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From the 10/15/2021 release of VAERS data:

Found 17,128 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1489037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-28
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   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: Medical History/Concurrent Conditions: Diabetes mellitus (underlying disease); Hypertension (underlying disease)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021846729

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from a Pfizer sales representative. The patient was an 81-year-old female. Medical history included underlying diseases of diabetes mellitus and hypertension. Concomitant medications were not reported. On 08Jun2021 at unknown time (the day of vaccination), the patient received the first 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 28Jun2021 at unknown time (19 days after the vaccination), the patient experienced cardio-respiratory arrest. On 28Jun2021 (19 days after the vaccination), the outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: On 08Jun2021 (the day of vaccination), the patient received the first vaccination. On 28Jun2021 (19 days after the vaccination), the patient experienced cardio-respiratory arrest. She died later. The seriousness and causality of the event were not reported. Information on the batch/lot number has been requested.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the event "Cardiorespiratory arrest " and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in re-sponse, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1489043 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Aortic valve stenosis; Atrial fibrillation paroxysmal; Cardiac failure; Chronic kidney disease; Diabetes mellitus; Hypertension; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021846739

Write-up: Loss of consciousness; Cardio-respiratory arrest; This is an initial spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21117736. The patient was a 96-year and 3-month-old male. Body temperature before vaccination and family history were not reported. Medical history included aortic valve stenosis (severe), angina pectoris, diabetes mellitus, hypertension, atrial fibrillation paroxysmal, chronic kidney disease, ischaemic heart disease, and cardiac failure. Concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number not reported, Expiration date not reported) for COVID-19 immunisation. On 02Jul2021 at 13:44 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC8736, Expiration date 30Sep2021) via an unspecified route of administration as the second single dose for COVID-19 immunisation. On 03Jul2021 at 07:30 (1 day after the vaccination), the patient experienced loss of consciousness and cardio-respiratory arrest. The course of the events was as follows: Since Dec2016, the patient was being followed up at the reporting hospital on outpatient basis. The course of ischaemic heart disease and cardiac failure was relatively favorable. On 03Jul2021 at 03:00 (the day of vaccination), during regular rounds, the patient was sleeping and had no problem. At 07:30, during regular rounds, he was found lying in a state of loss of consciousness and cardio-respiratory arrest. Cardiac massage was provided. The patient was transported to an acute hospital, but it did not help him because he died (death date 03Jul2021). It was unknown whether autopsy was done. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible causes of the events such as any other diseases were aortic valve stenosis and angina pectoris. The reporting physician commented as follows: Cardiac failure due to aortic valve stenosis or anginal attack (acute coronary syndrome) was in the background, and it was very likely that the sudden change was associated with those conditions.; Reported Cause(s) of Death: Loss of consciousness; Cardio-respiratory arrest


VAERS ID: 1489047 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Death, Imaging procedure
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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: Hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Imaging; Result Unstructured Data: Test Result:no findings including cerebral haemorrhage
CDC Split Type: JPPFIZER INC2021846759

Write-up: Cardiac death; cause of death was unknown; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 68-year-old male. Medical history included hypertension and type 2 diabetes mellitus. On 04Jul2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported) intramuscular as a DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient''s concomitant medications were not reported. On 05Jul2021 (1 day after the vaccination), the patient experienced cardiac death. The course of the event was as follows: On 05Jul2021, the patient was emergently transferred to the reporting hospital and death was confirmed. Imaging on Jul2021 revealed no findings including cerebral haemorrhage and it was assessed as cardiac death. Information was received from family member that on 04Jul2021, the patient received Pfizer''s vaccine at another city. The outcome of the event was fatal. Patient died on 05Jul2021. Cause of death was unknown (as reported). Causality was unknown but could not be denied. 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 unknown but could not be denied. Reporter''s Comment: Cause of death was unknown (as reported). Causality was unknown but could not be denied. Information on lot/batch number has been requested.; Reporter''s Comments: Cause of death was unknown (as reported). Causality was unknown but could not be denied.; 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 and assessed as unrelated. The case will be reassessed should additional 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 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: cause of death was unknown; Cardiac death


VAERS ID: 1489055 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-07-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 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: AMLODINE [AMLODIPINE BESILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021846888

Write-up: Subarachnoid haemorrhage; This is an initial spontaneous report received from a regulatory authority. The regulatory authority report number is v21118284. A contactable physician (anatomy doctor) reported that an 81-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 27Jun2021 (Batch/Lot number was not reported) at 81-years-old, as dose 2, single for COVID-19 immunization. The patient had medical history of hypertension and findings of arteriosclerosis. 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). Concomitant medication included amlodipine besilate (AMLODINE) 2.5 mg taken for hypertension, start and stop date were not reported. On 06Jun2021, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot number not reported, Expiration date not reported) via an unspecified route of administration as the first single dose for COVID-19 immunization. Body temperature before vaccination was not provided. On 27Jun2021 (the day of vaccination), the patient 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 the second single dose for COVID-19 immunization. The patient did not complain of side reactions or physical deconditioning (since there were no vaccination coupons, the details such as the situation at the time of vaccination were unknown). On 04Jul2021, at 14:40 (7 days, 14 hours, and 40 minutes after vaccination) on the receipt was the last time when the patient was conformed to be alive. On 04Jul2021 (7 days after the vaccination), the patient experienced subarachnoid haemorrhage. On 05Jul2021 (8 days after the vaccination), the patient''s child made a call to the patient; however, no response was obtained. Then, the child visited the patient to see how she was doing, and the patient was found dead in the bedroom at around 19:45 on the same day (8 days, 19 hours, and 45 minutes after vaccination). On 06Jul2021, at 10:30 (9 days, 10 hours, and 30 minutes after vaccination), an autopsy was performed in a university. The autopsy showed subarachnoid heamorrhage which was dominant in the right sylvian fissure. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable. The reporting physician commented as follows: In addition, the death occurred on day 7 after the vaccination, and thus, the causality between the event and BNT162B2 vaccination was considered unlikely. However, since the causality could not be assessed with only this case, this case was reported. There was no other possible cause of the event such as any other diseases. Information on the batch/lot number has been requested.; Sender''s Comments: Based on information provided, the event subarachnoid haemorrhage is more likely related to underlying disease of hypertension and arteriosclerosis but unrelated to BNT162B2 (COMIRNATY).; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1489059 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021846913

Write-up: died; Fever; This is a spontaneous report from a contactable consumer reporting on behalf of her acquaintance. A patient of unspecified age and gender received BNT162b2 (COMIRNATY), via an unspecified route of administration, on an unspecified date, as a single dose (dose number unknown), for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On an unspecified date, the patient had a fever and died. Cause of death was unknown. It was not reported if an autopsy was performed. Fever outcome was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died


VAERS ID: 1489083 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Body temperature, Electrocardiogram, Malaise, Nausea, Pneumonia aspiration, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 22
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: Chronic kidney disease; Coronary stent placement (8 sites); Diabetes mellitus; Diabetic nephropathy; Emphysema; Hepatic cancer; Hepatic function disorder; Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:pyrexia of 39.0 Centigrade; Test Date: 20210612; Test Name: ECG; Result Unstructured Data: Test Result:pointed out ST depressed
CDC Split Type: JPPFIZER INC2021847855

Write-up: Acute myocardial infarction and pneumonia aspiration were diagnosed; Acute myocardial infarction and pneumonia aspiration were diagnosed; Pyrexia of 39.0 degrees centigrade; Queasy; General malaise; This is a spontaneous initial report from a physician via regulatory authority. The patient was an 85-year-old male. There was no relevant past drug history. There were no known allergies. Other medical history included diabetes mellitus, diabetic nephropathy, emphysema, hepatic function disorder, chronic kidney disease, ischaemic heart disease, hepatic cancer, and coronary stents at 8 sites. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Jun2021 at 14:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscularly in the left arm for COVID-19 immunisation (at the age of 85 years old). On 07Jun2021 at unknown time (the day of vaccination), the patient experienced general malaise. On 10Jun2021 at 18:00 (3 days after the vaccination), the patient experienced pyrexia of 39.0 degrees centigrade. On 12Jun2021 at unknown time (5 days after the vaccination), acute myocardial infarction and pneumonia aspiration were diagnosed. On 29Jun2021 at unknown time (22 days after the vaccination), the patient died. The course of the events was as follows: On 07Jun2021 (the day of vaccination), the patient experienced general malaise since after the first vaccination. On 10Jun2021 (3 days after the vaccination), the patient experienced pyrexia of 39.0 degrees centigrade and started to receive oxygen. Eating and oral ingestion were difficult. On 11Jun2021 (4 days after the vaccination), gallstones, urinary tract infection, and myocardial infarction were suspected, and an examination was performed. On 12Jun2021 (5 days after the vaccination), electrocardiogram (ECG) pointed out ST depressed. Acute myocardial infarction and pneumonia aspiration were diagnosed. The patient temporarily recovered, but on 29Jun2021 (22 days after the vaccination), he was discharged dead. He had been supposed to leave the hospital although he was a critically ill patient with diabetes mellitus, diabetic mellitus (DM)-related nephropathy, emphysema, hepatic function disorder, hepatic cancer, and coronary stents at 8 sites. The possibility of painless myocardial infarction to develop had been anticipated since hospital admission. The reporter stated that the adverse events resulted in prolonged hospitalization (the vaccination was done during the hospitalization due to existing disease treatment) and death (as reported). The death cause was myocardial infarction (as reported). No autopsy was performed. Treatments for the adverse events included oxygen administration, transfusion, and nitroglycerin preparations. The reporting physician assessed the events as serious (hospitalization and death). The causality of the events was not reported. Report from the same contactable physician received from the Health Agency (HA). Regulatory authority report number is v21118178. New information reported includes follows: Body temperature before vaccination was 36.7 degrees centigrade. Event queasy was added (on 10Jun2021 06:00). The outcome was unknown. The course of the event was added as follows: On hospital admission, it was explained to family member that the patient might develop painless myocardial infarction before the patient was discharged from the hospital. The reporting physician assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was ischaemic heart disease.; Reported Cause(s) of Death: pneumonia aspiration; General malaise; Pyrexia of 39.0 degrees centigrade; Acute myocardial infarction


VAERS ID: 1489087 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 8
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: CARBOCISTEINE; HACHIMIJIOGAN; TAFLUPROST
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure chronic; Glaucoma; Interstitial pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021849012

Write-up: pneumonia; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. This is the first of the two reports. An 82-year-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration at a dose of 0.3 mL, on 16Jun2021 (the day of vaccination) as single for COVID-19 immunization. The patient had medical histories of cardiac failure chronic, atrial fibrillation, interstitial pneumonia, and glaucoma. The family history was not provided. The concomitant medications included carbocisteine, aconitum spp. processed root, alisma orientale tuber, cinnamomum cassia bark, cornus officinalis fruit, dioscorea spp. rhizome, paeonia x suffruticosa root bark, poria cocos sclerotium, rehmannia glutinosa root (HACHIMI-JIO-GAN) and tafluprost ophthalmic solution 0.0015%. On 26May2021, the patient previously received the first dose of BNT162b2 at a dose of 0.3 mL (COMIRNATY, Lot number: unknown, Expiration date: unknown) for COVID-19 immunization. On 14Jun2021, the patient experienced interstitial pneumonia aggravated acute suspected due to the onset of sputum bloody and cough. On 17Jun2021 (one day after the vaccination), the patient experienced pneumonia. The course of the event was as follows: On 26May2021, the patient received the first dose of BNT162b2 vaccination. On 14Jun2021, the patient experienced interstitial pneumonia aggravated acute suspected due to the onset of sputum bloody and cough. On 16Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 17Jun2021 (one day after vaccination), the patient was admitted to the hospital for treatment. the patient experienced pneumonia. On 25Jun2021 (9 days after vaccination), the patient died due to interstitial pneumonia aggravated acute and pneumonia. On 25Jun2021 (9 days after the vaccination), the outcome of the event was fatal. The events were unrelated to BNT162b2 vaccination.; Sender''s Comments: Based on known disease pathophysiology, the event of Death due to pneumonia, is assessed as not related to suspected product BNT162b2 /COMIRNATY and more likely due to underlying medical condition of interstitial pneumonia. 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: pneumonia


VAERS ID: 1489089 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021849244

Write-up: Unknown cause of death; slightly tired; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is i21102281. The patient was a 94-year-old male. Height and weight: unknown. Pregnancy: no. Adverse reaction history: unknown. Primary disease/complication: prostate cancer. Special notes: alcohol/smoking/allergy, all unknown. On 05Jul2021 at unknown time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0572, Expiration date 31Oct2021) (at the age of 94-year-old) at 0.3 mL intramuscularly as a single dose for COVID-19 immunisation. On 05Jul2021 at unknown time (after an unknown time gap from the vaccination), the patient experienced death. The outcome of the event was fatal. It was not reported whether autopsy was done. The course of the event was as follows: On 05Jul2021 (the day of vaccination), a 15-minute observation of health condition was performed. The patient had no symptoms of immediate allergic anaphylaxis and went home. He told his family that he was slightly tired. The patient felt better in the afternoon after having a sleep, and a wait-and-see approach was taken. Thereafter, the family found the patient dead early in the morning. Details such as causality with the vaccine were unknown. Procedure/diagnosis except those mentioned above that has an effect on the onset of the adverse reaction or others: no. Re-administration: no. The outcome of the event slightly tired was recovered on 05Jul2021. The reporting physician classified the event as serious. The causality of the event was not reported. The reporting physician commented as follows: There was a lack of information on drug therapy given after surgery of prostate cancer. No serious problem was noted in particular at the time of vaccination, and during the 15-minute observation of health condition, the patient was sitting on the chair and later walked back home by himself (with assistance). It was completely unclear whether the event was caused by the underlying disease, other factors, or the vaccine. The causal relationship was totally unclear as well.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1489097 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021855243

Write-up: Geromarasmus; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. The patient was a 92-year-old female. The family history was not provided. The patient had medical history of dementia (The patient seldom spoke. She opened her eyes and looked when she was talked to. She ate a little meal.) On unknown date in 2021 (the day of vaccination), the patient received a first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a unknown, single for COVID-19 immunization. The patient received BNT162b2 vaccination at the family''s wish this time. On unknown date in 2021 (unknown days after the vaccination), the patient experienced geromarasmus. On unknown date in 2021 (2 weeks after the vaccination), the outcome of the event was fatal. The patient died in her sleep due to geromarasmus. It was considered as her natural duration of life. The reporting physician assessed the event was unrelated to BNT162b2.; Sender''s Comments: Based on information provided, the event geromarasmus is related to advanced age of the patient but unrelated to BNT162b2 in concur with the physician.; Reported Cause(s) of Death: Geromarasmus


VAERS ID: 1489098 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Haemoptysis, Interstitial lung disease, Pancreatitis
SMQs:, Acute pancreatitis (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumatosis; Pulmonary fibrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021855553

