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From the 11/19/2021 release of VAERS data:

Found 19,249 cases where Vaccine is COVID19 and Patient Died

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Case Details

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VAERS ID: 1527764 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-22
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Body temperature, Cardio-respiratory arrest, Dyspnoea, Fall, Fibrin D dimer, Loss of consciousness, Malaise, Platelet count, Sudden cardiac death, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (narrow), 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), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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: 2021-07-27
   Days after onset: 5
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: Lung cancer stage I (Regular hospital visits for lung cancer (stage IA, resection in 2019, passed without recurrence)); Pulmonary resection (Regular hospital visits for lung cancer (stage IA, resection in 2019, passed without recurrence)); Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: K; Test Result: 8.8 meq; Comments: increased; Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210727; Test Name: D-dimer; Result Unstructured Data: Test Result:1174 ug/ml; Comments: increased; Test Date: 20210727; Test Name: Plt; Result Unstructured Data: Test Result:65000 /mm3
CDC Split Type: JPPFIZER INC202100958723

Write-up: cardiopulmonary arrest; fall with no response; fall with no response; malaise; shortness of breath; Sudden cardiac death from suspected thrombosis; Sudden cardiac death from suspected thrombosis; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21122037. A 73-year and 9-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) via an unspecified route of administration on 16Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included regular hospital visits for lung cancer (stage IA, resection in 2019, passed without recurrence), and mild renal failure from 2019. Body temperature before vaccination was 36.2 degrees centigrade on 16Jul2021. The patient had no family history. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) on unspecified date as single dose for COVID-19 immunisation. On 22Jul2021 (6 days after the vaccination), the patient experienced sudden cardiac death from suspected thrombosis. On 27Jul2021 (11 days after the vaccination), the outcome of the event was fatal. The course of the event sudden cardiac death from suspected thrombosis was as follows: The patient regularly visited the department of surgery at the reporting hospital for lung cancer, and the condition was stable. On 16Jul2021, the patient was vaccinated. Around 22Jul2021 (6 days after the vaccination), the patient experienced malaise and shortness of breath, he was being observed. However, the symptoms gradually deteriorated. On 27Jul2021 around 10:00, the final confirmation of the patient was made. At 12:30 (11 days 12 hrs 30 min after the vaccination), the patient was confirmed to fall with no response, and he was transported to the reporting hospital by ambulance. At the time of transportation, a resuscitation was performed on the patient in cardiopulmonary arrest (CPA); however, he was confirmed dead. In 2019, a detailed examination of the whole body was done for a surgery; however, only mild renal failure was pointed out, and no abnormalities at regular hospital visits were noted. Therefore, the cause of death was unknown. Lab data included on 27Jul2021, Platelet (Plt) was 65000/mm3 (as reported of 6.5 x10^4/uL), D-dimer increased to 1174 ug/mL, and potassium (K) increased to 8.8 mEq (as reported); thus, the death due to thrombotic factors such as pulmonary embolus was suggested. However, the family did not wish the patient to undergo an autopsy imaging or autopsy, and the definite cause of death was unknown. Therapeutic measures were taken as a result of sudden cardiac death from suspected thrombosis and cardiopulmonary arrest. Events resulted in emergency room visit. Outcome of events sudden cardiac death from suspected thrombosis and cardiopulmonary arrest was fatal, while of the other events was unknown. An autopsy was not performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as un-assessable. Other possible cause(s) of the event such as any other diseases was commented as: cause was unknown and other factors could be fully considered. Reporter comment: This case was reported because of unknown cause of death within 28 days of the vaccination. The patient had no underlying diseases leading to death, and he regularly visited the hospital; thus, there were few factors leading to the sudden exacerbation of the disease conditions. Laboratory findings included findings suggestive of thrombus and platelets decreased. So, vaccine-induced immune thrombotic thrombocytopenia (VITT), and other diseases were also considered as differential diseases. However, a determination could not made because it was difficult to distinguish from postmortem changes, and other tests could not be performed.; Reported Cause(s) of Death: Sudden cardiac death from suspected thrombosis; Sudden cardiac death from suspected thrombosis; cardiopulmonary arrest


VAERS ID: 1527767 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Cardiac arrest, Investigation, Loss of consciousness, Respiratory arrest, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: body temperature; Result Unstructured Data: Test Result:35.5 Centigrade; Comments: before vaccination; Test Date: 20210727; Test Name: examination; Result Unstructured Data: Test Result:diagnosed with Subarachnoid haemorrhage
CDC Split Type: JPPFIZER INC202100960155

Write-up: lying with no consciousness; Consciousness disturbed due to Subarachnoid haemorrhage; Consciousness disturbed due to Subarachnoid haemorrhage; Respiratory arrest; Cardiac arrest; This is a spontaneous report from a contactable primary physician received from the Regulatory authority. Regulatory authority report number is v21121566. The patient was a 76-year and 2-month-old male. Body temperature before vaccination was 35.5 degrees centigrade. The patient family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY5420, Expiration date 31Aug2021). On 24Jul2021 at 15:20 (the day of vaccination), the patient received the second 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 27Jul2021 at unknown time (three days after the vaccination), the patient experienced Consciousness disturbed due to Subarachnoid haemorrhage. On 28Jul2021 (four days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27Jul2021 at about 11:00, the family of patient confirmed that the patient was doing well, and left home. On 27Jul2021 at about 11:45, the patient was found lying with no consciousness, and ambulance was called. The patient was transported to hospital of the reporter. The detailed examination was performed and the patient was diagnosed with Subarachnoid haemorrhage. After the diagnosis, Respiratory arrest and Cardiac arrest occurred. On 28Jul2021 at 00:48, the patient was confirmed dead. The reporting physician did not report the seriousness of the event 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 report any further comment.; Reported Cause(s) of Death: Consciousness disturbed; Respiratory arrest; Cardiac arrest; lying with no consciousness; Subarachnoid haemorrhage


VAERS ID: 1527768 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Dyspnoea, Interstitial lung disease, Malaise
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: CT; Result Unstructured Data: Test Result:Interstitial pneumonia
CDC Split Type: JPPFIZER INC202100960169

Write-up: Interstitial pneumonia; Dyspnoea; Malaise; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21121542. An 80-years-old (reported as 80-year and 11-month-old) male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 09Jul2021 13:30 (Lot Number: FC5947; Expiration Date: 30Sep2021) at age of 80-years-old as dose 1, single for COVID-19 immunisation. Medical history included hypertension. Body temperature before vaccination was not reported. The patient family history was not reported. The patient''s concomitant medications were not reported. On 10Jul2021 in the morning (1 day after the vaccination), the patient experienced malaise and dyspnoea. On 13Jul2021 (4 days after the vaccination), findings of interstitial pneumonia were noted. The course of the event was as follows: In Nov2020, abnormality of the lung was not found. On 09Jul2021, the patient was vaccinated. On the next day, 10Jul2021, (1 day after the vaccination), malaise occurred. On 13Jul2021 (4 days after the vaccination), since symptoms did not improve, the patient visited the previous physician. Findings of interstitial pneumonia were noted through chest computerised tomography (CT). A possibility of organising pneumonia or eosinophilic pneumonia was considered, so steroid and immunosuppressant drug were used. However, without improvement, the patient died. Autopsy was being conducted. On 23Jul2021 (14 days after the vaccination), the patient died. The outcome of the event was fatal. The reporting physician classified the event as serious (Death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had no chronic pneumonic lesion. Findings of interstitial pneumonia was found shortly after the vaccination. The possibility of drug-induced lung disorder was high.; Reported Cause(s) of Death: Interstitial pneumonia; Dyspnoea; Malaise


VAERS ID: 1527769 (history)  
Form: Version 2.0  
Age: 102.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-07-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac failure chronic, Decreased appetite, Pyrexia, Respiratory arrest
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Bronchial asthma; Cardiac failure chronic; Chronic atrial fibrillation; Dementia; Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/77 mmHg; Test Date: 20210725; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210726; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Comments: pyrexia
CDC Split Type: JPPFIZER INC202100960201

Write-up: cardiac failure chronic aggravated; Respiratory arrest; Pyrexia (38.2 degrees centigrade); Could not eat; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number is v21121543. A 102-year and 4-month-old female patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0572, Expiration date 31Oct2021), via an unspecified route of administration on 25Jul2021 at 11:00 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included patient was treated mainly for problematic illnesses of ischaemic heart disease, chronic atrial fibrillation, cardiac failure chronic, and bronchial asthma. The patient was very old, also had severe dementia, and was bedridden. Body temperature before vaccination was 36.7 degrees centigrade on 25Jul2021. Family history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0203, Expiration date 30Sep2021) on 04Jul2021 as single dose for COVID-19 immunisation. On 26Jul2021 (13 hrs after the vaccination), the patient could not eat since at unknown time and experienced pyrexia (38.2 degrees centigrade) around 17:30 (1 day 6 hrs 30 min after the vaccination). On 27Jul2021 at 04:10 (1 day 17 hrs 10 min after the vaccination), the patient experienced respiratory arrest. On 27Jul2021 (1 day 13 hrs after the vaccination), the outcome of the events was fatal. The course of the events was as follows: On 04Jul2021, the patient received the first vaccination, and there had been no particular problem afterwards. On 25Jul2021 (the day of vaccination), the patient experienced no problem on the day of the second vaccination. However, on 26Jul2021 (13 hr after the vaccination), the patient could not eat. On the same day around 17:30, the patient experienced pyrexia (38.2 degrees centigrade with normal blood pressure at 130/77 mmHg). On 27Jul2021 at 04:10 (1 day 17 hrs 10 min after the vaccination), the patient experienced respiratory arrest and was confirmed dead. The patient also experienced cardiac failure chronic aggravated on unspecified date. Outcome of events was fatal. It was not reported if an autopsy was performed. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Refer below regarding other possible causes of the events such as any other diseases. Reporter comment: Although conditions including pyrexia triggered the onset, cardiac failure chronic aggravated was the likely direct cause of death. However, it was difficult to determine whether pyrexia was due to the vaccination, aspiration, or other causes.; Reported Cause(s) of Death: Could not eat; Pyrexia (38.2 degrees centigrade); cardiac failure chronic aggravated; Respiratory arrest


VAERS ID: 1527771 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Mydriasis, Oxygen saturation, Pyrexia, Respiratory arrest, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Atrial fibrillation (admitted to the hospital); Myotonic dystrophy (admitted to the hospital); Respiratory disorder (admitted to the hospital/ artificial ventilator was attached)
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210722; Test Name: body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210727; Test Name: Oxygen monitoring; Result Unstructured Data: Test Result:oxygen was unable to be measured with an oxygen; Comments: monitor
CDC Split Type: JPPFIZER INC202100960506

Write-up: sudden death; respiratory arrest; pupils dilated; inappetence; pyrexia of 38.1 degrees Celsius; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121517. A 52-year-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: FC5295; Expiration Date: 30Sep2021), via an unspecified route of administration at the age of 52-year-old on 21Jul2021 15:00 at 0.3 ML single dose for covid-19 immunisation. Medical history included the patient was being admitted to the reporting hospital for myotonic dystrophy, respiratory disorder and atrial fibrillation. She had respiratory disorder and a artificial ventilator was attached. And had history of arrhythmia (not ongoing). The patient had a family history of muscular dystrophy (patient''s mother). Body temperature before vaccination was 36.4 degrees centigrade on 21Jul2021. Concomitant medication included edoxaban tosilate (LIXIANA) taken for atrial fibrillation from an unspecified start date and ongoing. On 27Jul2021 at 06:29 (5 days/15 hours/29 minutes after the vaccination), the patient experienced death (reported as sudden death). On 27Jul2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 21Jul2021 (the day of vaccination), at 15:00, after a medical interview, the patient received the first dose of BNT162b2 vaccination at a dose of 0.3 mL. On 22Jul2021, in the morning, the patient had pyrexia of 38.1 degrees Celsius, and the fever decreased with oral administration of acetaminophen (CALONAL) 400 mg. On 23Jul2021, the patient complained of inappetence, and an infusion solution of 1000 mL/day was administered. On 25Jul2021, the infusion solution was completed on 26Jul2021, according to the roommate, the patient was speaking with energy until around 21:00. On 27Jul2021 from 2:00 to 3:00, the patient went to the restroom with an attendant nurse. On 27Jul2021, at 05:15, the nurse noticed that oxygen was unable to be measured with an oxygen monitor, and she visited the patient''s room. The patient had respiratory arrest and pupils dilated. At 06:29, the patient was confirmed to die. The outcome of events was fatal. The patient died on 27Jul2021. It was not reported 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 medical history of arrhythmia and myotonic dystrophy. The reporting physician commented as follows: Many cases of sudden death caused by this disease were reported. The causality between the event and BNT162b2 vaccination was unknown.; Reported Cause(s) of Death: sudden death; inappetence; pyrexia of 38.1 degrees Celsius; respiratory arrest; pupils dilated


VAERS ID: 1527773 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100960971

Write-up: Death; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The family history and medical history were not provided. Concomitant medications were not reported. On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced death. On unknown date in 2021 (unknown days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: Since the details were unknown, the person in charge would report at a later date. The causality between the event and BNT162b2 was not provided. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. The outcome of the event was fatal. Information about batch/lot number has been requested.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on current convention, the reported death is assessed as related to bnt162b2 until sufficient information is available to confirm an unrelated cause of death. Case will be reassessed once receiving additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Death


VAERS ID: 1527774 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

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

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: EPADEL [EICOSAPENTAENOIC ACID ETHYL ESTER]; AMLODIPINE; AZILVA; MAGMITT; LOXONIN PAP
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100963308

Write-up: Death; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121580. A 59-year-old (reported as 59-year and 5-month-old) female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 12Jul2021 09:30 (Batch/Lot Number: EY0573; Expiration Date: 30Sep2021) as dose 2, single at the age of 59-year-old for covid-19 immunisation. Medical history included hypertension and hyperlipidaemia. Body temperature before vaccination was not reported. Family history was not reported. On an unspecified date, the patient previously received the first dose of bnt162b2 (Lot# and ex b piration date were not reported). Concomitant medication included eicosapentaenoic acid ethyl ester (EPADEL) 600 1 capsule (p) 3 times daily, amlodipine OD (5) 1 tablet once daily, azilsartan (AZILVA) (40) 1 tablet twice daily, magnesium oxide (MAGMITT) (250) 1 tablet 3 times daily, and loxoprofen sodium dihydrate (LOXONIN PAP) 100 mg, all taken for unspecified indications, start and stop dates were not reported. On 12Jul2021 at 09:30 (the day of vaccination), the patient received the second dose of bnt162b2 (Solution for injection, Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 13Jul2021 at unknown time (1 day after the vaccination), the patient experienced death. The outcome of the event was fatal. The course of the event was as follows: On 12Jul2021, the patient received the vaccine. It was estimated that the patient died on 13Jul2021 in the early hours. On 24Jul2021, autopsy was conducted by the police but decomposition was already noted (the patient lived alone). In blood pressure record, there was a description on 12Jul2021 at 23:00. 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 not provided.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1527775 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure, Condition aggravated, Hypophagia, Pulmonary fibrosis, Tachypnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   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: Bedridden; Cardiac failure (Pulmonary fibrosis and cardiac failure were progressing gradually.); Circulatory instability; Hospitalisation (discharge to home became difficult); Oral intake reduced; Oxygen therapy; Pulmonary fibrosis (Pulmonary fibrosis and cardiac failure were progressing gradually.); Respiratory failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100963309

Write-up: The patient was breathing rapidly; Acute aggravation of cardiac failure was suspected; aggravation of pulmonary fibrosis was suspected; aggravation of pulmonary fibrosis was suspected; There were times when the dietary intake was slightly low; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121581. An 86-year and 5-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FD0889, Expiration date: 30Sep2021) at the age of 86 years old, on 16Jul2021 at 16:05 at single dose for COVID-19 immunisation. Body temperature before vaccination was 36.3 degrees centigrade. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire. Medical history included the patient was on inpatient treatment for ongoing pulmonary fibrosis and ongoing cardiac failure (pulmonary fibrosis and cardiac failure were progressing gradually), ongoing hospitalized in the ward for long-term care (discharge to home became difficult) from Apr2020, ongoing bedridden on the bed, ongoing barely capable of oral ingestion, ongoing respiratory and circulatory state were unstable/respiration failure and ongoing oxygen administration. The patient''s concomitant medications were not reported. On 16Jul2021 at 16:05 (the day of vaccination), the patient received the first dose of BNT162B2. On an unknown date (after the vaccination), there were times when the dietary intake was slightly low; the outcome of this event was not reported. On 24Jul2021 at 03:00 (8 days after the vaccination), the patient was breathing rapidly, and acute aggravation of cardiac failure, aggravation of pulmonary fibrosis, and others were suspected; the outcome of these events was fatal on the same date. The course of the events was as follows: On 16Jul2021 (the day of vaccination), the patient received the first BNT162B2 vaccination. Afterwards, no notable abnormality was found but there were times when the dietary intake was slightly low. On 24Jul2021 in the morning (8 days after the vaccination), the patient was breathing rapidly. Acute aggravation of cardiac failure, aggravation of pulmonary fibrosis, and others were suspected; therefore, interventions including dose increase for oxygen administration and fluid replacement were performed. However, the condition worsened rapidly, and the patient died on 24Jul2021 at 15:53. It was not reported if an autopsy was performed. The seriousness and causality of the event there were times when the dietary intake was slightly low were not reported. The reporting physician classified the other events as serious (death). The causality between the other events and BNT162B2 was not reported. Other possible causes of the events such as any other diseases included pulmonary fibrosis and cardiac failure. The reporting physician commented as follows: The patient had had respiratory failure due to pulmonary fibrosis, cardiac failure, and other conditions since before. The causal relationship between the vaccination and the episode seemed to be very unlikely.; Reporter''s Comments: The patient had had respiratory failure due to pulmonary fibrosis, cardiac failure, and other conditions since before. The causal relationship between the vaccination and the episode seemed to be very unlikely.; Reported Cause(s) of Death: aggravation of pulmonary fibrosis was suspected; The patient was breathing rapidly; Acute aggravation of cardiac failure was suspected; aggravation of pulmonary fibrosis was suspected


