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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: 1576708 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Investigation, Speech disorder
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: Test Date: 2021; Test Name: impact on quality of life; Result Unstructured Data: Test Result:10; Comments: 10/10
CDC Split Type: ITPFIZER INC202101026684

Write-up: stroke; slight speech difficulties; This is a spontaneous report from a contactable consumer downloaded from the WEB [IT-MINISAL02-768102]. A 90-year-old male patient received the second dose of BNT162B2 (COMIRNATY; lot number: unknown), via an unspecified route of administration on 14Mar2021 (at an unspecified age) at dose 2, single in the right arm for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Mar2021, the patient experienced slight speech difficulties. On 18Mar2021, the patient experienced stroke. The patient was hospitalized on an unspecified date in 2021 due to the events. The patient died on an unspecified date in 2021. It was unknown if autopsy was done. On 2021, the impact on quality of life was 10/10. Outcome of all the events was fatal. Sender''s comment: Card without information on date, time I and II vaccination, batch number, infusion arm. The reporter only provided e-mails to which, on the same date of 30Jul2021, I sent e-mails with a request for in-depth information to date with no response. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Stroke; slight speech difficulties


VAERS ID: 1576709 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   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: ITPFIZER INC202101026398

Write-up: patient collapsed on the ground and died; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-768121. A 51-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Left Arm on 31Jul2021 (Lot Number: FF7481; Expiration Date: 30Nov2021) as DOSE 2, 0.3ML SINGLE for covid-19 immunisation. The patient''s medical history included trigeminal neuralgia, migraine and dental problems. Concomitant medications were not reported. Historical vaccine includes dose 1 of Comirnaty received on 16Jun2021 (lot: FC5435). The patient''s family members reported that the patient collapsed on the ground on 03Aug2021, so the 118 hotline was contacted, and they tried to resuscitate the patient. The patient died on 03Aug2021. 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: patient collapsed on the ground and died


VAERS ID: 1576765 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer; Metastases to brain
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: pyrexia; Result Unstructured Data: Test Result: 38 Centigrade.
CDC Split Type: JPPFIZER INC202100986803

Write-up: Pyrexia of 38 degrees Celsius; Vomiting; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122114. The patient was a 71-year and 6-month-old male. Body temperature before vaccination was not provided. 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). Medical history included lung cancer and metastases to brain. On unknown date in 2021, the patient previously received the first dose of COVID-19 vaccine (Lot# unknown, Expiration date unknown). On 15Jun2021 (the day of vaccination), the patient received the second dose of COVID-19 vaccine (Lot number unknown, Expiration date unknown) via an unspecified route of administration as dose 2, single (at the age of 71 years old) for COVID-19 immunization. On 16Jun2021 (one day after the vaccination), the patient experienced pyrexia of 38 degrees Celsius and vomiting. On 28Jun2021 (13 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: Until 15Jun2021 (the day of vaccination), the patient had no pyrexia. The patient received the second dose of COVID-19 vaccine. On 16Jun2021 (one day after vaccination), in the morning, the patient experienced pyrexia of 38 degrees Celsius. At noon, when nutrition was administered via the gastrostomy tube, the patient experienced vomiting. The reporting physician classified the event as serious (death). The causality between the event and COVID-19 vaccine was not provided. Other possible causes of the event such as any other diseases were lung cancer and metastases to brain. The reporting physician commented as follows: Since the patient was bedridden for lung cancer and metastases to brain, it was considered unlikely that the patient died due to the vaccination. Although the pyrexia was improving during the hospital course, the pathological condition suddenly changed, and the patient died on 28Jun2021. It was unknown if autopsy was performed. Pfizer is a marketing authorization holder of COVID-19 vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 vaccine has submitted the same report to the regulatory authorities. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events fever and vomiting (fatal) and suspect drug BNT162B2 cannot be established. 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: pyrexia of 38 degrees Celsius; vomiting


VAERS ID: 1576778 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Gaze palsy, Haematemesis, Muscle spasms, Pneumonia aspiration, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Dystonia (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 4
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Late effects of cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 202107; Test Name: CT; Result Unstructured Data: Test Result:showed pneumonia in both lungs; Comments: performed as an autopsy imaging (AI)
CDC Split Type: JPPFIZER INC202100993495

Write-up: pale blooded watery vomit; cardio-respiratory arrest; Vomiting/large amount of vomiting; cramps of lower extremities; eyeballs raise upward; pneumonia in both lungs/pneumonia aspiration; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122209. A 92-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Jul2021 10:00 (Lot Number: EY0573; Expiration Date: 30Sep2021) as dose 1, single for COVID-19 immunization. Medical history included late effects of cerebral infarction on an unknown date. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.2 degrees centigrade. On 04Jul2021 at 23:00 (13 hours after the vaccination), the patient experienced vomiting. On 05Jul2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: on 04Jul2021 (the day of vaccination), at 10:00, the patient received the first dose of BNT162b2 vaccination. After the patient went home, he experienced vomiting at 23:00. On the same day, also at 23:00 (13 hours after vaccination), the patient had cramps of lower extremities and eyeballs raise upward. An ambulance was called. After the patient was admitted to the reporting hospital, he repeatedly had vomiting. On 05Jul2021, at 06:50 (20 hours and 50 minutes after vaccination), the patient had a large amount of vomiting (pale blooded watery vomit) and had cardio-respiratory arrest. Emergency resuscitation was performed. However, the patient was confirmed to die at 07:47 (21 hours and 47 minutes after vaccination). CT was performed as an autopsy imaging (AI) on Jul2021 and showed pneumonia in both lungs. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was reported as unknown. The reporting physician commented as follows: After the patient received BNT162b2 vaccination, he repeatedly had vomiting, and he had pneumonia aspiration and died.; Reported Cause(s) of Death: pneumonia in both lungs/pneumonia aspiration; vomiting; cramps of lower extremities; eyeballs raise upward; pale blooded watery vomit; cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: pneumonia in both lungs/pneumonia aspiration


VAERS ID: 1576785 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-29
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   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: CONIEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Obesity (Body mass index (BMI): 38)
Allergies:
Diagnostic Lab Data: Test Name: Body mass index (BMI); Result Unstructured Data: Test Result:38; Test Date: 20210709; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100995347

Write-up: death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122323. A 59-years-old male patient received BNT162B2 (COMIRNATY) at the age of 59-years-old, via an unspecified route of administration on 09Jul2021 18:00 (Batch/Lot Number: FA5715; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunization. Medical history included hypertension and obesity (body mass index (BMI): 38). Concomitant medication included benidipine hydrochloride (CONIEL) taken for an unspecified indication from an unspecified start date and ongoing. The patient was a 59-year and 3-month-old male. Body temperature before vaccination was 36.6 degrees centigrade. The family history was not provided. The patient had medical history of hypertension and obesity. The patient was orally taking benidipine hydrochloride (CONIEL (4)) 2 tablets per day. On 09Jul2021 at 18:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5715, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 29Jul2021 (20 days after the vaccination), the patient experienced death. On 29Jul2021 (20 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: 20 days after vaccination, the patient was found dead at his home. An autopsy by the police was performed. The results of the autopsy were unknown. The patient lived alone, and he seemed to collapse while he was changing his clothes. The patient had obesity with the height of 172 cm, the body weight of 115 kg, and BMI of 38. 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. There was other possible cause(s) of the event such as any other diseases, but detail was not provided. The reporting physician commented as follows: Since the patient had severe obesity, the event was unlikely to be related to BNT162b2 vaccination.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576786 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-08-02
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Cardiac arrest
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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100995351

Write-up: Cardiac arrest; thoracic aortic aneurysm rupture; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority report number is v21122303. An 89-year-old (also reported as 89-year and 11-month-old) male patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 21Jun2021 (Bath/lot number not reported), as dose 2, single, for COVID-19 immunisation. Relevant medical history included thoracic aortic aneurysm from an unknown date, not reported if ongoing or not. Concomitant medication was reported as unknown. The family history was not provided. Historical vaccine included BNT162B2 (COMIRNATY Solution for injection) received on 31May2021 (Batch/lot number unknown), as dose 1, single, for COVID-19 immunisation. Body temperature before vaccination was unknown. On 02Aug2021 at 09:00 (one month/12 days/9 hours after the vaccination), the patient experienced thoracic aortic aneurysm rupture and cardiac arrest. The patient died on 02Aug2021. The course of the event was as follows: On 02Aug2021, at 09:00 (one month, 12 days, and 9 hours after vaccination), the patient who had medical history of thoracic aortic aneurysm experienced cardiac arrest. On 02Aug2021 (one month/12 days after the vaccination), the outcome of the event was fatal. It was unknown if autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: The patient had medical history of thoracic aortic aneurysm. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac arrest; thoracic aortic aneurysm rupture


VAERS ID: 1576787 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Arteriosclerosis, Cardiac failure, Mitral valve incompetence, Ultrasound Doppler
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 22
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: intravascular ultrasound; Result Unstructured Data: Test Result:arteriosclerotic lesion; Comments: the coronary artery lesion on the intravascular ultrasound was arteriosclerotic lesion which was usually observed.
CDC Split Type: JPPFIZER INC202100995707

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122367. A 71-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jun2021 15:00 (Lot Number: FA5765; Expiration Date: 30Sep2021), at the age of 71-year-old, as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: EY0779, Expiration date 31Aug2021) for COVID-19 immunisation. On 16Jun2021 at 15:00 (one day after the vaccination), the patient experienced acute myocardial infarction. On 08Jul2021 (23 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 16Jun2021, at 15:00 (one day after the second dose of vaccination), the patient experienced acute myocardial infarction. Since the patient considered it as a side reaction to the vaccination, he did not visit the hospital until 2 days after the onset of the symptom on 17Jun2021 (2 days after vaccination). The patient visited the hospital after he had cardiac failure. Ischaemic mitral valve insufficiency was severe. Unfortunately, the outcome was death. Of note, the coronary artery lesion on the intravascular ultrasound was arteriosclerotic lesion which was usually observed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was arteriosclerosis. The reporting physician commented as follows: This case was reported at the family''s strong wish. The myocardial infarction seemed by the arteriosclerotic plaque rather than the thrombosis.; Reported Cause(s) of Death: Cardiac failure; Ischaemic mitral valve insufficiency; Arteriosclerosis; Acute myocardial infarction


VAERS ID: 1576788 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, CSF culture, Computerised tomogram head, Hypophagia, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 12
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: 20210708; Test Name: Head CT; Result Unstructured Data: Test Result:Performed; Comments: Subarachnoid haemorrhage and cerebral haemorrhage were denied.; Test Date: 20210708; Test Name: Spinal fluid; Result Unstructured Data: Test Result:Meningitis was denied.
CDC Split Type: JPPFIZER INC202100995725

Write-up: Consciousness disturbed; dietary intake declined; Pyrexia; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority report number is v21123133. A 83-year-old male patient received bnt162b2 (COMIRNATY), dose 2 at the age of 83-years-old via an unspecified route of administration on 28Jun2021 09:06 (Batch/Lot Number: EW0203; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. Body temperature before vaccination was not reported. The patient''s family history was unknown. Medical history was not reported. The patient''s concomitant medications were not reported. On 08Jun2021 at 09:38, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY0779, Expiration date 31Aug2021) for covid-19 immunisation. On 08Jul2021 at 23:22 (10 days after the vaccination), the patient experienced consciousness disturbed. The course of the event was as follows: On 28Jun2021, the patient received the second dose of BNT162b2 and thereafter presented with pyrexia. He became less responsive and also became bedridden. From around 04Jul2021, dietary intake declined but was able to drink water. From 07Jul2021, the level of his consciousness lowered. On 08Jul2021, he was urgently transferred to the reporting hospital (on arrival at hospital, the consciousness disturbed was prolonged for more than 8 hours). Head computed tomography ruled out subarachnoid haemorrhage and cerebral haemorrhage, and spinal fluid analysis ruled out meningitis. Based on the suspicion of nonconvulsive epilepsy, electroencephalographic examination was scheduled on the following day. On 10Jul2021, the patient was discharged dead without recovery of the consciousness. The reporting pharmacist classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unassessable. The reporting pharmacist stated that the cause of the event was unknown for other possible cause of the event such as any other diseases. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included computerised tomogram head: performed on 08Jul2021; Subarachnoid haemorrhage and cerebral haemorrhage were denied and csf culture: meningitis was denied on 08Jul2021. On 10Jul2021 (12 days after the vaccination), the outcome of the event consciousness disturbed was fatal. The outcome of the other events was unknown. The reporting pharmacist commented as follows: Although the cause of the event was unknown, this case had been reported according to the patient''s family members'' strong request.; Reported Cause(s) of Death: Consciousness disturbed


VAERS ID: 1576789 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Delirium, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   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: LANSOPRAZOLE; QUETIAPINE; THEOPHYLLINE; FOLIAMIN [FOLIC ACID]; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Late effects of cerebral infarction; Oesophageal hiatal hernia; Oxygen therapy (1L/min); Pulmonary fibrosis (Home Oxygen Therapy(HOT)1L/min)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100995801

Write-up: This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 96-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 12Jul2021 13:30 (Batch/Lot Number: EW0203; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included dementia, pulmonary fibrosis, both from an unknown date if ongoing Home Oxygen Therapy(HOT)1L/min, Late effects of cerebral infarction, Oesophageal hiatal hernia,all from an unknown date. Patient had his first dose of COMIRNATY (Lot Number: EW0203; first dose; at 13:30 ) for COVID-19 immunisation on 21Jun2021. Concomitant medications included lansoprazole; quetiapine; theophylline; folic acid (FOLIAMIN); furosemide. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. On 14Jul2021 (2 days after the vaccination),the patient experienced delirium.On 15Jul2021 at 13:08 (3 days after the vaccination), the patient experienced cardio-respiratory arrest. On 15Jul2021 (3 days after the vaccination), the patient experienced ventricular fibrillation. The outcome of the event delirium was unknown, other events was fatal without treatment. The reporting physician assessed the event as serious (Death). Autopsy was not performed. Clinical course provided as follows: The patient, with dementia and pulmonary fibrosis, had been living in the nursing home. On 12Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2. On 14Jul2021 (2 days after the vaccination), the patient had delirium symptom, letting out his voice at night. On 15Jul2021 at 12:15 (3 days after the vaccination), the patient ate all of his lunch. At 12:55, it was confirmed that the patient was alive. At 13:08, the staff found at the dining room that the patient drooped his head sitting in the wheelchair. The patient was in cardio-respiratory arrest. As ''''Do Not Attempt Resuscitation (DNAR) '''' had been requested, the patient''s death was then confirmed.Since the vaccination, the patient has not been tested for COVID-19. Patient died on 15Jul2021. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events : Cardio-respiratory Arrest, ventricular fibrillation, delirium and the administration of the vaccine 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: Ventricular fibrillation; Cardio-respiratory arrest


VAERS ID: 1576790 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-07-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   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: Acute myocardial infarction (acute myocardial infarction associated with smoking and dyslipidaemia); Dyslipidaemia (acute myocardial infarction associated with smoking and dyslipidaemia); Smoker (acute myocardial infarction associated with smoking and dyslipidaemia).
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100995965

Write-up: a possibility of idiopathic myocardial infarction; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122346. A 69-year-old (also reported as 69-year and 2-month-old) male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Jun2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included acute myocardial infarction associated with smoking and dyslipidaemia. The family history was not reported. Information was not reported 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''s concomitant medications were not reported. Body temperature before vaccination was not reported. On 05Jul2021 at 00:10, (8 days after the vaccination), the patient experienced a possibility of idiopathic myocardial infarction. The outcome of the event was fatal. The reporting physician classified the event 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 was acute myocardial infarction associated with smoking and dyslipidaemia. The reporting physician commented as follows: The causality was difficult to assess. Considering primary disease and social history, there was a possibility of idiopathic myocardial infarction. The patient died on 05Jul2021. It was not reported if an autopsy was performed. The lot number for bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: a possibility of idiopathic myocardial infarction


VAERS ID: 1576794 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Subdural haematoma, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   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: CLOPIDOGREL SULFATE; AMLODIPINE BESILATE; LIMAPROST ALFADEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thrombotic cerebral infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100999664