Write-up: Interstitial pneumonia; Gallstone pancreatitis; Sputum bloody; Anaemia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118501. A 91-years and 6-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 16May2021 (the day of vaccination), at the age of 91 years, as a dose 2, single for COVID-19 immunisation. The patient medical history included pulmonary fibrosis complicated by pneumatosis from 17Feb2014 to 26Sep2019. The patient concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on unspecified date, as a single dose for COVID-19 immunisation. On 17May2021 (1 day after vaccination), the patient experienced interstitial pneumonia. On 11Jun2021, patient experienced anaemia, on 14Jun2021 had sputum bloody and on 22Jun2021 had gallstone pancreatitis. On 03Jun2021 (18 days after the vaccination), the patient was admitted to the hospital due to interstitial pneumonia. On 27Jun2021 (42 days after the vaccination), patient died due to interstitial pneumonia. The outcome of the event interstitial pneumonia was fatal. The outcome of rest all the events was unknown. It was not reported whether an autopsy was performed or not. The course of the event was as follows: On 16May2021, the patient received the second dose of BNT162b2 vaccination. On 17May2021 (one day after vaccination), the patient had malaise, and he was emergently transferred to a previous hospital. On 18May2021 (2 days after vaccination), after betamethasone sodium phosphate (RINDERON) 6 mg was administered, the transfer to the hospital was adjusted; however, all beds were occupied and refused. From 20May2021 (4 days after vaccination) to 22May2021 (6 days after vaccination), methylprednisolone (mPSL) 1000 mg was administered. From 23May2021 (7 days after vaccination) to 24May2021 (8 days after vaccination), prednisolone (PSL) 60 mg was administered. From 25May2021 (9 days after vaccination) to 26May2021 (10 days after vaccination), PSL 50 mg was administered. From 27May2021 (11 days after vaccination) to 28May2021 (12 days after vaccination), PSL 40 mg was administered. From 29May2021 (13 days after vaccination) to 30May2021 (14 days after vaccination), PSL 30 mg was administered. From 31May2021 (15 days after vaccination) to 01Jun2021 (16 days after vaccination), PSL 20 mg was administered. On 02Jun2021 (17 days after vaccination), PSL 10 mg was administered. On 03Jun2021 (18 days after vaccination), in the afternoon, the patient had dyspnoea aggravated and poor oxygenation, and he was emergently transferred to the reporting hospital. After the patient was transferred to the reporting hospital, a noninvasive positive pressure ventilation (NPPV) was applied. From 03Jun2021 (18 days after vaccination) to 05Jun2021 (20 days after vaccination), a steroid pulse therapy with mPSL 1000 mg was performed. From 03Jun2021 (18 days after vaccination) to 10Jun2021 (25 days after vaccination), ceftriaxone (CTRX) 2 g x1 was administered. The respiratory condition was stabilized. On 06Jun2021 (21 days after vaccination), administration of PSL 50 mg was initiated. On 08Jun2021 (23 days after vaccination), the NPPV was removed. The sputum bloody disappeared, and the renal function resolved. On 11Jun2021 (26 days after vaccination), the patient had chest pain, and aortic stenosis (AS) was pointed out. The patient also had anaemia. On 12Jun2021 (27 days after vaccination), blood transfusion of red blood cells (RBC) 2 units was performed, and the patient was followed up. On 14Jun2021 (29 days after vaccination), the patient had sputum bloody again, and the respiratory condition was aggravated again. Since the patient poorly responded to a steroid, the third steroid pulse therapy was not performed. On 17Jun2021 (32 days after vaccination), PSL was tapered to 40 mg. On 25Jun2021 (40 days after vaccination), PSL was tapered to 30 mg. On 22Jun2021 (37 days after vaccination), the patient complained of epigastric pain, and he was diagnosed with gallstone pancreatitis. The respiratory condition was poor, and interstitial pneumonia was aggravated. On 25Jun2021 (40 days after vaccination), administration of morphine was initiated. On 27Jun2021 (42 days after vaccination), the patient died. The reporting physician classified the event 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 as follows (as reported): From 17Feb2014 to 26Sep2019, the patient was followed up for pulmonary fibrosis accompanied with pneumatosis in the hospital. Since the patient had difficulty in visiting the hospital, he was referred to the previous hospital. The reporting physician commented as follows: Since the patient had interstitial pneumonia aggravated after the second dose of the vaccination, the causality between the event and BNT162b2 vaccination was unknown; however, this case was reported.; Reported Cause(s) of Death: Interstitial pneumonia


VAERS ID: 1489099 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (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: JPPFIZER INC2021855584

Write-up: Death; The patient received BNT162b2 as 0.3 mg single for COVID-19 immunization; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. The patient was a 90-year-old male. On an unspecified date (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported) intramuscular as dose number unknown, 0.3 mg single for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date (after the vaccination), the patient experienced death. It was reported that the patient received BNT162b2 as, 0.3 mg single for COVID-19 immunization. The outcome of the event was fatal. It was unknown if autopsy was performed or not. The reporting pharmacist classified the event as serious (death). Causality was not provided.; Sender''s Comments: Based on the reported information, a causal association between the reported event and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1489100 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest pain, Decreased appetite, Myocardial ischaemia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Schizophrenia; Thrombocytopenic purpura
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade
CDC Split Type: JPPFIZER INC2021855606

Write-up: Ischaemic heart disease; did not have appetite; pyrexia; chest pain; This is an initial spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118086. The patient was a 72-year and 5-month-old female. Body temperature before vaccination was 36.3 degrees centigrade. The patient had no particular family history. The patient had medical history of disease that makes it difficult to stop bleeding (thrombocytopenic purpura) and schizophrenia. On 29May2021 at around 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW4811, Expiration date 31Jul2021) via an unspecified route of administration as the first single dose for COVID-19 immunization at the age of 72-year-old. On around 03Jun2021 (around 5 days after vaccination), the patient had pyrexia of 37s degrees Celsius and chest pain, and she orally took aspirin/aluminum glycinate/magnesium carbonate (BUFFERIN). On 05Jun2021 (6 days after vaccination), when the patient visited the reporting hospital, she consulted the physician. Since the patient had underlying diseases, she was encouraged to visit the internal medicine department. On 07Jun2021 (9 days after the vaccination), in the morning, the patient did not have appetite. The patient ate a watermelon at around 13:00. However, at around 14:00, the patient was found to collapse by her husband. The patient experienced ischaemic heart disease. Although the patient was emergently transferred, she died. It was unknown whether autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was the effect of underlying diseases. The reporting physician commented as follows: The patient was regularly visiting the reporting hospital once a month because the patient was diagnosed with schizophrenia. However, the patient seemed not to die suddenly. Since the patient suddenly died approximately 1 week after the vaccination, the event was judged to be related to BNT162b2 vaccination.; Reported Cause(s) of Death: Ischaemic heart disease


VAERS ID: 1489101 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
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 INC2021855667

Write-up: Death; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This case was 2nd of 3 patients. The patient''s age and gender were not reported. Medical history and concomitant medication were not reported. On an unspecified date (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported) via an unspecified route of administration as dose number unknown, single for COVID-19 immunisation. On an unspecified date (after the vaccination), the patient died. The cause of death was not reported. It was not reported whether autopsy was performed or not. The outcome of the event was fatal. Seriousness and causality were not provided.; 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 including underlying risk factors/predisposing condition and concomitant medications.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: 1489102 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Cardio-respiratory arrest, Chest pain, Cholecystitis, Computerised tomogram abdomen, Diarrhoea, Dizziness, Liver disorder, Loss of consciousness, Physical deconditioning, Scan with contrast, Sepsis, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-11
   Days after onset: 10
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: ATORVASTATIN; PLAVIX; JANUVIA [SITAGLIPTIN PHOSPHATE]; OPALMON; VOGLIBOSE; NITRODERM; DOPS; RISUMIC; IRRIBOW; ALLEGRA; METLIGINE
Current Illness: Diabetes mellitus; Haemodialysis
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Diabetic retinopathy; Foot amputation
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Blood gas; Result Unstructured Data: Test Result:no problem in oxygenation; Test Date: 202106; Test Name: Abdomen CT; Result Unstructured Data: Test Result:swelling of gallbladder wall; Comments: swelling of gallbladder wall, increase in concentration of peripheral adipose tissue (suspected sepsis), and cholecystitis; Test Date: 20210610; Test Name: Contrast-enhanced CT; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: JPPFIZER INC2021855668

Write-up: dizziness; physical deconditioning; aggravation of chest pain; diarrhoea; tachycardia; suspected acute liver disorder; loss of consciousness; CPA; suspected sepsis; cholecystitis; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21118190. The patient was a 70-year and 11-month-old (at vaccination) male. Medical history included induction of ongoing haemodialysis (HD), ongoing diabetes mellitus (DM), diabetic retinopathy, cardiac failure, and right foot amputation. Concomitant medication included atorvastatin (ATORVASTATIN) 10 mg, clopidogrel bisulfate (PLAVIX) 75 mg, sitagliptin phosphate (JANUVIA) 25 mg, limaprost alfadex (OPALMON) 10 ug, voglibose (VOGLIBOSE) 0.3 mg, glyceryl trinitrate (NITRODERM TTS), droxidopa (DOPS) 20 mg, amezinium metilsulfate (RISUMIC) 10 mg, ramosetron hydrochloride (IRRIBOW) 2.5 ug, fexofenadine hydrochloride (ALLEGRA) 60 mg, and midodrine hydrochloride (METLIGINE) 2 mg, all taken via oral. On 08Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization at the age of 70-year-old. On 08Jun2021 at night (on the same day of the vaccination), the patient experienced diarrhoea. On 09Jun2021 (1 day after the vaccination), the patient experienced dizziness, physical deconditioning, and aggravation of chest pain. On an unspecified date in Jun2021, the patient experienced suspected sepsis and cholecystitis. On 10Jun2021 (2 days after the vaccination), the patient experienced suspected acute liver disorder, loss of consciousness, CPA, and tachycardia. On 09Jun2021 (1 day after the vaccination), the patient was admitted to the hospital. On 11Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the events was as follows: On the day of the vaccination at night, the patient developed diarrhoea and went to toilet for about 20 times. On the following day on 09Jun2021 in the morning, the patient had dizziness. On the same day, dialysis was conducted. Before and after the dialysis, the patient had physical deconditioning. After returning home, the patient had aggravation of chest pain, which started about 10 days before. Since there was little improvement, ambulance was requested and the patient was hospitalized at 22:15. After the hospital admission, abdomen CT revealed swelling of gallbladder wall, increase in concentration of peripheral adipose tissue (suspected sepsis), and cholecystitis. Antimicrobial agent was initiated for cholecystitis and department of gastrointestinal medicine was consulted. At the department of gastrointestinal medicine, endoscopic sphincterotomy (EST) was conducted for the treatment of cholecystitis and endoscopic nasobiliary drainage (ENBD) tube was placed. The patient was fasted and treated with meropenem (MEPM) infusion (on 10Jun2021 at 02:57). On 10Jun2021, contrast-enhanced CT was conducted for suspected acute liver disorder. After the CT, the patient returned to the room and experienced loss of consciousness. In a short while, the patient was in cardiopulmonary arrest (CPA), for which cardiopulmonary resuscitation (CPR) was initiated. In addition to cardiac massage, intratracheal intubation was conducted and adrenaline was administered intravenously 3 times in total. At 16:25, spontaneous circulation returned and the patient was transferred to intensive care unit (ICU). After the transfer, the patient temporarily had tachycardia but pulse rate and blood pressure stabilized. Blood gas showed no problem in oxygenation. On 11Jun2021 at 03:05, ventricular tachycardia (VT) became ventricular fibrillation and soon became asystole. At 03:03, death was confirmed. The reporting pharmacist classified the event as serious (death). Causality assessment and other possible cause of the event such as any other diseases were not provided. The reporting pharmacist commented as follows: The patient has been on haemodialysis. The baseline of the patient was considerably unfavorable with diabetes mellitus, diabetic retinopathy, cardiac failure, and right foot amputation. As described in medical record, it was unknown whether the vaccination was the cause. It was suspected that the event was caused by underlying cardiac failure chronic complicated by infection, etc. A physician assessed that causality among the event, vaccination and result of contrast-enhanced CT was unknown.; Reported Cause(s) of Death: suspected sepsis; cholecystitis; suspected acute liver disorder; loss of consciousness; CPA


VAERS ID: 1489103 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
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 INC2021855677

Write-up: Death; This is a spontaneous report from a contactable physician received via a sales representative. This case was 3rd of 3 patients. A patient of unspecified age and gender received a dose of BNT162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported) via an unspecified route of administration an unspecified date (the day of vaccination) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date (after the vaccination), the patient experienced death. The cause of death was not reported. It was not reported whether autopsy was performed or not. The outcome of the event was fatal. Seriousness and causality were not provided. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Death cannot be fully assessed/excluded. The case will be reassessed if 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: Unknown cause of death


VAERS ID: 1489104 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-27
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral infarction, Gastroenteritis, Staphylococcal bacteraemia
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious diarrhoea (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210627; Test Name: Body temperature; Result Unstructured Data: Test Result:fever Centigrade; Comments: in the morning; Test Date: 20210628; Test Name: Body temperature; Result Unstructured Data: Test Result:fever Centigrade; Comments: he could not get up; Test Date: 20210628; Test Name: Body temperature; Result Unstructured Data: Test Result:38.0 Centigrade; Comments: at the hospital; Test Date: 20210628; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: After fluid replacement therapy; Test Date: 20210628; Test Name: Body temperature; Result Unstructured Data: Test Result:fever Centigrade; Comments: at night
CDC Split Type: JPPFIZER INC2021855937

Write-up: Staphylococcus aureus bacteraemia; cerebral infarction; acute gastroenteritis; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21118183. The patient was an 80-year and 10-month-old male. Body temperature before vaccination was 36.2 degrees Centigrade. Medical history included ongoing type 2 diabetes mellitus. He underwent aortic valve replacement (on 04Apr2016). Concomitant medications were not reported. The patient had no relevant family history. On 26May2021 at 10:30, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5420, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization at the age of 80-year-old. On 16Jun2021 at 10:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5765, Expiration date 30Sep2021) an unspecified route of administration as a single dose for COVID-19 immunization at the age of 80-year-old. On 27Jun2021 at 04:00 (11 day after the vaccination), the patient developed Staphylococcus aureus bacteraemia. On an unspecified date, the patient developed cerebral infarction. On 30Jun2021, the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 27Jun2021 in the morning, he had fever. In the afternoon, the patient consulted a holiday on-duty doctor and he was diagnosed with acute gastroenteritis. On 28Jun2021, the patient had fever and could not get up. Therefore, he was transferred to the reporter''s hospital by an ambulance. The patient had fever of 38.0 degrees Centigrade. After fluid replacement therapy was performed, the fever declined to 36.8 degrees Centigrade and he recovered enough to be able to walk to the bathroom to urinate. According to the reporter''s instruction, his progress was to be observed at home under diagnosis of acute gastroenteritis. That night, the patient developed fever again, so he was transferred to a different hospital and was hospitalized. The patient received the treatment for Staphylococcus aureus bacteraemia. However, cerebral infarction was combined which resulted in death on 30Jun2021. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Since fatal event occurred in a short period after the vaccination, this case was reported.; Reported Cause(s) of Death: Staphylococcus aureus bacteraemia; cerebral infarction