VAERS ID: 1527776 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardio-respiratory arrest, Drowning
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), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   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: Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100963311

Write-up: drowning in the bathroom; Cardio-respiratory arrest; lethal arrhythmia was suspected; This is a spontaneous report from a contactable physician, who was not the inoculator, received from the Regulatory Authority (RA). Regulatory authority report number is v21121569. A 71-year and 9-month-old male patient received BNT162B2 (COMIRNATY, Solution for injection, lot number and expiration date were unknown) on 13Jun2021 (also reported as 18Jun2021) at single dose for COVID-19 immunisation. Body temperature before vaccination and family history were not reported. Medical history included end stage lung cancer. The patient''s concomitant medications were not reported. On 13Jun2021 at unknown time (the day of vaccination), the patient received the unknown dose of BNT162B2. On 18Jun2021 at unknown time (five days after the vaccination), the patient drowning in the bathroom and died. The course of the event was as follows: The patient was in the state of cardio-respiratory arrest when he was transported to the emergency department. Death of the patient was confirmed straight. The cause of death was drowning in the bathroom. A factor of lethal arrhythmia was suspected. Originally the patient had end stage lung cancer, and the relationship to the vaccine was unknown. The patient died on 18Jun2021. It was not reported if an autopsy was performed. The reporting physician classified the event as fatal and not assessed the causality between the event and BNT162B2. Other possible cause of the event such as any other diseases was not reported. The reporting physician commented as follows: The causal relationship to the vaccine was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reporter''s Comments: The causal relationship to the vaccine was unknown.; Reported Cause(s) of Death: drowning in the bathroom; lethal arrhythmia was suspected; Cardio-respiratory arrest


VAERS ID: 1527777 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Death, Fall, Heat illness
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100963347

Write-up: unknown cause of death; Cerebral haemorrhage; Heat illness; fell during farm labour; This is a spontaneous report from a contactable physician received from a sales representative. An 85-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: unknown, Expiration date: unknown), via intramuscular on an unspecified date at single dose for COVID-19 immunisation. Body temperature before vaccination and family history were not reported. The patient had no medical history. The patient''s concomitant medications were not reported. On an unspecified date (the day of vaccination), the patient received the first dose of BNT162B2. On an unspecified date, the patient experienced heat illness and cerebral haemorrhage. On an unspecified date (14 days after the vaccination), the patient experienced death. Cause of death was not reported. It was not reported if an autopsy was performed. The course of the event was as follows: The patient died 2 weeks after the first dose of the vaccination. On an unspecified date, the patient fell during farm labour. There were evidences of heat illness and cerebral haemorrhage. The reporting physician did not report seriousness of the events heat illness and cerebral haemorrhage. The reporting physician reported that the causality between the events and BNT162B2 was unknown. The outcome of the event unknown cause of death was fatal. The outcome of the events cerebral haemorrhage, heat illness and fall was unknown (not reported). The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events fall, heat illness, and cerebral hemorrhage are conservatively assessed as related to BNT162B2 until further information becomes available. The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and assessed as unrelated. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1527778 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, 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: 2021-06-28
   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 INC202100963351

Write-up: possibility of a thrombotic disease was likely; Death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 86-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 22Jun2021 (Lot Number: FA5765; Expiration Date: 30Sep2021) (at age of 86-year-old) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY5420, Expiration date 31Aug2021) for covid-19 immunization. The family history, medical history and concomitant medications were not provided. On 28Jun2021 (6 days after the vaccination), the patient experienced death. On 28Jun2021 (6 days after vaccination), the patient died at his home. The cause of death was unknown (no autopsy was performed). The causality between the event and BNT162b2 vaccination was unknown at all. However, since the patient was undergoing a catheter, the possibility of a thrombotic disease was likely. The causality between the event and BNT162b2 was not provided. The patient died on 28Jun2021. An autopsy was not performed.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The reported thrombotic disease is likely an intercurrent medical condition and unrelated to 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death; possibility of a thrombotic disease was likely


VAERS ID: 1527779 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial rupture
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Dyslipidaemia; Hypertension; Mycobacterial infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100963421

Write-up: Cardiac rupture; This is a spontaneous report from a contactable physician received via Regulatory authority. The patient was a non-pregnant 85-year-old female. The 85-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 10Jul2021 10:00 (Lot Number: EW0207; Expiration Date: 30Sep2021) (at age of 85-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescription drugs 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 hypertension, diabetes mellitus, dyslipidaemia, and nontuberculous mycobacteria, but the patient'' s health condition was favorable. The patient''s concomitant medications were not reported. On 17Jul2021 at 12:00 (7 days and 2 hours after the vaccination), the patient experienced cardiac rupture. The event resulted in death. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (death). No autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. The reported event was as follows: The patient died due to cardiac rupture. The patient died on 19Jul2021. An autopsy was not performed.; Sender''s Comments: Based on currently known drug safety profile, the reported event cardiac rupture more likely represented intercurrent illness, but not related to bnt162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: cardiac rupture


VAERS ID: 1527780 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-22
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LUNESTA; DONEPEZIL; EZETIMIBE; CILOSTAZOL; AZILVA; BAZEDOXIFENE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Athetosis (old cerebral infarction sequelae); Dementia Alzheimer''s type; Gait disturbance (old cerebral infarction sequelae); Hyperlipidaemia; Hypertension; Late effects of cerebral infarction; Old cerebral infarction; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: at vaccination
CDC Split Type: JPPFIZER INC202100963493

Write-up: pulmonary oedema; appetite impaired; This is a spontaneous report from a contactable physician received communicated to a Pfizer sales representative. An 85-year and 7-month-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC8736, Expiration date 30Sep2021), via an unspecified route of administration on 14Jul2021 at 15:30 (the day of vaccination) (at the age of 85-years and 7-month-old), as Dose 1, single for COVID-19 immunisation. Body temperature at vaccination was 36.4 degrees centigrade, on 14Jul2021. The patient medical history (reported as Complicating diseases) included old cerebral infarction sequelae (gait disturbance, left side athetosis), Dementia Alzheimer''s type, Hypertension, Hyperlipidaemia and Osteoporosis, from an unknown date and unknown if ongoing. The patient family history was not reported. Concomitant medications included eszopiclone (LUNESTA), donepezil, ezetimibe, cilostazol, azilsartan (AZILVA) and bazedoxifene; all taken for an unspecified indication, start and stop date were not reported. The course of the event was as follows: On 14Jul2021, the patient received one dose of vaccination. On about 22Jul2021, appetite impaired was noted. On 27Jul2021 at unspecified time (thirteen days after the vaccination), the patient experienced pulmonary oedema which resulted in emergency room and physician office visit. On 27Jul2021 at about 04:00, the patient went to toilet with the husband support. After that, the husband spoke to the patient from outside of the door, but the patient did not make a response. The husband opened the door and found the patient sitting down. The patient was urgently transported to a local hospital, resuscitation was tried, but she died at the hospital on 27Jul2021 at 05:00. The cause of death was pulmonary oedema, but the cause of pulmonary oedema was unknown. On 27Jul2021 at 05:00 (thirteen days after the vaccination), the outcome of the event was fatal. At the time of death, the outcome of the event appetite impaired was unknown. It was not reported whether an autopsy was performed or not. The reporting physician classified the event as serious (fatal) and did not report the causality between the event and BNT162b2. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Pulmonary edema. 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: pulmonary oedema


VAERS ID: 1527784 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Chest X-ray, Chest injury, Coma scale, Computerised tomogram, Computerised tomogram head, Electrocardiogram, Headache, Pericardial effusion
SMQs:, Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (on oral treatment with antihypertensive drugs)
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric cancer; Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: Chest imaging; Result Unstructured Data: Test Result:showed no particular problem; Test Date: 20210613; Test Name: Result Unstructured Data: Test Result:two-digit score; Test Date: 20210614; Test Name: CT test; Result Unstructured Data: Test Result:revealed acute aortic dissection starting from the Centigrade; Comments: revealed acute aortic dissection starting from the ascending aorta root, pericardial effusion, and left intrathoracic rupture; Test Date: 20210613; Test Name: Head CT; Result Unstructured Data: Test Result:showed no particular problem; Test Date: 20210613; Test Name: EKG; Result Unstructured Data: Test Result:showed no particular problem
CDC Split Type: JPPFIZER INC202100967184

Write-up: Pericardial effusion; left intrathoracic rupture; headache; acute aortic dissection starting from the ascending aorta root; This is a spontaneous report from a contactable pharmacist received from the Regulatory authority. Regulatory authority report number is v21120482. A 75-year-old male patient received BNT162B2 (COMIRNATY), dose 2 on 09Jun2021 at 16:45 (Lot number EY5422, Expiration date 31Aug2021) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypertension (on oral treatment with antihypertensive drugs) and surgery for gastric cancer 15 years before. Body temperature before vaccination and family history were not reported. On an unknown date at unknown time, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 13Jun2021 at 13:00 (4 days after the vaccination), the patient experienced aortic dissection. On 14Jun2021 (5 days after the vaccination), the outcome of the event was fatal. It is unknown if autopsy was done. On 13Jun2021 around 13:00 (4 days after the vaccination), the patient experienced chest pain and headache. A wait-and-see approach was taken but no improvement was obtained. At 14:25, the patient visited the reporting hospital. Electrocardiogram (EKG), chest imaging, and head computerised tomography (CT) showed no particular problem, and headache were alleviated with analgesics. At 16:30, the patient went home. Around 23:00, the patient suddenly fell down (responsive to calling). At 23:20, an ambulance was called, and the Coma Scale score was 2 digits during contact with the emergency crews. When carried inside the ambulance, the patient experienced tonic convulsion and later had cardio-respiratory arrest. Resuscitation was continued, and the patient was transported urgently. At 23:42, they arrived at the reporting hospital. When transferred inside, the patient showed a waveform of pulseless electrical activity (PEA), and chest compression was therefore continued. On 14Jun2021 at 00:22, the patient''s death was confirmed. CT test on 14Jun2021 revealed acute aortic dissection starting from the ascending aorta root, pericardial effusion, and left intrathoracic rupture. The reporting pharmacist classified the events as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. There were other possible causes of the event such as any other diseases. Outcome of the events was fatal.; Reported Cause(s) of Death: Pericardial effusion; left intrathoracic rupture; Aortic dissection; headache


VAERS ID: 1527786 (history)  
Form: Version 2.0  
Age: 102.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac failure chronic, Decreased appetite, Heart rate, Oxygen saturation, Pyrexia, Somnolence
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: Cardiac failure chronic (NT-pro BNP was 1186 pg/mL)
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: blood pressure; Result Unstructured Data: Test Result:96/57; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:72/43; Test Date: 20210624; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210625; Test Name: body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Date: 20210626; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210630; Test Name: body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:39.0 Centigrade; Test Date: 20210708; Test Name: pulse rate; Result Unstructured Data: Test Result:102; Test Name: SpO2; Result Unstructured Data: Test Result:90s %; Comments: SpO2 was maintained at 90s% (it was 92 to 98% until 08Jul2021); Test Date: 20210708; Test Name: SpO2; Test Result: 92 %; Test Date: 20210709; Test Name: SpO2; Test Result: 82 %; Comments: at 15:00
CDC Split Type: JPPFIZER INC202100967306

Write-up: Cardiac failure chronic aggravated; patient had appetite impaired; Somnolence; Pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21120444. A 102-year-old female patient (also reported as 102-year and 3-month-old) received bnt162b2 (COMIRNATY), at same age, dose 1 via an unspecified route of administration on 24Jun2021 11:38 (Batch/Lot Number: FA5765; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s family had no allergic history. The patient had medical history of cardiac failure chronic (NT-pro BNP was 1186 pg/mL). The patient''s concomitant medications were not reported. The patient experienced cardiac failure chronic aggravated on an unspecified date, pyrexia on 25Jun2021 08:00. On 09Jul2021 (14 days after the vaccination), the outcome of the event was fatal. The patient died on 09Jul2021. It was not reported if an autopsy was performed. Body temperature before vaccination was 36.6 degrees centigrade (24Jun2021). The course of the event was as follows: On 25Jun2021 in the morning, the patient experienced pyrexia of 37.6 degrees Celsius. On 26Jun2021 (one day after vaccination), the body temperature was 37.7 degrees Celsius. Thereafter, slight fever persisted, and the patient had appetite impaired. On 30Jun2021 (5 days after vaccination), the patient had pyrexia of 38.4 degrees Celsius. On 04Jul2021 (9 days after vaccination), the body temperature was 37.7 degrees Celsius. On 05Jul2021 (10 days after vaccination), the body temperature was 38.3 degrees Celsius. On 08Jul2021 (13 days after vaccination), the blood pressure was 96/57, the pulse rate was 102, the body temperature was 39.0 degrees Celsius, and the SpO2 was 92%. On 09Jul2021 (14 days after vaccination), the patient tended to have somnolence. The blood pressure was 72/43, and the SpO2 was 82% at 15:00. At 21:45, the patient had respiratory arrest. At 22:55, the patient was confirmed to die by the house visit by a physician. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: From the beginning, the patient had no respiratory symptoms, and the SpO2 was maintained at 90s% (it was 92 to 98% until 08Jul2021). The patient had medical history of cardiac failure chronic, for which she was being treated. There was a possibility that the death was caused by the acute aggravation of cardiac failure chronic.; Reported Cause(s) of Death: Cardiac failure chronic aggravated; Pyrexia


VAERS ID: 1527789 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 2 LA / OT

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

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: Medical History/Concurrent Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100970127

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Regulatory Authority. A 73-years-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot number FC9909, Expiration date 30 Sept, 2021) via intramuscular route of administration in the arm left on 07Jul2021 at 10:45 (at the age of 73-years-old) at single dose for covid-19 immunisation. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient medical history included rheumatoid arthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. 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. The patient concomitant medication was none. The patient previously took carbamazepine and experienced drug eruption. the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot number EY3860, Expiration date 31Aug2021) via intramuscular route of administration in the arm left on 16Jun2021 at 10:45 (at the age of 73-years-old) at single dose for covid-19 immunization. On 14Jul2021 (7 days after the vaccination), the patient experienced death. The reported event was as follows: On 07Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. After the vaccination, the patient did not visit a hospital or consult with a physician. On 14Jul2021 at 14:33 (7 days, 3 hours, and 48 minutes after vaccination), the patient was found lying down at her home. The patient had postmortem rigidity, and her death was confirmed. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (death). The cause of the death was unknown. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1527790 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiac arrest, Feeling abnormal, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   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: AMLODIPINE; LANSOPRAZOLE; FUROSEMIDE; NITRODERM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Cardiac failure chronic; Endoscopic submucosal dissection; Gastric cancer; Gastric ulcer haemorrhage; Spinal cord injury
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: PCR (Nasal Swab); Test Result: Negative
CDC Split Type: JPPFIZER INC202100976123

Write-up: Acute myocardial infarction; Cardiac arrest; Feels poorly; This is a spontaneous report from a non-contactable physician received via COVID-19 Adverse Event Regulatory Authority. A 83-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number and Expiration date was not reported), via intramuscular route of administration, in left arm, on 29Jun2021 at 15:30, the day of vaccination (at the age of 83-year-old), as a single dose for covid-19 immunization. The patient participated in the group vaccination for COVID-19 vaccine. The patient medical history included cardiac failure chronic, early gastric cancer, postoperative state of endoscopic submucosal dissection, central spinal cord injury, bronchial asthma and gastric ulcer haemorrhage from an unknown date and unknown if ongoing. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included amlodipine, lansoprazole, furosemide and glyceryl trinitrate (NITRODERM) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Since the vaccination, the patient has been tested for COVID-19. After the vaccination, the patient noticed feels poorly, and he went into cardiac arrest in the venue. On 29Jun2021 (the same day of the vaccination), the patient was hospitalized for acute myocardial infarction for 1 day. On 30Jun2021 (1 day after the vaccination), the patient died. The patient underwent lab tests and procedures which included (PCR) (nasal swab) with a result of negative on 29Jun2021. Treatment included fluid replacement and noradrenaline. An autopsy was performed that revealed suspected acute myocardial infarction. The cause of death was acute myocardial infarction. The reporting physician assessed the event as serious (Death). The outcome of the events was reported as fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Acute myocardial infarction, cardiac arrest and feeling abnormal. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: Acute myocardial infarction; Autopsy-determined Cause(s) of Death: Suspected acute myocardial infarction