Write-up: Thrombotic subdural haematoma; Thrombotic subdural haematoma; This is a spontaneous report from a contactable physician. This report was received via a sales representative. An 83-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 15Jul2021 as dose number unknown, single for covid-19 immunisation. Medical history included atherothrombotic cerebral infarction right (in Mar2021). Concomitant medications included oral clopidogrel sulfate, oral amlodipine besilate, and oral limaprost alfadex, all taken for an unspecified indication from an unspecified start date and ongoing. On 16Jul2021 (one day after the vaccination), the patient experienced thrombotic subdural haematoma. The course of the event was as follows: On 15Jul2021 (the day of vaccination), the patient received a dose of BNT162b2 vaccination. On 16Jul2021 (one day after vaccination), the patient was emergently transferred, and she died (the cause of death was thrombotic subdural haematoma). It was unknown if an autopsy was performed. The reporting physician stated that the event was unrelated to BNT162b2. The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 can be excluded for the reported event of Subdural hematoma and Thrombosis, as there is also possible contributory effects from patient''s medical history of atherothrombotic cerebral infarction right. 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: thrombotic subdural haematoma


VAERS ID: 1576798 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   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: ADHD; Self injurious behaviour
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101008056

Write-up: Suicide; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122543. The 16-year and 5-month-old male patient received first dose of bnt162b2 (COMIRNATY) at 16-year-old on 15-JUL-2021 12:00 as dose 1, single (lot number: EY0583, expiration date: 31Oct2021) for COVID-19 immunisation. Body temperature before vaccination was 36.2 degrees Centigrade. Medical history included attention deficit hyperactivity disorder (ADHD) and Self injurious behaviour. Concomitant medications and family history were not provided. The course of the events was as follows: On 15Jul2021 at 12:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY0583, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 23Jul2021 at 18:30 (8 days after the vaccination), the patient experienced suicide and died. 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 23Jul2021, the patient jumped off the top floor of the apartment and died. It was assumed the he killed himself. The reporting physician classified the event as serious (fatal) and assessed that the event was not related to BNT162b2. Other possible cause of the event such as any other diseases was ADHD. The reporting physician commented as follows: The patient was prescribed oral medicines for ADHD at a psychiatry department, but recently he had stopped taking them, and self injurious behaviour had been noted.; Sender''s Comments: Event suicide represents an intercurrent medical condition and unrelated to bnt162b2 . The underlying history of attention deficit hyperactivity disorder (ADHD) and Self injurious behavior may play a explanation.; Reported Cause(s) of Death: Suicide


VAERS ID: 1576800 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dyspnoea, Myocardial infarction, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 1
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: BETAMETHASONE; ROSUVASTATIN; CILOSTAZOL; BIFIDOBACTERIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Intrahepatic bile duct cancer; Polymyalgia rheumatica; Pulmonary embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101008452

Write-up: Dyspnoea; Subacute myocardial infarction; Chills; Vomiting; This is a spontaneous report from a contactable physician received via COVID-19 Self-Reporting. The patient was an 89-year-old male. Body temperature before vaccination was not reported. The patient''s family history was not reported. Medical history included cerebral haemorrhage, polymyalgia rheumatica, intrahepatic bile duct cancer, and pulmonary embolism. The patient had no known allergies. Concomitant medications taken within 2 weeks of vaccination included betamethasone, rosuvastatin, cilostazol, and bifidobacterium tablet. 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. On 08Jun2021 at 12:00, the patient aged 89 previously received the first single dose of BNT162b2 (COMIRNATY, Lot# EY0573, Expiration date 30Sep2021) in the left arm. On 29Jun2021 at 12:00 (the day of vaccination), the patient aged 89 received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) intramuscularly in the left arm for COVID-19 immunization. On 02Jul2021 at 01:30 (3 days after the vaccination), the patient experienced chills and vomiting. On 03Jul2021 at 11:30 (4 days after the vaccination), the patient experienced dyspnoea and was taken to a hospital. On 03Jul2021 (4 days after the vaccination), the patient passed away. The course of the event was as follows: On 02Jul2021 at 01:30, the patient presented with chills and vomiting. On 03Jul2021 at 11:30, the patient experienced dyspnoea and was transferred to a hospital. He died on the same day. The cause of death was subacute myocardial infarction. The outcome of other events was unknown. It was unknown if any treatment was given for the events. Autopsy was not performed. The adverse events resulted in emergency room/department or urgent care, hospitalisation, death. Since the vaccination, the patient had not been tested for COVID-19. Sender''s Comments: The event fatal myocardial infarction is considered not related to BNT162B2. The patient had underlying medical conditions including cerebral hemorrhage, which are considered as risk factors for the event. The event dyspnea is considered associated with myocardial infarction and also not related to BNT162B2. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: Subacute myocardial infarction.


VAERS ID: 1576801 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Fibrin D dimer, Platelet count, Thrombosis
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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   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:
Current Illness: Haemodialysis; Peritoneal dialysis; Renal failure chronic (IgA nephropathy progression)
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic calcification (Mild aortic calcification was observed but dialysis complication was rarely noted.)
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Name: CT; Result Unstructured Data: Test Result:did not indicated any cause of the death; Comments: such as haemorrhage or others.; Test Name: D-dimer; Result Unstructured Data: Test Result:747; Comments: After death; Test Name: platelet; Result Unstructured Data: Test Result:77000; Comments: After death
CDC Split Type: JPPFIZER INC202101008470

Write-up: suspected thrombosis; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122611. The patient was a 70-year and 4-month-old female. Body temperature before vaccination was 36.4 degrees Centigrade. The patient family history was not reported. medical history included ongoing renal failure chronic (IgA nephropathy progression), peritoneal dialysis from 2012 and ongoing, haemodialysis from 2017 and ongoing, and mild aortic calcification (Mild aortic calcification was observed but dialysis complication was rarely noted). The patient had been treated with peritoneal dialysis and haemodialysis. On 10Jun2021 at 10:05 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose, at age of 70-year-old of vaccination, for COVID-19 immunization. On 11Jun2021 at approximately 17:00 (1 days after the vaccination), the patient suspected to had thrombosis. The patient was transported to another hospital. At 18:57, the patient died. The outcome of the event was fatal. The course of the event was as follows: Due to IgA nephropathy progression, the patient started peritoneal dialysis in 2012, and haemodialysis in 2017, which were under treatment. Mild aortic calcification was observed but dialysis complication was rarely noted. The patient had lived a stable life. On 10Jun2021 at 10:05 (the day of vaccination), the patient received the first dose of COVID-19 vaccination during dialysis. No adverse reaction was noted, and the patient returned home after dialysis. On 11Jun2021 at around 16:00 (1 days after the vaccination), the patient was taking a bath. Just after 17:00, the patient''s family member found the patient fall down on her face in the bath tab without response. An ambulance was requested, and she was transported to another hospital. At 18:11, on arrival, the patient was in cardio-respiratory arrest. There was no response to resuscitation. At 18:57, the patient was confirmed dead. It was unknown if autopsy was done. Computerised tomography (CT) did not indicated any cause of the death such as haemorrhage or others. Considering abnormal levels of D-dimer 747 and platelet 77000, there might have been some sort of thrombosis. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was haemodialysis that was being conducted due to renal failure chronic. The reporting physician commented as follows: One day after the vaccination given during stable dialysis, the event occurred. A presence of thrombosis was suspected on examination after death; thus, even though causality was unknown, relationship with BNT162b2 was suggested. ; Reported Cause(s) of Death: Cardio-respiratory arrest; suspected thrombosis


VAERS ID: 1576802 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypoxia
SMQs:, Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   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: Geromarasmus; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101008473

Write-up: Hypoxia aggravated acute/the oxygenation was suddenly aggravated; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122569. A 96-year-old (reported as 96-year and 11-month-old) male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Aug2021 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as dose 1, single at the age of 96-year-old for covid-19 immunisation. The patient had medical histories of geromarasmus and pneumonia aspiration. The patient was using a beta blocker. The family history was not provided. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.9 degrees centigrade. On 04Aug2021 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 05Aug2021 (one day after the vaccination), the patient experienced hypoxia aggravated acute. On 05Aug2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was bedridden for geromarasmus, and the condition which required total assistance was continued. The patient repeatedly had pneumonia aspiration, and hypoxia was continued. During the last 2 weeks, the condition was stable, and the patient received the first dose of bnt162b2 vaccination. Approximately 12 hours later, the oxygenation was suddenly aggravated, and the patient died. The patient died on 05Aug2021. 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. Other possible cause of the event such as any other diseases was geromarasmus.; Reported Cause(s) of Death: Hypoxia aggravated acute


VAERS ID: 1576803 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Physical deconditioning, Platelet count
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 7
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: 20210728; Test Name: platelets; Result Unstructured Data: Test Result:decreased; Test Date: 20210803; Test Name: platelets; Result Unstructured Data: Test Result:decreased to 4000
CDC Split Type: JPPFIZER INC202101008508

Write-up: Cerebral infarction; physical deconditioning; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122544. An 86-year-old female patient received the second dose of bnt162b2 (COMIRNATY) (lot number: unknown) on 24Jul2021 (at the age of 86-years-old) via unknown route of administration at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Body temperature before vaccination was not reported. It was unknown if the patient had relevant family history. 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 the first single dose for COVID-19 immunization. On 24Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as the second single dose for COVID-19 immunization. After the second vaccination, the patient had physical deconditioning. On 28Jul2021 (4 days after the vaccination), the patient developed cerebral infarction (severe) and was hospitalized. Decreased platelets had been already noted, for which the patient was treated with heparin and ozagrel sodium (XANBON). The initial symptom was thrombotic thrombocytopenic purpura (TPP). On 03Aug2021 (10 days after the vaccination), the platelet decreased to 4000, and the impression was that it was likely to be heparin-induced thrombocytopenia (HITT). Heparin was discontinued. The only remedy for HITT, argatroban was initiated. On 04Aug2021 (11 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The outcome of the event physical deconditioning was unknown. The reporting physician classified the events as serious (fatal outcome) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported if there were other possible causes of the events such as any other diseases. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1576804 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Imaging procedure, Respiratory disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   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: Atelectasis; Emphysema; Pneumonia (treated with antibiotics and tended to improve).
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: blood pressure; Result Unstructured Data: Test Result: decreased; Comments: at 16:50; Test Date: 20210729; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210729; Test Name: Imaging; Result Unstructured Data: Test Result: residual pleural effusion and atelectasis.
CDC Split Type: JPPFIZER INC202101008517

Write-up: respiratory status suddenly aggravated; blood pressure decreased; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122605. The patient was an 86-year and 8-month-old male. Body temperature before vaccination was 36.8 degrees centigrade. Family history was not reported. Medical history included emphysema, atelectasis, and pneumonia from 06Jul2021 which was treated with antibiotics and tended to improve. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not reported) for COVID-19 immunisation. On 27Jul2021, the antibiotics for pneumonia was suspended. On 29Jul2021 at 15:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) via an unspecified route of administration as the second single dose for COVID-19 immunization. Imaging revealed residual pleural effusion and atelectasis on 29Jul2021, but vital signs were stable and consciousness level and complexion were good; thus, the patient received BNT162b2. On 31Jul2021 at 16:50 (2 days 1 hour and 20 minutes after the vaccination), the patient experienced respiratory status suddenly aggravated and blood pressure decreased. The condition did not improve, and the patient died on the same date (31Jul2021). It was not reported if an autopsy was performed. The reporting physician classified the events as serious (fatal) and assessed that the events were related to BNT162b2. Other possible causes of the event such as any other diseases were emphysema, pleural effusion, and atelectasis, which were observed. The reporting physician commented as follows: General condition before the vaccination was good and there was no particular change in condition immediately after the vaccination. Since there was no other pathological condition that resulted in sudden change, causality between the events and the vaccine could not be denied. ; Reported Cause(s) of Death: respiratory status suddenly aggravated; blood pressure decreased; emphysema; pleural effusion; atelectasis


VAERS ID: 1576805 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac dysfunction, Depressed level of consciousness, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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: Apnoea; Dementia; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result: 36.4 Centigrade; Comments: before vaccination; Test Date: 20210731; Test Name: oxygen saturation; Result Unstructured Data: Test Result:80s to the lower 90s%.
CDC Split Type: JPPFIZER INC202101009726

Write-up: Cardiac function decreased; function kidney decreased; suspected pneumonia; depressed level of consciousness; oxygen saturation 80s to the lower 90s %; This is a spontaneous report from a contactable other healthcare professional (HCP) received from the Regulatory Authority. The Regulatory authority report number is v21122573. An 81-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) on 27Jul2021 09:45 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees centigrade. Medical history included diabetes mellitus, hypertension, dementia, and apnoea. The patient''s family history was not reported. The patient''s concomitant medications were not reported. On an unspecified date, the patient previously received the first dose of BNT162B2 (Lot number unknown). On 27Jul2021 at 09:45 (the day of vaccination), the patient received the second dose of BNT162B2. On 30Jul2021 at 20:00 (three days after the vaccination), the patient developed adverse event, but any symptoms on that time were not reported. On 31Jul2021 (four days after the vaccination), the patient was admitted to another hospital. On 01Aug2021 (five days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 31Jul2021, after the breakfast, depressed level of consciousness and oxygen saturation 80s to the lower 90s%. The patient was urgently transported to hospital. Cardiac function decreased, function kidney decreased, and suspected pneumonia were noted. The patient died on 01Aug2021. It was not reported if an autopsy was performed. The reporting other HCP classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was apnoea. The outcome of the events cardiac function decreased, function kidney decreased, and suspected pneumonia was fatal. The outcome of the events depressed level of consciousness and oxygen saturation 80s to the lower 90s% was unknown. Reporter''s comment: Nothing in particular to comment. Reporter''s Comments: Nothing in particular to comment; Reported Cause(s) of Death: Cardiac function decreased; function kidney decreased; possible pneumonia.


VAERS ID: 1576806 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest
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: 2021-08-03
   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: Atrial fibrillation (primary disease); Cardiac failure congestive (primary disease); Late effects of cerebral infarction (primary disease); Orthostatic hypotension (primary disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202101009919

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122636. The patient was a 85-year and 10-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade. The patient family history was not reported. The patient had primary disease of late effects of cerebral infarction, atrial fibrillation, cardiac failure congestive, and orthostatic hypotension. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunization.On 31Jul2021 at 15:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Aug2021 at an unknown time (3 days after the vaccination), the patient experienced cardio-respiratory arrest. On 03Aug2021 at an unknown time (3 days after the vaccination), the patient died. The outcome of the event was fatal. The course of the event was as follows: The patient was found cardio-respiratory arrest at home and was transported to the emergency department of another hospital. The reporting physician classified the event 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 primary diseases including late effects of cerebral infarction, atrial fibrillation, cardiac failure congestive, and orthostatic hypotension. The reporting physician commented as follows: The patient had primary diseases including late effects of cerebral infarction, atrial fibrillation, cardiac failure congestive, and orthostatic hypotension. There was a high possibility that these diseases were involved with the cause of the death.; Reported Cause(s) of Death: Cardio-respiratory arrest.