VAERS ID: 1489112 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac failure acute
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Cardiac failure chronic; Disuse syndrome; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:160/80; Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: Test Result:no fever
CDC Split Type: JPPFIZER INC2021863517

Write-up: Acute on chronic heart failure; This is a spontaneous report from a contactable pharmacist received via Pfizer sales representative. The patient was an 89-year-old male. Medical history included cardiac failure chronic and hypertension. Concomitant medications were not provided. Before the patient was transferred to the reporter''s hospital, the patient was diagnosed with disuse syndrome, but he was admitted to the reporter''s hospital under diagnosis of cardiac failure chronic and hypertension. The patient was bedridden, therefore a gastrostomy tube could not be placed. He was not receiving the treatment for hypertension. His most recent blood pressure level was around 160/80, around thisb level indicated PHg. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) at 0.3 mL via an unspecified route of administration as a single dose for COVID-19 immunization (at the age of 89-year-old). Before the second dose of vaccination, his consciousness level decreased, but he had no fever on that day, so he received the vaccination. On 08Jul2021 (1 day after the vaccination), the patient''s condition changed and died. A death certificate said that he died of acute on chronic heart failure. It was not reported if an autopsy was performed. The reporting pharmacist classified the event as serious (fatal outcome). The physician in charge stated that the patient died of old age and the causal relationship with BNT162b2 was uncertain. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the limited information in the case a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Acute on Chronic Heart Failure. 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 on chronic heart failure


VAERS ID: 1489116 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arterial occlusive disease
SMQs:, Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Renal failure chronic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021872889

Write-up: Acute Arterial occlusion; This is a spontaneous report received from a contactable physician via a sales representive. A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Solution for injection), intramuscular on Jun2021 (in late Jun2021) (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included renal failure chronic. The patient''s concomitant medications were not reported. On unspecified date in Jun2021, the patient experienced Acute Arterial occlusion. Clinical course was reported as follows: There was mail saying that after the comirnaty vaccination, the patient came to hospital due to Acute Arterial occlusion. The follow up information would be collected at the time of visit face to face. In late Jun2021, the patient received COMIRNATY at primary care physician''s hospital. One week later, the patient was admitted to the reporting hospital due to acute arterial occlusion on Jun2021. On 12Jul2021, the patient died. Pathological autopsy was scheduled to be conducted to investigate cause of death. The reporting physician classified the event as serious (death). Causality 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 event arterial occlusion and the suspect drug BNT162B2 cannot be excluded.; Reported Cause(s) of Death: Acute Arterial occlusion


VAERS ID: 1489121 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021873410

Write-up: Death; This is a spontaneous report from a contactable other healthcare professional received via the Agency and from the Regulatory Authority. Regulatory authority report number is v21119927. The patient was a non-pregnant 91-year-old female received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date: 30Sep2021) via intramuscular route of administration on 10Jul2021 at 13:45 (the day of vaccination)(at the age of 91-Year-old, Non-pregnant), in left arm as dose 1, single for COVID-19 immunisation. The patient had no other medical history or disease under treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products (allergies were not described in the vaccination coupons). Concomitant medications were not reported. The reported event was as follows: The medical history and others were not reported. Since the vaccination, the patient has not been tested for COVID-19: Unknown. On 10Jul2021 (the day of vaccination), the patient was followed up for 15 minutes after the vaccination. On 12Jul2021 (two day of vaccination), after the patient went home, she was emergently transferred, and she died at the hospital where she was transferred to. On 12Jul2021 (two day after the vaccination), the patient experienced death. The event resulted in death. The cause of death was unknown. It was unknown whether autopsy was performed or not. The outcome of the event was fatal with unknown treatment. The reporting other healthcare professional assessed the event as serious (death). The causality between the event and BNT162b2 vaccination was not provided.; Reported Cause(s) of Death: Death


VAERS ID: 1489123 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-06-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Computerised tomogram, 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: 2021-06-13
   Days after onset: 1
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: URIADEC; OLMETEC; NORVASC; HARNAL; VESICARE; HOCHUEKKITO [ANGELICA ACUTILOBA ROOT;ASTRAGALUS SPP. ROOT;ATRACTYLODES SPP. RHIZOME;BUPLEURUM FALCAT; SUMILU STICK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Dyslipidaemia; Hypertension; Inguinal hernia; Lumbar spine compression fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210612; Test Name: CT scan; Result Unstructured Data: Test Result:right middle cerebral artery aneurysm rupture; Comments: The patient was diagnosed with subarachnoid haemorrhage and cerebral haemorrhage due to right middle cerebral artery aneurysm rupture
CDC Split Type: JPPFIZER INC2021882419

Write-up: Subarachnoid haemorrhage; Cerebral haemorrhage; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 83-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date: 30Sep2021) via intramuscular administrated in the arm left on 06Jun2021 at 12:30 (at the age of 83-year-old) (the day of vaccination) as dose 1, single for COVID-19 immunization. Medical history included chronic kidney disease, hypertension, dyslipidaemia, lumbar spine compression fracture, and after surgery for inguinal hernia. Concomitant medication (within 2 weeks of vaccination) included topiroxotat (URIADEC), olmesartan medoxomil (OLMETEC), amlodipine besilate (NORVASC), tamsulosin hydrochloride (HARNAL), solifenacin succinate (VESICARE), angelica acutiloba root, astragalus spp. root, atractylodes spp. rhizome, bupleurum falcatum root, cimicifuga spp. rhizome, citrus aurantium peel, glycyrrhiza spp. root, panax ginseng root, zingiber officinale fresh rhizome, ziziphus jujuba fruit (HOCHUEKKITO) and felbinac (SUMILU STICK); all were ongoing. 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 had no allergies to medications, food, or other products. Since the vaccination, the patient was not been tested for COVID-19. On 12Jun2021, at 19:15 (6 days, 6 hours, and 45 minutes after vaccination), the patient had swooning backward from sitting position during the meeting of the resident''s association. The patient had disturbed consciousness, and an ambulance was called, and the patient was transferred to Hospital. On 12Jun2021, the patient was diagnosed with subarachnoid haemorrhage and cerebral haemorrhage due to right middle cerebral artery aneurysm rupture on the CT. Since the disturbed consciousness was severe, and disappearance of brain-stem reflex was noted, the patient was judged not to be indicated for surgery. The patient was not managed with an artificial ventilator, and he was followed up. On 12Sep2021 at 19:15 (6 days, 6 hours and 45 minutes after the vaccination), the patient experienced subarachnoid haemorrhage and cerebral haemorrhage. The event resulted in emergency room/department or urgent care, hospitalization and death. The reporting physician assessed the event as serious (hospitalization and death). The event resulted in emergency room/department or urgent care, hospitalization and death. On 13Jun2021, at 09:54 (6 days, 21 hours, and 24 minutes after vaccination), it was reported that the patient was dead. The autopsy was not performed. The causality between the event and BNT162b2 vaccination was not provided. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information, the causal relationship between BNT162B2 and the fatal events sub arachnoid haemorrhage and cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.; Reported Cause(s) of Death: Subarachnoid haemorrhage; Cerebral haemorrhage


VAERS ID: 1489168 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Kidney transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021844106

Write-up: After he completed his 2 doses of Comirnaty, he passed away.; This is a spontaneous report from a non-contactable consumer via a representative. A male patient of an unspecified age received the second and first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 2 single and, via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 1 single for covid-19 immunisation. Medical history included kidney implant patient. The patient''s concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the covid vaccine. After he completed his 2 doses of Comirnaty, he passed away. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: passed away


VAERS ID: 1489221 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute leukaemia, Biopsy bone marrow, Blood test, Computerised tomogram, Microbiology test, Pneumonia, Pyrexia, SARS-CoV-2 test, Skin bacterial infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 40
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: PREDNISONE
Current Illness: Polymyalgia rheumatica (family history: false; Muscular rheumatism)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: bone marrow biopsy; Result Unstructured Data: Test Result:unknown results; Test Date: 20210505; Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: CT scan; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: lung test (fungi, bacteria); Result Unstructured Data: Test Result:unknown results; Test Date: 20210505; Test Name: Tested twice for Corona; Result Unstructured Data: Test Result:both negative results
CDC Split Type: NLPFIZER INC2021843223

Write-up: Acute leukemia; Pneumonia; Fever; bacterial (skin) infection next to the eye (large, thick lump); This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, the regulatory authority report number is NL-LRB-00601996. A 70-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 26Apr2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing polymyalgia rheumatica (family history: false; muscular rheumatism). Concomitant medication included prednisone tablet. The patient experienced acute leukemia on 06May2021, pneumonia on 05May2021, fever on 27Apr2021, and bacterial (skin) infection next to the eye (large, thick lump) on 30Apr2021. The event acute leukemia was reported as serious per death and hospitalization (05May2021), the events fever and pneumonia were reported as serious per hospitalization (05May2021). The remaining event was reported as non-serious. The events were reported as follows: Acute leukemia: One day after the injection fever developed. The fourth day after the injection fever again, accompanied by a bacterial (skin) infection next to the eye. On day 9 to hospital, was found to have pneumonia. On day 10 it turned out to be acute leukemia. The patient underwent lab tests and procedures which included bone marrow biopsy on 2021, blood test on 05May2021, CT scan on 2021 and lung test (fungi, bacteria) on 2021, all with unknown results; and Tested twice for Corona: both negative results on 05May2021. Therapeutic measures were taken as a result of the reported events which included chemotherapy for acute leukemia and antibiotics for the other events. The outcome of the event pneumonia was unknown, of fever was not recovered, and of bacterial (skin) infection next to the eye (large, thick lump) was recovered on an unspecified date in 2021. The patient died on 06Jun2021, cause of death was reported as acute leukemia (fatal outcome). It was not reported if an autopsy was performed. Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty): no past drug therapy with BioNTech/Pfizer vaccine (Comirnaty); Acute leukemia: Hospitalization information: Pneumonia/Acute leukemia/chemotherapy; Additional information ADR: Fever developed one day after the injection. After two days this seemed to be gone. The fourth day after the injection, a fever again accompanied by a bacterial (skin) infection next to the eye (large, thick lump). With antibiotics, the bump disappeared, but the high fever persisted. On day nine (05May2021), taken to hospital via the GP by ambulance. Tested twice for Corona, both negative results. It turned out to be pneumonia. Received other antibiotics and did blood tests. On day ten (06May2021), it turned out to be acute leukemia. Later, it turned out that there were even multiple mutations of the cells. Confounding factors was reported as "Muscular rheumatism". No previous COVID-19 infection. Other diagnostic procedures included blood test, lung test (fungi, bacteria), CT scan, bone marrow biopsy. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reporter''s Comments: Summary of reporter''s comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no; Acute leukemia Hospitalization information: Pneumonia/Acute leukemia/chemotherapy; Confounding factors: Muscular rheumatism; Previous COVID-19 infection: No; Other diagnostic procedures: Blood test, lung test (fungi, bacteria), CT scan, bone marrow biopsy; Reported Cause(s) of Death: Acute leukemia


VAERS ID: 1489226 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   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: NLPFIZER INC2021864894

Write-up: Death; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority NL-LRB-0061127. A 67-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, batch/lot number: FC5089, expiration date was not reported) via an unspecified route of administration on 24Jun2021 (at the age of 67-years-old) as DOSE 2, 0.3 ML, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient''s historical vaccine included first dose of COMIRNATY for COVID-19 immunization received on 20May2021. It was reported that, physician concerns a female aged 67 years, with death (death) following administration of COVID-19 vaccin Pfizer for COVID 19 immunisation. The patient died one day after vaccination on 25Jun2021. The cause of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information was expected. Batch number already obtained.; Reported Cause(s) of Death: Unclear mgl cardiac. Ms was found dead


VAERS ID: 1489228 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-05
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood glucose, Blood lactic acid, Blood pH, Blood potassium, Blood sodium, Haemoglobin, Myocardial infarction, PCO2, PO2
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cannabis use (Medical history: none, except for cannabis use that, according to the anamnesis, has not been used for six months.)
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Sodium; Result Unstructured Data: 137 (unit unspecified); Test Date: 20210705; Test Name: PCO2; Result Unstructured Data: 125 (unit unspecified); Test Date: 20210705; Test Name: Lactate; Result Unstructured Data: 14,6 (unit unspecified); Test Date: 20210705; Test Name: Potassium; Result Unstructured Data: 4,3 ( (unit unspecified); Test Date: 20210705; Test Name: Blood pH; Result Unstructured Data: <6,8 (unit unspecified); Test Date: 20210705; Test Name: PO2; Result Unstructured Data: 17 (unit unspecified); Test Date: 20210705; Test Name: Hemoglobin; Result Unstructured Data: 9,1 (unit unspecified); Test Date: 20210705; Test Name: Glucose; Result Unstructured Data: 20.1 (unit unspecified); Test Name: Autopsy; Result Unstructured Data: first (provisional) findings autopsy: thrombus...
CDC Split Type: NLJNJFOC20210731464

Write-up: MYOCARDIAL INFARCTION WITH OCCLUDED LAD; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00614588] concerned a 24 year old male patient of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s past medical history included cannabis use according to the anamnesis, had not used for six months.. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974 expiry: unknown) 1 dosage forms, 1 total administered on 27-JUN-2021 for covid-19 immunisation (Drug start period- 7 days). No concomitant medications were reported. On 05-JUL-2021, the patient experienced myocardial infarction with occluded LAD (left anterior descending artery) and also died from myocardial infarction. An autopsy was performed on an unspecified date. Laboratory data included: Blood pH result was <6, 8 (unit unspecified), Glucose was 20.1 (unit unspecified), Hemoglobin was 9, 1 (unit unspecified), Lactate was 14, 6 (unit unspecified), PCO2 (partial pressure of carbon dioxide) was 125 (unit unspecified), PO2 (partial pressure of oxygen) was 17 (unit unspecified), Potassium was 4, 3 ( (unit unspecified), and Sodium was137 (unit unspecified). Laboratory data (dates unspecified) included: Autopsy (NR: not provided) first (provisional) findings autopsy: thrombus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210731464-covid-19 vaccine ad26.cov2.s-Myocardial infarction with occluded LAD. This event(s) is considered un-assessable. 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: MYOCARDIAL INFARCTION; Autopsy-determined Cause(s) of Death: MYOCARDIAL INFARCTION


VAERS ID: 1489233 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration, Pyrexia, Urosepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
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: OXAZEPAM; SIMVASTATINE; CHOLECALCIFEROL; ACETYLSALICYLIC ACID; BUMETANIDE; CARBASALATE CALCIUM; MICONAZOL [MICONAZOLE]; OMEPRAZOL; PARACETAMOL
Current Illness: Parkinsonism (Family history: Not present); Vascular dementia (Family history: Not present)
Preexisting Conditions: Medical History/Concurrent Conditions: Amblyopia (Family history: Not present); Heart failure (Family history: Not present); Transient ischaemic attack (Family history: Not present); VIth nerve paresis (Family history: Not present)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021456614