VAERS ID: 1527791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Loss of consciousness, Respiratory arrest, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100977620

Write-up: loss of consciousness due to subarachnoid haemorrhage; respiratory arrest; cardiac arrest; loss of consciousness due to subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory Authority Report. A 65-year and 9-month-old female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FD0348, Expiration date 31Oct2021) an unspecified route of administration on 29Jul2021 at 09:30 (the day of vaccination) as dose 2, single for COVID-19 immunization. Patient''s medical history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Family history was not provided. Historical vaccine included patient previously took the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FC5947, Expiration date 30Sep2021) an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.2 degrees centigrade on 29Jul2021. Concomitant medications were not reported. On 30Jul2021 (1 day after the vaccination), the patient experienced loss of consciousness due to subarachnoid haemorrhage. On that day, the patient developed respiratory arrest and cardiac arrest, and died. It was not reported if an autopsy was performed. The course of the events was as follows: On 30Jul2021 at around 09:30 in the morning, the family member confirmed that the patient was in a normal condition. At around 14:10, the patient was found lying down in an unconscious state. She was transferred to the reporter''s hospital by an ambulance where she was diagnosed with subarachnoid haemorrhage. After a diagnosis was made, she developed respiratory arrest and cardiac arrest. At 16:45, the patient''s death was confirmed. The reporting physician assessed the causality between the event and BNT162b2 as unassessable. It was unknown if there was other possible cause of the event such as any other diseases. The seriousness assessment was not provided. The outcome of events was fatal.; Reported Cause(s) of Death: subarachnoid haemorrhage


VAERS ID: 1527793 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-19
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Constipation, Cystitis
SMQs:, Cardiac failure (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 9
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: Hepatic disease; Renal disease
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100979105

Write-up: Cardiac failure acute suspected; Cystitis; constipation; This is a spontaneous report from a contactable physician received from the Regulatory Authority Report. A 54-year and 11-month-old male patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration on 07Jul2021 at 10:00 at the age of 54-year and 11-month-old as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.5 degrees centigrade on 07Jul2021. The family history was unknown. The patient had medical histories of renal disease and hepatic disease. Concomitant medications were unknown. On 28Jul2021 at 07:00 (21 days after the vaccination), the patient experienced cardiac failure acute suspected. On 28Jul2021 (21 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 07Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On 19Jul2021 (12 days after vaccination), the patient complained of constipation, for which a laxative was prescribed. On 27Jul2021 (20 days after vaccination), the patient complained of pyrexia of 39.5 degrees Celsius and urine odour foul, and he visited the reporting hospital. No other symptoms were observed. The patient was diagnosed with cystitis, for which an antibiotic was prescribed. On 28Jul2021 (21 days after vaccination), in the morning, the patient was found dead by his elder sister. An autopsy showed that the cause of death was cardiac failure suspected. The reporting physician classified the event, cardiac failure acute suspected 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 reporting physician commented as follows: The findings of the autopsy imaging (AI) was as follows: "Small cerebral infarction and micro-inflammatory findings were observed in the lungs; however, the findings which definitely identified the cause of death were not observed. The cause of death was considered as cardiac failure acute." (hearsay)The patient was visiting the department of psychiatry. The patient visited the reporting hospital for only common cold and constipation, and the details of chronic diseases were unknown. Outcome of the event cardiac failure acute suspected was fatal, of the events constipation and cystitis was unknown. ; Reported Cause(s) of Death: Cardiac failure acute suspected


VAERS ID: 1527810 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002617 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cardiac disorder, Imaging procedure, Pleural effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   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: Hyperlipidaemia; Hypertension (Mild (150s/80s))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.7 degrees Celsius; Test Name: Postmortem examination; Result Unstructured Data: Cause of death was suspected heart disease and the etiology was unclear. As per additional note, bilateral pleural effusions were noted on autopsy imaging (AI)
CDC Split Type: JPTAKEDA2021TJP065313

Write-up: bilateral pleural effusion; Heart disease; This case was received via regulatory authority (Reference number: 2021TJP065313) on 26-Jul-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC DISORDER (Heart disease) in a 50-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002617) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension (Mild (150s/80s)) and Hyperlipidaemia. On 22-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced CARDIAC DISORDER (Heart disease) (seriousness criterion death). On an unknown date, the patient experienced PLEURAL EFFUSION (bilateral pleural effusion). The patient died on 23-Jul-2021. The reported cause of death was heart disease. An autopsy was performed. At the time of death, PLEURAL EFFUSION (bilateral pleural effusion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.7 (normal) 36.7 degrees Celsius. On an unknown date, Imaging procedure: autopsy imaging Cause of death was suspected heart disease and the etiology was unclear. As per additional note, bilateral pleural effusions were noted on autopsy imaging (AI). For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. On 22-Jul-2021, after receiving first dose of the vaccine, no problem was observed while under observation for 15 minutes. It was unknown what the patient did after returning home. On 26-Jul-2021, the patient did not came to work in the morning and was visited to be found dead. Reports of postmortem examination showed the cause of death was suspected heart disease and the etiology was unclear. According to the additional note that bilateral pleural effusions were noted on autopsy imaging (AI). The physician who performed the postmortem examination was informed that the patient had received the vaccine, but there was no mention about it. The physician who performed the postmortem examination explained that the fluid had gradually accumulated over time and exceeded the limit. Autopsy was not performed. The estimated date of death was 23-Jul-2021. This is a case of a 50 year old male with history of hypertension and hyperlipidemia who died of Cardiac disorder 1 day after receiving first dose of vaccine. Very limited information regarding the event has been provided at this time. Patient''s comorbidities may have contributed to the event. No further information is expected.; Sender''s Comments: This is a case of a 50 year old male with history of hypertension and hyperlipidemia who died of Cardiac disorder 1 day after receiving first dose of vaccine. Very limited information regarding the event has been provided at this time. Patient''s comorbidities may have contributed to the event. No further information is expected.; Reported Cause(s) of Death: Heart disease


VAERS ID: 1527935 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myeloid leukaemia, Blood test, Chest X-ray, Fatigue, Malaise, Pneumonia, Pyrexia, Septic shock
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Toxic-septic shock conditions (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 49
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: AMOXICILLINE/CLAVULAANZUUR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:no results reported; Test Name: Thorax X; Result Unstructured Data: Test Result:no results reported
CDC Split Type: NLPFIZER INC202100954761

Write-up: Pneumonia; Septic shock; general malaise; fever; Acute myeloid leukaemia; fatigue; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 70-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Jun2021 (Batch/Lot Number: FD0785) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient did not have COVID-19 infection previously. The patient previous took first dose of bnt162b2 (COMIRNATY) on 27Apr2021 for COVID-19 immunisation. Concomitant medication included amoxicillin trihydrate, clavulanate potassium (AMOXICILLINE/CLAVULAANZUUR) taken for an unspecified indication, start and stop date were not reported. The patient experienced general malaise, fever, acute myeloid leukaemia and fatigue all on 03Jun2021 (as reported), pneumonia and septic shock both on an unspecified date. Immediately after the 2nd vaccination (as reported), the patient experienced fatigue, general malaise and fever period. Right after the second vaccination patient experienced fatigue, malaise and fever. He was diagnosed with acute myeloid leukaemia. Patient was admitted to hospital on the ICU where he received full supportive therapy. Later patient developed a pneumonia and septic shock, which caused his death. The patient underwent lab tests and procedures which included blood test and thorax X ray were made: no results reported. The patient died on 22Jul2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: fever; fatigue; general malaise; in recently discovered acute myeloid leukemia; due to pneumonie; Septic shock due to pneumonia in newly detected acute myeloid leukaemia


VAERS ID: 1527937 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-06-08
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal exposure during pregnancy, Foetal heart rate abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100956326

Write-up: Covid-19 vaccine exposure during pregnancy week 26 weeks; Miscarriage; approximately 1 month later the foetus got no heart rate anymore; This is a spontaneous report splitted from master case, which was received from a contactable consumer (parent) or other non hcp downloaded from the Regulatory Authority . This consumer or other non hcp reported information for both mother and foetus/baby. This is the second of two reports. This is a foetus report. A foetus patient of an unspecified gender received BNT162b2 (COMIRNATY, solution for injection, Lot Number: Unknown), via transplacental route on 03May2021 as dose number unknown, 0.3ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 08Jun2021, the patient''s mother experienced miscarriage, the patient''s mother was vaccinated at a pregnancy duration of 26 weeks, approximately 1 month later, the foetus got no heart rate anymore, covid-19 vaccine exposure during pregnancy week: 26 weeks. The patient died due to miscarriage on 08Jun2021, and autopsy details was unknown.; Reported Cause(s) of Death: Approximately 1 month later, the fetus got no heart rate anymore; Miscarriage


VAERS ID: 1527962 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-24
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210801333

Write-up: PASSED AWAY/DEATH; FLU-LIKE SYMPTOMS INCLUDING FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included obese. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) .5 ml, 1 total, administered on 24-JUL-2021 for Prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUL-2021, the patient experienced flu-like symptoms including fever. The patient was able to disclose adverse events he experienced to his friends and family members and the last they heard from patient was on 26 Jul 2021.The patient passed away on 01-AUG-2021, a week after the vaccination. On 01-AUG-2021, the patient died from unknown cause of death. An autopsy was not performed. The patient was cremated immediately after death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of passed away/death on 01-AUG-2021, and the outcome of flu-like symptoms including fever was not reported. This report was serious (Death).; Sender''s Comments: V0:20210801333- passed away/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: 1527969 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysarthria, Hemiparesis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100964421

Write-up: left sided body weakness; slurred speech; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority report. A 71-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Jun2021 (at the age of 71-years-old) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Jun2021, the patient experienced slurred speech and was hospitalized. The hospitalization was prolonged as a result of slurred speech. On the same day, the patient experienced left sided body weakness. The patient died due to slurred speech and left sided body weakness on an unspecified date. 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: left sided body weakness; slurred speech


VAERS ID: 1528018 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-07-04
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Incorrect route of product administration, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Drug abuse and dependence (broad), Medication errors (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 2
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: 20210704; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: PTPFIZER INC202100955104

Write-up: Vaccine failure, critical SARS-CoV-2 infection leading to death; Vaccine failure, critical SARS-CoV-2 infection leading to death; SARS-CoV-2 pneumonia; Route of Administration: INTRAVENOUS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority report number PT-INFARMED-T202107-1176 with Safety Report Unique Identifier PT-INFARMED-T202107-1176 . A 95-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), dose 2 intravenous on 24May2021 (Batch/Lot number was not reported) as a 0.3mL single dose, dose 1 intravenous (Inappropriate route of vaccination) on 26Apr2021 (Batch/Lot number was not reported) as a 0.3mL single dose for COVID-19 immunisation (reported as for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus). The patient''s medical history and concomitant medications were not reported. On 04Jul2021, the patient experienced vaccine failure, critical SARS-COV-2 infection leading to death and SARS-COV-2 pneumonia. It was reported that route of administration: intravenous. The adverse drug reaction (ADR) was detected approximately 41 days after the administration of the second dose of the suspected drug, with an approximate duration of 2 days until the patient''s death. ADR was characterized by the lack of efficacy of the drug with a complete vaccination schedule and resulted in the patient''s death after hospitalization. There was no suspicion of drug interactions. There was no information on previous reactions to other drugs. Specific treatment of the reaction with supportive care. ADR did not improve with treatment. There was no information on concomitant medication. Additional data: The notifier expressed his causal relationship between the onset of ADR and the patient''s death, with no mention of an autopsy. Evolution of ADR (Adverse Drug Reaction): death. On 04Jul2021, the patient underwent lab tests and procedures which included SARS-COV-2 PCR test: positive. The patient died on 06Jul2021. Cause of death: SARS-CoV-2 pneumonia. It was not reported if an autopsy was performed. The reporters assessment of the causal relationship of the [Inappropriate route of vaccination, COVID-19, Vaccination failure, COVID-19 pneumonia] with the suspect product was [Method of assessment: Unknown,Result of Assessment: definite]. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 pneumonia; Vaccine failure, critical SARS-CoV-2 infection leading to death; Vaccine failure, critical SARS-CoV-2 infection leading to death


VAERS ID: 1528078 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (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: SEPFIZER INC202100960255

Write-up: SUICID; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 27-years-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration in 2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient was previously healthy and no previous contact with psychiatry. The patient''s concomitant medications were not reported. The patient completed suicide (death) in 2021. Outcome of the event was fatal. It was unknown if an autopsy was done or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reported Cause(s) of Death: Completed suicide


VAERS ID: 1528286 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Dizziness, Hot flush
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100961314

Write-up: Death; Dizziness; Hot flushes; Severe weakness; This is a spontaneous report from a contactable other hcp (nurse). A 52-year-old female patient received BNT162B2 (COMIRNATY, lot/batch number: FE9174, expiration date: Oct2021), at the age of 52 years old, on 24Jul2021 at 09:30 at single dose for COVID-19 immunisation. The diluent lot/batch number was L1955, expiration date was May2023. The vaccine was reconstituted on 24Jul2021 at 09:00. Medical history was none. The patient was reported to have no chronic illnesses and no underlying conditions. The patient''s concomitant medications were not reported. On 25Jul2021 at 05:00, the patient was reported to have complained of dizziness, hot flushes and severe weakness. According to the reporter, the patient was reported to have died on 25Jul2021 at 05:15. An autopsy was not performed. The outcome of the event death was fatal. The outcome of the events dizziness, hot flushes and severe weakness was unknown.; Sender''s Comments: Based on the limited information given, a causal association between the event "death" and etanercept cannot be completely excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1528289 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100969792

Write-up: passed away approximately 3 weeks after getting vaccine; This is a spontaneous report from a contactable consumer via a sales representative. The consumer reported four cases. This is the first case. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a patient received Covid-19 Pfizer vaccine and passed away approximately 3 weeks after getting vaccine on an unspecified date. It was not reported if an autopsy was performed. lot/batch number has been requested in follow-up.; Sender''s Comments: Linked Report(s): PFIZER same reporter, same product/event, different patient.; PFIZER same reporter, same product/event, different patient.; PFIZER same reporter, same product/event, different patient.; Reported Cause(s) of Death: passed away approximately 3 weeks after getting vaccine


VAERS ID: 1528290 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100969820

Write-up: passed away approximately 3 weeks after getting vaccine; This is a spontaneous report from a contactable consumer via a sales representative. The consumer reported four cases. This is the second case. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a patient received Covid-19 Pfizer vaccine and passed away approximately 3 weeks after getting vaccine on an unspecified date. It was not reported if an autopsy was performed. lot/batch number has been requested in follow-up.; Sender''s Comments: Linked Report(s) : PFIZER same reporter, same product/event, different patient; Reported Cause(s) of Death: passed away approximately 3 weeks after getting vaccine


VAERS ID: 1528291 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100969821

Write-up: passed away approximately 3 weeks after getting vaccine; This is a spontaneous report from a contactable consumer via a sales representative. The consumer reported four cases. This is the third case. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a patient received Covid-19 Pfizer vaccine and passed away approximately 3 weeks after getting vaccine on an unspecified date. It was not reported if an autopsy was performed. lot/batch number has been requested in follow-up.; Sender''s Comments: Linked Report(s) :PFIZER same reporter, same product/event, different patient.; Reported Cause(s) of Death: passed away approximately 3 weeks after getting vaccine


VAERS ID: 1528292 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100969822

Write-up: passed away approximately 3 weeks after getting vaccine; This is a spontaneous report from a contactable consumer via a sales representative. The consumer reported four cases. This is the fourth case. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a patient received Covid-19 Pfizer vaccine and passed away approximately 3 weeks after getting vaccine on an unspecified date. It was not reported if an autopsy was performed. lot/batch number has been requested in follow-up.; Sender''s Comments: Linked Report(s) :PFIZER same reporter, same product/event, different patient.; Reported Cause(s) of Death: passed away approximately 3 weeks after getting vaccine


VAERS ID: 1528480 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-07-04
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-08-05
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: 2021-07-04
   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: Abstains from alcohol; Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202100966818

Write-up: heart attack; This is a spontaneous report from a contactable consumer from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-102568. A 69-year-old female patient received BNT162B2 (COMIRNATY) via unspecified route single dose for COVID-19 immunisation on 23Apr2021. The patient had no medical history, good health, no medication, no alcohol or cigarettes. The patient''s concomitant medications were not reported. The patient had heart attack with no medical history on 04Jul2021. The patient died of a heart attack. The patient died on 04Jul2021. It was unknown if an autopsy was performed. Outcome of the event was fatal. Reporter Comment: Evolution of the ADR (Adverse drug reaction)- Death No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Evolution of the ADR - Death; Reported Cause(s) of Death: heart attack


