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From the 11/26/2021 release of VAERS data:

Found 19,532 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1630507 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-29
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Aortic dissection, Body temperature, Cardiac tamponade, Cardio-respiratory arrest, Imaging procedure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 202105; Test Name: Imaging procedure; Result Unstructured Data: Test Result: aortic dissection and cardiac tamponade
CDC Split Type: JPPFIZER INC202101042814

Write-up: Thoracic aortic aneurysm rupture; Cardio-respiratory arrest; Aortic dissection; Cardiac tamponade; This is a spontaneous report from contactable physicians received via Regulatory Authority with Regulatory authority report number v21123348. A 31-year and 2-month-old patient received BNT162b2 (COMIRNATY, Solution for injection), intramuscular, administered in left arm on 15May2021 at 16:06 (the day of vaccination) (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) (at the age of 31-years-old) as dose 1, single for COVID-19 immunisation. The patient had no allergies to medications, food, or other products. The patient had no other medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Body temperature before vaccination was 36.3 degrees centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient experienced cardio-respiratory arrest on 29May2021 between the time from 22:40 to 22:45 (14 days 6 hours, and 34-39 minutes after the vaccination). On 30May2021 (15 days after the vaccination), the outcome of the cardio-respiratory arrest was fatal. The events resulted in emergency room/department visit or urgent care and death. The course of the event was reported as follows: The patient was in a condition of cardio-respiratory arrest. The patient was transferred to a university hospital, but the spontaneous circulation did not resume, and the patient was confirmed dead. The patient did not receive any treatment for the events. Imaging showed aortic dissection and cardiac tamponade. The reporting physician classified the events as serious (fatal) and assessed that the events was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The patient died on 30May2021. Cause of death was thoracic aortic aneurysm rupture. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Considering the nature of the reported events, there was not a reasonable possibility that the events aortic dissection, cardiac tamponade, thoracic aortic aneurysm rupture, and cardio-respiratory arrest were related to the suspect product BNT162B2 (COMIRNATY). This case will be re-assessed should additional information becomes available.; Reported Cause(s) of Death: Thoracic aortic aneurysm rupture


VAERS ID: 1630508 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Hemiplegia, Pneumonia aspiration
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: URSO [URSODEOXYCHOLIC ACID]; NOBELZIN; LANSOPRAZOLE; MYSLEE; HOCHUEKKITO [ANGELICA ACUTILOBA ROOT;ASTRAGALUS SPP. ROOT;ATRACTYLODES LANCEA RHIZOME;BUPLEURUM FALC; RISPERIDONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction (Hospitalized); Dementia (Hospitalized); Diabetes mellitus (Hospitalized); Hepatic cancer (Hospitalized); Hepatitis C (Hospitalized); Hospitalisation; Pressure sore (Hospitalized); Reflux esophagitis (Hospitalized)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101046489

Write-up: possibility of pneumonia aspiration; Right sided complete paralysis due to cerebral infarction; Right sided complete paralysis due to cerebral infarction; This is a spontaneous report from a contactable physician received from the Regulatory Authority. This is the second of two reports. The first report was received under regulatory authority report number v21123522. A 74-year-old male patient received first dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm left on 06Jul2021 at 12:00 (Lot Number: EY5422; Expiration Date: 31Aug2021) (at the age of 74-year-old) as single dose for COVID-19 immunisation. Medical history included dementia, hepatitis C, hepatic cancer, diabetes mellitus, reflux esophagitis, cerebral infarction and pressure sore (the patient was in the reporting hospital due to dementia, hepatitis C, hepatic cancer, diabetes mellitus, reflux esophagitis, cerebral infarction, and pressure sore). The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient had no allergies. Concomitant medications included oral ursodeoxycholic acid (URSO), oral zinc acetate (NOBELZIN), oral lansoprazole, oral zolpidem tartrate (MYSLEE), oral angelica acutiloba root/astragalus spp. Root/atractylodes lancea rhizome/bupleurum falcatum root/cimicifuga spp. Rhizome/citrus aurantium peel/glycyrrhiza spp. Root/panax ginseng root/zingiber officinale rhizome/ziziphus jujuba fruit (HOCHUEKKITO) and oral risperidone as needed. On 06Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Lot number: not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jul2021 (10 days after the vaccination), the patient experienced right sided complete paralysis due to cerebral infarction. On unspecified date, the patient experienced "a possibility of pneumonia aspiration". The course of the events was as follows: the patient was in the reporting hospital due to dementia and reflux esophagitis. On 06Jul2021, the patient received the first dose of BNT162b2. On 16Jul2021, the patient experienced right sided complete paralysis due to cerebral infarction. Afterwards, the symptom tended to improve. The patient was receiving piperacillin sodium/tazobactam sodium (TAZOPIPE) via a lateral injection tube for a possibility of pneumonia aspiration. Originally, the swallowing ability was not sufficient; however, decreased swallowing ability was observed and sputum increased a few days ago. On 27Jul2021 at 15:30, the patient received the second dose of BNT162b2. On 28Jul2021 at 11:50, the patient experienced respiratory arrest. The patient was determined to have asphyxia due to aspiration. The outcome of the events "right sided complete paralysis due to cerebral infarction" was recovering. The outcome of the event "a possibility of pneumonia aspiration" was not reported. Seriousness of the event "right sided complete paralysis due to cerebral infarction" and "a possibility of pneumonia aspiration", and causality assessment for the events were not reported. The patient died on 28Jul2021. No autopsy was done. The cause of patient death was reported as follows: aspiration or gastroesophageal reflux (swallowing ability was decreased due to dementia, reflux esophagitis and cerebral infarction; thus, the patient was prone to aspiration).; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101026440 Same reporter/patient/drug, Different event/dose; Reported Cause(s) of Death: Asphyxia due to aspiration or gastroesophageal reflux; Asphyxia due to aspiration or gastroesophageal reflux; Asphyxia due to aspiration or gastroesophageal reflux


VAERS ID: 1630511 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-26
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, C-reactive protein increased, Chest discomfort, Chronic obstructive pulmonary disease, Decreased appetite, Heart rate, Oxygen saturation, Pleurisy, Pneumonia, White blood cell count
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 40
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMBROXOL HYDROCHLORIDE; CLOPIDOGREL SULFATE; REBAMIPIDE; CELECOXIB; RIKKUNSHITO; TULOBUTEROL; PHYSIOLOGICAL SALINE SOLUTION; BISOLVON; VENETLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; Femoral head replacement; Femur fracture; Gastrectomy total; Gastric tube reconstruction; Ischaemic enterocolitis; Lumbar spine compression fracture; Macular degeneration; Oesophageal cancer (after total gastrectomy, gastric reconstruction); Otitis externa; Pneumonia; Pneumonia aspiration; Retinal detachment
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: blood pressure; Result Unstructured Data: Test Result:99/45 mmHg; Comments: at 08:20; Test Date: 20210611; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: at 08:20; Test Date: 20210630; Test Name: CRP; Result Unstructured Data: Test Result:2.67; Test Date: 20210702; Test Name: pulse rate; Result Unstructured Data: Test Result:84; Comments: at 08:20; Test Date: 20210702; Test Name: SpO2; Test Result: 91 %; Comments: at 08:20; Test Date: 20210531; Test Name: SpO2; Result Unstructured Data: Test Result:93-94 %; Test Date: 20210630; Test Name: WBC; Result Unstructured Data: Test Result:5350
CDC Split Type: JPPFIZER INC202101049805

Write-up: Pneumonia suspected (aggravation of COPD suspected); Pneumonia suspected (aggravation of COPD suspected); Pleurisy suspected; precordial discomfort; bilateral shoulder pain; appetite impaired; This is a spontaneous report from contactable physicians received from the Regulatory authority. Regulatory authority report number is v21123370. The patient was an 83-year and 10-month-old male. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no particular family history. Medical history included status post surgery for oesophageal cancer (total gastrectomy, gastric reconstruction) in 2006, bronchitis chronic (COPD), pneumonia aspiration in Jun2019, lumbar spine compression fracture, femur fracture, artificial femoral head insertion in 2019, macular degeneration in the left eye, retinal detachment in the left eye, ischaemic enterocolitis, otitis externa left, and pneumonia. Concomitant medications included ambroxol hydrochloride (AMBROXOL HYDROCHLORIDE OD Tablets 45 mg) 1 tablet, clopidogrel sulfate (CLOPIDOGREL 75 mg) 1 tablet once daily in the morning, rebamipide (REBAMIPIDE OD 100 mg) 2 tablets, celecoxib (CELECOXIB 100 mg) 2 tablets twice daily in the morning and evening, TSUMURA Rikkunshi-to 3 pack daily before each meal, tulobuterol (TULOBUTEROL Tape 1 mg), (inhalation) physiological saline 4.0 mL, bromhexine hydrochloride (BISOLVON) 2.0 mL, and salbutamol sulfate (VENETLIN) 0.5 mL in the morning and evening. It was reported that on 11Jun2021 at 10:14 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 26Jun2021 at 07:30 (15 days after the vaccination), the patient experienced precordial discomfort, bilateral shoulder pain, and appetite impaired. On 02Jul2021 (21 days after the vaccination), the patient was admitted to the hospital. On 05Aug2021 at 0:10 (55 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had medical history of lumbar spine compression fracture and femur fracture (artificial femoral head insertion in 2019). On 10Apr2021, the patient was admitted for the treatment of pneumonia to Hospital A. On 11Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. From around 26Jun2021, (15 days after vaccination), the patient had bilateral shoulder pain, precordial discomfort, and appetite impaired. On 30Jun2021 (19 days after vaccination), the WBC was 5350, the CRP was 2.67. Angina pectoris was deniable on the ECG. On 02Jul2021, at 08:10 (21 days after vaccination), rale was heard on both lungs. At 08:20, the body temperature was 37.7 degrees Celsius, the pulse rate was 84, the blood pressure was 99/45 mmHg, and the SpO2 was 91%. Thus, the patient was transferred to and seen at Hospital, where the patient was hospitalised for pleurisy suspected. The reporting physician classified the event as serious (death, hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases included COPD. The reporting physician commented as follows: The events occurred on 26Jun2021 which was 15 days after the first dose of BNT162b2 vaccination on 11Jun2021. In addition, the patient had an underlying disease of COPD, and thus, the assessment was difficult. However, the possibility could not be ruled out that pleurisy and pneumonia were triggered by the vaccination. The provision of information (to Hospital): Age: 83, Gender: Male, The level of care needed: 2. The name of injuries and diseases: Pneumonia suspected (aggravation of COPD suspected), oral intake was impossible. Medical history: Status post surgery for oesophageal cancer (status post total gastrectomy and gastric reconstruction) in 2006, bronchitis chronic (COPD), pneumonia aspiration in Jun2019, lumbar spine compression fracture, femur fracture, artificial femoral head insertion in 2019, macular degeneration in the left eye, retinal detachment in the left eye, ischaemic enterocolitis, otitis externa left, and pneumonia. The disease condition: 02Jul2021. On 10Apr2021, the patient was diagnosed with pneumonia, for which he was admitted to and received treatment in Hospital. On 31May2021(as reported date), the SpO2 was low as 93 to 94%, and the patient had sputum. Thus, an inhalation was initiated in the morning and evening (physiological saline 4.0 mL, bromhexine hydrochloride (BISOLVON) 2.0 mL, and salbutamol sulfate (VENETLIN) 0.5 mL; per dose). Since the amount of meal intake was small, the reporting physician have the patient drink one bottle of Mei Balance Mini. Since the respiratory condition and the amount of meal intake improved, and the patient wished to go home. Thus, the inhalation was changed to tulobuterol (TULOBUTEROL Tape) 2 mg on 11Jun2021 (on this day, the patient received the first dose of BNT162b2 vaccination). From aroung 26Jun2021 (15 days after vaccination), the patient had bilateral shoulder pain, precordial discomfort, and appetite impaired.On 30Jun2021 (19 days after vaccination), the laboratory data was as follows: the WBC was 5350 and the CRP was 2.67. On 01Jul2021 (20 days after vaccination), an intravenous drip infusion (DIV) was initiated; however, it leaked. Since the patient underwent total gastrectomy, gastrostomy was impossible. The reporting physician told the patient''s family about deathwatch. However, the family wished the inpatient treatment. On 02Jul2021, at 08:10 (21 days after vaccination), rale was significantly heard on both lungs. The body temperature was 37.7 degrees Celsius, the pulse rate was 84, the blood pressure was 99/45 mmHg, and the SpO2 was 91%.; Reported Cause(s) of Death: Pleurisy suspected; Pneumonia suspected (aggravation of COPD suspected); Pneumonia suspected (aggravation of COPD suspected)


VAERS ID: 1630516 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cardiomyopathy, Chest discomfort, Decreased appetite, Dyspnoea, Feeding disorder
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101058712

Write-up: Acute exacerbation of cardiac failure; cardiomyopathy; chest distress; appetite impaired; dyspnoea; unable to eat; This is a spontaneous report from a contactable pharmacist received from the Agency. Regulatory authority report number is v21123554. The patient was a 72-year and 2-month-old male. Body temperature before vaccination was not reported. The patient''s family history and medical history were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medications were not reported. On unknown date, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# EW0203, Expiration date 30Sep2021) via an unspecified route of administration as dose 1, single for COVID-19 immunisation. On 31Jul2021 (the day of vaccination), the patient received?the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021) via an unspecified route of administration as dose 2, single (at age of 72-year-old) for COVID-19 immunisation. On 11Aug2021 at 13:00 (11 days after the vaccination), the patient experienced acute exacerbation of cardiac failure. On 11Aug2021 (11 days after the vaccination), the patient was admitted to the hospital. On 16Aug2021 (16 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 02Nov2015, the patient underwent aortic replacement. From 31Jul021, 1 week after the second dose of vaccination, the patient started to complain of chest distress. He had appetite impaired at the same time. From around 07Aug2021, the patient became unable to eat (but was barely able to drink water). On 11Aug2021, the patient was admitted to the reporting hospital because cardiac failure or cardiomyopathy was suspected. Treatment for chronic cardiac failure was performed, and since dyspnoea was noted, palliative therapy with morphine was also given. On 16Aug2021, the patient died. It was not reported if an autopsy was performed. The reporting pharmacist classified acute exacerbation of cardiac failure as serious (death and hospitalization) and assessed the causality between the event and bnt162b2 as unassessable. Date of hospitalization : 11Aug2021, Date of discharge (death): 16Aug2021. Other possible causes of the event such as any other diseases were not reported. It was not reported if an autopsy was performed. Outcome of acute exacerbation of cardiac failure was fatal. The outcome of other events was unknown.; Reported Cause(s) of Death: Acute exacerbation of cardiac failure


VAERS ID: 1630517 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Electrocardiogram, Heart rate
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardio-respiratory arrest; Myocardial infarction (Diagnosed with myocardial infarction); Percutaneous coronary intervention (occlusion was noted)
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: waveform; Result Unstructured Data: Test Result:VF; Comments: Initial waveform showed VF; Test Date: 20210812; Test Name: pulse check; Result Unstructured Data: Test Result:VF
CDC Split Type: JPPFIZER INC202101059302

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable other health professional received from the Regulatory authority. Regulatory authority report number is v21124101. A 47-year-old male patient received COVID-19 vaccine (Manufacture unknown), dose 1 via an unspecified route of administration on 12Aug2021 13:45 (the day of vaccination) (Batch/Lot number and Expiration date were not reported) as single dose for covid-19 immunisation. Body temperature before vaccination was not reported. Medical history was as follows: CPA (cardiopulmonary arrest) developed on 11Mar2021, and myocardial infarction was diagnosed. The patient underwent elective PCI (percutaneous coronary intervention) on 01Apr2021 and 20May2021. Concomitant medications and family history were not provided. On 12Aug2021 at 20:48 (7 hours and 3 minutes after the vaccination), the patient experienced acute myocardial infarction. At 23:32, the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 12Aug2021, after the vaccination, the patient was at home without any change. He exercised on a treadmill for the purpose of rehabilitation, and shortly after he said that he felt dizziness, he collapsed. His family run up to him and found that he had lost consciousness and developed convulsion. Supraduction was noted. At 20:49, an emergency service was requested. When an emergency team arrived, chest compression was being performed by his family. Initial waveform showed VF (ventricular fibrillation). At 20:55, DC (direct current) defibrillation was performed. Two minutes later, pulse check revealed VF again. At 20:57, DC was performed for the second time. Cardiac massage was carried out by the emergency team. LT (laryngeal tube) was inserted and BVM (bag valve mask) was placed. Adrenaline 1 ampule was intravenously administered. At 21:20, the emergency team arrived. Although resuscitation was attempted, at 23:32, the patient died. The reporting other health professional classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Possible causes of the event were reported as follows: On 11Mar2021, while the patient was working, he developed CPA. He was diagnosed with myocardial infarction, and he underwent PCI. Since a lot of occlusion was noted, elective PCI was performed on 01Apr2021 and 20May2021. The lot number for bnt162b2, was not provided and will be requested during follow up. ; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1630520 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Cardio-respiratory arrest, Dehydration, Hyperkalaemia
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CABPIRIN; VALSARTAN; LASIX [FUROSEMIDE]; EPADEL [EICOSAPENTAENOIC ACID ETHYL ESTER]; ASTOMIN [DIMEMORFAN PHOSPHATE]; SPIOLTO RESPIMAT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; COPD; Hypertension; Pulmonary hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101062425

Write-up: Acute renal failure; hyperkalaemia; Dehydration; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received via database, also from the Agency. Regulatory authority report number is v21124119. The patient was a 84-year-8-month-old male. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included acetylsalicylic acid, vonoprazan fumarate (CABPIRIN); valsartan; furosemide (LASIX); eicosapentaenoic acid ethyl ester (EPADEL); dimemorfan phosphate (ASTOMIN); olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT), all taken for an unspecified indication from an unspecified start date and ongoing, within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient had allergies to medications, food, or other products. Other medical history included cardiac failure chronic, pulmonary hypertension, COPD, and hypertension. On 09Jul2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# EY5423, Expiration date 31Aug2021) via an unspecified route of administration at the age of 84-year-old for COVID-19 immunisation. On 30Jul2021 at 14:30 (the day of vaccination), the patient received the second single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via intramuscular route of administration in the left arm at the age of 84-year-old for COVID-19 immunisation. On 30Jul2021 at 16:50 (2 hours/20 minutes after the vaccination),the patient experienced cardio-respiratory arrest. The reporting physician classified cardio-respiratory arrest as serious (death) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases were acute renal failure and hyperkalaemia. On 30Jul2021 (2 hours after the vaccination, as reported), the patient experienced death. The event resulted in death. The outcome of the event was fatal with treatment including adrenaline and cardiac massage. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19. The reported event was as follows: On 30Jul2021 (the day of vaccination), at 14:30, the patient received the second dose of bnt162b2 vaccination. On the same day, at around 16:50 (around 2 hours and 20 minutes after vaccination), the patient was found to collapse on the road by the post-office clerk, and an ambulance was called. After the patient was found, cardiac massage was initiated. The last time when the patient was fine was unknown. The laryngeal mask airway (LMA) and cardiac massage were continued, and adrenaline 5A was administered; however, no return of spontaneous circulation was obtained. At 18:15 (3 hours and 45 minutes after vaccination), the patient was confirmed to die. Cause of death was acute renal failure and hyperkalaemia. Therapeutic measures were taken as a result of events. The patient died on 30Jul2021. No autopsy was performed. The reporting physician commented as follows: When the patient was transferred, the patient was not examined, and thus, the details were unknown. Dehydration, renal failure, and hyperkalaemia were suspected on the medical record. The outcome of dehydration was unknown. The outcome of other events was fatal.; Sender''s Comments: The event of Cardio-respiratory arrest, Acute renal failure and Hyperkalaemia is assessed as possibly related to the suspect drug Comirnaty based on strong temporal association, but consider also possible contributory effects from patient''s medical history of Cardiac failure chronic, Pulmonary hypertension, COPD and Hypertension. 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: acute renal failure; hyperkalaemia; Cardio-respiratory arrest


VAERS ID: 1630552 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood immunoglobulin M, COVID-19, COVID-19 pneumonia, Histology, Polymerase chain reaction
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Sickness
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: Autopsy; Result Unstructured Data: signs of pneumonia; Test Name: COVID-19; Result Unstructured Data: positive for COVID; Test Name: Histology; Result Unstructured Data: pending; Test Name: PCR; Result Unstructured Data: negative; Test Name: IgM; Result Unstructured Data: positive
CDC Split Type: LSJNJFOC20210842115

Write-up: COVID-19 PNEUMONIA; This spontaneous report was received from a consumer and from Health Authority via a company representative, and concerned a 73 year old female. Initial information was processed with additional information received on 23-AUG-2021. The patient''s height and weight were not reported. The patient''s concurrent conditions included: sickness. Her son reported that on the 25-JUL-2021 she was complaining of pain on the forehead, cough, tiredness, chest pain and back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose and vaccination site not reported, administered on 02-AUG-2021 for prophylactic vaccination. Vaccine was kept in good condition; no issue on vaccine quality was found. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 pneumonia. Following vaccination on 02-AUG-2021, the patient had dizziness and was helped by other patients attending the clinic to get a taxi home. The patient lived with a helper/maid and her two grand-children. When she got home she slept. On the 03-AUG-2021, patient''s son was called, because the patient was having chest pain, and coughing thick sputum mixed with blood. The patient also had fever. She refused to be taken to see the doctor, but called her priest who came and prayed for her. On 05-AUG-2021 at 20:40, the patient complained of chest heaviness, difficulty breathing, hungry for air and was restless. Soon after the patient was noted to not be breathing. The neighbors were also called to assist, but then death was reported to have occurred at about 20:50. Autopsy was done. Preliminary postmortem findings: signs of pneumonia were found in the lung during the autopsy. Postmortem COVID test was positive for COVID-19, COVID-19 IgM was positive, PCR was negative. Tissue for histology (site not reported) was taken; results pending. Reporter causality classification: co-incidental. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome was fatal. This report was serious (Death). This case is associated with product quality complaint; PQC number pending. This case, from the same reporter is linked to 20210816486, 20210816515, 20210816481, 20210842145 and 20210842105.; Sender''s Comments: V0: This spontaneous report received from a patient''s son and from a Health Authority concerns a 73-year-old female who died of Covid-19 pneumonia 3 days after receiving the Janssen Covid-19 vaccine. The patient had a concurrent "sickness"; 8 days before vaccination, the patient complained of forehead pain, cough, tiredness, chest pain, and back pain. No concomitant medications were reported. On the same day as vaccination, she experienced dizziness. One day post-vaccination, she was having chest pain and fever and was coughing thick sputum mixed with blood. She did not want to see a doctor at that time but asked her priest to pray for her. Three days post-vaccination, she complained of chest heaviness, difficulty breathing, hungry for air and was restless. Soon after, the patient stopped breathing and she died that evening. Preliminary postmortem autopsy findings included signs of pneumonia and positive testing for COVID-19; COVID-19 IgM was positive, PCR was negative. Results for tissue histology (site not reported) were pending. The reporter considered the fatal event coincidental to vaccination. Considering the presence of sickness prior to vaccination which could represent Covid-19 infection and that death due to Covid-19 pneumonia occurred on post-vaccination day 3 prior to the vaccine becoming efficacious, the relationship of the fatal event is assessed to be inconsistent to vaccination.