VAERS ID: 1576807 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Coma scale, Computerised tomogram, Death, Imaging procedure, Investigation, Magnetic resonance cholangiopancreatography, Movement disorder, Nausea
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), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: 20210730; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210802; Test Name: CS; Result Unstructured Data: Test Result:300; Test Date: 20210715; Test Name: CT; Result Unstructured Data: Test Result:suspected to have cancer at the lower end; Comments: suspected to have cancer at the lower end of the common bile; Test Name: AI; Result Unstructured Data: Test Result:the cause of death could not be identified; Test Date: 20210802; Test Name: pupils; Result Unstructured Data: Test Result:3 mm/3mm; Comments: no pupils dilated was noted; Test Date: 20210715; Test Name: MRCP; Result Unstructured Data: Test Result:suspected to have cancer at the lower end; Comments: suspected to have cancer at the lower end of the common bile
CDC Split Type: JPPFIZER INC202101009993

Write-up: Unknown cause of death; cardio-respiratory arrest; difficulty in body motion; queasy; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122553. An 86-year and 9-month-old female patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021), at the age of 86 years and 9 months old, on 30Jul2021 at 13:30 at 0.3 ml single dose for COVID-19 immunization. In the vaccination coupons, age was also reported as 85 and 88. Body temperature before vaccination was 36.4 degrees centigrade. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire. In the vaccination coupons for the second dose of BNT162B2 vaccination, this was not the first time to receive Coronavirus Disease 2019 vaccine (first dose on 09Jul2021, this was second dose). The name of present local municipal government (who issues a Certificate of Residence for the patient) correctly printed on the coupon ticket. The patient had read ''''Coronavirus Disease 2019 Vaccination Guide'''' and understood its effect and potential side effects. The patient fell under any of the following priority vaccination groups (65-year-old or older). The patient was not currently treated (with medications, etc.) for any disease. The patient had not been sick or had no fever in the past month. The patient was not feeling sick on the day of vaccination. The patient had never had convulsions (seizures). The patient had never had severe allergic reactions (anaphylaxis, etc.) to a medication or food. The patient had never been sick after receiving vaccination. The patient was not possibly pregnant (e.g. late period) or she was not currently breast-feeding. The patient had not received any other vaccines in the past two weeks (BNT162b2 only). The patient did not have any questions about this vaccination. The patient''s concomitant medications were not reported. On 09Jul2021, the patient previously received the first dose of BNT162B2 (Lot number FC5974, Expiration date 30Sep2021) at 0.3 ml single dose for COVID-19 immunization and experienced feeling of hot flushes. On 30Jul2021 at 13:30 (the day of vaccination), the patient received the second dose of BNT162B2. On 02Aug2021 at 06:00 (2 days/16 hours/30 minutes after the vaccination, also reported as 05:00), the patient experienced unknown cause of death. On 02Aug2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30Jul2021, the patient received the second dose of BNT162B2 vaccination. On 01Aug2021 at 18:30, the patient went to sleep. Until then, no significant changes from usual were observed. On 02Aug2021 at 03:00, on awaking, the patient complained of queasy; however, she was confirmed to survive. At around 05:00, the patient was found to have difficulty in body motion by her family, and an ambulance was called. At 05:05, the ambulance service arrived on the site. The patient was judged to have cardio-respiratory arrest, and resuscitation and administration of adrenaline were performed. When the patient arrived at the reporting hospital, Coma Scale (CS) was 300, the pupils were 3 mm/3mm, no pupils dilated was noted, and light reflex was not observed. Since the pulse rate and the respiration did not return, the condition was explained to her husband, and the resuscitation was discontinued. At 06:00, the patient died. The cause of death was unknown. Although an autopsy imaging (AI) was performed, the cause of death could not be identified. 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 outcome of the event unknown cause of death was fatal. The outcome of other events was unknown. The patient died on 02Aug2021 at 06:00. An autopsy was performed and results were not provided. Reporter''s comment: On 15Jul2021, the patient had feeling of hot flushes, and she was examined at the gastroenterological medicine department. The patient was suspected to have cancer at the lower end of the common bile duct on the computerised tomogram (CT) and Magnetic resonance cholangiopancreatography (MRCP). Thereafter, an examination was to be performed, this result was not cause of death, and the cause of death was unknown.; Reporter''s Comments: On 15Jul2021, the patient had feeling of hot flushes, and she was examined at the gastroenterological medicine department. The patient was suspected to have cancer at the lower end of the common bile duct on the computerised tomogram (CT) and Magnetic resonance cholangiopancreatography (MRCP). Thereafter, an examination was to be performed, this result was not cause of death, and the cause of death was unknown.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576808 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: Diabetes mellitus; Giddiness; Hypercholesterolaemia; Hypertension; Pericarditis; Pleurisy; Queasy; Reflux oesophagitis; Sjogren''s syndrome; Swaying feeling.
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result: 36.2 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202101010021

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician, the inoculator, received from the Regulatory Authority. Regulatory authority report number is v21122666. The patient was a 73-year-old female. Body temperature before vaccination was 36.2 degrees centigrade. The patient family history was not reported. Medical history was as follows: In Sep2007, the patient was admitted to another hospital for treatment of pleurisy, pericarditis and Sjogren''s syndrome. After that, the patient had received the treatment with steroids for about half year. Hypertension since 2012, hypercholesterolaemia since 2014, reflux oesophagitis since 2016, diabetes mellitus since 2019 and the patient regularly went to hospital. The patient had complained of giddiness and swaying since around Jun2021. Unspecified concomitant medications taken for giddiness and feeling queasy from 24Jul2021 prescribed by otologist. On 29Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). On 31Jul2021 at 15:37 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unknown date, the patient died of unknown cause. On 05Aug2021 (five days after the vaccination), the patient was confirmed dead by the local police. The course of the event was as follows: On 29Jun2021, the patient received the first dose of Comirnaty. On 31Jul2021, the patient received the second dose of Comirnaty. On 31Jul2021, the family of the patient contacted the patient. After that, the family could not get in touch with the patient and on 05Aug2021, the patient was confirmed dead by the police. The reporting physician classified the event as serious (fatal) and assessed that the causality between the event and BNT162b2 as unassessable. There was/were unspecified other possible cause(s) of the event. The reporting physician did not provide any comment.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576809 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 4
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: Hyperlipidaemia; Hypertension; Large intestine carcinoma; Large intestine operation (Postoperative state of large intestine carcinoma)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101014173

Write-up: This is a spontaneous report from a contactable physician received via Regulatory Authority. A 53-year-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) on 14Jul2021 at 10:30 intramuscular in the left arm at single dose for COVID-19 immunization, at age of 53 years old of vaccination. 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. Medical history included postoperative state of large intestine carcinoma, hypertension and hyperlipidaemia. Concomitant drug was unknown. On 14Jul2021 at 10:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization, at age of 53 years old of vaccination. On 28Jul2021 (14 days after the vaccination), the patient experienced cerebellar infarction. On 30Jul2021 (16 days after the vaccination), the patient was hospitalized for cerebellar infarction. On 01Aug2021 (18 days after the vaccination), the patient died. The outcome of the event was fatal with antithrombotic treatment. The reporting physician assessed the event as serious (death). The cause of death was cerebellar infarction. Autopsy was not performed. It was unknown if the patient was tested for COVID-19 after the vaccination.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event fatal cerebral infarction and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: Cerebellar infarction


VAERS ID: 1576812 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-09
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Computerised tomogram, Death, Pneumonia, SARS-CoV-2 test
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), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   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: Cardiomegaly (received no medical intervention); Hypertension (received no medical intervention); Lipids abnormal (received no medical intervention)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Autopsy imaging (AI)-CT; Result Unstructured Data: Test Result:ground-glass shadows in the dorsal half of bilater; Comments: ground-glass shadows in the dorsal half of bilateral lungs; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: JPPFIZER INC202101021206

Write-up: death/Unknown (pneumonia); death/Unknown (pneumonia); respiratory arrest/Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received. A 64-years-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: unknown as inoculated at another institution) at the age of 64-years, via intramuscular route on 28Jul2021 at single dose for COVID-19 immunization. The patient previously received the first single dose of BNT162b2 (COMIRNATY, solution for injection, lot number: unknown as inoculated at another institution) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient was a 64-year-old male. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. It was unknown if the patient had allergies to medications, food, and other products. Other medical history included hypertension, cardiomegaly, and lipids abnormal. It was reported that these were pointed out at medical checkup, but the patient received no medical intervention. Relevant past drug history was unknown. The description of the events was reported as follows: On 09Aug2021 at 05:30 (12 days after the vaccination), the patient developed respiratory arrest at his home and was transported by ambulance. At 05:47, the patient arrived at the reporting hospital. At the time, the patient was in cardio-respiratory arrest (pulseless electrical activity (PEA)). Cardiopulmonary resuscitation was continued; however, the patient had no response, and the death was confirmed at 06:43. Autopsy imaging (AI)-CT showed ground-glass shadows in the dorsal half of bilateral lungs, but the physician could not conclude that it was the direct cause of death. The result of COVID-19 PCR test was negative. The patient died on 09Aug2021. It was reported that no autopsy was done. The cause of death was reported as "unknown (pneumonia)". The events resulted in emergency room/department or urgent care. The outcome of the events was fatal. The patient received no treatment. The reporting physician assessed the events as serious (death, life-threatening). It was reported as unknown whether the patient has been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events cardiorespiratory arrest, pneumonia, death and 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: respiratory arrest/Cardio-respiratory arrest; death/Unknown (pneumonia); death/Unknown (pneumonia)


VAERS ID: 1576813 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Internal haemorrhage
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: 2021-07-02
   Days after onset: 2
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: Dementia with Lewy bodies; Edentulous
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202101023223

Write-up: This is a spontaneous report from a contactable nurse received from the Regulatory Authority. Regulatory authority report number is v21122753. The patient was a 94-year and 11-month-old female. Body temperature before vaccination on 29Jun2021 was 36.9 degrees centigrade. Family history and concomitant medication were not reported. Medical history included dementia with Lewy bodies, the patient had no teeth. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: not reported, Expiration date: not reported). On 29Jun2021 at 14:26 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EY5423, Expiration date: 31Aug2021) via an intramuscular route as a single dose for COVID-19 immunization at 94-year and 11-month-old. On 01Jul2021 at 23:00 (2 days after the vaccination), the patient experienced cardio-respiratory arrest. On 02Jul2021 (3 days after the vaccination), the outcome of the event cardio-respiratory arrest was fatal. The outcome of internal haemorrhage around the middle of the left tongue margin was unknown. It was unknown if autopsy was done. The course of the event was as follows: On 29Jun2021 at 14:26, the patient received the second dose of the COVID-19 vaccine. On 30Jun2021 at 09:00, internal haemorrhage around the middle of the left tongue margin was confirmed (the patient had no teeth). Internal haemorrhage did not appear to spread. On 01Jul2021 at 21:20, an aspiration was performed. On 01Jul2021 at 22:00, during a round, the patient''s condition was the same as usual. On 01Jul2021 at 23:00, during a round, the patient experienced pallor facial and respiratory arrest; thus, assistance was requested and the patient was taken to the emergency department. The reporting nurse classified the event cardio-respiratory arrest 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 geromarasmus. The reporting nurse commented as follows: No obvious symptoms of adverse reaction were observed. However, since the patient died after the second vaccination, this case was reported.; Reported Cause(s) of Death: Cardio-respiratory arrest.


VAERS ID: 1576814 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 - / -

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

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: Dialysis (go to hospital regularly); Heart disorder; Renal disease; Renal failure (end-stage)
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101023224

Write-up: unknown death; This is a spontaneous report from a contactable primary physician (also reported as clerical staff) received from the Regulatory authority; report number is v21122776. The patient was a 63-year and 9-month-old male. Age at vaccination was 63-year and 9-month-old male. Body temperature before vaccination was 35.8 degrees centigrade on 03Aug2021. The patient family history was not reported. Medical history included cardiac disease and kidney disease (the patient regularly went to hospital for the blood dialysis treatment due to end-stage renal failure). Concomitant therapy included dialysis treatment and treatment or medication. On 13Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY0583, Expiration date 31Oct2021) at age of 63-year-old. On 03Aug2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FE8162, Expiration date 30Nov2021) via an unspecified route of administration at 0.3 ml, as a single dose for COVID-19 immunization. On unknown date in Aug2021 at unknown time (unknown days after the vaccination), the patient experienced unknown death. On 05Aug2021 (two days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 03Aug2021 from 13:31 to 17:31, the patient received the dialysis treatment and returned home without significant changes. On 05Aug2021 at around 11:30, the hospital shuttle went to the patient home to pick him up for the dialysis treatment, but nobody responded. The family of the patient called the patient mobile phone, but no response. The local police were called. After that, the patient was confirmed dead by the local police. 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 was not reported. The reporting physician did not provide any further comment. Additional information from Prevaccination Screening for COVID-19 vaccine answered on 03Aug2021 was as follows: The patient was currently suffering from cardiac disease and kidney disease and receiving treatment or medication. The patient had not have a fever or gotten sick in the last month. There were no parts of the body that were not feeling well on the day of vaccination. The patient had never have a convulsion (seizure). The patient had never experienced severe allergic symptoms (such as anaphylaxis) from medications or foods. The patient had never been sick after receiving a vaccine. The patient had not have any vaccines within the last two weeks. In light of the results of the screening and examination, the physician assessed vaccine on that day was possible. After receiving a medical examination and explanation from a doctor and understanding the effects and side effects of the vaccine, the patient wished to receive the vaccine.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1576815 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-06
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Shock
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), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   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:
CDC Split Type: JPPFIZER INC202101023225

Write-up: cardiopulmonary arrest; Shock; This is a spontaneous report from a contactable physician (Emergency department) received from the Regulatory authority report number is v21122723. The patient was an 84-year and 3-month-old male. Body temperature before vaccination was unknown. The patient family history was unknown. Information was unknown reported 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 medical history and concomitant medication was not provided. On an unknown date, the patient previously received the first dose of COVID-19 Vaccine (Manufacturer Unknown, Lot number and, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 11Jul2021 or 12Jul2021 at unknown time (the day of vaccination), the patient received the second dose of COVID-19 Vaccine (Manufacturer Unknown, Solution for injection, Lot number and Expiration date unknown) via an unspecified route of administration as a single dose, for COVID-19 immunisation, at age of 84 years old of vaccination. On 06Aug2021 at 09:02 (25 days or 26 days after the vaccination), the patient experienced shock. The patient was transported to the reporting physician''s hospital. On 06Aug2021 at 10:36 (25 days or 26 days after the vaccination), the patient died. The outcome of the event was fatal. The course of the event was as follows: On 06Aug2021 at 08:40 (25 days or 26 days after the vaccination), the patient left the living room after saying ''''I''m going to the bathroom.'''' Then, his wife found the patient fall down in the bathroom. Emergency medical services were requested, and the patient was to be brought by ambulance to the reporting physician''s hospital. When the emergency staff arrived at the patient''s home, the patient was in shock status. At 09:04, cardiopulmonary arrest (CPA) was confirmed, for which cardiopulmonary resuscitation (CPR) was initiated. Even after arrival at the reporting physician''s hospital, a full course of resuscitation efforts was attempted. However, heart rate was not resumed. At 10:36, the death was confirmed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The outcome of all the events was fatal. Pfizer is the Marketing authorization holder of COVID-19 VACCINE in the country of incidence .This may be a duplicate report if another marketing authorization holder of COVID-19 VACCINE has submitted the same report to regulatory authorities. The lot number for the vaccine, COVID-19 Vaccine, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Shock; cardiopulmonary arrest


VAERS ID: 1576817 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardiac arrest, Chest pain, Computerised tomogram, Depressed level of consciousness, Scan myocardial perfusion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (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), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   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: Aneurysm (aneurysm of the ascending and descending aorta found on 28Jan2021); Angina pectoris; Chest pain (had become frequent in these days); Coronary artery bypass; Heart disorder; Ischaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210128; Test Name: CT; Result Unstructured Data: Test Result:aneurysm; Comments: in the ascending and descending aorta; Test Date: 20210806; Test Name: CT; Result Unstructured Data: Test Result:aortic dissection; Comments: ascending and descending aortic dissection; Test Name: myocardial scintigraphy; Result Unstructured Data: Test Result:aggravated ischaemia
CDC Split Type: JPPFIZER INC202101023236

