory failure on 3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient with persistent respiratory failure/ARDS requiring intubation. Course further complicated by CMV viremia as well as shock with rising procalcitonin concerning for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter. Goals of care conversations occurring with ICU team and family." "1204616-1" "1204616-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "BACTERIAL INFECTION" "10060945" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "BLOOD THYROID STIMULATING HORMONE NORMAL" "10005834" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "BRAIN NATRIURETIC PEPTIDE NORMAL" "10053409" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "CHEST TUBE INSERTION" "10050522" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "CHRONIC OBSTRUCTIVE PULMONARY DISEASE" "10009033" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "CLOSTRIDIUM TEST NEGATIVE" "10070271" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "COMPUTERISED TOMOGRAM ABNORMAL" "10010235" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "CORTISOL INCREASED" "10011207" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "DEATH" "10011906" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "DIARRHOEA" "10012735" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "DIZZINESS" "10013573" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "EAR DISCOMFORT" "10052137" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "FIBRIN D DIMER INCREASED" "10016581" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "FULL BLOOD COUNT NORMAL" "10017414" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "GENERAL PHYSICAL HEALTH DETERIORATION" "10049438" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "GLOMERULAR FILTRATION RATE DECREASED" "10018358" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "HAEMATOCRIT DECREASED" "10018838" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "HEADACHE" "10019211" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "HYPOXIA" "10021143" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "LUNG OPACITY" "10081792" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "LYMPHOCYTE COUNT DECREASED" "10025256" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "MEAN CELL VOLUME INCREASED" "10027004" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "METABOLIC FUNCTION TEST NORMAL" "10062192" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "MULTIMORBIDITY" "10063914" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "NAUSEA" "10028813" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "PAIN" "10033371" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "PLATELET COUNT NORMAL" "10035530" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "PNEUMOTHORAX" "10035759" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "PROTEIN URINE PRESENT" "10053123" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "PULMONARY MASS" "10056342" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "RED BLOOD CELL COUNT DECREASED" "10038153" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "SPECIFIC GRAVITY URINE INCREASED" "10050773" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "SPUTUM CULTURE POSITIVE" "10051612" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "STREPTOCOCCUS TEST NEGATIVE" "10070415" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "SUBCUTANEOUS EMPHYSEMA" "10042344" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "SYMPTOM RECURRENCE" "10080080" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "TROPONIN NORMAL" "10071322" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1204616-1" "1204616-1" "WHITE BLOOD CELL COUNT DECREASED" "10047942" "65-79 years" "65-79" "Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report." "1205121-1" "1205121-1" "ABDOMINAL DISCOMFORT" "10000059" "65-79 years" "65-79" "twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived." "1205121-1" "1205121-1" "BLOOD GLUCOSE INCREASED" "10005557" "65-79 years" "65-79" "twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived." "1205121-1" "1205121-1" "CONFUSIONAL STATE" "10010305" "65-79 years" "65-79" "twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived." "1205121-1" "1205121-1" "DISORIENTATION" "10013395" "65-79 years" "65-79" "twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived." "1205121-1" "1205121-1" "RESPIRATORY ARREST" "10038669" "65-79 years" "65-79" "twelve hours after getting the shot my wife woke up with an upset stomach; her blood sugar was also slightly elevated; within ~the next two hours she became disoriented and confused; I called 911 and within a couple of minutes of the first 911 call she stopped breathing and could not be revived." "1205282-1" "1205282-1" "CEREBROVASCULAR ACCIDENT" "10008190" "65-79 years" "65-79" "Patient had a stroke 11 days later(on 4/6/21) and expired" "1205282-1" "1205282-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient had a stroke 11 days later(on 4/6/21) and expired" "1206219-1" "1206219-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "Patient was at this hospital for brain scans to determine why a sudden exacerbation of Alzheimer's symptoms were occurring." "1206219-1" "1206219-1" "DEMENTIA ALZHEIMER'S TYPE" "10012271" "65-79 years" "65-79" "Patient was at this hospital for brain scans to determine why a sudden exacerbation of Alzheimer's symptoms were occurring." "1206219-1" "1206219-1" "SCAN BRAIN" "10061500" "65-79 years" "65-79" "Patient was at this hospital for brain scans to determine why a sudden exacerbation of Alzheimer's symptoms were occurring." "1207377-1" "1207377-1" "BLOOD TEST" "10061726" "65-79 years" "65-79" "Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021." "1207377-1" "1207377-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021." "1207377-1" "1207377-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021." "1207377-1" "1207377-1" "MULTIPLE ORGAN DYSFUNCTION SYNDROME" "10077361" "65-79 years" "65-79" "Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021." "1207377-1" "1207377-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" "Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021." "1207377-1" "1207377-1" "SCAN" "10061498" "65-79 years" "65-79" "Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021." "1207377-1" "1207377-1" "THROMBOSIS" "10043607" "65-79 years" "65-79" "Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021." "1207377-1" "1207377-1" "X-RAY NORMAL" "10048067" "65-79 years" "65-79" "Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021." "1207946-1" "1207946-1" "ABDOMINAL PAIN" "10000081" "65-79 years" "65-79" "Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis." "1207946-1" "1207946-1" "ABDOMINAL TENDERNESS" "10000097" "65-79 years" "65-79" "Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis." "1207946-1" "1207946-1" "APNOEA" "10002974" "65-79 years" "65-79" "Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis." "1207946-1" "1207946-1" "CARDIO-RESPIRATORY ARREST" "10007617" "65-79 years" "65-79" "Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis." "1207946-1" "1207946-1" "LABORATORY TEST" "10059938" "65-79 years" "65-79" "Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis." "1207946-1" "1207946-1" "LOSS OF CONSCIOUSNESS" "10024855" "65-79 years" "65-79" "Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis." "1207946-1" "1207946-1" "PULSE ABSENT" "10037469" "65-79 years" "65-79" "Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis." "1207946-1" "1207946-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "Pt c/o abdominal pain that began 5 min after vaccine administration, per pt's son. Pt main complaint in the ED was abdominal pain. On exam pt's abdomen was tender diffusely. Within minutes of initial evaluation the pt lost consciousness. Minutes later the pt was apneic and pulseless. Resuscitative efforts were initiated per ACLS protocol. During resuscitative efforts the pt received several rounds of code-dosed epinephrine. In addition, the pt received 1 dose of IV Benadryl in addition to medications standard for ACLS protocol. Benadryl was administered specifically to treat the possibility of anaphylaxis." "1208579-1" "1208579-1" "ATRIAL FIBRILLATION" "10003658" "65-79 years" "65-79" "Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21" "1208579-1" "1208579-1" "BLOOD TEST" "10061726" "65-79 years" "65-79" "Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21" "1208579-1" "1208579-1" "BRAIN STEM THROMBOSIS" "10062573" "65-79 years" "65-79" "Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21" "1208579-1" "1208579-1" "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "65-79 years" "65-79" "Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21" "1208579-1" "1208579-1" "DEATH" "10011906" "65-79 years" "65-79" "Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21" "1208579-1" "1208579-1" "INTRACARDIAC THROMBUS" "10048620" "65-79 years" "65-79" "Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21" "1208579-1" "1208579-1" "MAGNETIC RESONANCE IMAGING HEAD ABNORMAL" "10085256" "65-79 years" "65-79" "Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21" "1208579-1" "1208579-1" "MAGNETIC RESONANCE IMAGING HEART" "10083127" "65-79 years" "65-79" "Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21" "1208579-1" "1208579-1" "THROMBOSIS" "10043607" "65-79 years" "65-79" "Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21" "1209906-1" "1209906-1" "ARTHRALGIA" "10003239" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "ARTHRITIS" "10003246" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "DEATH" "10011906" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "DISORIENTATION" "10013395" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "FALL" "10016173" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "JOINT EFFUSION" "10023215" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "JOINT INJURY" "10060820" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "NAUSEA" "10028813" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "PAIN" "10033371" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "SEPSIS" "10040047" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "VOMITING" "10047700" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "WALKING AID USER" "10050778" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1209906-1" "1209906-1" "X-RAY ABNORMAL" "10048065" "65-79 years" "65-79" "On March 4 patient experienced vomiting. Early morning March 5 he fell and landed on his hip after being disoriented and experienced aches, weakness, and nausea without vomiting throughout the day. On March 6 he experienced excruciating pain in his left hip and went to the local emergency room following guidance from his primary care physician. He was diagnosed with fluid near his hip joint at the hospital and was discharged the same day. The next day, March 7 he was still in pain but able to walk with assistance. On March 8 he got an x-ray from an orthopedic physician and severe arthritis was found. March 10 the severe pain persisted, but he was able to walk with a walker. On March 12 he received a cortisone shot and required emergency medical assistance to get into a personal vehicle with a family member who drove to the appointment. The next few days, the pain persisted, became worse, and spread throughout his body. On March 16 he was transported by emergency medical services to the local emergency room for treatment and was diagnosed with sepsis and pneumonia. On March 18 he was still being treated when he experienced cardiac arrest while being intubated. He was resuscitated and was on a ventilator being treated for a few more days but ultimately succumbed to sepsis on March 30." "1213081-1" "1213081-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213081-1" "1213081-1" "BLOOD TEST" "10061726" "65-79 years" "65-79" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213081-1" "1213081-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213081-1" "1213081-1" "DEATH" "10011906" "65-79 years" "65-79" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213081-1" "1213081-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213081-1" "1213081-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213081-1" "1213081-1" "GASTRIC DISORDER" "10056819" "65-79 years" "65-79" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213081-1" "1213081-1" "MALAISE" "10025482" "65-79 years" "65-79" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213081-1" "1213081-1" "PAIN" "10033371" "65-79 years" "65-79" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213081-1" "1213081-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021." "1213115-1" "1213115-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "cardiac arrest at approximately 4:35pm, patient expired." "1213115-1" "1213115-1" "DEATH" "10011906" "65-79 years" "65-79" "cardiac arrest at approximately 4:35pm, patient expired." "1213958-1" "1213958-1" "BLOOD CALCIUM NORMAL" "10005397" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "BLOOD CHLORIDE NORMAL" "10005421" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "BLOOD CREATININE NORMAL" "10005484" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "BLOOD MAGNESIUM NORMAL" "10005656" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "BLOOD THYROID STIMULATING HORMONE NORMAL" "10005834" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "CHEST DISCOMFORT" "10008469" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "CHEST X-RAY NORMAL" "10008500" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "DEATH" "10011906" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "DISCOMFORT" "10013082" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "ELECTROCARDIOGRAM NORMAL" "10014373" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "FULL BLOOD COUNT NORMAL" "10017414" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "GASTROINTESTINAL PATHOGEN PANEL" "10082666" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "GLYCOSYLATED HAEMOGLOBIN" "10018480" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "LIPIDS NORMAL" "10024593" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1213958-1" "1213958-1" "TROPONIN NORMAL" "10071322" "65-79 years" "65-79" "PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021." "1222851-1" "1222851-1" "BLOOD TEST NORMAL" "10050540" "65-79 years" "65-79" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1222851-1" "1222851-1" "CSF TEST NORMAL" "10059702" "65-79 years" "65-79" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1222851-1" "1222851-1" "DEATH" "10011906" "65-79 years" "65-79" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1222851-1" "1222851-1" "HEADACHE" "10019211" "65-79 years" "65-79" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1222851-1" "1222851-1" "LOSS OF CONSCIOUSNESS" "10024855" "65-79 years" "65-79" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1222851-1" "1222851-1" "MALAISE" "10025482" "65-79 years" "65-79" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1222851-1" "1222851-1" "NAUSEA" "10028813" "65-79 years" "65-79" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1222851-1" "1222851-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1222851-1" "1222851-1" "SEIZURE" "10039906" "65-79 years" "65-79" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1222851-1" "1222851-1" "SPEECH DISORDER" "10041466" "65-79 years" "65-79" "12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures ." "1223167-1" "1223167-1" "BALANCE DISORDER" "10049848" "65-79 years" "65-79" "My father received the first dose on 2/13, and started to rapidly decline thereafter. He started having neurological issues, memory issues, and balance issues and eventually collapsed and was hospitalized on 3/5, intubated twice in two weeks, with his death occurring on 3/31/21." "1223167-1" "1223167-1" "DEATH" "10011906" "65-79 years" "65-79" "My father received the first dose on 2/13, and started to rapidly decline thereafter. He started having neurological issues, memory issues, and balance issues and eventually collapsed and was hospitalized on 3/5, intubated twice in two weeks, with his death occurring on 3/31/21." "1223167-1" "1223167-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "My father received the first dose on 2/13, and started to rapidly decline thereafter. He started having neurological issues, memory issues, and balance issues and eventually collapsed and was hospitalized on 3/5, intubated twice in two weeks, with his death occurring on 3/31/21." "1223167-1" "1223167-1" "GENERAL PHYSICAL HEALTH DETERIORATION" "10049438" "65-79 years" "65-79" "My father received the first dose on 2/13, and started to rapidly decline thereafter. He started having neurological issues, memory issues, and balance issues and eventually collapsed and was hospitalized on 3/5, intubated twice in two weeks, with his death occurring on 3/31/21." "1223167-1" "1223167-1" "MEMORY IMPAIRMENT" "10027175" "65-79 years" "65-79" "My father received the first dose on 2/13, and started to rapidly decline thereafter. He started having neurological issues, memory issues, and balance issues and eventually collapsed and was hospitalized on 3/5, intubated twice in two weeks, with his death occurring on 3/31/21." "1223167-1" "1223167-1" "NEUROLOGICAL SYMPTOM" "10060860" "65-79 years" "65-79" "My father received the first dose on 2/13, and started to rapidly decline thereafter. He started having neurological issues, memory issues, and balance issues and eventually collapsed and was hospitalized on 3/5, intubated twice in two weeks, with his death occurring on 3/31/21." "1223167-1" "1223167-1" "SYNCOPE" "10042772" "65-79 years" "65-79" "My father received the first dose on 2/13, and started to rapidly decline thereafter. He started having neurological issues, memory issues, and balance issues and eventually collapsed and was hospitalized on 3/5, intubated twice in two weeks, with his death occurring on 3/31/21." "1227279-1" "1227279-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "heart attack; stopped breathing; This is a spontaneous report from a contactable consumer. A 67-year-old female patient (mother) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Mar2021 (67-year-old) as single dose for COVID-19 immunization. Medical history included Hypothyroid, Sleep Apnea, Known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Patient is not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); apixaban (ELIQUIS); senna [senna alexandrina]; valsartan; clopidogrel; metoprolol; atorvastatin; macrogol 3350 (MIRALAX). The patient previously took vitamins, Claritin , first dose of bnt162b2 on 24Jan2021 01:00 PM (67-year-old) for COVID-19 immunization and exactly 3 weeks after the first dose, the patient had a heart attack and stroke. Exactly 3 weeks after the second dose (04Apr2021), the patient stopped breathing and died. It was reported that death cause was unknown but also likely heart attack (unspecified date). Ae resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died]. Number of days hospitalization is 10. Patient had no covid prior vaccination. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included covid test (Nasal Swab): negative on an unspecified date. The patient died on 04Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: stopped breathing; death cause: likely heart attack" "1227279-1" "1227279-1" "RESPIRATORY ARREST" "10038669" "65-79 years" "65-79" "heart attack; stopped breathing; This is a spontaneous report from a contactable consumer. A 67-year-old female patient (mother) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Mar2021 (67-year-old) as single dose for COVID-19 immunization. Medical history included Hypothyroid, Sleep Apnea, Known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Patient is not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); apixaban (ELIQUIS); senna [senna alexandrina]; valsartan; clopidogrel; metoprolol; atorvastatin; macrogol 3350 (MIRALAX). The patient previously took vitamins, Claritin , first dose of bnt162b2 on 24Jan2021 01:00 PM (67-year-old) for COVID-19 immunization and exactly 3 weeks after the first dose, the patient had a heart attack and stroke. Exactly 3 weeks after the second dose (04Apr2021), the patient stopped breathing and died. It was reported that death cause was unknown but also likely heart attack (unspecified date). Ae resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died]. Number of days hospitalization is 10. Patient had no covid prior vaccination. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included covid test (Nasal Swab): negative on an unspecified date. The patient died on 04Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: stopped breathing; death cause: likely heart attack" "1227279-1" "1227279-1" "SARS-COV-2 TEST" "10084354" "65-79 years" "65-79" "heart attack; stopped breathing; This is a spontaneous report from a contactable consumer. A 67-year-old female patient (mother) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Mar2021 (67-year-old) as single dose for COVID-19 immunization. Medical history included Hypothyroid, Sleep Apnea, Known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Patient is not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); apixaban (ELIQUIS); senna [senna alexandrina]; valsartan; clopidogrel; metoprolol; atorvastatin; macrogol 3350 (MIRALAX). The patient previously took vitamins, Claritin , first dose of bnt162b2 on 24Jan2021 01:00 PM (67-year-old) for COVID-19 immunization and exactly 3 weeks after the first dose, the patient had a heart attack and stroke. Exactly 3 weeks after the second dose (04Apr2021), the patient stopped breathing and died. It was reported that death cause was unknown but also likely heart attack (unspecified date). Ae resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died]. Number of days hospitalization is 10. Patient had no covid prior vaccination. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included covid test (Nasal Swab): negative on an unspecified date. The patient died on 04Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: stopped breathing; death cause: likely heart attack" "1228372-1" "1228372-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient's wife called in mid March 2021 letting us know that the patient, needed to re-schedule his 2nd dose of Moderna Covid-19 vaccine - he had missed his scheduled 2nd dose date due to being hospitalized - doctors had thought he might need a defibrillator but then discharged him without one. Patient's wife called back on 4/16 to let us know that he passed away on 4/14." "1228372-1" "1228372-1" "INCOMPLETE COURSE OF VACCINATION" "10072103" "65-79 years" "65-79" "Patient's wife called in mid March 2021 letting us know that the patient, needed to re-schedule his 2nd dose of Moderna Covid-19 vaccine - he had missed his scheduled 2nd dose date due to being hospitalized - doctors had thought he might need a defibrillator but then discharged him without one. Patient's wife called back on 4/16 to let us know that he passed away on 4/14." "1229152-1" "1229152-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "101.5 fever Friday night, followed by a seizure at 3am. She was found unresponsive late Saturday afternoon, and was pronounced dead at the hospital. Sudden cardiac arrest." "1229152-1" "1229152-1" "DEATH" "10011906" "65-79 years" "65-79" "101.5 fever Friday night, followed by a seizure at 3am. She was found unresponsive late Saturday afternoon, and was pronounced dead at the hospital. Sudden cardiac arrest." "1229152-1" "1229152-1" "PYREXIA" "10037660" "65-79 years" "65-79" "101.5 fever Friday night, followed by a seizure at 3am. She was found unresponsive late Saturday afternoon, and was pronounced dead at the hospital. Sudden cardiac arrest." "1229152-1" "1229152-1" "SEIZURE" "10039906" "65-79 years" "65-79" "101.5 fever Friday night, followed by a seizure at 3am. She was found unresponsive late Saturday afternoon, and was pronounced dead at the hospital. Sudden cardiac arrest." "1229152-1" "1229152-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "101.5 fever Friday night, followed by a seizure at 3am. She was found unresponsive late Saturday afternoon, and was pronounced dead at the hospital. Sudden cardiac arrest." "1230868-1" "1230868-1" "ARTHRALGIA" "10003239" "65-79 years" "65-79" "My dad took vaccine 4/1 5pm, he had arm pain 4/2 morning, felt like fever in the afternoon. After 5pm, he compliant with joint pain. He was found on the floor dead 4/3 at 1am at home." "1230868-1" "1230868-1" "DEATH" "10011906" "65-79 years" "65-79" "My dad took vaccine 4/1 5pm, he had arm pain 4/2 morning, felt like fever in the afternoon. After 5pm, he compliant with joint pain. He was found on the floor dead 4/3 at 1am at home." "1230868-1" "1230868-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" "My dad took vaccine 4/1 5pm, he had arm pain 4/2 morning, felt like fever in the afternoon. After 5pm, he compliant with joint pain. He was found on the floor dead 4/3 at 1am at home." "1230868-1" "1230868-1" "PYREXIA" "10037660" "65-79 years" "65-79" "My dad took vaccine 4/1 5pm, he had arm pain 4/2 morning, felt like fever in the afternoon. After 5pm, he compliant with joint pain. He was found on the floor dead 4/3 at 1am at home." "1236785-1" "1236785-1" "CARDIO-RESPIRATORY ARREST" "10007617" "65-79 years" "65-79" "Resident found unresponsive and without vital signs the morning on April 17, 2021 at 6:35am. The nurse started CPR, called a code, 911 called, AED applied. Local EMS responded, took over the code. EMS had contact with the local hospital ER, code called at the facility. Resident expired." "1236785-1" "1236785-1" "CARDIOVERSION" "10007661" "65-79 years" "65-79" "Resident found unresponsive and without vital signs the morning on April 17, 2021 at 6:35am. The nurse started CPR, called a code, 911 called, AED applied. Local EMS responded, took over the code. EMS had contact with the local hospital ER, code called at the facility. Resident expired." "1236785-1" "1236785-1" "DEATH" "10011906" "65-79 years" "65-79" "Resident found unresponsive and without vital signs the morning on April 17, 2021 at 6:35am. The nurse started CPR, called a code, 911 called, AED applied. Local EMS responded, took over the code. EMS had contact with the local hospital ER, code called at the facility. Resident expired." "1236785-1" "1236785-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "Resident found unresponsive and without vital signs the morning on April 17, 2021 at 6:35am. The nurse started CPR, called a code, 911 called, AED applied. Local EMS responded, took over the code. EMS had contact with the local hospital ER, code called at the facility. Resident expired." "1236785-1" "1236785-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Resident found unresponsive and without vital signs the morning on April 17, 2021 at 6:35am. The nurse started CPR, called a code, 911 called, AED applied. Local EMS responded, took over the code. EMS had contact with the local hospital ER, code called at the facility. Resident expired." "1236785-1" "1236785-1" "VITAL FUNCTIONS ABNORMAL" "10063644" "65-79 years" "65-79" "Resident found unresponsive and without vital signs the morning on April 17, 2021 at 6:35am. The nurse started CPR, called a code, 911 called, AED applied. Local EMS responded, took over the code. EMS had contact with the local hospital ER, code called at the facility. Resident expired." "1236916-1" "1236916-1" "ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED" "10000636" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "CARDIOVERSION" "10007661" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "DEATH" "10011906" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "FIBRIN D DIMER" "10016577" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "INTERNATIONAL NORMALISED RATIO NORMAL" "10022596" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "PLATELET COUNT NORMAL" "10035530" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "PROTHROMBIN TIME PROLONGED" "10037063" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1236916-1" "1236916-1" "VENTRICULAR FIBRILLATION" "10047290" "65-79 years" "65-79" "On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM." "1237434-1" "1237434-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient discovered down and unresponsive with immediate declaration of death. Pronounced dead 4/6/2021 11:45 PM" "1237434-1" "1237434-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Patient discovered down and unresponsive with immediate declaration of death. Pronounced dead 4/6/2021 11:45 PM" "1237511-1" "1237511-1" "ANTICOAGULANT THERAPY" "10053468" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "BREATH SOUNDS ABNORMAL" "10064780" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "COMPUTERISED TOMOGRAM HEAD NORMAL" "10072167" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "LUNG OPACITY" "10081792" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "PNEUMONIA ASPIRATION" "10035669" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "THERAPEUTIC HYPOTHERMIA" "10059485" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1237511-1" "1237511-1" "VOMITING" "10047700" "65-79 years" "65-79" "Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia" "1238270-1" "1238270-1" "ABDOMINAL PAIN" "10000081" "65-79 years" "65-79" "Patient was already in hospital for severe COPD. While there, he was given J&J Covid-19 vaccination. Approximately 11 days after vaccination, patient developed vomiting that could not be controlled. He later developed abdominal pain that worsened and also could not be controlled. Intravenous pain killers eventually hastened his passing." "1238270-1" "1238270-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient was already in hospital for severe COPD. While there, he was given J&J Covid-19 vaccination. Approximately 11 days after vaccination, patient developed vomiting that could not be controlled. He later developed abdominal pain that worsened and also could not be controlled. Intravenous pain killers eventually hastened his passing." "1238270-1" "1238270-1" "VOMITING" "10047700" "65-79 years" "65-79" "Patient was already in hospital for severe COPD. While there, he was given J&J Covid-19 vaccination. Approximately 11 days after vaccination, patient developed vomiting that could not be controlled. He later developed abdominal pain that worsened and also could not be controlled. Intravenous pain killers eventually hastened his passing." "1238440-1" "1238440-1" "ABSCESS LIMB" "10050473" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "ACUTE KIDNEY INJURY" "10069339" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "ACUTE RESPIRATORY DISTRESS SYNDROME" "10001052" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "COMPUTERISED TOMOGRAM THORAX NORMAL" "10057801" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "COUGH" "10011224" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "DIARRHOEA" "10012735" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "EPISTAXIS" "10015090" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "GASTROINTESTINAL HAEMORRHAGE" "10017955" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "METABOLIC DISORDER" "10058097" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "RENAL FAILURE" "10038435" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "THROMBOPHLEBITIS SUPERFICIAL" "10043595" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1238440-1" "1238440-1" "VENTRICULAR TACHYCARDIA" "10047302" "65-79 years" "65-79" "Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS." "1242118-1" "1242118-1" "ACUTE RESPIRATORY DISTRESS SYNDROME" "10001052" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "BACTERAEMIA" "10003997" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "GASTROINTESTINAL HAEMORRHAGE" "10017955" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "HYPERKALAEMIA" "10020646" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "HYPOXIA" "10021143" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "OLIGURIA" "10030302" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "RENAL REPLACEMENT THERAPY" "10074746" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "SEPSIS" "10040047" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "SHOCK" "10040560" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242118-1" "1242118-1" "THERAPEUTIC EMBOLISATION" "10057335" "65-79 years" "65-79" "Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9." "1242160-1" "1242160-1" "CARDIO-RESPIRATORY ARREST" "10007617" "65-79 years" "65-79" "CALLED TO TRANSFER PATIENT FROM 2C ADMITTING AREA TO ENDOSCOPY UNIT AROUND 1410. UPON ARRIVAL IN 2C TO TRANSFER PATIENT, PATIENT WAS ALERT AND RESPONSIVE TO NAME. WHEN WHEELED TO BEDSIDE IN ENDOSCOPY UNIT PATIENTS RIGHT ARM SLUMPED AND HE BECAME UNRESPONSIVE. RAPID RESPONSE CALLED. PATIENT TRANSFERRED TO STRETCHER, CODE BLUE CALLED, AND CPR STARTED. DR. ANESTHESIA AT BEDSIDE MANAGING AIRWAY. CODE TEAM RESPONDED. REFER TO ARREST RECORD." "1242160-1" "1242160-1" "DEATH" "10011906" "65-79 years" "65-79" "CALLED TO TRANSFER PATIENT FROM 2C ADMITTING AREA TO ENDOSCOPY UNIT AROUND 1410. UPON ARRIVAL IN 2C TO TRANSFER PATIENT, PATIENT WAS ALERT AND RESPONSIVE TO NAME. WHEN WHEELED TO BEDSIDE IN ENDOSCOPY UNIT PATIENTS RIGHT ARM SLUMPED AND HE BECAME UNRESPONSIVE. RAPID RESPONSE CALLED. PATIENT TRANSFERRED TO STRETCHER, CODE BLUE CALLED, AND CPR STARTED. DR. ANESTHESIA AT BEDSIDE MANAGING AIRWAY. CODE TEAM RESPONDED. REFER TO ARREST RECORD." "1242160-1" "1242160-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "CALLED TO TRANSFER PATIENT FROM 2C ADMITTING AREA TO ENDOSCOPY UNIT AROUND 1410. UPON ARRIVAL IN 2C TO TRANSFER PATIENT, PATIENT WAS ALERT AND RESPONSIVE TO NAME. WHEN WHEELED TO BEDSIDE IN ENDOSCOPY UNIT PATIENTS RIGHT ARM SLUMPED AND HE BECAME UNRESPONSIVE. RAPID RESPONSE CALLED. PATIENT TRANSFERRED TO STRETCHER, CODE BLUE CALLED, AND CPR STARTED. DR. ANESTHESIA AT BEDSIDE MANAGING AIRWAY. CODE TEAM RESPONDED. REFER TO ARREST RECORD." "1242160-1" "1242160-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "CALLED TO TRANSFER PATIENT FROM 2C ADMITTING AREA TO ENDOSCOPY UNIT AROUND 1410. UPON ARRIVAL IN 2C TO TRANSFER PATIENT, PATIENT WAS ALERT AND RESPONSIVE TO NAME. WHEN WHEELED TO BEDSIDE IN ENDOSCOPY UNIT PATIENTS RIGHT ARM SLUMPED AND HE BECAME UNRESPONSIVE. RAPID RESPONSE CALLED. PATIENT TRANSFERRED TO STRETCHER, CODE BLUE CALLED, AND CPR STARTED. DR. ANESTHESIA AT BEDSIDE MANAGING AIRWAY. CODE TEAM RESPONDED. REFER TO ARREST RECORD." "1242546-1" "1242546-1" "ARTERIOSCLEROSIS" "10003210" "65-79 years" "65-79" "Patient found deceased at home 19 days after first dose of Pfizer vaccine. No reported side effects after vaccine. Patient did not have regular medical care. Autopsy performed due to lack of medical history and recent vaccination. Autopsy revealed marked pre-existing cardiac disease (hypertensive and atherosclerotic cardiovascular disease), which is the determined cause of death. Autopsy also revealed marked thyroid gland enlargement with Hashimoto thyroiditis diagnosed on histologic exam. It is unknown if this is pre-existing, as patient did not seek medical care and did not complain of symptomatology." "1242546-1" "1242546-1" "AUTOIMMUNE THYROIDITIS" "10049046" "65-79 years" "65-79" "Patient found deceased at home 19 days after first dose of Pfizer vaccine. No reported side effects after vaccine. Patient did not have regular medical care. Autopsy performed due to lack of medical history and recent vaccination. Autopsy revealed marked pre-existing cardiac disease (hypertensive and atherosclerotic cardiovascular disease), which is the determined cause of death. Autopsy