VAERS ID: 1630565 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MAJNJFOC20210841913

Write-up: DEATH BY VACCINE; This spontaneous report received from social media from a consumer via a company representative concerned a patient of unknown age, sex, ethnicity and race. Initial information was received on 27-JUL-2021 and was processed with further information received on 13-AUG-2021. This case was created to replace AER 20210763684 which was nullified in error. All relevant information will be submitted under this case (Manufacturer Case Number 20210841913). The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient died by vaccine. The cause of death was unknown. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210763797. This case is associated with Product Quality Complaint Number 90000189506.; Sender''s Comments: V0: This spontaneous report received from social media from a consumer via a company representative concerned a patient of unknown age, sex, ethnicity and race. No past medical history or concomitant medications were reported. On an unspecified date, the patient died by vaccine. The cause of death was unknown. It was unknown if autopsy was performed. Information in the case is limited which precludes a meaningful medical assessment. Thus, the event is considered to have an indeterminate relationship to vaccine.; Reported Cause(s) of Death: DEATH DUE TO UNKNOWN CAUSE


VAERS ID: 1630767 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD (stabiele COPD)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via Agency (Reference number: 00662375) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA, FATIGUE and DYSPNOEA in a 71-year-old female patient who received mRNA-1273 for COVID-19 vaccination. Concurrent medical conditions included COPD. On 03-Jul-2021, the patient received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) .5 ml. On 03-Jul-2021, the patient experienced FATIGUE (seriousness criteria death and hospitalization prolonged). On 05-Jul-2021, the patient experienced PULMONARY OEDEMA (seriousness criteria death, hospitalization prolonged and medically significant). On an unknown date, the patient experienced DYSPNOEA (seriousness criteria death and hospitalization prolonged). The patient died on 28-Jul-2021. It is unknown if an autopsy was performed. No concomitant medication was given. No treatment medication was given. Company comment: Very limited information regarding these events have been provided at this time. Further information cannot be requested.; Sender''s Comments: Very limited information regarding these events have been provided at this time. Further information cannot be requested.; Reported Cause(s) of Death:


VAERS ID: 1630796 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Body temperature; Result Unstructured Data: Mild fever; Test Date: 20210812; Test Name: Body temperature; Result Unstructured Data: High fever
CDC Split Type: PHJNJFOC20210838404

Write-up: DEATH; CHILLS; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300099973] concerned an 86 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. The patient experienced a mild fever after vaccinated on 11-AUG-2021 and took biogesic (Paracetamol) every 4 hours. On 12-AUG-2021 patient still had a mild fever and progress to high fever and chills until 13-AUG-2021. On 14-Aug-2021 around 01:45 the informant said that the patient noticed of not moving and breathing and was rushed to hospital. Patient was declared dead on 14-AUG-2021. It was unspecified if an autopsy was performed. On 11-AUG-2021, Laboratory data included: Body temperature (NR: not provided) mild fever. On 12-AUG-2021, Laboratory data included: Body temperature (NR: not provided) high fever. On 14-AUG-2021, the patient died from fever, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210838404-covid-19 vaccine ad26.cov2.s-Death,chills,fever.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event; Reported Cause(s) of Death: FEVER; CHILLS


VAERS ID: 1630798 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Pain, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838865

Write-up: PNEUMONIA; BODY PAIN; CHILLS; BODY WEAKNESS; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 71 year old male of an unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A expiry: Unknown) dose was not reported, 1 total administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021 at 01:00 hours, the patient experienced fever, body pain, chills and body weakness. On 13-AUG-2021 at 20:08 hours, the patient experienced pneumonia. On an unspecified date in AUG-2021, the patient died from fever, chills, body pain, body weakness, and pneumonia. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to fever, chills, body pain, body weakness and pneumonia. This report was serious (Death).; Sender''s Comments: V0: 20210838865-COVID-19 VACCINE AD26.COV2.S- Pneumonia, fever, chills, body pain, body weakness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; CHILLS; BODY PAIN; BODY WEAKNESS; PNEUMONIA


VAERS ID: 1630801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: not provided
CDC Split Type: PHJNJFOC20210845091

Write-up: COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Reporter stated that on an unspecified date, after taking vaccination (in the evening), the patient started experiencing symptoms and assumed those side effects of vaccine and continued normal routine. Patient developed low grade fever and cough. On sixth day of vaccination patient got swab arranged and was admitted to hospital on day seven and was transferred to Intensive Care Unit (ICU) later on seventh day. On 12-AUG-2021, the patient died from covid-19 infection. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210845091-COVID-19 VACCINE AD26.COV2.S-Covid-19 Infection( Fatal)-This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: COVID-19 INFECTION


VAERS ID: 1630930 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-06-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatocellular carcinoma, Ultrasound abdomen
SMQs:, Liver malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C
Allergies:
Diagnostic Lab Data: Test Date: 20200720; Test Name: Ultrasound abdomen; Result Unstructured Data: No focal lesions
CDC Split Type: SIMODERNATX, INC.MOD20212

Write-up: onset of hepatic disease - HCC; This case was received via regulatory authority (Reference number: SI-JAZMP-NCPHV-2021SI0809_0809) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of HEPATOCELLULAR CARCINOMA (onset of hepatic disease - HCC) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Hepatitis C on 02-Dec-2020. On 16-May-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced HEPATOCELLULAR CARCINOMA (onset of hepatic disease - HCC) (seriousness criteria death and medically significant). The patient died on 29-Jun-2021. The reported cause of death was onset of hepatic disease - hcc. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2020, Ultrasound abdomen: normal (normal) No focal lesions. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. On an unknown date in Jun-2021 the laboratory exams performed to further understand the event included were Ultrasound scan and CT scan and the results were unknown. Company comment: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient''s underlying disease remains a contributory factor. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient''s underlying disease remains a contributory factor. Further information can''t be requested.; Reported Cause(s) of Death: onset of hepatic disease - HCC


VAERS ID: 1631908 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Muscular weakness, Myalgia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210835692

Write-up: JOINT PAIN; MUSCLE WEAKNESS; SEVERE TREMBLING; CHILLS; MUSCLE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, NL-LRB-00664003) concerned a 26 year old male of unspecified race and ethnicity. The patient''s weight was 85 kilograms, and height was 182 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, frequency one total, administered on 27-JUL-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The drug start period was one hour. On 28-JUL-2021, the patient experienced muscle pain. On 29-JUL-2021, the patient experienced severe trembling, muscle weakness and chills. On an unspecified date, the patient experienced joint pain. On 29-JUL-2021, the patient died from vaccination complication, and unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of severe trembling, joint pain, muscle weakness, muscle pain and chills on 29-JUL-2021. This report was serious (Death).; Sender''s Comments: V0: 20210835692-COVID-19 VACCINE AD26.COV2.S-severe trembling, muscle weakness, muscle pain, chills. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210835692-COVID-19 VACCINE AD26.COV2.S- joint pain. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: VACCINATION COMPLICATION; UNKNOWN CAUSE OF DEATH


VAERS ID: 1632115 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-07
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Administration site pain, Anti-platelet antibody, Blood fibrinogen, Body temperature, C-reactive protein, Cerebral haemorrhage, Cerebral venous thrombosis, Deep vein thrombosis, Disseminated intravascular coagulation, Electrocardiogram, Fibrin D dimer increased, Headache, Heparin-induced thrombocytopenia test, Heparin-induced thrombocytopenia test positive, Immunology test, Influenza like illness, International normalised ratio, Laboratory test, Magnetic resonance imaging head, Muscle spasms, Myalgia, Platelet count, Pregnancy test, Prothrombin time, Prothrombin time shortened, SARS-CoV-2 test, Superior sagittal sinus thrombosis, Thrombocytopenia, Ultrasound Doppler
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Comments: She was not on hormonal contraception
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Body temperature; Result Unstructured Data: 39 C; Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: 39 C; Test Date: 20210514; Test Name: Thrombocyte count; Result Unstructured Data: 296 x1000/microL; Test Date: 20210514; Test Name: EKG; Result Unstructured Data: confirmed thrombosis; Test Date: 20210514; Test Name: Thrombocyte count; Result Unstructured Data: $g200: normal; Test Date: 20210514; Test Name: C-reactive protein; Result Unstructured Data: 19 mg/dL; Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: 37.32 C; Test Date: 20210514; Test Name: APTT; Result Unstructured Data: 30 S; Test Date: 20210514; Test Name: Laboratory test; Result Unstructured Data: 119 AUC (postmortem); Test Date: 20210514; Test Name: Prothrombin time; Result Unstructured Data: 99 %; Test Date: 20210514; Test Name: INR; Result Unstructured Data: 1; Test Date: 20210517; Test Name: Body temperature; Result Unstructured Data: normal; Test Date: 20210517; Test Name: Fibrinogen; Result Unstructured Data: 0.8 g/L; Test Date: 20210517; Test Name: Thrombocyte count; Result Unstructured Data: < 25 g/L, Thrombocytopenia; Test Date: 20210517; Test Name: Thrombocyte count; Result Unstructured Data: 25 g/L; Test Date: 20210517; Test Name: Pregnancy test; Result Unstructured Data: Negative; Test Date: 20210517; Test Name: C-reactive protein; Result Unstructured Data: 19 mg/dL; Test Date: 20210517; Test Name: Venous Doppler; Result Unstructured Data: See relevant lab tests; Test Date: 20210517; Test Name: COVID-19 PCR test; Result Unstructured Data: Negative; Test Date: 20210519; Test Name: Head MRI; Result Unstructured Data: See relevant lab tests; Test Date: 20210519; Test Name: Prothrombin time; Result Unstructured Data: 48 %; Test Date: 20210519; Test Name: APTT; Result Unstructured Data: ratio 1.19; Test Date: 20210519; Test Name: Thrombocyte count; Result Unstructured Data: 50 g/L; Comments: (40 on citrate); Test Date: 20210519; Test Name: Fibrin D dimer abnormal; Result Unstructured Data: over 35000; Test Date: 20210519; Test Name: Fibrinogen; Result Unstructured Data: 91; Test Date: 20210520; Test Name: Laboratory test; Result Unstructured Data: 348 AUC (postmortem); Test Date: 20210520; Test Name: Laboratory test; Result Unstructured Data: 27 AUC (postmortem); Test Date: 20210520; Test Name: Anti-platelet antibodies; Result Unstructured Data: positive; Test Date: 20210520; Test Name: Laboratory test; Result Unstructured Data: 91 AUC (postmortem); Test Name: ELISA; Result Unstructured Data: PF4 assay negative; Test Name: Heparin-induced platelet antibody; Result Unstructured Data: positive
CDC Split Type: SIJNJFOC20210550911

Write-up: CEREBRAL VENOUS THROMBOSIS; SAGITTAL SINUS THROMBOSIS; INTRACEREBRAL BLEED; DISSEMINATED INTRAVASCULAR COAGULATION; HEPARIN-INDUCED THROMBOCYTOPENIA TEST POSITIVE; Fibrin D dimer increased; Prothrombin time decreased; THROMBOCYTOPENIA; DEEP VEIN THROMBOSIS; MUSCLE CRAMPS; INFLUENZA LIKE ILLNESS; MYALGIA; administration site pain; HEADACHE; This spontaneous report was received from a physician and pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, SI-JAZMP-NCPHV-2021SI0598_0598, PBE-FAMHP-DHH-N2021-92848] and from online article, and concerned a 37 year old female. The social media article reported that an adult female aged 41 died due to rare thrombosis; previous reports also mentioned a female under 40. The patient''s height, weight, and medical history were not reported. The patient''s was not on hormonal contraception. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, vaccination site not reported, batch number: XD955 expiry: 28/2/2023) 1 dosage form, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On 07-MAY-2021, the same day as receiving the vaccine, the patient experienced administration site pain and headache, both for 2 days. On 08-MAY-2021, the patient experienced malaise, tiredness (both recovering), and increased body temperature 39 Celsius. On 10-MAY-2021, (3 days post vaccine) the patient had flu-like symptoms including chills for 1 day, sore throat with linings and was diagnosed angina tonsillitis, difficulty swallowing, myalgia and arthralgia for 36 hours (all recovering), malaise, headache, tiredness, body temperature 39 degrees Celsius. On 14-MAY-2021, the patient experienced muscle cramps and thrombosis leg (fatal) as confirmed by electrocardiogram (ECG). The patient also had consultation for influenza like illness. She had normal thrombocytes 296 x1000/microL (Normal range (NR) not provided). On 14-MAY-2021, laboratory data included: APTT (NR: not provided) 30 S, Body temperature (NR: not provided) 37.32 C, C-reactive protein (NR: not provided) 19 mg/dL, EKG (NR: not provided) confirmed thrombosis, INR (NR: not provided) 1, Laboratory test (NR: not provided) 119 AUC (postmortem) and Prothrombin time (NR: not provided) 99 %. On 17-MAY-2021, following swelling of the leg, a deep vein thrombosis in the calf was detected. Treatment started with low molecular weight heparin, Innohep (tinzaparine) 10.000 once a day for 2 injections total despite thrombocytopenia 25 g/L. On 17-MAY-2021, laboratory data included: Body temperature (NR: not provided) normal, C-reactive protein (NR: not provided) 19 mg/dL, COVID-19 PCR test (NR: not provided) Negative, Fibrinogen (NR: not provided) 0.8 g/L, Pregnancy test (NR: not provided) Negative, and Venous Doppler showed acute deep popliteal venous thrombosis of all veins of the right leg; the femoral vein was transient. On 19-MAY-2021, patient was seen at emergency service for disturbance of consciousness and hemiplegia during the night. It was detected that patient had disseminated intravascular coagulation and cerebral hemorrhage (bilateral, intraparenchymatous) facilitated by a venous thrombosis of sagittal sinus thrombosis, thrombocytopenia due to vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) and anticoagulation treatment (coded to thrombocytopenia). Laboratory data included: APTT ratio 1.19, Fibrin D-dimer abnormal over 35000, fibrinogen 91 (fibrogenopenia), prothrombin time 48%, and thrombocyte count 50 g/L (40 on citrate); normal ranges not reported for all results. On 19-MAY-2021, a head magnetic resonance (MRI) showed supratentorially in both (brain) hemispheres numerous areas of bleeding, more on left; areas of hemorrhage are mainly extra axial along the cerebral falx, by dissection of the corpus callosum, and by effusion into the left (lateral) ventricle. Dilated venous thrombosis of the upper sagittal sinus on convexity was seen. Diffusion imaging showed changes with features of venous ischemia in almost the entire left hemisphere that spread to the paramedian areas and to the cerebral cortex of the right frontal and parietal lobes. A large mass effect was seen with transtentorial descending hernia, compression of the third ventricle of the diencephalon and midbrain (mesencephalon) and with significant obliteration (squeezing) of the fourth ventricle and cerebrospinal fluid spaces in the posterior (cranial) cavity. The neuroradiologist concluded that there was dilated sagittal sinus thrombosis at the vertex level, areas of intra- and extra-axial hemorrhage with intraventricular hemorrhage in the left lateral ventricle, and ischemia with venous features throughout the left hemisphere and part in the right hemisphere in the paramedian; and parietal lobe. Transtentorial displacement with mesencephalon / brainstem compression was also seen. Patient was admitted to intensive care unit, intubated, placed on mechanical ventilation and sedation. Treatment medications included mannitol 15 g in 15 minutes, polyvalent immunoglobulins 1g/kg/day for 2 days. Innohep (tinzaparine sodium) was discontinued and switch to Orgaran (danaparoid sodium) with monitoring of "anti Xa activity", dexamethasone 40 mg per day for 4 days. On 20-MAY-2021, the subject died from thrombosis, hemorrhage intracerebral, and thrombocytopenia after her hospitalization. Autopsy was performed and it proved venous thrombosis and intracranial hemorrhage, but written autopsy report could not be gained persuant to legislation. On 20-MAY-2021, Laboratory data included: Anti-platelet antibodies (NR: not provided) positive, and Laboratory test (NR: not provided) 27 AUC (postmortem), 348 AUC (postmortem), 91 AUC (postmortem). On 25-MAY-2021, positive test result was received for heparin-induced thrombopenia (HIT II). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of disseminated intravascular coagulation, thrombocytopenia, cerebral hemorrhage, fibrin d dimer increased, prothrombin time decreased, sagittal sinus thrombosis, deep vein thrombosis and cerebral venous thrombosis on 20-MAY-2021, was recovering from administration site pain, and myalgia, and the outcome of influenza like illness, headache, muscle cramps, and heparin-induced thrombocytopenia test positive was not reported. Sender''s Comment: External expert advices :Expert 1 : The PF4 assay. was negative by ELISA but positive by functional test. If we receive written confirmation of the positivity of the functional PF4 testing, there is in my view a clear causal link. We should also know whether this lady was on oral contraception with EE. Expert 2: The clinical presentation, the delay in vaccination, the age of the patient, the absence of other known favourable factors, the platelet count at the diagnosis of DVT at D10, the evolution towards a CVST with a low platelet count at D12 are strongly in favour of a TTS secondary to the vaccination. However, we do not have any information concerning the possible previous exposure to heparin treatment (necessary for classification according to the Brighton collaboration). We do not have either an echodoppler protocol concerning the diagnosis of lower limb DVT whereas this clinical presentation seems rare in the previously described cases (other cases of VIPIT with lower limb DVT). So highly suspicious case but incomplete information to give you a definitive analysis. Expert 3: At the time of writing this assessment, I have not yet received the results of the requested PF4 functional test (positive according to verbal information from Prof. x, no written protocol yet).Nevertheless, the diagnosis of a "thrombosis with thrombocytopenia syndrome" (TTS) seems to me to be highly probable (level 1). It is not mentioned in the case description if an echo-Doppler and/or a brain scan were performed to prove the thrombosis. I am not sure if the deep venous thrombosis of the lower limb was objectified (venous Doppler on 5/17) but the description of the cerebral findings requires imaging and it seems logical to me to think that the cerebral venous thrombosis and cerebral hemorrhage were objectified, along with the thrombocytopenia, which is sufficient to make the diagnosis. Additional elements in favor of this diagnosis are the timing after vaccination (D10), the flu-like symptoms (showing a strong immune response), the cerebral venous thrombosis immediately complicated by hemorrhage, the decreased PTT, the very high D-dimer values and unfortunately the fatal course of the disease. In my opinion, there is no other etiology than the vaccine to plausibly explain the occurrence of these medical events. I identify as "probable" the link with the vaccine but it could be "certain" in case of definitive confirmation of the presence of anti-PF4 antibodies. Expert 4 :The course, clinic, and biochemical tests do indeed fit a VITT. I would consider the correlation probable/likely (code 2).Strictly speaking, initially a HIT could not be excluded, but there were already low platelets at first presentation and no obvious heparin exposure beforehand, as far as known. The subsequent course would also be a short time frame for HIT. The positive anti-PF4-ELISA very strongly suggest a VITT, with strong reactivity in the absence of heparin (argues against HIT) and no additional increase with increasing concentrations of heparin. Thus, this fits the diagnosis of VITT according to the typical described biochemical and clinical course. This report was serious (Death, and Hospitalization Caused / Prolonged). This case is linked to duplicate cases 20210550864, 20210550753. Additional information was received on 17-AUG-2021 via Regulatory Authority. The following information was updated and incorporated into the case narrative: date of death was updated from 21-MAY-2021 to 20-MAY-2021, serious criteria of life threatening removed, events added (heparin-induced thrombocytopenia test positive and cerebral venous thrombosis), onset dates updated for events (thrombocytopenia and influenza like illness), and event terms updated (deep vein thrombosis and intracerebral bleed). Upon review, the following information was amended: Social Media added as source in structured field.; Sender''s Comments: Follow-up updated date of death and event details. This spontaneous report received from health professionals via regulatory authority & from an online article concerned a 37-year-old woman who died after experiencing thrombocytopenia on day 10 & cerebral venous sinus thrombosis (CVST) on day 12 after receiving Janssen Covid-19 vaccine. Medical history was not reported. Concomitant medications included paracetamol and the patient was not using hormonal contraception. Day 3, she had flu-like symptoms (chills, sore throat, malaise, myalgia, headache, & fever). Day 7, platelet count was 296,000. Day 10, a deep vein thrombosis was detected in right leg via venous doppler; Covid-19 PCR was negative. Treatment was initiated with low molecular weight heparin despite new thrombocytopenia (25,000). Day 12, the patient presented to the emergency department for disturbance of consciousness & hemiplegia during the night. She had disseminated intravascular coagulation (DIC). MRI showed cerebral hemorrhage with a CVST of sagittal sinus and transtentorial displacement with mesencephalon/brainstem compression. Lab data included: high D-dimer $g 35000, low fibrinogen 91, platelet count 50,000. Patient was intubated & placed on mechanical ventilation. Treatment medications included mannitol and polyvalent immunoglobulins for 2 days & dexamethasone for 4 days; tinzaparine was discontinued & switched to danaparoid. Patient died on day 12 from thrombosis, hemorrhage intracerebral, & thrombocytopenia. Autopsy confirmed venous thrombosis & intracranial hemorrhage. Anti-platelet antibody test & heparin-induced thrombopenia test were positive. Although the use of heparin may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (per definition from Brighton Collaboration), considering the low platelet count prior to heparin use and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: THROMBOSIS; INTRACEREBRAL BLEED; THROMBOCYTOPENIA; Autopsy-determined Cause(s) of Death: THROMBOSIS; INTRACEREBRAL BLEED


VAERS ID: 1632116 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Diarrhoea, Dizziness, Fatigue, Oxygen saturation, Oxygen saturation decreased, Rash, Swelling face, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 75
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: saturation; Result Unstructured Data: Test Result:less than 80
CDC Split Type: BEPFIZER INC202101067806