Write-up: Acute aortic dissection; depressed level of consciousness; chest pain; asystole; This is a spontaneous report from a contactable physician (Emergency outpatient department) received from the Regulatory authority report number is v21122767. The patient was an 83-year-old female. Body temperature before vaccination was 36.3 degrees Centigrade on 05Aug2021. The patient family history was not reported. Medical history included cardiac disease (as reported), in 2008, the patient underwent coronary artery bypass surgery for angina pectoris. Chest pain attack had become frequent in these days, and findings of aggravated ischaemia were observed on myocardial scintigraphy. Treatment with oral medicines had been pushed to the limit. On 28Jan2021, computerised tomography (CT) revealed aneurysm in the ascending and descending aorta. The patient''s concomitant drug was not reported. On 05Aug2021 at 15:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization, at age of 83 years old of vaccination. On 06Aug2021 at around 01:00 (approximately 9 hours and 45 minutes after the vaccination), the patient experienced acute aortic dissection, chest pain and depressed level of consciousness. The patient was transported to the reporting physician''s hospital. On 06Aug2021 at an unknown time (unknown day or time after the vaccination), the patient died. The course of the event was as follows: In 2008, the patient underwent coronary artery bypass surgery for angina pectoris. Chest pain attack had become frequent in these days, and findings of aggravated ischaemia were observed on myocardial scintigraphy. Treatment with oral medicines had been pushed to the limit. On 28Jan2021, computerised tomography (CT) revealed aneurysm in the ascending and descending aorta. On 05Aug2021 (the day of vaccination), the patient received the vaccination. On 06Aug2021 past 01:00 (approximately 9 hours and 45 minutes after the vaccination), the patient experienced chest pain (illegible) and depressed level of consciousness. When emergency medical service staff arrived, asystole was confirmed. The patient was immediately transported to the reporting physician''s hospital. CT showed ascending and descending aortic dissection. The outcome of the events for acute aortic dissection was fatal, for other events was unknown. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was not reported. The reporting physician commented as follows: This situation would have occurred even if the patient had not been vaccinated; thus, the possibility of considered involvement of BNT162b2 was considered unknown (illegible) or unrelated.; Reported Cause(s) of Death: Acute aortic dissection


VAERS ID: 1576818 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-24
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Blood test, Echocardiogram, Myocarditis, Oxygen saturation
SMQs:, 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: 2021-07-27
   Days after onset: 3
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: DEXAMETHASONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple myeloma (DRd therapy had been initiated)
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Coronary angiography; Result Unstructured Data: Test Result:no significant stenosis in coronary artery; Test Date: 20210726; Test Name: Blood test; Result Unstructured Data: Test Result:increase in cardiac enzymes; Test Date: 20210726; Test Name: Echocardiography; Result Unstructured Data: Test Result:decrease in wall motion; Test Date: 20210726; Test Name: SpO2; Result Unstructured Data: Test Result:decrease; Comments: at 22:00
CDC Split Type: JPPFIZER INC202101023237

Write-up: fulminant myocarditis; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21122758. The patient was an 85-year and 5-month-old female (age at vaccination was 85-year and 5-month old). Body temperature before vaccination was not reported. On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were unknown) via an unspecified route of administration as a single dose for COVID-19 immunization, lenalidomide (REVLIMID), daratumumab, route of administration, start and stop date, batch/lot number and dose were not reported for multiple myeloma recurrent. The patient had no family history. Medical history included recurrent multiple myeloma. Concomitant medications included dexamethasone taken for multiple myeloma recurrent. On 08Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and expiration date were unknown) for COVID-19 immunization. On 24Jul2021 at around 10:00 (25 days after the vaccination), the patient experienced fulminant myocarditis. On 24Jul2021, the patient developed pyrexia and chest discomfort, for which the patient was admitted to hospital and antibiotic was started. On 24Jul2021 (25 days after the vaccination), the patient was admitted to the hospital. On 26Jul2021 at 22:00, the patient experienced decrease in SpO2. Blood test revealed increase in cardiac enzymes and echocardiography revealed decrease in wall motion. Coronary angiography was performed but there was no significant stenosis in coronary artery. It was assessed as myocarditis and vasopressor was started for blood pressure decreased. The condition did not improve and on 27Jul2021 at 17:18, death was confirmed. The action taken in response to the events for lenalidomide and daratumumab was not applicable. On 27Jul2021 (28 days after the vaccination), the outcome of the event was fatal. The patient died on 27Jul2021. It was unknown if an autopsy was performed. The reporting physician classified the event 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 REVLIMID and DARZQURO. The reporting physician commented as follows: Relationship between the vaccination and the event could not be denied. The lot number for the vaccine BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: fulminant myocarditis


VAERS ID: 1576819 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardio-respiratory arrest, Chest X-ray, Computerised tomogram thorax, Dyspnoea exertional, Echocardiogram, Interstitial lung disease, Oxygen saturation, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Interstitial lung disease (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   Days after onset: 15
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: TAGRISSO
Current Illness: Lung cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: blood pressure; Result Unstructured Data: Test Result:degreased; Test Date: 20210727; Test Name: chest X-ray; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210805; Test Name: chest X-ray; Result Unstructured Data: Test Result:No disease which might cause CRA; Comments: No disease which might cause cardio-respiratory arrest; Test Date: 20210802; Test Name: chest CT; Result Unstructured Data: Test Result:Ground-glass opacity in the left lower lobe; Test Date: 20210805; Test Name: echocardiogram; Result Unstructured Data: Test Result:R ventricular dilation/L ventricular collapse; Comments: right ventricular dilation and left ventricular collapse; Test Date: 20210727; Test Name: SpO2; Result Unstructured Data: Test Result:maintained %; Test Date: 20210802; Test Name: SpO2; Result Unstructured Data: Test Result:91 to 95 %; Test Date: 20210802; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210803; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: JPPFIZER INC202101023238

Write-up: drug-induced pneumonia/drug-induced interstitial pneumonia; pulmonary thromboembolism; Sudden cardio-respiratory arrest; dyspnoea exertional; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122724. The patient was a 71-year-old female. Body temperature before vaccination was not provided. The family history was not provided. The patient had medical history of lung cancer, for which she was orally taking osimertinib mesilate (TAGRISSO). On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). On 19Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization at age of 71 years old. On 05Aug2021 at 08:30 (17 days after the vaccination), the patient experienced sudden cardio-respiratory arrest. On 02Aug2021 (14 days after the vaccination), the patient was admitted to the hospital. On 05Aug2021 (17 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was orally taking osimertinib mesilate (TAGRISSO) for recurrence of lung cancer. On 19Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 21Jul2021 (2 days after vaccination), the patient had dyspnoea exertional. On 27Jul2021 (8 days after vaccination), at the regular hospital visit, SpO2 was maintained, and chest X-ray showed no abnormalities. Thereafter, the dyspnoea on exertion persisted. On 02Aug2021 (14 days after vaccination), the patient visited the outpatient department of the reporting hospital. The SpO2 was 91 to 95%, and chest CT showed ground-glass opacity in the left lower lobe. On the same day, the patient was admitted to the reporting hospital. The PCR for SARS-CoV-2 test was negative on 02Aug2021 (14 days after vaccination) and 03Aug2021 (15 days after vaccination). The patient was considered to have drug-induced pneumonia, and a drip infusion of a steroid was initiated. On 05Aug2021, at 08:00 (17 days and 8 hours after vaccination), the patient sent a line to her family, but she did not complain in particular. At 08:30 (17 days, 8 hours, and 30 minutes after vaccination), the patient complained of dyspnoa, and she put the nurse call button. The patient had orthopnea and rapid breathing. The blood pressure decreased, and the patient had cardio-respiratory arrest. The patient was transferred to the intensive care unit (ICU). The sternum was compressed, the trachea intubation was performed, an artificial ventilator was attached, and catecholamine was administered. Then, the pulse rate returned once; however, the patient had cardiac arrest again. At 11:21 (17 days, 11 hours, and 21 minutes after vaccination), the patient died. The echocardiogram when the pulse rate returned showed right ventricular dilation and left ventricular collapse. Chest X-ray showed no diseases which might cause cardio-respiratory arrest. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was as follows: Almost no examination could be performed after a sudden change. Although there were many unclear points, pulmonary thromboembolism was most considerable. Others were deniable. The reporting physician commented as follows: At the time of the hospitalization, the cause of hypoxia was considered as drug-induced interstitial pneumonia. However, the range was not so large, and chest X-ray after a sudden change showed no expansion of the opacity. It was not considered that the sudden change occurred due to acute aggravation of interstitial pneumonia. It was most reasonable that the patient was complicated with pulmonary thromboembolism based on the clinical course; however, there was no direct evidence. If the patient would have thrombosis, the causality between the event and the vaccination was unknown. However, since the patient died, this case was reported. The outcome of events drug-induced pneumonia/ drug-induced interstitial pneumonia, pulmonary thromboembolism, dyspnoea exertional was not resolved. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Sudden cardio-respiratory arrest


VAERS ID: 1576820 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-08-03
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   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: JPPFIZER INC202101023245

Write-up: Suicide; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was an 80-year-old male. On 17Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as single dose for COVID-19 immunization. Relevant medical history was unknown. Concomitant medications were not reported. On 26Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunization. On 03Aug2021 (17 days after the vaccination), the patient experienced suicide at his home. The patient died on 03Aug2021. It was not reported whether an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2 vaccination. The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on known drug safety profile, there is less possibility of causal association between the event Suicide and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Suicide


VAERS ID: 1576821 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 3
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: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101023253

Write-up: cerebral infarction; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 72-year-old female. Underlying disease included hypertension. Concomitant medications were not reported. On an unspecified date, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# and Expiration date were not reported) via an unspecified route of administration as dose 1, single for COVID-19 immunisation. On 24Jun2021 at unspecified time (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot# and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 28Jun2021 (four days after the vaccination), the patient experienced cerebral infarction. The patient was admitted to hospital. On 01Jul2021 (seven days after the vaccination), the patient died. It was not reported if an autopsy was performed. The reporting physician assessed that the causality between the event and bnt162b2 as unknown. The outcome of the event was fatal. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on temporal association, the causal relationship between bnt162b2 and the event cerebral infarction cannot be excluded. The contributory role of the pre-existing hypertension in this elderly female cannot be ruled out as well. 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: cerebral infarction


VAERS ID: 1576824 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-13
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   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: Intellectual disability; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101023468

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory authority; report number is v21122809. A 35-years-old female patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 02Jul2021 16:00 (Lot Number: FC3661; Expiration Date: 30Sep2021) as dose 2, single (at age of 35-years-old) for covid-19 immunisation. Medical history included intellectual disability and sleep apnoea syndrome. The patient had no relevant family history. The patient''s concomitant medications were not reported. Historical Vaccine included the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA2453, Expiration date: 31Aug2021) on 10Jun2021 as a single dose for COVID-19 immunization. On 13Jul2021 at 15:00 (11 days after the vaccination), the patient experienced subarachnoid haemorrhage. On 13Jul2021 at 16:39 (11 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 13Jul2021 at around 15:00, since the patient complained of headache, she took CALONAL 200 mg, 2 tablets, and then went to the restroom. When she returned from the restroom, she lost consciousness and collapsed. An ambulance was called, and she was transferred to a hospital where cardiopulmonary resuscitation was performed. However, at 16:39, the patient passed away. The patient underwent lab tests and procedures which included body temperature: 36.5 centigrade before vaccination on 02Jul2021. Outcome of the event was fatal. The reporting physician classified the event as serious (fatal outcome) 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 event occurred 11 days after the second dose of the vaccination, therefore it could not be said that there was no causal relationship.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1576840 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-31
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002337 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Cardiac death, Cardiomegaly, Malaise, Pulmonary congestion, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), 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: 2021-07-31
   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: Dilated cardiomyopathy (Idiopathic dilated cardiomyopathy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP069699

Write-up: This case was received via Regulatory Authority (Reference number: 2021TJP069699) on 03-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This case, reported by a physician, was via adverse reaction reporting site (TASK0020683). On an unknown date, body temperature before the vaccination: 36.5 degrees Celsius. On 02-Jul-2021, at 13:30, the patient received the 1st dose of the vaccine. On 30-Jul-2021, at 13:30, the patient received the 2nd dose of the vaccine. On 31-Jul-2021, low-grade fever and malaise developed, so the patient took a rest. At 12:00, the patient was confirmed as normal for the last time by the conversation with the patients wife. At 13:15, when the wife went to see the patient, there was no response, and the patient was transported by ambulance with asystole. At 13:24, the patient was in a state of asystole when the ambulance crew contacted with him. After transportaion to the hospital, CPR was continued, and 6A of adrenaline was administered in total, but the patient was in a state of asystole throughout the whole time. At 14:07, the patient was confirmed dead. AiCT: there were images of cardiomegaly and congestion in the lung field, no intracranial hemorrhage, no intrathoracic or intraperitoneal hemorrhage, and no images suggestive of aortic dissection or cardiac tamponade. The cause of death was confirmed as acute cardiac death (1 hour from onset to death) at autopsy. Lethal arrhythmia may be one of the other possible contributing factors. The outcome of low-grade fever, malaise, asystole, cardiomegaly, and image of congestion in the lung field was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Low grade fever; Malaise; Asystole; Cardiomegaly; Pulmonary congestion; Cardiac death


VAERS ID: 1576841 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anal incontinence, Body temperature, Cardiac arrest, Malaise, Pupillary reflex impaired, Pyrexia, Respiratory arrest, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: 37.8 degrees Celsius; Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: 36 degrees Celsius, Body temperature slightly decreased
CDC Split Type: JPTAKEDA2021TJP069734

Write-up: Respiratory arrest; Cardiac arrest; Respiratory elimination; Loss of light reflex; Faecal incontinence; Vomiting; Malaise; Pyrexia; This case was received via Regulatory Authority (Reference number: 2021TJP069734) on 04-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. The license partner had received the report (Reference number: v21122358 ). This case, initially reported to the Regulatory Agency by a pharmacist, was received (Ref, v21122358). On an unknown date, body temperature before the vaccination: unknown. On an unknown date, the patient received the 1st dose of this vaccine. On 05-Jul-2021, the patient received the 2nd dose of this vaccine. On 06-Jul-2021, pyrexia of about 37.8 degrees Celsius developed. On 07-Jul-2021, body temperature was in the 36 degrees Celsius range. The patient had malaise but ate as usual. On 08-Jul-2021, around 18:30, the family member heard the patient''s sleep-breath. Around 19:30, the patient was in respiratory arrest, and an emergency call was made. At 19:33, the patient was raced to a hospital (using an automatic cardiac massage machine). CPR for asystole was performed, and oral vomit was aspirated. The patient had faecal incontinence. Route was secured, and adrenaline was administered intravenously 7 times. PAE occurred several times but returned to asystole. The patient''s family memeber did not request intubation or ventilator management. CPR was performed for about 1 hour, and its discontinuation was requested. Spontaneous circulation, spontaneous breathing, and loss of light reflex were noted. At 20:30, the patient was confirmed dead. The outcome of pyrexia, malaise, respiratory arrest, vomiting, faecal incontinence, cardiac arrest, respiratory elimination, and loss of light reflex was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Pyrexia; Malaise; Respiratory arrest; Vomiting; Faecal incontinence; Cardiac arrest; Respiratory arrest; Pupillary light reflex lost


VAERS ID: 1576842 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure congestive, Computerised tomogram, Cough, Decreased appetite, Diarrhoea, Dyspepsia, Dyspnoea, Gait inability, Lung neoplasm malignant, Malaise, Myalgia, Nausea, Orthopnoea, Pericardial effusion, Pneumonia, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Dermatitis atopic; Glucose tolerance impaired; Lung cancer (Postoperative lung cancer).
Preexisting Conditions: Medical History/Concurrent Conditions: Lung neoplasm surgery (Postoperative lung cancer).
Allergies:
Diagnostic Lab Data: Test Name: CT Scan; Result Unstructured Data: Diagnosed with pneumonia and pericardial effusion and further details were not specified.; Test Name: X-ray; Result Unstructured Data: Diagnosed with pneumonia and pericardial effusion and further details were not specified.
CDC Split Type: JPTAKEDA2021TJP069751