VAERS ID: 1528483 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hydrops foetalis, Investigation, Karyotype analysis, Maternal exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 50
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: 202106; Test Name: several exams; Result Unstructured Data: Test Result:all possible causes were discarded; Test Date: 20210721; Test Name: karyotype exam; Result Unstructured Data: Test Result:which exam was collected in the material in the on; Comments: which exam was collected in the material in the on 21Jul2021 when the patient died, that is: all tests that would identify genetic causes have already been done, and it was possible to discard all known causes; Test Date: 202106; Test Name: Ultrasound; Result Unstructured Data: Test Result:had hydrops fetalis/Anasarca
CDC Split Type: BRPFIZER INC202100950671

Write-up: a pregnancy that until 26 weeks went perfectly/ Until on 16Jun2021, the patient''s mother took the Pfizer vaccine; Fetal hydrops/Anasarca; This is a spontaneous report from a contactable consumer (patient''s grandmother). This consumer reported information for both mother and fetus. This is the fetus report. A fetus female patient received bnt162b2 (COMIRNATY), transplacental on 16Jun2021 (Batch/Lot number was not reported) at dose number unknown, single for COVID-19 immunisation. The patient''s medical history was and concomitant medications were not reported. The patient experienced fetal hydrops/anasarca in Jun2021. The patient''s mother was pregnant, a pregnancy that unfortunately ended at 30 weeks and 4 days, a pregnancy that until 26 weeks went perfectly, as expected, where mother and baby were in perfect health. Until on 16Jun2021, the patient''s mother took the Pfizer vaccine (sars cov2 immunizer), then a week later (in Jun2021), she started to have symptoms that she did not have before, until after a few days her baby stopped moving, so they ran to the hospital where an ultrasound was done which showed that her baby had hydrops fetalis/Anasarca. She was transferred to the hospital, an excellent public hospital that was a reference in fetal medicine, there several exams were performed and all possible causes were discarded, leaving only the karyotype exam to be performed, which exam was collected in the material in the on 21Jul2021 when the patient died, that is: all tests that would identify genetic causes have already been done, and it was possible to discard all known causes, thus leaving only the vaccine as the cause of the problem. Even the patient''s mother had the aminiotic fluid significantly increased, high blood pressure and a problem with blood clotting, after taking the vaccine. The patient died on 21Jul2021. It was unknown if an autopsy was performed. Information on Batch/Lot number has been requested.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-202100951502 mother case; Reported Cause(s) of Death: a pregnancy that until 26 weeks went perfectly/ Until on 16Jun2021, the patient''s mother took the Pfizer vaccine; Hydrops fetalis


VAERS ID: 1528525 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-05
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: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210806312

Write-up: UNKNOWN CAUSE OF DEATH; This spontaneous report received from a physician via a Regulatory Authority [NLP] concerned a 43 year old male 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, route of admin not reported, batch number: XD974 expiry: unknown) dose was not reported, 1 total administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, 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: 20210806312-Covid-19 vaccine ad26.cov2.s -UNKNOWN CAUSE OF 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: 1528571 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 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 INC202100974100

Write-up: sudden cardiac death; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 76914], license party for Comirnaty. A contactable physician reported that a 50-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sudden cardiac death on an unspecified date. However, the reporter is not sure whether the patient was vaccinated. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Sudden cardiac death and the suspect drug BNT162B2 cannot be excluded. 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: sudden cardiac death


VAERS ID: 1528653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-07-04
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Intracardiac thrombus, Pulmonary embolism
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   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: ATORVASTATIN 1A FARMA; ENALAPRIL KRKA; AMLODIPIN ACTAVIS [AMLODIPINE MESILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202100948619

Write-up: Lung embolism; Cardiac thrombosis; Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [DK-DKMA-WBS-0076020]. A 54-year-old male patient received the first dose of BNT162B2 (COMIRNATY; lot number: FC8889), intramuscular on 05Jun2021 (at an unspecified age) at dose 1, single for COVID-19 immunisation. Medical history included hypertension and hypercholesterolaemia. The patient was not known to have cardiac issues. Concomitant medications included atorvastatin calcium trihydrate (ATORVASTATIN 1A FARMA) 10 mg film-coated tablet for hypercholesterolaemia from 12Jan2021 to an unspecified date, enalapril maleate (ENALAPRIL KRKA) 10 mg tablet for hypertension from 04May2016 to an unspecified date, and amlodipine mesilate (AMLODIPIN ACTAVIS) 5 mg tablet for hypertension from 28Jan2016 to an unspecified date. There was no information regarding the patient''s past medications. On 04Jul2021, 29 days after the first vaccination, the patient developed cardiac arrest, cardiac thrombosis, and lung embolism. The patient died on 04Jul2021 due to the events. The reported causes of death were cardiac arrest, cardiac thrombosis, and lung embolism. It was not reported if treatment was given or a medical procedure was performed. Only inquest was performed with findings: "the health inspector concludes that the cause of death was either cardiac thrombosis, lung embolism or cardiac arrest. It is not possible to specify the cause of death further since the patient is not undergoing autopsy. The spouse of the patient could not deal with the consequences of the latency with a medical autopsy. There was no information regarding test results". The physician thinks that there was a causality to the vaccine due to the time course and because there were no other causes of the patient''s death. The patient switched general practitioner a week before the death, so the reporting physician never saw the patient. Outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac thrombosis; Cardiac arrest; Lung embolism


VAERS ID: 1529455 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: COPFIZER INC202100970198

Write-up: COVID; COVID; This is a spontaneous report from a contactable consumer via Colleague Pfizer. A contactable consumer indicated a 68-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unknown date, the patient who received both doses of the Pfizer vaccine and died after being subsequently infected with COVID. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: COVID


VAERS ID: 1529467 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Computerised tomogram head, Dyspnoea, Electrocardiogram, Respiratory distress, Sudden death, Troponin I
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tabaquism
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:Loss of predominantly supratentorial corticosubcor; Comments: Loss of predominantly supratentorial corticosubcortical differentiation (reverse sign). Signs of mass effect consisting of collapse of the ventricular system and basal cisterns and effacement of sulci and fissures of the convexity. Centered midline; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:note the presence of an out-of-hospital ECG tracin; Comments: note the presence of an out-of-hospital ECG tracing suggestive of coronary vasospasm of the circumflex territory, with subsequent normalization of the current of monophasic injury and evolution to diffuse repolarization alteration, with posterior baseline ECG characterized by sinus rhythm, long QT interval (460- 490 msec) and in telemetry significant monomorphic extrasystolic activity (morphology that suggests origin in RVOT) and R on T phenomenon without any documentation of sustained arrhythmogenesis. The Tn I Hs max recorded was 4836 ng / l.; Test Name: Tn I Hs; Result Unstructured Data: Test Result:4836 ng/L
CDC Split Type: ESPFIZER INC202100948641

Write-up: Sudden death unexplained; Distress respiratory; Gasping; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from regulatory authority, downloaded from the Regulatory agency. The regulatory authority report number is ES-AEMPS-948018. A 41-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Batch/Lot Number was not reported), via an unspecified route of administration on 08Jul2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included tabaquism from an unknown date to 2016. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, Batch/Lot Number: FC5436) on 17Jun2021 for COVID-19 immunisation. The patient experienced distress respiratory, gasping, and cardio-respiratory arrest on 09Jul2021; experienced sudden death unexplained on an unspecified date. Additional information: Lab test results, Electrocardiogram (on an unspecified date): "note the presence of an out-of-hospital ECG tracing suggestive of coronary vasospasm of the circumflex territory, with subsequent normalization of the current of monophasic injury and evolution to diffuse repolarization alteration, with posterior baseline ECG characterized by sinus rhythm, long QT interval (460- 490 msec) and in telemetry significant monomorphic extrasystolic activity (morphology that suggests origin in RVOT) and R on T phenomenon without any documentation of sustained arrhythmogenesis. The Tn I Hs max recorded was 4836 ng / l". Computerised tomogram head (on 11Jul2021): "Loss of predominantly supratentorial corticosubcortical differentiation (reverse sign). Signs of mass effect consisting of collapse of the ventricular system and basal cisterns and effacement of sulci and fissures of the convexity. Centered midline". The outcome of the events was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: sudden death; Distress respiratory; Gasping; Cardio-respiratory arrest


VAERS ID: 1529476 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-07-07
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100948612

Write-up: Pulmonary thromboembolism; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-949006. A 56-year-old female patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot number was not reported) via an unspecified route of administration on 12Jun2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Historical vaccine includes first dose of bnt162b2 (COMIRNATY; Batch/Lot number was not reported) on 22May2021 for COVID-19 immunization. On 07Jul2021, patient experienced pulmonary thromboembolism, she was hospitalized and died on an unspecified date. The event was reported as serious (death, hospitalization, life threatening). 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: Pulmonary thromboembolism


VAERS ID: 1529477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: 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: Cesarean section (x2)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100948617

Write-up: Haemorrhage subarachnoid; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB ES-AEMPS-949055. A 49-years-old non-pregnant female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Jul2021 (Batch/Lot Number: Unknown) as Dose 2, single for covid-19 immunisation. Medical history included caesarean section x2. The patient''s concomitant medications were not reported. The patient received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation. The patient experienced haemorrhage subarachnoid on 12Jul2021. The patient had no known CVRF (Cardiovascular Risk Factors) and no chronic drug treatments. Outcome of the event was fatal. 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: Haemorrhage subarachnoid


VAERS ID: 1529546 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-13
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6984 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood pressure diastolic, Blood pressure systolic, Body temperature, Carotid artery thrombosis, Coma scale, Expiratory reserve volume, Eye swelling, Fatigue, Fraction of inspired oxygen, Heart rate, Investigation, Ischaemic stroke, Magnetic resonance imaging head, Neurological examination, Oxygen saturation, PCO2, PO2, Radioisotope scan, pH body fluid
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 18
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: Arterial hypertension; Benign prostatic hyperplasia; Blindness, one eye; Ex-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: HCO3; Result Unstructured Data: Test Result:246 mmol/L; Test Date: 20210630; Test Name: diastolic blood pressure; Result Unstructured Data: Test Result:65 mmHg; Test Date: 20210630; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:100 mmHg; Test Date: 20210630; Test Name: Temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Test Date: 20210630; Test Name: Glasgow; Result Unstructured Data: Test Result:ventilated intubated patient; Test Date: 20210630; Test Name: Ventilation; Result Unstructured Data: Test Result:Controlled assisted volume ventilation; Test Date: 20210630; Test Name: fraction of inspired oxygen; Test Result: 60 %; Test Date: 20210630; Test Name: Heart rate; Result Unstructured Data: Test Result:46; Comments: b/min; Test Date: 20210630; Test Name: Amines; Result Unstructured Data: Test Result:No; Test Date: 20210630; Test Name: Brain MRI; Result Unstructured Data: Test Result:extent of the stroke to the territories of the lef; Comments: extent of the stroke to the territories of the left middle cerebral artery and both anterior cerebral artery.; Test Date: 20210630; Test Name: Neurological; Result Unstructured Data: Test Result:Patient RASS-5; Comments: Patient RASS-5 Weakly reactive miosis pupils; Test Date: 20210630; Test Name: SpO2; Test Result: 100 %; Test Date: 20210630; Test Name: pCO2; Result Unstructured Data: Test Result:34 mmHg; Test Date: 20210630; Test Name: pH; Result Unstructured Data: Test Result:7.46; Test Date: 20210630; Test Name: pO2; Result Unstructured Data: Test Result:208 mmHg; Test Date: 20210630; Test Name: perfusion scintigraphy; Result Unstructured Data: Test Result:occlusion of the T carotid with massive hypoperfus; Comments: occlusion of the T carotid with massive hypoperfusion in the areas of the left middle cerebral artery and the 2 nascent anterior cerebral arteries of the left internal carotid. The volume of the established infarction was evaluated at 240 ml, the mismatch at 190 ml, for a total of 430 ml of affected cerebral parenchyma. No thrombolysis or thrombectomy given the extent of the stroke.
CDC Split Type: FRPFIZER INC202100966979

Write-up: Ischaemic stroke/a right hemi-bodily paresis/disorders of consciousness/clonic movements/vomiting; Carotid thrombosis; Very tired; swollen eyes, bags under the eyes, knockout, no force; This is a spontaneous report from a contactable consumer downloaded from the regulatory agency-WEB FR-AFSSAPS-MP20215487. A 65-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 07Jun2021 (Batch/Lot Number: FC6984) as single dose for covid-19 immunisation. Medical history included benign prostatic hyperplasia, blindness (one eye), arterial hypertension, smoking quit. Patient was an athletic veteran. Concomitant medication included antihypertensive. Patient experienced ischaemic stroke and carotid thrombosis on 29Jun2021 and died on 01Jul2021 from both events. Patient also experienced very tired following the vaccination and did not received any treatment. Patient also experienced swollen eyes, bags under the eyes on 13Jun2021. Outcome of very tired and swollen eyes, bags under the eyes were not reported. Patient was very tired in the days following the vaccination. Patient initially very athletic, who was no longer able to play sports on the days following the vaccination due to abnormal fatigue. On 13Jun2021, patient experienced swollen eyes, bags under the eyes, knockout, no force. On 30Jun2021: the patient experienced in front of his wife a right hemi-bodily paresis. When help arrived, a right hemiplegia with gaze deviated to the left and disorders of consciousness was noted. Some clonic movements had occurred that required the administration of a diazepam (VALIUM) ampoule. Then patient exhibited reduced consciousness and vomiting during transport. It was decided to intubate him. On arrival at the emergency room at 1:40 am, a perfusion scintigraphy was performed: occlusion of the T carotid with massive hypoperfusion in the areas of the left middle cerebral artery and the 2 nascent anterior cerebral arteries of the left internal carotid. The volume of the established infarction was evaluated at 240 ml, the mismatch at 190 ml, for a total of 430 ml of affected cerebral parenchyma. No thrombolysis or thrombectomy given the extent of the stroke. The patient was urgently included in the LASTE (Local Anesthetic Systemic Toxicity) protocol (evaluation of mechanical thrombectomy as a last resort). The patient was randomized to the standard arm (usual treatment). A brain MRI is performed following and confirms the extent of the stroke to the territories of the left middle cerebral artery and both anterior cerebral artery. Admission to intensive care for continued treatment. Entrance clinical examination included: Initial Glasgow: ventilated intubated patient, Temperature: 35.4 ? C, systolic blood pressure: 100 mmHg, diastolic blood pressure: 62 mmHg, HR (heart rate): 46 b / min, fraction of inspired oxygen: 60%, SpO2: 100%, Amines: No, Ventilation: Controlled assisted volume ventilation, Neurologically: Patient RASS-5, sedated by midazolam and sufentanil, Weakly reactive miosis pupils, pH: 7.46, pO2: 208 mmHg, pCO2: 34 mmHg, HCO3: 246 mmol / L. Support on admission: right jugular central venous route with radiographic control, right radial arterial catheter, continuation of sedations with midazolam and sufentanil, hydrocortisone hemisuccinate, probabilistic antibiotic therapy with amoxicillin; clavulanic acid (AUGMENTIN), prevention of stress ulcer, prevention of thromboembolism by ischemic heart disease, close monitoring of DTCs, close monitoring of diuresis. Evolution: On 01Jul2021 in the morning: appearance of bilateral mydriasis: sedations are interrupted. Death on 01Jul202021. Conclusion: Carotid thrombosis and stroke on Day 22 post-vaccination in a 65-year-old patient with treated hypertension. Death of the patient. The patient died on 01Jul2021. An autopsy was not performed.; Reported Cause(s) of Death: Carotid thrombosis; Ischemic stroke


VAERS ID: 1529564 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Echocardiogram, Facial paralysis, Fatigue, Haemoptysis, Headache, Hypertension, Hypoaesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hearing impairment (broad), Infective pneumonia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBRUTINIB; DARATUMUMAB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic lymphocytic leukaemia
Allergies:
Diagnostic Lab Data: Test Date: 20201110; Test Name: Blood pressure; Result Unstructured Data: Test Result:Normal; Test Date: 20210505; Test Name: Echo-Doppler of the supra-optic trunks; Result Unstructured Data: Test Result:within the limit of normal for age; Test Date: 20210320; Test Name: COVID test; Test Result: Negative
CDC Split Type: FRPFIZER INC202100949177

Write-up: Death; Hypertension; Facial palsy/Feeling of left peripheral facial paralysis; Anaesthesia/hypaesthesia of the lower half of the left hemiface; Severe headache; Extreme fatigue; Coughing up blood; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number FR-AFSSAPS-PS20211683. A 55-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), intramuscular, administered in left arm on 20Apr2021 (at the age of 55 years old) as dose 2, single for COVID-19 immunization. Medical history included chronic lymphocytic leukaemia from Feb2013 to an unknown date. Concomitant medications included ibrutinib and daratumumab, both taken for chronic lymphocytic leukaemia, from 16Dec2020 to an unspecified date. The patient was previously vaccinated with the first dose of BNT162B2 (COMIRNATY, Batch/lot number: ET3620) intramuscular, administered on left arm, on 23Mar2021, as dose 1, single, for COVID-19 immunization. On 20Apr2021, the day of the second injection, the patient had a feeling of left peripheral facial paralysis, anaesthesia/hypaesthesia of the lower half of the left hemiface, with severe headache, extreme fatigue and coughing up blood. On 04May2021, around two weeks after the second injection, hypertension has occurred. On 05May2021, an Echo-Doppler of the supra-optic trunks following episodes of facial paralysis: examination within the limit of normal for age. And on 22May2021, patient''s death was reported with an unknown cause. The patient underwent lab tests and procedures which included blood pressure: normal on 10Nov2020, Echo-Doppler of the supra-optic trunks: within the limit of normal for age on 05May2021, and COVID test: negative on 20Mar2021. The patient died on 22May2021. It was not reported if an autopsy was performed. The outcome of other events was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on temporal relationship. The event of death with unknown cause is assessed as related until the cause of death is clarified. 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 appropriate action in response, will be promptly notified to Regulatory Authorities. and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, , as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1529568 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-06
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Retinal artery occlusion
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100966914