Write-up: heart failure; saturation lower than 80; dizzy; vomiting; diarrhoea; bloated face; tired; a light rash on neck and back; This is a spontaneous report from a contactable consumer. A young male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Apr2021, the patient experienced for the first time a light rash on neck and back. From 06May2021, he had to stay at home because of illness (diarrhea, rash, tired and bloated face). From 09May2021, he became dizzy and started vomiting. On 10May2021, we went to the family doctor and he thought it was because of the vaccine. He stayed at home that week but he did not get better. On 18May2021 we went back to the family doctor where a saturation of less than 80 was established. That day he was admitted to the hospital via emergency room and was diagnosed with heart failure. The link with the vaccine was described in hospital as "coincidental". On 02Jul2021 he was admitted again with heart failure and died on 09Jul20210. It was not reported if an autopsy was performed. The outcome of heart failure was fatal. The outcome of dizzy and vomiting was not resolved. The outcome of other events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart failure


VAERS ID: 1632184 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-07-19
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002912 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a pharmacist and describes the occurrence of ENCEPHALITIS and DEATH (Death) in a 21-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3003606 and 3002912) for COVID-19 vaccination. The patient''s past medical history included Migraine in 2019. On 12-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced ENCEPHALITIS (seriousness criteria death and medically significant). The patient died on 24-Jul-2021. The reported cause of death was Meningoencephalitis. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. On an unknown date, laboratory test performed (result not reported). Regarding the event of Encephalitis, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However regarding the event of death, Very limited information regarding this event has been provided at this time. Further information has been requested. No treatment information was provided. Company Comment: Regarding the event of Encephalitis, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However regarding the event of death, Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender''s Comments: Regarding the event of Encephalitis, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However regarding the event of death, Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Meningoencephalitis; Death


VAERS ID: 1633205 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 10020A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Disseminated intravascular coagulation, International normalised ratio, Multiple organ dysfunction syndrome, N-terminal prohormone brain natriuretic peptide, Platelet count, Prothrombin time, Pulmonary haemorrhage, Pyrexia, Septic shock, Troponin T
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dysphagia; Extremely preterm (less than 28 weeks); Hypoxic-ischaemic encephalopathy; Posthaemorrhagic hydrocephalus; Reflux oesophagitis; Respiratory insufficiency; Symptomatic epilepsy
Allergies:
Diagnostic Lab Data: Test Name: pTT; Result Unstructured Data: Test Result:$g180 seconds; Test Name: INR; Result Unstructured Data: Test Result:4.9; Test Name: proBNP; Result Unstructured Data: Test Result:24937 pg/mL; Test Name: Platelets; Result Unstructured Data: Test Result:min 3410x31uml; Test Name: Quick; Result Unstructured Data: Test Result:<10; Test Name: Troponin T; Result Unstructured Data: Test Result:1580 pg/mL
CDC Split Type: DEPFIZER INC202101072828

Write-up: Disseminated intravascular coagulation; Lung hemorrhage; Pyrexia; Multiorgan failure; Septic shock; This is a spontaneous report from a non-contactable other HCP. DE-PEI-202100168078. A 13-yars-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Batch/Lot Number: 10020A) dose 2 0.3 mL via an unknown route of administration on 11Aug2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history included extremely preterm (less than 28 weeks), Hypoxic-ischaemic encephalopathy, posthaemorrhagic hydrocephalus, symptomatic epilepsy, dysphagia, respiratory insufficiency, reflux oesophagitis on an unspecified date. The patient previously received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for Injection) dose 1, Batch/Lot number unknown) for COVID-19 immunisation on 16Jun2021. Concomitant medications were not reported. The patient underwent lab tests and procedures which included platelets min 3410x 31uml, Quick <10, INR$g4.9, pTT $g180 sec, proBNP 24937 pg/ml, Trop T 1580 pg/ml on an unknown date. The patient experienced multiorgan failure, lung hemorrhage, disseminated intravascular coagulation, pyrexia and septic shock on 13Aug2021. The patient died due to Unknown cause of death on 14Aug2021. Seriousness for the events was reported as death, hospitallization and life threatening. The autopsy details were not reported. Sender Comment: Platelets min 3410^31uml, Quick <10, INR$g4,9; pTT $g180 sec, proBNP 24937 pg/ml, Trop T 1580 pg/ml Relatedness of drug to reaction(s)/event (s) Result of Assessment D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1633532 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101089712

Write-up: died; This is a spontaneous report by a contactable consumer (patient''s aunt) via a Pfizer colleague. A 21-year-old female patient received bnt162b2 (COMIRNATY) on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient died on 20Aug2021 diue to the Comirnaty vaccine, but without informing details. The event occurred after using the product. It was unknown if Autopsy Done. The outcome of the event was fatal. Reporter comments: today that her niece, who is 21 years old, died on 20Aug2021 diue to the Comirnaty vaccine, but without informing details. Information on the batch number has been requested.; Reporter''s Comments: today that her niece, who is 21 years old, died on 20Aug2021 diue to the Comirnaty vaccine, but without informing details.; Reported Cause(s) of Death: died


VAERS ID: 1633664 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-06-29
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101077679

Write-up: PNEUMONIA; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 80972], license party for Comirnaty. A contactable consumer (brother-in-law) reported that a 72-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications was not reported. The patient experienced pneumonia (death, hospitalization, medically significant) on 29Jun2021. Therapeutic measures were taken as a result of pneumonia. The patient died. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101073976 Same reporter, same drug, same event, different patient; Reported Cause(s) of Death: pneumonia


VAERS ID: 1633692 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute aortic syndrome, Acute myocardial infarction, Angiocardiogram, Blood pressure systolic, Electrocardiogram, Electroencephalogram, Mean arterial pressure, Physical examination
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia; Hypertension arterial; Obesity; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Coronary angiography; Result Unstructured Data: Test Result:thrombotic occlusion; Comments: Coronary angiography showed thrombotic occlusion of a non-dominant circumflex coronary artery with failed angioplasty due to difficult percutaneous access, being a vessel of small caliber and development; Test Date: 2021; Test Name: Systolic Blood Pressure; Result Unstructured Data: Test Result:80 mmHg; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:lateral rectification; Comments: isoelectric SR and ST with lateral rectification; Test Date: 2021; Test Name: Electrocardiography; Result Unstructured Data: Test Result:high lateral ST elevation; Comments: high lateral ST elevation (posterolateral acute myocardial infarction) and mono-antiagregate with acute aortic syndromes (AAS); Test Date: 20210707; Test Name: Electroencephalography; Result Unstructured Data: Test Result:postanoxic encephalopathy; Comments: compatible in the clinical context of the patient with severe postanoxic encephalopathy with epileptiform activity; Test Date: 2021; Test Name: Mean Arterial Pressure; Result Unstructured Data: Test Result:55 mmHg; Test Date: 2021; Test Name: physical examination; Result Unstructured Data: Test Result:Hemodynamically stable and with Sinus Rhythm; Test Date: 2021; Test Name: mean arterial pressure; Result Unstructured Data: Test Result:55
CDC Split Type: ESPFIZER INC202101067739

Write-up: Acute myocardial infarction; mono-antiagregate with acute aortic syndromes (AAS); This is a spontaneous report from a contactable other Health Professional downloaded from the regulatory authority-WEB, regulatory authority number. A 56-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly, administered in arm (deltoid) on 30Jun2021 (Batch/Lot Number: FE3065) as dose 2 at 0.3 ml, single for COVID-19 immunisation. Medical history included obesity, active smoking, dyslipidemia, hypertension arterial which were considered as cardiovascular risk factors. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY), intramuscularly on 09Jun2021 (Lot Number: FC3143) at 0.3 ml, single for COVID-19 immunisation. The patient presented cardiac arrest on 02Jul (received the 2nd dose of Comirnaty on 30Jun2021), which took 13 minutes of basic resuscitation + 17 minutes of advanced cardiopulmonary resuscitation. Electrocardiography showed high lateral ST elevation (posterolateral acute myocardial infarction) and mono-antiagregate with acute aortic syndromes (AAS). Arrived at the hospital hemodynamically stable and with sinus rhythm. Coronary angiography showed thrombotic occlusion of a non-dominant circumflex coronary artery with failed angioplasty due to difficult percutaneous access, being a vessel of small caliber and development, so it was decided to finish the procedure. Admitted to the Observation Care Unit with isoelectric SR and ST with lateral rectification. Hypotension arterial marked with systolic blood pressure 80 and mean arterial pressure of 55 and persistent cephalic contractions. Therapeutic hypothermia protocol was performed (33T). Currently sedated, relaxed and analgesic. Electroencephalography 07Jul: Electroencephalography performed 5 days after cardiorespiratory resuscitation, compatible in the clinical context of the patient with severe postanoxic encephalopathy with epileptiform activity. The patient died on 14Jul2021. It was unknown if an autopsy was performed. The event acute myocardial infarction was considered serious due to fatal event and hospitalization. No follow-up attempts are needed. No further information is expected. ; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1633693 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101067188

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the, regulatory authority number ES-AEMPS-975938. A 73-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), intramuscularly on 04May2021 (at the age of 73-year-old) as dose 1 at 0.3 ml, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient started symptoms of precordial pain 2 hours after the COMIRNATY vaccine (04May2021) improved with aspirin 100 mg but presented progressive worsening of precordial pain on the afternoon of 04May, then cardiorespiratory arrest and Cardiac Resuscitation at home without success, the patient''s death was confirmed 05May2021. The patient died on 05May2021. Clinical autopsy confirmed diagnosis of acute myocardial infarction as cause of death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: acute myocardial infarction; Autopsy-determined Cause(s) of Death: acute myocardial infarction


VAERS ID: 1634320 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-15
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Inconclusive
CDC Split Type: GBPFIZER INC202101069515

Write-up: Death; This is a spontaneous report from a contactable consumer. The regulatory authority report number is GB-MHRA-WEBCOVID-202108171351024440-XG6VV. Safety Report Unique Identifier GB-MHRA-ADR 25810478. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included unspecified drugs (reported as SARS-COV-2 VIRUS). The patient experienced death (death, hospitalization, disability, medically significant, life threatening) on 15Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: inconclusive on an unspecified date. The patient died on 15Aug2021. It was not reported if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1634325 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101069177

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable consumer. The regulatory authority report number is GB-MHRA-WEBCOVID-202108172111564640-2CPPS, Safety Report Unique Identifier GB-MHRA-ADR 25813789. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Aug2021 (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. No health issues. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced pulmonary embolism (death, medically significant) on 16Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 16Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient died on an unspecified date. An autopsy was not performed. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1634376 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101073470

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (regulatory authority number: Not Applicable) based on information received by Pfizer from BioNtech SE (manufacturer control number), license party for bnt162b2 (COMIRNATY). This HCP reported same event for three patients. This is the first of three reports. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 08Aug2021, DH received three death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved three males aged from 53 to 63. This case was split for 1 of 3 death cases. A male patient with unknown age started to receive COVID-19 vaccine on unspecified date via unknown route at single dose (reported as unspecified dosing frequency) for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The cases were pending assessment by the Expert Committee. The event unknown cause of death was met the seriousness criterion of death. The action taken for COVID-19 vaccine regarding the event was not applicable. Patient died on an unknown date. It was unknown if the autopsy was done. Initial report was received on 12Aug2021. This is one of seven reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003099 (master case), 2021FOS003100, 2021FOS003101, 2021FOS003102, 2021FOS003103, 2021FOS003104 and 2021FOS003105. Fosun is a marketing authorization holder of one of COVID-19 vaccine Tozinameran in Hong Kong. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. Causality assessment between the event and bnt162b2 was possible per reporter and company. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101073468 same reporter, same product, same event, different patient.;HK-PFIZER INC-202101073469 same reporter, same product, same event, different patient.;HK-2021FOS003104 ;HK-2021FOS003105; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1634377 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101073468

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via department of health(Regulatory authority report number: not applicable), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003104), license party for bnt162b2 (COMIRNATY). This HCP reported same event for three patients. This is the second of three reports. This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 08Aug2021, DH received three death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved three males aged from 53 to 63. This case was split for 1 of 3 death cases. A male patient with unknown age started to receive COVID-19 vaccine on unspecified date via unknown route at single dose (reported as unspecified dosing frequency) for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The cases were pending assessment by the Expert Committee. The event unknown cause of death was met the seriousness criterion of death. The action taken for COVID-19 vaccine regarding the event was not applicable. Patient died on an unknown date. It was unknown if the autopsy was done. Initial report was received on 12Aug2021. This is one of seven reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003099 (master case), 2021FOS003100, 2021FOS003101, 2021FOS003102, 2021FOS003103, 2021FOS003104 and 2021FOS003105. There is a marketing authorization holder of one of COVID-19 vaccine Tozinameran. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. Causality assessment between the event and bnt162b2 was possible per reporter and company. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-2021FOS003103 ;HK-2021FOS003105 ;HK-PFIZER INC-202101073469 same reporter, same product, same event, different patient.;HK-PFIZER INC-202101073470 same reporter, same product, same event, different patient.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1634378 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101073469

Write-up: UNKNOWN CAUSE OF DEATH; This is a spontaneous report from a non-contactable healthcare professional via department of health(Regulatory authority report number: not applicable), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003105), license party for bnt162b2 (COMIRNATY). This HCP reported same event for three patients. This is the third of three reports. This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. In the preceding week till 11:59 pm on 08Aug2021, DH received three death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away. The cases involved three males aged from 53 to 63. This case was split for 1 of 3 death cases. A male patient with unknown age started to receive COVID-19 vaccine on unspecified date via unknown route at single dose (reported as unspecified dosing frequency) for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. There was no clinical evidence that the incident arose from vaccination. The cases were pending assessment by the Expert Committee. The event unknown cause of death was met the seriousness criterion of death. The action taken for COVID-19 vaccine regarding the event was not applicable. Patient died on an unknown date. It was unknown if the autopsy was done. Initial report was received on 12-Aug-2021. This is one of seven reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003099 (master case), 2021FOS003100, 2021FOS003101, 2021FOS003102, 2021FOS003103, 2021FOS003104 and 2021FOS003105. There is a marketing authorization holder of one of COVID-19 vaccine Tozinameran. This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Follow-up closed, no further information is possible. Causality assessment between the event and bnt162b2 was possible per reporter and company. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101073468 same reporter, same product, same event, different patient.;HK-PFIZER INC-202101073470 same reporter, same product, same event, different patient.;HK-2021FOS003103 ;HK-2021FOS003104; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1634393 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-14
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Seizure
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210842132

Write-up: BRAIN HEMORRHAGE/MASSIVE BRAIN BLEED; FITS; This spontaneous report received from a social media from consumer via a company representative concerned a 23-year-old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 13-AUG-2021, around an hour later of vaccination, the patient experienced headache and was feeling unwell which got worse at the weekend. On 14-AUG-2021, then he experienced fits and vomiting. On 16-AUG-2021, the patient died due to brain hemorrhage/massive brain bleed (headache/ vomiting and feeling unwell). It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of brain hemorrhage/massive brain bleed on 16-AUG-2021, and the outcome of fits was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210842132-covid-19 vaccine ad26.cov2.s- brain hemorrhage/massive brain bleed,fits.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event; Reported Cause(s) of Death: BRAIN HEMORRAGHE


VAERS ID: 1634398 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3344 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Extra dose administered, Off label use
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101068776

Write-up: died at home/The son found him unconscious in his home without pulse and breathe; Vaccine dose: 3; Vaccine dose: 3; This is a spontaneous report from a contactable other health professional. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccine dose 3 via an unspecified route of administration on 30Jul2021 (Lot Number: EW3344) (at the age of 75-year-old) as single dose for covid-19 immunisation. Medical history included background diseases and anticoagulant therapy. The patient''s concomitant medications were not reported. Historical vaccine included dose 1 and dose 2 of bnt162b2 for covid-19 immunisation, dates not specified. It was reported that the patient died at home (Time range in days 7 days, assumed on 06Aug2021). The son found him unconscious in his home without pulse and breathe. The patient died on 06Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The causal relationship between bnt162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: died at home/The son found him unconscious in his home without pulse and breathe


VAERS ID: 1634399 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2154 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Extra dose administered, Loss of consciousness, Off label use
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia (untreated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101072246

Write-up: Died in his home; incident of loss of consciousness; burning in chest; vaccinated with the third dose of Pfizer''s vaccine; vaccinated with the third dose of Pfizer''s vaccine; This is a spontaneous report from a contactable other hcp. Regulatory Authority report number is unspecified. A 72-year-old male patient received bnt162b2, dose 3 via an unspecified route of administration on 02Aug2021 (Lot Number: FF2154) as dose 3, single at the age of 72-year-old for covid-19 immunisation. Medical history included dyslipidaemia untreated. Historic vaccine was first and second dose of bnt162b2 received via an unspecified route of administration on an unknwon date (Lot Number unknown) as a single dose for covid-19 immunisation. Concomitant medications were not reported. On 02Aug2021 in the morning (10:00-11:00) he was vaccinated with the third dose of Pfizer''s vaccine. On the same day within a few hours an incident of loss of consciousness, he was taken to the emergency room with complaints of burning in chest. He refused to be hospitalized for observation. On 03Aug2021, he died in his home. On 02Aug2021 in the morning (10:00-11:00) he was vaccinated with the third dose of Pfizer''s vaccine. On the same day within a few hours an incident of loss of consciousness, he was taken to the emergency room with complaints of burning in chest. He refused to be hospitalized for observation. On 03Aug2021, he died in his home. It was not reported if an autopsy was performed. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events Death and Loss of consciousness and the suspect drug bnt162b2 cannot be 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: Died in his home


VAERS ID: 1634400 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2154 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Extra dose administered, Off label use, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CVA; Depression; Diabetes mellitus; Hemiparesis; Hypertension; Morbid obesity; Myalgia; Myositis; Parkinson''s disease; Vascular dementia; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: body temperature; Result Unstructured Data: Test Result:peak of 38.5 fever; Test Date: 20210119; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:borderline positive; Test Date: 20210121; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive; Test Date: 20210801; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative
CDC Split Type: ILPFIZER INC202101074062

Write-up: a third-dose vaccine against Corona/received another vaccine against Corona despite being recovering; a third-dose vaccine against Corona/received another vaccine against Corona despite being recovering; died in her room/died suddenly during the night; This is a spontaneous report from a contactable other HCP received via the Regulatory Authority. An 85-years-old female patient received BNT162B2, via an unspecified route of administration on 03Aug2021 (Lot Number: FF2154), at the age of 85-years-old, as dose 3, single for COVID-19 immunisation. Medical history included Vascular dementia, CVA (2015) & hemiparesis, Parkinson, HTN, DM (2017), morbid obesity, myalgia, myositis, vit D deficiency, depression. The patient''s concomitant medications were not reported. The patient previously received two vaccines against Corona on 27Dec2020 and 17Jan2021. Following an illness then at the institution she was examined on 19Jan2021 and found with a PCR borderline positive to Corona. On re-examination from 21Jan2021 positive PCR. To note, on the same day a peak of 38.5 fever was then transferred to the corona department at the institution. Now at 03Aug2021 she has received another vaccine against Corona despite being recovering. To note that in the institution''s sampling at 01Aug2021 she was negative for Corona. Except the above, without any unusual medical incidents or hospitalizations in the recent months. The patient died in her room in Aug2021. A resident of a geriatric institution, who died suddenly during the night after receiving a third-dose vaccine against Corona yesterday. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is 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: died in her room/died suddenly during the night


VAERS ID: 1634450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anxiety, Asthenia, Fear, Headache, Insomnia, Pain, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 106
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune anemia; Emphysema (pulmonary emphysema); Hypertension; Pacemaker insertion (cardiac) (pacemaker bearer); Solitary kidney (one kidney only); Thyroidectomy (total thyroidectomy for about 6 years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101067057

Write-up: when she moved with the walker, the use of her right leg and not having more strength in the right hand; Fear; Belly ache; Anguish; Poor vision; Insomnia; Headache; widespread pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority [IT-MINISAL02-771422]. An 88-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 19May2021 (Lot Number: Unknown) and dose 1 (Lot Number: Unknown) on 17Apr2021 both at the age of unknown as single dose for COVID-19 immunization. Medical history included hypertension, pacemaker bearer, autoimmune anemia, pulmonary emphysema, mono kidney, total thyroidectomy for about 6 years. The patient''s concomitant medications were not reported. On 19Apr2021, widespread pain, headache, abdominal pain (belly ache, more present than usual), insomnia, fear and anxiety (anguish) of being alone. Symptoms subsided slightly after about 10 days. At the third week, the patient who came for the second dose decided to postpone it for a week because the general conditions were very poor. The week after the patient decided to take the second dose. After two days, all the symptoms mentioned above recur, even accentuated. With the passage of time, her vision decreased (poor vision) from being able to read the newspapers even when she upgraded his glasses and in the last month she complained of losing every now and then, when she moved with the walker, the use of her right leg and not having more strength in the right hand on 19Apr2021. The patient experienced generalized reaction with first dose covid vaccine and further worsened with second dose after four weeks worse and worse until death on 03Aug2021. It was unknown if an autopsy was performed. Sender Comment: 09Aug2021 Regulatory Authority requests follow up info regarding: more detailed description of the ADR, name and batch of the vaccine, dates of administration, any discharge letters or Emergency Room minutes, other drugs taken. 11Aug2021 reminder. Reporter comment: Hypertension, pacemaker bearer, autoimmune anemia, pulmonary emphysema, mono kidney, total thyroidectomy for about 6 years No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Hypertension, pacemaker bearer, autoimmune anemia, pulmonary emphysema, mono kidney, total thyroidectomy for about 6 years; Reported Cause(s) of Death: when she moved with the walker, the use of her right leg and not having more strength in the right hand; Fear; Belly ache; Anguish; Poor vision; Insomnia; Headache; widespread pain