also revealed marked thyroid gland enlargement with Hashimoto thyroiditis diagnosed on histologic exam. It is unknown if this is pre-existing, as patient did not seek medical care and did not complain of symptomatology." "1242546-1" "1242546-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "Patient found deceased at home 19 days after first dose of Pfizer vaccine. No reported side effects after vaccine. Patient did not have regular medical care. Autopsy performed due to lack of medical history and recent vaccination. Autopsy revealed marked pre-existing cardiac disease (hypertensive and atherosclerotic cardiovascular disease), which is the determined cause of death. Autopsy also revealed marked thyroid gland enlargement with Hashimoto thyroiditis diagnosed on histologic exam. It is unknown if this is pre-existing, as patient did not seek medical care and did not complain of symptomatology." "1242546-1" "1242546-1" "CARDIAC DISORDER" "10061024" "65-79 years" "65-79" "Patient found deceased at home 19 days after first dose of Pfizer vaccine. No reported side effects after vaccine. Patient did not have regular medical care. Autopsy performed due to lack of medical history and recent vaccination. Autopsy revealed marked pre-existing cardiac disease (hypertensive and atherosclerotic cardiovascular disease), which is the determined cause of death. Autopsy also revealed marked thyroid gland enlargement with Hashimoto thyroiditis diagnosed on histologic exam. It is unknown if this is pre-existing, as patient did not seek medical care and did not complain of symptomatology." "1242546-1" "1242546-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient found deceased at home 19 days after first dose of Pfizer vaccine. No reported side effects after vaccine. Patient did not have regular medical care. Autopsy performed due to lack of medical history and recent vaccination. Autopsy revealed marked pre-existing cardiac disease (hypertensive and atherosclerotic cardiovascular disease), which is the determined cause of death. Autopsy also revealed marked thyroid gland enlargement with Hashimoto thyroiditis diagnosed on histologic exam. It is unknown if this is pre-existing, as patient did not seek medical care and did not complain of symptomatology." "1242546-1" "1242546-1" "HYPERTENSION" "10020772" "65-79 years" "65-79" "Patient found deceased at home 19 days after first dose of Pfizer vaccine. No reported side effects after vaccine. Patient did not have regular medical care. Autopsy performed due to lack of medical history and recent vaccination. Autopsy revealed marked pre-existing cardiac disease (hypertensive and atherosclerotic cardiovascular disease), which is the determined cause of death. Autopsy also revealed marked thyroid gland enlargement with Hashimoto thyroiditis diagnosed on histologic exam. It is unknown if this is pre-existing, as patient did not seek medical care and did not complain of symptomatology." "1242546-1" "1242546-1" "INFLAMMATION" "10061218" "65-79 years" "65-79" "Patient found deceased at home 19 days after first dose of Pfizer vaccine. No reported side effects after vaccine. Patient did not have regular medical care. Autopsy performed due to lack of medical history and recent vaccination. Autopsy revealed marked pre-existing cardiac disease (hypertensive and atherosclerotic cardiovascular disease), which is the determined cause of death. Autopsy also revealed marked thyroid gland enlargement with Hashimoto thyroiditis diagnosed on histologic exam. It is unknown if this is pre-existing, as patient did not seek medical care and did not complain of symptomatology." "1242546-1" "1242546-1" "PARATHYROID GLAND ENLARGEMENT" "10051653" "65-79 years" "65-79" "Patient found deceased at home 19 days after first dose of Pfizer vaccine. No reported side effects after vaccine. Patient did not have regular medical care. Autopsy performed due to lack of medical history and recent vaccination. Autopsy revealed marked pre-existing cardiac disease (hypertensive and atherosclerotic cardiovascular disease), which is the determined cause of death. Autopsy also revealed marked thyroid gland enlargement with Hashimoto thyroiditis diagnosed on histologic exam. It is unknown if this is pre-existing, as patient did not seek medical care and did not complain of symptomatology." "1242858-1" "1242858-1" "COVID-19" "10084268" "65-79 years" "65-79" "Patient contracted COVID 19 and subsequently expired from respiratory distress, following completion of the serious of two vaccination shots. She received her Moderna vaccinations on 1/7/21 and 2/4/21. I do not have access to the lot # info- would have to contact vaccination site to obtain" "1242858-1" "1242858-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient contracted COVID 19 and subsequently expired from respiratory distress, following completion of the serious of two vaccination shots. She received her Moderna vaccinations on 1/7/21 and 2/4/21. I do not have access to the lot # info- would have to contact vaccination site to obtain" "1242858-1" "1242858-1" "RESPIRATORY DISTRESS" "10038687" "65-79 years" "65-79" "Patient contracted COVID 19 and subsequently expired from respiratory distress, following completion of the serious of two vaccination shots. She received her Moderna vaccinations on 1/7/21 and 2/4/21. I do not have access to the lot # info- would have to contact vaccination site to obtain" "1242858-1" "1242858-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Patient contracted COVID 19 and subsequently expired from respiratory distress, following completion of the serious of two vaccination shots. She received her Moderna vaccinations on 1/7/21 and 2/4/21. I do not have access to the lot # info- would have to contact vaccination site to obtain" "1248842-1" "1248842-1" "BILEVEL POSITIVE AIRWAY PRESSURE" "10064530" "65-79 years" "65-79" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1248842-1" "1248842-1" "BLOOD GASES ABNORMAL" "10005539" "65-79 years" "65-79" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1248842-1" "1248842-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1248842-1" "1248842-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1248842-1" "1248842-1" "ELECTROCARDIOGRAM NORMAL" "10014373" "65-79 years" "65-79" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1248842-1" "1248842-1" "FULL BLOOD COUNT NORMAL" "10017414" "65-79 years" "65-79" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1248842-1" "1248842-1" "HYPERCAPNIA" "10020591" "65-79 years" "65-79" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1248842-1" "1248842-1" "PULMONARY CONGESTION" "10037368" "65-79 years" "65-79" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1248842-1" "1248842-1" "RESPIRATORY ACIDOSIS" "10038661" "65-79 years" "65-79" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1248842-1" "1248842-1" "TROPONIN NORMAL" "10071322" "65-79 years" "65-79" "Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased" "1256737-1" "1256737-1" "DEATH" "10011906" "65-79 years" "65-79" "Died blood clot in brain" "1256737-1" "1256737-1" "THROMBOSIS" "10043607" "65-79 years" "65-79" "Died blood clot in brain" "1257932-1" "1257932-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Witnessed sudden cardiac arrest" "1258524-1" "1258524-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient passed away in between dose 1 and 2. Cause unknown." "1259240-1" "1259240-1" "DEATH" "10011906" "65-79 years" "65-79" "PATIENT DID NOT SHOW FOR SECOND DOSE OF VACCINE WHEN CALLED WE WERE TOLD BY HIS WIFE THAT HE HAD A HEARTATTACK AND PASSED AWAY ON 04/13/2021" "1259240-1" "1259240-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "PATIENT DID NOT SHOW FOR SECOND DOSE OF VACCINE WHEN CALLED WE WERE TOLD BY HIS WIFE THAT HE HAD A HEARTATTACK AND PASSED AWAY ON 04/13/2021" "1260071-1" "1260071-1" "DEATH" "10011906" "65-79 years" "65-79" "FOUND DECEASED, COLD IN VEHICLE" "1260071-1" "1260071-1" "PERIPHERAL COLDNESS" "10034568" "65-79 years" "65-79" "FOUND DECEASED, COLD IN VEHICLE" "1260071-1" "1260071-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "FOUND DECEASED, COLD IN VEHICLE" "1260071-1" "1260071-1" "TOXICOLOGIC TEST" "10061384" "65-79 years" "65-79" "FOUND DECEASED, COLD IN VEHICLE" "1262410-1" "1262410-1" "BLOOD TEST" "10061726" "65-79 years" "65-79" "Heart Attack 2 days after 2nd dose of moderna vaccine - followed by death" "1262410-1" "1262410-1" "DEATH" "10011906" "65-79 years" "65-79" "Heart Attack 2 days after 2nd dose of moderna vaccine - followed by death" "1262410-1" "1262410-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "Heart Attack 2 days after 2nd dose of moderna vaccine - followed by death" "1262410-1" "1262410-1" "STENT PLACEMENT" "10048561" "65-79 years" "65-79" "Heart Attack 2 days after 2nd dose of moderna vaccine - followed by death" "1262914-1" "1262914-1" "ABNORMAL BEHAVIOUR" "10061422" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "BLOOD TEST ABNORMAL" "10061016" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "CARDIO-RESPIRATORY ARREST" "10007617" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "DEATH" "10011906" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "DISCOLOURED VOMIT" "10079120" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "EYE MOVEMENT DISORDER" "10061129" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "HALLUCINATION" "10019063" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "HEADACHE" "10019211" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "NAUSEA" "10028813" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "SCREAMING" "10039740" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1262914-1" "1262914-1" "VOMITING" "10047700" "65-79 years" "65-79" "pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated." "1264249-1" "1264249-1" "CHILLS" "10008531" "65-79 years" "65-79" "chills, dizziness. shortness of breath developed a few hours later ." "1264249-1" "1264249-1" "DIZZINESS" "10013573" "65-79 years" "65-79" "chills, dizziness. shortness of breath developed a few hours later ." "1264249-1" "1264249-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "chills, dizziness. shortness of breath developed a few hours later ." "1266405-1" "1266405-1" "ACUTE MYOCARDIAL INFARCTION" "10000891" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "ANGIOPLASTY" "10002475" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "ANTICOAGULANT THERAPY" "10053468" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "CHEST PAIN" "10008479" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "CORONARY ARTERY EMBOLISM" "10011084" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "HAEMODIALYSIS" "10018875" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "HEPARIN-INDUCED THROMBOCYTOPENIA TEST" "10050829" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "IMMUNOGLOBULIN THERAPY" "10069534" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "MULTIPLE ORGAN DYSFUNCTION SYNDROME" "10077361" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "PLATELET COUNT DECREASED" "10035528" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "PLATELET FACTOR 4" "10060192" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "PULMONARY EMBOLISM" "10037377" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "SUBARACHNOID HAEMORRHAGE" "10042316" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1266405-1" "1266405-1" "THROMBECTOMY" "10043530" "65-79 years" "65-79" "Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26." "1267350-1" "1267350-1" "ARTHRALGIA" "10003239" "65-79 years" "65-79" "Shortness of Breath Fever Body Pains - Shoulder, Hand pain" "1267350-1" "1267350-1" "DEATH" "10011906" "65-79 years" "65-79" "Shortness of Breath Fever Body Pains - Shoulder, Hand pain" "1267350-1" "1267350-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Shortness of Breath Fever Body Pains - Shoulder, Hand pain" "1267350-1" "1267350-1" "PAIN" "10033371" "65-79 years" "65-79" "Shortness of Breath Fever Body Pains - Shoulder, Hand pain" "1267350-1" "1267350-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" "Shortness of Breath Fever Body Pains - Shoulder, Hand pain" "1267350-1" "1267350-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Shortness of Breath Fever Body Pains - Shoulder, Hand pain" "1268373-1" "1268373-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "Patient collapsed and became unresponsive 24 hours after receiving second dose of vaccine." "1268373-1" "1268373-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient collapsed and became unresponsive 24 hours after receiving second dose of vaccine." "1268373-1" "1268373-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "Patient collapsed and became unresponsive 24 hours after receiving second dose of vaccine." "1268373-1" "1268373-1" "SYNCOPE" "10042772" "65-79 years" "65-79" "Patient collapsed and became unresponsive 24 hours after receiving second dose of vaccine." "1268373-1" "1268373-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Patient collapsed and became unresponsive 24 hours after receiving second dose of vaccine." "1271846-1" "1271846-1" "ABDOMINAL DISTENSION" "10000060" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "ABDOMINAL PAIN" "10000081" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "ACUTE KIDNEY INJURY" "10069339" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "ACUTE RESPIRATORY FAILURE" "10001053" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "CARDIAC FAILURE CONGESTIVE" "10007559" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "CHRONIC KIDNEY DISEASE" "10064848" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "CHRONIC LEFT VENTRICULAR FAILURE" "10063083" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "CHRONIC OBSTRUCTIVE PULMONARY DISEASE" "10009033" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "CORONARY ARTERY DISEASE" "10011078" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "FAILURE TO THRIVE" "10016165" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "MALNUTRITION" "10061273" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "MENTAL STATUS CHANGES" "10048294" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "METABOLIC ENCEPHALOPATHY" "10062190" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "RENAL TUBULAR NECROSIS" "10038540" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1271846-1" "1271846-1" "SEPTIC SHOCK" "10040070" "65-79 years" "65-79" "Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis." "1273174-1" "1273174-1" "DEATH" "10011906" "65-79 years" "65-79" "From one of the nurse vaccinators: the man who had a laryngectomy who gave me a hard time about an id when we first started..I was so happy to see his name on my list this morning. I saw that no one could contact him..I got into the building ..no answer at the door ..phone disconnected ..found the super..he died 3 weeks ago..he didn?t know cause..just emergent situation to hospital and passed." "1273487-1" "1273487-1" "BACK PAIN" "10003988" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "BEDRIDDEN" "10048948" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "BIOPSY" "10004720" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "CHILLS" "10008531" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "COMPUTERISED TOMOGRAM ABNORMAL" "10010235" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "DEATH" "10011906" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "HEADACHE" "10019211" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "LUNG NEOPLASM MALIGNANT" "10058467" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "MAGNETIC RESONANCE IMAGING ABNORMAL" "10078224" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "NEOPLASM MALIGNANT" "10028997" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "PAIN" "10033371" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1273487-1" "1273487-1" "X-RAY ABNORMAL" "10048065" "65-79 years" "65-79" "Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10" "1281748-1" "1281748-1" "AORTIC DISSECTION" "10002895" "65-79 years" "65-79" """"Janssen COVID-19 Vaccine EUA"" 3/18 twitching of foot...severe leg pain 7:45 PM 3/19 involved in a motor vehicle accident with cardiac arrest and a dissecting aortic aneurysm 12;45 PM"" "1281748-1" "1281748-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" """"Janssen COVID-19 Vaccine EUA"" 3/18 twitching of foot...severe leg pain 7:45 PM 3/19 involved in a motor vehicle accident with cardiac arrest and a dissecting aortic aneurysm 12;45 PM"" "1281748-1" "1281748-1" "MUSCLE TWITCHING" "10028347" "65-79 years" "65-79" """"Janssen COVID-19 Vaccine EUA"" 3/18 twitching of foot...severe leg pain 7:45 PM 3/19 involved in a motor vehicle accident with cardiac arrest and a dissecting aortic aneurysm 12;45 PM"" "1281748-1" "1281748-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" """"Janssen COVID-19 Vaccine EUA"" 3/18 twitching of foot...severe leg pain 7:45 PM 3/19 involved in a motor vehicle accident with cardiac arrest and a dissecting aortic aneurysm 12;45 PM"" "1281748-1" "1281748-1" "ROAD TRAFFIC ACCIDENT" "10039203" "65-79 years" "65-79" """"Janssen COVID-19 Vaccine EUA"" 3/18 twitching of foot...severe leg pain 7:45 PM 3/19 involved in a motor vehicle accident with cardiac arrest and a dissecting aortic aneurysm 12;45 PM"" "1282517-1" "1282517-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282517-1" "1282517-1" "COMMUNICATION DISORDER" "10061046" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282517-1" "1282517-1" "COVID-19" "10084268" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282517-1" "1282517-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282517-1" "1282517-1" "DISORIENTATION" "10013395" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282517-1" "1282517-1" "GAIT DISTURBANCE" "10017577" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282517-1" "1282517-1" "MALAISE" "10025482" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282517-1" "1282517-1" "MOBILITY DECREASED" "10048334" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282517-1" "1282517-1" "OXYGEN SATURATION DECREASED" "10033318" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282517-1" "1282517-1" "PRODUCTIVE COUGH" "10036790" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1282517-1" "1282517-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)" "1286114-1" "1286114-1" "AORTIC DISSECTION" "10002895" "65-79 years" "65-79" "At 11:30am on April 6th my dad had a type A Aortic Dissection. He was rushed in an ambulence to Hospital. 4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery. Dr. performed the surgery which my dad survived. He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery. While in the ICU, he contracted pneumonia and his lungs and kidneys began declining. 20 days after the aortic dissection he died in the hospital." "1286114-1" "1286114-1" "CARDIAC OPERATION" "10061026" "65-79 years" "65-79" "At 11:30am on April 6th my dad had a type A Aortic Dissection. He was rushed in an ambulence to Hospital. 4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery. Dr. performed the surgery which my dad survived. He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery. While in the ICU, he contracted pneumonia and his lungs and kidneys began declining. 20 days after the aortic dissection he died in the hospital." "1286114-1" "1286114-1" "CEREBROVASCULAR ACCIDENT" "10008190" "65-79 years" "65-79" "At 11:30am on April 6th my dad had a type A Aortic Dissection. He was rushed in an ambulence to Hospital. 4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery. Dr. performed the surgery which my dad survived. He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery. While in the ICU, he contracted pneumonia and his lungs and kidneys began declining. 20 days after the aortic dissection he died in the hospital." "1286114-1" "1286114-1" "DEATH" "10011906" "65-79 years" "65-79" "At 11:30am on April 6th my dad had a type A Aortic Dissection. He was rushed in an ambulence to Hospital. 4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery. Dr. performed the surgery which my dad survived. He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery. While in the ICU, he contracted pneumonia and his lungs and kidneys began declining. 20 days after the aortic dissection he died in the hospital." "1286114-1" "1286114-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "At 11:30am on April 6th my dad had a type A Aortic Dissection. He was rushed in an ambulence to Hospital. 4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery. Dr. performed the surgery which my dad survived. He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery. While in the ICU, he contracted pneumonia and his lungs and kidneys began declining. 20 days after the aortic dissection he died in the hospital." "1286114-1" "1286114-1" "LUNG DISORDER" "10025082" "65-79 years" "65-79" "At 11:30am on April 6th my dad had a type A Aortic Dissection. He was rushed in an ambulence to Hospital. 4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery. Dr. performed the surgery which my dad survived. He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery. While in the ICU, he contracted pneumonia and his lungs and kidneys began declining. 20 days after the aortic dissection he died in the hospital." "1286114-1" "1286114-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "At 11:30am on April 6th my dad had a type A Aortic Dissection. He was rushed in an ambulence to Hospital. 4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery. Dr. performed the surgery which my dad survived. He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery. While in the ICU, he contracted pneumonia and his lungs and kidneys began declining. 20 days after the aortic dissection he died in the hospital." "1286114-1" "1286114-1" "RENAL IMPAIRMENT" "10062237" "65-79 years" "65-79" "At 11:30am on April 6th my dad had a type A Aortic Dissection. He was rushed in an ambulence to Hospital. 4 hours later, they evaluated him and sent him by medivac to Hospital for emergency open heart surgery. Dr. performed the surgery which my dad survived. He continued to have additional complications in the ICU including a right brain stroke which may have happened during surgery. While in the ICU, he contracted pneumonia and his lungs and kidneys began declining. 20 days after the aortic dissection he died in the hospital." "1286158-1" "1286158-1" "CHEST DISCOMFORT" "10008469" "65-79 years" "65-79" "Pt had an appointment with her cardiologist 4/15/2021 and no changes in patient's health noted states daughter. Patient performed yard work at noon 4/16/2021 and developed chest tightness that was relieved by rest. After patient's nap at noon no more chest discomfort occurred. Patient went to bed that night and husband noted she was sleeping comfortbly with no breathing difficulties at midnight. At 3 am husband found patient cold and she had expired." "1286158-1" "1286158-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt had an appointment with her cardiologist 4/15/2021 and no changes in patient's health noted states daughter. Patient performed yard work at noon 4/16/2021 and developed chest tightness that was relieved by rest. After patient's nap at noon no more chest discomfort occurred. Patient went to bed that night and husband noted she was sleeping comfortbly with no breathing difficulties at midnight. At 3 am husband found patient cold and she had expired." "1286158-1" "1286158-1" "PERIPHERAL COLDNESS" "10034568" "65-79 years" "65-79" "Pt had an appointment with her cardiologist 4/15/2021 and no changes in patient's health noted states daughter. Patient performed yard work at noon 4/16/2021 and developed chest tightness that was relieved by rest. After patient's nap at noon no more chest discomfort occurred. Patient went to bed that night and husband noted she was sleeping comfortbly with no breathing difficulties at midnight. At 3 am husband found patient cold and she had expired." "1286592-1" "1286592-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "received both of his doses of the Pfizer COVID vaccine . Had a migraine after the first dose, and a mild headache after the second dose. Unclear whether or not he suffered chronic migraines, although there was paperwork at the death scene stating that he had an appointment for a MRI on 3/1/21. No recent influenza-like symptoms are reported. He was found dead in his home on 2/22/21, seated at a chair at his desk. Autopsy findings include an enlarged and dilated heart, granular kidneys, with the right kidney very shrunken and about half the size of the left kidney, and prostate hypertrophy. There is no trauma. The airway is not edematous. Ancillary studies that are pending include microscopy, toxicology (basic testing plus vitreous chemistries), a COVID swab, a respiratory viral panel swab, HIV testing, and neuropathology. The cause and manner of death on the death certificate will both be ?pending further studies? until these studies are completed." "1286592-1" "1286592-1" "BENIGN PROSTATIC HYPERPLASIA" "10004446" "65-79 years" "65-79" "received both of his doses of the Pfizer COVID vaccine . Had a migraine after the first dose, and a mild headache after the second dose. Unclear whether or not he suffered chronic migraines, although there was paperwork at the death scene stating that he had an appointment for a MRI on 3/1/21. No recent influenza-like symptoms are reported. He was found dead in his home on 2/22/21, seated at a chair at his desk. Autopsy findings include an enlarged and dilated heart, granular kidneys, with the right kidney very shrunken and about half the size of the left kidney, and prostate hypertrophy. There is no trauma. The airway is not edematous. Ancillary studies that are pending include microscopy, toxicology (basic testing plus vitreous chemistries), a COVID swab, a respiratory viral panel swab, HIV testing, and neuropathology. The cause and manner of death on the death certificate will both be ?pending further studies? until these studies are completed." "1286592-1" "1286592-1" "CARDIOMEGALY" "10007632" "65-79 years" "65-79" "received both of his doses of the Pfizer COVID vaccine . Had a migraine after the first dose, and a mild headache after the second dose. Unclear whether or not he suffered chronic migraines, although there was paperwork at the death scene stating that he had an appointment for a MRI on 3/1/21. No recent influenza-like symptoms are reported. He was found dead in his home on 2/22/21, seated at a chair at his desk. Autopsy findings include an enlarged and dilated heart, granular kidneys, with the right kidney very shrunken and about half the size of the left kidney, and prostate hypertrophy. There is no trauma. The airway is not edematous. Ancillary studies that are pending include microscopy, toxicology (basic testing plus vitreous chemistries), a COVID swab, a respiratory viral panel swab, HIV testing, and neuropathology. The cause and manner of death on the death certificate will both be ?pending further studies? until these studies are completed." "1286592-1" "1286592-1" "DEATH" "10011906" "65-79 years" "65-79" "received both of his doses of the Pfizer COVID vaccine . Had a migraine after the first dose, and a mild headache after the second dose. Unclear whether or not he suffered chronic migraines, although there was paperwork at the death scene stating that he had an appointment for a MRI on 3/1/21. No recent influenza-like symptoms are reported. He was found dead in his home on 2/22/21, seated at a chair at his desk. Autopsy findings include an enlarged and dilated heart, granular kidneys, with the right kidney very shrunken and about half the size of the left kidney, and prostate hypertrophy. There is no trauma. The airway is not edematous. Ancillary studies that are pending include microscopy, toxicology (basic testing plus vitreous chemistries), a COVID swab, a respiratory viral panel swab, HIV testing, and neuropathology. The cause and manner of death on the death certificate will both be ?pending further studies? until these studies are completed." "1286592-1" "1286592-1" "HEADACHE" "10019211" "65-79 years" "65-79" "received both of his doses of the Pfizer COVID vaccine . Had a migraine after the first dose, and a mild headache after the second dose. Unclear whether or not he suffered chronic migraines, although there was paperwork at the death scene stating that he had an appointment for a MRI on 3/1/21. No recent influenza-like symptoms are reported. He was found dead in his home on 2/22/21, seated at a chair at his desk. Autopsy findings include an enlarged and dilated heart, granular kidneys, with the right kidney very shrunken and about half the size of the left kidney, and prostate hypertrophy. There is no trauma. The airway is not edematous. Ancillary studies that are pending include microscopy, toxicology (basic testing plus vitreous chemistries), a COVID swab, a respiratory viral panel swab, HIV testing, and neuropathology. The cause and manner of death on the death certificate will both be ?pending further studies? until these studies are completed." "1286592-1" "1286592-1" "KIDNEY SMALL" "10023435" "65-79 years" "65-79" "received both of his doses of the Pfizer COVID vaccine . Had a migraine after the first dose, and a mild headache after the second dose. Unclear whether or not he suffered chronic migraines, although there was paperwork at the death scene stating that he had an appointment for a MRI on 3/1/21. No recent influenza-like symptoms are reported. He was found dead in his home on 2/22/21, seated at a chair at his desk. Autopsy findings include an enlarged and dilated heart, granular kidneys, with the right kidney very shrunken and about half the size of the left kidney, and prostate hypertrophy. There is no trauma. The airway is not edematous. Ancillary studies that are pending include microscopy, toxicology (basic testing plus vitreous chemistries), a COVID swab, a respiratory viral panel swab, HIV testing, and neuropathology. The cause and manner of death on the death certificate will both be ?pending further studies? until these studies are completed." "1286592-1" "1286592-1" "NEPHROSCLEROSIS" "10029159" "65-79 years" "65-79" "received both of his doses of the Pfizer COVID vaccine . Had a migraine after the first dose, and a mild headache after the second dose. Unclear whether or not he suffered chronic migraines, although there was paperwork at the death scene stating that he had an appointment for a MRI on 3/1/21. No recent influenza-like symptoms are reported. He was found dead in his home on 2/22/21, seated at a chair at his desk. Autopsy findings include an enlarged and dilated heart, granular kidneys, with the right kidney very shrunken and about half the size of the left kidney, and prostate hypertrophy. There is no trauma. The airway is not edematous. Ancillary studies that are pending include microscopy, toxicology (basic testing plus vitreous chemistries), a COVID swab, a respiratory viral panel swab, HIV testing, and neuropathology. The cause and manner of death on the death certificate will both be ?pending further studies? until these studies are completed." "1286629-1" "1286629-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1286629-1" "1286629-1" "BACK PAIN" "10003988" "65-79 years" "65-79" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1286629-1" "1286629-1" "DEATH" "10011906" "65-79 years" "65-79" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1286629-1" "1286629-1" "HISTOLOGY ABNORMAL" "10062059" "65-79 years" "65-79" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1286629-1" "1286629-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1286629-1" "1286629-1" "NAUSEA" "10028813" "65-79 years" "65-79" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1286629-1" "1286629-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1286629-1" "1286629-1" "TOXICOLOGIC TEST NORMAL" "10061383" "65-79 years" "65-79" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1286629-1" "1286629-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1286629-1" "1286629-1" "VOMITING" "10047700" "65-79 years" "65-79" "had second dose of Pfizer vaccine on 2/4 at 15:00, had back pain, nausea and vomiting around 18:00, went to the ER around midnight with abdominal symptoms and stable VS, and went unresponsive and was pronounced on 2/5 at 6:23 am. Dr. did the autopsy over the weekend. At autopsy, he has remote myocardial infarcts and what appears very recent myocardial infarct. Quick tox was negative for drugs. No hemorrhage or signs of inflammation in the injection site (right shoulder). No other findings. Cause and manner of death are currently pending for extensive histology and viral testing. F/u from OCME on 2/22/2021: histology slides and decedent has myocardial infarct. He will be signed out as such. Covid swab is negative" "1289378-1" "1289378-1" "ABDOMINAL PAIN" "10000081" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "ACUTE MYOCARDIAL INFARCTION" "10000891" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "ARTERIOSCLEROSIS" "10003210" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "HISTOLOGY ABNORMAL" "10062059" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "HYPERTENSION" "10020772" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "INSOMNIA" "10022437" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "TOXICOLOGIC TEST NORMAL" "10061383" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1289378-1" "1289378-1" "VOMITING" "10047700" "65-79 years" "65-79" "Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination." "1290894-1" "1290894-1" "DEATH" "10011906" "65-79 years" "65-79" "My sister died on 4-28-2021" "1295164-1" "1295164-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient's wife called today to inform us that her husband passed away on 04/17/2021. Patient experienced some side effects after receiving both doses of Moderna vaccine such as body ache and feeling of lethargy. Patient was taken to the hospital around 04/16/2021. Exact cause of the death is not known as wife did not want to get autopsy done." "1295164-1" "1295164-1" "LETHARGY" "10024264" "65-79 years" "65-79" "Patient's wife called today to inform us that her husband passed away on 04/17/2021. Patient experienced some side effects after receiving both doses of Moderna vaccine such as body ache and feeling of lethargy. Patient was taken to the hospital around 04/16/2021. Exact cause of the death is not known as wife did not want to get autopsy done." "1295164-1" "1295164-1" "PAIN" "10033371" "65-79 years" "65-79" "Patient's wife called today to inform us that her husband passed away on 04/17/2021. Patient experienced some side effects after receiving both doses of Moderna vaccine such as body ache and feeling of lethargy. Patient was taken to the hospital around 04/16/2021. Exact cause of the death is not known as wife did not want to get autopsy done." "1295200-1" "1295200-1" "ACUTE KIDNEY INJURY" "10069339" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "ANTICOAGULANT THERAPY" "10053468" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "CHEST TUBE INSERTION" "10050522" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "COVID-19" "10084268" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "ENCEPHALOPATHY" "10014625" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "PERIPHERAL ISCHAEMIA" "10034576" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "RENAL REPLACEMENT THERAPY" "10074746" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "SHOCK" "10040560" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1295200-1" "1295200-1" "THROMBECTOMY" "10043530" "65-79 years" "65-79" "Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29." "1297350-1" "1297350-1" "DEATH" "10011906" "65-79 