Write-up: CVA/ischemic stroke of the right internal carotid artery; occlusion of the central retinal artery; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Agency-WEB. The regulatory authority report number FR-AFSSAPS-RN20212324. A 78-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: ET6956), via intramuscular in left arm on 23Apr2021 at single dose for COVID-19 immunisation. The patient had no documented history. The patient had no COVID-19 history. The patient''s medical history and concomitant medications were not reported. On 06May2021, the patient developed fleeting amaurosis of the right eye. Diagnosis of an occlusion of the central retinal artery. Improvement but persistence of a decrease in visual acuity at the central level. On 14May2021, the patient died of a second stroke on complete occlusion of the right internal carotid artery. In total, the patient experienced occlusion of the central retinal artery and ischemic stroke of the right internal carotid artery. The patient had not been tested for COVID-19. The outcome of the event cerebrovascular accident (CVA)/ischemic stroke of the right internal carotid artery was fatal. The outcome of the event occlusion of the central retinal artery was unknown. The patient died on 14May2021. An autopsy was not performed.; Sender''s Comments: Linked Report(s) : FR-AFSSAPS-2021057833 AFSSAPS; Reported Cause(s) of Death: CVA/ischemic stroke of the right internal carotid artery


VAERS ID: 1529634 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100961628

Write-up: anaphylactic shock; The initial case was missing the following minimum criteria: unidentifiable reporter received via tweet who is not privately contactable. Upon receipt of follow-up information on 29Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from contactable consumers (one of family''s friend) via a Pfizer market research vendor for Pfizer market program. A 22-year-old male patient received first dose of BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration at the age of 22-year-old on 26Jul2021 14:00 at single dose for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient experienced anaphylactic shock on 26Jul2021. The patient died on 26Jul2021 at 23:00 from anaphylactic shock. The outcome of event was fatal. An autopsy was performed and results were not provided. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: anaphylactic shock


VAERS ID: 1529651 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-29
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Completed suicide, Disease recurrence, Insomnia, Investigation, Mental disorder, Neurosis, Paranoia
SMQs:, Suicide/self-injury (narrow), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Insomnia
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: mental health assessment; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202100943095

Write-up: insomnia; insomnia; paranoia; anxiety; anxiety; mental health crashed/ mental health crisis; Completed suicide; Neurosis; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107211211079840-RMGZJ, Safety Report Unique Identifier GB-MHRA-ADR 25686174. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included insomnia from an unknown date, anxiety from an unknown date. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient previously took antidepressants from unspecified date (intermittently taking anti depressants over a period of years). The patient experienced completed suicide on 14Jun2021, insomnia on an unspecified date, paranoia on an unspecified date, anxiety on an unspecified date, neurosis on 29May2021. Case Narrative: Within hours of receiving the 2nd dose the reporter''s Dad mental health crashed. The first sign was insomnia on the first night post vaccine which caused heightened paranoia and anxiety. (Ambulance called 30/5). The week that followed was truly horrendous, the insomnia paranoia and anxiety continued to get worse. Mid way through that week they contacted his GP for sleeping aids (sleeping tablets) and pushed for some mental health support. (none forthcoming). This neurosis continued to get darker nothing we said or discussed could snap the patient out of this deep negative loop. Nothing they did, no avenue they explored changed anything. it was as if the patient had just gone insane. On Sunday 09Jul (as reported) the patient made his first attempt on his own life by stabbing himself in the stomach several times with a 5inch kitchen knife. He was admitted to hospital. Following a mental health assessment on the Tuesday (as reported), the hospital deemed him fit for release Wednesday (as reported). Only for him to be put in a room alone on Tuesday night (as reported), which ultimately gave him the opportunity to make a 2nd successful attempt. This mental health crisis all started within hours of that 2nd jab. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient died on 14Jun2021. It was not reported if an autopsy was performed. The outcome of the event completed suicide was fatal, while the other evets were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Completed suicide


VAERS ID: 1529889 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-04
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   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: GBMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on 04-May-2021 The patient died on 04-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No relevant concomitant medications reported. No treatment medications reported. The batch number of the suspect product is unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Company comment: This is a case of death in a male patient of an unknown age. The patient''s medical history, concomitant medications, as well as temporal relationship between the use of the product and the event of death were not provided. It is unknown if an autopsy was performed and the cause of death is not provided. Very limited information regarding this event has been provided at this time. No further information is expected.; Sender''s Comments: This is a case of death in a male patient of an unknown age. The patient''s medical history, concomitant medications, as well as temporal relationship between the use of the product and the event of death were not provided. It is unknown if an autopsy was performed and the cause of death is not provided. Very limited information regarding this event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1529961 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardiac arrest, Cataplexy, Gastrointestinal disorder, Immune system disorder, Sepsis, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (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), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 33
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: GRPFIZER INC202100973516

Write-up: septic cataplexy; Cardiac arrest; septic cataplexy (sepsis); Tachycardia NOS; Arrhythmia (NOS); Gastrointestinal disorder NOS; Immune system disorder (NOS); This is a spontaneous report from a contactable consumer or other non hcp. This contactable consumer or other non hcp reported similar events for the same patient for different doses of Comirnaty. This is the 1st of two reports considering second dose administered. The report was downoaded from the WEB. The regulatory authority report number is GR-GREOF-20216150. A 73-year-old female patient received second dose bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 10May2021 as dose 2, single for COVID-19 immunisation.The patient medical history was not reported. There were no concomitant medications. Previously patient received first dose Comirnaty (batch/lot number not reported) on 16Apr2021 for COVID-19 immunisation and experienced Skin and subcutaneous tissue disorder and initial and metastatic cancer(aggravation/cause) which started on 01May2021. On 10May2021, the patient experienced immune system disorder nos. On 21May2021, the patient experienced gastrointestinal disorder nos. On 08Jun2021, the patient experienced tachycardia nos, arrythmia nos. The patient also experienced septic cataplexy and cardiac arrest. The patient died on 12Jun2021 and the cause of death was reported as immune system disorder nos, gastrointestinal disorder nos, tachycardia nos, arrythmia nos, septic cataplexy and cardiac arrest. It was not reported if an autopsy was performed. No follow-up activities possible. No further information expected. Information about lot/batch# cannot be obtain.; Sender''s Comments: Linked Report(s) : GR-PFIZER INC-202100985177 same patient, different dose of vaccine; Reported Cause(s) of Death: septic cataplexy; Cardiac arrest; septic cataplexy (sepsis); tachycardia nos; arrhythmia nos; immune system disorder nos; gastrointestinal disorder nos


VAERS ID: 1529963 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Death
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (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: HKPFIZER INC202100985235

Write-up: UNKNOWN CAUSE OF DEATH; COMA WITHOUT CONSCIOUSNESS; This is a spontaneous report from a contactable consumer based on information received by Pfizer from BioNtech SE (manufacturer control number HK-Fosun-2021FOS002840), license party for bnt162b2 (COMIRNATY). A 37-year-old male patient received bnt162b2 (COMIRNATY), via unspecified route of administration, on 11Jul2021 11:00 (Batch/Lot number was not reported) as first dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced coma without consciousness and unknown cause of death. It was further reported that after 3 days post vaccination, his mother found him fell into coma without consciousness at home (14Jul2021). The patient was then sent to hospital. He was certified dead in the hospital on the same day, now it was pending for death certificate. Coma without consciousness was considered as an important medical event. Outcome of the event coma without consciousness was unknown. The patient died on 14Jul2021. It was unknown whether an autopsy was performed. BioNtech SE comment: The medical review comments of the Department on the reports of coma and death are as follows: The seriousness of coma and death was: serious. Coma and death are not adverse events enlisted in the package insert of COMIRNATY, so its expectedness is: unexpected Given the limited information available to date, it is difficult to exclude a causal relationship, and the relationships between coma, death and COMIRNATY were considered as possible. Causality assessment for COMIRNATY Coma, Unknown cause of death Per Reporter=Possible Per Company (BioNtech SE) =Possible; Reported Cause(s) of Death: UNKNOW CAUSE OF DEATH


VAERS ID: 1530163 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-21
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chills, Fatigue, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDIO ASPIRIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100948771

Write-up: After the administration of the first dose of the Pfizer vaccine, which occurred on June 10th, he felt tiredness, chills, pyrexia, chest oppression, swollen legs. The death occurs on 29 June; After the administration of the first dose of the Pfizer vaccine, which occurred on June 10th, he felt tiredness, chills, pyrexia, chest oppression, swollen legs. The death occurs on 29 June; After the administration of the first dose of the Pfizer vaccine, which occurred on June 10th, he felt tiredness, chills, pyrexia, chest oppression, swollen legs. The death occurs on 29 June; After the administration of the first dose of the Pfizer vaccine, which occurred on June 10th, he felt tiredness, chills, pyrexia, chest oppression, swollen legs. The death occurs on 29 June; After the administration of the first dose of the Pfizer vaccine, which occurred on June 10th, he felt tiredness, chills, pyrexia, chest oppression, swollen legs. The death occurs on 29 June; This is a spontaneous report from a contactable consumer downloaded from the Regulatory authority, regulatory authority number IT-MINISAL02-757832. A 79-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 10Jun2021 (Batch/Lot Number: FD1921) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medication included acetylsalicylic acid (CARDIO ASPIRIN) taken for an unspecified indication, start and stop date were not reported. After the administration of the first dose of the pfizer vaccine, the patient felt tiredness, chills, pyrexia, chest oppression and swollen legs. The patient died on 29Jun2021. It was not reported if an autopsy was performed. Therapeutic measures (Efferalgan) were taken as a result of the events. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: No known allergies. He was taking cardio aspirin; Reported Cause(s) of Death: Chills; Fatigue; Pyrexia; Chest discomfort; swollen legs


VAERS ID: 1530171 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac disorder, Pulmonary embolism
SMQs:, Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 95
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRELEGY ELLIPTA; GEMCITABINE; FLUIMUCIL; DELTACORTENE; OMEPRAZEN [OMEPRAZOLE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Cancer of lung; Chemotherapy; Emphysema pulmonary
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100948618

Write-up: Severe pulmonary embolism; degenerative heart disease; paroxysmal atrial fibrillation; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Regulatory authority: IT-MINISAL02-759076. An 83-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot Number: ER9470) as a single dose for COVID-19 immunization. Medical history included lung cancer, emphysema, benign prostatic hyperplasia, and chemotherapy. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA); gemcitabine on 22Mar2021; acetylcysteine (FLUIMUCIL); prednisone (DELTACORTENE); and omeprazole sodium (OMEPRAZEN). The patient experienced severe pulmonary embolism on 01Apr2021 21:00. Clinical course was reported as follows: The patient had pulmonary edema on 01Apr2021 with progressive worsening of general conditions until 05Jul2021. Access to the emergency room on 01Apr2021 with final diagnosis of pulmonary embolism in pulmonary cancer. Hospitalization in geriatrics from 02Apr2021 to 08Apr2021 with diagnosis at discharge of pulmonary embolism and degenerative heart disease with paroxysmal atrial fibrillation. Oncological check-up on 20Apr2021. The patient died due to the events on 05Jul2021. It was unknown if an autopsy was performed. Reporters comments: The adverse reaction led to another clinically relevant condition - Concomitant conditions: Lung cancer - Reaction time: 21:00 - Sent by Regulatory authority; Chemotherapy, then suspended due to embolism Death on 05Jul2021. Senders comments: 14Jul2021 Regulatory authority contacted signaler and oncologist asked for clinical documentation that is attached to the form. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The adverse reaction led to another clinically relevant condition - Concomitant conditions: Lung cancer - Reaction time: 21:00 - Sent by VigiCovid19-sheet Chemotherapy, then suspended due to embolism Death on 07May2021.; Reported Cause(s) of Death: Severe pulmonary embolism; degenerative heart disease; paroxysmal atrial fibrillation


VAERS ID: 1530178 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-22
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Esophageal reflux; Pulmonary embolism; Sarcoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100948908

Write-up: This is a spontaneous report from a contactable physician, downloaded from the Regulatory authority, Regulatory authority number: IT-MINISAL02-759613. An 86-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 08Apr2021 (Batch/Lot Number: EW2246) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included sarcoma from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, pulmonary embolism from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced (pulmonary embolism) on 22Apr2021. The patient died on 24Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1530200 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Gastric ulcer haemorrhage, Investigation, Shock haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Gastric ulcer haemorrhage; Glaucoma; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: consciousness level; Result Unstructured Data: Test Result:approximately 200
CDC Split Type: JPPFIZER INC202100942299

Write-up: Shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission); Shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission); Shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission); This is a spontaneous report from a contactable pharmacist received via Regulatory authority. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in left arm on 04Jul2021 10:00 (at the age of 85-year-old) (Batch/Lot Number: FA5765; Expiration Date: 30Sep2021) as dose 2, single for covid-19 immunisation. Medical history included cerebral infarction, glaucoma, osteoporosis and gastric ulcer haemorrhage. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 4 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient''s concomitant medications were not reported. The patient received first dose of bnt162b2 on 13Jun2021 for covid-19 immunisation. On 05Jul2021 at 12:00 (1 day and 2 hours after the vaccination), the patient experienced shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission). The event resulted in the emergency room. The outcome of the event was fatal with treatment including emergency medical care. The course of the event was as follows: on 04Jul2021, the patient''s condition was stable after the vaccination. On 05Jul2021, the patient went out for a relative''s funeral, and her condition suddenly changed in a car on her way hospital. The patient was able to return to the hospital; however, pallor facial was noted and the consciousness level was approximately 200. Treatment was started at the emergency outpatient department. The reporting pharmacist assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19. The patient died on 05Jul2021. An autopsy was not performed.; Sender''s Comments: Based on available information and the drug temporal relationship, the causality between the events gastric ulcer haemorrhage, shock haemorrhagic and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission); Shock haemorrhagic due to haemorrhagic multiple gastric ulcers (name of injury or illness on admission)


VAERS ID: 1530209 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / -

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

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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Interstitial pneumonia; Respiratory failure
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100943884

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21120878. The patient was a 77-year-old (at vaccination) male. Body temperature before vaccination was 36.9 degrees centigrade. The family history was unknown. The patient was being treated for interstitial pneumonia and respiratory failure at another hospital. The patient had no history of allergy or anaphylaxis. On 15Jul2021 at 14:29 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Jul2021 (a day after the vaccination), the patient experienced unknown cause of death. The course of the event was as follows: On 15Jul2021 (the day of vaccination), the patient visited the reporting hospital for the first time for receiving the first dose of BNT162b2 vaccination. On 16Jul2021, in the middle of the day, when the patient''s neighbor visited the patient, the patient was found to collapse on the bed. 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 interstitial pneumonia and respiratory failure. The reporting physician commented as follows: It was informed that the patient was in the end stage of interstitial pneumonia and respiratory failure. Since the patient did not have anaphylaxis, the death caused by the underlying diseases was highly likely.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1530211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Body temperature, Decreased appetite, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   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; Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade
CDC Split Type: JPPFIZER INC202100943892

Write-up: Apnoea; Inappetence; Somnolence; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121383. The patient was a 96-year and 10-month-old male. Body temperature before vaccination was 36.8 degrees centigrade. Family history was not reported. Medical history included hypertension, hyperlipidaemia, and dementia, for which the patient was visiting the reporting hospital. There were no other diseases that required avoiding the vaccination. The first vaccination was performed on 26Jun2021 and developed no adverse reactions. On 26Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown) as single dose for COVID-19 immunization. On 17Jul2021 at 13:58 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EW0207, Expiration date: 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidaemia, and dementia. The patient''s concomitant medications were not reported. The patient experienced apnoea on 23Jul2021 11:00, inappetence and somnolence on 22Jul2021. The patient underwent lab tests and procedures which included body temperature: 36.8 centigrade on 17Jul2021. Therapeutic measures were taken as a result of apnoea. On 22Jul2021 (5 days after the vaccination, as reported), the patient experienced inappetence and tendency of somnolence. On 23Jul2021 at 11:00 (6 days after the vaccination, as reported), the patient experienced apnoea. The course of the event was as follows: On 17Jul2021 at around 14:00 (as reported, also reported as 13:58), the patient received the second dose of BNT162b2. He spent the subsequent 6 days as usual, but from the afternoon of 22Jul2021, inappetence and tendency of somnolence appeared and led him to stay in bed. On 23Jul2021 at around 11:00, the patient''s family member noticed that the patient did not show spontaneous breathing and requested ambulance transportation. Cardiopulmonary resuscitation was performed at the hospital but the patient was confirmed dead. On 24Jul2021 (7 days after the vaccination), the outcome of the apnoea was fatal, and the outcomes of the inappetence and somnolence were unknown. The patient died on 24Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event of apnoea as serious (death) and considered that the causality between the event and BNT162b2 was unassessable. The reporting physician did not provide the seriousness and causaltity for the events of inappetence and somnolence. The reporting physician considered that other possible causes of the event such as any other diseases were unassessable due to the patient''s advanced age. The reporting physician commented as follows: The causality was unknown. Opinion hearing was held by the local police.; Reporter''s Comments: The causality was unknown. Opinion hearing was held by the local police.; Reported Cause(s) of Death: Apnoea