VAERS ID: 1634529 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-08-09
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Alanine aminotransferase, Arrhythmia, Aspartate aminotransferase, Blood alkaline phosphatase, Blood chloride, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood fibrinogen, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood urea, C-reactive protein, Cardio-respiratory arrest, Condition aggravated, Congestive cardiomyopathy, Echocardiogram, Ejection fraction, Ejection fraction decreased, Fibrin degradation products, Haemoglobin, Liver disorder, Platelet count, Prothrombin time, Pupillary reflex impaired, Rhabdomyolysis, SARS-CoV-2 test, Ventricular hypokinesia, Ventricular tachycardia, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (narrow), Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OLMESARTAN; RABEPRAZOLE; AZOSEMIDE; BISOPROLOL; FEBUXOSTAT; SPIRONOLACTONE; EDOXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Cardiac failure chronic; Dilated cardiomyopathy
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: APTT; Test Result: 38.4 s; Comments: control value:27.2 seconds; Test Date: 20210809; Test Name: ALT; Result Unstructured Data: Test Result:67 IU/l; Test Date: 20210809; Test Name: AST; Result Unstructured Data: Test Result:173 IU/l; Test Date: 20210809; Test Name: ALP; Result Unstructured Data: Test Result:48 IU/l; Test Date: 20210809; Test Name: Cl; Result Unstructured Data: Test Result:99 mEq/l; Test Date: 20210809; Test Name: CK; Result Unstructured Data: Test Result:478 IU/l; Test Date: 20210809; Test Name: CK-MB; Result Unstructured Data: Test Result:120 IU/l; Test Date: 20210809; Test Name: Cr; Test Result: 2.16 mg/dl; Test Date: 20210809; Test Name: FIBG; Test Result: 161 mg/dl; Test Date: 20210809; Test Name: LDH; Result Unstructured Data: Test Result:281 IU/l; Test Date: 20210809; Test Name: K; Result Unstructured Data: Test Result:4.7 mEq/l; Test Date: 20210809; Test Name: Na; Result Unstructured Data: Test Result:136 mEq/l; Test Date: 20210809; Test Name: BUN; Test Result: 35.2 mg/dl; Test Date: 20210809; Test Name: CRP; Test Result: 0.02 mg/dl; Test Date: 20210810; Test Name: echocardiography; Result Unstructured Data: Test Result:no enlargement of atrium or ventricular cavity,; Comments: or no presence of pericardial fluid; Test Date: 20210810; Test Name: EF; Test Result: 15.1 %; Test Date: 20210809; Test Name: FDP; Result Unstructured Data: Test Result:19.2 ug/ml; Test Date: 20210809; Test Name: Hb; Result Unstructured Data: Test Result:12.5 g/dl; Test Date: 20210809; Test Name: platelet; Test Result: 124000 uL; Test Date: 20210809; Test Name: PT-INR; Result Unstructured Data: Test Result:1.47; Test Date: 20210809; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Date: 20210809; Test Name: WBC; Test Result: 12200 uL
CDC Split Type: JPPFIZER INC202101066450

Write-up: Acute kidney injury; Rhabdomyolysis; Liver disorder; Rhabdomyolysis aggravated; natural history of dilated cardiomyopathy; arrhythmia including ventricular tachycardia was presumed rather than cardiac failure.; ventricular tachycardia; Left ventricular hypokinesia; Ejection fraction (EF) was 15.1%.; Cardio-respiratory arrest; though light reflex was not noted; This is a spontaneous report from a contactable physician. Regulatory authority report number is v21124118. A 68-year-old (reported as 68-year and 2-month-old) male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021), dose 2 via an unspecified route of administration on 16Jul2021 (at the age of 68-year-old) as single dose for COVID-19 immunisation. Medical history included cardiac failure from Apr2019 for which he was admitted and treated at hospital, atrial fibrillation, dilated cardiomyopathy, and cardiac failure chronic. He had received outpatient care. The patient''s daily life and work had been favorable with the following prescription as concomitant medications: olmesartan, rabeprazole, azosemide, bisoprolol, febuxostat, spironolactone, and edoxaban. Body temperature before vaccination was not reported. The patient family history was nothing in particular. On 25Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FA4597, Expiration date 31Aug2021) at the age of 68-year-old as a single dose for COVID-19 immunization. On 09Aug2021 at 19:12 (24 days after the vaccination), the patient experienced cardio-respiratory arrest. The patient was transported to the reporting physician''s hospital. On 15Aug2021 (30 days after the vaccination), the patient died. The course of the event was as follows: On 09Aug2021 at 19:12 (24 days after the vaccination), the patient was confirmed in a state of cardio-respiratory arrest in the bathroom. It had been more than one hour since he was last seen. Receiving cardiopulmonary resuscitation, the patient arrived at the hospital at 20:02. Heart rate had already resumed, though light reflex was not noted. The patient did not have spontaneous respiration, so he was managed with artificial respiration. Blood test on arrival to the hospital included hemoglobin (Hb) 12.5 g/dL, white blood cell (WBC) 12200/uL, platelet 124000/uL, international normalized ratio of prothrombin time (PT-INR) 1.47, activated partial thromboplastin time (APTT), 38.4 seconds (control value:27.2 seconds), fibrinogen (FIBG) 161 mg/dL, fibrin degradation products (FDP)19.2 ug/mL, blood urea nitrogen (BUN) 35.2 mg/dL, creatinine (Cr) 2.16 mg/dL, alkaline phosphatase (ALP) 48 U/L, aspartate aminotransferase (AST) 173 IU/L, alanine aminotransferase (ALT) 67 IU/L, lactase dehydrogenase (LDH) 281 IU/L, creatine kinase (CK) 478 IU/L, creatine kinase MB (CK-MB) 120 IU/L, sodium (Na) 136 mEq/L, potassium (K) 4.7 mEq/L, chlorine (Cl) 99 mEq/L, C-reactive protein (CRP) 0.02 mg/dL, and SARS-CoV-2 polymerase chain reaction (PCR) negative. On 10Aug2021(25 days after the vaccination), echocardiography revealed no enlargement of atrium or ventricular cavity, or no presence of pericardial fluid. Left ventricular wall motion diffusely decreased. Ejection fraction (EF) was 15.1%. The patient experienced natural history of dilated cardiomyopathy, left ventricular hypokinesia on 10Aug2021. Circulation dynamics were unstable, and acute kidney injury, liver disorder and rhabdomyolysis were aggravated. On 15Aug2021 at 09:28 (30 days after the vaccination), the patient died. The reporting physician commented as follows: The patient, receiving cardiopulmonary resuscitation, was transported to the reporting physician''s hospital. Blood CK level was high. As the cause, acute coronary syndrome was also suspected (Circulation 2001; 104:2158); however, partial decrease of wall motion was denied on echocardiography. After the consultation with physicians of cardiovascular department, coronary angiography was ruled out. On the basis of the treatment information from hospital, natural history of dilated cardiomyopathy was most highly suspected. As there had not been any problem with his daily living and working until recent days, therefore arrhythmia including ventricular tachycardia was presumed rather than cardiac failure. Haemorrhage intracranial was not observed. The patient''s medication behavior had been unknown because he had managed it by himself. It was considered that the underlying diseases significantly contributed to cardio-respiratory arrest. Evaluation of causality with coronavirus vaccine and autopsy for acquiring some knowledge were consulted. The patient died due to Cardio-respiratory arrest and natural history of dilated cardiomyopathy, outcome of the other events was unknown. The patient''s family did not request an autopsy when he died. An autopsy was not performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. As for other possible cause of the event such as any other diseases, natural history of dilated cardiomyopathy was most highly suspected.; Reported Cause(s) of Death: Cardio-respiratory arrest; suspected natural history of dilated cardiomyopathy


VAERS ID: 1634533 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101070142

Write-up: Death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21123755. An 88-year-old male patient received bnt162b2 (COMIRNATY) dose 2 via an unspecified route of administration on 17Aug2021 13:49 (Lot Number: FF4204; Expiration Date: 31Oct2021) as dose 2, single for covid-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: not reported, Expiration date: not reported). The patient experienced death on 18Aug2021 08:00 (18 hours and 11 minutes after the vaccination). The patient underwent lab tests included body temperature: 36.0 centigrade on 17Aug2021 before vaccination. The patient died on 18Aug2021. It was not reported if an autopsy was performed. The course of the event was as follows: On 17Aug2021, after the vaccination of BNT162b2, the patient went home without complaint in particular. The patient had dinner and drunk until around 18:00 and went to bed. On the morning of 18Aug2021 at 08:00, a family member found the patient dead on the futon. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not reported. The reporting physician commented as follows: Although the event could not be assessed, the physician considered that the direct causal relationship between the event and the vaccination was low.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1634534 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute hepatic failure, Body temperature, Coagulopathy, Disease recurrence, Dyspnoea, Epistaxis, Hyperpyrexia, Multiple organ dysfunction syndrome, Musculoskeletal stiffness, Nausea, Pallor, Pyrexia, Seizure, Shock
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cirrhosis alcoholic; Convulsion (more than 10 years before); Epilepsy (the symptom was stable the first episode was more than 10 years before)
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101070165

Write-up: pyrexia of 42 degrees Celsius; acute hepatic failure; coagulation abnormal; shock; multi-organ failure; convulsion; similar to the condition of the first convulsion more than 10 years before; difficulty in breathing; patient had whole body stiffness, and formed at the mouth; epistaxis; pyrexia of 39 degrees Celsius; Complexion ill; queasy; This is a spontaneous report from a contactable nurse received from the Regulatory Agency . Regulatory authority report number is v21123782. The patient was a 50-year and 9-month-old female. Body temperature before vaccination was 36.3 degrees centigrade on 06Aug2021. The patient had no family history. The patient had medical histories of epilepsy and cirrhosis alcoholic. The epilepsy symptom was stable, the first episode was more than 10 years before, and the last episode was around Aug2020. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown) for COVID-19 immunisation. On 06Aug2021 at 16:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration as the second single dose for COVID-19 immunization. On 07Aug2021, at 00:00 (8 hours after vaccination), queasy was noted. On the same date at 05:00 (13 hours after vaccination), the patient''s son heard that the patient complained of pyrexia. Complexion ill was noted in the patient. At around 10:30, the husband talked to the patient; however, the patient seemed to be as usual. At 10:45, the son found later that ''''the patient had pyrexia of 39 degrees Celsius'''' was described in the sent message to social networking service. At 11:40, the sound of difficulty in breathing was heard, and the family member went down from the second floor to the first floor to see how the patient was doing. Then, the patient had whole body stiffness, and formed at the mouth. The patient also had epistaxis. This situation was similar to the condition of the first convulsion more than 10 years before. At 12:08, an ambulance was called. The patient was emergently transferred to the hospital where she visited regularly for cirrhosis alcoholic. On 08Aug2021 (one day and 8 hours after vaccination), the convulsion persisted, and the patient experienced pyrexia of 42 degrees Celsius, acute hepatic failure, coagulation abnormal, shock, and multi-organ failure, and thus, she was transferred to the reporting hospital. The patient was pointed out to have epilepsy more than 10 years before. The last episode was around Aug2020. The episodes occurred several times; however, other episode rather than the first one immediately aborted spontaneously. The patient often had convulsion due to physical deconditioning such as pyrexia. The patient was hospitalized from 08Aug2021 to 14Aug2021. On 14Aug2021 (8 days after the vaccination), the patient died. It was unknown if an autopsy was performed. The reporting nurse classified the events as serious (death), severity as severe, and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was cirrhosis alcoholic. The reporting nurse commented as follows: The causality between the events and the vaccination was unknown. The outcome of events convulsion, disease recurrence, hyperpyrexia was fatal, outcome of the other events was unknown.; Reported Cause(s) of Death: convulsion; pyrexia of 42 degrees Celsius; similar to the condition of the first convulsion more than 10 years before


VAERS ID: 1634535 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101070987

Write-up: The patient was transfered to hospital and died; This is a spontaneous report from a contactable pharmacist via medical information team. A 6-decade-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Lot Number: FF3622; Expiration Date: 30Nov2021) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unspecified date, the patient was transferred to hospital (reporter''s hospital) and died. It was not reported if an autopsy was performed.; Sender''s Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug 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: the patient was transferred to the hospital and died


VAERS ID: 1634560 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-06
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Emphysema, Histology, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Emphysema; HIV infection (+ev, was on ARV treatment from JUL-2016 to NOV-2019); Muscle tone decreased; Sickness; Tuberculosis; Unable to walk
Preexisting Conditions: Medical History/Concurrent Conditions: Asbestosis (Worked in ?asbestos mine as a miner for more than 30 years . Had to quit the job due to respiratory complications in 2010.)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Histology; Result Unstructured Data: pending
CDC Split Type: LSJNJFOC20210842145

Write-up: FEVER; ACUTE EXACERBATION OF CHRONIC HA EMPHYSEMA; This spontaneous report was received from Health Authority via a company representative, and concerned a 65 year old male. The patient''s height and weight were not reported. The patient''s past medical history included possible asbestos exposure. Patient worked in "?asbestos mine" as a miner for more than 30 years. He had to quit the job due to respiratory complications in 2010. Concurrent conditions included: HIV +ev (was on ARV from JUL-2016 to NOV-2019), asthma, chronic emphysema, severely wasted, and tuberculosis. Patient stopped ARV and salbutamol for asthma in NOV-2019, had worsening of symptoms and switched to traditional medications, but symptoms continued to worsen over years. Patient was very sick on the day of vaccination and was unable to walk to the vaccination site. He was vaccinated at home on his wife''s request. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose and vaccination anatomical site not reported, administered on 06-AUG-2021 at 11:00 for prophylactic vaccination. Batch number was not reported and has been requested. Vaccine was kept in good condition; no issue on vaccine quality was found. Concomitant medications included unspecified traditional medications. On 06-AUG-2021 at 17:00, the patient experienced acute exacerbation of chronic emphysema. At that time he had worsening of preexisting respiratory symptoms: wheezes, tiredness, weakness. On 07-AUG-2021 at 07:30, patient complained about fever, wheezing and difficult breathing. He called village health worker at 08:00 complaining about his symptoms. Patient died 08-AUG-2021 at 07:00. An autopsy was performed. Postmortem preliminary findings included: Lungs: cavitation of both upper lobes. A hard firm mass left upper lobe. Extensive emphysema of both lungs. Both lungs sent and small samples were sent for histology; results pending. Provisional diagnoses was of end stage lung disease post TB and possible silicosis emphysema. Reporter causality classification: Co-incidental. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of acute exacerbation of chronic ha emphysema on 08-AUG-2021, and the outcome of fever was not reported. This report was serious (Death). This case, from the same reporter is linked to 20210842115, 20210816481, 20210816486, 20210816515 and 20210842105.; Sender''s Comments: V0: This spontaneous report received from World Health Organization Committee via a company representative concerns a 65-year-old male who died of "acute exacerbation of chronic HA emphysema" 2 days after vaccine. Medical history included asbestos exposure for more than 30 years that caused respiratory complications. Concurrent conditions included asthma, chronic emphysema, severely wasted, tuberculosis, patient was HIV positive (receiving antiretroviral drugs (ARV) from 2016 till 2019). Concomitant medications included unspecified traditional medications. He stopped ARV and asthma medications, switched to traditional medications, however the symptoms continued to worsen over the years. Patient was very sick on the day of vaccination and was unable to walk to the vaccination site. He was vaccinated at home on his wife''s request. Six hours after vaccination he experienced severe exacerbation of chronic emphysema with worsening pre-existing respiratory symptoms: wheezes, tiredness, weakness. Next morning patient presented symptoms of fever, wheezing and difficult breathing and died on day 2 after vaccine. Postmortem preliminary findings included: Lungs: cavitation of both upper lobes. A hard firm mass left upper lobe. Extensive emphysema of both lungs. Histology results were pending at the time of the report. Provisional diagnosis was of end stage lung disease post TB and possible silicosis emphysema. The reporter causality assessment is co-incidental. Considering patient''s medical state the day of (and prior) to vaccine, underlying medical conditions and autopsy findings, the causal association of acute exacerbation of chronic emphysema and fever to vaccination is assessed to be inconsistent.


VAERS ID: 1634564 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-20
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003183 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Malaise, Nausea, Vaccination site plaque
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BRILIQUE
Current Illness: Vascular device user (cardiac stent)
Preexisting Conditions: Medical History/Concurrent Conditions: Coagulation disorder (cardiac stent); Coagulation disorder; Dyslipidemia (cardiac stent)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LUMODERNATX, INC.MOD20212

Write-up: CARDIAC ARREST; Malaise; envie de vomir; Vaccination site plaque; This case was received via Regulatory Authority (Reference number: LU-ALMPS-202102975) on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Malaise), NAUSEA and CARDIAC ARREST in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3003183 and 3003610) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Coagulation disorder (cardiac stent), Coagulation disorder and Dyslipidemia (cardiac stent). Concurrent medical conditions included Vascular device user (cardiac stent). Concomitant products included TICAGRELOR (BRILIQUE) for Vascular device user. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jul-2021, after starting mRNA-1273 (Spikevax), the patient experienced VACCINATION SITE PLAQUE (Vaccination site plaque). On 23-Jul-2021, the patient experienced MALAISE (seriousness criterion death) and NAUSEA (seriousness criterion death). On an unknown date, the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant). The patient died on 24-Jul-2021. The reported cause of death was Cardiac arrest. An autopsy was not performed. At the time of death, VACCINATION SITE PLAQUE (Vaccination site plaque) outcome was unknown. No treatment medications were not provided. Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1634635 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse drug reaction, COVID-19, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Found out COVID-19
CDC Split Type: PHJNJFOC20210842445

Write-up: CONFIRMED COVID-19 INFECTION; SIDE EFFECT CONTRIBUTED TO DEATH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient''s height, and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had SARS-CoV-2 PCR test (polymerase chain reaction) test and found out COVID-19 (confirmed covid-19 infection). On an unspecified date, the patient experienced side effect that was contributed to death and confirmed covid-19 infection(fever). On 07-AUG-2021, the patient was hospitalized (unspecified cause). Number of days of hospitalization was not reported. On 10-AUG-2021, the patient died from side effect contributed to death and confirmed covid-19 infection. It was unknown whether an autopsy was performed or not. The cause of death included confirmed covid-19 infection and side effect contributed to death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210842445-covid-19 vaccine ad26.cov2.s- side effect contributed to death.confirmed covid-19 infectionThis event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: SIDE EFFECT CONTRIBUTED TO DEATH; CONFIRMED COVID-19 INFECTION


VAERS ID: 1634636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210844178

Write-up: COVID-19 TEST POSITIVE; Death; This spontaneous report received from a consumer concerned via social media (news article) a 35 year old female of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported, 1 total administered on 26-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-AUG-2021, the patient died from unknown cause of death. On an unspecified date, a COVID-19 virus test (swab test) was done for which the patient was found positive. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 01-AUG-2021, and the outcome of covid-19 virus test positive was not reported. This report was serious (Death). This case, from the same reporter is linked to 20210847179, 20210847165, 20210847127 and 20210847115.; Sender''s Comments: V0-20210844178-Covid-19 Vaccine AD26.COV2.S-Death. This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1634637 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210844370

Write-up: PASSED AWAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, therapy start date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient passed away due to the unknown cause. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210844370-covid-19 vaccine ad26.cov2.s-passed away. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN


VAERS ID: 1634638 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown cause of death
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210847165

Write-up: DEATH; This spontaneous report received from a consumer concerned via social media (news article) a female of unspecified age of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: unknown cause of death. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 08-AUG-2021, the patient died from unknown cause of death in hospital after three days of admission. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged) This case, from the same reporter is linked to 20210844178, 20210847179, 20210847127 and 20210847115.; Sender''s Comments: V0: 20210847165- Covid-19 vaccine ad26.cov2.s-death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1634639 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210847179

Write-up: DEATH; This spontaneous report received from a consumer concerned via social media (news article) a 37 year old male of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 26-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210844178, 20210847165 and 20210847127.; Sender''s Comments: V0: 20210847179- COVID-19 VACCINE AD26.COV2.S -Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1636093 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had unspecified comorbidities and was taking medicines.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210847127

Write-up: DEATH; This spontaneous report received from a consumer via (news article) concerned a male of unspecified age. The patient''s height, weight and medical history were not reported. The patient had unspecified comorbidities and was taking medicines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient was declared dead. The patient died of an unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210844178, 20210847165, 20210847179 and 20210847115.; Sender''s Comments: V0: 20210847127-COVID-19 VACCINE AD26.COV2.S -Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1637639 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D016A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Hypertension, Inappropriate schedule of product administration, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Hypertension (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101078903

Write-up: General condition deterioration, renal failure, hypertension; General condition deterioration, renal failure, hypertension; General condition deterioration, renal failure, hypertension; received dose 1 on 13Apr2021, dose 2 on 01Jun2021; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100165003. A 90-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 01Jun2021 (Batch/Lot Number: 1D016A) (at the age of 90-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included the patient received first dose of Comirnaty intramuscular on 13Apr2021 (lot number: ET 304507) for covid-19 immunisation. The patient experienced general condition deterioration, renal failure, hypertension on 01Jun2021. The event was reported as serious due to death, hospitalization. The outcome of the event general condition deterioration, renal failure, hypertension was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender''s comments: Death certificate attached Causality between Comirnaty and Renal failure per RA was D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: General condition deterioration, renal failure, hypertension; General condition deterioration, renal failure, hypertension; General condition deterioration, renal failure, hypertension


VAERS ID: 1637975 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCDN1 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cardio-respiratory arrest, Dyspnoea, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Tabaquism (Smoking 1 pack per day)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101072846

Write-up: dyspnea; cardiac arrest; syncopal discomfort; convulsions; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-CF20212385 A 52-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscularly administered in left arm at the age of 52-years-old on 12Aug2021 11:10 (Batch Number: SCDN1) as single dose for covid-19 immunisation. Medical history included smoking 1 pack per day, arterial hypertension. The patient didn''t have a history of COVID. The patient''s concomitant medications were not reported. The patient experienced cardio-respiratory arrest on 12Aug2021. At 3:00 pm 12Aug2021, he presented with dyspnea for which he asks his neighbor for help. It followed syncopal discomfort and convulsions followed by cardiac arrest for which the neighbor who called the emergency services begins resuscitation. Finding of a cardiac arrest by the firefighters who would not be able to resuscitate him. Forensic autopsy scheduled for 16August2021, investigation for open cause of death. The outcome of the events was fatal. The patient died on 12Aug2021. An autopsy was not performed.; Reported Cause(s) of Death: Cardio-respiratory arrest; dyspnea; syncopal discomfort; convulsions; cardiac arrest


VAERS ID: 1637976 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Toxicologic test
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: toxicology; Result Unstructured Data: Test Result:absence; Comments: alcohol, cocaine and derivatives, opiates, amphetamines, cannabinoids and psychoactive drugs and toxins
CDC Split Type: FRPFIZER INC202101072842

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency WEB FR-AFSSAPS-CF20212386. A 38-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular on 26Jul2021 (at vaccination age of 38-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. As reported, on 26Jul2021, death the same day in the afternoon on the highway detected by the firefighters. On 30Jul2021, legal medical autopsy was performed. Negative toxicological research was as follows: "absence of alcohol, cocaine and derivatives, opiates, amphetamines, cannabinoids and psychoactive drugs and toxins". The patient died on 26Jul2021. An autopsy was performed and results were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1638014 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-07-20
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, COVID-19 pneumonia, Oxygen saturation, Respiratory rate, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; LEVOTHYROXINE; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Down''s syndrome; Hypothyroidism; Strabismus
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: blood pressure; Result Unstructured Data: Test Result:120/76; Test Date: 20210720; Test Name: oxygen saturation; Test Result: 96 %; Comments: under 3L of O2; Test Date: 20210720; Test Name: oxygen saturation; Test Result: 88 %; Comments: in ambient air; Test Date: 20210722; Test Name: oxygen saturation; Test Result: 92 %; Comments: under 12L of O2; Test Date: 20210723; Test Name: oxygen saturation; Result Unstructured Data: Test Result:85-90 %; Comments: under 15L of O2; Test Date: 20210723; Test Name: respiratory rate; Result Unstructured Data: Test Result:60/min; Test Date: 202107; Test Name: screening PCR test; Result Unstructured Data: Test Result:L452R; Comments: PCR CT 22.
CDC Split Type: FRPFIZER INC202101072950