years" "65-79" "My father in law died one day after his COVID vaccine. His doctor did not seem to care. She ruled it natural causes. She did not order an autopsy. He did have underlying heart conditions, but the timing of his death was suspicious." "1300070-1" "1300070-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Pt. arrived the hospital on 5/1/21 c/o SOB. Within a few hours, she went into cardiac arrest and was resuscitated. Pt. was placed on a Ventilator. She expired on 5/4/21." "1300070-1" "1300070-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt. arrived the hospital on 5/1/21 c/o SOB. Within a few hours, she went into cardiac arrest and was resuscitated. Pt. was placed on a Ventilator. She expired on 5/4/21." "1300070-1" "1300070-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Pt. arrived the hospital on 5/1/21 c/o SOB. Within a few hours, she went into cardiac arrest and was resuscitated. Pt. was placed on a Ventilator. She expired on 5/4/21." "1300070-1" "1300070-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "Pt. arrived the hospital on 5/1/21 c/o SOB. Within a few hours, she went into cardiac arrest and was resuscitated. Pt. was placed on a Ventilator. She expired on 5/4/21." "1300070-1" "1300070-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "Pt. arrived the hospital on 5/1/21 c/o SOB. Within a few hours, she went into cardiac arrest and was resuscitated. Pt. was placed on a Ventilator. She expired on 5/4/21." "1306869-1" "1306869-1" "ACUTE CORONARY SYNDROME" "10051592" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "ACUTE RESPIRATORY DISTRESS SYNDROME" "10001052" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "ALCOHOL USE" "10048921" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "CENTRAL VENOUS CATHETERISATION" "10053377" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "COVID-19" "10084268" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "DEATH" "10011906" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "HYPOTENSION" "10021097" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "HYPOTHERMIA" "10021113" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "LIFE SUPPORT" "10024447" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "MULTIPLE ORGAN DYSFUNCTION SYNDROME" "10077361" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "PULSELESS ELECTRICAL ACTIVITY" "10058151" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "SEPTIC SHOCK" "10040070" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "SUBSTANCE USE" "10070964" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "SUPRAVENTRICULAR TACHYCARDIA" "10042604" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "TOXICOLOGIC TEST ABNORMAL" "10061382" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1306869-1" "1306869-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support." "1311665-1" "1311665-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "Subject suffered a massive heart attack while mowing the law . May be attributable to the Covid vaccine as the subject had been to the cardiologist prior to both vaccine and EKG and Stress test were perfectly normal" "1311693-1" "1311693-1" "AGITATION" "10001497" "65-79 years" "65-79" "Patient was giventhe Janseen covid vaccine on 5/5. Apparently the patient 6 days later was reportedly aggitated had hallucinations and trouble breathing. The patient proceeded to lay down to rest. The patient never awoke." "1311693-1" "1311693-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient was giventhe Janseen covid vaccine on 5/5. Apparently the patient 6 days later was reportedly aggitated had hallucinations and trouble breathing. The patient proceeded to lay down to rest. The patient never awoke." "1311693-1" "1311693-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Patient was giventhe Janseen covid vaccine on 5/5. Apparently the patient 6 days later was reportedly aggitated had hallucinations and trouble breathing. The patient proceeded to lay down to rest. The patient never awoke." "1311693-1" "1311693-1" "HALLUCINATION" "10019063" "65-79 years" "65-79" "Patient was giventhe Janseen covid vaccine on 5/5. Apparently the patient 6 days later was reportedly aggitated had hallucinations and trouble breathing. The patient proceeded to lay down to rest. The patient never awoke." "1314603-1" "1314603-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "BACK PAIN" "10003988" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "BLOOD TEST NORMAL" "10050540" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "CHILLS" "10008531" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "DEATH" "10011906" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "DYSGEUSIA" "10013911" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "ILLNESS" "10080284" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "LOSS OF CONSCIOUSNESS" "10024855" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "NAUSEA" "10028813" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1314603-1" "1314603-1" "VOMITING" "10047700" "65-79 years" "65-79" "Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter." "1315815-1" "1315815-1" "ANGIOGRAM" "10061637" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "AORTIC VALVE SCLEROSIS" "10002917" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "ASTHENIA" "10003549" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "ATRIAL FIBRILLATION" "10003658" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "CHEST X-RAY" "10008498" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "CORONARY ARTERY DISEASE" "10011078" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "DIARRHOEA" "10012735" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "DRUG INEFFECTIVE" "10013709" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "DYSPHONIA" "10013952" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "DYSPNOEA EXERTIONAL" "10013971" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "ECHOCARDIOGRAM" "10014113" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "FATIGUE" "10016256" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "HEADACHE" "10019211" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "HEART RATE" "10019299" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "HYPERDYNAMIC LEFT VENTRICLE" "10068359" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "HYPOTENSION" "10021097" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "HYPOXIA" "10021143" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "IMMUNE-MEDIATED LUNG DISEASE" "10085352" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "INTENTIONAL PRODUCT USE ISSUE" "10076308" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "INTERSTITIAL LUNG DISEASE" "10022611" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "MALAISE" "10025482" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "MITRAL VALVE INCOMPETENCE" "10027727" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "MUSCULAR WEAKNESS" "10028372" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "NAUSEA" "10028813" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "PULMONARY ARTERIAL PRESSURE" "10060196" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "PULMONARY FIBROSIS" "10037383" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "PULMONARY OEDEMA" "10037423" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "RIGHT ATRIAL DILATATION" "10067282" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "RIGHT VENTRICULAR FAILURE" "10039163" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "THERAPEUTIC PRODUCT EFFECT INCOMPLETE" "10082200" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "TRICUSPID VALVE INCOMPETENCE" "10044640" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "ULTRASOUND SCAN" "10045434" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "UNEVALUABLE EVENT" "10062355" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "VOMITING" "10047700" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1315815-1" "1315815-1" "WHITE BLOOD CELL COUNT" "10047939" "65-79 years" "65-79" ""Dysphonia; Intentional product use issue; dyspnea on exertion; pulmonary edema; immune mediated pneumonitis; right ventricular failure; atrial fibrillation; hyperdynamic left ventricle; mitral valve incompetence; Interstitial lung disease; Tricuspid valve incompetence; Pulmonary fibrosis; Hypoxia; Hypotension; Unevaluable event; Headache; Therapeutic product effect incomplete; Drug ineffective; Vomiting; Asthenia; Diarrhoea; Nausea; pneumonia; Right atrial dilatation; Aortic valve sclerosis; Coronary artery disease; Malaise; Muscular weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Hypoxia), DYSPNOEA EXERTIONAL (dyspnea on exertion), PULMONARY OEDEMA (pulmonary edema), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis), RIGHT VENTRICULAR FAILURE (right ventricular failure), ATRIAL FIBRILLATION (atrial fibrillation), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle), MITRAL VALVE INCOMPETENCE (mitral valve incompetence), INTERSTITIAL LUNG DISEASE (Interstitial lung disease), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence), PULMONARY FIBROSIS (Pulmonary fibrosis), INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue), DYSPHONIA (Dysphonia) and HYPOTENSION (Hypotension) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) for Myasthenic syndrome. The patient's past medical history included Pulmonary arterial pressure abnormal on 03-Jul-2018, Migraine (Ever since he was a kid), Headache, Small cell lung cancer metastatic (In liver and lymph nodes; brain metastases; right-sided pulmonary nodules), Metastases to liver, Metastases to lymph nodes (One measurable mediastinal lymph node; lymphadenopathy), Gait disturbance, Metastases to central nervous system, Muscular weakness and Radiotherapy (of his head and lung for his cancer). Concurrent medical conditions included Myasthenic syndrome (Cannot walk without FIRDAPSE). Concomitant products included PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81) and FUROSEMIDE for an unknown indication. On 18-Sep-2020, the patient started AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) (Oral) 10 milligram three times a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOXIA (Hypoxia) (seriousness criteria death, hospitalization and medically significant), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death and hospitalization), IMMUNE-MEDIATED LUNG DISEASE (immune mediated pneumonitis) (seriousness criteria death and hospitalization), RIGHT VENTRICULAR FAILURE (right ventricular failure) (seriousness criteria death, hospitalization and medically significant), ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria death, hospitalization and medically significant), HYPERDYNAMIC LEFT VENTRICLE (hyperdynamic left ventricle) (seriousness criteria death, hospitalization and medically significant), MITRAL VALVE INCOMPETENCE (mitral valve incompetence) (seriousness criteria death, hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (Interstitial lung disease) (seriousness criteria death and hospitalization), TRICUSPID VALVE INCOMPETENCE (Tricuspid valve incompetence) (seriousness criteria death, hospitalization and medically significant), PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criteria death, hospitalization and medically significant), DYSPHONIA (Dysphonia) (seriousness criteria death and hospitalization), HYPOTENSION (Hypotension) (seriousness criteria death and hospitalization), PNEUMONIA (pneumonia), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced DYSPNOEA EXERTIONAL (dyspnea on exertion) (seriousness criteria death and hospitalization), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) (seriousness criteria death and hospitalization), UNEVALUABLE EVENT (Unevaluable event), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient was hospitalized from 27-Jan-2021 to 15-Feb-2021 due to DYSPHONIA, then from 31-Jan-2021 to 15-Feb-2021 due to ATRIAL FIBRILLATION, DYSPNOEA EXERTIONAL, HYPERDYNAMIC LEFT VENTRICLE, HYPOTENSION, HYPOXIA, IMMUNE-MEDIATED LUNG DISEASE, INTENTIONAL PRODUCT USE ISSUE, INTERSTITIAL LUNG DISEASE, MITRAL VALVE INCOMPETENCE, PULMONARY FIBROSIS, PULMONARY OEDEMA, RIGHT VENTRICULAR FAILURE and TRICUSPID VALVE INCOMPETENCE. The last dose administered for AMIFAMPRIDINE PHOSPHATE (FIRDAPSE) was on 18-Feb-2021. The patient died on 19-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PNEUMONIA (pneumonia), UNEVALUABLE EVENT (Unevaluable event), ASTHENIA (Asthenia), DIARRHOEA (Diarrhoea), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Therapeutic product effect incomplete), DRUG INEFFECTIVE (Drug ineffective), RIGHT ATRIAL DILATATION (Right atrial dilatation), AORTIC VALVE SCLEROSIS (Aortic valve sclerosis), CORONARY ARTERY DISEASE (Coronary artery disease), MALAISE (Malaise), MUSCULAR WEAKNESS (Muscular weakness), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2018, Pulmonary arterial pressure: pulmonary arterial pressure elevated (High) Pulmonary arterial pressure elevated. In 2021, Angiogram: no evidence for central pulmonary embolus. (Inconclusive) No evidence for central pulmonary embolus. Slight interval decrease in the patient's 2 previously identified right sided pulmonary nodules. Slight decrease in the one measurable mediastinal lymph node. The patient's other lymphadenopathy is probably also improved but difficult to measure due to the technique. Worsening airspace disease in a somewhat interstitial pattern. Pulmonary edema would be the first consideration. Infection would be the second consideration. Severe centrilobar and paraseptal emphysema with basilar predominately peripheral reticular opacities consistent with fibrotic lung disease.. In 2021, Chest X-ray: no infiltrate (Inconclusive) no infiltrate. In 2021, Echocardiogram: severe right atrial ventricular dilatation with... (abnormal) Severe right atrial ventricular dilatation with reduced RV systolic function (""D"" sign). Small and under-filled left ventricle with hyperdynamic systolic function, estimated LVEF is 75%. Minimal aortic valve sclerosis with no stenosis. Moderate mitral and tricuspid valve regurgitation. Estimated PA systolic pressure is severely elevated (68.6 mmHg). Compared to the prior report dated 7/3/2018; there is a worsening right heart dilatation and function. There is increased mitral and tricuspid valve regurgitation. No significant change in estimated PA pressure.. In 2021, Heart rate: abnormal (abnormal) abnormal. In 2021, Pulmonary arterial pressure: 68.6 mmhg (High) Severely elevated. In 2021, Ultrasound scan: no evidence of deep venous thrombosis in the... (Inconclusive) No evidence of deep venous thrombosis in the bilateral lower extremities. In 2021, White blood cell count: no leukocytosis (Inconclusive) No leukocytosis. Concomitant medications included unknown statins. On 02-0CT-2020, Co- suspect drug chemotherapy is given to the patient to treat small cell lung cancer metastatic, Metastases to liver and Metastases to lymph nodes. On an unspecified date(s) in 2021, the patient had radiation of his head and lung for his cancer. Initially on 18-SEP-2020,the patient started with 10mg of firdapse , On 02-OCT-2020, the dose increased to 20mg. On 22-SEP-2020, while in the hospital the patient experienced blood pressure fluctuations. the patient experienced a headache that was ""4/10.Treatment medications included acetaminophen; aspirin; caffeine and ibuprofen for headache, treated with prednisone 60mg and methyl prednisolone for immune mediated pneumonitis,On an unspecified date, the patient was treated with midodrine, patient was cautiously diuresed with IV furosemide bolus dosing followed by gtt (drip) given ""soft pressures. the patient was treated with low dose diltiazem For paroxysmal a-fib (atrial fibrillation) and MAT (medication-assisted treatment). patient was initially given amiodarone 400mg daily x 7 days for blood pressure, then the dose reduced to 200mg, On an unspecified date, patient was treated with low dose metoprolol (12.5 mg), patient was treated with Xarelto (rivaroxaban) 15 mg daily for stroke risk reduction.On an unspecified date, the patient's diuretic (presumed IV Lasix drip) was transitioned to torsemide 5 mg, orally daily.patient received atovaquone for PJP (Pneumocystis jiroveci pneumonia) prophylaxis and treated with empiric antibiotics for CAP (community acquired pneumonia). On unspecified date, steroid regimen was increased.On an unspecified date, the patient's respiratory symptoms improved and was weaned to 2 liters of oxygen. While hospitalized, the patient received non drug treatment like PT (physical therapy) and OT (occupational therapy), the patient was treated with supplemental O2 (oxygen) and IVF (intravenous fluids). Company Comment: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and the vaccination date has been provided at this time. A contributory role of the concurrent medical conditions and medical history is considerable. A causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death"" "1316583-1" "1316583-1" "CEREBRAL HAEMORRHAGE" "10008111" "65-79 years" "65-79" "Couldn't Breath, Died due to Blood Clots on Lungs, Bilateral Pulmonary Embolism, Bleeding on the Brain." "1316583-1" "1316583-1" "PULMONARY EMBOLISM" "10037377" "65-79 years" "65-79" "Couldn't Breath, Died due to Blood Clots on Lungs, Bilateral Pulmonary Embolism, Bleeding on the Brain." "1316583-1" "1316583-1" "PULMONARY THROMBOSIS" "10037437" "65-79 years" "65-79" "Couldn't Breath, Died due to Blood Clots on Lungs, Bilateral Pulmonary Embolism, Bleeding on the Brain." "1316583-1" "1316583-1" "RESPIRATORY ARREST" "10038669" "65-79 years" "65-79" "Couldn't Breath, Died due to Blood Clots on Lungs, Bilateral Pulmonary Embolism, Bleeding on the Brain." "1323057-1" "1323057-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "Death" "1323057-1" "1323057-1" "DEATH" "10011906" "65-79 years" "65-79" "Death" "1327132-1" "1327132-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Cardiac Arrest" "1330697-1" "1330697-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient died 4/28/2021" "1330956-1" "1330956-1" "DEATH" "10011906" "65-79 years" "65-79" "on 4/20/21, 9 am (24hrs after receiving the second shot, he complained that the couldn't breath and his throat hurt, we gave him some tylenol,) then we call 911 by 3pm because he looked pale. by 6pm we were told that he was going uptown, because he might need a ventilator. Then at 12:30 a.m. on 4/21/21 we were told he was alert and in emergency diaylsis and he should be okay. Then they called us at 8 a.m. to say that he had passed away due to a heart attack." "1330956-1" "1330956-1" "DIALYSIS" "10061105" "65-79 years" "65-79" "on 4/20/21, 9 am (24hrs after receiving the second shot, he complained that the couldn't breath and his throat hurt, we gave him some tylenol,) then we call 911 by 3pm because he looked pale. by 6pm we were told that he was going uptown, because he might need a ventilator. Then at 12:30 a.m. on 4/21/21 we were told he was alert and in emergency diaylsis and he should be okay. Then they called us at 8 a.m. to say that he had passed away due to a heart attack." "1330956-1" "1330956-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "on 4/20/21, 9 am (24hrs after receiving the second shot, he complained that the couldn't breath and his throat hurt, we gave him some tylenol,) then we call 911 by 3pm because he looked pale. by 6pm we were told that he was going uptown, because he might need a ventilator. Then at 12:30 a.m. on 4/21/21 we were told he was alert and in emergency diaylsis and he should be okay. Then they called us at 8 a.m. to say that he had passed away due to a heart attack." "1330956-1" "1330956-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "on 4/20/21, 9 am (24hrs after receiving the second shot, he complained that the couldn't breath and his throat hurt, we gave him some tylenol,) then we call 911 by 3pm because he looked pale. by 6pm we were told that he was going uptown, because he might need a ventilator. Then at 12:30 a.m. on 4/21/21 we were told he was alert and in emergency diaylsis and he should be okay. Then they called us at 8 a.m. to say that he had passed away due to a heart attack." "1330956-1" "1330956-1" "OROPHARYNGEAL PAIN" "10068319" "65-79 years" "65-79" "on 4/20/21, 9 am (24hrs after receiving the second shot, he complained that the couldn't breath and his throat hurt, we gave him some tylenol,) then we call 911 by 3pm because he looked pale. by 6pm we were told that he was going uptown, because he might need a ventilator. Then at 12:30 a.m. on 4/21/21 we were told he was alert and in emergency diaylsis and he should be okay. Then they called us at 8 a.m. to say that he had passed away due to a heart attack." "1330956-1" "1330956-1" "PALLOR" "10033546" "65-79 years" "65-79" "on 4/20/21, 9 am (24hrs after receiving the second shot, he complained that the couldn't breath and his throat hurt, we gave him some tylenol,) then we call 911 by 3pm because he looked pale. by 6pm we were told that he was going uptown, because he might need a ventilator. Then at 12:30 a.m. on 4/21/21 we were told he was alert and in emergency diaylsis and he should be okay. Then they called us at 8 a.m. to say that he had passed away due to a heart attack." "1334899-1" "1334899-1" "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "65-79 years" "65-79" "Grand mal seizure; encephalopathy" "1334899-1" "1334899-1" "ENCEPHALOPATHY" "10014625" "65-79 years" "65-79" "Grand mal seizure; encephalopathy" "1334899-1" "1334899-1" "GENERALISED TONIC-CLONIC SEIZURE" "10018100" "65-79 years" "65-79" "Grand mal seizure; encephalopathy" "1334899-1" "1334899-1" "MAGNETIC RESONANCE IMAGING HEAD ABNORMAL" "10085256" "65-79 years" "65-79" "Grand mal seizure; encephalopathy" "1337251-1" "1337251-1" "ANGIOGRAM PULMONARY ABNORMAL" "10002441" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "BLOOD GLUCOSE INCREASED" "10005557" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "CHEST PAIN" "10008479" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "COMPUTERISED TOMOGRAM ABDOMEN NORMAL" "10057800" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "COVID-19" "10084268" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "CYANOSIS" "10011703" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "DEATH" "10011906" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "HAEMORRHAGE INTRACRANIAL" "10018985" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "HYPOTENSION" "10021097" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "HYPOXIA" "10021143" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "MENTAL STATUS CHANGES" "10048294" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "PLATELET COUNT NORMAL" "10035530" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "PULMONARY EMBOLISM" "10037377" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1337251-1" "1337251-1" "TROPONIN NORMAL" "10071322" "65-79 years" "65-79" "To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital." "1347843-1" "1347843-1" "AGEUSIA" "10001480" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "ANOSMIA" "10002653" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "APNOEA" "10002974" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "ATRIAL FIBRILLATION" "10003658" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BLOOD BICARBONATE NORMAL" "10005361" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BLOOD CHLORIDE DECREASED" "10005419" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BLOOD CREATININE INCREASED" "10005483" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BLOOD GLUCOSE NORMAL" "10005558" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BLOOD LACTIC ACID" "10005632" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BLOOD POTASSIUM DECREASED" "10005724" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BLOOD SODIUM DECREASED" "10005802" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BLOOD UREA INCREASED" "10005851" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BRONCHIAL WALL THICKENING" "10067182" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BRONCHITIS" "10006451" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "BUNDLE BRANCH BLOCK LEFT" "10006580" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "CHEST PAIN" "10008479" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "COUGH" "10011224" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "COVID-19" "10084268" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "DEATH" "10011906" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "ELECTROCARDIOGRAM ABNORMAL" "10014363" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "HAEMODIALYSIS" "10018875" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "HEART RATE IRREGULAR" "10019304" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "INFLUENZA A VIRUS TEST NEGATIVE" "10070417" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "INFLUENZA B VIRUS TEST" "10071544" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "LABILE BLOOD PRESSURE" "10023533" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "RENAL IMPAIRMENT" "10062237" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "RENAL REPLACEMENT THERAPY" "10074746" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "TRANSCUTANEOUS PACING" "10083519" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "TROPONIN I INCREASED" "10058268" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1347843-1" "1347843-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21." "1351679-1" "1351679-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Difficulty Breathing, Pain" "1351679-1" "1351679-1" "PAIN" "10033371" "65-79 years" "65-79" "Difficulty Breathing, Pain" "1352518-1" "1352518-1" "AUTOIMMUNE HAEMOLYTIC ANAEMIA" "10073785" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1352518-1" "1352518-1" "DEATH" "10011906" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1352518-1" "1352518-1" "DIALYSIS" "10061105" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1352518-1" "1352518-1" "DIZZINESS" "10013573" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1352518-1" "1352518-1" "FATIGUE" "10016256" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1352518-1" "1352518-1" "HAEMOGLOBIN DECREASED" "10018884" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1352518-1" "1352518-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1352518-1" "1352518-1" "LABORATORY TEST" "10059938" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1352518-1" "1352518-1" "SPLENECTOMY" "10041642" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1352518-1" "1352518-1" "TRANSFUSION" "10066152" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1352518-1" "1352518-1" "VOMITING" "10047700" "65-79 years" "65-79" "My father had a reaction soon after the first dose in which he vomited violently. The vomiting continued over the next several months but less frequent along with dizziness and fatigue. On April 10 he was admitted to the emergency room with low hemoglobin numbers. Things quickly escalated from there. He was admitted to the ICU and diagnosed with autoimmune hemolytic anemia. After a month in the ICU, over 60 blood transfusions, 20 dialysis, multiple pharmaceutical treatments and a splenectomy, my father died on May 13." "1354740-1" "1354740-1" "DEATH" "10011906" "65-79 years" "65-79" "Death" "1354978-1" "1354978-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "He received the vaccine and had a heart attack on May 3, 2021 and passed away on May 4th. They did an full autopsy" "1354978-1" "1354978-1" "DEATH" "10011906" "65-79 years" "65-79" "He received the vaccine and had a heart attack on May 3, 2021 and passed away on May 4th. They did an full autopsy" "1354978-1" "1354978-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "He received the vaccine and had a heart attack on May 3, 2021 and passed away on May 4th. They did an full autopsy" "1359313-1" "1359313-1" "CEREBRAL THROMBOSIS" "10008132" "65-79 years" "65-79" "My husband had a stroke on 01/25/2021, with one large blood clot and many small blood clots. He was put on a ventilator until 02/06/2021 when I asked to have it removed. I died within 5 minutes after it being removed." "1359313-1" "1359313-1" "CEREBROVASCULAR ACCIDENT" "10008190" "65-79 years" "65-79" "My husband had a stroke on 01/25/2021, with one large blood clot and many small blood clots. He was put on a ventilator until 02/06/2021 when I asked to have it removed. I died within 5 minutes after it being removed." "1359313-1" "1359313-1" "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "65-79 years" "65-79" "My husband had a stroke on 01/25/2021, with one large blood clot and many small blood clots. He was put on a ventilator until 02/06/2021 when I asked to have it removed. I died within 5 minutes after it being removed." "1359313-1" "1359313-1" "DEATH" "10011906" "65-79 years" "65-79" "My husband had a stroke on 01/25/2021, with one large blood clot and many small blood clots. He was put on a ventilator until 02/06/2021 when I asked to have it removed. I died within 5 minutes after it being removed." "1359313-1" "1359313-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "My husband had a stroke on 01/25/2021, with one large blood clot and many small blood clots. He was put on a ventilator until 02/06/2021 when I asked to have it removed. I died within 5 minutes after it being removed." "1361035-1" "1361035-1" "ADAMTS13 ACTIVITY NORMAL" "10074492" "65-79 years" "65-79" "3 days post vaccine, patient developed progressive DOE. Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary. TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died." "1361035-1" "1361035-1" "CARCINOEMBRYONIC ANTIGEN INCREASED" "10007266" "65-79 years" "65-79" "3 days post vaccine, patient developed progressive DOE. Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary. TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died." "1361035-1" "1361035-1" "CATHETERISATION CARDIAC" "10007815" "65-79 years" "65-79" "3 days post vaccine, patient developed progressive DOE. Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary. TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died." "1361035-1" "1361035-1" "DEATH" "10011906" "65-79 years" "65-79" "3 days post vaccine, patient developed progressive DOE. Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary. TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died." "1361035-1" "1361035-1" "DYSPNOEA EXERTIONAL" "10013971" "65-79 years" "65-79" "3 days post vaccine, patient developed progressive DOE. Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary. TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died." "1361035-1" "1361035-1" "ECHOCARDIOGRAM ABNORMAL" "10061593" "65-79 years" "65-79" "3 days post vaccine, patient developed progressive DOE. Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary. TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died." "1361035-1" "1361035-1" "MICROANGIOPATHIC HAEMOLYTIC ANAEMIA" "10027527" "65-79 years" "65-79" "3 days post vaccine, patient developed progressive DOE. Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary. TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died." "1361035-1" "1361035-1" "PULMONARY HYPERTENSION" "10037400" "65-79 years" "65-79" "3 days post vaccine, patient developed progressive DOE. Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary. TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died." "1361035-1" "1361035-1" "VASODILATATION" "10047141" "65-79 years" "65-79" "3 days post vaccine, patient developed progressive DOE. Ultimately dx with microagiopathic hemolytic anemia and severe pulmonary HTN thought to be pre- and post capillary. TTP ruled out with normal ADAMTS 13, attempted IV vasodilation but ultimately died." "1362251-1" "1362251-1" "ABDOMINAL DISCOMFORT" "10000059" "65-79 years" "65-79" "Upset stomach and vomiting. Shortness of breath. Pressure in chest. Heart attack and DEATH." "1362251-1" "1362251-1" "CHEST DISCOMFORT" "10008469" "65-79 years" "65-79" "Upset stomach and vomiting. Shortness of breath. Pressure in chest. Heart attack and DEATH." "1362251-1" "1362251-1" "DEATH" "10011906" "65-79 years" "65-79" "Upset stomach and vomiting. Shortness of breath. Pressure in chest. Heart attack and DEATH." "1362251-1" "1362251-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Upset stomach and vomiting. Shortness of breath. Pressure in chest. Heart attack and DEATH." "1362251-1" "1362251-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "Upset stomach and vomiting. Shortness of breath. Pressure in chest. Heart attack and DEATH." "1362251-1" "1362251-1" "VOMITING" "10047700" "65-79 years" "65-79" "Upset stomach and vomiting. Shortness of breath. Pressure in chest. Heart attack and DEATH." "1367997-1" "1367997-1" "DEATH" "10011906" "65-79 years" "65-79" "Massive Heart Attack resulting in death." "1367997-1" "1367997-1" "ELECTROCARDIOGRAM ABNORMAL" "10014363" "65-79 years" "65-79" "Massive Heart Attack resulting in death." "1367997-1" "1367997-1" "LABORATORY TEST" "10059938" "65-79 years" "65-79" "Massive Heart Attack resulting in death." "1367997-1" "1367997-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "Massive Heart Attack resulting in death." "1369968-1" "1369968-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Fatigue on 6/2/21 followed by cardiac arrest & death" "1369968-1" "1369968-1" "DEATH" "10011906" "65-79 years" "65-79" "Fatigue on 6/2/21 followed by cardiac arrest & death" "1369968-1" "1369968-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Fatigue on 6/2/21 followed by cardiac arrest & death" "1374104-1" "1374104-1" "DEATH" "10011906" "65-79 years" "65-79" "Died 2/26/2021" "1381212-1" "1381212-1" "ABDOMINAL PAIN UPPER" "10000087" "65-79 years" "65-79" "Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure" "1381212-1" "1381212-1" "BACK DISORDER" "10003983" "65-79 years" "65-79" "Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure" "1381212-1" "1381212-1" "COVID-19" "10084268" "65-79 years" "65-79" "Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure" "1381212-1" "1381212-1" "DRUG INEFFECTIVE" "10013709" "65-79 years" "65-79" "Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure" "1381212-1" "1381212-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure" "1381212-1" "1381212-1" "ENDOSCOPY" "10014805" "65-79 years" "65-79" "Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure" "1381212-1" "1381212-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure" "1381212-1" "1381212-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure" "1381212-1" "1381212-1" "SARS-COV-2 TEST" "10084354" "65-79 years" "65-79" "Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure" "1382410-1" "1382410-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient was hospitalized and passed away" "1382535-1" "1382535-1" "DEATH" "10011906" "65-79 years" "65-79" "Case was hospitalized and passed away. **2nd dose given 2/6/2021." "1382578-1" "1382578-1" "DEATH" "10011906" "65-79 years" "65-79" "case was hospitalized and passed away. **2nd dose 2/8/2021" "1382612-1" "1382612-1" "DEATH" "10011906" "65-79 years" "65-79" "case was hospitalized and passed away." "1382612-1" "1382612-1" "HOSPITALISATION" "10054112" "65-79 years" "65-79" "case was hospitalized and passed away." "1382641-1" "1382641-1" "BLINDNESS" "10005169" "65-79 years" "65-79" "Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went to the hospital after the eye doctor told her she had had a stroke. Eventually, after 4 trips to the hospital, 2 trips to rehab, we discovered the strokes apparently triggered non-convulsive seizures which they could never end up getting under control. She passed away on 31 May 2021." "1382641-1" "1382641-1" "CEREBROVASCULAR ACCIDENT" "10008190" "65-79 years" "65-79" "Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went to the hospital after the eye doctor told her she had had a stroke. Eventually, after 4 trips to the hospital, 2 trips to rehab, we discovered the strokes apparently triggered non-convulsive seizures which they could never end up getting under control. She passed away on 31 May 2021." "1382641-1" "1382641-1" "COMPUTERISED TOMOGRAM" "10010234" "65-79 years" "65-79" "Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went to the hospital after the eye doctor told her she had had a stroke. Eventually, after 4 trips to the hospital, 2 trips to rehab, we discovered the strokes apparently triggered non-convulsive seizures which they could never end up getting under control. She passed away on 31 May 2021." "1382641-1" "1382641-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went to the hospital after the eye doctor told her she had had a stroke. Eventually, after 4 trips to the hospital, 2 trips to rehab, we discovered the strokes apparently triggered non-convulsive seizures which they could never end up getting under control. She passed away on 31 May 2021." "1382641-1" "1382641-1" "ELECTROENCEPHALOGRAM" "10014407" "65-79 years" "65-79" "Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went to the hospital after the eye doctor told her she had had a stroke. Eventually, after 4 trips to the hospital, 2 trips to rehab, we discovered the strokes apparently triggered non-convulsive seizures which they could never end up getting under control. She passed away on 31 May 2021." "1382641-1" "1382641-1" "MAGNETIC RESONANCE IMAGING" "10078223" "65-79 years" "65-79" "Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went to the hospital after the eye doctor told her she had had a stroke. Eventually, after 4 trips to the hospital, 2 trips to rehab, we discovered the strokes apparently triggered non-convulsive seizures which they could never end up getting under control. She passed away on 31 May 2021." "1382641-1" "1382641-1" "SEIZURE" "10039906" "65-79 years" "65-79" "Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went to the hospital after the eye doctor told her she had had a stroke. Eventually, after 4 trips to the hospital, 2 trips to rehab, we discovered the strokes apparently triggered non-convulsive seizures which they could never end up getting under control. She passed away on 31 May 2021." "1387032-1" "1387032-1" "AMNESIA" "10001949" "65-79 years" "65-79" "Dizziness, loss of memory, fatigue, and death 10 days later" "1387032-1" "1387032-1" "DEATH" "10011906" "65-79 years" "65-79" "Dizziness, loss of memory, fatigue, and death 10 days later" "1387032-1" "1387032-1" "DIZZINESS" "10013573" "65-79 years" "65-79" "Dizziness, loss of memory, fatigue, and death 10 days later" "1387032-1" "1387032-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Dizziness, loss of memory, fatigue, and death 10 days later" "1388182-1" "1388182-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388182-1" "1388182-1" "DEATH" "10011906" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388182-1" "1388182-1" "HEART RATE INCREASED" "10019303" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388182-1" "1388182-1" "INFECTION" "10021789" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388182-1" "1388182-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388182-1" "1388182-1" "OXYGEN SATURATION DECREASED" "10033318" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388182-1" "1388182-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388182-1" "1388182-1" "PNEUMONIA NECROTISING" "10055672" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388182-1" "1388182-1" "PNEUMONIA PSEUDOMONAL" "10035731" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388182-1" "1388182-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1388182-1" "1388182-1" "SEPSIS" "10040047" "65-79 years" "65-79" "Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital, and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections." "1398476-1" "1398476-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "Death; Felt like he was dying; Can't move; Hurting pain over the whole body; Weak; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), FEELING ABNORMAL (Felt like he was dying), MOVEMENT DISORDER (Can't move), PAIN (Hurting pain over the whole body) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 028L20A) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease in 2000 and Stroke (recovered) in 1992. Concurrent medical conditions included Diabetes since 2000, Blood pressure high (stable) since 1964, Atherosclerosis since 2016 and Heart attack (recovered) since 2019. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure, DULOXETINE for Depression, METFORMIN HYDROCHLORIDE for Diabetes, FERROUS SULFATE HEPTAHYDRATE (FERROUS SULFATE [FERROUS SULFATE HEPTAHYDRATE]) for Iron deficiency, LAMOTRIGINE for Seizure, ACETYLSALICYLIC ACID (ASPIRIN 81) from 18-Jul-2017 to an unknown date, CALCITRIOL, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE, VITAMIN B12 NOS, COLECALCIFEROL (VITAMIN D3 1000), INSULIN GLARGINE (LANTUS), ACITRETIN, ATORVASTATIN, LOSARTAN POTASSIUM (COZAAR), DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE (METFORMINE HCL) and LAMOTRIGINE for an unknown indication. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like he was dying) (seriousness criteria death and hospitalization), MOVEMENT DISORDER (Can't move) (seriousness criteria death and hospitalization), PAIN (Hurting pain over the whole body) (seriousness criteria death and hospitalization) and ASTHENIA (Weak) (seriousness criteria death and hospitalization). The patient was treated with TRAMADOL for Pain, at a dose of 50 mg; LORAZEPAM for Anxiety, at a dose of 0.5 mg and MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg. The patient died on 05-Mar-2021. The reported cause of death was heart and kidney failure and Kidney failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: unknown (Inconclusive) Inconclusive. This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received, includes patient's gender. On 07-Jun-2021: Follow up received, includes Patient information, historical conditions, batch number, cause of death, concomitant drugs.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Heart and kidney failure; kidney failure" "1398476-1" "1398476-1" "DEATH" "10011906" "65-79 years" "65-79" "Death; Felt like he was dying; Can't move; Hurting pain over the whole body; Weak; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), FEELING ABNORMAL (Felt like he was dying), MOVEMENT DISORDER (Can't move), PAIN (Hurting pain over the whole body) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 028L20A) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease in 2000 and Stroke (recovered) in 1992. Concurrent medical conditions included Diabetes since 2000, Blood pressure high (stable) since 1964, Atherosclerosis since 2016 and Heart attack (recovered) since 2019. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure, DULOXETINE for Depression, METFORMIN HYDROCHLORIDE for Diabetes, FERROUS SULFATE HEPTAHYDRATE (FERROUS SULFATE [FERROUS SULFATE HEPTAHYDRATE]) for Iron deficiency, LAMOTRIGINE for Seizure, ACETYLSALICYLIC ACID (ASPIRIN 81) from 18-Jul-2017 to an unknown date, CALCITRIOL, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE, VITAMIN B12 NOS, COLECALCIFEROL (VITAMIN D3 1000), INSULIN GLARGINE (LANTUS), ACITRETIN, ATORVASTATIN, LOSARTAN POTASSIUM (COZAAR), DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE (METFORMINE HCL) and LAMOTRIGINE for an unknown indication. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like he was dying) (seriousness criteria death and hospitalization), MOVEMENT DISORDER (Can't move) (seriousness criteria death and hospitalization), PAIN (Hurting pain over the whole body) (seriousness criteria death and hospitalization) and ASTHENIA (Weak) (seriousness criteria death and hospitalization). The patient was treated with TRAMADOL for Pain, at a dose of 50 mg; LORAZEPAM for Anxiety, at a dose of 0.5 mg and MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg. The patient died on 05-Mar-2021. The reported cause of death was heart and kidney failure and Kidney failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: unknown (Inconclusive) Inconclusive. This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received, includes patient's gender. On 07-Jun-2021: Follow up received, includes Patient information, historical conditions, batch number, cause of death, concomitant drugs.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Heart and kidney failure; kidney failure" "1398476-1" "1398476-1" "FEELING ABNORMAL" "10016322" "65-79 years" "65-79" "Death; Felt like he was dying; Can't move; Hurting pain over the whole body; Weak; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), FEELING ABNORMAL (Felt like he was dying), MOVEMENT DISORDER (Can't move), PAIN (Hurting pain over the whole body) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 028L20A) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease in 2000 and Stroke (recovered) in 1992. Concurrent medical conditions included Diabetes since 2000, Blood pressure high (stable) since 1964, Atherosclerosis since 2016 and Heart attack (recovered) since 2019. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure, DULOXETINE for Depression, METFORMIN HYDROCHLORIDE for Diabetes, FERROUS SULFATE HEPTAHYDRATE (FERROUS SULFATE [FERROUS SULFATE HEPTAHYDRATE]) for Iron deficiency, LAMOTRIGINE for Seizure, ACETYLSALICYLIC ACID (ASPIRIN 81) from 18-Jul-2017 to an unknown date, CALCITRIOL, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE, VITAMIN B12 NOS, COLECALCIFEROL (VITAMIN D3 1000), INSULIN GLARGINE (LANTUS), ACITRETIN, ATORVASTATIN, LOSARTAN POTASSIUM (COZAAR), DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE (METFORMINE HCL) and LAMOTRIGINE for an unknown indication. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like he was dying) (seriousness criteria death and hospitalization), MOVEMENT DISORDER (Can't move) (seriousness criteria death and hospitalization), PAIN (Hurting pain over the whole body) (seriousness criteria death and hospitalization) and ASTHENIA (Weak) (seriousness criteria death and hospitalization). The patient was treated with TRAMADOL for Pain, at a dose of 50 mg; LORAZEPAM for Anxiety, at a dose of 0.5 mg and MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg. The patient died on 05-Mar-2021. The reported cause of death was heart and kidney failure and Kidney failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: unknown (Inconclusive) Inconclusive. This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received, includes patient's gender. On 07-Jun-2021: Follow up received, includes Patient information, historical conditions, batch number, cause of death, concomitant drugs.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Heart and kidney failure; kidney failure" "1398476-1" "1398476-1" "MOVEMENT DISORDER" "10028035" "65-79 years" "65-79" "Death; Felt like he was dying; Can't move; Hurting pain over the whole body; Weak; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), FEELING ABNORMAL (Felt like he was dying), MOVEMENT DISORDER (Can't move), PAIN (Hurting pain over the whole body) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 028L20A) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease in 2000 and Stroke (recovered) in 1992. Concurrent medical conditions included Diabetes since 2000, Blood pressure high (stable) since 1964, Atherosclerosis since 2016 and Heart attack (recovered) since 2019. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure, DULOXETINE for Depression, METFORMIN HYDROCHLORIDE for Diabetes, FERROUS SULFATE HEPTAHYDRATE (FERROUS SULFATE [FERROUS SULFATE HEPTAHYDRATE]) for Iron deficiency, LAMOTRIGINE for Seizure, ACETYLSALICYLIC ACID (ASPIRIN 81) from 18-Jul-2017 to an unknown date, CALCITRIOL, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE, VITAMIN B12 NOS, COLECALCIFEROL (VITAMIN D3 1000), INSULIN GLARGINE (LANTUS), ACITRETIN, ATORVASTATIN, LOSARTAN POTASSIUM (COZAAR), DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE (METFORMINE HCL) and LAMOTRIGINE for an unknown indication. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like he was dying) (seriousness criteria death and hospitalization), MOVEMENT DISORDER (Can't move) (seriousness criteria death and hospitalization), PAIN (Hurting pain over the whole body) (seriousness criteria death and hospitalization) and ASTHENIA (Weak) (seriousness criteria death and hospitalization). The patient was treated with TRAMADOL for Pain, at a dose of 50 mg; LORAZEPAM for Anxiety, at a dose of 0.5 mg and MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg. The patient died on 05-Mar-2021. The reported cause of death was heart and kidney failure and Kidney failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: unknown (Inconclusive) Inconclusive. This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received, includes patient's gender. On 07-Jun-2021: Follow up received, includes Patient information, historical conditions, batch number, cause of death, concomitant drugs.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Heart and kidney failure; kidney failure" "1398476-1" "1398476-1" "PAIN" "10033371" "65-79 years" "65-79" "Death; Felt like he was dying; Can't move; Hurting pain over the whole body; Weak; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), FEELING ABNORMAL (Felt like he was dying), MOVEMENT DISORDER (Can't move), PAIN (Hurting pain over the whole body) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 028L20A) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease in 2000 and Stroke (recovered) in 1992. Concurrent medical conditions included Diabetes since 2000, Blood pressure high (stable) since 1964, Atherosclerosis since 2016 and Heart attack (recovered) since 2019. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure, DULOXETINE for Depression, METFORMIN HYDROCHLORIDE for Diabetes, FERROUS SULFATE HEPTAHYDRATE (FERROUS SULFATE [FERROUS SULFATE HEPTAHYDRATE]) for Iron deficiency, LAMOTRIGINE for Seizure, ACETYLSALICYLIC ACID (ASPIRIN 81) from 18-Jul-2017 to an unknown date, CALCITRIOL, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE, VITAMIN B12 NOS, COLECALCIFEROL (VITAMIN D3 1000), INSULIN GLARGINE (LANTUS), ACITRETIN, ATORVASTATIN, LOSARTAN POTASSIUM (COZAAR), DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE (METFORMINE HCL) and LAMOTRIGINE for an unknown indication. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like he was dying) (seriousness criteria death and hospitalization), MOVEMENT DISORDER (Can't move) (seriousness criteria death and hospitalization), PAIN (Hurting pain over the whole body) (seriousness criteria death and hospitalization) and ASTHENIA (Weak) (seriousness criteria death and hospitalization). The patient was treated with TRAMADOL for Pain, at a dose of 50 mg; LORAZEPAM for Anxiety, at a dose of 0.5 mg and MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg. The patient died on 05-Mar-2021. The reported cause of death was heart and kidney failure and Kidney failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: unknown (Inconclusive) Inconclusive. This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received, includes patient's gender. On 07-Jun-2021: Follow up received, includes Patient information, historical conditions, batch number, cause of death, concomitant drugs.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Heart and kidney failure; kidney failure" "1398476-1" "1398476-1" "VITAL SIGNS MEASUREMENT" "10072952" "65-79 years" "65-79" "Death; Felt like he was dying; Can't move; Hurting pain over the whole body; Weak; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), FEELING ABNORMAL (Felt like he was dying), MOVEMENT DISORDER (Can't move), PAIN (Hurting pain over the whole body) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 028L20A) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease in 2000 and Stroke (recovered) in 1992. Concurrent medical conditions included Diabetes since 2000, Blood pressure high (stable) since 1964, Atherosclerosis since 2016 and Heart attack (recovered) since 2019. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure, DULOXETINE for Depression, METFORMIN HYDROCHLORIDE for Diabetes, FERROUS SULFATE HEPTAHYDRATE (FERROUS SULFATE [FERROUS SULFATE HEPTAHYDRATE]) for Iron deficiency, LAMOTRIGINE for Seizure, ACETYLSALICYLIC ACID (ASPIRIN 81) from 18-Jul-2017 to an unknown date, CALCITRIOL, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE, VITAMIN B12 NOS, COLECALCIFEROL (VITAMIN D3 1000), INSULIN GLARGINE (LANTUS), ACITRETIN, ATORVASTATIN, LOSARTAN POTASSIUM (COZAAR), DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE (METFORMINE HCL) and LAMOTRIGINE for an unknown indication. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL (Felt like he was dying) (seriousness criteria death and hospitalization), MOVEMENT DISORDER (Can't move) (seriousness criteria death and hospitalization), PAIN (Hurting pain over the whole body) (seriousness criteria death and hospitalization) and ASTHENIA (Weak) (seriousness criteria death and hospitalization). The patient was treated with TRAMADOL for Pain, at a dose of 50 mg; LORAZEPAM for Anxiety, at a dose of 0.5 mg and MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg. The patient died on 05-Mar-2021. The reported cause of death was heart and kidney failure and Kidney failure. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: unknown (Inconclusive) Inconclusive. This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received, includes patient's gender. On 07-Jun-2021: Follow up received, includes Patient information, historical conditions, batch number, cause of death, concomitant drugs.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with a history of Coronary artery disease and Stroke, who died of heart and kidney failure 19 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Heart and kidney failure; kidney failure" "1413086-1" "1413086-1" "CONFUSIONAL STATE" "10010305" "65-79 years" "65-79" "Coughing started about May 5, 2021, confusion started on about May 8, 2021, put on oxygen in Emergency room on May 9, 2021. Admitted to hospital where he stayed until his death on June 18, 2021." "1413086-1" "1413086-1" "COUGH" "10011224" "65-79 years" "65-79" "Coughing started about May 5, 2021, confusion started on about May 8, 2021, put on oxygen in Emergency room on May 9, 2021. Admitted to hospital where he stayed until his death on June 18, 2021." "1413086-1" "1413086-1" "DEATH" "10011906" "65-79 years" "65-79" "Coughing started about May 5, 2021, confusion started on about May 8, 2021, put on oxygen in Emergency room on May 9, 2021. Admitted to hospital where he stayed until his death on June 18, 2021." "1413086-1" "1413086-1" "SARS-COV-2 TEST" "10084354" "65-79 years" "65-79" "Coughing started about May 5, 2021, confusion started on about May 8, 2021, put on oxygen in Emergency room on May 9, 2021. Admitted to hospital where he stayed until his death on June 18, 2021." "1413141-1" "1413141-1" "ABNORMAL BEHAVIOUR" "10061422" "65-79 years" "65-79" "Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS." "1413141-1" "1413141-1" "BLOOD TEST" "10061726" "65-79 years" "65-79" "Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS." "1413141-1" "1413141-1" "COVID-19" "10084268" "65-79 years" "65-79" "Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS." "1413141-1" "1413141-1" "DELIRIUM" "10012218" "65-79 years" "65-79" "Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS." "1413141-1" "1413141-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS." "1413141-1" "1413141-1" "GAIT INABILITY" "10017581" "65-79 years" "65-79" "Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS." "1413141-1" "1413141-1" "HEADACHE" "10019211" "65-79 years" "65-79" "Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS." "1413141-1" "1413141-1" "LABORATORY TEST" "10059938" "65-79 years" "65-79" "Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS." "1413141-1" "1413141-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS." "1417294-1" "1417294-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "CARDIO-RESPIRATORY ARREST" "10007617" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "CHEST PAIN" "10008479" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "COVID-19" "10084268" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "HYPOXIC-ISCHAEMIC ENCEPHALOPATHY" "10070511" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "MYOCARDIAL NECROSIS MARKER INCREASED" "10075211" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "PYREXIA" "10037660" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "VACCINE BREAKTHROUGH INFECTION" "10067923" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417294-1" "1417294-1" "VENTRICULAR FIBRILLATION" "10047290" "65-79 years" "65-79" "I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM." "1417329-1" "1417329-1" "COVID-19" "10084268" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/5/21 after the completion of a full Pfizer vaccine series (Dose 1 on 12/28/20 and Dose 2 on 1/18/21). The patient later died on 4/9/21. Cause of Death is listed as ?Metastatic Rectal cancer?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION, DIABETES MELLITUS Comments: Spoke to the case adult daughter. She informed that the case resides at a rehabilitation center. The case's daughter stated that her mother is not having any symptoms and was fully vaccinated. The daughter did not have all the information on dates of vaccine. called center spoke to the administrator who provided the information. The case was at the hospital from 3/27-4/1. Rehab requires a (-) test result to return and a (-) test four days after returning. The case test (+) on her 4th day 4/5.nnn" "1417329-1" "1417329-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/5/21 after the completion of a full Pfizer vaccine series (Dose 1 on 12/28/20 and Dose 2 on 1/18/21). The patient later died on 4/9/21. Cause of Death is listed as ?Metastatic Rectal cancer?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION, DIABETES MELLITUS Comments: Spoke to the case adult daughter. She informed that the case resides at a rehabilitation center. The case's daughter stated that her mother is not having any symptoms and was fully vaccinated. The daughter did not have all the information on dates of vaccine. called center spoke to the administrator who provided the information. The case was at the hospital from 3/27-4/1. Rehab requires a (-) test result to return and a (-) test four days after returning. The case test (+) on her 4th day 4/5.nnn" "1417329-1" "1417329-1" "RECTAL CANCER METASTATIC" "10055097" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/5/21 after the completion of a full Pfizer vaccine series (Dose 1 on 12/28/20 and Dose 2 on 1/18/21). The patient later died on 4/9/21. Cause of Death is listed as ?Metastatic Rectal cancer?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION, DIABETES MELLITUS Comments: Spoke to the case adult daughter. She informed that the case resides at a rehabilitation center. The case's daughter stated that her mother is not having any symptoms and was fully vaccinated. The daughter did not have all the information on dates of vaccine. called center spoke to the administrator who provided the information. The case was at the hospital from 3/27-4/1. Rehab requires a (-) test result to return and a (-) test four days after returning. The case test (+) on her 4th day 4/5.nnn" "1417329-1" "1417329-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/5/21 after the completion of a full Pfizer vaccine series (Dose 1 on 12/28/20 and Dose 2 on 1/18/21). The patient later died on 4/9/21. Cause of Death is listed as ?Metastatic Rectal cancer?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION, DIABETES MELLITUS Comments: Spoke to the case adult daughter. She informed that the case resides at a rehabilitation center. The case's daughter stated that her mother is not having any symptoms and was fully vaccinated. The daughter did not have all the information on dates of vaccine. called center spoke to the administrator who provided the information. The case was at the hospital from 3/27-4/1. Rehab requires a (-) test result to return and a (-) test four days after returning. The case test (+) on her 4th day 4/5.nnn" "1422836-1" "1422836-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021." "1422836-1" "1422836-1" "COUGH" "10011224" "65-79 years" "65-79" "Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021." "1422836-1" "1422836-1" "DEATH" "10011906" "65-79 years" "65-79" "Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021." "1422836-1" "1422836-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021." "1422836-1" "1422836-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021." "1422836-1" "1422836-1" "NASOPHARYNGITIS" "10028810" "65-79 years" "65-79" "Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021." "1422836-1" "1422836-1" "SLEEP DISORDER" "10040984" "65-79 years" "65-79" "Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021." "1422836-1" "1422836-1" "WEIGHT INCREASED" "10047899" "65-79 years" "65-79" "Slight cold on day of vaccine. The doctor said give him the vaccine anyway. Patient woke up the next morning with a cold that did not go away. He started gaining a lot of weight (10pounds in 2 weeks), he couldn?t sleep laying on his back, he was fatigued, coughing, short of breath. He passed away May 27th, 2021." "1424124-1" "1424124-1" "DEATH" "10011906" "65-79 years" "65-79" "The pharmacist was contacted by patients daughter on 6/23/2021. She said that patient was found deceased on the morning of 6/20/2021. They believe he passed away sometime on 6/19/2021." "1426140-1" "1426140-1" "SUDDEN DEATH" "10042434" "65-79 years" "65-79" "On Saturday, 2/27/21, a little over 24 hours after receiving vaccine, sudden death occurred." "1427108-1" "1427108-1" "COVID-19" "10084268" "65-79 years" "65-79" "COVID symptoms began 3/16, positive test 3/19, hospital admission 3/22, death 4/1" "1427108-1" "1427108-1" "DEATH" "10011906" "65-79 years" "65-79" "COVID symptoms began 3/16, positive test 3/19, hospital admission 3/22, death 4/1" "1427108-1" "1427108-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "COVID symptoms began 3/16, positive test 3/19, hospital admission 3/22, death 4/1" "1427462-1" "1427462-1" "DEATH" "10011906" "65-79 years" "65-79" "Client did not have immediate adverse event following vaccine administration. Client died on 6/11/2021, approximately 8 weeks after receiving COVID19 Janssen vaccine. Cause of death is unknown by this reporter." "1427664-1" "1427664-1" "COVID-19" "10084268" "65-79 years" "65-79" "Died 3/6/2021" "1427664-1" "1427664-1" "DEATH" "10011906" "65-79 years" "65-79" "Died 3/6/2021" "1427664-1" "1427664-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Died 3/6/2021" "1427697-1" "1427697-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "Tested positive for COVID-19 on 3/7, likely an incidental finding. Died of liver cancer 3/17." "1427697-1" "1427697-1" "COVID-19" "10084268" "65-79 years" "65-79" "Tested positive for COVID-19 on 3/7, likely an incidental finding. Died of liver cancer 3/17." "1427697-1" "1427697-1" "DEATH" "10011906" "65-79 years" "65-79" "Tested positive for COVID-19 on 3/7, likely an incidental finding. Died of liver cancer 3/17." "1427697-1" "1427697-1" "HEPATIC CANCER" "10073069" "65-79 years" "65-79" "Tested positive for COVID-19 on 3/7, likely an incidental finding. Died of liver cancer 3/17." "1427697-1" "1427697-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Tested positive for COVID-19 on 3/7, likely an incidental finding. Died of liver cancer 3/17." "1427848-1" "1427848-1" "COVID-19" "10084268" "65-79 years" "65-79" "Symptom onset 4/12, hospital admission date 4/19, died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to COVID-19, hepatic encephalopathy, liver cirrhosis" "1427848-1" "1427848-1" "DEATH" "10011906" "65-79 years" "65-79" "Symptom onset 4/12, hospital admission date 4/19, died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to COVID-19, hepatic encephalopathy, liver cirrhosis" "1427848-1" "1427848-1" "HEPATIC CIRRHOSIS" "10019641" "65-79 years" "65-79" "Symptom onset 4/12, hospital admission date 4/19, died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to COVID-19, hepatic encephalopathy, liver cirrhosis" "1427848-1" "1427848-1" "HEPATIC ENCEPHALOPATHY" "10019660" "65-79 years" "65-79" "Symptom onset 4/12, hospital admission date 4/19, died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to COVID-19, hepatic encephalopathy, liver cirrhosis" "1427848-1" "1427848-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Symptom onset 4/12, hospital admission date 4/19, died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to COVID-19, hepatic encephalopathy, liver cirrhosis" "1427848-1" "1427848-1" "SEPSIS" "10040047" "65-79 years" "65-79" "Symptom onset 4/12, hospital admission date 4/19, died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to COVID-19, hepatic encephalopathy, liver cirrhosis" "1427858-1" "1427858-1" "COVID-19" "10084268" "65-79 years" "65-79" "COVID-19 symptom onset 4/23, hospital admission date 4/30, died 5/14. Primary cause of death COVID-19 viral pneumonia" "1427858-1" "1427858-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "COVID-19 symptom onset 4/23, hospital admission date 4/30, died 5/14. Primary cause of death COVID-19 viral pneumonia" "1427858-1" "1427858-1" "DEATH" "10011906" "65-79 years" "65-79" "COVID-19 symptom onset 4/23, hospital admission date 4/30, died 5/14. Primary cause of death COVID-19 viral pneumonia" "1427858-1" "1427858-1" "PNEUMONIA VIRAL" "10035737" "65-79 years" "65-79" "COVID-19 symptom onset 4/23, hospital admission date 4/30, died 5/14. Primary cause of death COVID-19 viral pneumonia" "1427858-1" "1427858-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "COVID-19 symptom onset 4/23, hospital admission date 4/30, died 5/14. Primary cause of death COVID-19 viral pneumonia" "1427870-1" "1427870-1" "ACUTE RESPIRATORY FAILURE" "10001053" "65-79 years" "65-79" "COVID-19 symptom onset 5/3, hospital admission 5/11, and death on 5/18/2021. Primary cause of death acute hypoxic respiratory failure, underlying cause COVID-19 viral pneumonia" "1427870-1" "1427870-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "COVID-19 symptom onset 5/3, hospital admission 5/11, and death on 5/18/2021. Primary cause of death acute hypoxic respiratory failure, underlying cause COVID-19 viral pneumonia" "1427870-1" "1427870-1" "DEATH" "10011906" "65-79 years" "65-79" "COVID-19 symptom onset 5/3, hospital admission 5/11, and death on 5/18/2021. Primary cause of death acute hypoxic respiratory failure, underlying cause COVID-19 viral pneumonia" "1427870-1" "1427870-1" "PNEUMONIA VIRAL" "10035737" "65-79 years" "65-79" "COVID-19 symptom onset 5/3, hospital admission 5/11, and death on 5/18/2021. Primary cause of death acute hypoxic respiratory failure, underlying cause COVID-19 viral pneumonia" "1427870-1" "1427870-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "COVID-19 symptom onset 5/3, hospital admission 5/11, and death on 5/18/2021. Primary cause of death acute hypoxic respiratory failure, underlying cause COVID-19 viral pneumonia" "1432196-1" "1432196-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432196-1" "1432196-1" "DEATH" "10011906" "65-79 years" "65-79" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432196-1" "1432196-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432196-1" "1432196-1" "INFLUENZA LIKE ILLNESS" "10022004" "65-79 years" "65-79" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432196-1" "1432196-1" "LUNG DISORDER" "10025082" "65-79 years" "65-79" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432196-1" "1432196-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432196-1" "1432196-1" "OXYGEN SATURATION DECREASED" "10033318" "65-79 years" "65-79" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432196-1" "1432196-1" "PARAESTHESIA" "10033775" "65-79 years" "65-79" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432196-1" "1432196-1" "RENAL FAILURE" "10038435" "65-79 years" "65-79" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432196-1" "1432196-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it." "1432207-1" "1432207-1" "APHASIA" "10002948" "65-79 years" "65-79" "Trouble speaking, cold chills, hot flashes. Death on 5/21" "1432207-1" "1432207-1" "CHILLS" "10008531" "65-79 years" "65-79" "Trouble speaking, cold chills, hot flashes. Death on 5/21" "1432207-1" "1432207-1" "DEATH" "10011906" "65-79 years" "65-79" "Trouble speaking, cold chills, hot flashes. Death on 5/21" "1432207-1" "1432207-1" "HOT FLUSH" "10060800" "65-79 years" "65-79" "Trouble speaking, cold chills, hot flashes. Death on 5/21" "1432736-1" "1432736-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Death; Cardiac arrest; Fatigue; This case was received on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), CARDIAC ARREST (Cardiac arrest) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Hemodialysis. Concurrent medical conditions included Chronic kidney disease (On HD). On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant) and FATIGUE (Fatigue) (seriousness criterion death). The patient died on 02-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment/concomitant medications were reported. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Unknown cause of death" "1432736-1" "1432736-1" "DEATH" "10011906" "65-79 years" "65-79" "Death; Cardiac arrest; Fatigue; This case was received on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), CARDIAC ARREST (Cardiac arrest) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Hemodialysis. Concurrent medical conditions included Chronic kidney disease (On HD). On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant) and FATIGUE (Fatigue) (seriousness criterion death). The patient died on 02-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment/concomitant medications were reported. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Unknown cause of death" "1432736-1" "1432736-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Death; Cardiac arrest; Fatigue; This case was received on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), CARDIAC ARREST (Cardiac arrest) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Hemodialysis. Concurrent medical conditions included Chronic kidney disease (On HD). On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant) and FATIGUE (Fatigue) (seriousness criterion death). The patient died on 02-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment/concomitant medications were reported. Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Unknown cause of death" "1433128-1" "1433128-1" "CHEST TUBE INSERTION" "10050522" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "CHILLS" "10008531" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "COUGH" "10011224" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "COVID-19" "10084268" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "DIARRHOEA" "10012735" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "NEUROMUSCULAR BLOCKADE" "10029315" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "PNEUMOMEDIASTINUM" "10050184" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "PNEUMOTHORAX" "10035759" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "SARS-COV-2 ANTIBODY TEST" "10084501" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433128-1" "1433128-1" "SEDATION" "10039897" "65-79 years" "65-79" "Patient developed dyspnea, diarrhea, chills and cough. Presented at the ED on 06/11 and was found to be COVID-19 positive. Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB, flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple pressors, and full vent support, the patient continued to decline and remained with increasing pressor requirements. He suffered severe pneumomediastinum and bilateral pneumothoraces requiring bilateral chest tubes" "1433741-1" "1433741-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient found unresponsive at home, CPR administered by EMS/ER, patient deceased." "1433741-1" "1433741-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "Patient found unresponsive at home, CPR administered by EMS/ER, patient deceased." "1433741-1" "1433741-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "Patient found unresponsive at home, CPR administered by EMS/ER, patient deceased." "1434080-1" "1434080-1" "DEATH" "10011906" "65-79 years" "65-79" "2nd vaccine given 2/19/2021" "1440841-1" "1440841-1" "CYANOSIS" "10011703" "65-79 years" "65-79" "secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30" "1440841-1" "1440841-1" "DEATH" "10011906" "65-79 years" "65-79" "secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30" "1440841-1" "1440841-1" "HYPOTONIA" "10021118" "65-79 years" "65-79" "secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30" "1440841-1" "1440841-1" "PALLOR" "10033546" "65-79 years" "65-79" "secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30" "1440841-1" "1440841-1" "SECRETION DISCHARGE" "10053459" "65-79 years" "65-79" "secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30" "1440841-1" "1440841-1" "VOMITING" "10047700" "65-79 years" "65-79" "secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30" "1445766-1" "1445766-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "she died from a blood clot that ran into her heart; felt very very tired; nauseas for the first couple of days; nauseas for the first couple of daysdidn't eat well for the first couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart), FATIGUE (felt very very tired), NAUSEA (nauseas for the first couple of days) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced NAUSEA (nauseas for the first couple of days) (seriousness criterion death) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) (seriousness criterion death). On 04-Apr-2021, the patient experienced FATIGUE (felt very very tired) (seriousness criterion death). On 08-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart) (seriousness criteria death and medically significant). The patient died on 08-Apr-2021. The reported cause of death was she died from a blood clot that ran into her heart. It is unknown if an autopsy was performed. As per source document the patient received the 2nd dose on 4 or 5 April 2021 and she died from a blood clot that ran into her heart on 8Apr2021. Treatment medication was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Relevant concomitant medications were not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: she died from a blood clot that ran into her heart" "1445766-1" "1445766-1" "FATIGUE" "10016256" "65-79 years" "65-79" "she died from a blood clot that ran into her heart; felt very very tired; nauseas for the first couple of days; nauseas for the first couple of daysdidn't eat well for the first couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart), FATIGUE (felt very very tired), NAUSEA (nauseas for the first couple of days) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced NAUSEA (nauseas for the first couple of days) (seriousness criterion death) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) (seriousness criterion death). On 04-Apr-2021, the patient experienced FATIGUE (felt very very tired) (seriousness criterion death). On 08-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart) (seriousness criteria death and medically significant). The patient died on 08-Apr-2021. The reported cause of death was she died from a blood clot that ran into her heart. It is unknown if an autopsy was performed. As per source document the patient received the 2nd dose on 4 or 5 April 2021 and she died from a blood clot that ran into her heart on 8Apr2021. Treatment medication was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Relevant concomitant medications were not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: she died from a blood clot that ran into her heart" "1445766-1" "1445766-1" "INTRACARDIAC THROMBUS" "10048620" "65-79 years" "65-79" "she died from a blood clot that ran into her heart; felt very very tired; nauseas for the first couple of days; nauseas for the first couple of daysdidn't eat well for the first couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart), FATIGUE (felt very very tired), NAUSEA (nauseas for the first couple of days) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced NAUSEA (nauseas for the first couple of days) (seriousness criterion death) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) (seriousness criterion death). On 04-Apr-2021, the patient experienced FATIGUE (felt very very tired) (seriousness criterion death). On 08-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart) (seriousness criteria death and medically significant). The patient died on 08-Apr-2021. The reported cause of death was she died from a blood clot that ran into her heart. It is unknown if an autopsy was performed. As per source document the patient received the 2nd dose on 4 or 5 April 2021 and she died from a blood clot that ran into her heart on 8Apr2021. Treatment medication was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Relevant concomitant medications were not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: she died from a blood clot that ran into her heart" "1445766-1" "1445766-1" "NAUSEA" "10028813" "65-79 years" "65-79" "she died from a blood clot that ran into her heart; felt very very tired; nauseas for the first couple of days; nauseas for the first couple of daysdidn't eat well for the first couple of days; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart), FATIGUE (felt very very tired), NAUSEA (nauseas for the first couple of days) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced NAUSEA (nauseas for the first couple of days) (seriousness criterion death) and DECREASED APPETITE (nauseas for the first couple of daysdidn't eat well for the first couple of days) (seriousness criterion death). On 04-Apr-2021, the patient experienced FATIGUE (felt very very tired) (seriousness criterion death). On 08-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (she died from a blood clot that ran into her heart) (seriousness criteria death and medically significant). The patient died on 08-Apr-2021. The reported cause of death was she died from a blood clot that ran into her heart. It is unknown if an autopsy was performed. As per source document the patient received the 2nd dose on 4 or 5 April 2021 and she died from a blood clot that ran into her heart on 8Apr2021. Treatment medication was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Relevant concomitant medications were not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: she died from a blood clot that ran into her heart" "1446668-1" "1446668-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Patient died 5 days after receiving the covid vaccine of a heart attack or a blood clot that stop the heart" "1446668-1" "1446668-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient died 5 days after receiving the covid vaccine of a heart attack or a blood clot that stop the heart" "1446668-1" "1446668-1" "INTRACARDIAC THROMBUS" "10048620" "65-79 years" "65-79" "Patient died 5 days after receiving the covid vaccine of a heart attack or a blood clot that stop the heart" "1446668-1" "1446668-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "Patient died 5 days after receiving the covid vaccine of a heart attack or a blood clot that stop the heart" "1454169-1" "1454169-1" "DEATH" "10011906" "65-79 years" "65-79" "Death" "1457210-1" "1457210-1" "DEATH" "10011906" "65-79 years" "65-79" "Caller stated that she was contacted by Sherriff department that father called 911. When ambulance arrived they did CPR. When they took him to the hospital they perform CPR again. Father was pronounced dead at 1am." "1457210-1" "1457210-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "Caller stated that she was contacted by Sherriff department that father called 911. When ambulance arrived they did CPR. When they took him to the hospital they perform CPR again. Father was pronounced dead at 1am." "1457614-1" "1457614-1" "ABNORMAL BEHAVIOUR" "10061422" "65-79 years" "65-79" "Patient's wife states that he was not the same the evening after receiving the vaccine. She stated that he was unable to hold objects and his eyes were bulging from his head. He was going to a nursing facility after vaccination and later died on 7/4/21." "1457614-1" "1457614-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient's wife states that he was not the same the evening after receiving the vaccine. She stated that he was unable to hold objects and his eyes were bulging from his head. He was going to a nursing facility after vaccination and later died on 7/4/21." "1457614-1" "1457614-1" "EXOPHTHALMOS" "10015683" "65-79 years" "65-79" "Patient's wife states that he was not the same the evening after receiving the vaccine. She stated that he was unable to hold objects and his eyes were bulging from his head. He was going to a nursing facility after vaccination and later died on 7/4/21." "1457614-1" "1457614-1" "MOTOR DYSFUNCTION" "10061296" "65-79 years" "65-79" "Patient's wife states that he was not the same the evening after receiving the vaccine. She stated that he was unable to hold objects and his eyes were bulging from his head. He was going to a nursing facility after vaccination and later died on 7/4/21." "1459439-1" "1459439-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "CHEST X-RAY NORMAL" "10008500" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "COMPUTERISED TOMOGRAM THORAX ABNORMAL" "10057799" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "COUGH" "10011224" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "DIFFERENTIAL WHITE BLOOD CELL COUNT NORMAL" "10012787" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "FULL BLOOD COUNT NORMAL" "10017414" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "HAEMOPTYSIS" "10018964" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "MEDIASTINAL MASS" "10027076" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "METABOLIC FUNCTION TEST NORMAL" "10062192" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "PULMONARY MASS" "10056342" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1459439-1" "1459439-1" "WEIGHT DECREASED" "10047895" "65-79 years" "65-79" "Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family" "1464403-1" "1464403-1" "DEATH" "10011906" "65-79 years" "65-79" "As per patients family, approx 2 days after receiving Moderna Dose #2 Immunization( was received 5/13/21) patient developed soreness of Rt Arm, body ache, shortness of breath. Was sleeping upright in wheelchair.in order to breath easier. Family stated due to pt having polio as a child, he was fearful of hospitals and refused to have family call 911 These symptoms continued until 6/1/2021 when pt was found dead in wheelchair.by family." "1464403-1" "1464403-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "As per patients family, approx 2 days after receiving Moderna Dose #2 Immunization( was received 5/13/21) patient developed soreness of Rt Arm, body ache, shortness of breath. Was sleeping upright in wheelchair.in order to breath easier. Family stated due to pt having polio as a child, he was fearful of hospitals and refused to have family call 911 These symptoms continued until 6/1/2021 when pt was found dead in wheelchair.by family." "1464403-1" "1464403-1" "PAIN" "10033371" "65-79 years" "65-79" "As per patients family, approx 2 days after receiving Moderna Dose #2 Immunization( was received 5/13/21) patient developed soreness of Rt Arm, body ache, shortness of breath. Was sleeping upright in wheelchair.in order to breath easier. Family stated due to pt having polio as a child, he was fearful of hospitals and refused to have family call 911 These symptoms continued until 6/1/2021 when pt was found dead in wheelchair.by family." "1464403-1" "1464403-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" "As per patients family, approx 2 days after receiving Moderna Dose #2 Immunization( was received 5/13/21) patient developed soreness of Rt Arm, body ache, shortness of breath. Was sleeping upright in wheelchair.in order to breath easier. Family stated due to pt having polio as a child, he was fearful of hospitals and refused to have family call 911 These symptoms continued until 6/1/2021 when pt was found dead in wheelchair.by family." "1464775-1" "1464775-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "Death. It's not known if pt. died on March 31 or soon thereafter. His body was found on April 7, but he was incommunicado before that when I tried to contact him over the Easter weekend. He was found on the floor of his bedroom as if he were getting ready for bed and keeled over." "1464775-1" "1464775-1" "DEATH" "10011906" "65-79 years" "65-79" "Death. It's not known if pt. died on March 31 or soon thereafter. His body was found on April 7, but he was incommunicado before that when I tried to contact him over the Easter weekend. He was found on the floor of his bedroom as if he were getting ready for bed and keeled over." "1465600-1" "1465600-1" "ANAEMIA" "10002034" "65-79 years" "65-79" "Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna" "1465600-1" "1465600-1" "ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS" "10050894" "65-79 years" "65-79" "Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna" "1465600-1" "1465600-1" "BLOOD DISORDER" "10061590" "65-79 years" "65-79" "Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna" "1465600-1" "1465600-1" "DEATH" "10011906" "65-79 years" "65-79" "Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna" "1465600-1" "1465600-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna" "1465600-1" "1465600-1" "HYPOPHAGIA" "10063743" "65-79 years" "65-79" "Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna" "1465600-1" "1465600-1" "RENAL FAILURE" "10038435" "65-79 years" "65-79" "Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna" "1470106-1" "1470106-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "PATIENT ADMITTED TO HOSPITAL ON 6/25/21 DUE TO RESP DISTRESS. COVID TESTING POSITIVE. DIAGNOSED WITH COVID PNEUMONIA. ON 6/25/21 NAD 6/26/21. PATIENT DIED ON 7/8/2021." "1470106-1" "1470106-1" "DEATH" "10011906" "65-79 years" "65-79" "PATIENT ADMITTED TO HOSPITAL ON 6/25/21 DUE TO RESP DISTRESS. COVID TESTING POSITIVE. DIAGNOSED WITH COVID PNEUMONIA. ON 6/25/21 NAD 6/26/21. PATIENT DIED ON 7/8/2021." "1470106-1" "1470106-1" "RESPIRATORY DISTRESS" "10038687" "65-79 years" "65-79" "PATIENT ADMITTED TO HOSPITAL ON 6/25/21 DUE TO RESP DISTRESS. COVID TESTING POSITIVE. DIAGNOSED WITH COVID PNEUMONIA. ON 6/25/21 NAD 6/26/21. PATIENT DIED ON 7/8/2021." "1470106-1" "1470106-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "PATIENT ADMITTED TO HOSPITAL ON 6/25/21 DUE TO RESP DISTRESS. COVID TESTING POSITIVE. DIAGNOSED WITH COVID PNEUMONIA. ON 6/25/21 NAD 6/26/21. PATIENT DIED ON 7/8/2021." "1481780-1" "1481780-1" "BACK PAIN" "10003988" "65-79 years" "65-79" "lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1481780-1" "1481780-1" "CHILLS" "10008531" "65-79 years" "65-79" "lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1481780-1" "1481780-1" "DEATH" "10011906" "65-79 years" "65-79" "lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1481780-1" "1481780-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1481780-1" "1481780-1" "JOINT SWELLING" "10023232" "65-79 years" "65-79" "lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1481780-1" "1481780-1" "MOBILITY DECREASED" "10048334" "65-79 years" "65-79" "lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1481780-1" "1481780-1" "PERIPHERAL SWELLING" "10048959" "65-79 years" "65-79" "lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1481780-1" "1481780-1" "PULMONARY OEDEMA" "10037423" "65-79 years" "65-79" "lungs filled up with fluids; terrible pain in his back; couldn't lay had to sleep sat down; swelling of his ankles; swelling of his hands; shortness of breath; chills; died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (died) and PULMONARY OEDEMA (lungs filled up with fluids) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Diabetes. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (lungs filled up with fluids) (seriousness criterion medically significant), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills). The patient died on 01-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PULMONARY OEDEMA (lungs filled up with fluids), BACK PAIN (terrible pain in his back), MOBILITY DECREASED (couldn't lay had to sleep sat down), JOINT SWELLING (swelling of his ankles), PERIPHERAL SWELLING (swelling of his hands), DYSPNOEA (shortness of breath) and CHILLS (chills) outcome was unknown. No treatment medication was provided. Patient took concomitant medication for Blood pressure and Diabetes.; Sender's Comments: This is case of death in a 72-year-old male patient with medical history of blood pressure and diabetes who died more than a month after receiving the mRNA-1273 vaccine. Cause of death was not reported. Very limited information regarding the event has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death" "1486583-1" "1486583-1" "ABDOMINAL PAIN" "10000081" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "ABSTAINS FROM ALCOHOL" "10000340" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "AORTIC ARTERIOSCLEROSIS" "10065558" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "ARTERIOSCLEROSIS" "10003210" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "CHOLELITHIASIS" "10008629" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL" "10057798" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "COMPUTERISED TOMOGRAM PELVIS ABNORMAL" "10081333" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "GENERAL PHYSICAL HEALTH DETERIORATION" "10049438" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "HEPATIC CIRRHOSIS" "10019641" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "HEPATIC MASS" "10057110" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "HEPATOMEGALY" "10019842" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "INDURATION" "10060708" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "LYMPHADENOPATHY" "10025197" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "METASTASES TO LUNG" "10027458" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "PULMONARY MASS" "10056342" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "ULTRASOUND ABDOMEN ABNORMAL" "10052039" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "UMBILICAL HERNIA" "10045458" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486583-1" "1486583-1" "WEIGHT DECREASED" "10047895" "65-79 years" "65-79" "Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence." "1486859-1" "1486859-1" "BRAIN DEATH" "10049054" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "FALL" "10016173" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "FATIGUE" "10016256" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "FIBRIN D DIMER" "10016577" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "HAEMORRHAGE INTRACRANIAL" "10018985" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "HEADACHE" "10019211" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "LABORATORY TEST NORMAL" "10054052" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "LOSS OF CONSCIOUSNESS" "10024855" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "MALAISE" "10025482" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "MOTOR DYSFUNCTION" "10061296" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "ORGAN DONOR" "10058985" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "PLATELET COUNT NORMAL" "10035530" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "RESPIRATION ABNORMAL" "10038647" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "SNORING" "10041235" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "TRISMUS" "10044684" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1486859-1" "1486859-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" ""2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and ""not feeling well"". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation."" "1494294-1" "1494294-1" "ARTERIOVENOUS FISTULA SITE HAEMORRHAGE" "10055123" "65-79 years" "65-79" "Approximately 24 hours after receiving the first dose of the COVID vaccine, patient fell ill with extreme tiredness, profuse vomiting and loss of consciousness. Patient never regained consciousness, pronounced brain dead after AVM rupture and died on 3/8/21." "1494294-1" "1494294-1" "BRAIN DEATH" "10049054" "65-79 years" "65-79" "Approximately 24 hours after receiving the first dose of the COVID vaccine, patient fell ill with extreme tiredness, profuse vomiting and loss of consciousness. Patient never regained consciousness, pronounced brain dead after AVM rupture and died on 3/8/21." "1494294-1" "1494294-1" "DEATH" "10011906" "65-79 years" "65-79" "Approximately 24 hours after receiving the first dose of the COVID vaccine, patient fell ill with extreme tiredness, profuse vomiting and loss of consciousness. Patient never regained consciousness, pronounced brain dead after AVM rupture and died on 3/8/21." "1494294-1" "1494294-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Approximately 24 hours after receiving the first dose of the COVID vaccine, patient fell ill with extreme tiredness, profuse vomiting and loss of consciousness. Patient never regained consciousness, pronounced brain dead after AVM rupture and died on 3/8/21." "1494294-1" "1494294-1" "ILLNESS" "10080284" "65-79 years" "65-79" "Approximately 24 hours after receiving the first dose of the COVID vaccine, patient fell ill with extreme tiredness, profuse vomiting and loss of consciousness. Patient never regained consciousness, pronounced brain dead after AVM rupture and died on 3/8/21." "1494294-1" "1494294-1" "LOSS OF CONSCIOUSNESS" "10024855" "65-79 years" "65-79" "Approximately 24 hours after receiving the first dose of the COVID vaccine, patient fell ill with extreme tiredness, profuse vomiting and loss of consciousness. Patient never regained consciousness, pronounced brain dead after AVM rupture and died on 3/8/21." "1494294-1" "1494294-1" "VOMITING" "10047700" "65-79 years" "65-79" "Approximately 24 hours after receiving the first dose of the COVID vaccine, patient fell ill with extreme tiredness, profuse vomiting and loss of consciousness. Patient never regained consciousness, pronounced brain dead after AVM rupture and died on 3/8/21." "1500607-1" "1500607-1" "CARDIAC FAILURE" "10007554" "65-79 years" "65-79" "Heart Failure; troubled breathing; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD since an unknown date and Arteriosclerosis since an unknown date. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DYSPNOEA (troubled breathing). On an unknown date, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criteria death and medically significant). The patient died on 29-May-2021. The reported cause of death was Chronic obstructive pulmonary disease, Heart failure and Atherosclerosis. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (troubled breathing) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No concomitant product information was provided. No treatment information was provided. This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS. It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Sender's Comments: This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS. It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: Chronic Obstructive Pulmonary Disease; Heart Failure; Atherosclerosis" "1500607-1" "1500607-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Heart Failure; troubled breathing; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD since an unknown date and Arteriosclerosis since an unknown date. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DYSPNOEA (troubled breathing). On an unknown date, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criteria death and medically significant). The patient died on 29-May-2021. The reported cause of death was Chronic obstructive pulmonary disease, Heart failure and Atherosclerosis. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (troubled breathing) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No concomitant product information was provided. No treatment information was provided. This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS. It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Sender's Comments: This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS. It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: Chronic Obstructive Pulmonary Disease; Heart Failure; Atherosclerosis" "1500649-1" "1500649-1" "BLISTER" "10005191" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "DIZZINESS" "10013573" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "HERNIA" "10019909" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "HERPES ZOSTER" "10019974" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "NEURALGIA" "10029223" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "PRURITUS" "10037087" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "RASH" "10037844" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "WEIGHT" "10047890" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1500649-1" "1500649-1" "WEIGHT DECREASED" "10047895" "65-79 years" "65-79" "Hernia; Shortness of breath; Lightheaded; losing weight; appetite had decreased; itching; Heart attack; He had a bad case of shingles and needed something for nerve pain, the nerve pain was bad.; Shingles; They put tegaderm on his stomach and he developed blisters.; Rash on his arms and legs; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, administered in Arm Left on 16Feb2021 at age of 67 years old (Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholesterol and Hernia. Concomitant product included ongoing ASPIRIN [ACETYLSALICYLIC ACID] at 81mg tablet once a day by mouth given his age to help from getting blood clots. None additional vaccines administered on same date of the Pfizer suspect. None prior Vaccinations within 4 weeks. He did not have high blood pressure and was not a diabetic. The only thing he took was an aspirin and cholesterol pill and his cholesterol was better than hers, she does not know the name of the cholesterol pill he took, states it begins with r, unknown dose, and he took half a pill once a day by mouth, every night. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at age of 67 years old at as DOSE 1, SINGLE (Lot: EL8982) for covid-19 immunisation and experienced Shingles. After he got the second dose, he developed a rash on 20Feb2021 on his arms and legs. He went to the doctor and they gave him a steroid and something for itching. He did not think anything about the shot. On 25Mar2021 he had hernia surgery done and they put tegaderm on his stomach and he developed blisters. He had about 12 blisters on his stomach. He has had tegaderm dressings in the past and never broke out. He developed shingles on 22Apr2021. He had a heart attack and died 15May2021. No autopsy done. She had to do CPR on him at home. She is looking for answers. Her husband complained of shortness of breath and being lightheaded. She met a younger man that also developed shingles after the Pfizer covid vaccine. Her husband had a lot more shingles compared to the young man. Her husband had shingles that looked like clusters. Her husbands shingles was terrible and she has pictures of that. Her husband was doing fine before he took the shot. She knows the shot has caused people to get shingles, have heart attacks and all other stuff. She is not going to ask if it can happen, because she knows it can. She mentions something about a family member that put it in and something in regards to things happening after the shot but she did not provide further clarification. He started losing weight after the shot. He was normally 168 lbs and died at about 158 lbs. His appetite had decreased. She had to get him off the bed and put him on the floor to do cpr. Reports his shingles had cleared up on 6May2021 and they were scabbed up but he was left with severe pain. He called the doctor the Monday before he died and told him that he had a bad case of shingles and needed something for nerve pain, the nerve pain was bad. The doctor sent him medicine and the medication came in the day he died, and never took the medication. He died that Saturday and she has his death certificate that states the cause of death . The paramedics tried cpr as well. AEs require a visit Emergency Room. No physician office. Outcome of the event Heart attack was fatal. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest" "1505466-1" "1505466-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "Death within a few days of second dose of Pfizer COVID-19 vaccine" "1505466-1" "1505466-1" "DEATH" "10011906" "65-79 years" "65-79" "Death within a few days of second dose of Pfizer COVID-19 vaccine" "1507866-1" "1507866-1" "ANAPHYLACTIC SHOCK" "10002199" "65-79 years" "65-79" "Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock" "1507866-1" "1507866-1" "AORTIC DISSECTION" "10002895" "65-79 years" "65-79" "Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock" "1507866-1" "1507866-1" "BLOOD PRESSURE MEASUREMENT" "10076581" "65-79 years" "65-79" "Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock" "1507866-1" "1507866-1" "BURNING SENSATION" "10006784" "65-79 years" "65-79" "Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock" "1507866-1" "1507866-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock" "1507866-1" "1507866-1" "HAEMORRHAGE" "10055798" "65-79 years" "65-79" "Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock" "1507866-1" "1507866-1" "HEART RATE" "10019299" "65-79 years" "65-79" "Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock" "1507866-1" "1507866-1" "PARALYSIS" "10033799" "65-79 years" "65-79" "Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock" "1507866-1" "1507866-1" "THROMBOSIS" "10043607" "65-79 years" "65-79" "Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock" "1512407-1" "1512407-1" "APNOEA" "10002974" "65-79 years" "65-79" "Patient awakened me with 2 deep snoring sounds and then stopped breathing. I began CPR. Fire Dept, Paramedics and Hospital used paddles to get a heart beat but it was unstainable. He was pronounced deceased at the hospital due to a heart attack. He had no previous heart disease diagnosis." "1512407-1" "1512407-1" "CARDIOVERSION" "10007661" "65-79 years" "65-79" "Patient awakened me with 2 deep snoring sounds and then stopped breathing. I began CPR. Fire Dept, Paramedics and Hospital used paddles to get a heart beat but it was unstainable. He was pronounced deceased at the hospital due to a heart attack. He had no previous heart disease diagnosis." "1512407-1" "1512407-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient awakened me with 2 deep snoring sounds and then stopped breathing. I began CPR. Fire Dept, Paramedics and Hospital used paddles to get a heart beat but it was unstainable. He was pronounced deceased at the hospital due to a heart attack. He had no previous heart disease diagnosis." "1512407-1" "1512407-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "Patient awakened me with 2 deep snoring sounds and then stopped breathing. I began CPR. Fire Dept, Paramedics and Hospital used paddles to get a heart beat but it was unstainable. He was pronounced deceased at the hospital due to a heart attack. He had no previous heart disease diagnosis." "1512407-1" "1512407-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" "Patient awakened me with 2 deep snoring sounds and then stopped breathing. I began CPR. Fire Dept, Paramedics and Hospital used paddles to get a heart beat but it was unstainable. He was pronounced deceased at the hospital due to a heart attack. He had no previous heart disease diagnosis." "1512407-1" "1512407-1" "SNORING" "10041235" "65-79 years" "65-79" "Patient awakened me with 2 deep snoring sounds and then stopped breathing. I began CPR. Fire Dept, Paramedics and Hospital used paddles to get a heart beat but it was unstainable. He was pronounced deceased at the hospital due to a heart attack. He had no previous heart disease diagnosis." "1522680-1" "1522680-1" "COVID-19" "10084268" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of patient. The patient is fully vaccinated and the second dose of Pfizer. Date of second vaccine was listed as 05/08. Case began new medication, began vommiting 6/25. Got tested for COVID-19, tested +,. The patient was is in end stage liver disease awaiting a transplant and was tested as part of routine testing for weekly paracentesis. The patient's wife reports that he began three new medications on 6/24 and began vomiting that evening. Patient was admitted after testing positive because the test caused him to miss his paracentesis procedure and has no other symptoms. Patient is listed as having died from COVID-19, end stage liver failure, and liver cirrhosis." "1522680-1" "1522680-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of patient. The patient is fully vaccinated and the second dose of Pfizer. Date of second vaccine was listed as 05/08. Case began new medication, began vommiting 6/25. Got tested for COVID-19, tested +,. The patient was is in end stage liver disease awaiting a transplant and was tested as part of routine testing for weekly paracentesis. The patient's wife reports that he began three new medications on 6/24 and began vomiting that evening. Patient was admitted after testing positive because the test caused him to miss his paracentesis procedure and has no other symptoms. Patient is listed as having died from COVID-19, end stage liver failure, and liver cirrhosis." "1522680-1" "1522680-1" "HEPATIC CIRRHOSIS" "10019641" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of patient. The patient is fully vaccinated and the second dose of Pfizer. Date of second vaccine was listed as 05/08. Case began new medication, began vommiting 6/25. Got tested for COVID-19, tested +,. The patient was is in end stage liver disease awaiting a transplant and was tested as part of routine testing for weekly paracentesis. The patient's wife reports that he began three new medications on 6/24 and began vomiting that evening. Patient was admitted after testing positive because the test caused him to miss his paracentesis procedure and has no other symptoms. Patient is listed as having died from COVID-19, end stage liver failure, and liver cirrhosis." "1522680-1" "1522680-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of patient. The patient is fully vaccinated and the second dose of Pfizer. Date of second vaccine was listed as 05/08. Case began new medication, began vommiting 6/25. Got tested for COVID-19, tested +,. The patient was is in end stage liver disease awaiting a transplant and was tested as part of