Write-up: Urosepsis/Not recovering after urospesis and retention bladder acquired two days after receiving 2nd vaccination; Then decline in function temporary; Pyrexia; This is spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is NL-LRB-00509789. This is a second of two reports. An 86-years-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, strength: 0.3 ml, lot number: unknown), via an unspecified route of administration on 25Feb2021 (at the age of 86-years) as single dose for covid-19 immunization. Medical history included transient ischaemic attack from 20Jan2011 to an unknown date, vith nerve paresis from 20Jan2011 to an unknown date, ongoing vascular dementia, amblyopia from 01Jan2010 to an unknown date, ongoing parkinsonism. Concomitant medication(s) included oxazepam (OXAZEPAM); simvastatine (SIMVASTATINE); cholecalciferol (CHOLECALCIFEROL); acetylsalicylic acid (ACETYLSALICYLIC ACID); bumetanide (BUMETANIDE); carbasalate calcium (CARBASALATE CALCIUM); miconazol [miconazole] (MICONAZOL [MICONAZOLE]); omeprazole (OMEPRAZOL); paracetamol (PARACETAMOL). On an unspecified date in 2021, after first dose, the patient then decline in function temporary. The patient had pyrexia and urosepsis and was not recovering after urospesis and retention bladder acquired two days after receiving 2nd vaccination. The patient was hospitalized for urosepsis. Therapeutic measures were taken as a result of event then decline in function temporary. The event then decline in function temporary resulted in emergency room visit. The patient died on 17Apr2021 due to urosepsis. An autopsy was not performed. The outcome of event urosepsis was fatal and for rest of events it was unknown. Authority comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes adverse drug events: Then decline in function temporary Date: 25Feb2021 No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained. Follow up (04May2021): New information reported from a contactable healthcare professional from the regulatory, regulatory authority number NL-LRB-00509789 (spontaneous report) includes a new reference number NL-LRB-00515407. Case has been upgraded from non-serious to serious case due to additional fatal event of Urosepsis. New information included: patient''s age updated, relevant medical history, death details updated, additional events ''Pyrexia, Urosepsis'' were added. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Parkinson''s disease aggravated; Urosepsis (Not recovering after urospesis and retention bladder acquired two days after receiving 2nd vaccination)


VAERS ID: 1489237 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-28
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Dyspnoea, General physical health deterioration
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: NOPFIZER INC2021843435

Write-up: poor physical condition with increasing dyspnea and chest pain; poor physical condition with increasing dyspnea and chest pain; Deterioration of the condition after dose no 2; found dead/death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, Regulatory authority report number NO-NOMAADVRE-FHI-2021-U2pp9r. A 64-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single; and via intramuscular on 16Jun2021 (Lot Number: FD9234, unknown expiration) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. 6-week interval between doses 1 and 2. After dose 1, he was reportedly in a poor physical condition with increasing dyspnea and chest pain. Deterioration of the condition after dose no 2. He was found dead in his own home 13 days after vaccination with dose no. 2. According to relatives, he was previously healthy. The last contact with the emergency room was in 2003. The patient died on 28Jun2021 due to unknown cause. Outcome of the remaining events was unknown. It was unknown if an autopsy was performed. The event death was assessed as possible to COMIRNATY per Regulatory Authority. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: found dead/death


VAERS ID: 1489269 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
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 INC2021846965

Write-up: Death; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is unknown. This is the first one of the 2 serious reports reported on deaths. A patient (demographics unknown) received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, the patient experienced death. The cause of death was unknown. It was unknown if an autopsy was performed. It was reported that up to 29May2021: there were 364 non-serious and 8 serious reports this week.. Sadly, two of these serious reports reported on deaths. No safety concerns with the COMIRNATY vaccine were raised by these reports. Three of the serious reports were described as allergic reactions, and there was one report each for deep vein thrombosis, cardiogenic syncope and haemorrhage. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NZ-PFIZER INC-2021846972 same source, same event, different patient; Reported Cause(s) of Death: death


VAERS ID: 1489270 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
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 INC2021846972

Write-up: Death; This is a spontaneous report from a contactable other health professional via regulatory authority. Regulatory authority report number is unknown. This is the second one of the 2 serious reports reported on deaths. A patient (demographics unknown) received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On unknown date, the patient experienced death. The cause of death was unknown. It was unknown if an autopsy was performed. It was reported that up to 29May2021: there were 364 non-serious and 8 serious reports this week.. Sadly, two of these serious reports reported on deaths. No safety concerns with the COMIRNATY vaccine were raised by these reports. Three of the serious reports were described as allergic reactions, and there was one report each for deep vein thrombosis, cardiogenic syncope and haemorrhage. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NZ-PFIZER INC-2021846965 same source, same event, different patient; Reported Cause(s) of Death: death


VAERS ID: 1489291 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   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: Atrial fibrillation; Chronic heart failure; End stage renal disease; Hemodialyzed; Hypertension; Mitral valve insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021843257

Write-up: Death; This is a spontaneous report received from a contactable Physician downloaded from the Regulatory Authority report number is PL-URPL-3-750-2021. A 72-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 17Mar2021 11:50 (Batch/Lot Number: ET3674; Expiration Date: 31Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date to 19Mar2021 , cardiac failure chronic from an unknown date to 19Mar2021 , hypertension from an unknown date to 19Mar2021 , Mitral valve insufficiency from an unknown date to 19Mar2021, end stage renal disease from an unknown date to 19Mar2021, haemodialysis from an unknown date to 19Mar2021. The patient''s concomitant medications were not reported. On 19Mar2021 07:00 (reported also as about 43 hours after vaccination) patient died, information about the patient''s death was received (unknown cause). The death took place at home. Confirmed by the ambulance crew. No post-vaccination reaction in the patient''s history. The reporting person classified them as severe. Due to the assessment of the reporting person and the death of the Patient (cause: unknown, date: 19Mar2021, 07:00), the URPL classified the report as severe. The data contained in the electronic report are all available to URPL - in the case of obtaining additional information, another version will be sent. Relatedness of drug to reaction(s)/event(s): Source of assessment: URPL; Method of assessment: WHO; Result of Assessment: unclassified. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1489292 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0932 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   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: PLPFIZER INC2021843283

Write-up: Sudden cardiac death; sudden cardiac arrests; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is PL-URPL-3-751-2021. A 66-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 02Jun2021 (Lot Number: FD0932; Expiration Date: 30Jun2021) as DOSE 2, SINGLE at the age of 66 years old, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The report was from the district sanitary and epidemiological station. It was reported that the patient''s death as a result of sudden cardiac arrest. Death during sleep after vaccination he did not report any side effects, he felt well. Additional information: in the past, the Patient did not develop any post-vaccination reactions. Result: death (date: 06Jun2021 12:00) Reason: sudden cardiac arrests. The reporter classified them as serious. Due to the assessment of the reporting person and the patient''s death, Regulatory Authority classified the notification as "serious". Health result: death (date: 06Jun2021 at 12:00, cause: unknown) The data contained in the electronic report are all available to Regulatory Authority - in the case of obtaining additional information (for which the appropriate sanitary and epidemiological station was asked by e-mail) it will be sent another version. The patient died on 06Jun2021. It was not reported if an autopsy was performed. Sender''s comments: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides) Due to the lack of complete information on the circumstances of the patient''s death, it is not possible to precisely determine the causal relationship. Regulatory Authority requested additional information by e-mail to the appropriate sanitary and epidemiological station. The temporal relationship speaks for a causal relationship. The reporting person classified them as serious. Due to the assessment of the reporting person and the patient''s death, Regulatory Authority classified the report as serious. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reported Cause(s) of Death: Sudden cardiac death; sudden cardiac arrest


VAERS ID: 1489293 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Encephalitis, Encephalopathy, Haemorrhagic pneumonia, Meningitis aseptic, Meningitis viral, Psychomotor hyperactivity, Pyrexia, Speech disorder
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bradycardia (Post-vaccination bradycardia)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:39.0; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4
CDC Split Type: PLPFIZER INC2021843176

Write-up: Sensorium decreased; Speech disorder; Psychomotor agitation; Fever; Meningitis viral; Encephalitis; Encephalopathy; Haemorrhagic pneumonia; Lymphatic Meningitis (Lymphocytic Meningitis); This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB regulatory authority number PL-URPL-3-780-2021. A 40-year-old male patient received bnt162b2 (COMIRNATY), dose 1 at the age of 40-years-old intramuscular, administered in arm left on 02May2021 11:56 (Batch/Lot Number: EY3014; Expiration Date: 31Aug2021) as DOSE 1, 0.3 mL single for covid-19 immunisation. Medical history included bradycardia (Post-vaccination bradycardia) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The physician reported that the events occurred on 10May2021 20:00. The patient was admitted to the Department of Neurology on 12May2021 due to deterioration of contact (sensorium decreased), speech disorders of psychomotor agitation and fever up to 39 degrees Celsius (Highest temperature: 39.0 - 39.4, Duration of fever: longer). Based on the diagnosis, an initial diagnosis of viral meningitis and encephalitis was made. It was also reported that the patient experienced encephalopathy. Despite intensive treatment, the patient''s condition deteriorated. On 19May2021, he was pronounced dead. On 20May2021, a post-mortem examination was performed, the result of which the physician received on 09Jun2021. Information received from reporting doctor on 09Jun21, the cause of death was hemorrhagic pneumonia and lymphatic meningitis and encephalitis (the result of an autopsy). The doctor is not sure if the death was related to the vaccination (only the time coincidence). Post-vaccination reaction in the patients history. The reporter classified them as serious. Due to the assessment of the reporter, the nature of the side effects and the patients death, Regulatory Authority classified the report as serious. An autopsy was performed that revealed hemorrhagic pneumonia, lymphocytic meningitis, encephalitis (post-mortem examination). The outcome of the events was fatal. Sender Comment: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides). Pyrexia is an expected side effect following the administration of Comirnaty The other side effects are unexpected. Deterioration of contact with the patient, speech disorders and psychomotor agitation could be a symptom of developing CNS inflammation. It cannot be ruled out that the fever was only / also the effect of developing CNS inflammation. The reporter (a physician) was not sure if the patients death was related to vaccination or if there was only a time coincidence. The temporal relationship speaks for a cause-and-effect relationship. The reporter classified them as severe. Due to the assessment of the reporter, the nature of the side effects and the patients death, Regulatory Authority classified the report as serious. No follow-up attempts possible. No further information expected.; Autopsy-determined Cause(s) of Death: Encephalitis; Hemorrhagic pneumonia; Lymphocytic meningitis


VAERS ID: 1489294 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-10
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7842 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Malaise, Oxygen saturation, Oxygen saturation decreased, Pain, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia; Exercise tolerance decreased; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:60-70 %
CDC Split Type: PLPFIZER INC2021843180

Write-up: Malaise; Chills; Tachypnoea; saturation 60-70%; Pain; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority. A 61-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 25May2021 at 15:48 (Lot Number: FA7842; Expiration Date: 23Jun2021) at the age of 61-years-old as dose 2, single for COVID-19 immunisation. Medical history included dyslipidemia, exercise tolerance decreased and hypertension; all from an unknown date to 10Ju2021; all not ongoing. The patient''s concomitant medications were not reported. The patient experienced malaise, chills, tachypnoea (tachypnoea), saturation 60-70% and pain (on 10Jun2021 at 02:00. After 3:00 a.m., the it was reported that the husband stated that his wife had no signs of life, called Emergency Medical Team, cardiopulmonary resuscitation for 40 minutes - death was confirmed. All events were reported as serious due to fatal outcome. Treatment was received for all events reported. The outcome of all events was fatal. The patient died on 10Jun2021. An autopsy was not performed. Sender''s comments: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides) Deterioration and chills are an expected side effect of Comirnaty administration The other side effects are unexpected. Until June 23Jun2021 in the database, with the result of the patient''s death, 319 cases of dyspnoea and 105 cases of oxygen saturation decreased after administration of Comirnaty were reported. It cannot be ruled out that the patient''s medical history contributed to her death. The doctor could not determine if there was a link between vaccination and death. The temporal relationship speaks for a cause-and-effect relationship. The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the patient''s death, URPL classified the report as "severe". No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Malaise; Chills; Tachypnoea; saturation 60-70%; Pain


VAERS ID: 1489295 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4342 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021843167

Write-up: Found dead (cause undetermined); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. An 80-year-old male patient received BNT162B2 (PFIZER, Batch/Lot Number: FD4342; Expiration Date: 30Sep2021), intramuscular, administered in left arm on 11Jun2021 13:42 (at the age of 80 years old) as dose 2, 0.3ml single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was found dead (cause undetermined) on 12Jun2021 07:00. The description of the report stated: Death - corpse found around 7 AM 12Jun2021. The patient was not under chronic treatment. In the past, the patient did not develop any post-vaccination reactions. The patient died on 12Jun2021. It was not reported if an autopsy was performed. The reporting person classified them as severe. Due to the assessment of the reporting person and the patient''s death, URPL classified the report as serious. Sender Comment: Comirnates are mRNA vaccine against COVID-19 (with modified nucleosides). The reporting person classified them as severe. Due to the assessment of the reporting person and the patient''s death, URPL classified the report as serious. Due to the lack of additional information (potential, allergies, etc.) allowing to establish a causal relationship, an unclassifiable relationship has been made between vaccination and death. URPL requested additional information and explanations by e-mail to the appropriate sanitary and epidemiological station. Information from structural fields in source document: Relatedness of drug to reaction(s)/event(s): Found dead (cause undetermined), Source of assessment: URPL, Method of assessment: WHO, Result of Assessment: unclassified. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Found dead (cause undetermined)