Write-up: Vaccination failure; COVID-19 pneumonitis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB FR-AFSSAPS-MA20212985. A 61-year-old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 2 intramuscular on 18Apr2021 (age at vaccination: 61-year-old) (Batch/Lot Number: EW4815) as DOSE 2, SINGLE, dose 1 intramuscular on 21Mar2021 (age at vaccination: 61-year-old) (Batch/Lot Number: ET3620) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypothyroidism, diabetes, trisomy 21 and convergent strabismus: all from an unknown date and unknown if ongoing. Concomitant medications included allopurinol; levothyroxine and metformin: all taken for an unspecified indication, start and stop date were not reported. On 20Jul2021, the patient was hospitalized for SARCOV2 pneumonia and died of COVID19 pneumonia despite the complete vaccination with COMIRNATY. Upon admission: 96% saturation under 3L of O2 (88% in ambient air), blood pressure at 120/76. No respiratory distress. Slowly unfavorable respiratory function on 22Jul2021, 92% saturation under 12 L of 02, PCR CT 22. On 23Jul2021, respiratory rate at 60 / min, crackles rising in mid-field, abdominal breathing, sat02 85-90% under 15L. On 25Jul2021, breathing broke. Screening PCR test: L452R. The patient underwent lab tests and procedures which included blood pressure: 120/76 on 20Jul2021, oxygen saturation: 96 % under 3L of O2 and 88 % on 20Jul2021 in ambient air, oxygen saturation: 92 % on 22Jul2021 under 12L of O2, oxygen saturation: 85-90 % on 23Jul2021 under 15L of O2, respiratory rate: 60/min on 23Jul2021 and screening PCR test (Sars-Cov-2 test): L452R (PCR CT 22) on an unknown date in Jul2021. Therapeutic measures were taken as a result of the events. The patient died on 26Jul2021. It was unknown if an autopsy was performed. The seriousness reported for the events vaccination failure and COVID-19 pneumonitis were death, life threatening and hospitalization. The outcome of the events was fatal. No follow-up attempts are possible, no information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101073152 Same drug and event, different patient; Reported Cause(s) of Death: On 20Jul2021, hospitalization for SARCOV2 pneumonia; On 20Jul2021, hospitalization for SARCOV2 pneumonia


VAERS ID: 1638026 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness: Hypertension arterial (treated with AMLODIPINE)
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (neurovegetative dementia)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101072938

Write-up: found deceased; This is a spontaneous report from a contactable physician downloaded from the RA, regulatory authority number FR-AFSSAPS-MA20213168. An 88-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Jun2021 at the age of 88 years old(Lot Number: FC1526) as DOSE 2, SINGLE for covid-19 immunisation. First dose was received on 14May2021 lot#FA5829 at the age of 88 years old for Covid-19 immunisation. Medical history included ongoing Hypertension arterial treated with AMLODIPINE; dementia (neurovegetative dementia). Concomitant medications included amlodipine (AMLODIPINE) taken for hypertension, start and stop date were not reported. Patient was found deceased in her bed on the morning of 10Jun2021, 6 days after a 2nd dose of COMIRNATY.The patient died on 10Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: found deceased


VAERS ID: 1638132 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-27
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101073020

Write-up: Death unexplained; This is a spontaneous report from a contactable consumer (patient''s daughter) downloaded from the Regulatory Agency-WEB FR-AFSSAPS-RN20212516. A 73-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 23Apr2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. no long-term treatment informed. The patient experienced death unexplained on 27May2021 at home during the nap. No notion of functional complaint in the previous hours or days. The patient died on 27May2021. An autopsy was performed and results were not provided. Autopsy performed: no notable abnormality. Subject to other elements of investigations which could be carried out within the framework of legal or amicable compensation procedures''''. Official bulletin of the Ministry in charge of health. The lot number for the vaccine Comirnaty was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1638413 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ723 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Erythema, Hyponatraemia, Imaging procedure, Investigation, Neoplasm progression, Oedema peripheral, Platelet count, Platelet count decreased, Thrombocytopenia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Malignancy related conditions (narrow), Accidents and injuries (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 66
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EPOETIN ALFA HEXAL; DEPAKINE CHRONO; SUOMI; MOSTRELAN; FILGRASTIM HEXAL; EPANUTIN [PHENYTOIN]; BRIVIACT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Chemotherapy (Last chemotherapy Apr2021.); Epileptic seizure; Gastroesophageal reflux prophylaxis; Lung cancer (cancer of lung, metastases to brain)
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Hyponatremia; Result Unstructured Data: Test Result:Mild Hyponatremia (Low sodium levels); Test Date: 202105; Test Name: imaging assessment; Result Unstructured Data: Test Result:metastasis of the disease (to brain and locally); Test Name: clinical examination; Result Unstructured Data: Test Result:Bruising of right cervical area (neck) and; Comments: Bruising of right cervical area (neck) and bruising of right upper limb; Test Name: clinical examination; Result Unstructured Data: Test Result:Intense redness of right upper limb and edema; Comments: Intense redness of right upper limb and edema of right upper limb; Test Name: clinical examination; Result Unstructured Data: Test Result:End stage cancer; Test Date: 202105; Test Name: Platelet count; Result Unstructured Data: Test Result:200000; Test Date: 20210630; Test Name: Platelet count; Result Unstructured Data: Test Result:44.000
CDC Split Type: GRPFIZER INC202101073296

Write-up: Bruising of right cervical area (neck) and right upper limb.; Intense redness of right upper limb; Edema of the right upper limb; Mild hyponatremia; Thrombocytopenia; Platelet count decreased; metastatic cancer/In May2021, he had epileptic seizures and from imaging assessment was found metastasis of the disease (to brain and locally); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number. A 51-years-old male patient received the second dose of BNT162B2 (COMIRNATY), dose 2 intramuscular on 04May2021 (Lot Number: EJ723) as single dose for covid-19 immunisation. Medical history included chemotherapy and immunotherapy, last chemotherapy Apr2021, lung cancer from Nov2019, cancer of lung, metastases to brain, anaemia, epileptic seizure, gastroesophageal reflux prophylaxis. Concomitant medications included epoetin alfa (EPOETIN ALFA HEXAL) taken for anaemia from 01Nov2020 to 29Jan2021; valproate sodium, valproic acid (DEPAKINE CHRONO) taken for epileptic seizure from 22May2021; dexamethasone sodium phosphate (SUOMI) taken for cancer of lung, metastases to brain from 11May2021; famotidine (MOSTRELAN) taken for gastroesophageal reflux prophylaxis, start and stop date were not reported; filgrastim (FILGRASTIM HEXAL) taken for anaemia from 11Nov2020 to an unspecified stop date; phenytoin (EPANUTIN [PHENYTOIN]) taken for epileptic seizure from 11May2021 to 22May2021; brivaracetam (BRIVIACT) taken for epileptic seizure from 22May2021 to an unspecified stop date. Historical vaccine included the first dose of BNT162B2 on 09Apr2021 (Lot Number: ELO2243) for COVID-19 immunisation. The patient experienced metastatic cancer from May2021, bruising of right cervical area (neck) and right upper limb (death, hospitalization, medically significant) on an unspecified date, edema of the right upper limb (death, hospitalization, medically significant) on 01Jul2021, intense redness of right upper limb (death, hospitalization, medically significant) on 03Jul2021, mild hyponatremia (death, hospitalization, medically significant) on 30Jun2021, thrombocytopenia (death, hospitalization, medically significant) on 30Jun2021, platelet count decreased (death, hospitalization, medically significant) on 30Jun2021. In May2021, he had epileptic seizures and from imaging assessment was found metastasis of the disease (to brain and locally). In addition, from the laboratory examination was found thrombocytopenia (on 30Jul2021) (PLT 44.000) (previous PLT count 200000) and mild hyponatremia. From the clinical examination: Bruising of right cervical area (neck) and bruising of right upper limb. His admission to the pathology clinic, but he came out from the clinic voluntarily. He had reported aggravation of the bruising. His admission to the Emergency department on 03Jul2021 due to edema of the right upper limb. The patient had during the examination, the same hematological image. Clinical examination: Intense redness of right upper limb and edema of right upper limb. He was admitted to a 3-level Hospital for further investigation and treatment of the symptomatology. End stage cancer from the last examination. He discharged from the Hospital and passed away on 06Jul2021. The patient underwent lab tests and procedures which included hyponatraemia: mild hyponatremia (low sodium levels) on 30Jun2021, platelet count: 200000 in May2021, platelet count: 44.000 on 30Jun2021. The patient died on 06Jul2021. Patient died on 06Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Bruising of right cervical area (neck) and right upper limb.; Edema of the right upper limb; Intense redness of right upper limb; Mild hyponatremia; Thrombocytopenia; Platelet count decreased; metastatic cancer/In May2021, he had epileptic seizures a


VAERS ID: 1638477 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7416 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Extra dose administered, Off label use, Respiratory distress, Sepsis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; Coronary heart disease; CVA; Dementia; Diabetes mellitus; Hyperlipidemia; Hypertensive
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101072580

Write-up: Died in hospital from galloping sepsis/severe sepsis apparently from a respiratory source; respiratory distress, desaturations; Dose number:3; Dose number:3; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose number 3 via an unspecified route of administration on an unspecified date (Lot Number: FF7416) (at the age of 76-year-old) as single dose for covid-19 immunisation. Medical history included CVA, Hyperlipidemia, dementia, CHD, Chronic renal failure, DM, HTS. The patient''s concomitant medications were not reported. Historical vaccine included dose 1 and dose 2 of bnt162b2 for covid-19 immunisation, dates not specified. It was reported that the patient died in hospital from galloping sepsis. Description of clinical course was as follows. Evacuated to the emergency room, respirated and anesthetized in light of respiratory distress, desaturations and fever from the morning hours, the patient presented a clinical picture of severe sepsis apparently from a respiratory source. The patient died on an unspecified date (time range 3 days from last dose). It was not reported if an autopsy was performed. The outcome of "galloping sepsis" was fatal, of "respiratory distress, desaturations" was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events Sepsis and Respiratory distress and the suspect drug cbnt162b2 cannot be 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: galloping sepsis


VAERS ID: 1638546 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-20
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin G, COVID-19, Immunology test, Serology test, Vaccination failure, Viral test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: IgG; Result Unstructured Data: Test Result:260; Comments: BAU/ml; Test Name: chemiluminescent immunoassay (CLIA); Result Unstructured Data: Test Result:Unknown results; Comments: chemiluminescent immunoassay (CLIA) for anti-SARS-CoV-2 IgG detection (anti-spike protein antibodies).; Test Date: 20210320; Test Name: serological; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210320; Test Name: rapid antigenic nasopharyngeal swabs; Test Result: Positive ; Comments: SARS-CoV-2 positivity
CDC Split Type: ITPFIZER INC202101081971

Write-up: SARS-CoV-2 positivity; SARS-CoV-2 positivity; This is a literature report. This author reported similar events for ten patients. This is the first of ten reports. A 99-year-old patient of an unspecified gender received two doses of BNT162b2 mRNA COVID-19 vaccine (Comirnaty, BioNTech Manufacturing) between January and early February 2021, via an unspecified route of administration (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced sars-cov-2 positivity on 20Mar2021 with symptoms dyspnea; inappetence; asthenia; muscle pain. The patient underwent lab tests and procedures which included IgG: 260 BAU/ml on 20Mar2021, chemiluminescent immunoassay (CLIA) for anti-SARS-CoV-2 IgG detection (anti-spike protein antibodies): unknown results, serological: unknown results on 20Mar2021, rapid antigenic nasopharyngeal swabs: SARS-CoV-2 positivity on 20Mar2021. The action taken in response to the event for bnt162b2 was not applicable. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, patient old age and other underlying medical factors cannot be ruled out. 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.,Linked Report(s) : IT-PFIZER INC-202101082136 Same Article/Event/Suspect and Different Patient;IT-PFIZER INC-202101082145 Same Article/Event/Suspect and Different Patient;IT-PFIZER INC-202101082154 Same Article/Event/Suspect and Different Patient;IT-PFIZER INC-202101082190 Same Article/Event/Suspect and Different Patient;IT-PFIZER INC-202101082201 Same Article/Event/Suspect and Different Patient;IT-PFIZER INC-202101082158 Same Article/Event/Suspect and Different Patient;IT-PFIZER INC-202101082194 Same Article/Event/Suspect and Different Patient;IT-PFIZER INC-202101082163 Same Article/Event/Suspect and Different Patient;IT-PFIZER INC-202101090743 Same Article/Event/Suspect and Different Patient; Reported Cause(s) of Death: SARS-CoV-2 positivity; SARS-CoV-2 positivity


VAERS ID: 1638639 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bradycardia, Cardio-respiratory arrest, Respiratory arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensated cirrhosis; Hepatic failure; Pneumonia aspiration; Pyothorax; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101071089

Write-up: Respiratory arrest; cardio-respiratory arrest; bradycardia; This is a spontaneous report from a contactable physician. Regulatory authority report number is v21123860. A 62-year and 5-month-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 17Aug2021 14:20 (Lot Number: FE8206; Expiration Date: 31Oct2021) (at age of 62-year and 5-month-old) as DOSE 1, SINGLE for covid-19 immunisation. Body temperature before vaccination was 35.9 degrees centigrade. The family history was not provided. The patient had medical histories of alcoholic decompensated cirrhosis, hepatic failure, renal failure chronic, pyothorax, and pneumonia aspiration.The patient''s concomitant medications were not reported. On 18Aug2021 at 05:00 (14 hours/40 minutes after the vaccination), the patient experienced bradycardia, respiratory arrest, and cardio-respiratory arrest. On 14Jul2021 (before the vaccination), the patient was admitted to the hospital. On 18Aug2021 (one day after the vaccination), the outcome of the events respiratory arrest, and cardio-respiratory arrest was fatal. The course of the event was as follows: On 18Aug2021, at around 05:00 (14 hours and 40 minutes after vaccination), the patient suddenly had bradycardia. Thereafter, the patient experienced respiratory arrest and cardio-respiratory arrest. On the same day, at 06:33 (16 hours and 13 minutes after vaccination), the patient was confirmed to die. The outcome of events respiratory arrest, and cardio-respiratory arrest was fatal and of bradycardia was unknown.An autopsy was not performed. The reporting physician classified the event as serious (death and hospitalization) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was aggravation of the underlying diseases. The reporting physician commented as follows: The patient could die at any moment. From 14Jul2021, the patient was being admitted to the hospital for a long time. The physician consulted with the family about the vaccination, and the patient received the vaccination. It was considered that the patient died due to aggravation of the underlying diseases.; Reporter''s Comments: The patient could die at any moment. From 14Jul2021, the patient was being admitted to the hospital for a long time. The physician consulted with the family about the vaccination, and the patient received the vaccination. It was considered that the patient died due to aggravation of the underlying diseases.; Sender''s Comments: Based on the available information and known disease pathophysiology, the events are assessed as not related to BNT162b2 and more likely due to the patient''s risk for developing diseases secondary to age and underlying medical conditions.; Reported Cause(s) of Death: respiratory arrest; cardio-respiratory arrest; aggravation of the underlying diseases


VAERS ID: 1638640 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-07
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Faeces discoloured, Gastrointestinal haemorrhage, Haematemesis, Platelet count, Shock haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210707; Test Name: platelet count; Result Unstructured Data: Test Result:10,5000; Comments: no platelets decreased
CDC Split Type: JPPFIZER INC202101071096

Write-up: Haemorrhage of digestive tract; Shock heamorrhagic; haematemesis; black stools; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21124130. A 68-year and 8-month-old male patient received bnt162b2 (COMIRNATY), dose 2, via an unspecified route of administration on 02Jul2021 09:55 (at the age of 68 years old) (Lot Number: EY5423; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). Body temperature before vaccination on 02Jul2021 was 36.7 degrees centigrade. The patient experienced haemorrhage of digestive tract (death) on 07Jul2021 02:50, shock heamorrhagic (death) on 07Jul2021 02:50, haematemesis (Medically Significant) on 07Jul2021 02:50, black stools on 07Jul2021 02:50. On 02Jul2021 at 09:55 (the day of vaccination), the patient received the second dose of BNT162b2. On 07Jul2021 at 02:50 (4 days/16 hours/55 minutes after the vaccination), the patient experienced haematemesis, black stools, haemorrhage of digestive tract, and shock heamorrhagic. The course of the event was as follows: On 07Jul2021, at 02:50 (4 days, 16 hours, and 55 minutes after vaccination), the patient was transferred to the reporting hospital by an ambulance for haematemesis and black stools. The patient experienced haemorrhage of digestive tract and haemorrhagic shock. The intubation was performed, and resuscitation was tried with full cardiopulmonary resuscitation (CPR); however, the patient''s life could not be saved (the reference data: the platelet count at the hospital visit was 10,5000 (07Jul2021)). The patient died on 07Jul2021. An autopsy was not performed. On 07Jul2021 (5 days after the vaccination), the outcome of the events haemorrhage of digestive tract and shock heamorrhagic was fatal, of the other events was unknown. The reporting physician classified the events haemorrhage of digestive tract and shock heamorrhagic as serious (death) and assessed that the events was unrelated to BNT162b2. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: Although the haemorrhage of digestive tract suddenly occurred, no platelets decreased was observed, and embolism was not suspected. Thus, it was considered that the events were unrelated to the vaccination. ; Reporter''s Comments: Although the haemorrhage of digestive tract suddenly occurred, no platelets decreased was observed, and embolism was not suspected. Thus, it was considered that the events were unrelated to the vaccination.; Reported Cause(s) of Death: shock heamorrhagic; Haemorrhage of digestive tract


VAERS ID: 1638641 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-20
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Echocardiogram, Pulmonary embolism, Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Gonarthrosis
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: Blood test; Result Unstructured Data: Test Result:elevated D-dimer; Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before vaccination; Test Date: 20210720; Test Name: echocardiography; Result Unstructured Data: Test Result:right-sided cardiac overload
CDC Split Type: JPPFIZER INC202101071128

Write-up: pulmonary thromboembolism; Thrombosis (including thromboembolism) (with thrombocytopenia only); Thrombosis (including thromboembolism) (with thrombocytopenia only); This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21123827. The patient was a 70-year and 1-month-old female. Age at vaccination was 70-year and 1-month-old. The patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) via an unspecified route of administration on 05Jul2021 as a single dose for COVID-19 immunization. Medical history included diabetes mellitus and gonarthrosis. Body temperature before vaccination was 35.9 degrees centigrade.The patient family history was not reported. Concomitant medications were not reported. Historical Vaccine included the first dose of BNT162b2 (COMIRNATY, Lot# FA4597, Expiration date 31Aug2021) on an unspecified date as a single dose for COVID-19 immunization. On 20Jul2021 at 07:30 (fifteen days after the second vaccination), the patient experienced pulmonary thromboembolism and thrombosis (including thromboembolism) (with thrombocytopenia only). The patient died of pulmonary thromboembolism and thrombosis (including thromboembolism) (with thrombocytopenia only) on 20Jul2021, it was not provided if the autopsy was done. The course of the event was as follows: On 20Jul2021, cardio-respiratory arrest occurred, and an ambulance was called. Adrenaline was given and the patient turned to ROSC (return of spontaneous circulation). Blood test showed elevated D-dimer on 20Jul2021. The finding of echocardiography was right-sided cardiac overload on 20Jul2021. The patient was diagnosed with pulmonary thromboembolism and hospitalized. After that, cardio-respiratory arrest occurred again. On the same day at 13:10, the patient was confirmed dead. The reporting physician classified the event as serious (fatal) and assessed that the causality between the event and BNT162b2 as un-assessable. There was no other possible cause of the event such as any other diseases. The reporting physician did not provide any further comment. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: pulmonary thromboembolism; Thrombosis (including thromboembolism) (with thrombocytopenia only); Thrombosis (including thromboembolism) (with thrombocytopenia only)


VAERS ID: 1638642 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Brain herniation, Brain oedema, Cerebral infarction, Coma scale, Computerised tomogram head, Electrocardiogram, Headache, Malaise, Nausea, Platelet count, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210816; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0-37.9 Centigrade; Comments: from the evening; Test Date: 20210818; Test Name: JCS; Result Unstructured Data: Test Result:300; Comments: on arrival at the hospital; Test Date: 20210818; Test Name: Head CT; Result Unstructured Data: Test Result:extensive cerebral infarction and brain oedema; Comments: Images of extensive cerebral infarction and brain oedema were confirmed in the right cerebral hemisphere.; Test Date: 20210818; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Sinus rhythm with no irregular pulse; Test Date: 20210818; Test Name: Plt; Result Unstructured Data: Test Result:335 x10^3/uL; Comments: no decrease; Test Date: 20210818; Test Name: COVID test; Test Result: Negative ; Comments: COVID test type post vaccination: Unknown
CDC Split Type: JPPFIZER INC202101071293