Write-up: Cardiac failure congestive; Lung cancer; Diarrhoea; Heartburn; Inappetence; The patient had orthopnea; Nausea; Pericardial effusion; Pneumonia; Patient was unable to walk properly even for about 5 minutes; Shortness of breath; Cough; Malaise; Myalgia in the arm; This case was received via the Regulatory Authority (Reference number: 2021TJP069751) on 03-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This case, reported by a physician, was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0020687). On an unknown date, body temperature before the vaccination: unknown. On 08-Jul-2021, the patient received the 1st dose of this vaccine. On 09-Jul-2021, the patient experienced myalgia in the arm and malaise. On 10-Jul-2021, short of breath and cough occurred. The symptom tended to get worse. On 19-Jul-2021, the patient was unable to walk properly even for about 5 minutes, and cough also persisted. The patient visited a primary care physician and underwent X-ray and CT, and the patient was seemed to be diagnosed with pneumonia and pericardial effusion (details unspecified). On 20-Jul-2021, the patient had nausea, diarrhoea, heartburn, and inappetence. The patient had orthopnea. On 24-Jul-2021, before dawn, the patient was confirmed dead. According to the postmortem report, the patient died due to cardiac failure congestive and lung cancer around 22-Jul-2021. The outcome of malaise, shortness of breath, cough, pneumonia, and pericardial effusion was fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 61 year-old male patient with a history of lung cancer, who died approximately 16 days after receiving the first dose of the mRNA-1273 vaccine. There is a discrepancy in source document regarding the date of death. For the event lung neoplasm malignant: based on information received and the natural history of lung cancer, the event is assessed as unlikely related to mRNA-1273. For the rest of the events, very limited information has been provided at this time. However, patient''s significant history of lung cancer could be a confounding factor that may play a possible contributory role, providing alternative explanation.; Reported Cause(s) of Death: Malaise; Shortness of breath; Cough; Pneumonia; Pericardial effusion; Cardiac failure congestive; Lung cancer


VAERS ID: 1576859 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse drug reaction
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: KRJNJFOC20210827798

Write-up: UNSPECIFIED ADVERSE REACTIONS; This spontaneous report received from a consumer concerned 7 patients. 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, one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced unspecified adverse reactions. On an unspecified date, the patient died from unspecified adverse reactions. It was unknown if the 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: V0:20210827798- covid-19 vaccine ad26.cov2.s -UNSPECIFIED ADVERSE REACTIONS . 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: UNSPECIFIED ADVERSE REACTIONS


VAERS ID: 1576860 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Condition aggravated, Death, Diarrhoea, Loss of consciousness, Rash
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   Days after onset: 34
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRMODERNATX, INC.MOD20212

Write-up: unconscious; condition got even worse at night; Death; Rash; Diarrhea with abdominal pain; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), LOSS OF CONSCIOUSNESS (unconscious), DIARRHOEA (Diarrhea with abdominal pain), ABDOMINAL PAIN (Abdominal pain), CONDITION AGGRAVATED (condition got even worse at night) and RASH (Rash) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIARRHOEA (Diarrhea with abdominal pain) (seriousness criterion hospitalization) and ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization). In July 2021, the patient experienced RASH (Rash) (seriousness criterion hospitalization). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criteria hospitalization and medically significant) and CONDITION AGGRAVATED (condition got even worse at night) (seriousness criterion hospitalization). The patient died on 04-Aug-2021. The cause of death was not reported. An autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (unconscious), DIARRHOEA (Diarrhea with abdominal pain), ABDOMINAL PAIN (Abdominal pain), CONDITION AGGRAVATED (condition got even worse at night) and RASH (Rash) outcome was unknown. Concomitant product was not provided by the reporter. Lab data was not provided by the reporter. Treatment product was not provided y the reporter. Company Comment Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-07-09
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Arthritis, Cyanosis, Dyspnoea, Pulmonary embolism, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 16
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: Juvenile idiopathic arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC202101010732

Write-up: Anxiety; Syncope; Cyanosis; Periodic shortness of breath, pronounced shortness of breath on 2021/07/25; Pulmonary thromboembolism; suspicion of arthritis flare; ankle arthralgia; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number LV-SAM-2021076347. This physician reported events for the same patient after 2 doses of the vaccine. This is the first of two reports for the second dose. Only this case is serious. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 15Jun2021 (Batch/Lot Number: FC2336) as 0.3ml, single dose for covid-19 immunisation. The patient''s medical history includes Juvenile idiopathic arthritis (seronegative juvenile idiopathic arthritis, start in 2006, rheumatologist last seen in 2013, On 09Jul2021 patient went to GP with complaint of ankle arthralgia. Due to suspicion of arthritis flare, patient sent for blood testing and consultation with a rheumatologist, which was not done). The patient''s concomitant medications were not reported. The patient received the 1st vaccination dose with Comirnaty (BioNTech, batch No. EW6126) 0,3 ml intramuscularly on 25May2021. After receiving the 1st vaccination dose on 25May2021 the patient experienced fatigue and body temperature increased (37.3 C). The events of fatigue and body temperature increased resolved after 2 days. The patient received the 2nd vaccination dose with Comirnaty (BioNTech, batch No. FC2336) 0,3 ml intramuscularly on 15Jun2021. The patient experienced no symptoms immediately after 2nd vaccination dose. On 09Jul2021 patient went to GP with complaint of ankle arthralgia. Due to suspicion of arthritis flare, patient sent for blood testing and consultation with a rheumatologist, which was not done. On 13Jul2021 (also reported on 15Jul2021) the patient started to experience periodic shortness of breath. On 25Jul2021 the patient experienced pronounced shortness of breath, cyanosis, anxiety, syncope. The emergency medical services were called at 12:00 and the patient was hospitalized at 13:02. On 25Jul2021 the patient was diagnosed with pulmonary thromboembolism. The outcome of the event pulmonary thromboembolism is fatal, the patient was pronounced dead on 25Jul2021 at 13:46. Autopsy is in progress. The outcome of other events was unknown.; Sender''s Comments: Linked Report(s) : LV-PFIZER INC-202101020906 same patient, different events after 1st/2nd dose; Reported Cause(s) of Death: Pulmonary thromboembolism


VAERS ID: 1576955 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: 00646946) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003604) for COVID-19 vaccination. No Medical History information was reported. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 10-Jul-2021 The patient died on 10-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant products were not provided. Treatment medication were not reported. Company comment: This case refers to a 29-year-old male patient who died 4 days after receiving the dose 1 of mRNA-1273. Cause of death was not reported. Very limited information regarding the event has been provided at this time insufficient for causality assessment.; Sender''s Comments: This case refers to a 29-year-old male patient who died 4 days after receiving the dose 1 of mRNA-1273. Cause of death was not reported. Very limited information regarding the event has been provided at this time insufficient for causality assessment.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1576956 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-20
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 - / -

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

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101016141

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00650513. A 70-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FA8016) at single dose on 01Jun2021 via an unknown route for COVID-19 immunisation. Medical history and concomitant drug were not provided. Patient had no previous COVID-19 infection. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY) at single dose on 27Apr2021 for COVID-19 immunisation. Serious adverse event was reported as fatigue, unclear: no obvious side effects reported beforehand with onset date of 20Jul2021 (also reported as 2 months after start) and seriousness criterion of death. Patient passed away on 20Jul2021 (also reported as 5 weeks after 2nd vaccination). No diagnostic procedures performed. The outcome of fatigue was fatal. It was unknown if autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: fatigue, unclear: no obvious side effects reported beforehand


VAERS ID: 1576957 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood pressure measurement, Blood test, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: HYDROCHLOORTHIAZIDE; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Solitary kidney (donated a kidney 17 years ago)
Allergies:
Diagnostic Lab Data: Test Name: autopsy; Result Unstructured Data: Test Result:it could not be confirmed nor denied that she died; Comments: it could neither be confirmed nor denied that she died as a result of cardiac arrest. The brain was not examined. All other organs showed no evidence.; Test Date: 202104; Test Name: blood pressure; Result Unstructured Data: Test Result:was good; Test Date: 202104; Test Name: other blood results; Result Unstructured Data: Test Result:were good
CDC Split Type: NLPFIZER INC202101016145

Write-up: Death: Sudden death without awareness of underlying conditions/Cause could not be determined with certainty; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number NL-LRB-00650821. Safety Report Unique Identifier NL-LRB-00655495. A 70-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01May2021 (Lot Number: ET6956) as 0.3 mL single dose for covid-19 immunisation. Medical history included Solitary kidney: donated a kidney 17 years ago; Blood pressure abnormal. No Previous COVID-19 infection. Concomitant medications included hydrochlorothiazide and losartan for blood pressure. The patient experienced death: sudden death without awareness of underlying conditions on 03May2021. Cause could not be determined with certainty. Patient''s health prior to vaccination was good. She was working in her garden in the days before her death. A day before her death, reporter saw patient and she had no complaints/side effects. On the day of her death she took her car to a garage. Passing away. Diagnostic procedures: Autopsy excluding brain. 1. There were no complaints. The reporter saw and spoke to her on Sunday (02May). She was in normal shape. Monday morning, 03May, she brought her car to the garage. 2. No deterioration of health. The days before, the backyard was taken care of. She was still pulling conifers out of the garden herself. 3. Mother (patient) lived with her husband. There was no question of home care. 4. She was on blood pressure medication: Hydrochlorothiazide 12.5 and Losartankalium 50 mg. She had been for a check-up the week before her death (Apr2021) and at that time her blood pressure and other blood results were good. (She underwent this annual checkup because she donated a kidney 17 years ago). 5a. To present knowledge, it could not be confirmed nor denied that she died as a result of cardiac arrest. The brain was not examined. All other organs showed no evidence. 5b. That would follow as soon as the family doctor returns from vacation. They had not requested one yet. 6. No, she had no symptoms and so no test was taken. The outcome of sudden death was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death: sudden death without awareness of underlying conditions/Cause could not be determined with certainty.; Autopsy-determined Cause(s) of Death: To the best of knowledge it could not be confirmed nor denied that she died as a result of cardiac arrest.


VAERS ID: 1577034 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-26
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Chills, Decreased appetite, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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:
CDC Split Type: PHJNJFOC20210823970

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096825] concerned a 64 year old male of unspecified 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) dose was not reported, 1 total administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021 at 10:00, the patient experienced fever, chills, body weakness and loss of appetite. On an unspecified date, the patient experienced covid-19. On an unspecified date, the patient died from fever, chills, weakness, appetite lost, and covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of body weakness and loss of appetite on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210823970-Covid-19 vaccine ad26.cov2.-Fever, chills, weakness, loss of appetite , and covid-19. 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; WEAKNESS; APPETITE LOST; COVID-19


VAERS ID: 1577039 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Chest pain, Dysphagia, Fatigue
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), 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: PHJNJFOC20210824082

Write-up: CHEST PAIN; HYPERTENSION; DIFFICULTY OF SWALLOWING; FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300096200] concerned a 59 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, with frequency as 1 total administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021 at 04:00, the patient experienced chest pain, hypertension, difficulty of swallowing, fatigue and died. 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).; Sender''s Comments: V0: 20210824082-covid-19 vaccine ad26.cov2.s -Chest pain, Hypertension, Difficulty of swallowing, fatigue. 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: FATIGUE; DIFFICULTY OF SWALLOWING; HYPERTENSION; CHEST PAIN


VAERS ID: 1577043 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21321A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824177

Write-up: FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA (PH-PHFDA-300097291)] concerned a 69 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 and batch number: 21321A, expiry: unknown) dose was not reported,1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 19:00 the patient experienced fatigue and was hospitalized on unknown date. On an unspecified date, the patient died from fatigue. 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).; Sender''s Comments: V0.20210824177-covid-19 vaccine ad26.cov2.s -Fatigue. 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: FATIGUE


VAERS ID: 1577047 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   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:
CDC Split Type: PHJNJFOC20210824221

Write-up: ABDOMINAL PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096378] concerned a 77 year old male of unspecified 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, frequency time 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021 at around 01:00 the patient experienced severe abdominal pain and at 01:15 the patient died from abdominal pain. 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; 20210824221-covid-19 vaccine ad26.cov2.s - Severe abdominal pain. 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: ABDOMINAL PAIN


VAERS ID: 1577058 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: PHJNJFOC20210824371

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority (PHIFDA, PH-PHFDA-300096514) concerned an 80 year old male of unspecified 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 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 02:00, the patient died from sudden attack of severe abdominal pain followed by loss of consciousness. 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- 20210824371-Covid-19 vaccine ad26.cov2.S- Abdominal pain. 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: ABDOMINAL PAIN


VAERS ID: 1577079 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-28
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 20SC21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Nausea, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: PHJNJFOC20210824619

Write-up: SHORTNESS OF BREATH; FEVER; COUGH; NAUSEA; VOMITING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095692] concerned a 36 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, and batch number: 20SC21A) dose was not reported, 1 total, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, at 08:00, the patient experienced shortness of breath, fever, cough, nausea and vomiting. On an unspecified date, the patient died from shortness of breath, fever, cough, nausea and vomiting. 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 shortness of breath, fever, cough, nausea and vomiting on an unspecified date. This report was serious (Death).; Sender''s Comments: V0: 20210824619-covid-19 vaccine ad26.cov2.s-shortness of breath, fever, cough, nausea and vomiting. 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; NAUSEA; VOMITING; FEVER; SHORTNESS OF BREATH


VAERS ID: 1577081 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213021A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   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: PHJNJFOC20210824684

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096036] concerned a 62 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 not reported, batch number: 213021A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 09:30, the patient died from unknown cause of death. 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: 20210824684-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: 1577084 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: PHJNJFOC20210824738

Write-up: cough, loss of appetite, blood clot; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097326] concerned a 69 year old male. 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 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021 at 05:00, the patient experienced cough, loss of appetite, blood clot. On an unspecified date, the patient died from cough, loss of appetite, blood clot. 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: 20210824738-Covid-19 vaccine ad26.cov2.- Cough, loss of appetite, blood clot. 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, LOSS OF APPETITE, BLOOD CLOT


VAERS ID: 1577101 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue
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: PHJNJFOC20210824935

Write-up: FATIGUE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097893] concerned an 81 year old female of unknown 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,expiry: unknown) dose was not reported,1 total, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced fatigue. On 2021, the patient died from fatigue. 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 20210824935-covid-19 vaccine ad26.cov2.s-Fatigue. 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: FATIGUE


VAERS ID: 1577105 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C214 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest pain, Cough, Dyspnoea, Malaise, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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: 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: Test Date: 20210804; Test Name: Oxygen saturation; Result Unstructured Data: 63 %, low
CDC Split Type: PHJNJFOC20210824989

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300097671] concerned a 63 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: 213C214, and expiry: UNKNOWN) dose was not reported,1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, at 07:19, the patient experienced fever and body weakness (General malaise). On 04-AUG-2021, at 7:00, the patient experienced cough, chest pain and laboratory data Included oxygen saturation of 63 percent (low) and at 7:19, the patient experienced body weakness (weakness). On 05-AUG-2021, at 07:19, the patient experienced difficulty of breathing. On an unspecified date, the patient was hospitalized due to cough, chest pain, difficulty of breathing, body weakness (weakness) and oxygen saturation of 63 percent. On an unspecified date, the patient died from fever, cough, difficulty of breathing, body weakness (weakness), chest pain, 63 percent oxygen saturation, and body weakness (General malaise). 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: 20210824989-covid-19 vaccine ad26.cov2.s-fever, cough, difficulty of breathing, body weakness, chest pain, 63 percent oxygen saturation, and 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; COUGH; DIFFICULTY OF BREATHING; BODY WEAKNESS; CHEST PAIN; 63% OXYGEN SATURATION; BODY WEAKNESS


VAERS ID: 1577110 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Pyrexia, Vaccination site pain
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: 2021-08-02
   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: Alcohol use (Someone saw him drinking liquor in the morning.)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210825036

Write-up: FEVER; CHILLS; PAIN ON INJECTION SITE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300097063] concerned a 95-year-old male of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient''s concurrent conditions included: alcohol user (Someone saw him drinking liquor in the morning). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency time was 1 total administered on 29-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 31-JUL-2021, the patient experienced fever, chills and pain on injection site and treatment medication Included he took paracetamol 500 milligram. On 02-AUG-2021, the patient died from fever, chills and pain on injection site at around 3-4 AM, patient was found dead on his bed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of fever, chills and pain on injection site on 02-AUG-2021. This report was serious (Death).; Sender''s Comments: V0 20210825036-COVID-19 VACCINE AD26.COV2.S-fever, chills, pain on injection site. 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; PAIN ON INJECTION SITE