VAERS ID: 1530213 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Respiratory arrest, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad)

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: Hepatocellular carcinoma; Palliative care
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210710; Test Name: SpO2; Test Result: 65 %
CDC Split Type: JPPFIZER INC202100943910

Write-up: Death; respiration arrested; Oxygen saturation (SpO2) decreased to 65%; wheezing breath; laboured respiration; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21120880. A 92-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 09Jul2021 14:10 (Batch/Lot Number: FC8736; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing hepatocellular carcinoma and palliative care. The patient''s concomitant medications were not reported. On unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW4811, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 10Jul2021 at 21:38 (1 day after the vaccination), the patient died. Cause of death was not provided. The course of the event was as follows: After the second dose of the vaccination, there was nothing unusual about the patient''s symptoms, and the patient was able to eat all of her dinner with total assistance. On 10Jul2021 at approximately 0:10, ten hours after the vaccination, the patient experienced wheezing breath and laboured respiration when a nurse went the rounds. Oxygen saturation (SpO2) decreased to 65%. Although treatment with oxygen inhalation was performed, respiratory status deteriorated gradually. On 10Jul2021 at 21:10 (31 hours after the vaccination), respiration arrested. On 10Jul2021 at 21:38, the patient was confirmed dead. The outcome of the event death was fatal, other events was unknown.Body temperature on 09Jul2021 was 36.8 centigrade. The reporting physician classified the event as serious (Death) and assessed that the event was related to BNT162b2. Other possible causes of the event such as any other diseases were hepatocellular carcinoma and cardiac failure congestive. The reporting physician commented as follows: The patient suffered from hepatocellular carcinoma for which she had been admitted at the palliative care ward. However, the symptoms were slowly-progressive, and no sign of aspiration was noted. As the cause of the death, a possibility of the vaccination was considered. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1530227 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100944502

Write-up: Death; This is a spontaneous report from a contactable physician received via Pfizer sales representative. A 74-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular on 24Jul2021 (Batch/Lot Number: EY5423; Expiration Date: 31Aug2021) at the age of 74 years old as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and Expiration date unknown) on 30Jun2021. The patient experienced death on 25Jul2021. The course of the event was provided as follows: On 24Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. After the vaccination, no abnormalities were observed, and the patient went home. On 25Jul2021 (one day after vaccination), in the morning, the patient was found to collapse at his home by his family. The patient was transferred to the nearby hospital; however, he was confirmed to die. The patient died on 25Jul2021. It was not reported if an autopsy was performed. The causality between the event and BNT162b2 vaccination was not provided. Cause of death was not provided.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1530228 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-13
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100944805

Write-up: interstitial pneumonia acute; pyrexia; This is a spontaneous report from a non-contactable pharmacist received via a Pfizer sales representative. A 9-decade-old female patient received bnt162b2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration, on 29Jun2021, as dose 2, single for COVID-19 immunisation. Medical history included rheumatism. The patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (COMIRNATY, Lot/Expiration date: unknown) on unspecified date in 2021, for COVID-19 immunisation. On 13Jul2021 (14 days after the vaccination), it was reported that the patient experienced pyrexia and interstitial pneumonia acute. On 22Jul2021 (23 days after the vaccination), the outcome of the events was fatal. The course of the events was as follows: On 29Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination at another institution (detail was unknown). On 13Jul2021 (14 days after vaccination), the patient experienced pyrexia. On 21Jul2021 (22 days after vaccination), the patient was admitted to the reporting hospital. On 22Jul2021 (23 days after vaccination), the patient died due to interstitial pneumonia acute. The outcome of the events was fatal. The event seriousness and causality between the event and BNT162b2 was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events interstitial pneumonia , pyrexia 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 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: interstitial pneumonia acute


VAERS ID: 1530230 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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: Test Date: 20210530; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210603; Test Name: Cerebrospinal fluid examination; Result Unstructured Data: Test Result:showed no abnormality; Comments: after vaccination
CDC Split Type: JPPFIZER INC202100945793

Write-up: Unconscious; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121011. A 75-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30May2021 (Batch/Lot Number: FA2453; Expiration Date: 31Aug2021) (at the age of 75 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had been unconscious on 03Jun2021 10:35. The course of the event was as follows: On 03Jun2021 at 10:35 (3 days after the vaccination), the family member who was living separately found the patient unconscious in the bathtub at home. After a call (emergency call) was made, the emergency crews arrived and confirmed that the patient was clearly dead. Cerebrospinal fluid examination showed no abnormality. No autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician commented that it was unknown whether there were other possible causes or not. The patient underwent lab tests and procedures which included body temperature: 36.0 centigrade on 30May2021 before vaccination and Cerebrospinal fluid examination (after vaccination) showed no abnormality on 03Jun2021. The patient died on 03Jun2021. An autopsy was not performed.; Reported Cause(s) of Death: Unconscious


VAERS ID: 1530232 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Autopsy, Decreased appetite, Diarrhoea, Dyspnoea, Oxygen saturation, Physical deconditioning, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: AI; Result Unstructured Data: Test Result:diffuse lesions in the lung were recognized.; Comments: diffuse lesions in the lung were recognized. Either interstitial pneumonia or pulmonary oedema could be considered as direct cause; Test Date: 20210720; Test Name: the level with a pulse oximeter; Result Unstructured Data: Test Result:70s
CDC Split Type: JPPFIZER INC202100951725

Write-up: Apnoea; physical deconditioning; inappetence; breathing difficulty; vomiting; diarrhoea; This is a spontaneous report from a contactable other health professional (patient''s family member) received from the Regulatory authority. Regulatory authority report number is v21121012. A 79-year and 3-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FD0889, Expiration date 30Sep2021) an unspecified route of administration on 19Jul2021 at around 15:00 (at the age of 79 years old) as dose 2, single for COVID-19 immunization. Body temperature before vaccination was not reported. Medical history, concomitant medications, and family history were not provided. The patient received the first dose of BNT162b2 (Lot# EW0207, Expiration date 30Sep2021) an unspecified route of administration on 28Jun2021, as a single dose for COVID-19 immunization. On 19Jul2021 at around 23:00 (around 8 hours after the vaccination), vomiting and diarrhoea were noted. On 20Jul2021 (1 day after the vaccination), physical deconditioning, inappetence and breathing difficulty were noted. At around 22:45, the patient developed apnoea. At 23:40, the patient died. The course of the events was as follows: The information was obtained from the patient''s family member. On 19Jul2021 at around 23:00, vomiting and diarrhoea appeared. The patient''s eldest son noticed that the patient went to the bathroom more frequently than usual at night (it was unknown how frequent times he went). On 20Jul2021 in the morning, physical deconditioning was noted. The patient did not eat breakfast. The level (SpO2 [oxygen saturation percutaneous]) measured with a pulse oximeter was in the range of 70. The patient himself said that he was fine. At 09:00, the patient''s wife had something to do and went out. The eldest son stated that the patient seemed to have difficulty in breathing. The patient said that he had diarrhoea twice. Although the eldest son advised him to go to a hospital, he said that he was fine. At 15:00, when the wife returned home, it seemed that the patient still felt sick. He ate a small amount of jelly but seemed to spit it on the tissue later. At around 22:00, the patient could have a conversation, however, at around 22:45, it was found the patient did not breathe. Therefore, an emergency service was requested. While transferring the patient to a hospital, the emergency service team performed cardiopulmonary resuscitation. After arrived at a hospital, cardiopulmonary resuscitation was continuously performed, but it did not work. At 23:40, the patient''s death was pronounced. The outcome of the event ''apnoea'' was fatal, for the rest of the events was unknown. The patient died on 20Jul2021. An autopsy was performed that revealed diffuse lesions in the lung were recognized. either interstitial pneumonia or pulmonary oedema could be considered as direct cause. The reporting other health professional classified the event ''apnoea'' as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Reporter''s comment: Based on the results of AI (autopsy imaging) which performed after the patient died, diffuse lesions in the lung were recognized. Either interstitial pneumonia or pulmonary oedema could be considered as direct cause. The patient''s previous lung state was uncertain, but given the fact that his physical condition worsened and he made a poor progress after 19Jul2021, it was considered that the causal relationship with BNT162b2 could not be ruled out. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Based on the results of AI (autopsy imaging) which performed after the patient died, diffuse lesions in the lung were recognized. Either interstitial pneumonia or pulmonary oedema could be considered as direct cause. The patient''s previous lung state was uncertain, but given the fact that his physical condition worsened and he made a poor progress after 19Jul2021, it was considered that the causal relationship with BNT162b2 could not be ruled out.; Reported Cause(s) of Death: Apnoea; Autopsy-determined Cause(s) of Death: diffuse lesions in the lung were recognized. Either interstitial pneumonia or pulmonary oedema could be considered as direct cause; diffuse lesions in the lung were recognized. Either interstitial pneumonia or pulmonary oedema could be considered as


VAERS ID: 1530234 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-07-02
   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: Hospitalisation; Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100951751

Write-up: Sudden cardiac death; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121146. The patient was a 92-year-old female. Body temperature before vaccination was 36.2 degrees centigrade. Family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Medical history included patient had been hospitalized for transient ischaemic attack. The patient''s concomitant medications were not reported. On an unknown date at unknown time, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, lot number not reported, expiration date not reported) for COVID-19 immunisation. On 18Jun2021 at 13:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as DOSE 2, SINGLE (single dose) for COVID-19 immunisation. On 02Jul2021 at 14:38 (14 days after the vaccination), the patient experienced sudden cardiac death. On 02Jul2021 (14 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had been hospitalized for transient ischaemic attack. Patient improved and suddenly died during preparation for discharge. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. It was not reported whether there were other possible causes of the event such as any other diseases. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1530235 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100951815

Write-up: Death; This is a spontaneous report from a non-contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 62-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified antihypertensive drug within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19: Unknown. The patient had no allergies to medications, food, or other products. Other medical history included hypertension. On 03Jul2021 at 13:30, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY3860, Expiration date 31Aug2021) at the age of 62-year-old, intramuscular, left arm for COVID-19 immunisation. On 24Jul2021 at 13:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021) at the age of 62-year-old, via intramuscular route of administration in the arm left for COVID-19 immunisation. On 26Jul2021 (one day/10 hours/30 minutes after the vaccination), the patient experienced death. The event resulted in death. It was unknown if the autopsy was performed. The outcome of the event was fatal with unknown treatment. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19: Unknown. The reported event was as follows: On 26Jul2021, the patient died. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on current convention, the reported death is assessed as related to BNT162b2 until sufficient information is available to confirm an unrelated cause of death. Case will be reassessed once receiving additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Death


VAERS ID: 1530248 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-28
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   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: Food allergy; Forearm fracture; Hip prosthesis user
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100963618

Write-up: Died at home; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A non-pregnant 73-year-old female patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via intramuscular in the arm right on 16Jul2021 at 14:00 for COVID-19 immunization at the age of 73-year-old. Medical history included bilateral hip prosthesis and forearm fracture right (the details were unknown). The patient had allergy to kelp. Prior to vaccination, the patient was not diagnosed with COVID-19. 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. Since the vaccination, the patient has not been tested for COVID-19. On 28Jul2021 (12 days after the vaccination), the patient died at home. The event resulted in death. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (death). Cause of death was reported as unknown at the time of report. It was unknown that autopsy was performed or not.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: unknown at the time of report


VAERS ID: 1530251 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-06-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral disorder, Computerised tomogram, Hydrocephalus, Investigation, 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: 2021-07-19
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Chronic rheumatoid arthritis was reported.)
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: Before vaccination; Test Date: 20210630; Test Name: computed tomography; Result Unstructured Data: Test Result:subarachnoid haemorrhage and acute hydrocephalus; Comments: subarachnoid haemorrhage and acute hydrocephalus was diagnosed; Test Date: 20210630; Test Name: first medical examination; Result Unstructured Data: Test Result:unknown results; Comments: patient was already in comatose
CDC Split Type: JPPFIZER INC202100964346

Write-up: Bilateral cerebral disorder; Subarachnoid haemorrhage; Acute hydrocephalus; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121646.?? An 86-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FC5947, expiration date 30Sep2021) at single dose on 30Jun2021 13:58 via an unknown route at 86-year-old for COVID-19 immunisation. Body temperature before vaccination was 37.0 degrees centigrade. Medical history included chronic rheumatoid arthritis. Family history was not reported. Concomitant drugs included acetylsalicylic acid (BAYASPIRIN). On 30Jun2021 at 13:58 (the day of vaccination), the patient BNT162b2 (COMIRNATY). On 30Jun2021 at around 23:00 (around 9 hours 2 minutes after the vaccination), the patient presented with the symptoms that were diagnosed as subarachnoid haemorrhage, and acute hydrocephalus. On 18Jul2021 (18 days after the vaccination), the patient experienced bilateral cerebral disorder. On 19Jul2021 at 03:30 (19 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30Jun2021 at around 18:00, the patient completed the preparation of supper (this was assumed by the patient''s family member), but at around 23:00, the patient''s oldest son found her lying unconscious. She was then transferred to medical center A. According to the referral provided by the medical center A, the patient was already in comatose at the first medical examination. Based on the results of head computed tomography, subarachnoid haemorrhage and acute hydrocephalus was diagnosed, for which external ventricular drainage was performed. On 18Jul2021, the patient''s condition suddenly changed, with rehaemorrhage and diffuse damage in the bilateral cerebral hemisphere noted. On 19Jul2021 at 15:30, the patient died. Outcome of the events subarachnoid haemorrhage, acute hydrocephalus, and bilateral cerebral disorder was fatal. The reporting physician classified the event as serious(death) and assessed that the causality between the event and BNT162b2 was unassessable. Other possible cause of the event such as any other diseases was not reported.; Reported Cause(s) of Death: Subarachnoid haemorrhage; Acute hydrocephalus; bilateral cerebral disorder


VAERS ID: 1530253 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Marasmus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100964597

Write-up: Death due to senility; Blood pressure dropped transient; This is a spontaneous report from a contactable physician received via a company representative. The patient was a 90-year-old female. Underlying disease/complication was unknown. Other medications were not reported. On 25Jun2021 at unknown time, the patient aged 90 previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 16Jul2021 at unknown time (the day of vaccination), the patient aged 90 received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number not reported, Expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 17Jul2021 (1 day after the vaccination), the patient experienced blood pressure dropped transient; the outcome of this event was recovered on an unknown date. On 23Jun2021 at unknown time (7 days after the vaccination), the patient experienced death due to senility. On 23Jun2021 (7 days after the vaccination), the outcome of the event death due to senility was fatal. The course of the event was as follows: On 25Jun2021, the first vaccination was given. On 16Jul2021 (the day of vaccination), the second vaccination was given. On 17Jul2021 (1 day after the vaccination), the blood pressure temporarily decreased but spontaneously recovered. On 23Jun2021 (7 days after the vaccination), the patient experienced death due to senility. The dietary intake had been gradually decreasing since before the vaccination, and there were no unusual points for the cause of death. The reporting physician classified the event death due to senility as serious (death) and blood pressure dropped transient was serious but not provided seriousness criteria. The reporting physician reported that the vaccine was possibly related to blood pressure dropped transient and unrelated to death. The reporting physician commented that a direct causal relationship with the vaccine was unlikely.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Marasmus and Blood pressure decreased cannot be totally excluded.; Reported Cause(s) of Death: Death due to senility


VAERS ID: 1530255 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   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: Chemotherapy; Lung cancer; Oxygen therapy (home oxygen therapy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100966299

Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121858. An 85-year and 4-month-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) on 27Jul2021 at single dose for COVID-19 immunisation. Body temperature before vaccination was 36.1 degrees centigrade. Family history was not reported. Medical history included ongoing lung cancer, ongoing receiving home oxygen therapy (HOT) and ongoing chemotherapy/under treatment with anticancer drug. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number unknown, Expiration date unknown) on an unspecified date at single dose for COVID-19 immunisation. On 27Jul2021 at an unknown time (the day of vaccination), the patient received the second dose of BNT162B2. On the morning of 28Jul2021 (1 day after the vaccination), the patient experienced respiratory arrest. On 28Jul2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27Jul2021, the patient with no significant change went home after the vaccination. On the morning of 28Jul2021, the family found the patient was not breathing. The death was confirmed at a destination. The patient died on 28Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were lung cancer and receiving HOT and chemotherapy.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1530256 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Myotonic dystrophy
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100966359