Write-up: Consciousness disturbed; Cerebral infarction; Brain oedema; Brain herniation; Pyrexia of 37.0-37.9 degrees Centigrade; Malaise; Headache; Queasy; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution (COVAES) and from a contactable physician received via regulatory authority report number is v21123979. A 52-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscular at the age of 52-year-old on 16Aug2021 (Lot Number: FF3622; Expiration Date: 30Nov2021) as single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. The patient underwent a health checkup every year and had no medical history. Body temperature before vaccination was 36.3 degrees centigrade on 16Aug2021. The patient had no family history. There were no concomitant medications. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient previously took the first dose bnt162b2 (COMIRNATY) (Solution for injection, Lot number EY0572, Expiration date: 31Oct2021, Pfizer) on 26Jul2021 at the age of 52-year-old for COVID-19 immunisation. After the first vaccination, the patient had only pain at the injection site and no symptoms such as pyrexia. The patient experienced consciousness disturbed (death, hospitalization) on 18Aug2021 10:00, cerebral infarction (death, hospitalization) on 18Aug2021 , brain oedema (death, hospitalization) on 18Aug2021 , brain herniation (death, hospitalization) on 18Aug2021 , pyrexia of 37.0-37.9 degrees centigrade on 16Aug2021, malaise on 16Aug2021, headache on 16Aug2021, queasy on 16Aug2021. The patient was hospitalized for consciousness disturbed , cerebral infarction, brain oedema, brain herniation from 18Aug2021 to 18Aug2021. The course of the event was as follows: Since the vaccination, the patient was tested negative for COVID-19 on 18Aug2021. COVID test type post vaccination: Unknown. On 18Aug2021 at 10:00 (2 days after the vaccination), the patient experienced consciousness disturbed.On 18Aug2021 (2 days after the vaccination), the patient was admitted to the hospital.On 18Aug2021 (2 days after the vaccination), the outcome of the event was fatal. The event resulted in emergency room/department or urgent care, hospitalization, and death. The outcome of the event was fatal with treatment including infusion management. On 16Aug2021, the patient received the second dose of the COVID-19 vaccine. From the evening of the same day, the patient had pyrexia of 37.0-37.9 degrees centigrade, malaise, headache, and queasy. On 17Aug2021, the symptoms did not change, and the patient was lying down at home. On the same day around 18:00, the patient took antipyretic analgesic (acetaminophen (CALONAL) tablet). On the morning of 18Aug2021 at 07:30, the patient''s wife went to work. When she came home around 18:00, the patient collapsed at home and did not respond to her call; thus, she requested an ambulance. The level of consciousness, Japan Coma Scale (JCS) was 300 on arrival at hospital. The bilateral pupils dilated and glossoptosis were observed. On a head CT, images of extensive cerebral infarction and brain oedema were confirmed in the right cerebral hemisphere. An electrocardiogram showed sinus rhythm with no irregular pulse. A blood test showed no decrease in platelet count (Plt) of 335 x10^3/uL. The patient had already had a brain herniation. On 18Aug2021 at 21:41, the patient died.The reporting physician classified the event as serious (death, hospitalization) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was cerebral infarction. The reporting physician commented as follows: The 52-year-old male patient with no medical history complained of poor physical condition immediately after receiving the COVID-19 vaccine, and he experienced cerebral infarction and died two days after the vaccination. Although no decrease in platelet count was confirmed, it could not be ruled out that the vaccination could affect the occurrence of cerebral infarction.The patient underwent lab tests and procedures which included body temperature: 36.3 centigrade on 16Aug2021 (before vaccination ), body temperature: 37.0-37.9 centigrade on 16Aug2021 (from the evening ), coma scale: 300 on 18Aug2021 (on arrival at the hospital ), computerised tomogram head: Images of extensive cerebral infarction and brain oedema were confirmed in the right cerebral hemisphere on 18Aug2021, electrocardiogram: sinus rhythm with no irregular pulse on 18Aug2021 , platelet count: 335 x10^3/ul on 18Aug2021 (no decrease), SARS-CoV-2 test: negative on 18Aug2021 (Covid test type post vaccination: Unknown). Therapeutic measures were taken as a result of events. Emergency Room Visit and Physician Office Visit for events consciousness disturbed , cerebral infarction, brain oedema, brain herniation. The patient died on 18Aug2021. An autopsy was not performed. The outcome of events pyrexia of 37.0-37.9 degrees centigrade, malaise, headache, and queasy was unknown. The outcome of other events was fatal.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events Altered state of consciousness, Cerebral infarction, Brain oedema, Brain herniation and the suspect drug bnt162b2 cannot be 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: Cerebral infarction; Brain herniation; Brain oedema; Consciousness disturbed


VAERS ID: 1638644 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Pulmonary thrombosis, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (neurology); Hyperlipidaemia (internal medicine); Hypertension (internal medicine); Obsessive-compulsive neurosis (neurology)
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade
CDC Split Type: JPPFIZER INC202101072312

Write-up: the patient was found dead; thrombosis in the lungs and the legs was confirmed; thrombosis in the lungs and the legs was confirmed; This is a spontaneous report from a contactable physician (anatomist) received from the Agency. Regulatory authority report number is v21124142. A 54-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11Aug2021 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) as DOSE 2, SINGLE, at age of 54 years old of vaccination, for covid-19 immunisation. Patient received the first dose of COMIRNATY on unknown date. Body temperature before vaccination was 36.9 degrees Centigrade. The patient family history was not reported. Medical history included epilepsy and obsessive-compulsive neurosis (neurology), and hypertension and hyperlipidaemia (internal medicine). On 14Aug2021 (3 days after the vaccination), the patient was found dead. On 17Aug2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was found dead at his home. After the death, thrombosis in the lungs and the legs was confirmed by autopsy. These examinations for details were ongoing. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. As for other possible causes of the event such as any other diseases, details were unknown because of ongoing examinations after the autopsy, which were being reviewed. The reporting physician commented as follows: The details were unknown at the time of reporting, as this case was under examination. Outcome of events thrombosis in the lungs and the legs was unknown.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1638645 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Cardiac arrest, Electrocardiogram, Epilepsy, Respiratory disorder, Seizure, Ventricular arrhythmia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALEVIATIN [PHENYTOIN]; MYSTAN; ZONISAMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (for which the patient received treatment with the oral medications as an outpatient basis.)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Autopsy imaging; Result Unstructured Data: Test Result:no haemorrhage intracranial; Comments: did not reveal any haemorrhage intracranial, pneumonia, pneumothorax or pleural effusion; Test Date: 20210811; Test Name: electrocardiography; Result Unstructured Data: Test Result:asystole
CDC Split Type: JPPFIZER INC202101073620

Write-up: Ventricular arrhythmia (suspected); epileptic seizure developing with respiratory disorder; epileptic seizure developing with respiratory disorder; asystole; convulsion; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution, and from the Agency via regulatory authority report number v21124147. A 42-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) at single dose intramuscular on 09Aug2021 at 42 year-old for COVID-19 immunisation. Other medical history included epilepsy, for which the patient received treatment with the oral medications as an outpatient basis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received phenytoin (ALEVIATIN), clobazam (MYSTAN), and zonisamide within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. On 15Jul2021, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) intramuscular at 42-year-old for COVID-19 immunization. On 11Aug2021 (2 days after the vaccination), the patient died by ventricular arrhythmia (suspected). The event resulted in Emergency room and urgent care. The course of the event was as follows: On 11Aug2021 (2 days after the vaccination), the patient was thought that he had left to go to the bathroom after taking a nap, but he was developing epileptic seizure. The seizure itself occurred frequently. However, at this time, the symptom developed with respiratory disorder, so emergency medical services were requested. When emergency crews arrived, the pulse was not palpable, and jaw breathing was noted. The initial rhythm was asystole on electrocardiography. While the emergency crews placed an intravenous line and administered adrenaline with cardiopulmonary resuscitation, they arrived at the Emergency room of the reporting physician''s hospital. Without response to the resuscitation, the patient died. Autopsy imaging (AI) did not reveal any haemorrhage intracranial, pneumonia, pneumothorax or pleural effusion. Pyelonephritis was also denied. No abnormal macro findings were noted on the autopsy. Since the vaccination, the patient has not been tested for COVID-19. It was also reported that patient experienced convulsion. The outcome of the event ventricular arrhythmia (suspected) was fatal with treatment including cardiopulmonary resuscitation and administration of adrenaline. Outcome of the other events was unknown. The reporting physician assessed the event ventricular arrhythmia (suspected) as serious (death). Autopsy was performed, and autopsy remarks were unknown. The reporting physician assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was unknown if the vaccination had induced epileptic seizure in this case. (Whether the patient had presented with pyrexia was not clear, and it was also unknown if pyrexia itself had ever acted as an inducer.); Reported Cause(s) of Death: Ventricular arrhythmia (suspected)


VAERS ID: 1638647 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101076073

Write-up: died; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration as dose 1, single for COVID-19 immunization. Medical history included lung cancer. The patient''s concomitant medications were not reported. The patient had lung cancer. Three days after the first dose of COMIRNATY, the reporting physician received information from the patient''s family that the patient''s second vaccination would be canceled because the patient died. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. 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: died


VAERS ID: 1638648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-07-16
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood test, Computerised tomogram, Dyspnoea, Interstitial lung disease, Multiple organ dysfunction syndrome
SMQs:, Anaphylactic reaction (narrow), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANASTROZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer recurrent
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Escherichia coli and gram-negative bacteria; Comments: Escherichia coli and gram-negative bacteria; Test Date: 20210719; Test Name: CT; Result Unstructured Data: Test Result:showed shadow in the lungs, and the patient was di; Comments: showed shadow in the lungs, and the patient was diagnosed with interstitial pneumonia
CDC Split Type: JPPFIZER INC202101076136

Write-up: Multi-organ failure; Blood pressure decreased; Interstitial pneumonia; Difficulty in breathing; This is a spontaneous report from a contactable physician received from a Pfizer sales representative. A 76-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 13Jul2021 (the day of vaccination)as DOSE 1, SINGLE for COVID-19 immunization. Co-suspect medication included oral abemaciclib from 07May2021 for treatment of MBC (metastatic breast cancer). Body temperature before vaccination and family history were not reported. Medical history included hormone-positive HER2-negative recurrent breast cancer. Concomitant medication included anastrozole from 07May2021 for treatment of MBC. On 07May2021, the patient started to be treated with abemaciclib and anastrozole for recurrent breast cancer (treatment of metastatic breast cancer (MBC)). On 13Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2. On 16Jul2021 (3 days after the vaccination), the patient complaining of difficulty in breathing visited a hospital. On 19Jul2021 (6 days after the vaccination), a CT was performed and showed shadow in the lungs, and the patient was diagnosed with interstitial pneumonia. In the reporting physician''s opinion, abemaciclib was a suspected drug for interstitial pneumonia. On the same day, steroid pulse therapy for interstitial pneumonia was started. On 23Jul2021, a ventilator was started due to worsening of the symptoms. On 01Aug2021 (19 days after the vaccination), the patient experienced blood pressure decreased and multi-organ failure, and she died. The physician determined that the direct cause of death was multi-organ failure. Escherichia coli and gram-negative bacteria were detected in the blood. The reporting physician did not classify the events and did not assess the causality between the event and bnt162b2. The patient died on 01Aug2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is 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: Multi-organ failure


VAERS ID: 1638649 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101076592

Write-up: cardiac arrest (when he was found); sudden cardiac death; This is a spontaneous report from a contactable physician. Regulatory authority report number is v21124074. The patient was an 85-year and 3-month-old male. Age at vaccination was 85-year and 3-month-old. Body temperature before vaccination was 36.3 degrees centigrade. The patient family history was not reported. Medical history included prostate cancer. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). On 11Jul2021 at 10:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 12Jul2021 at 09:30 (one day after the vaccination), the patient experienced cardiac arrest (when he was found). On 12Jul2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 12Jul2021 at around 09:30, a citizen saw the patient collapsed at a bench of local bus stop in front of a train station and called an ambulance. After that, it was also reported to the reporter hospital that was located in front of the same train station. Two nurses went to the site and supported. The remarks by the nurses were consciousness level 300, a difference between both pupils, breathing was noted but jaw breathing, weak pulse, cold sweat and urinary incontinence. The ambulance took the patient to advanced emergency hospital, but the death was confirmed at 10:45. The direct cause of death was sudden cardiac death according to the postmortem examination. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had been under the endocrine therapy for prostate cancer, and the general condition was stable. The prognosis was in good condition. Thus it was unlikely that the patient died from that disease.; Reported Cause(s) of Death: sudden cardiac death


VAERS ID: 1638650 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest X-ray, Interstitial lung disease, Oxygen saturation, Pyrexia
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: around 21:00; Test Date: 202106; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0-37.5 Centigrade; Test Date: 20210611; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Pneumonia-like shadow mainly composed of stroma; Test Date: 20210611; Test Name: Saturation; Test Result: 90 %; Comments: decreased
CDC Split Type: JPPFIZER INC202101077514

Write-up: Interstitial pneumonia; pyrexia of 37.5 degrees; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number. The patient was an 82-year-old male. Body temperature before vaccination was 36.5 degrees centigrade. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 04Jun2021 at 12:30 (the day of vaccination), the patient aged 82 received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA5829, Expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 11Jun2021 at 08:30 (6 days and 20 hours after the vaccination), the patient experienced interstitial pneumonia. On 11Jun2021 (7 days after the vaccination), the patient was admitted to the hospital. On 25Jun2021 (21 days after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 04Jun2021 around 21:00 (the day of vaccination), pyrexia of 37.5 degrees centigrade occurred, and he visited the reporting clinic on 07Jun2021. At the time of visit, the patient had no subjective symptoms other than pyrexia, and he was followed up. Afterwards, pyrexia of 37.0-37.5 degrees centigrade persisted and dyspnoea also occurred; thus, the patient visited the clinic on 11Jun2021. At the time of visit, the oxygen saturation had decreased to 90%. A chest X-ray was performed and showed a pneumonia-like shadow mainly composed of the stroma, and the patient was hospitalized. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had not undergone chest X-ray in the past, and the causal relationship with the vaccination was unknown; however, the patient had been taking the dog for a walk every morning until the day of vaccination.; Reported Cause(s) of Death: Interstitial pneumonia


VAERS ID: 1638651 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Urine output, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Gastric cancer (post-operation); Generalised oedema; Operation NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210817; Test Name: urine output; Result Unstructured Data: Test Result:decreased; Test Date: 20210817; Test Name: vital signs; Result Unstructured Data: Test Result:no change
CDC Split Type: JPPFIZER INC202101078228

Write-up: cardio-respiratory arrest; This is a spontaneous report from a contactable physician (inoculator) received from the regulatory authority. Regulatory authority report number is v21124186. A 92-year and 9-month-old female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF2782, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization on 17Aug2021 at 14:25. Age at vaccination was 92-year and 9-month-old. Body temperature before vaccination was 36.6 degrees centigrade. The patient family history was not reported. Medical history included generalised oedema, gastric cancer (post-operation) and chronic cardiac failure. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5295, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17Aug2021 at 17:30 (three hours and five minutes after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: The patient had generalised oedema due to gastric cancer and chronic cardiac failure, but she had been able to take a small amount of food. Symptoms including urine output decreased was noted on the day of vaccination, but no change in vital signs shortly after the vaccination. At 17:30, nurses noticed respiratory arrest when they made the rounds. On 17Aug2021 (the day of vaccination), the outcome of the event was fatal. The reporting physician classified the event as serious (fatal) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were cardiac failure and gastric cancer. The reporting physician commented as follows: the causality to the vaccine was unknown.; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1638718 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-18
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101073592

Write-up: Her father, a healthy, vital man, was fully vaccinated. In April already/ yesterday he died from the consequences of Corona; yesterday he died from the consequences of Corona; This is a Spontaneous report received from a contactable consumer reported for her father. A male patient of unknown age received first dose of BNT162B2 (COMIRNATY) on unknown date, and second dose of BNT162B2 (COMIRNATY) on Apr2021, both at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient, a healthy, vital man, was fully vaccinated. In April already. He had no underlying ailments and yesterday (18Aug2021) he died from the consequences of Corona. The outcome of both events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: yesterday he died from the consequences of Corona; yesterday he died from the consequences of Corona


VAERS ID: 1638730 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210847115

Write-up: DEATH; This spontaneous report received from a consumer via social media (news article) concerned multiple patients of unspecified age, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number unknown, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, multiple patients (4) died, and cause of death was unknown. As per the reporter "This is akin to the case of 4 pilots of airways who died within one week after vaccination (sic)." It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210844178, 20210847165, 20210847179 and 20210847127.; Sender''s Comments: V0: 20210847115-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1638736 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-30
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101079336

Write-up: cough; Unresponsive to stimuli; Difficulty breathing; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300099603. A 63-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 10Jul2021 (Batch/Lot number was not reported) (at the age of 63-year-old) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 30Jul2021, the patient experienced "cough, unresponsive to stimuli, and difficulty breathing", which resulted in hospitalization and death. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cough; Difficulty breathing; Unresponsive to stimuli


VAERS ID: 1640645 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852129

Write-up: UNCONSCIOUS; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300100348] concerned a 49 year old male of unknown race, and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021 05:00, the patient experienced unconscious and died from unconscious. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210852129- covid-19 vaccine ad26.cov2.s -Unconscious. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNCONSCIOUS


VAERS ID: 1640646 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-18
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 2132C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dyspnoea, Headache
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852262

Write-up: DIARRHEA; HEADACHE; DIFFICULTY OF BREATHING; This spontaneous report received from a health care professional via a Regulatory Authority (PHIFDA, PH-PHFDA-300101224) concerned a 39 year old female of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 2132C21A, expiry: unknown) dose was not reported, 1 total administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-AUG-2021 at 11:00, patient experienced and died due to diarrhea, headache and difficulty of breathing. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210852262-COVID-19 VACCINE AD26.COV2.S-diarrhea, headache, difficulty of breathing. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: DIARRHEA; HEADACHE; DIFFICULTY OF BREATHING


VAERS ID: 1640647 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852300

Write-up: CHEST PAIN; CHEST TIGHTNESS; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 67 year old male of unknown race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, at 3:30 pm the patient experienced chest pain and chest tightness. On an unspecified date, the patient died from chest pain, and chest tightness. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). .; Sender''s Comments: V0. 20210852300-covid-19 vaccine ad26.cov2.s -Chest pain, chest tightness.. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: CHEST PAIN; CHEST TIGHTNESS


VAERS ID: 1640649 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-10
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chills, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852346

Write-up: DIFFICULTY OF BREATHING; CHILLS; BACK PAIN; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300101416] concerned a 68 year old male of unspecified ethnic origin and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. It was unknown whether autopsy was performed or not. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, once total administered on 02-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 10-AUG-2021 09:00, the patient experienced chills, back pain and fever. On 19-AUG-2021 18:30, the patient experienced difficulty of breathing. On an unspecified date, the patient died from chills, back pain, fever, and difficulty of breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210852346-COVID-19 VACCINE AD26.COV2.S-Chills,Back pain,Fever,Difficulty of breathing. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: CHILLS; BACK PAIN; FEVER; DIFFICULTY OF BREATHING


VAERS ID: 1640650 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-15
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852446

Write-up: COUGH; This spontaneous report received from a health care professional via a Regulatory Authority concerned an 81 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 15-AUG-2021, the patient experienced cough, and was hospitalized (date and days unspecified). On an unspecified date, the patient died from cough. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough was fatal. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210852446-covid-19 vaccine ad26.cov2.s -Cough. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH


VAERS ID: 1640651 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852520

Write-up: SHORTNESS OF BREATH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA , PH-PHFDA-300100270] concerned a female of unspecified age, race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205C21A, and expiry: Unknown) dose was not reported, 01 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced shortness of breath. On an unspecified date, she died from shortness of breath. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: 20210852520-Covid-19 vaccine ad26.cov2.s-Shortness of breath. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SHORTNESS OF BREATH


VAERS ID: 1640652 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-12
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852611

Write-up: SHORTNESS OF BREATH; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100287] concerned a 57 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-AUG-2021, the patient experienced shortness of breath and cough. On AUG-2021, the patient died from shortness of breath, and cough. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210852611-Covid-19 vaccine ad26.cov2.s- Shortness of breath and cough. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SHORTNESS OF BREATH; COUGH


VAERS ID: 1640654 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-13
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852698

Write-up: Headache; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300100054] concerned a 51 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, at 09:00 hours the patient experienced severe headache and sudden loss of consciousness. On an unspecified date in AUG-2021, the patient died from headache. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210852698-COVID-19 VACCINE AD26.COV2.S-Headache. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEADACHE


VAERS ID: 1640655 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unable to walk
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852739

Write-up: COUGH; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority PH-PHFDA-300101072 concerned a 68 year old male with an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included: stroke, and concurrent conditions included: unable to walk. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported,1 total administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021 at 08:00, the patient experienced cough and fever. On an unspecified date, the patient died from cough, and fever. It was unknown, if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Disability Or Permanent Damage).; Sender''s Comments: V0: 20210852739-Covid-19 vaccine ad26.cov2.s-Cough, Fever. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; FEVER


VAERS ID: 1640660 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 057D21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20212

Write-up: Seizure; Fever; This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) and PYREXIA (Fever) in a 61-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 057D21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion death). On 12-Aug-2021 at 10:00 PM, the patient experienced SEIZURE (Seizure) (seriousness criteria death and medically significant). The patient died on 12-Aug-2021. The reported cause of death was Seizure and Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: Very scant information is available and no further information is expected. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender''s Comments: Very scant information is available and no further information is expected. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: Seizure; Fever


VAERS ID: 1640662 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Body temperature; Result Unstructured Data: Greater than 38 degree Celsius
CDC Split Type: PHPHFDA300099740

Write-up: seizure febrile; Fever greater than 38-degree celsius; This regulatory authority case was reported by an other health care professional and describes the occurrence of FEBRILE CONVULSION (seizure febrile) and PYREXIA (Fever greater than 38-degree celsius) in a 61-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PYREXIA (Fever greater than 38-degree celsius) (seriousness criterion death). On 12-Aug-2021, the patient experienced FEBRILE CONVULSION (seizure febrile) (seriousness criterion death). The patient died on 12-Aug-2021. The reported cause of death was seizure febrile and fever greater than 38-degree celsius. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, Body temperature: greater than 38 degree celsius (High) Greater than 38 degree Celsius. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. This is a case of a 61 year old male patient who died 2 days after receiving the vaccine. Very limited information regarding these events have been provided at this time. Febrile seizures are usually diagnosed in children up to age 7, however , since this is an RA case, it was captured as such. No further information is expected.; Sender''s Comments: This is a case of a 61 year old male patient who died 2 days after receiving the vaccine. Very limited information regarding these events have been provided at this time. Febrile seizures are usually diagnosed in children up to age 7, however , since this is an RA case, it was captured as such. No further information is expected.; Reported Cause(s) of Death: Seizure febrile; Fever greater than 38-degree celsius


VAERS ID: 1640900 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20212

Write-up: Died after getting the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died after getting the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided. The reporter stated that there were limited information on adverse event. Company comment: Extremely limited and second hand information with no validation is give and not further information is expected. based on current available information and the lack of temporal association between product use, if any, and the date and cause of the event a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Extremely limited and second hand information with no validation is give and not further information is expected. based on current available information and the lack of temporal association between product use, if any, and the date and cause of the event a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1641877 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101079876

Write-up: Suspicion of delayed allergic reaction; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-2021000779. A 66-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Jan2021 (Lot Number: EJ6797) at the age of 66-years-old as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced suspicion of delayed allergic reaction on 11Jan2021 (2 days after vaccination) for four days (event''s stop date was reported as: 14Jan2021). The event assessed as life threatening and caused death. The patient died on an unspecified date. It was unknown if an autopsy was performed. Brighton Collaboration Definition Level: unknown. Reaction(s) / Event(s) Assessed by Regulatory Authority, Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hypersensitivity