VAERS ID: 1489298 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute respiratory distress syndrome, Alanine aminotransferase, Aspartate aminotransferase, Asthenia, Bacterial test, Base excess, Bilirubin urine, Blood albumin, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood chloride, Blood creatinine, Blood glucose, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Blood urine, Body temperature, Bradycardia, C-reactive protein, Carbon dioxide, Cardiac arrest, Chest X-ray, Circulatory collapse, Computerised tomogram thorax, Condition aggravated, Cough, Cyanosis, Cyanosis central, Depressed level of consciousness, Dyspnoea, Dyspnoea at rest, Fibrin D dimer, Fibrin D dimer increased, Gait disturbance, General physical health deterioration, Glomerular filtration rate, Glucose urine, Haematocrit, Haemoglobin, Heart rate, Interleukin level, International normalised ratio, Loss of consciousness, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Neutrophil count, Nitrite urine, Oxygen saturation, PCO2, PO2, Platelet count, Platelet distribution width, Platelet-large cell ratio, Protein urine, Prothrombin time ratio, Pyrexia, Rales, Red blood cell count, Red blood cells urine, Red cell distribution width, Respiratory failure, SARS-CoV-2 test, SARS-CoV-2 test positive, Specific gravity urine, Speech disorder, Tachypnoea, Urine analysis, Urine ketone body, Urobilinogen urine, White blood cell count, pH body fluid, pH urine
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (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), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Proteinuria (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (patient was treated); Hypothyroidism (patient was treated)
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: PO2; Result Unstructured Data: Test Result:169.4 mmHg; Test Date: 20210415; Test Name: PO2; Result Unstructured Data: Test Result:80.4 mmHg; Test Date: 20210416; Test Name: PO2; Result Unstructured Data: Test Result:72.2 mmHg; Test Date: 20210417; Test Name: PO2; Result Unstructured Data: Test Result:80 mmHg; Test Date: 20210417; Test Name: PO2; Result Unstructured Data: Test Result:51.9 mmHg; Test Date: 20210417; Test Name: PO2; Result Unstructured Data: Test Result:60.8 mmHg; Test Date: 20210405; Test Name: Protein urine; Result Unstructured Data: Test Result:trace mg/dl; Test Date: 20210414; Test Name: Prothrombin ratio; Test Result: 65 %; Test Date: 20210404; Test Name: erythrocytes; Result Unstructured Data: Test Result:3.68; Comments: Jmln/ul; Test Date: 20210405; Test Name: erythrocytes; Result Unstructured Data: Test Result:3.13; Comments: Jmln/ul; Test Date: 20210408; Test Name: erythrocytes; Result Unstructured Data: Test Result:3.04; Test Date: 20210412; Test Name: erythrocytes; Result Unstructured Data: Test Result:3.33; Test Date: 20210414; Test Name: erythrocytes; Result Unstructured Data: Test Result:2.98; Test Date: 20210414; Test Name: erythrocytes; Result Unstructured Data: Test Result:238; Test Date: 20210405; Test Name: Red blood cells urine; Result Unstructured Data: Test Result:fresh RBC: 0-1 per field (FOV); Comments: fresh RBC: 0-1 per field (FOV) lixiviated erythrocytes:0-1 (min; max); Test Date: 20210404; Test Name: RDW-CV; Test Result: 13 %; Test Date: 20210412; Test Name: RDW-CV; Test Result: 13 %; Test Date: 20210414; Test Name: RDW-CV; Test Result: 13 %; Test Date: 20210404; Test Name: COVID-19 Test; Test Result: Positive ; Test Date: 20210405; Test Name: Urine specific gravity; Result Unstructured Data: Test Result:1.018 g/mL; Test Date: 20210405; Test Name: Urinalysis; Result Unstructured Data: Test Result:cloudy urine; Comments: transparency: cloudy urine taint: yellow squamous epithelial cells: multiple; Test Date: 20210405; Test Name: Urine ketone body; Result Unstructured Data: Test Result:absent; Test Date: 20210405; Test Name: Urobilinogen; Result Unstructured Data: Test Result:normal mg/dl; Test Date: 20210404; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Eo, Baso, Mono 0.2 thousand per microlitre; Test Date: 20210405; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Eo, Baso, Mono 0.1 thousand per microlitre; Test Date: 20210408; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Eo, Baso, Mono 0.2 thousand per microlitre; Test Date: 20210412; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Eo, Baso, Mono 0.4 thousand per microlitre; Test Date: 20210414; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Eo, Bazo, Mono 0.4 thousand per microlitre; Test Date: 20210416; Test Name: APTT; Result Unstructured Data: Test Result:undetectable; Test Date: 20210416; Test Name: APTT; Result Unstructured Data: Test Result:undetectable; Test Date: 20210412; Test Name: APTT; Test Result: 33 s; Test Date: 20210413; Test Name: APTT; Test Result: 30 s; Test Date: 20210414; Test Name: APTT; Test Result: 139 s; Test Date: 20210415; Test Name: APTT; Test Result: 62 s; Test Date: 20210415; Test Name: APTT; Test Result: 125 s; Test Date: 20210416; Test Name: APTT; Test Result: 39 s; Test Date: 20210416; Test Name: APTT; Test Result: 154 s; Test Date: 20210404; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:32 IU/l; Test Date: 20210414; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:57 IU/l; Test Date: 20210404; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:54 IU/l; Test Date: 20210414; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:52 IU/l; Test Date: 20210405; Test Name: Bacteria urine; Result Unstructured Data: Test Result:very numerous; Test Name: BE (B); Result Unstructured Data: Test Result:-3 mmol/L; Comments: min: -3; Test Date: 20210404; Test Name: BE (B); Result Unstructured Data: Test Result:5.8 mmol/L; Comments: min: -3; Test Date: 20210408; Test Name: BE (B); Result Unstructured Data: Test Result:4.4 mmol/L; Comments: min: -3; Test Date: 20210411; Test Name: BE (B); Result Unstructured Data: Test Result:5.4 mmol/L; Comments: min: -3; Test Date: 20210412; Test Name: BE (B); Result Unstructured Data: Test Result:2.9 mmol/L; Comments: min: -3; Test Date: 20210413; Test Name: BE (B); Result Unstructured Data: Test Result:4.7 mmol/L; Comments: min: -3; Test Date: 20210413; Test Name: BE (B); Result Unstructured Data: Test Result:4.4 mmol/L; Comments: min: -3; Test Date: 20210414; Test Name: BE (B); Result Unstructured Data: Test Result:4.2 mmol/L; Comments: min: -3; Test Date: 20210414; Test Name: BE (B); Result Unstructured Data: Test Result:4.1 mmol/L; Comments: min: -3; Test Date: 20210415; Test Name: BE (B); Result Unstructured Data: Test Result:4.5 mmol/L; Comments: min: -3; Test Date: 20210415; Test Name: BE (B); Result Unstructured Data: Test Result:5.4 mmol/L; Comments: min: -3; Test Date: 20210415; Test Name: BE (B); Result Unstructured Data: Test Result:6.7 mmol/L; Comments: min: -3; Test Date: 20210416; Test Name: BE (B); Result Unstructured Data: Test Result:7.9 mmol/L; Comments: min: -3; Test Date: 20210417; Test Name: BE (B); Result Unstructured Data: Test Result:7 mmol/L; Comments: min: -3; Test Date: 20210417; Test Name: BE (B); Result Unstructured Data: Test Result:5.5 mmol/L; Comments: min: -3; Test Date: 20210417; Test Name: BE (B); Result Unstructured Data: Test Result:-1.5 mmol/L; Comments: min: -3; Test Date: 20210405; Test Name: Urine bilirubin; Result Unstructured Data: Test Result:absent; Test Date: 20210414; Test Name: Albumin; Result Unstructured Data: Test Result:2.9 g/dl; Test Date: 20210404; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:60 IU/l; Test Name: HCO3; Result Unstructured Data: Test Result:19.1 mmol/L; Test Date: 20210404; Test Name: HCO3; Result Unstructured Data: Test Result:29.2 mmol/L; Test Date: 20210413; Test Name: HCO3; Result Unstructured Data: Test Result:28.1 mmol/L; Test Date: 20210414; Test Name: HCO3; Result Unstructured Data: Test Result:27.8 mmol/L; Test Date: 20210414; Test Name: HCO3; Result Unstructured Data: Test Result:27.7 mmol/L; Test Date: 20210415; Test Name: HCO3; Result Unstructured Data: Test Result:29.9 mmol/L; Test Date: 20210415; Test Name: HCO3; Result Unstructured Data: Test Result:28.1 mmol/L; Test Date: 20210415; Test Name: HCO3; Result Unstructured Data: Test Result:28.9 mmol/L; Test Date: 20210416; Test Name: HCO3; Result Unstructured Data: Test Result:31 mmol/L; Test Date: 20210417; Test Name: HCO3; Result Unstructured Data: Test Result:30.1 mmol/L; Test Date: 20210417; Test Name: HCO3; Result Unstructured Data: Test Result:21.3 mmol/L; Test Date: 20210417; Test Name: HCO3; Result Unstructured Data: Test Result:28.8 mmol/L; Test Date: 20210408; Test Name: Plasma bicarbonate; Result Unstructured Data: Test Result:27.9 mmol/L; Test Date: 20210411; Test Name: Plasma bicarbonate; Result Unstructured Data: Test Result:28.8 mmol/L; Test Date: 20210412; Test Name: Plasma bicarbonate; Result Unstructured Data: Test Result:26.7 mmol/L; Test Date: 20210413; Test Name: Plasma bicarbonate; Result Unstructured Data: Test Result:28.1 mmol/L; Test Date: 20210404; Test Name: Bilirubin total; Test Result: 0.49 mg/dl; Test Date: 20210404; Test Name: Chloride; Result Unstructured Data: Test Result:92 mmol/L; Test Date: 20210405; Test Name: Chloride; Result Unstructured Data: Test Result:97 mmol/L; Test Date: 20210408; Test Name: Chloride; Result Unstructured Data: Test Result:101 mmol/L; Test Date: 20210412; Test Name: Chloride; Result Unstructured Data: Test Result:95 mmol/L; Test Date: 20210414; Test Name: Chloride; Result Unstructured Data: Test Result:99 mmol/L; Test Date: 20210415; Test Name: Chloride; Result Unstructured Data: Test Result:103 mmol/L; Test Date: 20210416; Test Name: Chloride; Result Unstructured Data: Test Result:103 mmol/L; Test Date: 20210417; Test Name: Chloride; Result Unstructured Data: Test Result:103 mmol/L; Test Date: 20210404; Test Name: Creatinine; Test Result: 1.02 mg/dl; Test Date: 20210414; Test Name: Creatinine; Test Result: 0.82 mg/dl; Test Date: 20210414; Test Name: Glucose; Test Result: 126.24 mg/dl; Test Date: 20210404; Test Name: Lactate; Test Result: 11.11 mg/dl; Test Date: 20210414; Test Name: Lactate; Test Result: 16.87 mg/dl; Test Date: 20210404; Test Name: Potassium; Result Unstructured Data: Test Result:2.76 mmol/L; Test Date: 20210405; Test Name: Potassium; Result Unstructured Data: Test Result:3.47 mmol/L; Test Date: 20210406; Test Name: Potassium; Result Unstructured Data: Test Result:3.22 mmol/L; Test Date: 20210408; Test Name: Potassium; Result Unstructured Data: Test Result:4 mmol/L; Test Date: 20210412; Test Name: Potassium; Result Unstructured Data: Test Result:3.73 mmol/L; Test Date: 20210414; Test Name: Potassium; Result Unstructured Data: Test Result:4.31 mmol/L; Test Date: 20210415; Test Name: Potassium; Result Unstructured Data: Test Result:3.53 mmol/L; Test Date: 20210416; Test Name: Potassium; Result Unstructured Data: Test Result:3.19 mmol/L; Test Date: 20210417; Test Name: Potassium; Result Unstructured Data: Test Result:4.93 mmol/L; Test Date: 20210412; Test Name: blood pressure; Result Unstructured Data: Test Result:130/60; Test Name: RR; Result Unstructured Data: Test Result:130/65 mmHg; Test Name: RR; Result Unstructured Data: Test Result:115/65 mmHg; Test Name: RR; Result Unstructured Data: Test Result:157/80 mmHg; Test Name: RR; Result Unstructured Data: Test Result:145/80 mmHg; Test Name: RR; Result Unstructured Data: Test Result:125/65 mmHg; Test Date: 20210404; Test Name: Sodium; Result Unstructured Data: Test Result:133 mmol/L; Test Date: 20210405; Test Name: Sodium; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210406; Test Name: Sodium; Result Unstructured Data: Test Result:136 mmol/L; Test Date: 20210408; Test Name: Sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210412; Test Name: Sodium; Result Unstructured Data: Test Result:136 mmol/L; Test Date: 20210414; Test Name: Sodium; Result Unstructured Data: Test Result:135 mmol/L; Test Date: 20210415; Test Name: Sodium; Result Unstructured Data: Test Result:141 mmol/L; Test Date: 20210416; Test Name: Sodium; Result Unstructured Data: Test Result:140 mmol/L; Test Date: 20210417; Test Name: Sodium; Result Unstructured Data: Test Result:141 mmol/L; Test Date: 20210404; Test Name: Urea; Test Result: 33.15 mg/dl; Test Date: 20210414; Test Name: Urea; Test Result: 43.16 mg/dl; Test Date: 20210405; Test Name: Blood urine; Result Unstructured Data: Test Result:normal; Test Date: 20210328; Test Name: Body temperature; Result Unstructured Data: Test Result:38.6; Test Date: 20210404; Test Name: tCO; Result Unstructured Data: Test Result:27.5 mmol/L; Test Date: 20210408; Test Name: tCO; Result Unstructured Data: Test Result:27.5 mmol/L; Test Date: 20210411; Test Name: tCO; Result Unstructured Data: Test Result:27.3 mmol/L; Test Date: 20210412; Test Name: tCO; Result Unstructured Data: Test Result:24.2 mmol/L; Test Date: 20210413; Test Name: tCO; Result Unstructured Data: Test Result:28 mmol/L; Test Date: 20210413; Test Name: tCO; Result Unstructured Data: Test Result:27 mmol/L; Test Date: 20210414; Test Name: tCO; Result Unstructured Data: Test Result:27.1 mmol/L; Test Date: 20210414; Test Name: tCO; Result Unstructured Data: Test Result:26.3 mmol/L; Test Date: 20210415; Test Name: tCO; Result Unstructured Data: Test Result:28.9 mmol/L; Test Date: 20210415; Test Name: tCO; Result Unstructured Data: Test Result:26.6 mmol/L; Test Date: 20210415; Test Name: tCO; Result Unstructured Data: Test Result:25.6 mmol/L; Test Date: 20210416; Test Name: tCO; Result Unstructured Data: Test Result:32.1 mmol/L; Test Date: 20210417; Test Name: tCO; Result Unstructured Data: Test Result:28.6 mmol/L; Test Date: 20210417; Test Name: tCO; Result Unstructured Data: Test Result:34.1 mmol/L; Test Date: 20210417; Test Name: tCO; Result Unstructured Data: Test Result:30.2 mmol/L; Test Date: 20210414; Test Name: Chest X-ray; Result Unstructured Data: Test Result:State after insertion of the central line - cathet; Comments: State after insertion of the central line - catheter tip in the superior vena cava projection. Peripheral inflammatory densities in the lungs. The diaphragm-rib angles are slightly shallower. Atherosclerosis of thoracic aorta; heart and small circulation normal. Degenerative and productive changes and right spine scoliosis Th.; Test Date: 20210404; Test Name: Chest CT; Result Unstructured Data: Test Result:On both sides, irregular areas of interstitial den; Comments: On both sides, irregular areas of interstitial densities (ground glass with thickening of the intralobular septum) in the lungs