routine testing for weekly paracentesis. The patient's wife reports that he began three new medications on 6/24 and began vomiting that evening. Patient was admitted after testing positive because the test caused him to miss his paracentesis procedure and has no other symptoms. Patient is listed as having died from COVID-19, end stage liver failure, and liver cirrhosis." "1522680-1" "1522680-1" "VOMITING" "10047700" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of patient. The patient is fully vaccinated and the second dose of Pfizer. Date of second vaccine was listed as 05/08. Case began new medication, began vommiting 6/25. Got tested for COVID-19, tested +,. The patient was is in end stage liver disease awaiting a transplant and was tested as part of routine testing for weekly paracentesis. The patient's wife reports that he began three new medications on 6/24 and began vomiting that evening. Patient was admitted after testing positive because the test caused him to miss his paracentesis procedure and has no other symptoms. Patient is listed as having died from COVID-19, end stage liver failure, and liver cirrhosis." "1523231-1" "1523231-1" "CHEST X-RAY" "10008498" "65-79 years" "65-79" "Unrelated to vaccine: He had community acquired pneumonia; sepsis and septic shock. Went by ambulance to ER and that evening they got him to ICU room. I think they were administering strong antibiotic. He was in the hospital three days. Came home on Jan 27th. We started hospice on Jan 29 and he passed on February 23rd." "1523231-1" "1523231-1" "DEATH" "10011906" "65-79 years" "65-79" "Unrelated to vaccine: He had community acquired pneumonia; sepsis and septic shock. Went by ambulance to ER and that evening they got him to ICU room. I think they were administering strong antibiotic. He was in the hospital three days. Came home on Jan 27th. We started hospice on Jan 29 and he passed on February 23rd." "1523231-1" "1523231-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "Unrelated to vaccine: He had community acquired pneumonia; sepsis and septic shock. Went by ambulance to ER and that evening they got him to ICU room. I think they were administering strong antibiotic. He was in the hospital three days. Came home on Jan 27th. We started hospice on Jan 29 and he passed on February 23rd." "1523231-1" "1523231-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "Unrelated to vaccine: He had community acquired pneumonia; sepsis and septic shock. Went by ambulance to ER and that evening they got him to ICU room. I think they were administering strong antibiotic. He was in the hospital three days. Came home on Jan 27th. We started hospice on Jan 29 and he passed on February 23rd." "1523231-1" "1523231-1" "SEPSIS" "10040047" "65-79 years" "65-79" "Unrelated to vaccine: He had community acquired pneumonia; sepsis and septic shock. Went by ambulance to ER and that evening they got him to ICU room. I think they were administering strong antibiotic. He was in the hospital three days. Came home on Jan 27th. We started hospice on Jan 29 and he passed on February 23rd." "1523231-1" "1523231-1" "SEPTIC SHOCK" "10040070" "65-79 years" "65-79" "Unrelated to vaccine: He had community acquired pneumonia; sepsis and septic shock. Went by ambulance to ER and that evening they got him to ICU room. I think they were administering strong antibiotic. He was in the hospital three days. Came home on Jan 27th. We started hospice on Jan 29 and he passed on February 23rd." "1534829-1" "1534829-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "Death from blood clot" "1534829-1" "1534829-1" "DEATH" "10011906" "65-79 years" "65-79" "Death from blood clot" "1534829-1" "1534829-1" "EMBOLISM" "10061169" "65-79 years" "65-79" "Death from blood clot" "1534829-1" "1534829-1" "THROMBOSIS" "10043607" "65-79 years" "65-79" "Death from blood clot" "1535468-1" "1535468-1" "CEREBRAL HAEMORRHAGE" "10008111" "65-79 years" "65-79" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1535468-1" "1535468-1" "CEREBRAL VENOUS SINUS THROMBOSIS" "10083037" "65-79 years" "65-79" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1535468-1" "1535468-1" "COAGULATION FACTOR V LEVEL ABNORMAL" "10061771" "65-79 years" "65-79" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1535468-1" "1535468-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1535468-1" "1535468-1" "EPILEPSY" "10015037" "65-79 years" "65-79" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1535468-1" "1535468-1" "FACTOR V LEIDEN MUTATION" "10058279" "65-79 years" "65-79" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1535468-1" "1535468-1" "MAGNETIC RESONANCE IMAGING HEAD" "10085255" "65-79 years" "65-79" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1535468-1" "1535468-1" "PALLIATIVE CARE" "10059513" "65-79 years" "65-79" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1535468-1" "1535468-1" "SEIZURE" "10039906" "65-79 years" "65-79" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1535468-1" "1535468-1" "SUPERIOR SAGITTAL SINUS THROMBOSIS" "10042567" "65-79 years" "65-79" "Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage. He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt but had his hemorrhage first. The patient had a seizure upon arrival and was intubated. Ultimately, we have pursued palliative care this afternoon." "1573968-1" "1573968-1" "DEATH" "10011906" "65-79 years" "65-79" "My mother experienced fatigue, headache, arm pain, nausea, loss of appetite and passed away two days after second dose of Covid-19 Pfizer vaccine. *Please note: Hospital has patient listed with a 7/4/1945 birth date which was incorrect and never corrected. Birth certificate shows 7/5/1945 as correct date of birth." "1573968-1" "1573968-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "My mother experienced fatigue, headache, arm pain, nausea, loss of appetite and passed away two days after second dose of Covid-19 Pfizer vaccine. *Please note: Hospital has patient listed with a 7/4/1945 birth date which was incorrect and never corrected. Birth certificate shows 7/5/1945 as correct date of birth." "1573968-1" "1573968-1" "FATIGUE" "10016256" "65-79 years" "65-79" "My mother experienced fatigue, headache, arm pain, nausea, loss of appetite and passed away two days after second dose of Covid-19 Pfizer vaccine. *Please note: Hospital has patient listed with a 7/4/1945 birth date which was incorrect and never corrected. Birth certificate shows 7/5/1945 as correct date of birth." "1573968-1" "1573968-1" "HEADACHE" "10019211" "65-79 years" "65-79" "My mother experienced fatigue, headache, arm pain, nausea, loss of appetite and passed away two days after second dose of Covid-19 Pfizer vaccine. *Please note: Hospital has patient listed with a 7/4/1945 birth date which was incorrect and never corrected. Birth certificate shows 7/5/1945 as correct date of birth." "1573968-1" "1573968-1" "NAUSEA" "10028813" "65-79 years" "65-79" "My mother experienced fatigue, headache, arm pain, nausea, loss of appetite and passed away two days after second dose of Covid-19 Pfizer vaccine. *Please note: Hospital has patient listed with a 7/4/1945 birth date which was incorrect and never corrected. Birth certificate shows 7/5/1945 as correct date of birth." "1573968-1" "1573968-1" "PAIN IN EXTREMITY" "10033425" "65-79 years" "65-79" "My mother experienced fatigue, headache, arm pain, nausea, loss of appetite and passed away two days after second dose of Covid-19 Pfizer vaccine. *Please note: Hospital has patient listed with a 7/4/1945 birth date which was incorrect and never corrected. Birth certificate shows 7/5/1945 as correct date of birth." "1586737-1" "1586737-1" "ANGIOGRAM ABNORMAL" "10060956" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "COMPUTERISED TOMOGRAM THORAX ABNORMAL" "10057799" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "COVID-19" "10084268" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "DEATH" "10011906" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "DIARRHOEA" "10012735" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "DIZZINESS" "10013573" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "HYPOPHAGIA" "10063743" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "HYPOXIA" "10021143" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "LEUKOCYTOSIS" "10024378" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "LUNG OPACITY" "10081792" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "OXYGEN SATURATION DECREASED" "10033318" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "PYREXIA" "10037660" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1586737-1" "1586737-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "The patient tested positive for COVID-19 on 7/24. She felt well for the first week following the test but then started to have symptoms including dizziness, SOB, weakness, diarrhea, and decreased PO intake. She was started on prednisone 5 mg PO on 8/5 and presented to urgent care on 8/10 because her symptoms continued to worsen. She went to an outside hospital ED and was hypoxic to 91% requiring NC. CXR and CTA chest at that time showed diffuse ground glass opacities. She was administered dexamethasone 6 mg IV and 1 L of normal saline. She arrived to the hospital on 8/11 satting well on 4L of nasal cannula. She continued on dexamethasone. Thereafter, her oxygen requirements escalated to max high flow nasal cannula on 8/13 and 8/14. She received tocilizumab 8 mg/kg IV x 1 on 8/14 and transferred to the medical intensive care unit. On 8/15, she was having oxygen desaturations to the 70s and 80s and was intubated. Over the next 24 hours, she developed increasing pressor requirements, was spiking fevers, and started on iNO. She was started on vancomycin and cefepime and her leukocytosis progressed to >200. The patient was made DNR and passed on 8/17." "1629075-1" "1629075-1" "ACUTE KIDNEY INJURY" "10069339" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "ASTHENIA" "10003549" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "ATELECTASIS" "10003598" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "BLOOD CULTURE NEGATIVE" "10005486" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "BLOOD TEST ABNORMAL" "10061016" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "COVID-19" "10084268" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "CULTURE URINE NEGATIVE" "10011639" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "DEATH" "10011906" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "HAEMATEMESIS" "10018830" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "HYPOTENSION" "10021097" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "LETHARGY" "10024264" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "LOWER URINARY TRACT SYMPTOMS" "10071289" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "MALAISE" "10025482" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "OXYGEN SATURATION DECREASED" "10033318" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "POLLAKIURIA" "10036018" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "URINARY TRACT INFECTION" "10046571" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1629075-1" "1629075-1" "URINE ANALYSIS ABNORMAL" "10062226" "65-79 years" "65-79" ""PMH of diet controlled DM, hepatitis C induced cirrhosis, CAD with stent replacement, HTN, osteoarthritis, colonic polyps, history of several liver lesions with an elevated AFP consistent with multifocal HCC (refused biopsy) sent in from PCP office for evaluation of hypotension. Patient has been c/o generalized weakness with decreased appetite for 1 week. Patient also endorses urinary symptoms mainly frequency. Denies any CP, SOB, LH, dizziness, N/V/D, HA, abdominal pain, fever, chills or any other complaints. In the ED blood work showed AKI. UA was positive for UTI and incidentally he was found to be covid +. Patient denies any SOB and is not hypoxic. CXR is unremarkable. In the ED patient was given IVF and was started on ceftriaxone x 5 days for UTI. CXR without evidence of pneumonia. On 8/16 Breathing comfortably. However, SPO2 was as low as 80s with activity on 8/13, started on Decadron. On 8/17: 8/17 RRT was called this morning for hypotension with BP 70/40s. Per RN patient received 500cc over night which did not respond, remains hypotensive. Patient reports he ""doesn't feel well"". At bedside, patient is lethargic but responsive to commands, satting 97% on room air. Patient transferred to the MICU and Pt emergently intubated at beginning of ACLS and during intubation was noted to have large amount of coffee ground emesis in esophagus and airway concerning for possible UGIB and aspiration. Despite resuscitative efforts for over 30 minutes, no sustained ROSC was able to be obtained."" "1632684-1" "1632684-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Patient received second vaccination on 07/06/2021. The next day the patient was having problem breathing with shortness of breath." "1634215-1" "1634215-1" "DEATH" "10011906" "65-79 years" "65-79" "Death. Heart attack" "1634215-1" "1634215-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "Death. Heart attack" "1637006-1" "1637006-1" "ABDOMINAL PAIN" "10000081" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "COUGH" "10011224" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "COVID-19" "10084268" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "DEATH" "10011906" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "FATIGUE" "10016256" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "FLANK PAIN" "10016750" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "HEADACHE" "10019211" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "HYPOPHAGIA" "10063743" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "MYALGIA" "10028411" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "PYREXIA" "10037660" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1637006-1" "1637006-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "65 year old male with history of CKD, medullary sponge kidney with recurrent nephrolithiasis presenting for myalgias, fatigue and decreased PO intake for the past 4 days. Symptoms started on 5Aug with fevers and myalgias and presented for COVID test that was initially negative. Continued to have worsening shortness of breath and fatigue and went to be evaluated on 07Aug and found to be COVID pos and was given prednisone taper and albuterol inhaler and discharged home. Since then was having new right flank/abdominal pain consistent with previous kidney stones and called the urology clinic to try to get and appointment and when describing his symptoms was told to go to the ED to be evaluated. Endorses fevers, headache, shortness of breath and cough but denies nausea, vomiting, diarrhea, chest pain, dysuria, polyuria, hematuria, hematemesis, melena, lower extremity edema, orthopnea. Patient died 18 Aug 2021, COD COVID-19 pneumonia." "1647424-1" "1647424-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "He couldn't breathe/ husband passed away after receiving the 2nd dose; This is a spontaneous report from a contactable consumer (wife). A 73-year-old patient (husband) received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Batch/Lot number: was not reported, Expiration date: was not reported, Age at vaccination: 73-year-old) via an unspecified route of administration on 19Apr2021 11:00 AM as dose 2, single for COVID-19 immunization. Medical history included kidney failure. Concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date for covid-19 immunization. It was reported that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator. She stated they both received the 2nd dose of the covid vaccine on 19Apr2021 around 11:00 am. On tuesday, the following day, around 1:00 pm, he couldn't breathe, so he went to the hospital at about 1:30 pm. They said he had to go to the big hospital downtown as they did not have dialysis and her husband had had kidney failure. In the morning, she was told that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator.; Reported Cause(s) of Death: He couldn't breathe/ husband passed away after receiving the 2nd dose" "1655806-1" "1655806-1" "COVID-19" "10084268" "65-79 years" "65-79" "Pt had a breakthrough case of COVID 19 in August 2021 required hospitalization, mechanical ventilation and then he expired on 8/29/21" "1655806-1" "1655806-1" "DEATH" "10011906" "65-79 years" "65-79" "Pt had a breakthrough case of COVID 19 in August 2021 required hospitalization, mechanical ventilation and then he expired on 8/29/21" "1655806-1" "1655806-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "Pt had a breakthrough case of COVID 19 in August 2021 required hospitalization, mechanical ventilation and then he expired on 8/29/21" "1655806-1" "1655806-1" "VACCINE BREAKTHROUGH INFECTION" "10067923" "65-79 years" "65-79" "Pt had a breakthrough case of COVID 19 in August 2021 required hospitalization, mechanical ventilation and then he expired on 8/29/21" "1658499-1" "1658499-1" "COVID-19" "10084268" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 79-year-old female patient. The patient received two doses of the Pfizer vaccine on 3/04 and 3/25. On 8/12/21 and again on 8/13/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/25 and the cause of death is listed as ?Pneumonia; COVID 19.? Pre-existing conditions are unknown." "1658499-1" "1658499-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 79-year-old female patient. The patient received two doses of the Pfizer vaccine on 3/04 and 3/25. On 8/12/21 and again on 8/13/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/25 and the cause of death is listed as ?Pneumonia; COVID 19.? Pre-existing conditions are unknown." "1658499-1" "1658499-1" "PNEUMONIA" "10035664" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 79-year-old female patient. The patient received two doses of the Pfizer vaccine on 3/04 and 3/25. On 8/12/21 and again on 8/13/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/25 and the cause of death is listed as ?Pneumonia; COVID 19.? Pre-existing conditions are unknown." "1658499-1" "1658499-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 79-year-old female patient. The patient received two doses of the Pfizer vaccine on 3/04 and 3/25. On 8/12/21 and again on 8/13/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/25 and the cause of death is listed as ?Pneumonia; COVID 19.? Pre-existing conditions are unknown." "1658499-1" "1658499-1" "VACCINE BREAKTHROUGH INFECTION" "10067923" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 79-year-old female patient. The patient received two doses of the Pfizer vaccine on 3/04 and 3/25. On 8/12/21 and again on 8/13/21, the patient tested positive via a PCR test for COVID-19 (vaccine breakthrough). The patient died on 8/25 and the cause of death is listed as ?Pneumonia; COVID 19.? Pre-existing conditions are unknown." "1662371-1" "1662371-1" "COVID-19" "10084268" "65-79 years" "65-79" "Hospitalization/Death due to COVID-19 Reported per Pfizer COIVID-19 Vaccine EUA" "1662371-1" "1662371-1" "DEATH" "10011906" "65-79 years" "65-79" "Hospitalization/Death due to COVID-19 Reported per Pfizer COIVID-19 Vaccine EUA" "1662371-1" "1662371-1" "POLYMERASE CHAIN REACTION" "10050967" "65-79 years" "65-79" "Hospitalization/Death due to COVID-19 Reported per Pfizer COIVID-19 Vaccine EUA" "1662371-1" "1662371-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Hospitalization/Death due to COVID-19 Reported per Pfizer COIVID-19 Vaccine EUA" "1667385-1" "1667385-1" "AUTOPSY" "10050117" "65-79 years" "65-79" "My dad had received the Johnson and Johnson shot end of April. He was sick for a few days with the normal side effects. In July he died from myocarditis the autopsy came back as. Research has been showing that it is linked to the vaccine and to report it to help research just in case." "1667385-1" "1667385-1" "DEATH" "10011906" "65-79 years" "65-79" "My dad had received the Johnson and Johnson shot end of April. He was sick for a few days with the normal side effects. In July he died from myocarditis the autopsy came back as. Research has been showing that it is linked to the vaccine and to report it to help research just in case." "1667385-1" "1667385-1" "GENERAL SYMPTOM" "10060891" "65-79 years" "65-79" "My dad had received the Johnson and Johnson shot end of April. He was sick for a few days with the normal side effects. In July he died from myocarditis the autopsy came back as. Research has been showing that it is linked to the vaccine and to report it to help research just in case." "1667385-1" "1667385-1" "MALAISE" "10025482" "65-79 years" "65-79" "My dad had received the Johnson and Johnson shot end of April. He was sick for a few days with the normal side effects. In July he died from myocarditis the autopsy came back as. Research has been showing that it is linked to the vaccine and to report it to help research just in case." "1667385-1" "1667385-1" "MYOCARDITIS" "10028606" "65-79 years" "65-79" "My dad had received the Johnson and Johnson shot end of April. He was sick for a few days with the normal side effects. In July he died from myocarditis the autopsy came back as. Research has been showing that it is linked to the vaccine and to report it to help research just in case." "1667385-1" "1667385-1" "VIRAL INFECTION" "10047461" "65-79 years" "65-79" "My dad had received the Johnson and Johnson shot end of April. He was sick for a few days with the normal side effects. In July he died from myocarditis the autopsy came back as. Research has been showing that it is linked to the vaccine and to report it to help research just in case." "1685326-1" "1685326-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient of Hospice who requested to have Covid Vaccine. Our Community Paramedic, took the vaccine to the Hospice on 9/2/2021. He administered the vaccine and waited 15 minutes to observe for reactions. No adverse reactions were noted. The following morning we received a call from the nurse at the Hospice House that pt was pronounced deceased on 9/3/2021 in early am." "1692895-1" "1692895-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692895-1" "1692895-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692895-1" "1692895-1" "COMPUTERISED TOMOGRAM THORAX ABNORMAL" "10057799" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692895-1" "1692895-1" "COUGH" "10011224" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692895-1" "1692895-1" "COVID-19" "10084268" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692895-1" "1692895-1" "DEATH" "10011906" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692895-1" "1692895-1" "LUNG CONSOLIDATION" "10025080" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692895-1" "1692895-1" "LUNG OPACITY" "10081792" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692895-1" "1692895-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692895-1" "1692895-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1692895-1" "1692895-1" "VACCINE BREAKTHROUGH INFECTION" "10067923" "65-79 years" "65-79" "Breakthrough case on 9/8. Unfortunately passed from cardiac arrest on 9/11/21" "1714925-1" "1714925-1" "COVID-19" "10084268" "65-79 years" "65-79" "Hospitalized for COVID and died as a result of COVID pneumonia" "1714925-1" "1714925-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "Hospitalized for COVID and died as a result of COVID pneumonia" "1714925-1" "1714925-1" "DEATH" "10011906" "65-79 years" "65-79" "Hospitalized for COVID and died as a result of COVID pneumonia" "1714925-1" "1714925-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Hospitalized for COVID and died as a result of COVID pneumonia" "1723828-1" "1723828-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "patient died on 9/13/21. He was healthy prior to sudden cardiac arrest at approx. 8:00 am on 9/9/21. His CT scan showed multiple clots in his right lung. Patient had no history of clots. He had no heart disease or lung disease. Origin of clots is unknown. Patient was 9 months post 2nd Covid vaccine. COULD THE VACCINE CAUSED THE CLOTS AT 9 months post vaccine?" "1723828-1" "1723828-1" "COMPUTERISED TOMOGRAM THORAX ABNORMAL" "10057799" "65-79 years" "65-79" "patient died on 9/13/21. He was healthy prior to sudden cardiac arrest at approx. 8:00 am on 9/9/21. His CT scan showed multiple clots in his right lung. Patient had no history of clots. He had no heart disease or lung disease. Origin of clots is unknown. Patient was 9 months post 2nd Covid vaccine. COULD THE VACCINE CAUSED THE CLOTS AT 9 months post vaccine?" "1723828-1" "1723828-1" "DEATH" "10011906" "65-79 years" "65-79" "patient died on 9/13/21. He was healthy prior to sudden cardiac arrest at approx. 8:00 am on 9/9/21. His CT scan showed multiple clots in his right lung. Patient had no history of clots. He had no heart disease or lung disease. Origin of clots is unknown. Patient was 9 months post 2nd Covid vaccine. COULD THE VACCINE CAUSED THE CLOTS AT 9 months post vaccine?" "1723828-1" "1723828-1" "PULMONARY THROMBOSIS" "10037437" "65-79 years" "65-79" "patient died on 9/13/21. He was healthy prior to sudden cardiac arrest at approx. 8:00 am on 9/9/21. His CT scan showed multiple clots in his right lung. Patient had no history of clots. He had no heart disease or lung disease. Origin of clots is unknown. Patient was 9 months post 2nd Covid vaccine. COULD THE VACCINE CAUSED THE CLOTS AT 9 months post vaccine?" "1723828-1" "1723828-1" "THROMBOSIS" "10043607" "65-79 years" "65-79" "patient died on 9/13/21. He was healthy prior to sudden cardiac arrest at approx. 8:00 am on 9/9/21. His CT scan showed multiple clots in his right lung. Patient had no history of clots. He had no heart disease or lung disease. Origin of clots is unknown. Patient was 9 months post 2nd Covid vaccine. COULD THE VACCINE CAUSED THE CLOTS AT 9 months post vaccine?" "1732122-1" "1732122-1" "DEATH" "10011906" "65-79 years" "65-79" "Death sometime the next A.M." "1732172-1" "1732172-1" "ACIDOSIS" "10000486" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "ACUTE RESPIRATORY FAILURE" "10001053" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "AGEUSIA" "10001480" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "BLOOD BICARBONATE INCREASED" "10005360" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "BLOOD CHLORIDE DECREASED" "10005419" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "BLOOD CREATININE INCREASED" "10005483" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "BLOOD POTASSIUM NORMAL" "10005726" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "BLOOD SODIUM NORMAL" "10005804" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "BLOOD UREA NORMAL" "10005857" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "C-REACTIVE PROTEIN INCREASED" "10006825" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "CATHETER PLACEMENT" "10052915" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "CONTINUOUS HAEMODIAFILTRATION" "10066338" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "COUGH" "10011224" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "COVID-19" "10084268" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "DEATH" "10011906" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "END STAGE RENAL DISEASE" "10077512" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "GENERAL PHYSICAL HEALTH DETERIORATION" "10049438" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "HAEMOGLOBIN DECREASED" "10018884" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "HYPERVOLAEMIA" "10020919" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "HYPOTENSION" "10021097" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "INFLAMMATORY MARKER TEST" "10074736" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "INFLUENZA A VIRUS TEST NEGATIVE" "10070417" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "INFLUENZA B VIRUS TEST" "10071544" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "INFLUENZA VIRUS TEST NEGATIVE" "10070718" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "LUNG OPACITY" "10081792" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "PLATELET COUNT NORMAL" "10035530" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "PLEURAL EFFUSION" "10035598" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "SHOCK" "10040560" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1732172-1" "1732172-1" "WHITE BLOOD CELL COUNT DECREASED" "10047942" "65-79 years" "65-79" "8/25/21 Pt was seen by PCP office for cough and loss of taste. Was positive for SARS-CoV-2 8/29/21 He presented to the ED w/ worsening cough and SOB. RA pulse ox was 85%. He was admitted. Hospital course as below. Family did change his care to comfort care and the patient died on 9/4/21 Patient is a 66 year old male with a history of end-stage renal disease requiring hemodialysis, chronic systolic heart failure with LVEF 20%, chronic hypotension, anemia of chronic disease, secondary hyperparathyroidism, DVT who was admitted on August 28 for acute hypoxemic respiratory failure, Covid pneumonia, and fluid volume overload. Nephrology was consulted with management of hemodialysis while hospitalized. Infectious disease was consulted. He was started on IV steroids, IV remdesivir, and daily inflammatory markers. The patient experienced worsening hypoxemia and respiratory failure requiring high flow nasal cannula. He required escalating requirements on high flow nasal cannula and was transferred to the intensive care unit on 9/2/2021. Critical care was consulted for management. Palliative care was consulted for goals of care discussion with no changes in plan of care. On 9/3/2021, the patient deteriorated requiring endotracheal intubation and mechanical ventilation. He was placed in the prone position due to hypoxemia. He developed severe acidosis. Temporary HD catheter was placed. This evening, he had continued acidosis with increasing vasopressor requirements. The case was discussed with nephrology and he was started on CVVHD. There were complications with initiation of CVVHD as multiple filters clotted off after initiation. The patient developed progressive hypotension and shock requiring max dosing of norepinephrine, phenylephrine, vasopressin, epinephrine. He received a total of 6 A of sodium bicarb. The patient's deteriorating condition was discussed with his daughters. He was transitioned to a DNR CCA. The patient expired cessation of vital signs on 9/4/2021 at 1:10am. Discharge Diagnoses: Acute hypoxemic respiratory failure Covid pneumonia ESRD HD dependent Shock Systolic heart failure with LVEF 20% OSA on CPAP" "1740836-1" "1740836-1" "AMNESIA" "10001949" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "CONFUSIONAL STATE" "10010305" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "FEEDING DISORDER" "10061148" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "GAIT INABILITY" "10017581" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "LABORATORY TEST" "10059938" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES" "10079487" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "MALAISE" "10025482" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "MALNUTRITION" "10061273" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "MOBILITY DECREASED" "10048334" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "PAIN" "10033371" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "PRURITUS" "10037087" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "RENAL IMPAIRMENT" "10062237" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "SPEECH DISORDER" "10041466" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "STAPHYLOCOCCUS TEST NEGATIVE" "10070413" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1740836-1" "1740836-1" "VOMITING" "10047700" "65-79 years" "65-79" "my mother complained of pains all over her body the night of first shot. She continued to have pain. My mother also became very confused after 1st shot and would speak inappropriately and repeat herself often. She stayed in bed all day and had no energy to to do regular routine. She was very itchy and vomited after 2nd dose. the day after second dose she was unable to ambulate and continued throwing up. When I called ambulance she could not even answer basic questions like how old she was." "1744331-1" "1744331-1" "AGEUSIA" "10001480" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744331-1" "1744331-1" "ANOSMIA" "10002653" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744331-1" "1744331-1" "DEATH" "10011906" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744331-1" "1744331-1" "DECREASED APPETITE" "10061428" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744331-1" "1744331-1" "DIZZINESS" "10013573" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744331-1" "1744331-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744331-1" "1744331-1" "FATIGUE" "10016256" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744331-1" "1744331-1" "HEADACHE" "10019211" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744331-1" "1744331-1" "LABORATORY TEST" "10059938" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744331-1" "1744331-1" "NAUSEA" "10028813" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1744331-1" "1744331-1" "PERICARDIAL EFFUSION" "10034474" "65-79 years" "65-79" "Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell (lasted about a week, then disappeared) Fatigue, Dizzy, Nausea, Loss of taste, Loss of smell, trouble breathing, headaches, loss of appetite(05/09/2021, went to hospital twice, was discharged too early the first time; 11 May 2021; returned to the hospital 21 May 2021 due to shortness of breath, fatigue, dizzy, nausea, loss of appetite, which the trouble breathing and shortness of breath was due to fluid build-up around the heart and his lungs). Admitted approximately late afternoon 21 May 2021 and did not get discharged, died on 9 June 2021 in the Hospice house." "1753844-1" "1753844-1" "DEATH" "10011906" "65-79 years" "65-79" "Death" "1756001-1" "1756001-1" "ADVERSE EVENT" "10060933" "65-79 years" "65-79" "Heart attack; Arthrosclerosis; COPD; Other terms on autopsy report caller does not understand after the second dose; Not feeling well after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), JOINT STIFFNESS (Arthrosclerosis), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced MALAISE (Not feeling well after the second dose). On 20-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death, medically significant and life threatening), JOINT STIFFNESS (Arthrosclerosis) (seriousness criteria death, medically significant and life threatening), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criteria death, medically significant and life threatening) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) (seriousness criteria death, medically significant and life threatening). The patient died on 20-Sep-2021. The reported cause of death was Heart attack, Arthrosclerosis and copd. An autopsy was performed, but no results were provided. At the time of death, MALAISE (Not feeling well after the second dose) outcome was unknown. No concomitant medical information were reported. No treatment information was reported. Company comment: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Heart attack; arthrosclerosis; COPD" "1756001-1" "1756001-1" "CHRONIC OBSTRUCTIVE PULMONARY DISEASE" "10009033" "65-79 years" "65-79" "Heart attack; Arthrosclerosis; COPD; Other terms on autopsy report caller does not understand after the second dose; Not feeling well after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), JOINT STIFFNESS (Arthrosclerosis), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced MALAISE (Not feeling well after the second dose). On 