VAERS ID: 1641909 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D016A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101078969

Write-up: Renal failure; first dose of Comirnaty on 13Apr2021, second dose on 01Jun2021; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory authority, company number DE-PEI-202100166325. A 90-year-old male patient received the second dose of bnt162b2 (COMIRNATY), intramuscular on 01Jun2021 (Batch/Lot Number: 1D016A) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient previously took the first dose of bnt162b2 (COMIRNATY) on 13Apr2021 (lot number: ET304507), intramuscularly at single dose for COVID-19 immunisation. The patient experienced renal failure on 16Jun2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The event causality assessment was reported as Indeterminate. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1641917 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101079345

Write-up: Anterolateral myocardial infarction; bnt162b2 (COMIRNATY), dose 2 on 24Jun2021/dose 1 on 13May2021; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the WEB, regulatory authority number DE-PEI-202100168271. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 24Jun2021 (Lot Number: FD7958) at the age of unknown as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on 13May2021 (Lot Number: EX7823) at the age of unknown for COVID-19 immunization. The patient experienced anterolateral myocardial infarction/ fatal heart attack ca. on 27Jun2021 07:10. The patient died on 27Jun2021. It was unknown if an autopsy was performed. Sender''s comments: Emergency doctor''s visit Relatedness of bnt162b2 to reaction(s)/event (s) assessed by PEI was D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Anterolateral myocardial infarction


VAERS ID: 1641926 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT angiography; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202101079348

Write-up: middle cerebral artery infarct/Left hemispheric, ischaemic medial infarct; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory authority-WEB, regulatory authority number DE-PEI-202100168546. A 70-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 17May2021 (Lot Number: EX8680) at the age of 70-year-old as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on 26Apr2021 (BATCH/LOT number unknown) at the age of 70-year-old for COVID-19 immunization. On 20May2021 the patient experienced middle cerebral artery infarct (left hemispheric, ischaemic medial infarct). The patient was fatal for middle cerebral artery infarct on 25May2021. It was unknown if an autopsy was performed. This report is serious - death, hospitalization, life threatening. Sender Comment: CT Angiography Relatedness of bnt162b2 to reaction(s)/event (s) per Agency assessment was D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: middle cerebral artery infarct/Left hemispheric, ischaemic medial infarct


VAERS ID: 1641980 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-25
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD; Diabetes; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101079314

Write-up: Found dead in bed with foam at the mouth, four weeks after the first Biontech vaccination.; This is a spontaneous report from a consumer. DE-PEI-CADR2021160828, Safety Report Unique Identifier DE-PEI-202100165354. A 72-year-old female patient received 1st dose of BNT162B2 (COMIRNATY) at single dose on 28Apr2021 via an unknown route for COVID-19 immunisation. Medical history included diabetes, osteoporosis, COPD, all ongoing. Patient did not have concerned any known allergies. Concomitant drug was not provided. Serious adverse event was reported as "found dead in bed with foam at the mouth, four weeks after the first Biontech vaccination" with onset date of 25May2021 and seriousness criterion of death. It was reported that patient was actually fit during this period (as of 20Aug2021). Death came unexpectedly. The patient''s outcome was fatal. This report was serious due to death. Assessment: Comirnaty/ Unknown cause of death was D. unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: found dead in bed with foam at the mouth, four weeks after the first Biontech vaccination


VAERS ID: 1641981 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN
Current Illness: Hypertension; Smoker (Smoker for 40 years)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101079310

Write-up: Death temporally related to a COVID-19 vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency-WEB DE-PEI-CADR2021161206, Safety Report Unique Identifier DE-PEI-202100165614. A 54-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 09Jul2021 (Batch/Lot Number: Unknown) at single dose for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing smoker for 40 years. Patient was not concerned known of any allergies. Concomitant medication included candesartan taken for hypertension, start and stop date were not reported. On 18Jul2021 the patient experienced unknown cause of death (death temporally related to a covid-19 vaccination). The deceased was found dead on 18Jul2021 in his apartment, lying on his back on the sofa, found without abnormalities such as rubbing off the mouth and nose. The evening before, had a beer with a friend in a pub until 12.25 a.m. It was not reported if an autopsy was performed. No follow-up attempts is possible. Information on batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1641982 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Cardiac insufficiency; Infarct myocardial; Rheumatics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101078934

Write-up: Renal failure; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory authority-WEB DE-PEI-CADR2021161293, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100165861. A 75-year-old male patient received BNT162B2 (COMIRNATY) on 14May2021 at single dose for COVID-19 immunisation. The patient''s medical history included: Asthma, Cardiac insufficiency, Infarct myocardial, Rheumatics, all ongoing. The patient had No allergies. Concomitant medication was not reported. On 28May2021 the patient experienced Renal failure. The patient died on 28Jun2021 due to Renal failure. The casual relationship between the event Renal failure with Comirnaty was Unclassifiable per Agency. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Renal failure


VAERS ID: 1641984 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-05-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Language disorder, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery; Heart disorder; Heart valve replacement; Lung fibrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101079352

Write-up: Unknown cause of death; Symptoms of paralysis in the arm and speech disorders; Symptoms of paralysis in the arm and speech disorders; This is a spontaneous report from a non-contactable consumer regulatory authority number DE-PEI-CADR2021162823. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100167586. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 27Apr2021 (Lot Number: Unknown) at the age of unknown as single dose for COVID-19 immunization. Medical history included stopped lung fibrosis, stopped heart disorder, stopped bypass surgery, heart valve replacement in 2021. The patient''s concomitant medications were not reported. The patient''s weight was 70 kg, and height was 165 cm. On 01May2021 the patient experienced symptoms of paralysis in the arm and speech disorders. On 08May2021 the patient experienced unknown cause of death. It was unknown if an autopsy was performed. The patient''s outcome was not recovered for palsy and language disorder. Seriousness criteria was hospitalization. Sender Comment: Information on risk factors or previous illnesses included lung fibrosis, heart disease Bypass status (about 10 years ago) currently heart valve. 4 days after the first vaccination (Saturday, 01May2021) patient had symptoms like a stroke, so consumer called the emergency doctor. He decided not to take him to the local hospital but to another hospital, 20 km away, where he had received a new heart valve a few weeks earlier. The attending doctor told consumer on Monday (03May2021) that he had neither had a stroke nor a heart attack. Between the lines consumer heard perplexity. On Wednesday (05May2021) consumer had called him one last time and he had massive problems speaking. Patient passed away on Saturday (08May2021). Relatedness of Comirnaty to all events assessed was D. Unclassifiable. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1641985 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Myocarditis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101078963

Write-up: Infarct myocardial; Myocarditis; This is a spontaneous report from a non-contactable consumer downloaded from the Regualtory Agency-WEB, regulatory authority number DE-PEI-CADR2021162910, Safety Report Unique Identifier DE-PEI-202100167478. A 38-year-old male patient received bnt162b2 (COMIRNATY) (strength: 0.3 ml), via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: Unknown) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced infarct myocardial on an unspecified date, and myocarditis on 01Aug2021. Seriousness reported as death. The patient died on 14Aug2021. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s): Source of assessment: PEI. Result of Assessment: D Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial; Myocarditis


VAERS ID: 1641997 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROMETHAZIN; AMLODIPINE; ZOPICLON; FORADIL; ASS; SIMVASTATIN; ATROVENT; PIPAMPERON; SPIRIVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortocoronary bypass; Apoplexy; Arteriopathy; COPD; Hypertension; Lipid metabolism disorder; Radiation therapy; Reduced general condition (patient in poor general condition, but still drove a car, went shopping); Surgery; Tumor
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101084448

Write-up: Death on 20Jun21, 10 days after the 2nd vaccination/Most likely sudden death; This is a spontaneous report from a contactable physician (patient''s parent) received via Regulatory Authority. A 79-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 10Jun2021 (Lot Number: FC3095) at age of 78-year-old as single dose for covid-19 immunisation. Medical history included Ateriopathy, aortocoronary bypass from 1983, lipid metabolism disorder, hypertension, COPD, condition after left carotid surgery from Oct2015, condition after left apoplexy from Dec2015, status after lung tumor operation on the right from Dec2015, status after radiation 2017, lung tumor in remission (patient in poor general condition, but still drove a car, went shopping)." No Known allergies. Concomitant medications included promethazine hydrochloride (PROMETHAZIN); amlodipine; zopiclone (ZOPICLON); formoterol fumarate (FORADIL); acetylsalicylic acid (ASS); simvastatin; ipratropium bromide (ATROVENT); pipamperone hydrochloride (PIPAMPERON); tiotropium bromide monohydrate (SPIRIVA). The patient previously took bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 12May2021 (Lot Number: EX8680) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced death on 20Jun2021, 10 days after the 2nd vaccination. No treatment received. Death cause: "Found death in the stairwell. Most likely sudden death, without craniocerebral trauma, none fractures". Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. 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: Most likely sudden death


VAERS ID: 1642132 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-24
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Agitation, Asthenia, Blood bicarbonate, Blood creatinine, Blood lactate dehydrogenase, Blood pressure measurement, Body temperature, C-reactive protein, Cell death, Chest X-ray, Coma, Coma scale, Computerised tomogram, Diarrhoea, Dysarthria, Echocardiogram, Electrocardiogram, Electromyogram, Epstein-Barr virus test, Fall, Fatigue, Fibrin D dimer, Gastrointestinal haemorrhage, Guillain-Barre syndrome, Haemoglobin, Hallucination, visual, Hepatic function abnormal, Hypotension, Infective aneurysm, Investigation, Ischaemic stroke, Microbiology test, PCO2, PO2, Pneumonia, Polyneuropathy, Positron emission tomogram, Prothrombin level, Pyelonephritis acute, Pyrexia, Renal function test, Respiratory failure, Speech disorder, Transaminases, Troponin, Ultrasound abdomen, pH body fluid
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 51
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KOMBOGLYZE; METFORMIN; KARDEGIC; APROVEL; REPAGLINIDE; BISOPROLOL; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia; Hypertension arterial (associated with hypertrophic heart disease); Hypertrophic heart disease; Non-insulin-dependent diabetes mellitus; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: basemia; Result Unstructured Data: Test Result:20 mmol/L; Test Date: 20210531; Test Name: creatinine; Result Unstructured Data: Test Result:8 mg/l; Test Date: 20210614; Test Name: creatinine; Result Unstructured Data: Test Result:14 mg/l; Test Date: 20210531; Test Name: Lactatemia; Result Unstructured Data: Test Result:2.5 mmol/L; Comments: 2.5, is high; Test Date: 20210616; Test Name: blood pressure; Result Unstructured Data: Test Result:low; Test Date: 20210531; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210614; Test Name: cytolysis; Result Unstructured Data: Test Result:Downward cytolysis, 20% prothrombin level with low; Comments: Downward cytolysis, 20% prothrombin level with low factor V.; Test Date: 20210614; Test Name: Chest x-ray; Result Unstructured Data: Test Result:Dulling of the right cul-de-sac; Comments: Dulling of the right cul-de-sac; Test Date: 20210531; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:15/15; Test Date: 20210607; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:03/15; Comments: 03/15; Test Name: injected skull computed tomography; Result Unstructured Data: Test Result:unknown results; Comments: unknown results; Test Date: 20210531; Test Name: CRP; Result Unstructured Data: Test Result:186 mmHg; Test Name: CRP; Result Unstructured Data: Test Result:50 mg/l; Test Date: 20210401; Test Name: stress ultrasound; Result Unstructured Data: Test Result:normal; Test Date: 20210531; Test Name: ECG; Result Unstructured Data: Test Result:RRS at 90 cpm with an undershift of ST in lower; Test Date: 20210605; Test Name: ECG; Result Unstructured Data: Test Result:without modification; Test Date: 20210611; Test Name: electromyogram; Result Unstructured Data: Test Result:major damage to all 4 limbs, with total abolition; Comments: major damage to all 4 limbs, with total abolition of neurological activity; Test Date: 20210618; Test Name: electromyogram; Result Unstructured Data: Test Result:signs of axonal degeneration which already confirm; Comments: signs of axonal degeneration which already confirms the peripheral involvement; Test Date: 20210622; Test Name: EBV PCR; Result Unstructured Data: Test Result:Positive EBV PCR with low viral load; Comments: Positive EBV PCR with low viral load; Test Date: 20210531; Test Name: D-Dimers; Result Unstructured Data: Test Result:3400 ug/L; Test Date: 20210615; Test Name: hemoglobin; Result Unstructured Data: Test Result:Stable hemoglobin with a hematoma on the inner sid; Comments: Stable hemoglobin with a hematoma on the inner side of the right thigh; Test Date: 20210606; Test Name: examination; Result Unstructured Data: Test Result:Discovery of an addition image on the mitral valve; Comments: Discovery of an addition image on the mitral valve: Infectious endocarditis? (But no breath, no growing HC). Isolated dysarthria without other signs of focusing: ischemic stroke? Mycotic aneurysm?; Test Date: 20210609; Test Name: examination; Result Unstructured Data: Test Result:Motor deficit of the 4 limbs, osteotendinous refle; Comments: Motor deficit of the 4 limbs, osteotendinous reflex abolished in the 4 limbs, Indifferent plantar skin reflex. Persistent motor deficit. Sphincteric atony. Apyretic under Tazocillin in probabilistic treatment without microbiological documentation; Test Date: 20210614; Test Name: examination; Result Unstructured Data: Test Result:Still quadriplegic, osteotendinous reflex absent,; Comments: Still quadriplegic, osteotendinous reflex absent, Plantar skin reflex indifferent. Grimaces at the stimulation but without opening the eyes on demand without direct contact with it. Respiratory: Increase in O2 requirements to 50% associated with a drop in its P / F ratio at 170 pulmonary artery: Some crackles at the level of the right base; Test Date: 20210625; Test Name: examination; Result Unstructured Data: Test Result:preserved diuresis, quadriplegic; opens eyes on de; Comments: preserved diuresis, quadriplegic; opens eyes on demand, pseudomonas on bronchial aspiration.; Test Date: 20210606; Test Name: Bacteriological samples; Result Unstructured Data: Test Result:cytobacteriological examination of sputum; Escheri; Comments: cytobacteriological examination of sputum; Escherichia coli bacterial translocation; Legionella antigenuria + Pneumococcus; several blood culture series; Test Date: 20210531; Test Name: pCO2; Result Unstructured Data: Test Result:28 mmHg; Test Date: 20210605; Test Name: pCO2; Result Unstructured Data: Test Result:48 mmHg; Test Date: 20210605; Test Name: ph; Result Unstructured Data: Test Result:7.32; Test Date: 20210531; Test Name: PaO2; Result Unstructured Data: Test Result:69 mmHg; Test Date: 20210621; Test Name: PET scan; Result Unstructured Data: Test Result:no signs of endocarditis, liver abscess or neoplas; Comments: no signs of endocarditis, liver abscess or neoplastic aetiology; Test Date: 20210614; Test Name: prothrombin level; Test Result: 20 %; Test Date: 20210621; Test Name: prothrombin level; Result Unstructured Data: Test Result:improvement %; Comments: improvement; Test Date: 20210531; Test Name: Renal function; Result Unstructured Data: Test Result:normal; Comments: normal; Test Date: 20210621; Test Name: transaminase; Result Unstructured Data: Test Result:improvement; Comments: improvement; Test Date: 20210605; Test Name: troponinemia; Result Unstructured Data: Test Result:626 ng/L; Test Date: 20210612; Test Name: Abdominal echo; Result Unstructured Data: Test Result:effusion +++; Comments: effusion +++
CDC Split Type: FRPFIZER INC202101079532

Write-up: Guillain Barre syndrome; double respiratory and neurological failure; polyradiculoneuropathy; acute right pyelonephritis; digestive bleeding melena-like; low blood pressure; Sudden deterioration of liver function; coma around 8 a.m. with a Glasgow coma scale at 03/15 with pupils on IRS; pneumonia/Treatment-associated infectious lung disease; dysarthria; ischemic stroke; Mycotic aneurysm; agitation; visual hallucinations; hemodynamic acute lung edema; febrile patient (40 centrigrade); profuse diarrhea; speech disorders; fatigue; asthenia; fall; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LL20215565. A 75-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 01May2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included dyslipidaemia, Arterial hypertension associated with hypertrophic heart disease (last stress ultrasound on 01Apr2021 normal), Non-insulin dependent type 2 diabetes and Moderate obesity (BMI 35). Concomitant medication(s) included metformin hydrochloride, saxagliptin hydrochloride (KOMBOGLYZE); metformin; acetylsalicylate lysine (KARDEGIC); irbesartan (APROVEL); repaglinide; bisoprolol; atorvastatin. On 24May2021, the patient experienced fall. Since 28May2021, the patient experienced speech disorders with fatigue and asthenia. From 29May2021: profuse diarrhea. On 31May2021: febrile patient (40 centrigrade), well aware with a GCS at 15/15 with absence of motor deficit, stable on the hemodynamic plan, ECG which performs an RRS at 90 cpm with an undershift of ST in lower. Shunt effect with pCO2 at 28 mmHg with PaO2 at 69 mmHg with basemia at 20 mmol / l. Lactatemia is high at 2.5 mmol / l, biological inflammatory syndrome (CRP at 186 mmHg). D-Dimers are increased to 3400 ug / l. Renal function is normal with a creatinine level of 8 mg / l. 31May2021 to 06Jun2021 : hospitalization in Nephrology for the management of acute right pyelonephritis: favorable outcome under Cefotaxime with a stable CRP at 50 mg / L but the patient has persistent speech disorders. During the night of 05Jun to 06Jun: episode of agitation with visual hallucinations and tears off her peripheral passages. Increase in its oxygen requirements up to 6 l / min with the appearance of signs of struggle and a gas measurement which reveals respiratory acidosis: pH: 7.32 with a capnia at 48 mmHg. The diagnosis of hemodynamic acute lung edema is suspected and the patient is placed on Furosemide self-pushing syringe with a good response to the diuresis but without impact on her hematosis. To note first troponinemia point at 626 ng / l without modification on the ECG. 06Jun2021: transfer to intensive care. Mixed respiratory distress (hypercapnic and hypoxaemic), the origin of which remains to be determined. Treatment-associated infectious lung disease is not ruled out. Discovery of an addition image on the mitral valve: Infectious endocarditis? (But no breath, no growing blood culture). Isolated dysarthria without other signs of focusing: ischemic stroke? Mycotic aneurysm? Support: Monitoring. Non-invasive ventilation alternating high flow nasal oxygen. Bacteriological samples: cytobacteriological examination of sputum; Escherichia coli bacterial translocation; Legionella antigenuria + Pneumococcus; several blood culture series. In front of dysarthria: injected skull computed tomography + lumbar puncture. Assessment of the extension of a probable AE: Angio-crane. injected thoraco-abdomino-pelvic tomodensitometry done on 31May. Provide transesophageal echocardiography. Decision to put on antibiotic therapy for pneumonia associated with care and for AE: TAZOCILLIN + OXACILLIN. 07Jun2021: Patient presented with a coma around 8 a.m. with a Glasgow coma scale at 03/15 with pupils on IRS. Knowing that the patient was kept on non-invasive ventilation overnight and that on stopping non-invasive ventilation at 6.30 am, she is conscious with correct gas measurements. Orotracheal intubation with induction of KETAMINE / ESMERON. Day 1 of hospitalization for double respiratory and neurological failure requiring the use of mechanical ventilation. On Tazocillin 4gx3 with Oxacillin stop. 09Jun2021: Stop sedations, open and close the eyes on demand. Motor deficit of the 4 limbs, osteotendinous reflex abolished in the 4 limbs, Indifferent plantar skin reflex. Persistent motor deficit. Sphincteric atony. Apyretic under Tazocillin in probabilistic treatment without microbiological documentation. 10Jun2021: diagnostic research. 12Jun2021: Sudden deterioration of liver function: introduction of proton pump inhibitor + SANDOSTATIN and stabilization of coagulation. Abdominal echo: effusion +++ 14Jun2021: Still quadriplegic, osteotendinous reflex absent, Plantar skin reflex indifferent. Grimaces at the stimulation but without opening the eyes on demand without direct contact with it. Under Eupressyl in a self-pushing syringe. The patient presented a digestive bleeding melena-like on Saturday and Sunday associated with a deglobulization requiring the use of transfusions of 4 red blood cells and 6 fresh frozen plasma. Respiratory: Increase in O2 requirements to 50% associated with a drop in its P / F ratio at 170 pulmonary artery: Some crackles at the level of the right base. Chest x-ray: Dulling of the right cul-de-sac. Renal function improving creatinine at 14 mg / l. Downward cytolysis, 20% prothrombin level with low factor V. 15Jun2021: Stable under Eupressyl in a self-pushing syringe, urine output preserved without signs of peripheral hypo perfusion. Introduction of bisoprolol at low dose 1.25 mg / D. Stable hemoglobin with a hematoma on the inner side of the right thigh. Faced with hemostasis disorders =$g Decision to start treatment with immunoglobulins rather than plasma exchanges. 16Jun2021: beta-blockers reintroduced at a dose of 1.25 mg / day, Eupressyl stopped. She presented low blood pressure during the call, hence an LR per 1000 ml of RL (Ringer''s solution). 17Jun2021: Main hypothesis: Acute hepatic ischemic phenomenon (on low flow or emboli) with hepato-cellular insufficiency in the process of improvement. On 18Jun2021: electromyogram: signs of axonal degeneration which already confirms the peripheral involvement. Interest of doing a second course of immunoglobulins in 15 days. electromyogram carried out on 11Jun which shows major damage to all 4 limbs, with total abolition of neurological activity. 21Jun2021: Day 22 of hospitalization for management of Guillain-Barre syndrome of undetermined post-infectious cause? Post-vaccination? She had to date a PET scan showing no signs of endocarditis, liver abscess or neoplastic aetiology. For hepatocellular insufficiency there is an improvement in factor V, TP, transaminase. 22Jun2021: Positive EBV PCR with low viral load. Still dependent on ventilation, situation Confirmed polyradiculoneuropathy, severe damage, risk of not recovering totally. Liver improvement, 25Jun2021: probable adrenal insufficiency, preserved diuresis, quadriplegic; opens eyes on demand, pseudomonas on bronchial aspiration. 14Jun2021: death of the patient. Further examinations and results/ other evaluated etiologies: Polyradiculoneuritis post Covid vaccine or post infectious syndrome (fever at 40 centigrade, high CRP)? The outcome of polyradiculoneuropathy was fatal, others was unknown. The patient died on 14Jul2021. It was unknown if the autopsy done. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: polyradiculoneuropathy