occupy about 20% of the lungs - image of mild inflammatory changes in COVID-19. Suspicious foci in the lungs were not visualized, only a single, minor post-inflammatory calcification was present within the pleural fissures and a slight peripherally inflammatory atelectatic area segm.10 of the right lung. Mediastinal lymph nodes not enlarged. Correct width of aorta. The walls of the esophagus are not thickened. Degenerative changes and curvature of the spine Th. The included epigastric region without contrast appears to be normal. Chest CT scan without contrast enhancement; Test Date: 20210404; Test Name: Leukocyte count; Result Unstructured Data: Test Result:5; Comments: thous/pl; Test Date: 20210405; Test Name: Leukocyte count; Result Unstructured Data: Test Result:2.5; Comments: thous/pl; Test Date: 20210408; Test Name: Leukocyte count; Result Unstructured Data: Test Result:5.1; Test Date: 20210412; Test Name: Leukocyte count; Result Unstructured Data: Test Result:7.5; Test Date: 20210414; Test Name: Leukocyte count; Result Unstructured Data: Test Result:10.2; Test Date: 20210404; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Eo, Baso, Mono 5%; Test Date: 20210405; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Eo, Baso, Mono 6%; Test Date: 20210408; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Eo, Baso, Mono 5%; Test Date: 20210412; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Eo, Baso, Mono 6%; Test Date: 20210414; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Eo, Bazo, Mono 4%; Test Date: 20210405; Test Name: Leukocyte count; Result Unstructured Data: Test Result:Erit fresh: 3-5; 0-1; Erit part leached: 0-1; Comments: in the field view Erit fresh: 3-5; 0-1; Erit part leached: 0-1; Test Date: 20210404; Test Name: C-reactive protein; Result Unstructured Data: Test Result:14.92 mg/l; Test Date: 20210407; Test Name: C-reactive protein; Result Unstructured Data: Test Result:64.76 mg/l; Test Date: 20210408; Test Name: C-reactive protein; Result Unstructured Data: Test Result:85.66 mg/l; Test Date: 20210412; Test Name: C-reactive protein; Result Unstructured Data: Test Result:193.55 mg/l; Test Date: 20210414; Test Name: C-reactive protein; Result Unstructured Data: Test Result:146.99 mg/l; Test Date: 20210414; Test Name: C-reactive protein; Result Unstructured Data: Test Result:126.31 mg/l; Test Date: 20210416; Test Name: C-reactive protein; Result Unstructured Data: Test Result:132.2 mg/l; Test Date: 20210414; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:49015.5 ng/ml; Test Date: 20210415; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:26053.36 ng/ml; Test Date: 20210417; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:7104.98 ng/ml; Test Date: 20210404; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:1233.6 ng/L; Test Date: 20210405; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:584.41 ng/L; Test Date: 20210406; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:798.87 ng/L; Test Date: 20210408; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:627.68 ng/L; Test Date: 20210412; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:1023.32 ng/L; Test Date: 20210404; Test Name: eGFR (index); Result Unstructured Data: Test Result:52.6; Comments: mL/min/1.73m2; Test Date: 20210414; Test Name: eGFR (index); Result Unstructured Data: Test Result:67.6; Comments: Units: mL/min/l,73 m2; Test Date: 20210405; Test Name: Urine glucose; Result Unstructured Data: Test Result:absent mg/dl; Test Date: 20210404; Test Name: Hematocrit; Test Result: 35 %; Test Date: 20210405; Test Name: Hematocrit; Test Result: 30 %; Test Date: 20210408; Test Name: Hematocrit; Test Result: 29 %; Test Date: 20210412; Test Name: Hematocrit; Test Result: 32 %; Test Date: 20210414; Test Name: Hematocrit; Test Result: 28 %; Test Date: 20210404; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.8 g/dl; Test Date: 20210405; Test Name: Haemoglobin; Result Unstructured Data: Test Result:10 g/dl; Test Date: 20210408; Test Name: Haemoglobin; Result Unstructured Data: Test Result:9.7 g/dl; Test Date: 20210412; Test Name: Haemoglobin; Result Unstructured Data: Test Result:10.7 g/dl; Test Date: 20210414; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.8; Comments: q/dTT; Test Date: 20210412; Test Name: HR; Result Unstructured Data: Test Result:61; Test Date: 20210412; Test Name: Interleukin 6; Result Unstructured Data: Test Result:192.4 pg/mL; Test Date: 20210414; Test Name: INR; Result Unstructured Data: Test Result:1.56; Test Date: 20210404; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:0.8; Comments: thous/pl; Test Date: 20210405; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:0.7; Comments: thous/pl; Test Date: 20210408; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:1.4; Test Date: 20210412; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:0.7; Test Date: 20210414; Test Name: Lymphocyte count; Result Unstructured Data: Test Result:0.5; Comments: thous/pl; Test Date: 20210404; Test Name: Lymphocyte count; Test Result: 16 %; Test Date: 20210405; Test Name: Lymphocyte count; Test Result: 29 %; Test Date: 20210408; Test Name: Lymphocyte count; Test Result: 28 %; Test Date: 20210412; Test Name: Lymphocyte count; Test Result: 9 %; Test Date: 20210414; Test Name: Lymphocyte count; Test Result: 5 %; Test Date: 20210404; Test Name: MCH; Test Result: 32 pg; Test Date: 20210405; Test Name: MCH; Test Result: 96 pg; Test Date: 20210408; Test Name: MCH; Test Result: 96 pg; Test Date: 20210412; Test Name: MCH; Test Result: 96 pg; Test Date: 20210412; Test Name: MCH; Test Result: 32 pg; Test Date: 20210414; Test Name: MCH; Test Result: 33 pg; Test Date: 20210404; Test Name: MCHC; Result Unstructured Data: Test Result:34 g/dl; Test Date: 20210405; Test Name: MCHC; Result Unstructured Data: Test Result:33.8 g/dl; Test Date: 20210408; Test Name: MCHC; Result Unstructured Data: Test Result:33.1 g/dl; Test Date: 20210412; Test Name: MCHC; Result Unstructured Data: Test Result:33.6 g/dl; Test Date: 20210414; Test Name: MCHC; Result Unstructured Data: Test Result:34.6 g/dl; Test Date: 20210404; Test Name: MCV; Result Unstructured Data: Test Result:94; Comments: fL; Test Date: 20210405; Test Name: MCV; Result Unstructured Data: Test Result:95; Comments: fL; Test Date: 20210408; Test Name: MCV; Result Unstructured Data: Test Result:96; Comments: fL; Test Date: 20210412; Test Name: MCV; Result Unstructured Data: Test Result:96; Comments: fL; Test Date: 20210414; Test Name: MCV; Result Unstructured Data: Test Result:95; Comments: fL; Test Date: 20210404; Test Name: MPV; Result Unstructured Data: Test Result:10.2; Comments: fL; Test Date: 20210405; Test Name: MPV; Result Unstructured Data: Test Result:10.5; Comments: fL; Test Date: 20210408; Test Name: MPV; Result Unstructured Data: Test Result:9.9; Comments: fL; Test Date: 20210412; Test Name: MPV; Result Unstructured Data: Test Result:8.92; Comments: fL; Test Date: 20210414; Test Name: MPV; Result Unstructured Data: Test Result:9.1; Comments: fL; Test Date: 20210404; Test Name: neutrophils; Result Unstructured Data: Test Result:4; Comments: thous/pl; Test Date: 20210405; Test Name: neutrophils; Result Unstructured Data: Test Result:1.7; Comments: thous/pl; Test Date: 20210408; Test Name: neutrophils; Result Unstructured Data: Test Result:3.5; Comments: thous/pl; Test Date: 20210412; Test Name: neutrophils; Result Unstructured Data: Test Result:6.4; Test Date: 20210414; Test Name: neutrophils; Result Unstructured Data: Test Result:9.3; Test Date: 20210404; Test Name: neutrophils; Test Result: 80 %; Test Date: 20210405; Test Name: neutrophils; Test Result: 66 %; Test Date: 20210408; Test Name: neutrophils; Test Result: 67 %; Test Date: 20210412; Test Name: neutrophils; Test Result: 86 %; Test Date: 20210414; Test Name: neutrophils; Test Result: 91 %; Test Date: 20210405; Test Name: Nitrite urine; Result Unstructured Data: Test Result:present; Test Name: Oxygen saturation; Test Result: 91 %; Test Name: Oxygen saturation; Test Result: 90 %; Test Name: Oxygen saturation; Test Result: 94 %; Test Name: Oxygen saturation; Test Result: 88 %; Test Name: Oxygen saturation; Test Result: 78 %; Test Name: Oxygen saturation; Test Result: 77 %; Test Name: Oxygen saturation; Test Result: 84 %; Test Date: 20210412; Test Name: saturation; Test Result: 99 %; Test Name: saturation; Test Result: 94 %; Test Date: 20210404; Test Name: saturation; Test Result: 88.5 %; Comments: deg; Test Date: 20210408; Test Name: saturation; Test Result: 92.6 %; Test Date: 20210411; Test Name: saturation; Test Result: 86.7 %; Test Date: 20210412; Test Name: saturation; Test Result: 88.4 %; Test Date: 20210413; Test Name: saturation; Test Result: 93.9 %; Test Date: 20210413; Test Name: saturation; Test Result: 99.5 %; Test Date: 20210414; Test Name: saturation; Test Result: 96.5 %; Test Date: 20210414; Test Name: saturation; Test Result: 96.2 %; Test Date: 20210415; Test Name: saturation; Test Result: 99.6 %; Test Date: 20210415; Test Name: saturation; Test Result: 96.7 %; Test Date: 20210415; Test Name: saturation; Test Result: 98.7 %; Test Date: 20210416; Test Name: saturation; Test Result: 95.4 %; Test Date: 20210416; Test Name: saturation; Test Result: 91.8 %; Test Date: 20210417; Test Name: saturation; Test Result: 84.7 %; Test Date: 20210417; Test Name: saturation; Test Result: 87.8 %; Test Name: pCO2; Result Unstructured Data: Test Result:31 mmHg; Test Date: 20210404; Test Name: pCO2; Result Unstructured Data: Test Result:43.6 mmHg; Test Date: 20210408; Test Name: pCO2; Result Unstructured Data: Test Result:46.1 mmHg; Test Date: 20210411; Test Name: pCO2; Result Unstructured Data: Test Result:43 mmHg; Test Date: 20210412; Test Name: pCO2; Result Unstructured Data: Test Result:38.4 mmHg; Test Date: 20210413; Test Name: pCO2; Result Unstructured Data: Test Result:38.8 mmHg; Test Date: 20210413; Test Name: pCO2; Result Unstructured Data: Test Result:44.5 mmHg; Test Date: 20210414; Test Name: pCO2; Result Unstructured Data: Test Result:41.2 mmHg; Test Date: 20210414; Test Name: pCO2; Result Unstructured Data: Test Result:44.4 mmHg; Test Date: 20210415; Test Name: pCO2; Result Unstructured Data: Test Result:37 mmHg; Test Date: 20210415; Test Name: pCO2; Result Unstructured Data: Test Result:45.2 mmHg; Test Date: 20210415; Test Name: pCO2; Result Unstructured Data: Test Result:37.4 mmHg; Test Date: 20210416; Test Name: pCO2; Result Unstructured Data: Test Result:47.7 mmHg; Test Date: 20210417; Test Name: pCO2; Result Unstructured Data: Test Result:147.3 mmHg; Test Date: 20210417; Test Name: pCO2; Result Unstructured Data: Test Result:51 mmHg; Test Date: 20210417; Test Name: pCO2; Result Unstructured Data: Test Result:48.6 mmHg; Test Name: pH; Result Unstructured Data: Test Result:6.95 pH units; Test Date: 20210404; Test Name: pH; Result Unstructured Data: Test Result:7.46 pH units; Test Date: 20210408; Test Name: pH; Result Unstructured Data: Test Result:7.423 pH units; Test Date: 20210411; Test Name: pH; Result Unstructured Data: Test Result:7.459 pH units; Test Date: 20210412; Test Name: pH; Result Unstructured Data: Test Result:7.462 pH units; Test Date: 20210412; Test Name: pH; Result Unstructured Data: Test Result:7.459 pH units; Test Date: 20210413; Test Name: pH; Result Unstructured Data: Test Result:7.438 pH units; Test Date: 20210413; Test Name: pH; Result Unstructured Data: Test Result:7.482 pH units; Test Date: 20210414; Test Name: pH; Result Unstructured Data: Test Result:7.43 pH units; Test Date: 20210414; Test Name: pH; Result Unstructured Data: Test Result:7.457 pH units; Test Date: 20210415; Test Name: pH; Result Unstructured Data: Test Result:7.495 pH units; Test Date: 20210415; Test Name: pH; Result Unstructured Data: Test Result:7.459 pH units; Test Date: 20210415; Test Name: pH; Result Unstructured Data: Test Result:7.505 pH units; Test Date: 20210416; Test Name: pH; Result Unstructured Data: Test Result:6.972 pH units; Test Date: 20210416; Test Name: pH; Result Unstructured Data: Test Result:7.451 pH units; Test Date: 20210416; Test Name: pH; Result Unstructured Data: Test Result:7.421 pH units; Test Date: 20210417; Test Name: pH; Result Unstructured Data: Test Result:7.42 pH units; Test Date: 20210417; Test Name: pH; Result Unstructured Data: Test Result:6.972 pH units; Test Date: 20210405; Test Name: Urine pH; Result Unstructured Data: Test Result:5.5 pH units; Test Date: 20210404; Test Name: Platelets; Result Unstructured Data: Test Result:89; Comments: thous/pl; Test Date: 20210405; Test Name: Platelets; Result Unstructured Data: Test Result:81; Comments: thous/pl; Test Date: 20210408; Test Name: Platelets; Result Unstructured Data: Test Result:124; Test Date: 20210412; Test Name: Platelets; Result Unstructured Data: Test Result:342; Test Date: 20210414; Test Name: Platelets; Result Unstructured Data: Test Result:369; Comments: thousand/uD; Test Date: 20210404; Test Name: PDW; Result Unstructured Data: Test Result:12; Comments: fL; Test Date: 20210405; Test Name: PDW; Result Unstructured Data: Test Result:14; Comments: fL; Test Date: 20210408; Test Name: PDW; Result Unstructured Data: Test Result:13; Comments: fL; Test Date: 20210412; Test Name: PDW; Result Unstructured Data: Test Result:11; Comments: fL; Test Date: 20210414; Test Name: PDW; Result Unstructured Data: Test Result:11; Comments: fL; Test Date: 20210404; Test Name: P-LCR; Test Result: 27 %; Test Date: 20210405; Test Name: P-LCR; Test Result: 30 %; Test Date: 20210408; Test Name: P-LCR; Test Result: 25 %; Test Date: 20210412; Test Name: P-LCR; Test Result: 18 %; Test Date: 20210414; Test Name: P-LCR; Test Result: 21 %; Test Name: PO2; Result Unstructured Data: Test Result:120.1 mmHg; Test Date: 20210404; Test Name: PO2; Result Unstructured Data: Test Result:51 mmHg; Test Date: 20210408; Test Name: PO2; Result Unstructured Data: Test Result:63 mmHg; Test Date: 20210411; Test Name: PO2; Result Unstructured Data: Test Result:48.3 mmHg; Test Date: 20210412; Test Name: PO2; Result Unstructured Data: Test Result:51.1 mmHg; Test Date: 20210413; Test Name: PO2; Result Unstructured Data: Test Result:66.6 mmHg; Test Date: 20210413; Test Name: PO2; Result Unstructured Data: Test Result:152.6 mmHg; Test Date: 20210414; Test Name: PO2; Result Unstructured Data: Test Result:79.7 mmHg; Test Date: 20210414; Test Name: PO2; Result Unstructured Data: Test Result:80.1 mmHg; Test Date: 20210415; Test Name: PO2; Result Unstructured Data: Test Result:107.4 mmHg
CDC Split Type: PLPFIZER INC2021843871