VAERS ID: 1577146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chest pain, Cough, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 antigen test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210826579

Write-up: EPIGASTRIC PAIN; CHEST PAIN; COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA,PH-PHFDA-300097363] concerned a 60 year old female. 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: 212C21A, expiry: unknown) dose was not reported, one total, administered on 22-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced cough. On 05-AUG-2021, the patient experienced epigastric pain and chest pain. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) Positive. On an unspecified date, the patient died from cough, epigastric pain, and chest pain. 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 20210826579-COVID-19 VACCINE AD26.COV2.S-cough, epigastric pain, chest pain. 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; EPIGASTRIC PAIN; CHEST PAIN


VAERS ID: 1577149 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
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: 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: Cardiac disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101002325

Write-up: allegedly died due to complications; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included unspecified cardiac condition. The patient''s concomitant medications were not reported. The patient allegedly died due to complications on an unspecified date. It was unknown if an autopsy was performed. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: allegedly died due to complications


VAERS ID: 1577169 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Dyspnoea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 23
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: 20210410; Test Name: Body temperature; Result Unstructured Data: Test Result:39.0-39.4; Test Date: 202104; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive
CDC Split Type: PLPFIZER INC202101010736

Write-up: Fever; Dyspnea; Sars-Cov-2 Rt-PCR test was performed - positive; This is a spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is PL-URPL-3-833-2021. A 54-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 10Apr2021 10:54 (Lot Number: EW2243; Expiration Date: 11Apr2021) (at age of 54-year-old) as dose 1, 0.3 mL, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Date of the reaction 10Apr2021 at 17:10. On the report of adverse reaction after vaccination, the following was noted: fever 39.0-39.4. After vaccination on 10Apr2021 fever and shortness of breath occurred. The patients condition worsened, and the Sars-Cov-2 Rt-PCR test was performed - positive. On 24Apr2021 the patient died. Therefore, the infection with COVID-19 immediately after the administration of the 1st dose, the infection could have started even before vaccination. The disease occurred in the time coincidence until vaccination. The person reporting adverse event following immunisation qualified it as serious. Agency for Registration of Medicinal Products assessed the adverse events following immunisation as serious (death). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fever; Dyspnea; COVID-19


VAERS ID: 1577170 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 1433 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   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: Alcohol abuse; Alcoholic seizure (The patient was not treated systematically for the disease.); Gastroesophageal reflux (The patient was not treated systematically for the disease.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101010870

Write-up: patient was found dead in his house, laying naked on the floor; vomit; This is a spontaneous report received from a contactable physician downloaded from the Agency WEB. The regulatory authority report number is PL-URPL-3-835-2021. A 59-year-old male patient received second dose of BNT162B2 (COMIRNATY), via intramuscular, administered in left arm on 14Jul2021 14:19 (Lot Number: FC 1433; Expiration Date: 07Aug2021, at the age of 59-year-old ) as single dose for covid-19 immunisation. Medical history included alcohol-induced epilepsy (alcohol abuse) and gastric reflux disease. The patient was not treated systematically for the disease. The patient''s concomitant medications were not reported. On 15Jul2021 at 11:15 a post-vaccination reaction occurred. Patient was found dead in his house, laying naked on the floor in his own vomit. On 16Jul2021, the patient''s general practitioner (GP) was interviewed, and the following information was obtained: the patient suffered from alcohol-induced epilepsy (alcohol abuse) and gastric reflux disease. The patient was not treated systematically for the diseases mentioned. He was found in his own house naked on the floor in his own vomit. The called doctor declared death. The prosecutor present at the inspection did not order an autopsy. The outcome of the event "patient was found dead in his house, laying naked on the floor" was fatal, for event vomit was unknown. The patient died on 15Jul2021. An autopsy was not performed. The reporting person classified them as serious. Health Agency also classified the application as serious. Sender comment: Comirnaty are an mRNA vaccine against COVID-19 (with modified nucleosides). Vomiting was an expected side effect of Comirnaty. There was a time relationship between the administration of the vaccine and the occurrence of the reaction. However, due to the information about alcohol abuse by the patient and the lack of information about alcohol consumption (or not) after administration of the vaccine, the causal relationship has not been assessed. Relatedness of drug to event: vomiting, Result of Assessment: unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: patient was found dead in his house, laying naked on the floor


VAERS ID: 1577274 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial ischaemia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Other ischaemic heart disease (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: Bladder neoplasm; Coronary artery stenosis (constricted coronary arteries); Ischemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100996719

Write-up: Ischemic heart disease; Fever; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number SE-MPA-2021-061580. An 87-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on May2021 (Batch/Lot Number: EY2172) at the age of 87 years old, as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included ongoing ischemic heart disease, ongoing coronary artery stenosis (constricted coronary arteries), ongoing tumor of the bladder, myocardial infarction from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Historical vaccination included first dose of bnt162b2 (COMIRNATY) given on Mar2021 (batch# EY2172) for COVID-19 immunisation. Reported suspected adverse event was fatal ischemic heart disease in May2021, the same day as vaccination. The patient also had fever on May2021. The patient died on an unspecified date. An autopsy was performed, and results were not provided. The description includes information that allergy runs in the family on the man''s side, but not to what, nor whether the man himself had reacted to anything in the past. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fever; Ischemic heart disease


VAERS ID: 1577311 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-05-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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:
CDC Split Type: SEPFIZER INC202101010759

Write-up: major brain haemorrhage; NUMBNESS IN HALF OF THE BODY; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number SE-MPA-2021-066026. A 69-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 19Apr2021 as single dose for COVID-19 immunizaiton. Medical history and concomitant medication were not reported. The patient was previously healthy. In May2021, two weeks after the first shot, the patient experienced numbness in one side of her body, went to the emergency room but this was dismissed as an adverse reaction to the vaccine and she was allowed to go home. Just over a week later the same numbness returned again and the woman took public transport to hospital and on the way she suffered a major brain haemorrhage and died a few hours later in hospital. The cause of death was cerebral bleeding. Autopsy was not reported. The outcome of events was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral bleeding


VAERS ID: 1577326 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101016256

Write-up: Malignant arrhythmia; This is a spontaneous report received from a contactable Physician downloaded from the WEB. The regulatory authority report number is SE-MPA-2021-069964. A 61-years-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular in May2021 (Lot Number: EX8680) as 0.3 ml single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatal malignant arrhythmia 4 days later in May2021. The patient died in May2021. An autopsy was performed that revealed mild arteriosclerosis but no signs of bleeding or thrombosis. The only real findings are enlarged heart and bilateral pulmonary edema as signs of acute circulatory disturbance. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: malignant arrhythmia; Autopsy-determined Cause(s) of Death: Mild arteriosclerosis


VAERS ID: 1577337 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Diarrhoea, Fatigue, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
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: SEPFIZER INC202101026225

Write-up: Blood clot; lack of energy; tired; diarrhea; high blood pressure; This is a spontaneous report from a contactable consumer. An 83-years-old female patient (mother) received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 for COVID-19 immunisation. The patient experienced blood clot (death, hospitalization) on an unspecified date in 2021, lack of energy on an unspecified date in 2021 with outcome of unknown, tired on an unspecified date in 2021 with outcome of unknown, diarrhea on an unspecified date in 2021 with outcome of unknown, high blood pressure on an unspecified date in 2021 with outcome of unknown. Clinical course reported as follow: Patient got both doses and died of a blood clot the 06Jun2021. The reporter thought patient got the second dose in April. After that she felt tired some days. She had even told acquaintances that she had diarrhoea. She had a little high blood pressure and the reporter picked up her medication during these times. The blood clot that was building in her stomach have not just happened over one night. She was admitted to hospital on the 26May2021. The bowel had not gotten oxygen and when they investigated her after they said that she should have needed to operate away parts of the bowel. The patient died on 06Jun2021. It was not reported if an autopsy was performed. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Blood clot


VAERS ID: 1577683 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-03-19
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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: 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 Name: Sars-cov-2 test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101016139

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39205. A 95 Years old Female patient received BNT162B2 (COMIRNATY), 1st dose on 08Jan2021 (batch/lot number EJ6796, expiration date 30Apr2021); 2nd dose on 29Jan2021 (batch/lot number EJ6134, expiration date 30Apr2021) at single dose for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. On 19Mar2021 the patient experienced Vaccination failure, other, SARS-CoV-2 infection. The patient''s outcome was fatal. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6796. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6134. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1577684 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-11
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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:
CDC Split Type: ATPFIZER INC202101016114

Write-up: Vaccination failure, other, SARS-CoV-2 infection; Vaccination failure, other, SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39261. A 93-year-old male patient received BNT162B2 (COMIRNATY), 1st dose on 01Apr2021(lot number ET7205, expiration date 31Jul2021), 2nd dose on 22Apr2021 (lot number EW4815, expiration date 31Jul2021), both at single dose for COVID-19 immunisation. Medical history and concomitant drug were not provided. Serious adverse event was reported as Vaccination failure, other, SARS-CoV-2 infection with onset date of 11May2021 and seriousness criterion of death. Outcome of SARS-CoV-2 infection was fatal. Quality investigation conclusion for lot ET7205: The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET7205. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Quality investigation conclusion for lot EW4815: The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EW4815. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Vaccination failure, other, SARS-CoV-2 infection; Vaccination failure, other, SARS-CoV-2 infection


VAERS ID: 1577685 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drowning, Epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Accidents and injuries (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016215

Write-up: Epeleptic seizures every 2-3 days; Drowned in pool due to epileptic seizure; Drowned in pool due to epileptic seizure; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39286. A 56-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced drowned in pool due to epileptic seizure on Jul2021, epeleptic seizures every 2-3 days on 14Jul2021 with outcome of not recovered. Patient drowned in pool due to epileptic seizure. The patient died on Jul2021. It was not reported if an autopsy was performed. Sender''s comments: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Drowned in pool due to epileptic seizure; Drowned in pool due to epileptic seizure


VAERS ID: 1577731 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, 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)

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: CAPFIZER INC202101022719

Write-up: Cerebrovascular accident; This is a Spontaneous report from a contactable Consumer Or Other Non Health Professional. This is a report received from the Regulatory Authority via an on-line database search. Regulatory authority report number 000944395. This information was initially reported to Regulatory Authority on 02Apr2021 from the community. A female patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN which was reported as COVID-19 VACCINE), via unknown route on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident (death) on an unspecified date with fatal outcome. 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.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1577732 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyslexia, Intellectual disability, Interchange of vaccine products, Mental disorder, Myocardial infarction, Neoplasm malignant, Off label use, Retinal degeneration, Retinal detachment, Retinal tear
SMQs:, Myocardial infarction (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (broad), Retinal disorders (narrow), Medication errors (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
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: Medical History/Concurrent Conditions: ECT (Duration of Hospitalization: 4. Hospitalization prolonged: yes. Treatment Received: unknown.); Meningitis meningococcal (Hospitalization Prolonged: Yes. Treatment received: No.); Mental disorder NOS (diagnostic and statistical manual of mental disorders)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101029604

Write-up: heart attack; retina tear; retina detachment; all dsm 5; retardation; cancer; retina thinning; dyslexia; Interchange of vaccine products; Interchange of vaccine products; This is a spontaneous report received from contactable consumers (patient''s parents) 29-year-old contactable male (patient) regarding Pfizer product Pfizer-BioNTech COVID-19 vaccine (BNT162b2) the following was reported. A 29-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot Number: Unknown) as DOSE 2 (INITIAL PFIZER DOSE), SINGLE for covid-19 immunization, at the age at vaccination of 29 years. Medical history included ECT (electroconvulsive therapy) from 10Mar2020 (Duration of Hospitalization: 4. Hospitalization prolonged: yes. Treatment Received: unknown), Meningitis acwy from May2018 (Hospitalization Prolonged: Yes. Treatment received: No), whole dsm5 (diagnostic and statistical manual of mental disorders). The patient''s concomitant medications were not reported. Historical vaccine included first dose of Moderna (Batch/Lot number: not available) on May2021 (also reported as 31Jul2021, pending confirm). The patient experienced retina tear- retina detachment-heart attack-all dsm (diagnostic and statistical manual of mental disorders) 5-dyslexia-retardation-cancer-retina thinning, all on unknown date. Treatment received was unknown. The event heart attack with seriousness criteria of death, hospitalization, medically significant with fatal outcome, other events with seriousness criteria of medically significant with outcome of unknown. The adverse events result in: Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient also experienced interchange of vaccine products on an unspecified date with outcome of unknown. The patient died on 10Aug2021. It was not reported if an autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, unknown if the patient been tested for COVID-19. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: DEATH


VAERS ID: 1577783 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-06-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemoglobin, Leukopenia, Sepsis
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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: [IRON]
Current Illness: Hypothyreosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Haemoglobin; Result Unstructured Data: low
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Sepsis; This regulatory authority case was reported by a physician and describes the occurrence of SEPSIS (Sepsis) and LEUKOPENIA in a 79-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. Concurrent medical conditions included Hypothyreosis. Concomitant products included [IRON] for Haemoglobinaemia. On 27-May-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 200 microgram. On 17-Jun-2021, the patient experienced SEPSIS (Sepsis) (seriousness criteria death, hospitalization and medically significant) and LEUKOPENIA (seriousness criteria death, hospitalization and medically significant). The patient died on 08-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Haemoglobin: 11.2 (Low) low. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered SEPSIS (Sepsis) and LEUKOPENIA to be possibly related. No treatment medication information was mentioned by reporter Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per overall case assessment by Authority. Low hemoglobin not captured as a separate event as it can be a symptom associated with sepsis and / or leukopenia; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per overall case assessment by Authority. Low hemoglobin not captured as a separate event as it can be a symptom associated with sepsis and / or leukopenia; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1577801 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-17
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: 2021-08-07
   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: INVEGA SUSTENNA
Current Illness: Schizophrenia
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: COJNJFOC20210828762

Write-up: DEATH; This spontaneous report received from a health care professional concerned a 28 year old male. The patient''s weight was not reported and height was 144 centimeters. The patient''s concurrent conditions included: schizophrenia. 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 31-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included paliperidone palmitate for schizophrenia. On 07-AUG-2021, the patient died due to unknown cause. The patient was found with the top part (head) of the body on the bed and the lower part (the feet) towards the floor, the face looked like as patient was sleeping. There was nothing strange no sign of vomiting, no saliva and nor blood. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause on 07-AUG-2021. This report was serious (Death).; Sender''s Comments: V0: 20210828762-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: 1577811 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Death
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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: DEPFIZER INC202100987730

Write-up: Death; collapse; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-DCGMA-21189191, Safety Report Unique Identifier DE-PEI-202100089163. A 78-year-old male patient received (age at vaccination: 78-year-old) bnt162b2 (COMIRNATY also reported as mRNA TOZINAMERAN, lot ER9480), intramuscular on 07Apr2021 at unknown dose, 0.3ml single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 07Apr2021. An autopsy was performed and results were not provided. The outcome of collapse was unknown. Reporter''s comments: 15 minutes after receiving the vaccine dose, the person collapsed requiring resuscitation. Event assessment : Comirnaty/ all events/PEI /Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reporter''s Comments: 15 minutes after receiving the vaccine dose, the person collapsed requiring resuscitation.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1577812 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
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: 2021-04-07
   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: DEPFIZER INC202100987553

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-DCGMA-21189208], Safety Report Unique Identifier [DE-PEI-202100088783]. An 81-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3ml, Lot number was unknown), intramuscular on 30Mar2021 (at the age of 81-year-old) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 07Apr2021 the patient experienced death. Cause of death was unknown. The patient died on 07Apr2021. It was unknown if an autopsy was performed. The casual relationship of Comirnaty and death assessed as Unclassifiable by the Regulatory Authority. Reporter comment: =adverse drug reaction: Unexplained cause of death, Unknown. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected. Reporter''s Comments: Unexplained cause of death, Reported Cause(s) of Death: death.