VAERS ID: 1642138 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214011 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SEROPLEX
Current Illness: Depression; Early menopause; Tabaquism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Ischemic stroke; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-LY20218616) on 20-Aug-2021 and was forwarded to Moderna on 20-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (Ischemic stroke) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214011) for COVID-19 vaccination. Concurrent medical conditions included Depression, Tabaquism and Early menopause. Concomitant products included ESCITALOPRAM OXALATE (SEROPLEX) for an unknown indication. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced ISCHAEMIC STROKE (Ischemic stroke) (seriousness criteria death and medically significant). The patient died on 28-Jul-2021. The reported cause of death was avc isch?mique. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication also includes Seroplex. Treatment information was not provided by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: AVC isch?mique


VAERS ID: 1642141 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-30
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Generalised oedema, Restlessness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified; Osteoarthritis; Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101088636

Write-up: Cardiac arrest; generalized edema; restlessness; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LY20219784. A 66-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: unknown), via intramuscular on 18May2021 at single dose for COVID-19 immunisation. Medical history included unspecified heart disease, osteoarthritis, rheumatism. The patient had no COVID history. The patient''s concomitant medications were not reported. On 30May2021, the patient''s daughter noted generalized edema, restlessness. No medical consultation. On 01Jun2021, patient found deceased at home by her family around 18:00. Patient''s daughter indicated a death by cardiac arrest which would have occurred on the night of 31May2021 to 01Jun2021 between 21:30 and 06:00. The colleague of the general practitioner was contacted again; the last consultation dates back to Mar2021, for reasons of fatigue. Her daughter had no information to say whether the heart disease was stable or not. Cardiac arrest stop date was reported as 01Jun2021. Severity criterion was death. The patient died on 01Jun2021. It was not reported if an autopsy was performed. The outcome of event cardiac arrest was fatal. The outcome of events generalized edema and restlessness was unknown. In total, 66-year-old patient with a history of heart disease, found dead at home on day 15 post BNT162B2 vaccination.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1642143 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin G, Body temperature, COVID-19, Computerised tomogram, Extra dose administered, Investigation, Off label use, Oxygen saturation, SARS-CoV-2 test, Serology test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 89
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RITUXIMAB; TAMSULOSIN HYDRCHLORIDE; TELMISARTAN; CALCIDOSE VITAMINE D; RINOCLENIL; ONBREZ BREEZHALER; KARDEGIC; MESTINON RETARD; MESTINON
Current Illness: Arterial hypertension; Benign prostatic hypertrophy; COPD; Effort angina; Myasthenia gravis; Sleep apnea syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Overweight; Oxygen therapy; Respiratory failure
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: IgG; Result Unstructured Data: Test Result:8.12; Test Date: 20210810; Test Name: body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Comments: Hyperthermia; Test Date: 20210810; Test Name: CT scan; Result Unstructured Data: Test Result:suggestive of Covid-19 pneumonia; Comments: with extensive involvement of the anomalies; Test Name: Characterization of the virus; Result Unstructured Data: Test Result:Variant unrealized; Test Date: 20210810; Test Name: Oxygen saturation; Test Result: 90 %; Comments: ambient air saturation; Test Date: 20210811; Test Name: Oxygen saturation; Test Result: 88 %; Comments: Oxygenation at 6l / min; Test Date: 20210812; Test Name: Oxygen saturation; Test Result: 88 %; Test Date: 20210802; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210811; Test Name: serology; Result Unstructured Data: Test Result:Antibodies againts SARS COv 2
CDC Split Type: FRPFIZER INC202101088632

Write-up: Covid-19 confirmed by positive PCR test; Covid-19 confirmed by positive PCR test; off label use; Extra dose administered; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-MP20216551. A 72-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: unknown) on 03Mar2021, the second dose of BNT162B2 (lot number: unknown) on 31Mar2021 and the third dose of BNT162B2 (lot number: unknown) on 17May2021, all doses via intramuscular at single dose for COVID-19 immunisation. Medical history included ongoing autoimmune myasthenia gravis, ongoing post-smoking chronic obstructive pulmonary disease (COPD), ongoing stress angina, ongoing arterial hypertension, ongoing obstructive sleep apnea syndrome supported with device, ongoing benign prostatic hypertrophy, overweight and respiratory failure under home oxygen therapy. Concomitant medications included rituximab at 1 injection every 6 months via intravenous taken for autoimmune myasthenia gravis; tamsulosin hydrochloride (TAMSULOSIN HYDRCHLORIDE, formulation: capsule) at 0.4 mg, daily orally taken for benign prostatic hypertrophy; telmisartan (formulation: tablet) at 80 mg, daily orally taken for arterial hypertension; calcium carbonate, colecalciferol (CALCIDOSE VITAMINE D, formulation: powder for oral solution) at 1 DF, daily orally taken for osteoporosis prophylaxis; beclometasone dipropionate (RINOCLENIL, formulation: nasal spray, suspension, strength: 100 ug) at 1 DF, freq:12 h via nasal taken for unspecified indication; indacaterol maleate (ONBREZ BREEZHALER, formulation: inhalation powder) at 1 DF, daily via resp inhalation taken for COPD; acetylsalicylate lysine (KARDEGIC, formulation: powder for oral solution, strength: 75 mg) at 75 mg, daily orally taken for an unspecified indication; pyridostigmine bromide (MESTINON RETARD, formulation: prolonged-release tablet, strength: 180 mg) at 180 mg, daily orally taken for autoimmune myasthenia gravis; pyridostigmine bromide (MESTINON, formulation: coated tablet, strength: 60 mg) at 60 mg, freq:8 h orally taken for autoimmune myasthenia gravis. The patient experienced COVID-19 confirmed by positive PCR test on 02Aug2021. The patient was hospitalized for COVID-19 confirmed by positive PCR test from 10Aug2021. The patient also experienced off label use and extra dose administered on 17May2021. The main clinical signs were as follows: On 30Jul2021, the patient was asthenic. On 02Aug2021, PCR positive, increase in asthenia with deterioration of general condition. On 10Aug2021, emergency consultation for dyspnea, cough and breathing difficulties, 90% ambient air saturation. Right pulmonary focus on auscultation, fine crackling of the two bases. Put under oxygen 3l / min. Hyperthermia at 38.9 ? C. Hospitalization in covid service. CT scan suggestive of COVID-19 pneumonia with extensive involvement of the anomalies. On 11Aug2021, oxygenation at 6l / min, saturation at 88%. On 12Aug2021, switching to optiflow, saturation at 88%. Hospitalization in intensive care. Immune plasma treatment started. Serology showed antibodies againts SARS COv 2. IgG: 8.12. On 13Aug2021, significant deterioration of the respiratory state, decision not to intubate in view of the patient''s comorbidities. On 14Aug2021, the patient experienced death. Characterization of the virus: Variant unrealized. The patient died on 14Aug2021. It was not reported if an autopsy was performed. The outcome of events COVID-19 confirmed by positive PCR test was fatal. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Covid-19 confirmed by positive PCR test; Covid-19 confirmed by positive PCR test


VAERS ID: 1642147 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholesteatoma; Epilepsy; Fracture multiple; Rhabdomyolysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Rhabdomyolysis; This case was received via regulatory authority (Reference number) on 20-Aug-2021 and was forwarded to Moderna on 20-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis) in a 33-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Epilepsy, Fracture multiple, Cholesteatoma and Rhabdomyolysis. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criteria death and medically significant). The patient died on 12-Aug-2021. The reported cause of death was d?faillance multivisc?rale. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment medications was not provided. This is a case of death in a 33-year-old male subject, with a history of Epilepsy, Fracture multiple, Cholesteatoma and Rhabdomyolysis who died 4 days after receiving first dose of vaccine due to multiorgan failure. Very limited information has been provided at this time.; Sender''s Comments: This is a case of death in a 33-year-old male subject, with a history of Epilepsy, Fracture multiple, Cholesteatoma and Rhabdomyolysis who died 4 days after receiving first dose of vaccine due to multiorgan failure. Very limited information has been provided at this time.; Reported Cause(s) of Death: d?faillance multivisc?rale


VAERS ID: 1642465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Brain abscess, Lymphadenopathy, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 88
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioma; Difficulty breathing; Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021526437

Write-up: severe sore throat, enlargement of the lymph nodes in the shoulder and angioma which she has in her tongue since birth; severe sore throat, enlargement of the lymph nodes in the shoulder and angioma which she has in her tongue since birth; brain abscess; This is a spontaneous report from a contactable consumer, downloaded from the Regulatory Agency-WEB, Regulatory authority number: IT-MINISAL02-725354. An 80-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in the right arm on 14Apr2021 (Batch/Lot Number: Unknown) as dose 2, single for Covid-19 immunisation. Medical history included congenital angioma, difficulty breathing and pollen allergy. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, on an unknown date (Batch/Lot Number: Unknown) as dose 1, single for Covid-19 immunisation. On 15Apr2021, the patient had a severe sore throat, enlargement of the lymph nodes in the shoulder and angioma which she has in her tongue since birth. On 03Aug2021, the reporter communicated the patient''s death on 12Jul2021 due to brain abscess on an unspecified date in 2021; clinical documentation was requested. Therapeutic measures were taken as a result of the events severe sore throat, enlargement of the lymph nodes in the shoulder and angioma which she has in her tongue since birth. The outcome of the events was fatal. The patient died on 12Jul2021. It was unknown if an autopsy was performed. Reporter''s Comment: Enlargement of the congenital angioma located in the tongue with consequent difficulty breathing. Sore throat and swollen lymph nodes in the shoulder. Eliquis treated fibrillant patient. History of pollen and parietary allergies. Sender Comment: 03Aug2021 update on the case: the reporter communicated the patient''s death on 12 July 2021 due to brain abscess. 03Aug2021 clinical documentation was requested by e-mail. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected. Follow-up (09Aug2021): New information received from a contactable consumer includes patient data (death details), clinical course details. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.*; Reporter''s Comments: Enlargement of the congenital angioma located in the tongue with consequent difficulty breathing. Sore throat and swollen lymph nodes in the shoulder. Eliquid treated fibrillant patient History of pollen and parietary allergies.; Reported Cause(s) of Death: brain abscess


VAERS ID: 1642520 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-06-04
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2241 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Pulmonary embolism
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101079589

Write-up: Pulmonary embolism one month after the 2nd dose of the vaccine Pfizer; ended up in a coma and died after another 2 weeks; Pulmonary embolism one month after the 2nd dose of the vaccine Pfizer; ended up in a coma and died after another 2 weeks; This is a spontaneous report from a contactable consumer or other non HCP. The regulatory authority report number is IT-MINISAL02-772025. An 87-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 04May2021 (lot: EW2241) as single dose in left shoulder for COVID-19 immunisation. Medical history included Alzheimer''s disease. Concomitant medications were not reported. Pulmonary embolism on 04Jun2021 one month after the 2nd dose of the vaccine Pfizer; ended up in a coma on 04Jun2021 and died after another 2 weeks. On the basis of what has been indicated, the date of administration has been changed, which relates to the second dose of vaccine. Impact on quality of life (10/10). Intensive therapy for 3 days; discharged. Attached to an oxygen cylinder and forced to a Total parenteral nutrition. It was unknown if Autopsy Done. The outcome of the event was fatal. Reporter comments: Alzheimer''s disease Sender comments: On the basis of what has been indicated, the date of administration has been changed, which relates to the second dose of vaccine. The GP is contacted for any clinical report. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Alzheimer''s disease; Reported Cause(s) of Death: Embolism lung; Coma


VAERS ID: 1642525 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-16
Onset:2021-05-15
   Days after vaccination:516
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Asthenia, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Death, Decreased appetite, Hypokinesia, Malaise, Myalgia, Pneumonia, Rhabdomyolysis, Urine chromium increased
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-20
   Days after onset: 36
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Alcoholic cirrhosis; Carotid artery disease; Carotid artery stenosis; Chronic ischemic heart disease, unspecified; Recovered smoker
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:in the norm; Test Date: 20210114; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:117; Test Date: 20210515; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:31782
CDC Split Type: ITPFIZER INC202101089092

Write-up: Rhabdomyolysis; Acute kidney failure; nosocomial pneumonia; Hyperchromic urine; Died on 20Jun2021; CPK 31782; Progressive Myalgia; Asthenia; Loss of appetite; Malaise; Motor slowdown; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB IT-MINISAL02-772619 received via regulatory authority. A 73-year-old male patient received first dose of BNT162B2 (COMIRNATY), intramuscularly on 05May2021 15:57 (lot number: FA5831, expiration date 31Aug2021) as 0.3 mL, single dose for COVID-19 immunization; atorvastatin calcium (TORVAST, Film-coated tablet), orally from 16Dec2019 to 15May2021 at 80 mg once a day for tight carotid stenosis. Medical history included alcoholic cirrhosis from 01Jan2019, carotid vasculopathy with tight stenosis, chronic ischemic heart disease in high-dose statin therapy, well tolerated, since 2019, annually monitored the CPK(creatine phosphokinase) always in the norm. Recovered smoker, Alcohol use from 01Jan1990. Concomitant medications were not reported. On 15May2021, the patient experienced progressive myalgia, asthenia, loss of appetite, malaise, motor slowdown, CPK (creatine phosphokinase) 31782, Hospitalization for rhabdomyolysis and acute kidney failure, nosocomial pneumonia, hyperchromic urine. Patient died on 20Jun2021. An autopsy was not carried out. Lab data also included 14Jan2021 CPK value 117. The action taken for atorvastatin calcium was permanently withdrawn on 15May2021. The outcome of event died was fatal, outcome of other events were unknown.; Reported Cause(s) of Death: Died


VAERS ID: 1642529 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-20
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin G, COVID-19, Immunology test, SARS-CoV-2 test, Serology test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: IgG; Result Unstructured Data: Test Result:2019; Comments: BAU/ml; Test Name: chemiluminescent immunoassay (CLIA); Result Unstructured Data: Test Result:Unknown results; Comments: chemiluminescent immunoassay (CLIA) for anti-SARS-CoV-2 IgG detection (anti-spike protein antibodies).; Test Date: 20210320; Test Name: rapid antigenic nasopharyngeal swabs; Test Result: Positive ; Comments: SARS-CoV-2 positivity; Test Date: 20210320; Test Name: serological; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: ITPFIZER INC202101082136

Write-up: SARS-CoV-2 positivity; SARS-CoV-2 positivity; This is a literature report. This author reported similar events for ten patients. This is the second of ten reports. A 96-year-old patient of an unspecified gender received two doses of BNT162b2 mRNA COVID-19 vaccine (Comirnaty, between January and early February 2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced sars-cov-2 positivity on 20Mar2021. Symptoms: Fever; Dyspnea; Inappetence; Asthenia; Muscle pain; Symptom Onset Date 22Mar2021. The patient underwent lab tests and procedures which included IgG: 2019 BAU/ml on 20Mar2021, chemiluminescent immunoassay (CLIA) for anti-SARS-CoV-2 IgG detection (anti-spike protein antibodies): unknown results, serological: unknown results on 20Mar2021, rapid antigenic nasopharyngeal swabs: SARS-CoV-2 positivity on 20Mar2021. The action taken in response to the event for bnt162b2 was not applicable. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, patients old age and other underlying medical conditions cannot be ruled out in the contributory role 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.,Linked Report(s) : IT-PFIZER INC-202101081971 Same Article/Event/Suspect and Different Patient; Reported Cause(s) of Death: SARS-CoV-2 positivity; SARS-CoV-2 positivity


VAERS ID: 1642530 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-26
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin G, COVID-19, Immunology test, SARS-CoV-2 test, Serology test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: IgG; Result Unstructured Data: Test Result:559; Comments: BAU/ml; Test Name: chemiluminescent immunoassay (CLIA); Result Unstructured Data: Test Result:Unknown results; Comments: chemiluminescent immunoassay (CLIA) for anti-SARS-CoV-2 IgG detection (anti-spike protein antibodies).; Test Date: 20210326; Test Name: rapid antigenic nasopharyngeal swabs; Test Result: Positive ; Comments: SARS-CoV-2 positivity; Test Date: 20210326; Test Name: serological; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: ITPFIZER INC202101082158

Write-up: sars-cov-2 positivity; sars-cov-2 positivity; This is a report from the Vaccines. 2021, vol: 9 (8), DOI 10.3390/vaccines9080859 entitled An Outbreak of COVID-19 among mRNA-Vaccinated Nursing Home Residents. This author reported similar events for ten patients. This is the fifth of ten reports. A 90-year-old patient of an unspecified gender received two doses of BNT162b2 mRNA COVID-19 vaccine (Comirnaty, BioNTech Manufacturing GmbH) between January and early February 2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced sars-cov-2 positivity on 26Mar2021. Symptoms: Fever; Cough; Dyspnea; Asthenia; Symptom Onset Date 29Mar2021. The patient underwent lab tests and procedures which included IgG: 559 BAU/ml on 26Mar2021, chemiluminescent immunoassay (CLIA) for anti-SARS-CoV-2 IgG detection (anti-spike protein antibodies): unknown results, serological: unknown results on 26Mar2021, rapid antigenic nasopharyngeal swabs: SARS-CoV-2 positivity on 26Mar2021. The action taken in response to the event for bnt162b2 was not applicable. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However patient old age and other underlying factors cannot be ruled out in the contributory role 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.,Linked Report(s) : IT-PFIZER INC-202101081971 Same Article/Event/Suspect and Different Patient; Reported Cause(s) of Death: sars-cov-2 positivity; sars-cov-2 positivity


VAERS ID: 1642607 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-08-19
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Computerised tomogram, Electrocardiogram, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PREDONINE [PREDNISOLONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery (for lung cancer); Diabetes mellitus; Hypertension; Lung cancer; Old cerebral infarction (old)
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: CT; Result Unstructured Data: Test Result:ground glass opacity of both lungs; Test Date: 20210820; Test Name: CT; Result Unstructured Data: Test Result:severe emphysema image and infiltrative shadow of; Comments: severe emphysema image and infiltrative shadow of both lungs, mainly in the left lung lower lobe, and metal-clips-like shadow that was estimated as post right lung lower lobectomy; Test Date: 20210819; Test Name: electrocardiogram; Result Unstructured Data: Test Result:asystole; Comments: on arrival of the rescue crews; Test Date: 20210819; Test Name: PCR with nasopharyngeal swab; Test Result: Positive ; Comments: CT value 23.5
CDC Split Type: JPPFIZER INC202101083071

Write-up: Chronic obstructive pulmonary disease; COVID-19 positive/the doubt of pneumonia associated with novel coronavirus infection; COVID-19 positive/the doubt of pneumonia associated with novel coronavirus infection; This is a spontaneous report from the contactable postmortem examination physician received from the Regulatory authority. Regulatory authority report number is v21124412. The patient was a 72-year-old male. Age at vaccination was 72-year-old. Body temperature before vaccination and the patient family history were not reported. Medical history included hypertension, diabetes mellitus, old cerebral infarction (details about medication taken was unknown), lung cancer and lung cancer surgery. After the lung cancer surgery, recently the patient had been under chemotherapy with pembrolizumab (KEYTRUDA), but it was ceased because the patient developed drug-induced lung disorder. Then he was prescribed a steroid drug (prednisolone (PREDONINE)). It was unknown what was written about underlying diseases on the screening questionnaire. Concomitant drug was prednisolone (PREDONINE). On 18Jun2021, the patient received the first dose of BNT162b2 (COMIRNATY) at single dose, for COVID-19 immunization. The manufacturer was estimated as Pfizer because it was three weeks until the second dose. On 09Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. On 19Aug2021 at unspecified time (about one and a half months after the second vaccination), the patient experienced the doubt of pneumonia associated with novel coronavirus infection, and experienced chronic obstructive pulmonary disease on an unspecified date. On 19Aug2021 (about one and a half months after the second vaccination), the outcome of the events the doubt of pneumonia associated with novel coronavirus infection was fatal, outcome of the event chronic obstructive pulmonary disease was unknown. The course of the event was as follows: From the daytime to the evening on 19Aug2021, the patient was out with the wife. When they returned home, he complained of the symptoms including sweating, complexion ill and dyspnoea, and it took about one hour to move from their car to the living room on the second floor. The patient had a lie-down and rest, but after a short time, began to snore. Because he did not answer to name call, an ambulance was called. On arrival of the rescue crews, the electrocardiogram showed asystole. The heart beat again at some point, but the patient died at 21:59. There appeared to be no information about upper respiratory symptoms or pyrexia. However, polymerase chain reaction (PCR) with nasopharyngeal swab was conducted at the destination medical institution and proved COVID-19 positive (CT value 23.5). From 10:00 on 20Aug2021, the postmortem examination was conducted at the reporter institute. Computerised tomogram (CT) was performed at the time and showed severe emphysema image and infiltrative shadow of both lungs, mainly in the left lung lower lobe, and metal-clips-like shadow that was estimated as post right lung lower lobectomy. According to the physician in charge of the lung cancer treatment, ground glass opacity of both lungs was observed in CT on 28Jul2021, thus the reporter judged that at least the right lung lesion in drug-induced lung disorder was recovering at the time of death. Combined with the result of PCR, the cause of death was considered as the doubt of pneumonia associated with novel coronavirus infection. The reporter estimated that there was high possibility that the patient died from pneumonia that was equivalent to a moderate disease because of the underlying poor respiratory function. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were chronic obstructive pulmonary disease and drug-induced lung disorder exacerbation (note that novel coronavirus infection coexisted). The reporting physician commented as follows: The reporter had the information that the patient received COVID-19 vaccines on 18Jun2021 and 09Jul2021, but at a time relatively close to them, the patient developed drug-induced lung disorder associated with chemotherapy and steroids were given (The last administration date of pembrolizumab was 19May2021, Lung disorder was exacerbated and the administration of prednisolone was started on 30Jun2021, that was increased up to 40 mg/day, recently reduced to 20 mg/day.), thus there was a possibility that susceptibility to infection continued even after the vaccination. According to the physician in charge of the lung cancer treatment, ground glass opacity of both lungs was observed in CT on 28Jul2021, thus the reporter estimated that at least the right lung lesion in drug-induced lung disorder was recovering at the time of death and new lesion developed in left lung lower lobe. Combined with the result of PCR, the cause of death was considered as the doubt of pneumonia associated with novel coronavirus infection. The reporter estimated that there was high possibility that the patient died from pneumonia that was equivalent to a moderate disease because of the underlying poor respiratory function. Besides, the infection route was not clear at the time of reporting. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: the doubt of pneumonia associated with novel coronavirus infection/COVID-19 positive; COVID-19 positive/the doubt of pneumonia associated with novel coronavirus infection


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