Write-up: COVID-19 virus test positive; Fibrin D dimer high; Cough; shortness of breath; Numerous crackles over the lung fields; ARDS; Unconscious patient; Condition worsened; Semi-conscious patient, almost unconscious; Severe state 2 days after vaccination; Weakness 2 days after vaccination; The patient spoke very poorly 2 days after vaccination; Fever 38.6 2 days after vaccination; The patient did not walk without the help of third parties 2 days after vaccination; Bradycardia; cardiac arrest in the asystole mechanism; Circulatory failure required the supply of catecholamines; Respiratory failure aggravated; dyspnoea at rest; Tachypnoea; Cyanosis peripheral; Cyanosis central; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB [PL-URPL-DML-MLP.4401.2.390.2021]. A 78-year-old female patient received her first dose of BNT162B2 (COMIRNATY; lot number: ET3674), via an unspecified route of administration on 26Mar2021 (at an unspecified age) at dose 1, single for COVID-19 immunisation. Medical history included arterial hypertension and hypothyroidism; both for which the patient was treated. The patient''s concomitant medications were not reported. On 28Mar2021, 2 days after the vaccination, the patient experienced weaknesss, so the patient called an ambulance and diagnosis of the doctors was unknown. The patient''s daughter arrived and fount the patient in a serious condition. On the same day, on 28Mar2021, the patient spoke very poorly, fever of 38.6, the patient did not walk without the help of third parties, the patient was in a severe state. On Apr2021, an ambulance was refused. Due to the events experienced, the patient''s daughter put the half-conscious patient into a car and was brought to the emergency department. There, the doctor suspected coronavirus and was referred to the hospital. The patient was almost unconscious and had a COVID-19 virus test on 04Apr2021 which turned out to be positive. The patient was referred to the gynecological department, the patient was already unconscious on Apr2021. After a few days, on Apr2021, the patient''s condition worsened and was transferred to the anesthesia ward, where the patient died on 19Apr2021. The doctor on duty told the patient''s daughter that the high level of D-dimer was the cause of death. It was reported that the patient was admitted to the gynecological department on 04Apr2021 at 11:30 with recognition on disposal as COVID-19, virus identified. On 04Apr2021, the patient had increasing weakness, cough, and shortness of breath, without fever. The patient had ARDS on 04Apr2021. Due to the patient''s current illnesses, she was treatment from 01Apr2021 by a general practitioner and took SUMAMED. During hospitalization, the patient received oxygen therapy with a straight mask, then with a reservoir, and CPAP was used from 13Apr2021. During medical consultations on 12Apr2021 14:33 it was stated that the patient was conscious of oxygen therapy with a reservoir, BP (blood pressure) was 130/60, HR (heart rate) was 61, Sat (saturation) was 99%. No report of feeling of breathlessness and currently does not require treatment in the ICU. It was recommended to continue with oxygen therapy with periodic production of PEEP (blowing into a water bottle through a drip tube), control of D-dimers, infusion of unfractionated heparin 25 thousand. IU / 12 hours with APTT control. Recommended time extension 150-200 sec. On anesthesiological consultation on 13Apr2021 11:58, it was stated that the patient has with COVID-19 infection. The image was worse on lung tomography than on admission. At the time of examination on 13Apr2021 11:58, the patient was: conscious, had dyspnoea at rest, tachypnoea, peripheral and central cyanosis. Mask ventilation was ineffective. "NIV, FiO2-50% was used; PIP_9; PEEP-9; f-12 / min. Sat-94%" were given to the patient. Numerous crackles over the lung fields were found that started on 04Apr2021. The doctor proposed Fraxiparina 2x 0.8 ml subcutaneously, lPP-lx40 mg intravenously; ACC-lx400mg intravenously (morning); antibiotic as medications; and suggested examinations every day: acid-base balance twice a day; d-dimers 1x daily. In case of deterioration, another anaesthesiological consultation. Due to the patient''s deteriorating condition, she was transferred to the intensive care unit (ICU) on 14Apr2021. The patient was admitted to the ICU in a very difficult general condition. Initially, non-invasive ventilation was performed. On 14Apr2021, respiratory failure aggravated. The patient was intubated and mechanically ventilated. Appropriate pharmacotherapy was started. Enteral and parenteral nutrition was performed. On 19Apr2021, circulatory failure required the supply of catecholamines. Despite the treatment, the patients condition continued to deteriorate. On 19Apr2021, around 10:00 am, there was a progressive bradycardia, followed by cardiac arrest in the asystole mechanism. The pupils are wide and active. Blood pressure undetectable. Due to the exhaustion of therapeutic options and the appearance of the signs of death, the patient was pronounced dead at 10:30. The patient underwent lab tests and procedures which included: 04Apr2021: Lactates, quantitatively (mg/dl; min: 4.50, max: 19.80): 11.11; 05Apr2021: Urine glucose (strip) (mg/dl): absent; Urine transparency: cloudy; Urine color: yellow; Urine specific gravity (g/ml; min: 1.0150 max: 1.03): 1.018; Urine pH (min: 5 max: 7): 5.5; Urine Ketones (mg/dl; max: 5): absent; Urine Urobilinogen (mg/dl): normal; Urine Bilirubin: absent; Protein in urine (strip) (mg / dl): trace; Nitrite urine: present; Urine blood: normal; Leukocytes: normal; Flat epithelium: numerous; Leukocytes (min: 0 max: 5) [in the field of view]; Erit. fresh (min: 0 max: 5): 3-5; 0-1; Erit. part leached: 0-1; Bacteria: very numerous. Biochemical research included: CRP, quantitative (mg/L; min: 0 max: 5): 04Apr2021: 14.92; 07Apr2021: 64.76, 12Apr2021: 193.55; 14Apr2021: 146.99; Creatinine (mg/dl; min: 0.50 max: 0.9): 04Apr2021: 1.02; Potassium (mmol/L; min: 3.50 max: 5): 04Apr2021: 2.76; 05Apr2021: 3.47; 06Apr2021: 3.22; 08Apr2021: 4; 12Apr2021: 3.73; Sodium (mmol/L; min: 136 max: 145): 04Apr2021: 133; 05Apr2021: 134; 06Apr2021: 136; 12Apr2021: 136; ALT (U/l; mm: max: 33): 04Apr2021: 32; AST (U/l; max: 32); 04Apr2021: 54; Chlorides (mmol/L; min: 98 max: 107): 04Apr2021: 92; 05Apr2021: 97; 08Apr2021: 101; 12Apr2021: 95; D-dimer, quantitative (ng/ml; min: max: 500): 04Apr2021: 1233.6; 05Apr2021: 584.41; 06Apr2021: 798.87; 08Apr2021: 627.68 12Apr2021: 1023.32; 14Apr2021: 49015.5; pH (min: 7.35 max: 7.45): 04Apr2021: 7.46 13Apr2021: 7.482; pO2 (mmHg; min: 83 max: 108): 04Apr2021: 51; 13Apr2021: 152.6; HCO3 (mmol/L; min: 21 max: 26): 04Apr2021: 29.2; 13Apr2021: 28.1; BE (B) (mmol/L; min: -3 max: 3): 04Apr2021: 5.8; 13Apr2021: 4.4; Saturation (deg.; min: 94 max: 98): 04Apr2021: 88.5; 13Apr2021: 99.5; pCO2 (min: 32 max: 48) [mmHg] 04Apr2021: 43.6; 13Apr2021: 38.8; tCO (mmol/L; min: max :): 04Apr2021: 27.5; 13Apr2021: 28; Alkaline phosphatase (U/l; min: 35 max: 104): 04Apr2021: 60; Total Bilirubin (mg/dl; min: 0.30 max: 1.20): 04Apr2021: 0.49; eGFR (index) (ml / min / l, 73 m2): 04Apr2021: 52.6. Hematological Research on 04Apr2021 includes: Leukocytes (thous / pl; min: 3.80 max: 10): 04Apr2021: 5; 12Apr2021: 7.5; Erythrocytes (Jmln / ul; min: 3.70 max: 5.10): 04Apr2021: 3.68; 12Apr2021: 3.33; Hemoglobin (g/di; min: 12 max: 16): 04Apr2021: 11.8; 12Apr2021: 10.7; Hematocrit (%; min: 37 max: 47): 04Apr2021: 35; 12Apr2021: 32; MCV (fl; min: 80 max: 99): 04Apr2021: 94; 12Apr2021: 96; MCH (pg; min: 27 max: 35): 04Apr2021: 32; 12Apr2021: 32; MCHC (g/dL; min: 32 max: 37): 04Apr2021: 34; 12Apr2021: 33.6; Platelets (thous / pl; min: 140 max: 440): 04Apr2021: 89; 12 Apr2021: 342; Other (Eo, Bazo, Mono)% (%; min: 6 max: 12): 04Apr2021: 5; 12Apr2021: 6; % Neutrophils (%; min: 40 max: 70): 04Apr2021: 80; 12Apr2021: 86; Lymphocytes # (thous / pl; min: 1.40 max: 3.50): 04Apr2021: 0.8; 12Apr2021: 0.7; Other (Eo, Bazo, Mono) # (thous / pl ; min: 0.60 max: 1.10): 04Apr2021: 0.2; 12Apr2021: 0.4; Neutrophils # (thous / pl; min: 2.50 max: 7): 04Apr2021: 4; 12Apr2021: 6.4; RDW-CV (min: 11.60 max: 14.80): 04Apr2021: 13; 12Apr2021: 13; PDW (fl; min: 9 max: 17): 04Apr2021: 12; 12Apr2021: 11; MPV (min: 9 max: 13): 04Apr2021: 10.2; 12Apr2021: 8.92; P-LCR (%; min: 13 max: 43): 04Apr2021: 27; 12Apr2021: 18; Lymphocytes (%; min: 20 max: 45): 04Apr2021: 16; 12Apr2021: 9. Immunodiagnostic tests includes: Interleukin 6 (pg/ml; min: 0 max: 7): 12Apr2021: 192.4. Coagulation tests includes: APTT (sec; min: 26 max: 43): 12Apr2021: 33, 13Apr2021: 30. COVID-19 Test on 04Apr2021: positive. Other additional tests includes: RR: 130/65, 115/65, 157/80 145/80, 125/65 mmHg. Saturation: 91-90-94-88-78-77-84%. Chest CT scan without contrast enhancement on 04Apr2021: On both sides, irregular areas of interstitial densities (frosted glass with thickening of the medullary septum) in the lungs occupy about 20% of the lungs - a picture of mild inflammatory changes in COVID-19. Suspected foci in the lungs were not visualized, only a single, minor post-inflammatory calcifications within the pleural fissures and a small peripheral post-inflammatory area in the segm. 10 of the right lung were present. Mediastinal lymph nodes not enlarged. The aorta of correct width. The walls of the esophagus are not thickened. Degenerative changes and curvature of the spine Th. The included epigastric region without contrast appears to be normal. Laboratory tests included: Analytical Research on 14Apr2021: Lactates, quantitative ( mg/dl; min: 4.50 max: 19.80): 16.87. Biochemical research included: CRP, quantitative (mg/l; min: 0 max: 5): 14Apr2021: 126.31, 16Apr2021: 132.3; Creatinine (mg/dL; min: 0.50 max: 0.90): 14Apr2021: 0.82; Glucose (mg/dL; min: 70 max: 99): 14Apr2021: 126.24; Urea (mg/dl; min: max: 71): 14Apr2021: 43.16; Potassium (mmol/l; min: 3.50 max: 5): 14Apr2021: 4.31, 17Apr2021: 4.93; Sodium (mmol/l; min: 136 max: 145): 14Apr2021: 135, 17Apr2021: 141; ALT (U/l; max: 33): 14Apr2021: 57; AST (U/l; max: 32): 14Apr2021: 52; Chlorides (mmol/l; min: 98 max: 107): 14Apr2021: 99, 17Apr2021: 103; D-dimer, quantitatively (ng ml; max: 500): 15Apr2021: 26053.36, 17Apr2021: 7104.98; Albumin (g/dL; min: 3.40 max: 4.80): 14Apr2021: 2.9; eGFR (index) (ml/min/l, 73 m2): 14Apr2021: 67.6; pH (min: 7.35 max: 7.45): 14Apr2021: 7.457; 16Apr2021: 7.451, 17Apr2021: 6.972; last examination (illegible date): 6.95; pO2 (mmHg; min: 83 max: 108) [mmHg]: 14Apr2021: 80.1; 16Apr2021: 72.2, 17Apr2021: 80; last survey (illegible date): 120.1; HCO3 (mmol/L; min: 21 max: 26): 14Apr2021: 27.8; 2021-04-16: 31 17Apr2021: 21.3; last examination (illegible date): 19.1l BE (B) (mmol/l; min: -3 max: 3): 14Apr2021: 4.2, 16Apr2021: 7.9, 17Apr2021: -1.5; last test (illegible date): - 3; Saturation (min: 94 max: 98) [%]: 14Apr2021: 96.5; 16Apr2021: 95.4 17Apr2021: 84.7; last examination (illegible date): 94; pCO 2 (min: 32 max: 48) [mmHg] 14Apr2021: 41.2; 16Apr2021: 47.7 17Apr2021: 147.3 last examination (illegible date): 139; tCO (min: max :) [mmol/L] 14Apr2021: 26.3; 2021-04-16: 32.1 2021-04-17: 34.1. last examination (date illegible): 31; tCO (min: max :) [mmol/L] 14Apr2021: 26.3; 2021-04-16: 32.1 2021-04-17: 34.1. last examination (date illegible): 31; Hematological research on 14Apr2021 includes: Leukocytes (min: 3.80 max: 10) [thous /pl] 10.2; Erythrocytes (min: 3.70 max: 5.10) Lmln /yl] 238; Hemoglobin (min: 12 and max: 16) [q/dTT] 9.8; Hematocrit (min: 37 max: 47) [%] 28; MCV (min: 80 max-99) fl 95; MCH (million: 27 max: 35) [pg] 33; MCHC (min: 32 max: 37) [g / dL] 34.6; Platelets (min: 140 max: 440) [thousand/uD] 369; Other (Eo, Bazo, Mono)% (min: 6 max: 12) [%] 4; Neutrophils% (min: 40 max: 70) [%] 91; Lymphocytes II (min: 1.40 max: 3.50) [thous/pl] 0.5; Other (Eo, Bazo, Mono) # (min: 0.60 max: 1.10) [thousand/pl] 0.4; Neutrophils # (min: 2.50 max: 7) [thousand/pl] 9.3; RDW-CV (min: 11.60 max: 14.80) I% L 13; PDW (min: 9 max: 17) [fl] 11; MPV (min: 9 max: 13) [fl] 9.1; P-LCR (min: 13 max: 43) [%] 21; Lymphocytes% (min: 20 max: 45) [%] 5. Coagulation research 14Apr2021; Prothrombin index (Quick) (min: 70 max: 120) [%] 65; INR (min: 0.90 max: 1.20) 1.56; APTT (min: 26 max: 43) [sec] 14Apr2021: 139 15Apr2021: 62; 125; 16Apr2021: undetectable; 39; 154 16Apr2021: undetectable. The patient underwent Chest X-ray on 14Apr2021: The state after insertion of the central line - catheter tip in the superior vena cava projection. Peripheral inflammatory densities in the lungs. The diaphragm-rib angles are slightly shallower. atherosclerotic thoracic aorta; heart and circulation normal. Degenerative-productive changes and right-sided scoliosis of the spine Th. BE (B):08Apr2021: 4.4, 11Apr2021: 5.4, 12Apr2021: 2.9; 13Apr2021: 4.7, 14Apr2021, 4.1, 15Apr2021: 4.5, 15Apr2021: 5.4, 15Apr2021: 6.7, 17Apr2021: 7; 17Apr2021: 5.5; Plasma carbonate: 08Apr2021: 27.9, 11Apr2021: 28.8; 12Apr2021: 26.7; 13Apr2021: 28.1; Chloride: 15Apr2021: 103, 16Apr2021: 103; Potassium: 15Apr2021: 3.53, 16Apr2021: 3.19; Sodium: 08Apr2021: 139, 15Apr2021: 141, 16Apr2021: 140; HCO3: 14Apr2021: 27.7, 15Apr2021: 29.9, 28.1, 28.9, 17Apr2021: 30.1, 28.8; Urea: 04Apr2021: 33.15; tCO: 08Apr2021: 27.5, 11Apr2021: 27.3, 12Apr2021: 24.2, 13Apr2021: 27, 14Apr2021: 27.1, 15Apr2021: 28.9, 15Apr2021: 26.6, 25.6, 17Apr2021: 28.6, 30.2; CRP: 08Apr2021: 85.66, 16Apr2021, 132.2; Hematocrit: 05Apr2021: 30, 08Apr2021: 29; Hemoglobin: 05Apr2021: 10, 08Apr2021: 9.7; Lymphocyte count: 05Apr2021: 0.7, 08Apr2021: 1.4; Lymphocyte count (%): 05Apr2021: 29, 08Apr2021: 28; MCH: 05Apr2021: 96, 08Apr2021: 96, 12Apr2021: 96; MCHC: 05Apr2021: 33.8, 08Apr2021: 33.1; MCV: 05Apr2021: 95, 08Apr2021: 96; MPV: 05Apr2021: 10.5, 08Apr2021: 9.9; Neutrophils: 05Apr2021: 1.7, 08Apr2021: 3.5; Neutrophils (%): 05Apr2021: 66, 08Apr2021: 67; Saturation (%): 08Apr2021, 92.6, 11Apr2021: 86.7, 12Apr2021: 88.4, 13Apr2021: 93.9, 14Apr2021: 96.2, 15Apr2021: 99.6, 96.7, 98.7; 16Apr2021: 91.8; 17Apr2021: 87.8; PCO2: 08Apr2021: 46.1, 11Apr2021: 43, 12Apr2021: 38.4, 13Apr2021: 44.5, 14Apr2021: 44.4, 15Apr2021: 37, 45.2, 37.4, 17Apr2021: 51, 48.6; pH: 08Apr2021: 7.423, 11Apr2021: 7.459, 12Apr2021: 7.462, 7.459, 13Apr2021: 7.438, 14Apr2021: 7.43, 15Apr2021: 7.495, 7.459, 7.505, 16Apr2021: 6.972, 7.421, 17Apr2021: 7.42; Platelets: 05Apr2021: 81, 08Apr2021: 124; PDW: 05Apr2021: 14; 08Apr2021: 13; P-LCR: 05Apr2021: 30, 08Apr2021: 25; PO2: 08Apr2021: 63, 11Apr2021: 48.3, 12Apr2021: 51.1, 13Apr2021: 66.6, 14Apr2021: 79.7, 15Apr2021: 107.4, 169.4, 80.4, 17Apr2021: 51.9, 60.8; Erythrocytes: 05Apr2021: 3.13, 08Apr2021: 3.04, 14Apr2021: 2.98; Leukocyte count: 05Apr2021: 2.5, 08Apr2021: 5.1; Red blood cells urine: 05Apr2021: fresh RBC: 0-1 per field (FOV), lixiviated erythrocytes:0-1 (min; max); Leukocyte count: Eo, Baso, Mono 0.2 thousand per microlitre 04Apr2021, Eo, Baso, Mono 0.1 thousand per microlitre 05Apr2021, Eo, Baso, Mono 0.2 thousand per microlitre 08Apr2021, Eo, Baso, Mono 0.4 thousand per microlitre 12Apr2021, Eo, Bazo, Mono 0.4 thousand per microlitre 14Apr2021; Leukocyte count: Eo, Baso, Mono 5% 04Apr2021, Eo, Baso, Mono 6% 05Apr2021, Eo, Baso, Mono 5% 08Apr2021, Eo, Baso, Mono 6% 12Apr2021, Eo, Bazo, Mono 4% 14Apr2021. It was reported that the patient received treatments for the events which included: Oxygen therapy, CPAP, Biotrakson, Remdesivir, Dexaven, Kalipoz, Enterol, Fragmin, IPP, Perfalgan, Spasmalgon, No-Spa, PWE, Optylite, Pyralgin, Levofloxacin, Hydroxyzyna, 0.9% NaCI Own drugs - Xetanor, Beto 50 ZK, Acard, Telmizek, Heparin, Fraxyparin, IPP, ACC, Ketrel, Polpril, Midanium, Pyralgina, Poltram, Insulin, 15% KCI, Rocuronium, Fentanyl, Plofed, NaHCO3, Cordarone, Levonor, Resonium, Furosemide, SMOF-Kabiven, Diason, Krystaloidy. (100.61) Insertion of artery catheter on 14Apr2021, (100.62) Insertion of central venous catheter on 14Apr2021, (57.01) Bladder catheterization through a disposable coil on 14Apr2021, (89.397) Intra-abdominal pressure measurement on 14Apr2021, (99.99900) Suction of the upper respiratory tract on 14Apr2021, (93.1804) Improving the respiratory system - patting on 14Apr2021, (93.1811) Postural drainage on 14Apr2021, (93.92) Other mechanical ventilation on 14Apr2021, (99.152) Partial parenteral nutrition on 14Apr2021, (99.87) Enteral nutrition on 14Apr2021, and (89,540) Basic vital functions monitoring. It was unknown if autopsy was performed. The reporting person selected the criterion for reporting severe death. Regulatory Authority classified the application as severe (death, hospitalization). Outcome of all the events was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information the reported event is attributed to an underlying or an intercurrent medical condition and it is assessed as unrelated to the suspect drug. 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: Weakness 2 days after vaccination; The patient spoke very poorly 2 days after vaccination; Fever 38.6 2 days after vaccination; The patient did not walk without the help of third parties 2 days after vaccination; Semi-conscious patient, almost uncons