Write-up: Death 3 hours after the vaccination; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121763. The patient was a 55-year and 11-month-old male. Body temperature before vaccination was 36.2 degrees Centigrade. The patient had no family history. Medical history included myotonic dystrophy and diabetes mellitus. On 05Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FD1945, Expiration date 31Oct2021) via unspecified route single dose for COVID-19 immunisation. On 26Jul2021 at 15:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection) via unspecified route single dose for COVID-19 immunisation. On 26Jul2021 at 18:30 (the same day of the vaccination), the patient died. The course of the event was as follows: The patient regularly went to another hospital for treatment of myotonic dystrophy and diabetes mellitus. On 05Jul2021, the patient received the first dose of COVID-19 vaccine. Then, clinical course was uneventful. On 26Jul2021, the day of the second dose of COVID-19 vaccine, his body temperature before vaccination was 36.2 degrees Centigrade. Although the patient had difficulty in moving his body from the primary disease, it was considered that the patient was able to be vaccinated on the basis of vaccine screening questionnaire and general condition. After consent was obtained, the patient received the second dose of COVID-19 vaccine at 15:30 (26Jul2021). Then, the patient returned home, and he couched soon. At 18:30 (26Jul2021), his family found the patient was down. The patient died. On 27Jul2021, autopsy was performed. On 28Jul2021, the reporting physician was informed by phone; there was no obvious abnormality. 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 unassessable as the reporting physician described above. The reporting physician commented as follows: The symptom of anaphylaxis was not noted. There was no obvious abnormality at postmortem inspection (autopsy), but the results would be obtained 60 days after the intramuscular vaccination. The causal relationship was unassessable; however, causality with the vaccine could not be denied, because the patient died suddenly just 3 hours after the vaccination. Thus, this case was reported here.; Reported Cause(s) of Death: Death 3 hours after the vaccination


VAERS ID: 1530258 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis, Marasmus
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 55
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: JPPFIZER INC202100966981

Write-up: Cellulitis; Geromarasmus; This is a spontaneous report from a contactable physician received from the Regulatory authority. The regulatory authority report number is v21121887. A 95-year and 4-month-old male patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular at single dose in the left deltoid on 01Jun2021 at the age of 95-year-old for COVID-19 immunization. Body temperature before vaccination was not provided. The first dose was in 2021. Medical history and concomitant medication were not reported. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 02Jun2021 (one day after the vaccination), the patient experienced cellulitis. On 08Jun2021 (7 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 01Jun2021 (the day of vaccination), the patient received the second dose of BNT162B2 vaccination. On 02Jun2021 (one day after vaccination), in the morning, the patient had redness, swelling, feeling hot, and pain from the left elbow joint to the hand. The patient visited another clinic, where he was diagnosed with cellulitis, and oral administration of potassium clavulanate/amoxicillin hydrate (AUGMENTIN) and amoxicillin hydrate (SAWACILLIN) was initiated. However, no improvement was observed, and since several days before, the patient became unable to take meals. Thus, the patient was referred to and visited the reporting hospital on 08Jun2021 (7 days after vaccination). On 08Jun2021 (7 days after vaccination), no redness and pain on the left upper arm was noted. Oedema remained. It was diagnosed that the cellulitis was improving. Thereafter, the patient experienced geromarasmus in Jun2021. On 26Jul2021 (one month and 25 days after vaccination), the patient died due to geromarasmus. It was unknown if an autopsy was performed or not. The outcome of events was fatal. The reporting physician classified the events as serious (hospitalization and 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 not reported. The lot number for the vaccine BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cellulitis; Geromarasmus


VAERS ID: 1530260 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   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: Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100970145

Write-up: Suicide; This is a spontaneous report from a non-contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 39-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 21Jul2021 16:30 at age of 39-year-old as dose 1, single for COVID-19 immunisation. Medical history included schizophrenia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had allergies. The patient''s concomitant medications were not reported. On 28Jul2021 at 16:30 (7 days after the vaccination), the patient experienced suicide. The event resulted in death. The patient died on 28Jul2021. It was not reported if an autopsy was performed. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (death). No causality assessment was provided. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.; Sender''s Comments: Fatal event suicide represents an intercurrent medical condition and unrelated to 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: 1530261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carcinoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100970163

Write-up: acute myocardial infarction; This is a spontaneous report from a non-contactable physician received via Regulatory authority. A non-pregnant 65-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 02Jul2021 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included carcinoma. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. On 02Jul2021 at unspecified time (the day of vaccination), the patient received?the first single dose of BNT162b2. On 10Jul2021 at unspecified time (eight days after the vaccination), the patient experienced acute myocardial infarction. On 17Jul2021 at unspecified time (fifteen days after the vaccination), the patient died from acute myocardial infarction. Autopsy was not performed. The outcome of the event was fatal with unspecified treatment. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Limited information can not support a complete medical assessment. A possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of acute myocardial infarction due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1530262 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Body temperature, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100970223

Write-up: Apnoea; Shortness of breath; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121888. A 93-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration at the age of 93-year-old on 24Jul2021 14:00 (Lot Number: FC3661; Expiration Date: 30Sep2021) as single dose for COVID-19 immunisation. Medical history included cardiac failure and hypertension. The patient was a 93-year and 7-month-old female. Body temperature before vaccination was 36.8 degrees centigrade on 24Jul2021. The family history was not provided. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY) in 2021 for COVID-19 immunisation. On 27Jul2021 (3 days after the vaccination), the patient experienced shortness of breath. On 28Jul2021 (4 days after the vaccination), the patient experienced apnoea. On 29Jul2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient visited a hospital regularly for cardiac failure, hypertension, and others. On 24Jul2021 at 14:00 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 27Jul2021 (3 days after vaccination) (as reported), the patient experienced shortness of breath, and she went to the duty at night, and she went home without abnormalities. On 28Jul2021 (4 days after vaccination) (as reported), the patient was found to have apnoea at dinner by her family. 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 cardiac failure. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was considered unlikely considering the length of time that has elapsed after the vaccination, and the patient''s age. However, this case was reported. The patient underwent lab tests and procedures which included body temperature: 36.8 centigrade on 24Jul2021 (Before vaccination). The patient died on 29Jul2021. It was not reported if an autopsy was performed. The outcome of events was fatal.; Reported Cause(s) of Death: Apnoea; shortness of breath


VAERS ID: 1530263 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-11
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood fibrinogen, Blood urea, Body temperature, C-reactive protein increased, Deep vein thrombosis, Disseminated intravascular coagulation, Fibrin D dimer, Fibrin degradation products, Haemoglobin, Peripheral artery occlusion, Platelet count, Pyrexia, Skin exfoliation, Vomiting, White blood cell count
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: CRP; Result Unstructured Data: Test Result:12.2; Test Date: 20210616; Test Name: fibrin d dimer; Result Unstructured Data: Test Result:138.4 mg/ml; Test Date: 20210616; Test Name: FDP; Result Unstructured Data: Test Result:164.0 mg/ml; Test Date: 20210611; Test Name: Hb; Result Unstructured Data: Test Result:12.6; Test Date: 20210616; Test Name: platelet count; Result Unstructured Data: Test Result:3,6000 uL; Test Date: 20210611; Test Name: PLT; Result Unstructured Data: Test Result:8,0000; Test Date: 20210611; Test Name: WBC; Result Unstructured Data: Test Result:8600; Test Date: 20210611; Test Name: Creatinine; Result Unstructured Data: Test Result:4.06; Test Date: 20210616; Test Name: fibrinogen; Test Result: 46.4 mg/dl; Test Date: 20210611; Test Name: BUN; Result Unstructured Data: Test Result:62.2; Test Date: 20210611; Test Name: body temperature; Result Unstructured Data: Test Result:39 to 40 Centigrade
CDC Split Type: JPPFIZER INC202100970246

Write-up: skin peeling; Disseminated intravascular coagulation; deep vein thrombosis of the right lower limb; arterial occlusion of the right lower limb; pyrexia of 39 to 40 degrees Celsius; vomiting; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121902. A 95-year-old and 10-month-old female patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 24May2021 (Lot number unknown, Expiration date unknown) at the age of 95-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Body temperature before vaccination was not provided. The family history was not provided. The patient received the first dose of BNT162B2 via an unspecified route of administration on 30Apr2021 (Lot Number: unknown; Expiration date: unknown) as single dose for COVID-19 immunization. The clinical course was as follows: On 13Jun2021 (20 days after the vaccination), the patient experienced disseminated intravascular coagulation, deep vein thrombosis of the right lower limb, and arterial occlusion of the right lower limb. The outcome of the event was fatal. On 30Apr2021, the patient received the first dose of COVID-19 vaccine. On 11Jun2021 (18 days after vaccination), since the patient had pyrexia of 39 to 40 degrees Celsius and vomiting, fluid replacement was administered at her nearby hospital. On 13Jun2021 (20 days after vaccination), the patient had oedema right lower limb. On 15Jun2021 (22 days after vaccination), the patient had discoloration of the right lower limb, and she visited the reporting hospital on 16Jun2021 (23 days after vaccination). The platelet count was 3,6000/uL, the FDP was 164.0 mg/mL, D-dimer was 138.4 mg/mL, and the fibrinogen was 46.4 mg/dL. Thus, the patient met the diagnostic criteria of disseminated intravascular coagulation. The intravascular ultrasound showed deep vein thrombosis of the right lower limb, and moreover, the arterial blood flow below the right knee decreased. Subcutaneous bleeding was noted in a wide range of the right lower limb. The discoloration of the skin was aggravated, and the tip of the toe became black. The patient had skin peeling on the whole legs. Although the patient was treated, she died on 21Jun2021 (28 days after vaccination). (On 11Jun2021, the blood examination at her nearby hospital showed WBC of 8600, Hb of 12.6, PLT of 8,0000, BUN of 62.2, Cr of 4.06, and CRP of 12.2.). The reporting physician classified the event as serious (death) and assessed that the causality between the event and COVID-19 vaccine as unassessable. Other possible cause of the event such as any other diseases was as follows: The possibility could not be ruled out that the event was caused by other infection. The reporting physician commented as follows: It was considered important that thrombosis was noted both on the arteries and veins. The event of disseminated intravascular coagulation caused patient died. It was not reported about autopsy. The outcome of pyrexia, vomiting and skin peeling was unknown. The outcome of other events was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Disseminated intravascular coagulation


VAERS ID: 1530264 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Fall, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   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: Blood pressure reading high
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100970406

Write-up: Death due to heart attack; falling; cardiopulmonary arrest; This is a spontaneous report from a contactable physician via a sales representative. The patient was a 91-year-old male. Medical history included mild high blood pressure. Body temperature before vaccination, family history, and concomitant medication were not reported. On 09Jul2021 (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number, Expiration date and Dose number were not reported) via an unspecified route of administration at single dose for COVID-19 immunization. On 19Jul2021 (10 days after the vaccination), the patient experienced death due to heart attack. Around noon, the patient was found falling and being in cardiopulmonary arrest while cutting the grass. The patient had no trauma. The reporting physician determined that the patient died from heart attack. The outcome of the event death due to heart attack was fatal, outcome of other events were unknown. The cause of death was heart attack. It was unknown if autopsy was done. The reporting physician reported that the event was unrelated to BNT162b2. The reporting physician commented that the patient was elderly; however, he had few underlying diseases and only had mild high blood pressure. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: based on the avaialable information the causality between the suspect vaccine BNT162B2 and the fatal events heart attack , cardiopulmonary arrest cannot be completely ruled out , case can be assessed once the further information is available . patient also suffers from underlying medical conditions which could also be possible additive factor for the fatal event .; Reported Cause(s) of Death: Death due to heart attack


VAERS ID: 1530265 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Interstitial lung disease
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 34
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: RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Hypertension; Interstitial pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: body temperature; Result Unstructured Data: Test Result:normal; Comments: before vaccination; Test Date: 20210720; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 degrees Celsius
CDC Split Type: JPPFIZER INC202100970410

Write-up: possible interstitial pneumonia aggravated; Unknown cause of death; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21121907. The patient was an 82-year and 1-month-old female. On 16Jun2021 (as reported) at unknown time (the day of vaccination) (at age of 82-year-old), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a dose2, single dose for COVID-19 immunization. Body temperature before vaccination was normal. The patient family history was not reported. Medical history included interstitial pneumonia, hypertension and bronchial asthma. Concomitant medication included fluticasone furoate/vilanterol trifenatate (RELVAR200ELLIPTA). On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). On 20Jun2021 at unknown time (four days after the vaccination), the patient experienced interstitial pneumonia. On 23Jun2021 (seven days after the vaccination), the patient was admitted to the hospital. On 24Jul2021 (about one month and one week after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was regularly going to hospital for interstitial pneumonia and bronchial asthma. She was under the treatment of Home Oxygen Therapy (HOT) at 0.5 liter/min. On 16Jun2021, the patient received the vaccination. On 20Jul2021 (as reported), the patient started to have pyrexia at 37.5 degrees Celsius. Malaise aggravated. On 23Jun2021, the patient presented to hospital due to the worsening of breathing difficulty, and she was hospitalized with interstitial pneumonia aggravated. Steroid pulse therapy was performed. Oxygenation showed a shift to improve, but general physical condition worsened gradually, and the patient died on 24Jul2021 at 13:24. The reporting physician classified the event as serious (fatal) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was possible interstitial pneumonia aggravated. The reporting physician commented as follows: It was a case that interstitial pneumonia aggravated after receiving the COVID-19 vaccine. The causal relationship was unknown.; Reporter''s Comments: It was a case that interstitial pneumonia aggravated after receiving the COVID-19 vaccine. The causal relationship was unknown.; Reported Cause(s) of Death: Unknown cause of death; possible interstitial pneumonia aggravated


VAERS ID: 1530321 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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: NLPFIZER INC202100948862

Write-up: not feeling well; muscle pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00632378. A 77-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration (at the age of 77-years-old) on 13Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient received first dose of Comirnaty on an unspecified date at 0.3 ml, single dose for covid-19 immunisation. On 13Jun2021, the patient experienced malaise and myalgia following administration of covid-19 vaccine. The event was treated with placing a stent. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender''s comments: Due to inconsistency between latency time and start of reaction, latency time was removed. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information expected.; Reporter''s Comments: Previous COVID-19 infection: No Diagnostic procedures: yes; Reported Cause(s) of Death: Myalgia; Malaise


VAERS ID: 1530323 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Fatigue, Headache, 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), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: NLPFIZER INC202100948791

Write-up: Nausea; Fatigue; Headache; Cardiac arrest; This is a spontaneous report from a contactable consumer downloaded from the Regulatory authority, regulatory authority number NL-LRB-00632999 reporting the similar events for the 2 patients. This is one of 2 reports. A 77-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24May2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the first dose of bnt162b2 (COMIRNATY) on 19Apr2021 (batch/lot # not provided) for COVID-19 immunization and had headache and nausea. Then, the 2nd dose on 24May2021. On 25May2021, the patient had nausea, fatigue, headache. Then, the patient had cardiac arrest on that same day, then resuscitation (CPR) was provided. The patient then died due to the events on unknown date in 2021. The outcome of the events was considered as fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202100961707 same patient/ drug, different event/doses; Reported Cause(s) of Death: cardiac arrest, then CPR, then died; nausea; fatigue; headache


VAERS ID: 1530324 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 8
Permanent Disability? Yes
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 INC202100949036

Write-up: Severe CVA, death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB. The regulatory authority number is NL-LRB-00633770. A 78-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: Unknown) as single dose (at the age of 78-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 13Jul2021, the patient experienced severe cerebrovascular accident (CVA), death. The event was considered serious, death, life threatening, disabling or incapacitating by the regulatory authority. The patient died on 21Jul2021 with cause of death reported as "Because of the vaccination!! Result of severe CVA". It was not reported if an autopsy was performed. Reporter comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine(Comirnaty): unknown No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine(Comirnaty): unknown; Reported Cause(s) of Death: Because of the vaccination!! Result of severe CVA


VAERS ID: 1530327 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 58
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Renal disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100967105

Write-up: Heart failure; Had poor kidneys; lot of fluid in the legs/leg edema; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer or other non-HCP downloaded from the Regulatory authority NL-LRB-00637747. This is first of two reports, for the second dose. An 81-year-old female patient received the 2nd dose of BNT162B2 (COMIRNATY, lot number: unknown) via an unspecified route of administration on 14Apr2021 at age of 81 year old as single dose for COVID-19 immunisation. Medical history renal disorder and heart failure. Concomitant medications included non-specified diuretic. The patient previously received the 1st dose of BNT162B2 (COMIRNATY) on 18Feb2021 for COVID-19 immunisation, experienced leg oedema. The patient experienced lot of fluid in the legs/leg edema on 16Apr2021, heart failure and had poor kidneys on an unspecified date; inappropriate schedule of vaccine administered on 14Apr2021. Treatment: Leg edema was treated with morphine. Heart failure and had poor kidneys were reported as cause of death. It was unknown if autopsy was performed. Confounding factors: Kidney problems. The patient had no previous COVID-19 infection. The outcome of heart failure, had poor kidneys and lot of fluid in the legs/leg edema was fatal. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202100972363 same patient/drug, different dose of vaccine, different events; Reported Cause(s) of Death: lot of fluid in the legs/leg edema; Heart failure; Had poor kidneys