20-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death, medically significant and life threatening), JOINT STIFFNESS (Arthrosclerosis) (seriousness criteria death, medically significant and life threatening), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criteria death, medically significant and life threatening) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) (seriousness criteria death, medically significant and life threatening). The patient died on 20-Sep-2021. The reported cause of death was Heart attack, Arthrosclerosis and copd. An autopsy was performed, but no results were provided. At the time of death, MALAISE (Not feeling well after the second dose) outcome was unknown. No concomitant medical information were reported. No treatment information was reported. Company comment: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Heart attack; arthrosclerosis; COPD" "1756001-1" "1756001-1" "JOINT STIFFNESS" "10023230" "65-79 years" "65-79" "Heart attack; Arthrosclerosis; COPD; Other terms on autopsy report caller does not understand after the second dose; Not feeling well after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), JOINT STIFFNESS (Arthrosclerosis), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced MALAISE (Not feeling well after the second dose). On 20-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death, medically significant and life threatening), JOINT STIFFNESS (Arthrosclerosis) (seriousness criteria death, medically significant and life threatening), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criteria death, medically significant and life threatening) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) (seriousness criteria death, medically significant and life threatening). The patient died on 20-Sep-2021. The reported cause of death was Heart attack, Arthrosclerosis and copd. An autopsy was performed, but no results were provided. At the time of death, MALAISE (Not feeling well after the second dose) outcome was unknown. No concomitant medical information were reported. No treatment information was reported. Company comment: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Heart attack; arthrosclerosis; COPD" "1756001-1" "1756001-1" "MALAISE" "10025482" "65-79 years" "65-79" "Heart attack; Arthrosclerosis; COPD; Other terms on autopsy report caller does not understand after the second dose; Not feeling well after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), JOINT STIFFNESS (Arthrosclerosis), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced MALAISE (Not feeling well after the second dose). On 20-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death, medically significant and life threatening), JOINT STIFFNESS (Arthrosclerosis) (seriousness criteria death, medically significant and life threatening), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criteria death, medically significant and life threatening) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) (seriousness criteria death, medically significant and life threatening). The patient died on 20-Sep-2021. The reported cause of death was Heart attack, Arthrosclerosis and copd. An autopsy was performed, but no results were provided. At the time of death, MALAISE (Not feeling well after the second dose) outcome was unknown. No concomitant medical information were reported. No treatment information was reported. Company comment: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Heart attack; arthrosclerosis; COPD" "1756001-1" "1756001-1" "MYOCARDIAL INFARCTION" "10028596" "65-79 years" "65-79" "Heart attack; Arthrosclerosis; COPD; Other terms on autopsy report caller does not understand after the second dose; Not feeling well after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), JOINT STIFFNESS (Arthrosclerosis), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced MALAISE (Not feeling well after the second dose). On 20-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death, medically significant and life threatening), JOINT STIFFNESS (Arthrosclerosis) (seriousness criteria death, medically significant and life threatening), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criteria death, medically significant and life threatening) and ADVERSE EVENT (Other terms on autopsy report caller does not understand after the second dose) (seriousness criteria death, medically significant and life threatening). The patient died on 20-Sep-2021. The reported cause of death was Heart attack, Arthrosclerosis and copd. An autopsy was performed, but no results were provided. At the time of death, MALAISE (Not feeling well after the second dose) outcome was unknown. No concomitant medical information were reported. No treatment information was reported. Company comment: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, male patient with no relevant medical history, who experienced the unexpected events of Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and other Adverse event (Nos). Patient initially experienced malaise (not feeling well) approximately 3 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The patient reportedly passed away approximately 7 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine); and autopsy revealed cause of death as Myocardial infarction, Arthrosclerosis, Chronic obstructive pulmonary disease, and Other unspecified terms on autopsy (Adverse event Nos). The rechallenge was not applicable as events occurred after second dose with fatal outcome. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Heart attack; arthrosclerosis; COPD" "1768415-1" "1768415-1" "DEATH" "10011906" "65-79 years" "65-79" "He had due to chemo hospital stay had 9 months of extremely low white blood cell count that didn't move at all. 1/07/21 on a Thursday he had his first COVID vaccine, his has labs drawn done every Friday and when he went to the Doc. On 1/8 the white blood cell count had moved up just a little. And it was still moving up just a little and had his 2nd dose on Friday 2/4/21. And from then on every week when he went in for bloodwork it would go up just a little more. It continued to go up slowly and when he had his 3rd vaccine Aug 7th after the shot while in the hospital his white blood cell count went up 40k (he hit 340K) in a 12 hour period. We got to the emergency room they took lab work and by 8pm the next day it went up by 40K. They were pulling white blood cells out and he was making more that they could pull out. On 9/10 we lost him, the white blood cells attached his organs and made them all start shutting down. On Aug 12th before his vaccine his white blood cell count was 104K. By 9/6 he was over 300K. So his wbc tripled from his 2nd shot to his 3rd shot." "1768415-1" "1768415-1" "EXTRA DOSE ADMINISTERED" "10064366" "65-79 years" "65-79" "He had due to chemo hospital stay had 9 months of extremely low white blood cell count that didn't move at all. 1/07/21 on a Thursday he had his first COVID vaccine, his has labs drawn done every Friday and when he went to the Doc. On 1/8 the white blood cell count had moved up just a little. And it was still moving up just a little and had his 2nd dose on Friday 2/4/21. And from then on every week when he went in for bloodwork it would go up just a little more. It continued to go up slowly and when he had his 3rd vaccine Aug 7th after the shot while in the hospital his white blood cell count went up 40k (he hit 340K) in a 12 hour period. We got to the emergency room they took lab work and by 8pm the next day it went up by 40K. They were pulling white blood cells out and he was making more that they could pull out. On 9/10 we lost him, the white blood cells attached his organs and made them all start shutting down. On Aug 12th before his vaccine his white blood cell count was 104K. By 9/6 he was over 300K. So his wbc tripled from his 2nd shot to his 3rd shot." "1768415-1" "1768415-1" "LABORATORY TEST" "10059938" "65-79 years" "65-79" "He had due to chemo hospital stay had 9 months of extremely low white blood cell count that didn't move at all. 1/07/21 on a Thursday he had his first COVID vaccine, his has labs drawn done every Friday and when he went to the Doc. On 1/8 the white blood cell count had moved up just a little. And it was still moving up just a little and had his 2nd dose on Friday 2/4/21. And from then on every week when he went in for bloodwork it would go up just a little more. It continued to go up slowly and when he had his 3rd vaccine Aug 7th after the shot while in the hospital his white blood cell count went up 40k (he hit 340K) in a 12 hour period. We got to the emergency room they took lab work and by 8pm the next day it went up by 40K. They were pulling white blood cells out and he was making more that they could pull out. On 9/10 we lost him, the white blood cells attached his organs and made them all start shutting down. On Aug 12th before his vaccine his white blood cell count was 104K. By 9/6 he was over 300K. So his wbc tripled from his 2nd shot to his 3rd shot." "1768415-1" "1768415-1" "MULTIPLE ORGAN DYSFUNCTION SYNDROME" "10077361" "65-79 years" "65-79" "He had due to chemo hospital stay had 9 months of extremely low white blood cell count that didn't move at all. 1/07/21 on a Thursday he had his first COVID vaccine, his has labs drawn done every Friday and when he went to the Doc. On 1/8 the white blood cell count had moved up just a little. And it was still moving up just a little and had his 2nd dose on Friday 2/4/21. And from then on every week when he went in for bloodwork it would go up just a little more. It continued to go up slowly and when he had his 3rd vaccine Aug 7th after the shot while in the hospital his white blood cell count went up 40k (he hit 340K) in a 12 hour period. We got to the emergency room they took lab work and by 8pm the next day it went up by 40K. They were pulling white blood cells out and he was making more that they could pull out. On 9/10 we lost him, the white blood cells attached his organs and made them all start shutting down. On Aug 12th before his vaccine his white blood cell count was 104K. By 9/6 he was over 300K. So his wbc tripled from his 2nd shot to his 3rd shot." "1768415-1" "1768415-1" "WHITE BLOOD CELL COUNT INCREASED" "10047943" "65-79 years" "65-79" "He had due to chemo hospital stay had 9 months of extremely low white blood cell count that didn't move at all. 1/07/21 on a Thursday he had his first COVID vaccine, his has labs drawn done every Friday and when he went to the Doc. On 1/8 the white blood cell count had moved up just a little. And it was still moving up just a little and had his 2nd dose on Friday 2/4/21. And from then on every week when he went in for bloodwork it would go up just a little more. It continued to go up slowly and when he had his 3rd vaccine Aug 7th after the shot while in the hospital his white blood cell count went up 40k (he hit 340K) in a 12 hour period. We got to the emergency room they took lab work and by 8pm the next day it went up by 40K. They were pulling white blood cells out and he was making more that they could pull out. On 9/10 we lost him, the white blood cells attached his organs and made them all start shutting down. On Aug 12th before his vaccine his white blood cell count was 104K. By 9/6 he was over 300K. So his wbc tripled from his 2nd shot to his 3rd shot." "1768471-1" "1768471-1" "BLOOD TEST" "10061726" "65-79 years" "65-79" "after shot on thursday, on friday his white blood cell count moved up just a little when he did his routine weekly blood work on fridays. the wbc count went up dispite the fact that he had been doing weekly xarixo shots (white blood cell boosting shots) from may 2020 - jan 2021 and the wbc did not move even after this time. and for the first time it went up after his 1st covid shot. WBC count slowly started going up and never stopped and continued to go up and when he got his 3rd shot in august it went up an accelerated rate in the 3 weeks and then he died. I noticed before his aug shot, he was at 700 at his wbc count and was at 100k on his august shot and 3 wks later at nearly 400K after that shot." "1768471-1" "1768471-1" "DEATH" "10011906" "65-79 years" "65-79" "after shot on thursday, on friday his white blood cell count moved up just a little when he did his routine weekly blood work on fridays. the wbc count went up dispite the fact that he had been doing weekly xarixo shots (white blood cell boosting shots) from may 2020 - jan 2021 and the wbc did not move even after this time. and for the first time it went up after his 1st covid shot. WBC count slowly started going up and never stopped and continued to go up and when he got his 3rd shot in august it went up an accelerated rate in the 3 weeks and then he died. I noticed before his aug shot, he was at 700 at his wbc count and was at 100k on his august shot and 3 wks later at nearly 400K after that shot." "1768471-1" "1768471-1" "EXTRA DOSE ADMINISTERED" "10064366" "65-79 years" "65-79" "after shot on thursday, on friday his white blood cell count moved up just a little when he did his routine weekly blood work on fridays. the wbc count went up dispite the fact that he had been doing weekly xarixo shots (white blood cell boosting shots) from may 2020 - jan 2021 and the wbc did not move even after this time. and for the first time it went up after his 1st covid shot. WBC count slowly started going up and never stopped and continued to go up and when he got his 3rd shot in august it went up an accelerated rate in the 3 weeks and then he died. I noticed before his aug shot, he was at 700 at his wbc count and was at 100k on his august shot and 3 wks later at nearly 400K after that shot." "1768471-1" "1768471-1" "WHITE BLOOD CELL COUNT INCREASED" "10047943" "65-79 years" "65-79" "after shot on thursday, on friday his white blood cell count moved up just a little when he did his routine weekly blood work on fridays. the wbc count went up dispite the fact that he had been doing weekly xarixo shots (white blood cell boosting shots) from may 2020 - jan 2021 and the wbc did not move even after this time. and for the first time it went up after his 1st covid shot. WBC count slowly started going up and never stopped and continued to go up and when he got his 3rd shot in august it went up an accelerated rate in the 3 weeks and then he died. I noticed before his aug shot, he was at 700 at his wbc count and was at 100k on his august shot and 3 wks later at nearly 400K after that shot." "1768471-1" "1768471-1" "WHITE BLOOD CELL DISORDER" "10061414" "65-79 years" "65-79" "after shot on thursday, on friday his white blood cell count moved up just a little when he did his routine weekly blood work on fridays. the wbc count went up dispite the fact that he had been doing weekly xarixo shots (white blood cell boosting shots) from may 2020 - jan 2021 and the wbc did not move even after this time. and for the first time it went up after his 1st covid shot. WBC count slowly started going up and never stopped and continued to go up and when he got his 3rd shot in august it went up an accelerated rate in the 3 weeks and then he died. I noticed before his aug shot, he was at 700 at his wbc count and was at 100k on his august shot and 3 wks later at nearly 400K after that shot." "1775763-1" "1775763-1" "ACUTE RESPIRATORY FAILURE" "10001053" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "BIOPSY LUNG" "10004794" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "BRONCHOALVEOLAR LAVAGE" "10049413" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "BRONCHOSCOPY" "10006479" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "CARDIAC FAILURE" "10007554" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "CHEST X-RAY ABNORMAL" "10008499" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "CHILLS" "10008531" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "COUGH" "10011224" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "FIBRIN D DIMER INCREASED" "10016581" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "GRAM STAIN POSITIVE" "10018656" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "INTERSTITIAL LUNG DISEASE" "10022611" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "MALAISE" "10025482" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "NEUTROPHILIA" "10029379" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "ORGANISING PNEUMONIA" "10067472" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "OXYGEN SATURATION DECREASED" "10033318" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "PNEUMONITIS" "10035742" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "POSITIVE AIRWAY PRESSURE THERAPY" "10086397" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "PULMONARY FIBROSIS" "10037383" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "SMEAR SITE UNSPECIFIED NORMAL" "10041209" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1775763-1" "1775763-1" "TREMOR" "10044565" "65-79 years" "65-79" "Patient passed away on 4/21/2021. Was hospitalized twice after receiving Covid vaccine. Patient is a 75-year-old woman with interstitial lung disease, HFpEF, HTN, CAD (2v CABG 1999) who was admitted on 4/8/2021 for dyspnea and cough. She had recently been admitted to medical center 3/28-3/31/2021 for acute hypoxemic respiratory failure that was felt to be due to HFpEF vs pneumonia vs pneumonitis-ILD. She was treated with antibiotics, steroids, and diuretics at that admission. Upon this admission, patient was again treated with antibiotics, steroids, and diuretics. She had a bronchoscopy with BAL and transbronchial biopsy on 4/14/2021. BAL Gram stain showed few GPC and PJP smear negative. Transbronchial biopsy revealed organizing pneumonia. She was treated with pulse dose steroids with taper. She was continued on antibiotics and diuretics. Despite these therapies, her respiratory status worsened. She required HFNC. On the morning of 4/21/2021, patient's respiratory status deteriorated. After discussion with family, they opted to pursue comfort care. Patient passed away and was pronounced at 0633 on 4/21/2021." "1782792-1" "1782792-1" "CARDIAC FAILURE CONGESTIVE" "10007559" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 75-year-old male patient. The patient received two doses of the Moderna vaccine on 3/19/21 and 4/16/21. The patient tested positive for COVID-19 on 4/23/21 (5 days post second dose) via PCR. The patient died 5/1/21 (15 days post second dose) and the cause of death is listed as ?Pneumonia secondary to COVID 19?. Other significant conditions contributing to death but not resulting in underlying cause are listed as ?gastrointestinal hemorrhage, acute cholecystitis, and congestive heart failure.?" "1782792-1" "1782792-1" "CHOLECYSTITIS ACUTE" "10008614" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 75-year-old male patient. The patient received two doses of the Moderna vaccine on 3/19/21 and 4/16/21. The patient tested positive for COVID-19 on 4/23/21 (5 days post second dose) via PCR. The patient died 5/1/21 (15 days post second dose) and the cause of death is listed as ?Pneumonia secondary to COVID 19?. Other significant conditions contributing to death but not resulting in underlying cause are listed as ?gastrointestinal hemorrhage, acute cholecystitis, and congestive heart failure.?" "1782792-1" "1782792-1" "COVID-19" "10084268" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 75-year-old male patient. The patient received two doses of the Moderna vaccine on 3/19/21 and 4/16/21. The patient tested positive for COVID-19 on 4/23/21 (5 days post second dose) via PCR. The patient died 5/1/21 (15 days post second dose) and the cause of death is listed as ?Pneumonia secondary to COVID 19?. Other significant conditions contributing to death but not resulting in underlying cause are listed as ?gastrointestinal hemorrhage, acute cholecystitis, and congestive heart failure.?" "1782792-1" "1782792-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 75-year-old male patient. The patient received two doses of the Moderna vaccine on 3/19/21 and 4/16/21. The patient tested positive for COVID-19 on 4/23/21 (5 days post second dose) via PCR. The patient died 5/1/21 (15 days post second dose) and the cause of death is listed as ?Pneumonia secondary to COVID 19?. Other significant conditions contributing to death but not resulting in underlying cause are listed as ?gastrointestinal hemorrhage, acute cholecystitis, and congestive heart failure.?" "1782792-1" "1782792-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 75-year-old male patient. The patient received two doses of the Moderna vaccine on 3/19/21 and 4/16/21. The patient tested positive for COVID-19 on 4/23/21 (5 days post second dose) via PCR. The patient died 5/1/21 (15 days post second dose) and the cause of death is listed as ?Pneumonia secondary to COVID 19?. Other significant conditions contributing to death but not resulting in underlying cause are listed as ?gastrointestinal hemorrhage, acute cholecystitis, and congestive heart failure.?" "1782792-1" "1782792-1" "GASTROINTESTINAL HAEMORRHAGE" "10017955" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 75-year-old male patient. The patient received two doses of the Moderna vaccine on 3/19/21 and 4/16/21. The patient tested positive for COVID-19 on 4/23/21 (5 days post second dose) via PCR. The patient died 5/1/21 (15 days post second dose) and the cause of death is listed as ?Pneumonia secondary to COVID 19?. Other significant conditions contributing to death but not resulting in underlying cause are listed as ?gastrointestinal hemorrhage, acute cholecystitis, and congestive heart failure.?" "1782792-1" "1782792-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 75-year-old male patient. The patient received two doses of the Moderna vaccine on 3/19/21 and 4/16/21. The patient tested positive for COVID-19 on 4/23/21 (5 days post second dose) via PCR. The patient died 5/1/21 (15 days post second dose) and the cause of death is listed as ?Pneumonia secondary to COVID 19?. Other significant conditions contributing to death but not resulting in underlying cause are listed as ?gastrointestinal hemorrhage, acute cholecystitis, and congestive heart failure.?" "1782872-1" "1782872-1" "COVID-19" "10084268" "65-79 years" "65-79" "Respiratory distress, Intubation, death" "1782872-1" "1782872-1" "DEATH" "10011906" "65-79 years" "65-79" "Respiratory distress, Intubation, death" "1782872-1" "1782872-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "Respiratory distress, Intubation, death" "1782872-1" "1782872-1" "RESPIRATORY DISTRESS" "10038687" "65-79 years" "65-79" "Respiratory distress, Intubation, death" "1782872-1" "1782872-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Respiratory distress, Intubation, death" "1782965-1" "1782965-1" "ACUTE MYOCARDIAL INFARCTION" "10000891" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "ATRIAL FIBRILLATION" "10003658" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "BRADYCARDIA" "10006093" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "CARDIAC ARREST" "10007515" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "CARDIOGENIC SHOCK" "10007625" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "CATHETERISATION CARDIAC ABNORMAL" "10007816" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "CHEST PAIN" "10008479" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "CORONARY ARTERIAL STENT INSERTION" "10052086" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "CORONARY ARTERY OCCLUSION" "10011086" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "COVID-19" "10084268" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "ECHOCARDIOGRAM ABNORMAL" "10061593" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "ENDOTRACHEAL INTUBATION" "10067450" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "HYPOXIA" "10021143" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "PERCUTANEOUS CORONARY INTERVENTION" "10065608" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "SYSTOLIC DYSFUNCTION" "10071436" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "TEMPORARY TRANSVENOUS PACING" "10085182" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "UNRESPONSIVE TO STIMULI" "10045555" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1782965-1" "1782965-1" "X-RAY" "10048064" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77-year-old female patient. According to records, patient was a 77 y/o woman with a hx of hypertension, hyperlipidemia, hx of tachycardia-induced cardiomyopathy (with normalization of LV function), chronic atrial fibrillation complicated by embolic renal infarction (on rivaroxaban), hx of rectal cancer, sacral decubitus ulcer, resident who had been positive for COVID19 since about a month prior to admission who presented to ED on 1/26 with substernal chest pain, where she was found to be in atrial fibrillation with bradycardia and to have an inferior STEMI. A transvenous pacer was emergently placed in the emergency room and patient was intubated because of hypoxia and unresponsiveness. Of note, COVID19 PCR was still positive. Emergent cardiac catheterization was done, which demonstrated a totally occluded RCA. PCI was performed and three drug eluting stents were placed in the RCA. The transvenous pacer was repositioned under fluoroscopic guidance. Vasopressor support was started in the cath lab. Upon ICU arrival, patient had rapidly escalating vasopressor requirements and persistent bradycardia, but the pacer was no longer capturing (despite maximal output). Echocardiography demonstrated severe systolic dysfunction. Mrs. Wightman had three consecutive cardiac arrests. TIMELINE: The patient tested positive for COVID-19 on 11/24/20 and 12/08/21 via PCR. The patient then received two doses of the Pfizer vaccine on 12/30/20 and 1/20/21. The patient tested positive for COVID-19 again on 1/26. The patient died on 1/27/21, one week after their second dose of Pfizer vaccine and one day after testing positive for COVID-19. The suspected cause of death is listed as ?cardiac arrest secondary to STEMI, cardiogenic shock?. I am reporting this case now because vaccination status was not considered to be a factor in cardiac arrest at the time this report was initially made." "1783015-1" "1783015-1" "ACUTE RESPIRATORY DISTRESS SYNDROME" "10001052" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "ANAEMIA" "10002034" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "CEREBRAL INFARCTION" "10008118" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "COVID-19" "10084268" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "COVID-19 PNEUMONIA" "10084380" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "FASCIOTOMY" "10016237" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "HYPOXIA" "10021143" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "MULTIPLE ORGAN DYSFUNCTION SYNDROME" "10077361" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "PERIPHERAL ARTERY THROMBOSIS" "10072564" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "RESPIRATORY FAILURE" "10038695" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "THROMBECTOMY" "10043530" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1783015-1" "1783015-1" "THROMBOCYTOPENIA" "10043554" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report." "1786208-1" "1786208-1" "SUDDEN DEATH" "10042434" "65-79 years" "65-79" "Patient died suddenly. Because there was no foul play, an autopsy was not done. ER doc guessed massive heart attack. Patient's cardiologist does not believe it was a heart attack because his labs were fine in July. His blood pressure was controlled." "1787777-1" "1787777-1" "SUDDEN DEATH" "10042434" "65-79 years" "65-79" "Sudden death on 9/3/2021" "1804053-1" "1804053-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient passed away three days after receiving his third Pfizer COVID vaccine." "1808191-1" "1808191-1" "BRAIN DEATH" "10049054" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "BRAIN HERNIATION" "10006126" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "BRAIN OEDEMA" "10048962" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "CEREBRAL HAEMORRHAGE" "10008111" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "COMA" "10010071" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "COMPUTERISED TOMOGRAM HEAD ABNORMAL" "10072168" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "HYDROCEPHALUS" "10020508" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "INTRAVENTRICULAR HAEMORRHAGE" "10022840" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "NEUROLOGICAL DECOMPENSATION" "10068357" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "NEUROLOGICAL EXAMINATION ABNORMAL" "10056832" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "QUADRIPARESIS" "10049680" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1808191-1" "1808191-1" "SKULL FRACTURE" "10061365" "65-79 years" "65-79" "Patient is a 73 y.o. adult with no known past medical history who presents to the Emergency Department via EMS for evaluation of a potential stroke. Per EMS, the patient was found flat on his back at approximately 4 PM by neighbors outside of his apartment in a parking lot. EMS states that they found a receipt in the patients belongings for a purchase at a local pharmacy at 2:30 PM. Patient presents to the ED with unknown last known well time as well as a complete left side neglect. Head CT showed right parietal skull fracture, right parietal ICH with mixed density concerning for ongoing hemorrhage, extravasation, cerebral edema, brain compression and IVH. Repeat head CT with expansion of hemorrhage, worsening IVH with hydrocephalus, cerebral edema and herniation. Clinically with rapid neurologic decline and coma with functional quadraparesis at time of admission. Etiology unclear, potentially underlying vascular malformation, unknown if iatrogenic coagulopathy, or trauma. Possible hemorrhage of underlying mass not excluded. Neurosurgery consulted, discussed overnight. Due to massive expansion and no meaningful improvement in neurologic exam with medical intervention, surgical intervention not offered as would not benefit patient due to extent of injury and poor neurologic prognosis. Patient underwent brain death testing and time of death was called 10/22/21 at 1441." "1837453-1" "1837453-1" "BLOOD TEST" "10061726" "65-79 years" "65-79" "Stroke on 2/12/2021, death on 2/28/2021 Was in 3 hospitals:" "1837453-1" "1837453-1" "CEREBROVASCULAR ACCIDENT" "10008190" "65-79 years" "65-79" "Stroke on 2/12/2021, death on 2/28/2021 Was in 3 hospitals:" "1837453-1" "1837453-1" "COMPUTERISED TOMOGRAM" "10010234" "65-79 years" "65-79" "Stroke on 2/12/2021, death on 2/28/2021 Was in 3 hospitals:" "1837453-1" "1837453-1" "DEATH" "10011906" "65-79 years" "65-79" "Stroke on 2/12/2021, death on 2/28/2021 Was in 3 hospitals:" "1837453-1" "1837453-1" "ECHOCARDIOGRAM" "10014113" "65-79 years" "65-79" "Stroke on 2/12/2021, death on 2/28/2021 Was in 3 hospitals:" "1849135-1" "1849135-1" "CARDIAC FAILURE" "10007554" "65-79 years" "65-79" "Developed pulmonary fluid and difficulty breathing after 2nd Covid vaccine in March 2021. Died from pulmonary edema and heart failure 9 days after 3rd dose." "1849135-1" "1849135-1" "CATHETERISATION CARDIAC" "10007815" "65-79 years" "65-79" "Developed pulmonary fluid and difficulty breathing after 2nd Covid vaccine in March 2021. Died from pulmonary edema and heart failure 9 days after 3rd dose." "1849135-1" "1849135-1" "COMPUTERISED TOMOGRAM" "10010234" "65-79 years" "65-79" "Developed pulmonary fluid and difficulty breathing after 2nd Covid vaccine in March 2021. Died from pulmonary edema and heart failure 9 days after 3rd dose." "1849135-1" "1849135-1" "DEATH" "10011906" "65-79 years" "65-79" "Developed pulmonary fluid and difficulty breathing after 2nd Covid vaccine in March 2021. Died from pulmonary edema and heart failure 9 days after 3rd dose." "1849135-1" "1849135-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "Developed pulmonary fluid and difficulty breathing after 2nd Covid vaccine in March 2021. Died from pulmonary edema and heart failure 9 days after 3rd dose." "1849135-1" "1849135-1" "ECHOCARDIOGRAM" "10014113" "65-79 years" "65-79" "Developed pulmonary fluid and difficulty breathing after 2nd Covid vaccine in March 2021. Died from pulmonary edema and heart failure 9 days after 3rd dose." "1849135-1" "1849135-1" "PULMONARY OEDEMA" "10037423" "65-79 years" "65-79" "Developed pulmonary fluid and difficulty breathing after 2nd Covid vaccine in March 2021. Died from pulmonary edema and heart failure 9 days after 3rd dose." "1850989-1" "1850989-1" "ASTHENIA" "10003549" "65-79 years" "65-79" "My father got very sick and weak- his heart started shutting down and he died" "1850989-1" "1850989-1" "CARDIAC FAILURE" "10007554" "65-79 years" "65-79" "My father got very sick and weak- his heart started shutting down and he died" "1850989-1" "1850989-1" "DEATH" "10011906" "65-79 years" "65-79" "My father got very sick and weak- his heart started shutting down and he died" "1850989-1" "1850989-1" "MALAISE" "10025482" "65-79 years" "65-79" "My father got very sick and weak- his heart started shutting down and he died" "1851032-1" "1851032-1" "DEATH" "10011906" "65-79 years" "65-79" "Patient developed altered mental status and 4+ pitting edema on 9/11/21. Her condition deteriorated over the next 2 days, and she was hospitalized on 9/13/21 for 1 day. She returned on comfort care/hospice, and expired on 9/17/21." "1851032-1" "1851032-1" "DIFFERENTIAL WHITE BLOOD CELL COUNT" "10012784" "65-79 years" "65-79" "Patient developed altered mental status and 4+ pitting edema on 9/11/21. Her condition deteriorated over the next 2 days, and she was hospitalized on 9/13/21 for 1 day. She returned on comfort care/hospice, and expired on 9/17/21." "1851032-1" "1851032-1" "FULL BLOOD COUNT" "10017411" "65-79 years" "65-79" "Patient developed altered mental status and 4+ pitting edema on 9/11/21. Her condition deteriorated over the next 2 days, and she was hospitalized on 9/13/21 for 1 day. She returned on comfort care/hospice, and expired on 9/17/21." "1851032-1" "1851032-1" "GENERAL PHYSICAL HEALTH DETERIORATION" "10049438" "65-79 years" "65-79" "Patient developed altered mental status and 4+ pitting edema on 9/11/21. Her condition deteriorated over the next 2 days, and she was hospitalized on 9/13/21 for 1 day. She returned on comfort care/hospice, and expired on 9/17/21." "1851032-1" "1851032-1" "MENTAL STATUS CHANGES" "10048294" "65-79 years" "65-79" "Patient developed altered mental status and 4+ pitting edema on 9/11/21. Her condition deteriorated over the next 2 days, and she was hospitalized on 9/13/21 for 1 day. She returned on comfort care/hospice, and expired on 9/17/21." "1851032-1" "1851032-1" "METABOLIC FUNCTION TEST" "10062191" "65-79 years" "65-79" "Patient developed altered mental status and 4+ pitting edema on 9/11/21. Her condition deteriorated over the next 2 days, and she was hospitalized on 9/13/21 for 1 day. She returned on comfort care/hospice, and expired on 9/17/21." "1851032-1" "1851032-1" "OEDEMA" "10030095" "65-79 years" "65-79" "Patient developed altered mental status and 4+ pitting edema on 9/11/21. Her condition deteriorated over the next 2 days, and she was hospitalized on 9/13/21 for 1 day. She returned on comfort care/hospice, and expired on 9/17/21." "1865402-1" "1865402-1" "ACUTE MYOCARDIAL INFARCTION" "10000891" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 69 year-old male patient. Patient received two doses of the Pfizer vaccine, according to immunization records. The first dose was on 1/11/21 and the second was on 02/01/2021. The patient died on 02/02/21 (one day post dose 2) in nursing home. The death certificate lists ?acute myocardial infarction? as