VAERS ID: 1577813 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Dyspnoea, Restlessness
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 3
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: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Diabetic foot (Diabetic foot with toe inflammation); Hypertension; Inflammation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987574

Write-up: Restlessness; Drop of blood pressure; Dyspnoea; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, DCGMA number DE-DCGMA-21189294. This report was forwarded via the Regulatory Authority number DE-PEI-202100097884. An 87-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 28Mar2021 (Lot Number: ER7812), at the age of 87-years-old, as dose 2, 0.3 ml, single for Prophylactic vaccination. Medical history included diabetic foot with toe inflammation, diabetes mellitus and hypertension, all from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included insulin taken for diabetes mellitus, start and stop date were not reported, drug for hypertension tablets 1-0-1 and antibiotics tablets 250mg 1-0-1 for 1 week against inflammation of the foot. The patient previously took first dose of bnt162b2 (COMIRNATY) on 07Mar2021 for COVID-19 vaccination. On 29Mar2021 the patient experienced Drop of blood pressure, dyspnoea and restlessness. This report is serious - death, hospitalization. The patient died on 01Apr2021. It was not reported if an autopsy was performed. Reporter''s comment: AEs: After 2nd vaccination 28Mar2021 dyspnoea, drop in blood pressure, restlessness. Hospitalization was carried out by ambulance. Died in hospital on 01Apr2021. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: AEs: After 2nd vaccination 28Mar2021 dyspnoea, drop in blood pressure, restlessness. Hospitalization was carried out by ambulance. Died in hospital on 01Apr2021.; Reported Cause(s) of Death: Drop of blood pressure; Dyspnoea; Restlessness


VAERS ID: 1577814 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   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: Adiposis; COPD; Hypertension; Sleep apnea syndrome (SAS).
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s encephalopathy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987661

Write-up: Death; This is as spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-DCGMA-21189296, Safety report unique identifier DE-PEI-202100095044. A 57-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 25Mar2021 (Batch/Lot Number: Unknown) (at age 57-years-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing adiposis, ongoing sleep apnoea syndrome SAS, Hasimoto''s encephalopathy from Apr2020 to an unknown date, ongoing chronic obstructive pulmonary disease, and ongoing hypertension. The patient''s concomitant medications were not reported. On 26Mar2021, the patient experienced death. It was not reported if an autopsy was performed. Relatedness of drug to event: Source of assessment: 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: Death.


VAERS ID: 1577815 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-27
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET 3045 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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: PANTOPRAZOL [PANTOPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis; Gastrooesophageal reflux disease; Hypermenorrhoea.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987562

Write-up: Death sudden; Especially fulminant pulmonary embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-DCGMA-21189832. Safety Report Unique Identifier DE-PEI-202100083016. This report was forwarded via Regulatory authority. A 53-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Lot Number: ET 3045; at the age of 53-years (as reported)) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunisation. Medical history included gastritis, gastrooesophageal reflux disease, and hypermenorrhoea all from an unknown date and unknown if ongoing. Concomitant medication included (PANTOPRAZOL [PANTOPRAZOLE]) taken for gastritis. On 27Apr2021, the patient experienced especially fulminant pulmonary embolism, death sudden. Therapeutic measures were taken as the result of the events which included unsuccessful resuscitation. The outcome of the events was fatal. The patient died on 27Apr2021. An autopsy was not performed. Reporter''s comment: Measures: unsuccessful resuscitation. On 05May2021, it was reported that an autopsy was not carried out. There is no further information about the circumstances of death. Event assessment: / Comirnaty / All Events / Unclassifiable No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Measures: unsuccessful resuscitation. On 05May2021, it was reported that an autopsy was not carried out. There is no further information about the circumstances of death.; Reported Cause(s) of Death: Death sudden; Especially fulminant pulmonary embolism.


VAERS ID: 1577816 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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: Hepatitis C
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987708

Write-up: Slight chills in the evening; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority (Regulatory Authority report number: number DE-DCGMA-21190050). A 74-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: EX3599; Expiration date was not reported), intramuscular on 28Apr2021 as dose number unknown, 0.3 ml single, for COVID-19 immunization. Medical history included hepatitis C (not ongoing). The patient''s concomitant medications were not reported. On 29Apr2021, the patient had slight chills in the evening. The patient had died on 29Apr2021 due the slight chills. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Slight chills in the evening


VAERS ID: 1577817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-19
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Base excess, Blood bicarbonate, Blood gases, Electrocardiogram, Fall, Heart rate, Hypotension, Oxygen saturation, PCO2, PO2, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: AMLODIPIN [AMLODIPINE]; TAMSULOSIN; ASS; CANDESARTAN; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Exsiccosis; Hepatic steatosis; Hyponatraemia; Ileus of intestine (Colon ileus); Intestinal resection (Sigma resection); Prostatic hyperplasia; Sigmoid diverticulitis; Splenectomy.
Allergies:
Diagnostic Lab Data: Test Name: Base excess; Result Unstructured Data: Test Result:6.3 mmol/L; Test Name: H2CO3; Test Result: 20 mmol; Test Name: Arterial Blood Gas; Result Unstructured Data: Test Result:7.39 pH units; Test Name: ECG; Result Unstructured Data: Test Result: continuous SR with preserved circadian rhythm; Comments: sporadic (less than 1%) monomorphic premature ventricular contractions, once as a burst over 4 beats, No bradycardia, tachycardia, or pauses; Test Name: Heart rate; Result Unstructured Data: Test Result:76 (63-117) / min; Test Name: Oxygen saturation; Test Result: 81.4 %; Test Name: pCO2; Result Unstructured Data: Test Result:4.1; Comments: kPa; Test Name: pO2; Result Unstructured Data: Test Result:6.2; Comments: kPa.
CDC Split Type: DEPFIZER INC202100987635

Write-up: Syncope; Hypotension; Fall; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB (Regulatory authority report number is DE-DCGMA-21190275, Safety Report Unique Identifier DE-PEI-202100079887). A 68-year-old male patient received BNT162B2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) as dose number unknown, 0.3 mL, single for COVID-19 immunisation. Medical history included intestinal resection (Sigma resection) from an unknown date which was not ongoing; exsiccosis, hyponatraemia, arterial hypertension, hepatic steatosis, splenectomy, ileus of intestine, sigmoid diverticulitis, prostatic hyperplasia; all from an unknown date and unknown if ongoing. Concomitant medications included amlodipin [amlodipine] (AMLODIPIN [AMLODIPINE]) taken for hypertension, tamsulosin taken for benign prostatic hyperplasia, acetylsalicylic acid (ASS) taken for an unspecified indication, candesartan taken for hypertension, and metoprolol taken for hypertension, all start and stop date were not reported. The patient''s weight was 95 kg, and height was 180 cm. On 19May2021, the patient experienced syncope, hypotension and fall. The patient underwent lab tests and procedures on unspecified date which included base excess (BE): 6.3 mmol/l, H2CO3 (blood bicarbonate): 20 mmol, arterial blood gas (BGA): 7.39 pH units, electrocardiogram (ECG): continuous SR with preserved circadian rhythm, sporadic (less than 1%) monomorphic premature ventricular contractions, once as a burst over 4 beats, No bradycardia, tachycardia, or pauses, heart rate: 76 (63-117)/min, oxygen saturation (sO2): 81.4 %, pCO2: 4.1 kPa, pO2: 6.2 kPa. Therapeutic measures were taken as a result of syncope, hypotension, fall. This report was serious due to death, unknown cause of death. The outcome of the events was fatal. The patient died on an unspecified date. An autopsy was not performed. Reporter comment: Syncope clarification according to standard operating procedures Patient found in hospital with no signs of life, immediate reanimation according to Hospital Council guidelines and the hospitals standard operating procedures. It is not clear whether she only had her first vaccination or the second one. An upper inflow congestion during reanimation and subsequent autopsy was prominent. Event assessment between Comirnaty and all events was unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reporter''s Comments: Syncope clarification according to standard operating procedures Patient found in hospital with no signs of life, immediate reanimation according to Hospital Council guidelines and the hospitals standard operating procedures. It is not clear whether she only had her first vaccination or the second one. An upper inflow congestion during reanimation and subsequent autopsy was prominent.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1577818 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   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: Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987536

Write-up: Death; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority-WEB DCGMA number DE-DCGMA-21190822. This report was forwarded via the Regulatory Authority Safety Report Unique Identifier DE-PEI-202100105386. A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on an unspecified date (Batch/Lot Number: Unknown) as single dose (at the age of 77-years-old) for COVID-19 immunization. Medical history included rheumatism from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death on 02Jun2021. The patient died on 02Jun2021. It was not reported if an autopsy was performed. This report is serious - death. "Summary (full translation available upon request)". Reporter comment: The patient was found dead in bed in the emergency medical service. The day before, the second vaccination took place. Next to the bed was a bucket filled with water and on the bedside cabinet was a pack of Diclofenac 25mg, from which 1 tablet was missing. Only slight rheumatism was known from previous illnesses, no medication. Relatedness of drug to reaction/event: Source of assessment: Result of Assessment D. Unclassifiable Relatedness of drug to reaction/event: Source of assessment: Method of Assessment Regulatory Authority No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: The patient was found dead in bed in the emergency medical service. The day before, the second vaccination took place. Next to the bed was a bucket filled with water and on the bedside cabinet was a pack of Diclofenac 25mg, from which 1 tablet was missing. Only slight rheumatism was known from previous illnesses, no medication.; Reported Cause(s) of Death: Death.


VAERS ID: 1577819 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Head injury, Headache
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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: Carcinoma liver; Hepatic cirrhosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987715

Write-up: Unknown cause of death; Pain head; Head injury; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-DCGMA-21190875. An 81-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 14Apr2021 (at the age of 81 years old) (Lot number was not reported) as dose number unknown, 0.3 ml single for COVID-19 immunisation. Medical history included hepatic cirrhosis and carcinoma liver; both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 16Apr2021 the patient experienced head injury, pain head and death (unknown cause of death). The patient''s outcome was fatal for all events. The patient died on 16Apr2021. An autopsy was performed and results were not provided. No follow-up attempts are possible. Information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death; Pain head; Head injury


VAERS ID: 1577820 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D018A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Cyanosis
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN [METFORMIN HYDROCHLORIDE]; METOPROLOL; EXFORGE HCT; ALLOPURINOL; RIVAROXABAN; PANTOPRAZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; INEGY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis; Arterial hypertension; Atrial fibrillation; Carotid artery occlusion; Chronic kidney disease stage 2; COPD; Fatty liver; GERD; Hypertensive renal disease; Hyperuricaemia; Left ventricular failure; Lipid metabolism disorder NOS; Penile malignant neoplasm; Single vessel disease (Coronary artery disease); Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987731

Write-up: sudden collapse; Cyanosis; This is as spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority. Report number DE-DCGMA-21191052 with safety report unique identifier DE-PEI-202100112858. A 76-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 09Jun2021 (Batch/Lot Number: 1D018A) (at the age of 76 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included single vessel disease (coronary artery disease), type 2 diabetes mellitus, arterial hypertension, hyperuricemia, atrial fibrillation, aortic valve stenosis, chronic kidney disease stage 2, penile malignant neoplasm, gastroesophageal reflux disease (GERD), lipid metabolism disorder NOS, carotid artery occlusion, left ventricular failure, chronic obstructive pulmonary disease (COPD), fatty liver and hypertensive renal disease, all unknown if ongoing. Concomitant medications included metformin hydrochloride (METFORMIN [METFORMIN HYDROCHLORIDE]) taken for type 2 diabetes mellitus, start and stop date were not reported; metoprolol taken for coronary artery disease, start and stop date were not reported; amlodipine besilate, hydrochlorothiazide, valsartan (EXFORGE HCT) taken for arterial hypertension, start and stop date were not reported; allopurinol taken for hyperuricaemia, start and stop date were not reported; rivaroxaban taken for atrial fibrillation, start and stop date were not reported; pantoprazole sodium sesquihydrate (PANTOPRAZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) taken for gastroesophageal reflux disease, start and stop date were not reported; and ezetimibe, simvastatin (INEGY) taken for lipid metabolism disorder NOS, start and stop date were not reported. The patient experienced sudden collapse (Collapse circulatory) and cyanosis on 10Jun2021. Admission to emergency room by ambulance, cardiopulmonary resuscitation. This report is serious - death, hospitalization. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness assessment (both events): D. Unclassifiable. Source of assessment: Regulatory Authority . Reporter''s comment: lethal outcome of unexplained cause; admission to emergency room by ambulance, cardiopulmonary resuscitation. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: lethal outcome of unexplained cause; admission to emergency room by ambulance, cardiopulmonary resuscitation; Reported Cause(s) of Death: Collapse circulatory; Cyanosis


VAERS ID: 1577821 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-06-04
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse; Arterial hypertension; Depression; Lumbar spine degeneration
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987722

Write-up: Lung embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company report number DE-DCGMA-21191064. Additional case identifier includes DE-PEI-202100112859. A 70-year-old male patient received bnt162b2 (COMIRNATY), (strength: 0.3 mL), intramuscular on 16Jul2021 (Batch/Lot Number: Unknown), at the age of 70 years old, as 0.3 mL, single dose for COVID-19 immunisation. The patient''s medical history included depression unknown if ongoing, alcohol abuse (not ongoing), arterial hypertension unknown if ongoing and lumbar spine degeneration unknown if ongoing. Concomitant medications were not reported. The patient received the first dose of COMIRNATY on 07Apr2021 at 0.3 ml for COVID-19 immunization. On 04Jun2021, the patient experienced lung embolism. The event was considered serious requiring hospitalization, life-threatening and resulted in death according to the regulatory authority. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1577822 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   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: Atrial fibrillation; Coronary disease; Myocardial infarction; Peripheral arterial occlusive disease; Type 1 diabetes mellitus.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987726

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DCGMA, company number DE-DCGMA-21191121. This report was forwarded via the regulatory authority, however no RA number was provided. A 69-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10May2021 at 69-year-old (Batch/Lot Number: Unknown) as DOSE 2, 0.3ML SINGLE for covid-19 immunization. Medical history included Coronary disease from an unknown date and unknown if ongoing, Type 1 diabetes mellitus from an unknown date and unknown if ongoing , Peripheral arterial occlusive disease from an unknown date and unknown if ongoing, Myocardial infarction from an unknown date to unknown date, Atrial fibrillation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient took first dose of bnt162b2 (COMIRNATY), on 19Apr2021 at 69-year-old as dose 1, 0.3ml single for covid-19 immunization. The patient experienced death on 11May2021. The patient died on 11May2021. It was not reported if an autopsy was performed. This report is serious - 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: Death


VAERS ID: 1577823 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-06
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 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: Medical History/Concurrent Conditions: Arterial hypertension; Cardiac failure chronic; Chronic renal insufficiency; Coronary artery disease; Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987530

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-DCGMA-21191248. An 81-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: EX3599), at the age of 81 years old, as 0.3 ml single for covid-19 immunisation. Medical history included coronary artery disease, diabetes mellitus, arterial hypertension, cardiac failure chronic, chronic kidney disease, all from unspecified date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death on 06May2021. Unknown cause of death. Autopsy was not performed. The patient''s outcome was fatal for death. Relatedness of drug to reaction death was Inconsistent causal association to immunization. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1577824 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration
SMQs:, Medication errors (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: Hypercholesterolaemia; Hypertension (Mild Hypertension)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987725

Write-up: Death/Unknown cause of death; 1st dose 01Apr2021, 2nd dose 13May2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-DCGMA-21191317. This report was forwarded via Regulatory Authority, however no regulatory authority number was provided. An 82-year-old male patient received bnt162b2 (COMIRNATY, lot number was not reported), via an unspecified route of administration on 13May2021 as dose 2, 0.3 mL single for covid-19 immunization. Medical history included ongoing hypercholesterolaemia and ongoing hypertension (mild hypertension). The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY), intramuscular, on 01Apr2021, as dose 1, 0.3 mL single for covid-19 immunization. The patient experienced death/ unknown cause of death on an unspecified date. The patient received the 1st dose on 01Apr2021, and 2nd dose on 13May2021. 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.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578773 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-27
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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: Medical History/Concurrent Conditions: Cardiac failure; Coronary artery disease; Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987777