VAERS ID: 1530328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Asthenia, Dysphagia, Investigation, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Dementia (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), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: many examinations; Result Unstructured Data: Test Result: Nothing came out of scans.
CDC Split Type: NLPFIZER INC202100967103

Write-up: lose power/loss of strength; swallow problems; Speech loss; Sore legs; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00639577. A 78-years-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 12Apr2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. No previous COVID-19 infection. One week after starting vaccination, the patient experienced lose power/loss of strength, swallow problems, speech loss, sore legs. The patient had many examinations in hospital. Nothing came out of scans. Likely neurological side effects of Pfizer. They didn''t want to be examined. Outcome of the events was fatal. The patient died on 11Jul2021. It was not reported if an autopsy was performed. Sender Comment: Due to an inconsistency between latency time and started date of the reactions, the start date was removed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: lose power/loss of strength; swallow problems; Speech loss; Sore legs


VAERS ID: 1530329 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Fatigue, Haemoptysis, Hyperpyrexia, Malaise, Myalgia, Pneumonia, SARS-CoV-2 test, Sepsis, Vaccination site pain, Vaccination site pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (allergy test has led to severe rash on arms,); Allergy to antibiotic (allergy: various antibiotics); Allergy to arthropod bite (hypersensitive reactions to mosquito bites); Hay fever
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: hyperpyrexia; Result Unstructured Data: Test Result:40.5 to 42 Centigrade; Test Date: 20210701; Test Name: coronatest negative; Test Result: Negative
CDC Split Type: NLPFIZER INC202100987893

Write-up: Muscle pain; Coughing blood; Cough; Suspected pneumonia; Not feeling well; resulting in sepsis; Fatigue; Fever: 40.5 to 42 degrees Celcius; Reaction at or around the injection site: pain; Reaction at or around the injection site: itching; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory authority, regulatory authority number NL-LRB-00644523. This is first of two reports. A 66-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 09Jun2021 (age at vaccination: 66-year-old) as single dose for covid-19 immunization. Medical history included allergy to various antibiotics, hypersensitive reactions to mosquito bites, allergy test has led to severe rash on arms, hay fever all from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first dose of Comirnaty on 05May2021 as 0.3 ml single dose for covid-19 immunization and experienced Arm discomfort. Patient did not diagnose with covid-19 prior to vaccination. Other diagnostic procedures was reported as no. It was reported within 1 day patient experienced injection site pain and injection site pruritus. On 29Jun2021 patient experienced cough, suspected pneumonia, not feeling well, resulting in sepsis, fatigue, fever: 40.5 to 42 degrees Celsius and on 30Jun2021 patient experienced coughing blood. It was reported Suspected pneumonia resulting in sepsis: From 29Jun2021 high fever and cough, 30Jun2021 corona test was advised, 01Jul2021 tested negative. Coughing up blood 30Jun2021. 02Jul2021 called GP again, advised to watch as fever decreased a bit and to contact him if fever increased. 05 or 06Jul deceased. The patient underwent lab tests and procedures which included body temperature: 40.5 to 42 centigrade on 29Jun2021, sars-cov-2 test: negative on 01Jul2021. The patient died on 06Jul2021. It was not reported if an autopsy was performed. The outcome for the event injection site pain, injection site pruritus was resolved on 2021. Reporter Comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Rigid arm Date: 05May2021. Suspected pneumonia resulting in sepsis: Additional information ADR: From 29Jun high fever and cough, 30Jun coronatest advised, 01Jul tested negative. Coughing up blood 30Jun. 02Jul called GP again, advised to watch as fever decreased a bit and to contact him if fever increased. 05/06Jul deceased No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Rigid arm Date: 05May2021 Suspected pneumonia resulting in sepsis: Additional information ADR: From 29Jun high fever and cough, 30Jun coronatest advised, 01Jul tested negative. Coughing up blood 30Jun. 02Jul called GP again, advised to watch as fever decreased a bit and to contact him if fever increased. 05/06Jul deceased; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202100996461 same patient, different dose; Reported Cause(s) of Death: Pneumonia + sepsis; Pneumonia + sepsis


VAERS ID: 1530338 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-07
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure systolic, Coma scale, Computerised tomogram head, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 2
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: 20210707; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:more than 200 mmHg; Comments: At the first pre-hospital examination he had high systolic blood pressure, $g 200 mmHg; Test Date: 20210707; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:7; Comments: At the first pre-hospital examination he was unconscious with a GCS score of 7; Test Date: 20210707; Test Name: CT brain scan; Result Unstructured Data: Test Result:severe subarachnoid and parenchymal haemorrhage; Comments: CT scan revealed severe subarachnoid and parenchymal haemorrhage after rupture of aneurism in arteria cerebri media left side in M2.
CDC Split Type: NOPFIZER INC202100966982

Write-up: Subarachnoid hemorrhage from the left side of the cerebral artery; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority. Report number; NO-NOMAADVRE-FHI-2021-Un27x5. Safety Report Unique Identifier is NO-NOMAADVRE-E2B_00039012. A 67-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot no FE2083) on 24Jun2021 12:00 intramuscular in left arm on 24Jun2021 12:00 for COVID-19 immunisation. Medical history and concomitant drug were not provided. The patient was previously healthy. Historical vaccine included the first dose BNT162B2 (COMIRNATY, lot no EX6564) on 12May2021 for COVID-19 immunisation. Thirteen days after the second dose, on 07Jul2021, he developed subarachnoid haemorrhage from arteria cerebri media left side. At the first pre-hospital examination he was unconscious with a GCS score of 7 and high systolic blood pressure, $g 200 mmHg. He was acutely hospitalized and still unconscious on arrival at the hospital. CT scan revealed severe subarachnoid and parenchymal haemorrhage after rupture of aneurism in arteria cerebri media left side in M2. The patient died two days later, 09Jul2021. Outcome of the event was fatal. The reactions are serious, and the outcome was fatal. The causality assessment was possible. The reporter will forward the discharge journal, and try to get information on any possible risk factors. The report was assessed as serious with death, hospitalization, and life-threating. The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Subarachnoid hemorrhage from the left side of the cerebral artery


VAERS ID: 1530346 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202100968149

Write-up: death; This is a spontaneous report from a contactable other health professional via the Regulatory authority (Regulatory authority number unknown). A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced death on an unspecified date. 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: death


VAERS ID: 1530347 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202100968201

Write-up: death; This is a spontaneous report from a contactable other health professional via the Regulatory authority (Regulatory authority number unknown). A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on an unspecified date. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1530348 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202100968209

Write-up: death; This is a spontaneous report from a contactable other health professional via the Regulatory authority (Regulatory authority number unknown). A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an unspecified indication. The medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. 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: death


VAERS ID: 1530352 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-21
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / 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: 2021-07-21
   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: PHPFIZER INC202100970919

Write-up: sudden death; This is a spontaneous report from a contactable HCP. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300093386. A 58-year-old male patient received an unknown dose of BNT162B2 (COMIRNATY) via intramuscular on 05Jul2021 (Batch/Lot Number: FD5996) at the age of 58-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 21Jul2021 at 22:30, the patient experienced sudden death. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1530353 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Malaise, Nasopharyngitis, Pyrexia
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)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   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: PHPFIZER INC202100970920

Write-up: Fever; cough; colds; Shortness of breath; body malaise; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory authority. Regulatory authority report number PH-PHFDA-300093397. A 72-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly on 24Jun2021 (at the age of 72 years old) (Lot Number: FD5996) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever (death) on 28Jun2021, cough (death) on 28Jun2021, colds (death) on 28Jun2021, shortness of breath (death) on 28Jun2021, body malaise (death) on 28Jun2021. The patient died on 28Jun2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; cough; colds; shortness of breath; body malaise


VAERS ID: 1530354 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat
SMQs:, Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100970921

Write-up: cold and clammy skin; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300093403. A 53-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 30Jun2021 (at the age of 53 years old) (Lot Number: FD5996) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cold and clammy skin (death) on 07Jul2021. It was reported that the patient usually woke up at 3am in the morning but on 07Jul2021, when the helper tried to wake her up. She noticed that the patient was not moving and has cold and clammy skin. The patient died on 07Jul2021. It was unknown if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: cold and clammy skin


VAERS ID: 1530355 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-07
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Cough, Dyspnoea, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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: PHPFIZER INC202100970922

Write-up: difficulty of breathing; cough; fever; abdominal pain; vomiting; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300093416. A 85-year-old female patient received bnt162b2 (COMIRNATY), via intramuscular on 28Jun2021 (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 cough (death) and fever (death) both on 09Jul2021, difficulty of breathing (death) on 11Jul2021, abdominal pain (death) and vomiting (death) both on 07Jul2021. 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.; Reported Cause(s) of Death: cough; fever; difficulty of breathing; Abdominal pain; Vomiting


VAERS ID: 1530356 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Nasopharyngitis
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad)

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100970923

Write-up: general weakness; cough and colds; cough and colds; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300093569. A 76-years-old male patient received bnt162b2 (COMIRNATY), at the age of 76-years-old intramuscular on 30Jun2021 (Lot Number: FD5996) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced general weakness, cough and colds on 15Jul2021, all resulted in death. The patient died on 15Jul2021. 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: general weakness; cough and colds; cough and colds


VAERS ID: 1530357 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Dysarthria, Haematoma, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202100970924

Write-up: Slight fever; Back pain; Vomiting; Slurred speech; Hematoma on both thighs; This is a spontaneous report from a contactable other healthcare professional, received from the Regulatory Authority. The regulatory authority report number is PH-PHFDA-300093707. A 64-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FD5996) via intramuscular on 14Jul2021 (at the age of 63-year-old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 15Jul2021, the patient experienced slight fever, back pain, vomiting, slurred speech, hematoma on both thighs. The outcome of the events was fatal. The patient died on 15Jul2021. 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 fever; Back pain; Vomiting; Slurred speech; Hematoma on both thighs


VAERS ID: 1530361 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-24
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain stem infarction, Headache, Ischaemic stroke, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EFECTIN; ATYWIA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202100949245

Write-up: Breathing arrested/respiratory arrest.; Ischaemic stroke; Brain stem infarction/brainstem ischemic stroke; Headache, back part of the head; This is a spontaneous report from a contactable consumer (fiance of the patient) downloaded from the Regulatory authority. Report number PL-URPL-DML-MLP.4401.2.460.2021. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 09May2021 (at the age of 30-year-old)(Batch/Lot Number: EY7015) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included venlafaxine hydrochloride (EFECTIN) taken as antidepressant therapy from Sep2019 to 05Jun2021; and dienogest, ethinylestradiol (ATYWIA) taken as contraception from Oct2015 to 05Jun2021. The patient received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. The patient received two doses approximately 30 days. On 24May2021, the patient experienced headache at back part of the head which was persisting for 12 days (24May2021 to 05Jun2021). On 05Jun2021, the patient experienced brain stem infarction/brainstem ischemic stroke. On 12Jun2021, the patient had another ischemic stroke. The patient was hospitalized from 05Jun2021 to 21Jun2021. The reporter marked the criterion for reporting a severe death and hospitalization. The patient died on 21Jun2021. The cause of death given by the reporter was respiratory arrest. An autopsy was not performed. Sender''s comments: ischemic stroke, which can manifest as headache and result in respiratory arrest, is an unexpected effect of the Comirnaty vaccine. There is currently no correlation between Comirnaty vaccine administration and thromboembolic events. Although headache is included in the Comirnaty Summary of Product Characteristics, it should be associated with the occurrence of stroke in this case. There is a temporal relationship between the administration of the vaccine and the onset of symptoms. The submitter marked the criterion for severe notification death and hospitalization. Regulatory authority classified the notification as severe. Reaction(s) / Event(s) Assessed by Regulatory authority. Method of assessment: WHO, Result of Assessment: unlikely. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on limited information in the case , the reported events and the suspect drug BNT162B2 cannot be totally excluded or assess. Case reassess 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: Breathing arrested/respiratory arrest


VAERS ID: 1531183 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH VTAE15MQMZANPE / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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: ZAPFIZER INC202100954406

Write-up: died; This is a spontaneous report from a non-contactable consumer. A 73-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: VTAE15MQMZANPE) administration on 03Jun2021 (at age of 73 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 04Jun2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: died


VAERS ID: 1531184 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Local reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100954591

Write-up: Local reaction; This is a spontaneous report from a non-contactable consumer. A 61-years-old female patient received BNT162b2 (COMIRNATY) via unknown route of administration at age of 61 years on 19May2021 (Batch/Lot Number: EY4834) as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced local reaction (death) on 25May2021. The patient died on 25May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: local reaction


VAERS ID: 1531185 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: ZAPFIZER INC202100954592

Write-up: Death; Weakness; Vomiting; This is a spontaneous report from a non-contactable consumer. A 57-year-old female patient received BNT162b2 (COMIRNATY) via an unspecified route of administration on 26May2021 at age of 57 years old (Batch/Lot Number: EY4834) at dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications was not reported. The patient experienced weakness and vomiting, both on 04Jun2021. The patient died on an unspecified date. It is unknown if autopsy was performed or not. The outcome of weakness and vomiting was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1531186 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0297 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100954593

Write-up: Death; This is a spontaneous report from a non-contactable consumer. A 68-year-old female patient received BNT162b2 (COMIRNATY) via an unspecified route of administration on 08Jun2021 (Lot Number: FD0297) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient died on 15Jun2021. An autopsy was not performed. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1531187 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anuria, Death, Dyspnoea, Headache
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: ZAPFIZER INC202100954594

Write-up: Death; Anuria; Dyspnoea; Headache; This is a spontaneous report from a non-contactable consumer. A 67-years-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: FA7812), at the age of 67-years-old, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dyspnoea, headache and anuria on 18Jun2021. The patient died on an unspecified date. The cause of death is not reported. It was not reported if an autopsy was performed. The outcome of the events dyspnoea, headache and anuria was unknown. No further information was provided at the time of this report.; Reported Cause(s) of Death: Death


VAERS ID: 1531188 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0921 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Febrile convulsion, Local reaction
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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: ZAPFIZER INC202100956432

Write-up: Febrile seizure; Local reaction; This is a spontaneous report from a non-contactable consumer. An 86-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 14Jul2021 (Lot Number: FD0921), dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced febrile seizure and local reaction on 14Jul2021. The patient died due to febrile seizure and local reaction on an unspecified date. An autopsy was not performed. No further information was available at the time of this report.; Reported Cause(s) of Death: Febrile seizure; Local reaction


VAERS ID: 1531203 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-07-19
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Inappropriate schedule of product administration
SMQs:, Guillain-Barre syndrome (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   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: ZAPFIZER INC202100972859

Write-up: General body weakness; died; first dose on 04Jun2021 10:27/second dose on 19Jul2021 15:22; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 04Jun2021 10:27 (Batch/Lot Number: FC3558; Expiration Date: 29Jun2021, at the age of 70-year-old) as single dose, and second dose via an unspecified route of administration on 19Jul2021 15:22 (Batch/Lot Number: FE2090; Expiration Date: 07Aug2021, at the age of 70-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was reported to have complained of general body weakness on an unspecified date. The patient died on 21Jul2021 before she could be taken to hospital. The outcome of the event died was fatal, for event general body weakness was unknown. Autopsy was performed; report not provided.; Sender''s Comments: Based on the limited information the causal association between the event unknown cause of death with the usage of the vaccine BNT162B2 can neither be meaningfully assessed nor excluded. The case will be reassessed if there is new information 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died


VAERS ID: 1531206 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOXAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (On Foxair 50/250 Inhaler)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100994950

Write-up: Patient was found dead at home; This is a spontaneous report from a contactable Other Health Professional. A 46-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 22Jul2021 11:00 (lot number: FE9174; expiration date: 22Jul2021), at single dose for covid-19 immunisation. Medical history included asthma (on Foxair 50/250 Inhaler). Concomitant medication included fluticasone propionate, salmeterol xinafoate (FOXAIR) for asthma. Diluent lot number was L1955D; Expiration Date was May2023. Date and time of reconstitution was on 22Jul2021 at 09:00. The patient was found dead at home on 25Jul2021. As reported, the patient was a known asthma patient and received the COVID-19 vaccine on 22Jul2021. She came back home, the patient was stable at home and she was staying with her 3 year old daughter. They slept on Saturday 24Jul2021. In the morning the following day at about 15:00; The daughter was seen by the tenant through the window inside the room with the mother who had already demised. The daughter stated her mother didn''t wake up. The case was reported to the police immediately and the body taken to forensic. It was not reported if an autopsy was performed.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease of asthma may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Patient was found dead at home, day after they were vaccinated


VAERS ID: 1531348 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-13
Submitted: 0000-00-00
Entered: 2021-08-06
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: AUPFIZER INC202100999543

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other health professional via the Goods Administration (GA). Regulatory authority report number is 593330. A 64-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident on 13May2021. Onset Time in Days: 22days. The outcome of the event was fatal. 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: 1531349 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
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: AUPFIZER INC202100999545

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other health professional via the Goods Administration (GA). Regulatory authority report number is 593828. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident on an unspecified date. The outcome of the event was fatal. 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


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