the immediate cause of death secondary to ?hypertensive heart disease? (unknown onset). Other significant conditions contributing to death but not resulting in underlying cause include Parkinson?s disease, hypothyroidism, and hyperlipidemia." "1865402-1" "1865402-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 69 year-old male patient. Patient received two doses of the Pfizer vaccine, according to immunization records. The first dose was on 1/11/21 and the second was on 02/01/2021. The patient died on 02/02/21 (one day post dose 2) in nursing home. The death certificate lists ?acute myocardial infarction? as the immediate cause of death secondary to ?hypertensive heart disease? (unknown onset). Other significant conditions contributing to death but not resulting in underlying cause include Parkinson?s disease, hypothyroidism, and hyperlipidemia." "1865402-1" "1865402-1" "HYPERTENSIVE HEART DISEASE" "10020823" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 69 year-old male patient. Patient received two doses of the Pfizer vaccine, according to immunization records. The first dose was on 1/11/21 and the second was on 02/01/2021. The patient died on 02/02/21 (one day post dose 2) in nursing home. The death certificate lists ?acute myocardial infarction? as the immediate cause of death secondary to ?hypertensive heart disease? (unknown onset). Other significant conditions contributing to death but not resulting in underlying cause include Parkinson?s disease, hypothyroidism, and hyperlipidemia." "1865504-1" "1865504-1" "CARDIO-RESPIRATORY ARREST" "10007617" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 75 year-old female patient. Patient received two doses of the Moderna vaccine, according to immunization records. The first dose was on 4/23/21 and the second was on 5/17/2021. The patient was found dead at home on 5/19/2021 (2 days post second dose). The death certificate lists ?cardiopulmonary arrest? as the immediate cause of death secondary to ?CHF, Interstitial Lung Disease, OSA, AFIB (FEW weeks) and RHEUMATOID ARTHRITIS, HTN, DIABETES (MANY years).? No additional information is available." "1865504-1" "1865504-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 75 year-old female patient. Patient received two doses of the Moderna vaccine, according to immunization records. The first dose was on 4/23/21 and the second was on 5/17/2021. The patient was found dead at home on 5/19/2021 (2 days post second dose). The death certificate lists ?cardiopulmonary arrest? as the immediate cause of death secondary to ?CHF, Interstitial Lung Disease, OSA, AFIB (FEW weeks) and RHEUMATOID ARTHRITIS, HTN, DIABETES (MANY years).? No additional information is available." "1869829-1" "1869829-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" ""Pt developed a cough with wheezing and shortness of breath day 3 post vaccine. She saw our medical practice for care on day 4 post vaccine. On Wednesday 11/10/21 (day 9 post vaccine) she had a ""coughing fit"" and lost consciousness. EMS was dispatched and attempted to resuscitate patient but she died shortly there after at the Emergency department."" "1869829-1" "1869829-1" "COUGH" "10011224" "65-79 years" "65-79" ""Pt developed a cough with wheezing and shortness of breath day 3 post vaccine. She saw our medical practice for care on day 4 post vaccine. On Wednesday 11/10/21 (day 9 post vaccine) she had a ""coughing fit"" and lost consciousness. EMS was dispatched and attempted to resuscitate patient but she died shortly there after at the Emergency department."" "1869829-1" "1869829-1" "DEATH" "10011906" "65-79 years" "65-79" ""Pt developed a cough with wheezing and shortness of breath day 3 post vaccine. She saw our medical practice for care on day 4 post vaccine. On Wednesday 11/10/21 (day 9 post vaccine) she had a ""coughing fit"" and lost consciousness. EMS was dispatched and attempted to resuscitate patient but she died shortly there after at the Emergency department."" "1869829-1" "1869829-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" ""Pt developed a cough with wheezing and shortness of breath day 3 post vaccine. She saw our medical practice for care on day 4 post vaccine. On Wednesday 11/10/21 (day 9 post vaccine) she had a ""coughing fit"" and lost consciousness. EMS was dispatched and attempted to resuscitate patient but she died shortly there after at the Emergency department."" "1869829-1" "1869829-1" "LOSS OF CONSCIOUSNESS" "10024855" "65-79 years" "65-79" ""Pt developed a cough with wheezing and shortness of breath day 3 post vaccine. She saw our medical practice for care on day 4 post vaccine. On Wednesday 11/10/21 (day 9 post vaccine) she had a ""coughing fit"" and lost consciousness. EMS was dispatched and attempted to resuscitate patient but she died shortly there after at the Emergency department."" "1869829-1" "1869829-1" "RESUSCITATION" "10038749" "65-79 years" "65-79" ""Pt developed a cough with wheezing and shortness of breath day 3 post vaccine. She saw our medical practice for care on day 4 post vaccine. On Wednesday 11/10/21 (day 9 post vaccine) she had a ""coughing fit"" and lost consciousness. EMS was dispatched and attempted to resuscitate patient but she died shortly there after at the Emergency department."" "1869829-1" "1869829-1" "SARS-COV-2 TEST NEGATIVE" "10084273" "65-79 years" "65-79" ""Pt developed a cough with wheezing and shortness of breath day 3 post vaccine. She saw our medical practice for care on day 4 post vaccine. On Wednesday 11/10/21 (day 9 post vaccine) she had a ""coughing fit"" and lost consciousness. EMS was dispatched and attempted to resuscitate patient but she died shortly there after at the Emergency department."" "1869829-1" "1869829-1" "WHEEZING" "10047924" "65-79 years" "65-79" ""Pt developed a cough with wheezing and shortness of breath day 3 post vaccine. She saw our medical practice for care on day 4 post vaccine. On Wednesday 11/10/21 (day 9 post vaccine) she had a ""coughing fit"" and lost consciousness. EMS was dispatched and attempted to resuscitate patient but she died shortly there after at the Emergency department."" "1873627-1" "1873627-1" "ARRHYTHMIA" "10003119" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 73 year-old female patient. The patient received two doses of the Pfizer Vaccine: First: 2/27/2021 Second: 03/20/2021 The patient was found dead at home on 3/27/2021 (7 days post second dose). The immediate cause of death listed on the death certificate is ?cardiopulmonary arrest? (few minutes) secondary to ?arrhythmia? (few minutes) and ?hypertensive heart disease? (few years). I do not have any additional information about other underlying conditions that may have contributed to this person?s death." "1873627-1" "1873627-1" "CARDIO-RESPIRATORY ARREST" "10007617" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 73 year-old female patient. The patient received two doses of the Pfizer Vaccine: First: 2/27/2021 Second: 03/20/2021 The patient was found dead at home on 3/27/2021 (7 days post second dose). The immediate cause of death listed on the death certificate is ?cardiopulmonary arrest? (few minutes) secondary to ?arrhythmia? (few minutes) and ?hypertensive heart disease? (few years). I do not have any additional information about other underlying conditions that may have contributed to this person?s death." "1873627-1" "1873627-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 73 year-old female patient. The patient received two doses of the Pfizer Vaccine: First: 2/27/2021 Second: 03/20/2021 The patient was found dead at home on 3/27/2021 (7 days post second dose). The immediate cause of death listed on the death certificate is ?cardiopulmonary arrest? (few minutes) secondary to ?arrhythmia? (few minutes) and ?hypertensive heart disease? (few years). I do not have any additional information about other underlying conditions that may have contributed to this person?s death." "1873627-1" "1873627-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 73 year-old female patient. The patient received two doses of the Pfizer Vaccine: First: 2/27/2021 Second: 03/20/2021 The patient was found dead at home on 3/27/2021 (7 days post second dose). The immediate cause of death listed on the death certificate is ?cardiopulmonary arrest? (few minutes) secondary to ?arrhythmia? (few minutes) and ?hypertensive heart disease? (few years). I do not have any additional information about other underlying conditions that may have contributed to this person?s death." "1873627-1" "1873627-1" "HYPERTENSIVE HEART DISEASE" "10020823" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 73 year-old female patient. The patient received two doses of the Pfizer Vaccine: First: 2/27/2021 Second: 03/20/2021 The patient was found dead at home on 3/27/2021 (7 days post second dose). The immediate cause of death listed on the death certificate is ?cardiopulmonary arrest? (few minutes) secondary to ?arrhythmia? (few minutes) and ?hypertensive heart disease? (few years). I do not have any additional information about other underlying conditions that may have contributed to this person?s death." "1873689-1" "1873689-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 65 year-old male patient. The patient received two doses of the Pfizer Vaccine: First: 3/17/2021 Second: 4/07/2021 The patient was found dead at home on 4/19/2021 (12 days post second dose). The immediate cause of death listed on the death certificate is ?coronary artery disease.? Other significant conditions contributing to death but not resulting in underlying cause are listed as ?hypertension COPD?. I do not have any additional information about other underlying conditions that may have contributed to this person?s death." "1873689-1" "1873689-1" "CORONARY ARTERY DISEASE" "10011078" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 65 year-old male patient. The patient received two doses of the Pfizer Vaccine: First: 3/17/2021 Second: 4/07/2021 The patient was found dead at home on 4/19/2021 (12 days post second dose). The immediate cause of death listed on the death certificate is ?coronary artery disease.? Other significant conditions contributing to death but not resulting in underlying cause are listed as ?hypertension COPD?. I do not have any additional information about other underlying conditions that may have contributed to this person?s death." "1873689-1" "1873689-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 65 year-old male patient. The patient received two doses of the Pfizer Vaccine: First: 3/17/2021 Second: 4/07/2021 The patient was found dead at home on 4/19/2021 (12 days post second dose). The immediate cause of death listed on the death certificate is ?coronary artery disease.? Other significant conditions contributing to death but not resulting in underlying cause are listed as ?hypertension COPD?. I do not have any additional information about other underlying conditions that may have contributed to this person?s death." "1885533-1" "1885533-1" "CEREBRAL ARTERIOSCLEROSIS" "10065559" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77 year-old female patient. Patient was a resident of a facility for approximately two years prior to death. Patient received three doses of the Pfizer vaccine. The first was on 1/03/2021, the second was on 1/24/21 and the third was on 9/30/2021, according to immunization records. The patient passed away on 9/30/2021 (the same day the third dose was received) in nursing facility. The death certificate lists ?Cerebral Arteriosclerosis (1 year)? as the immediate cause of death. Prior medical information (obtained from facility) includes: 2019-Time of Death: Hypertension, Wernicke?s encephalopathy 2020- Time of Death: Liver cirrhosis, history of TIAs, unspecified chronic kidney disease (stage 3), 2021- Time of Death: Hyperlipidemia The patient was prescribed amlodipine (heart medicine) and Lipitor." "1885533-1" "1885533-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77 year-old female patient. Patient was a resident of a facility for approximately two years prior to death. Patient received three doses of the Pfizer vaccine. The first was on 1/03/2021, the second was on 1/24/21 and the third was on 9/30/2021, according to immunization records. The patient passed away on 9/30/2021 (the same day the third dose was received) in nursing facility. The death certificate lists ?Cerebral Arteriosclerosis (1 year)? as the immediate cause of death. Prior medical information (obtained from facility) includes: 2019-Time of Death: Hypertension, Wernicke?s encephalopathy 2020- Time of Death: Liver cirrhosis, history of TIAs, unspecified chronic kidney disease (stage 3), 2021- Time of Death: Hyperlipidemia The patient was prescribed amlodipine (heart medicine) and Lipitor." "1885533-1" "1885533-1" "HYPERLIPIDAEMIA" "10062060" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 77 year-old female patient. Patient was a resident of a facility for approximately two years prior to death. Patient received three doses of the Pfizer vaccine. The first was on 1/03/2021, the second was on 1/24/21 and the third was on 9/30/2021, according to immunization records. The patient passed away on 9/30/2021 (the same day the third dose was received) in nursing facility. The death certificate lists ?Cerebral Arteriosclerosis (1 year)? as the immediate cause of death. Prior medical information (obtained from facility) includes: 2019-Time of Death: Hypertension, Wernicke?s encephalopathy 2020- Time of Death: Liver cirrhosis, history of TIAs, unspecified chronic kidney disease (stage 3), 2021- Time of Death: Hyperlipidemia The patient was prescribed amlodipine (heart medicine) and Lipitor." "1889080-1" "1889080-1" "BLOOD LACTIC ACID INCREASED" "10005635" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "CARDIOGENIC SHOCK" "10007625" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL" "10057798" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "DEATH" "10011906" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "ECHOCARDIOGRAM ABNORMAL" "10061593" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "EJECTION FRACTION DECREASED" "10050528" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "HYPOTENSION" "10021097" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "LEFT VENTRICULAR DYSFUNCTION" "10049694" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "PERIPHERAL VENOUS DISEASE" "10075049" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "PULSELESS ELECTRICAL ACTIVITY" "10058151" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "SCAN WITH CONTRAST ABNORMAL" "10062152" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889080-1" "1889080-1" "TROPONIN INCREASED" "10058267" "65-79 years" "65-79" ""The patient was in his usual state of health until 48 hours after receiving his 3rd ""booster"" Moderna COVID vaccine. He presented in cardiogenic shock as evidenced by hypotension, elevated lactate, CT imaging showing reversal/reflux of contrast in the IVC and hepatic veins, and echo showing severe LV dysfunction (EF 10%) with a prior echo that was EF 50% in 2020. The patient suffered refractory hypotension despite efforts to maintain blood pressures with multiple pressors and eventually developed PEA arrest. Troponin minimally positive on admission and rose to a high level, suggesting a possible etiology of myocardial infarction (likely LAD territory based on echo) versus myocarditis as a result of the vaccine booster. The patient unfortunately was pronounced deceased on 11/21/21 about 8 hours after presentation to the ED."" "1889986-1" "1889986-1" "CARDIAC IMAGING PROCEDURE ABNORMAL" "10053453" "65-79 years" "65-79" "On 5/18/2021 patient admitted in Hospital with SOB Patient died 9/25/21 in hospice care Also significant- Patient had about 5 days of Votrient (half dose) before this episode. He had just started this chemo agent." "1889986-1" "1889986-1" "CHEMOTHERAPY" "10061758" "65-79 years" "65-79" "On 5/18/2021 patient admitted in Hospital with SOB Patient died 9/25/21 in hospice care Also significant- Patient had about 5 days of Votrient (half dose) before this episode. He had just started this chemo agent." "1889986-1" "1889986-1" "DEATH" "10011906" "65-79 years" "65-79" "On 5/18/2021 patient admitted in Hospital with SOB Patient died 9/25/21 in hospice care Also significant- Patient had about 5 days of Votrient (half dose) before this episode. He had just started this chemo agent." "1889986-1" "1889986-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "On 5/18/2021 patient admitted in Hospital with SOB Patient died 9/25/21 in hospice care Also significant- Patient had about 5 days of Votrient (half dose) before this episode. He had just started this chemo agent." "1889986-1" "1889986-1" "ECHOCARDIOGRAM ABNORMAL" "10061593" "65-79 years" "65-79" "On 5/18/2021 patient admitted in Hospital with SOB Patient died 9/25/21 in hospice care Also significant- Patient had about 5 days of Votrient (half dose) before this episode. He had just started this chemo agent." "1889986-1" "1889986-1" "MYOCARDITIS" "10028606" "65-79 years" "65-79" "On 5/18/2021 patient admitted in Hospital with SOB Patient died 9/25/21 in hospice care Also significant- Patient had about 5 days of Votrient (half dose) before this episode. He had just started this chemo agent." "1890266-1" "1890266-1" "THROMBOSIS" "10043607" "65-79 years" "65-79" "Blood clot" "1892837-1" "1892837-1" "DEATH" "10011906" "65-79 years" "65-79" "shortness of breath, followed by syncope and collapse and subsequently death" "1892837-1" "1892837-1" "DYSPNOEA" "10013968" "65-79 years" "65-79" "shortness of breath, followed by syncope and collapse and subsequently death" "1892837-1" "1892837-1" "SYNCOPE" "10042772" "65-79 years" "65-79" "shortness of breath, followed by syncope and collapse and subsequently death" "1893761-1" "1893761-1" "ABDOMINAL PAIN" "10000081" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "ARTERIAL OCCLUSIVE DISEASE" "10062599" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "BLOOD PRESSURE ABNORMAL" "10005728" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "CHOLECYSTECTOMY" "10008611" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "CHOLELITHIASIS" "10008629" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "DEATH" "10011906" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "DYSPHAGIA" "10013950" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "HAEMATEMESIS" "10018830" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "INTENSIVE CARE" "10022519" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "MECHANICAL VENTILATION" "10067221" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "PANCREATITIS" "10033645" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "PYREXIA" "10037660" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "SEPSIS" "10040047" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "SURGERY" "10042609" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "TACHYCARDIA" "10043071" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "TRACHEOSTOMY" "10044320" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1893761-1" "1893761-1" "VOMITING" "10047700" "65-79 years" "65-79" "Received 1st injection in March. Had 2nd dose set up in 20 days but after 11 days was sent to hospital for throwing up and abdominal pain. Was diagnosed with full stones and pancreatitis. Had surgery to remove gull bladder. Sent home after a week but returned to hospital after 4 days with sepsis and put in icu. Had fever and tachycardia. Spent 45 days in hospital. Sent home with a thickened diet because had swallowing issues. After 4 days went back to hospital after throwing up blood and bile. Spent 2 months back in hospital with tachycardia and blood pressure issues. Had developed narcotic pancreatitis and had 2 more surgeries to fix a block in arteries. Put on vent twice and couldn?t get o2 levels regulated. Ended up with a Trach before going home with hospice and passing away 9 days later." "1896992-1" "1896992-1" "ACUTE RESPIRATORY FAILURE" "10001053" "65-79 years" "65-79" "Covid Vaccination Monitoring Documentation: PT admitted 11/9/21 ? 11/12/21. POC SARS COV2 ANTIGEN resulted 11/11/21. Patient had Pfizer covid vaccine 1/30/21 Lot: EL9265, Pfizer covid vaccine 2/20/21 Lot# EL9266. Patient expired 11/12/21. Documented cause of death: Acute respiratory failure 2/2 covid 19, sepsis, tracheobronchomalacia." "1896992-1" "1896992-1" "COVID-19" "10084268" "65-79 years" "65-79" "Covid Vaccination Monitoring Documentation: PT admitted 11/9/21 ? 11/12/21. POC SARS COV2 ANTIGEN resulted 11/11/21. Patient had Pfizer covid vaccine 1/30/21 Lot: EL9265, Pfizer covid vaccine 2/20/21 Lot# EL9266. Patient expired 11/12/21. Documented cause of death: Acute respiratory failure 2/2 covid 19, sepsis, tracheobronchomalacia." "1896992-1" "1896992-1" "DEATH" "10011906" "65-79 years" "65-79" "Covid Vaccination Monitoring Documentation: PT admitted 11/9/21 ? 11/12/21. POC SARS COV2 ANTIGEN resulted 11/11/21. Patient had Pfizer covid vaccine 1/30/21 Lot: EL9265, Pfizer covid vaccine 2/20/21 Lot# EL9266. Patient expired 11/12/21. Documented cause of death: Acute respiratory failure 2/2 covid 19, sepsis, tracheobronchomalacia." "1896992-1" "1896992-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "Covid Vaccination Monitoring Documentation: PT admitted 11/9/21 ? 11/12/21. POC SARS COV2 ANTIGEN resulted 11/11/21. Patient had Pfizer covid vaccine 1/30/21 Lot: EL9265, Pfizer covid vaccine 2/20/21 Lot# EL9266. Patient expired 11/12/21. Documented cause of death: Acute respiratory failure 2/2 covid 19, sepsis, tracheobronchomalacia." "1896992-1" "1896992-1" "SEPSIS" "10040047" "65-79 years" "65-79" "Covid Vaccination Monitoring Documentation: PT admitted 11/9/21 ? 11/12/21. POC SARS COV2 ANTIGEN resulted 11/11/21. Patient had Pfizer covid vaccine 1/30/21 Lot: EL9265, Pfizer covid vaccine 2/20/21 Lot# EL9266. Patient expired 11/12/21. Documented cause of death: Acute respiratory failure 2/2 covid 19, sepsis, tracheobronchomalacia." "1896992-1" "1896992-1" "TRACHEOMALACIA" "10056397" "65-79 years" "65-79" "Covid Vaccination Monitoring Documentation: PT admitted 11/9/21 ? 11/12/21. POC SARS COV2 ANTIGEN resulted 11/11/21. Patient had Pfizer covid vaccine 1/30/21 Lot: EL9265, Pfizer covid vaccine 2/20/21 Lot# EL9266. Patient expired 11/12/21. Documented cause of death: Acute respiratory failure 2/2 covid 19, sepsis, tracheobronchomalacia." "1897085-1" "1897085-1" "DEATH" "10011906" "65-79 years" "65-79" "Deceased 10/16/2021" "1897085-1" "1897085-1" "SARS-COV-2 RNA" "10085493" "65-79 years" "65-79" "Deceased 10/16/2021" "1909167-1" "1909167-1" "CSF OLIGOCLONAL BAND PRESENT" "10011562" "65-79 years" "65-79" "The patient developed a rapidly progressive lower motor neuron disorder beginning in March 2021 and progressing from her legs to her arms to her bulbar and respiratory muscles, resulting in death in November 2021." "1909167-1" "1909167-1" "CSF TEST ABNORMAL" "10059703" "65-79 years" "65-79" "The patient developed a rapidly progressive lower motor neuron disorder beginning in March 2021 and progressing from her legs to her arms to her bulbar and respiratory muscles, resulting in death in November 2021." "1909167-1" "1909167-1" "DEATH" "10011906" "65-79 years" "65-79" "The patient developed a rapidly progressive lower motor neuron disorder beginning in March 2021 and progressing from her legs to her arms to her bulbar and respiratory muscles, resulting in death in November 2021." "1909167-1" "1909167-1" "ELECTROMYOGRAM ABNORMAL" "10014431" "65-79 years" "65-79" "The patient developed a rapidly progressive lower motor neuron disorder beginning in March 2021 and progressing from her legs to her arms to her bulbar and respiratory muscles, resulting in death in November 2021." "1909167-1" "1909167-1" "INFLAMMATORY MARKER INCREASED" "10069826" "65-79 years" "65-79" "The patient developed a rapidly progressive lower motor neuron disorder beginning in March 2021 and progressing from her legs to her arms to her bulbar and respiratory muscles, resulting in death in November 2021." "1909167-1" "1909167-1" "MOTOR NEURONE DISEASE" "10028003" "65-79 years" "65-79" "The patient developed a rapidly progressive lower motor neuron disorder beginning in March 2021 and progressing from her legs to her arms to her bulbar and respiratory muscles, resulting in death in November 2021." "1909167-1" "1909167-1" "NERVE CONDUCTION STUDIES ABNORMAL" "10029175" "65-79 years" "65-79" "The patient developed a rapidly progressive lower motor neuron disorder beginning in March 2021 and progressing from her legs to her arms to her bulbar and respiratory muscles, resulting in death in November 2021." "1909307-1" "1909307-1" "ARTERIOSCLEROSIS" "10003210" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 73-year-old male LTCF patient. The patient received their first dose of the Pfizer vaccine on 1/06/21. The patient tested positive for COVID-19 on 1/26/21 via PCR (20 days post dose 1). The patient received their second dose of the Pfizer vaccine on 5/26/21 and their third dose of the Pfizer vaccine on 10/27/21. The patient tested positive for COVID-19 a second time via PCR on 11/16/21. On 11/27/21 (one-month post dose-3 and 11 days post positive test) the patient expired (listed as COVID-19 death). The cause of death listed on the death certificate is atherosclerosis (3 years). Known patient history includes cardiovascular disease. This is the first instance I have observed within my home county of a person with a repeat infection, fully vaccinated + boosted, passing away with COVID." "1909307-1" "1909307-1" "COVID-19" "10084268" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 73-year-old male LTCF patient. The patient received their first dose of the Pfizer vaccine on 1/06/21. The patient tested positive for COVID-19 on 1/26/21 via PCR (20 days post dose 1). The patient received their second dose of the Pfizer vaccine on 5/26/21 and their third dose of the Pfizer vaccine on 10/27/21. The patient tested positive for COVID-19 a second time via PCR on 11/16/21. On 11/27/21 (one-month post dose-3 and 11 days post positive test) the patient expired (listed as COVID-19 death). The cause of death listed on the death certificate is atherosclerosis (3 years). Known patient history includes cardiovascular disease. This is the first instance I have observed within my home county of a person with a repeat infection, fully vaccinated + boosted, passing away with COVID." "1909307-1" "1909307-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 73-year-old male LTCF patient. The patient received their first dose of the Pfizer vaccine on 1/06/21. The patient tested positive for COVID-19 on 1/26/21 via PCR (20 days post dose 1). The patient received their second dose of the Pfizer vaccine on 5/26/21 and their third dose of the Pfizer vaccine on 10/27/21. The patient tested positive for COVID-19 a second time via PCR on 11/16/21. On 11/27/21 (one-month post dose-3 and 11 days post positive test) the patient expired (listed as COVID-19 death). The cause of death listed on the death certificate is atherosclerosis (3 years). Known patient history includes cardiovascular disease. This is the first instance I have observed within my home county of a person with a repeat infection, fully vaccinated + boosted, passing away with COVID." "1909307-1" "1909307-1" "SARS-COV-2 TEST POSITIVE" "10084271" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 73-year-old male LTCF patient. The patient received their first dose of the Pfizer vaccine on 1/06/21. The patient tested positive for COVID-19 on 1/26/21 via PCR (20 days post dose 1). The patient received their second dose of the Pfizer vaccine on 5/26/21 and their third dose of the Pfizer vaccine on 10/27/21. The patient tested positive for COVID-19 a second time via PCR on 11/16/21. On 11/27/21 (one-month post dose-3 and 11 days post positive test) the patient expired (listed as COVID-19 death). The cause of death listed on the death certificate is atherosclerosis (3 years). Known patient history includes cardiovascular disease. This is the first instance I have observed within my home county of a person with a repeat infection, fully vaccinated + boosted, passing away with COVID." "1912752-1" "1912752-1" "CONDITION AGGRAVATED" "10010264" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 68 year-old female patient. Patient received their first and second doses of the Moderna vaccine on 4/21/21 and 5/18/21 respectively, according to immunization records. Patient received their third dose of the Moderna Vaccine on 11/22/21. The patient was found deceased at home on 11/23/2021 (1 day after third dose). The death certificate lists ?hypertension (5 years)? as the immediate cause of death. Other significant conditions contributing to the death but not resulting in underlying cause include hyperlipidemia. I have no further information regarding the patient?s medical history." "1912752-1" "1912752-1" "DEATH" "10011906" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 68 year-old female patient. Patient received their first and second doses of the Moderna vaccine on 4/21/21 and 5/18/21 respectively, according to immunization records. Patient received their third dose of the Moderna Vaccine on 11/22/21. The patient was found deceased at home on 11/23/2021 (1 day after third dose). The death certificate lists ?hypertension (5 years)? as the immediate cause of death. Other significant conditions contributing to the death but not resulting in underlying cause include hyperlipidemia. I have no further information regarding the patient?s medical history." "1912752-1" "1912752-1" "HYPERTENSION" "10020772" "65-79 years" "65-79" "I am the epidemiologist reporting on behalf of 68 year-old female patient. Patient received their first and second doses of the Moderna vaccine on 4/21/21 and 5/18/21 respectively, according to immunization records. Patient received their third dose of the Moderna Vaccine on 11/22/21. The patient was found deceased at home on 11/23/2021 (1 day after third dose). The death certificate lists ?hypertension (5 years)? as the immediate cause of death. Other significant conditions contributing to the death but not resulting in underlying cause include hyperlipidemia. I have no further information regarding the patient?s medical history." "1912847-1" "1912847-1" "BLOOD GLUCOSE FLUCTUATION" "10049803" "65-79 years" "65-79" "After the 2nd vaccine, patient was diagnosed with a rare malanoma in her vagina. Started treatment for cancer. Got booster on 9/18/2021 (Pfizer, Lot # FF2588). Hospitalized with heart problem , eratic heartbeat. Fluxuating suger number. Diagnosed with mayocarditis. and septis." "1912847-1" "1912847-1" "CARDIAC DISORDER" "10061024" "65-79 years" "65-79" "After the 2nd vaccine, patient was diagnosed with a rare malanoma in her vagina. Started treatment for cancer. Got booster on 9/18/2021 (Pfizer, Lot # FF2588). Hospitalized with heart problem , eratic heartbeat. Fluxuating suger number. Diagnosed with mayocarditis. and septis." "1912847-1" "1912847-1" "HEART RATE IRREGULAR" "10019304" "65-79 years" "65-79" "After the 2nd vaccine, patient was diagnosed with a rare malanoma in her vagina. Started treatment for cancer. Got booster on 9/18/2021 (Pfizer, Lot # FF2588). Hospitalized with heart problem , eratic heartbeat. Fluxuating suger number. Diagnosed with mayocarditis. and septis." "1912847-1" "1912847-1" "MALIGNANT MELANOMA" "10025650" "65-79 years" "65-79" "After the 2nd vaccine, patient was diagnosed with a rare malanoma in her vagina. Started treatment for cancer. Got booster on 9/18/2021 (Pfizer, Lot # FF2588). Hospitalized with heart problem , eratic heartbeat. Fluxuating suger number. Diagnosed with mayocarditis. and septis." "1912847-1" "1912847-1" "MYOCARDITIS" "10028606" "65-79 years" "65-79" "After the 2nd vaccine, patient was diagnosed with a rare malanoma in her vagina. Started treatment for cancer. Got booster on 9/18/2021 (Pfizer, Lot # FF2588). Hospitalized with heart problem , eratic heartbeat. Fluxuating suger number. Diagnosed with mayocarditis. and septis." "1912847-1" "1912847-1" "SEPSIS" "10040047" "65-79 years" "65-79" "After the 2nd vaccine, patient was diagnosed with a rare malanoma in her vagina. Started treatment for cancer. Got booster on 9/18/2021 (Pfizer, Lot # FF2588). Hospitalized with heart problem , eratic heartbeat. Fluxuating suger number. Diagnosed with mayocarditis. and septis." "---" "Dataset: The Vaccine Adverse Event Reporting System (VAERS)" "Query Parameters:" "Title: 211214 CDC covid VAERS report - all reports" "Age: 65-79 years" "Date Died: 2020; 2021" "Date of Onset: 2020; 2021" "Date Report Completed: 2020; 2021" "Date Report Received: 2020; 2021" "Date Vaccinated: 2020; 2021" "State / Territory: New Jersey; New Mexico; New York; North Carolina; North Dakota; Ohio; Oklahoma" "Vaccine Products: COVID19 VACCINE (COVID19)" "VAERS ID: All" "Group By: VAERS ID; Symptoms; Age" "Show Totals: False" "Show Zero Values: Disabled" "---" "Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information." "---" "Query Date: Dec 14, 2021 4:26:30 PM" "---" "Suggested Citation: Accessed at http://wonder.cdc.gov/vaers.html on Dec 14, 2021 4:26:30 PM" "---" Messages: "1. The full results are too long to be displayed, only non-zero rows are available." "2. VAERS data in CDC WONDER are updated every Friday. Hence, results for the same query can change from week to week." "3. These results are for 288 total events." "4. When grouped by VAERS ID, results initially don't show Events Reported, Percent, or totals. Use Quick or More Options to" "restore them, if you wish." "5. Click on a VAERS ID to see a report containing detailed information for the event." "---" Footnotes: "1. Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse" "event (possible side effect)." "---" Caveats: "1.

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine" "manufacturers, and the public can submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports" "alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain" "information that is incomplete, inaccurate, coincidental, or unverifiable. Most reports to VAERS are voluntary, which means they" "are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports" "should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope" "and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA's multi-system approach to" "post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events," "also known as ""safety signals."" If a safety signal is found in VAERS, further studies can be done in safety systems such as" "the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have" "the same limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine." "

Key considerations and limitations of VAERS data:

" "2." "3. Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers, and" "Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the total" "number of unique events. If percentages are shown, then the associated percentage of total unique event reports will exceed 100%" "in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported, because many" "reports include more than 1 Symptom. When more than 1 Symptom occurs in a single report, then the percentage of Symptoms to" "unique events is more than 100%. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Suppress." "4. Data contains VAERS reports processed as of 12/03/2021. The VAERS data in WONDER are updated weekly, yet the VAERS system" "receives continuous updates including revisions and new reports for preceding time periods. Duplicate event reports and/or" "reports determined to be false are removed from VAERS. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Reporting." "5. About COVID19 vaccines: "