Write-up: Death/Vaccination complication; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-DCGMA-21190008. A 72-year-old male patient received bnt162b2 (COMIRNATY, Lot number was unknown), via an unspecified route of administration on 06Apr2021 (at the age of 72-year-old) as dose number unknown, 0.3 ml, single for COVID-19 immunization. Medical history included coronary artery disease from 2001, cardiac failure from 2001 and infarct myocardial from 2001. The patient''s concomitant medications were not reported. On 27Apr2021, the patient experienced death/vaccination complication. The patient died on 27Apr2021. Cause of death was vaccination complication. It was unknown if an autopsy was performed. No follow-up attempts are possible; information on batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: vaccination complication


VAERS ID: 1578774 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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: 2021-06-01
   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: CANDESARTAN; ALLOPURINOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987789

Write-up: Sudden death, cause unknown; This is a spontaneous report downloaded from the Regulatory Authority; number DE-DCGMA-21191263, Safety Report Unique Identifier DE-PEI-202100127486. A 50-year-old male patient received bnt162b2 (COMIRNATY), dose 2 at the age of 50-years-old intramuscular on 07Jun2021 (Batch/Lot Number: Unknown) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included candesartan and allopurinol both taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (COMIRNATY) at the age of 50-years-old on 03May2021 (Bach/lot number: unknown) as dose 1, 0.3 ml, single for covid-19 immunisation. The patient experienced sudden death, cause unknown on an unspecified date in Jun2021. The patient died on an unspecified date in Jun2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Result of assessment per Regulatory Authority was unclassifiable (D.). Reporter''s comments: Found death, police turned on because the cause of death remained unexplained. No follow-up Information on batch/lot number cannot be obtained attempts are possible. No further information expected.; Reporter''s Comments: Found death, police turned on because the cause of death remained unexplained.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1578775 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
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: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987629

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-DCGMA-21191316. A 76-year-old female patient received bnt162b2 (COMIRNATY, Strength: 0.3 mL; Lot number was not reported), intramuscular on 07May2021 (at the age of 76-years-old) as dose number unknown, 0.3 mL single for covid-19 immunisation. The patient medical history included ongoing chronic obstructive pulmonary disease (COPD). The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced death. The patient died on an unspecified date. It was unknown if an autopsy was performed. This report is serious - death. Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and event Death as D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578780 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac failure, Chills, Fall, Interchange of vaccine products
SMQs:, Cardiac failure (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987587

Write-up: Decompensation cardiac; General debility; Fall; Rigors; Interchange of vaccine products; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority with regulatory authority number DE-PEI-202100133830. A 70-year-old male patient received bnt162b2 (COMIRNATY also reported as COMIRNATY (MRNA TOZINAMERAN); reported strength was 0.3 mL), dose 2 at vaccination age of 70-year-old via an unspecified route of administration on 02Jul2021 (Lot Number: FE6975) as dose 2 (initial PFIZER dose), single for covid-19 immunisation; and covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date at dose 1, single for covid-19 vaccination. The patient''s medical history and concomitant medications were not reported. On 03Jul2021 the patient experienced rigors, general debility, and fall which were considered as serious fatal. On 06Jul2021 the patient experienced decompensation cardiac which was considered as serious fatal. The report was considered as serious with seriousness criteria of death. The outcome of the vents was fatal. The patient died on 06Jul2021. An autopsy was not performed. Relatedness of drug to reactions/events with the source of the Regulatory Authority and the result of assessment was D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Decompensation cardiac; rigors; general debility; fall


VAERS ID: 1578781 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 14
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 (well adjusted)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987577

Write-up: Inappetence; first dose of COMIRNATY (strength: 0.3 mL) on 10May2021/second dose on 28Jun2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number is DE-PEI-202100133922. A 69-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 mL), via an unspecified route of administration on 28Jun2021 (Batch/Lot Number: FE6975) as dose 2, 0.3 mL single (at the age of 69-years-old) for COVID-19 immunisation. Medical history included arterial hypertension: well adjusted. Concomitant medications were not reported. The patient received the first dose of COMIRNATY (strength: 0.3 mL) on 10May2021 for COVID-19 vaccination and the second dose on 28Jun2021. On an unspecified date, the patient experienced inappetence. The patient died on 12Jul2021. The regulatory authority assessed the event as serious, fatal; and unclassifiable by Regulatory Authority. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: inappetence


VAERS ID: 1578784 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-06-16
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: DEPFIZER INC202100987560

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority. The regulatory authority number is DE-PEI-202100134130. An adult male patient of unspecified age received the dose of BNT162B2 (COMIRNATY; strength: 0.3 ml; lot number: EX8679), via an unspecified route of administration on 05May2021 (at an unspecified age) at dose number unknown, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Jun2021, the patient experienced sudden cardiac death. The patient died on 16Jun2021. No autopsy was done. Outcome of the event was fatal. Causality of BNT162B2 (COMIRNATY) to the event sudden cardiac death was unclassifiable.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1578797 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-11
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Cardiac failure acute, Pancytopenia, Platelet disorder, Prothrombin time, White blood cell disorder
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   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: Allergy to nuts; Fruit allergy; Multiple sclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: thrombocytes; Result Unstructured Data: Test Result:27.000; Test Date: 20210711; Test Name: Spontaneous Quick value; Test Result: 10 %; Test Date: 20210711; Test Name: leukocytes; Result Unstructured Data: Test Result:2.5
CDC Split Type: DEPFIZER INC202100987738

Write-up: Anaphylactic shock; Acute heart failure; Pancytopenia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100137297. An 88-year-old female patient received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN), via an unspecified route of administration on 22Jun2021 (Batch/Lot Number: Unknown) at the age of 88 years old as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included Multiple sclerosis and allergy to nuts and apples. Concomitant medication included immunosuppressive medication about every two weeks. Three weeks after vaccination (on 11Jul2021), the patient experienced anaphylactic shock after eating, acute heart failure and pancytopenia (also reported duration 5 hours). 40 minutes after the anaphylactic shock, the patient underwent lab tests and procedures (11Jul2021) which included spontaneous quick value: 10 %, thrombocytes: 27.000, leukocytes: 2.5. The patient died on 11Jul2021. It was not reported if an autopsy was performed. This report is serious - death. Sender comment: Discharge report: Lethal outcome a.e. after anaphylactic shock with circulatory failure: Observed collapse after eating a grain roll... Fulminant aspiration with possibly rapidly developing Acute respiratory distress syndrome Severe cross-allergy to nuts and apples. Medical history: Presentation via Registered dietitian + NA. Patient. has a known nut allergy and is allergic to nuts after eating - of a bun syncopated in a manner requiring resuscitation. A doctor on site has immediately Resuscitation started. Massive aspiration in the field, suction by Registered dietitian, intubation, Fenistil, prednisolone and suprarenin. With continuation of the resuscitation measures Drive to us. Shortly before arrival return of spontaneous circulation with stable sustained release and not measurable respiratory rate. Patient ventilated by bag, difficult to ventilate. on 22Jun2021 Covid 9 vaccination (Biontech) received MS is pre-existing, currently no immunosuppressive therapy, however all 14 days of injection therapy with currently unclear active substance. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Anaphylactic shock; Pancytopenia; Acute heart failure


VAERS ID: 1578803 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: DEPFIZER INC202100987719

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100138666. A 67-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FE6975) (at the age of 67 years) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 09Jul2021. The patient died on 09Jul2021. 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: Unknown cause of death


VAERS ID: 1578815 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Inappropriate schedule of product administration, Lung infiltration, Lung transplant rejection
SMQs:, Interstitial lung disease (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 63
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: Adiposis; Alpha-1 anti-trypsin deficiency; COPD; Lung transplant; Pneumothorax; Portopulmonary hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987668

Write-up: Lung transplant rejection; ARDS; Lung infiltration; 1st dose Comirnaty: 03Apr2021, 2nd dose: 15May2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100142237. A 61-year-old female patient received bnt162b2 (COMIRNATY; strength: 0.3 mL), dose 2 via an unspecified route of administration on 15May2021 (Lot Number: Unknown) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included alpha-1 antitrypsin deficiency, pneumothorax, chronic obstructive pulmonary disease (COPD), lung transplant from 01Jan2021 to an unknown date, portopulmonary hypertension, and adiposis. The patient''s concomitant medications were not reported. Historical vaccine included Comirnaty (1st dose, strength: 0.3 ml) on 03Apr2021 for COVID-19 immunisation. On 24Jun2021, the patient had lung transplant rejection, acute respiratory distress syndrome (ARDS), and lung infiltration. The patient died on 17Jul2021. The outcome of lung transplant rejection, acute respiratory distress syndrome (ARDS), and lung infiltration was fatal. It was not reported if an autopsy was performed. Relatedness of drug to events was assessed as being D. Unclassifiable. Reported dose of Comirnaty 2 (for clarification). Information about lot/batch number has been requested.; Reported Cause(s) of Death: Lung transplant rejection; ARDS; Lung infiltration


VAERS ID: 1578817 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Cardiomyopathy, Chills, Decreased appetite, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (narrow), Arthritis (broad), 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: Comments:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Pyrexia; Result Unstructured Data: Test Result: Pyrexia.
CDC Split Type: DEPFIZER INC202100987559

Write-up: Cardiomyopathy; Pyrexia; Chills; Appetite lost; Shoulder pain; Headache; This is a spontaneous report downloaded from the Regulatory Authority-WEB, Regulatory authority report number DE-PEI-202100142251, from a non-contactable physician. A 27-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: FD7958) (at the age of 27 years) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY), dose 1 on 16Jun2021 (Batch/Lot Number: Unknown) (at the age of 27 years) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. The patient experienced cardiomyopathy, pyrexia, chills, appetite lost, shoulder pain, headache, all on 14Jul2021 with seriousness of death and life-threatening. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of all events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: shoulder pain; headache; appetite lost; cardiomyopathy; pyrexia; chills


VAERS ID: 1578826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiogenic shock, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: Medical History/Concurrent Conditions: Aortic valve replacement
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987765

Write-up: Shock cardiogenic; Dyspnoea; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, company number DE-PEI-202100142663. An 80-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (also reported as 04Jun2021) (Batch/Lot Number: Unknown) as dose number unknown, 0.3 ml, single for COVID-19 immunization. The patient''s weight was not reported, and height was not reported. Medical history included aortic valve replacement. The patient''s concomitant medications were not reported. On 08Apr2021 the patient experienced dyspnoea, device failure, defect, shock cardiogenic. The patient died on 08Apr2021 due to the events. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiogenic shock; dyspnoea


VAERS ID: 1578827 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 19
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; Atrial fibrillation; COPD; Emphysema pulmonary
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987677

Write-up: COPD exacerbation; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, regulatory authority number DE-PEI-202100142839. A 76-year-old male patient received bnt162b2 (COMIRNATY, Strength: 0.3 mL; Lot Number: EX3599), via an unspecified route of administration on 27Apr2021 (at the age of 76-years-old) as dose number unknown, 0.3 mL single for covid-19 immunisation. The patient medical history included COPD (chronic obstructive pulmonary disease), atrial fibrillation, arterial hypertension and emphysema pulmonary. The patient''s concomitant medications were not reported. On 28Apr2021, the patient experienced COPD exacerbation. The outcome of COPD exacerbation was fatal. The patient died on 17May2021. Cause of death was COPD exacerbation. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Chronic obstructive pulmonary disease


VAERS ID: 1578828 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D016A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   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: Medical History/Concurrent Conditions: Aortic valve insufficiency; Coronary disease.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987740

Write-up: Sudden cardiac death; Dose 1 on 28Apr2021/dose 2 on 09Jun2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100143128. A 69-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: 1D016A) (at the age of 68 years) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included aortic valve insufficiency and coronary disease. The patient''s concomitant medications were not reported. The patient had the first dose of bnt162b2 (COMIRNATY) on 28Apr2021 (at the age of 68 years) for covid-19 vaccination. The patient experienced sudden cardiac death on 21Jun2021. The patient died on 21Jun2021 due to sudden cardiac death. An autopsy was not performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1578829 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987695

Write-up: Cardiac failure (NOS); This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100143555. A 78-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FE6975) (at the age of 78-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced cardiac failure (NOS) which resulted to fatal outcome. The patient died on 14Jul2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac failure (NOS)


VAERS ID: 1578830 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Nasopharyngitis, 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: 2021-07-17
   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: DEPFIZER INC202100987678

Write-up: Sudden death; Cold symptoms; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, (regulatory authority: DE-PEI-202100143558). A 54-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Strength: 0.3 ml, Batch/Lot Number: Unknown), via an unspecified route of administration on 14Jul2021 (received at the age of 54-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced cold symptoms on 15Jul2021 and sudden death on 17Jul2021. The patient died on 17Jul2021. It was not reported if an autopsy was performed. The casual relationship of Comirnaty and both events assessed as Unclassifiable by the RA. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cold symptoms; Sudden death


VAERS ID: 1578833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 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: DEPFIZER INC202100987532

Write-up: Death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100143727. This consumer reported similar events for two patients. This is the first of two reports. An elderly female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 17Mar2021 08:00 (Lot Number: ER7812) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient experienced death. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Event assessment between Comirnaty and all events per RA was indeterminate. Sender''s comments: I would like to inform you that: My parents were vaccinated against SARS-CoV-2 on 17Mar2021 at 8:00 am. Neither of them had any acute health problems! Both have since passed away. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202100994641 same reporter/suspect drug/ event, different patient; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1578835 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Hypereosinophilic syndrome, Inappropriate schedule of product administration, Lung carcinoma cell type unspecified stage 0
SMQs:, Anaphylactic reaction (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 (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (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:
CDC Split Type: DEPFIZER INC202100987660

Write-up: Hypereosinophilic syndrome; Bronchial carcinoma in situ; Acute respiratory failure; BNT162B2 dose 1: 01Ap2021, dose 2: 14May2021; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority DE-PEI-202100144672. A 79-year-old male patient received (age at vaccination: 79-year-old) bnt162b2 (COMIRNATY 0.3ml, lot unknown), via an unspecified route of administration on 14May2021 as dose 2, single for Covid-19 immunisation. The patient''s medical history was not reported, no concomitant medications. He had his dose 1 of bnt162b2 (lot unknown) on 01Apr2021. On 04Jun2021, the patient experienced acute respiratory failure, hypereosinophilic syndrome and bronchial carcinoma in situ all with fatal outcome. The patient died on an unspecified date. An autopsy was not performed. Relatedness of drug to reactions/events Comirnaty/ all events/ B. Indeterminate. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Hypereosinophilic syndrome; Bronchial carcinoma in situ; Acute respiratory failure


VAERS ID: 1578840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   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: Apoplexy (Condition after several apoplexies); Diabetes mellitus; Hemiparesis; Hypertension; Struma (hypertensive struma).
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987799

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority number is DE-PEI-202100144865. A 73-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus, hypertension, condition after several apoplexies, hemiparesis, and hypertensive struma. Concomitant medications were not reported. On 23Apr2021, the patient experienced infarct myocardial. The patient died on 23Apr2021. It was unknown if an autopsy was performed. Sender comment: Heart attack with bypass operation 8 day after the vaccination, subsequently exitus letalis on account of complications. Base illness: diabetes mellitus, hypertension, condition after several apoplexies, hemiparesis, hypertensive struma. Year of birth given only. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Heart attack.


VAERS ID: 1578845 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FO30A / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adiposis; Atrial fibrillation; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987791

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100145041. A 63-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FO30A, expiry date not reported), via an unspecified route of administration on 16Jul2021 (at the age of 63 years old) as dose 2, 0.3 ml, single for covid-19 immunization. Medical history included adiposis, nicotine abuse, and atrial fibrillation, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient received the first dose of Comirnaty for covid-19 vaccination on 18Jun2021 at 0.3 ml. The patient experienced unknown cause of death on an unspecified date in 2021. The event caused hospitalization from an unknown date in 2021. It was unknown if an autopsy was performed. Follow-up attempt are not possible. No expected further information.; Reported Cause(s) of Death: Unknown cause of death


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