VAERS ID: 1489403 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 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: COVID-19 (severe COVID-19 infection in Jun2020 with treatment in hospital)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021843575

Write-up: large transmural heart attack; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB SE-MPA-2021-053577. A 50-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included severe COVID-19 infection in Jun2020 with treatment in hospital. The patient''s concomitant medications were not reported. The patient experienced large transmural myocardial infarction/ large transmural heart attack with onset 15 Days after the given vaccine (Jun2021). The reporter states that the man had no previous heart problems and despite massive resuscitation attempts, he died. Therapeutic measures were taken as a result of large transmural heart attack. The patient died on an unspecified date. It was not reported if an autopsy was performed. More information is requested by the Regulatory Authority and the report will be updated. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: large transmural heart attack


VAERS ID: 1489425 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6326 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Angiogram, Arthralgia, Body temperature, Body temperature increased, Echocardiogram, Electrocardiogram, Malaise, Myocardial rupture, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Other ischaemic heart disease (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (since //2005 approximately); Prostate cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal syndrome acute; Acid reflux (esophageal); Hernia; Memory impairment (Drugs for urinary incontinence - had memory difficulties. Approximately //2014-15); Migraine with aura; Perforation of colon; Radical prostatectomy; Transient ischaemic attack; Urine incontinence (previous memory impairment due to urine incontinence medicine and hydrochlorothiazide)
Allergies:
Diagnostic Lab Data: Test Name: angiography; Result Unstructured Data: Test Result:unknown; Test Name: little elevated temperature; Result Unstructured Data: Test Result:37.5; Comments: a little elevated temperature; Test Name: Ultrasound heart; Result Unstructured Data: Test Result:unknown; Test Name: ECG; Result Unstructured Data: Test Result:unknown; Test Date: 202105; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021843968

Write-up: OBDUCTION SHOWED HEART ROPE; TROUBLESHOOTING PROBLEMS; JOINT WORK; he felt a little rough; a little elevated temperature, 37.5; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority. A 66-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in Apr2021 (Batch/Lot Number: EW6326) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included abdominal syndrome acute from 2004, migraine with aura, ongoing hypertension approximately since 2005, hernia, perforation of colon from 2014, radical prostatectomy from 2014, ongoing prostate cancer, acid reflux (esophageal), previous memory impairment due to urine incontinence medicine and hydrochlorothiazide (Drugs for urinary incontinence - had memory difficulties. Approximately //2014-15), and transient ischaemic attack. The patient''s concomitant medications were not reported. The patient previously took hydrochlorothiazide and experienced previous memory impairment. It also appears in the report that the patient himself felt that he was generally sensitive to medicine. On 28Apr2021, the patient experienced joint work. In May2021, the patient experienced obduction showed heart rope and troubleshooting problems. The events were assessed as serious (death and hospitalization). It was further reported that suspect adverse events were Angina pectoris, Joint pain and Myocardial rupture. The nurse stated in accordance with the autopsy report that the cause of death was a cardiac rupture with onset about 22 days after the vaccination. The nurse states that the man had angina for the first time about nine days after the vaccination during the daily walk with the dog, which passed after a while of rest. However, he experienced another angina on the evening walk and was hospitalized. The nurse describes that the man was examined with electrocardiogram (ECG), Ultrasound heart, angiography and he got 2 stents inserted in the coronary artery and a few days later 2 more stents were inserted. 10 days later, the patient went home but he felt a little rough, had joint pain, and a little elevated temperature, 37.5. The nurse stated that the patient performed a covid-19 test 20 days after the vaccination since he had some symptoms but it ended up being negative. The next day after the test he felt better and went for a walk, about 1 km and he was feeling good throughout the day and evening and was happy to be home. It appears in the report that the patient during a conversation at 2 o''clock at night was feeling well and he was sleeping. According to the nurse, the patient had set the clock at 7.30 and got up, taken his medication, and then probably suffered a heart rupture and fell to the floor without getting himself in a prone side position. The nurse mentioned that the man had a telephone next to him but did not alert SOS. Therapeutic measures were taken as a result of troubleshooting problems (angina pectoris) which includes stents. The patient died on an unspecified date. The cause of death was cardiac rupture. The outcome of the events he felt a little rough and a little elevated temperature, 37.5 was unknown at the time of death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac rupture


VAERS ID: 1489446 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, 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: SODIUM HYDROGEN CARBONATE; MIMPARA; PREDNISOLON ALTERNOVA; MIRTAZAPIN KRKA; ADPORT; MYCOPHENOLATE MOFETIL SANDOZ; ZOPIKLON PILUM; BACTRIM; OMEPRAZOL TEVA [OMEPRAZOLE SODIUM]; OXASCAND; BISOPROLOL SANDOZ; CANDESARTAN SANDOZ; VALGANCICLOVIR T
Current Illness: Anxiety; Cardiomyopathy; Depression; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Blisters (Bl?sor p? kroppen som en tidigare l?kemedelsbiverkan av Furosemid); Kidney transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: LUNGEMBOLI; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (LUNGEMBOLI) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 immunisation. The patient''s past medical history included Blisters (Blisters on the body as a previous drug side effect of Furosemide) and Kidney transplant on 18-Feb-2021. Concurrent medical conditions included Hypertension since 2005, Anxiety, Cardiomyopathy since 2005 and Depression. Concomitant products included SODIUM HYDROGEN CARBONATE, CINACALCET HYDROCHLORIDE (MIMPARA), PREDNISOLONE (PREDNISOLON ALTERNOVA), MIRTAZAPINE (MIRTAZAPIN KRKA), TACROLIMUS (ADPORT), MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL SANDOZ), ZOPICLONE (ZOPIKLON PILUM), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), OMEPRAZOLE SODIUM (OMEPRAZOL TEVA [OMEPRAZOLE SODIUM]), OXAZEPAM (OXASCAND), BISOPROLOL FUMARATE (BISOPROLOL SANDOZ), CANDESARTAN CILEXETIL (CANDESARTAN SANDOZ), VALGANCICLOVIR HYDROCHLORIDE (VALGANCICLOVIR TEVA) and SERTRALINE HYDROCHLORIDE (SERTRALIN TEVA) for Adverse event. In April 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In May 2021, the patient experienced PULMONARY EMBOLISM (LUNGEMBOLI) (seriousness criteria death and medically significant). The reported cause of death was Pulmonary embolism. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded The past history of cardiomyopathy and hypertension are confounders; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded The past history of cardiomyopathy and hypertension are confounders; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1489467 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
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: 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: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKMODERNATX, INC.MOD20212

Write-up: smrt; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No medical history was reported. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was performed, but no results were provided. No concomitant medications were provided. Treatment for the events were not provided. This is a case of death of an unknown patient, after receiving vaccine (Lot number unknown); Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Per Regulatory SD, because of insufficient information on this case, the causal relationship cannot be assess. The assessment by the pathologist is not yet available. After addition of information, the causality will be verified.; Sender''s Comments: This is a case of death of an unknown patient, after receiving vaccine (Lot number unknown); Very limited information regarding the clinical details pertaining to death was provided at this time. No further information is expected. Per Regulatory SD, because of insufficient information on this case, the causal relationship cannot be assess. The assessment by the pathologist is not yet available. After addition of information, the causality will be verified.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1489469 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
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: TRPFIZER INC2021875429

Write-up: death; This is a spontaneous report from a non-contactable consumer. A patient of an unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. The reporter had heard of a serious adverse event (death) through a third person, but have not yet obtained consent from the third person to report it. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: death


VAERS ID: 1489877 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F00927 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Cerebrovascular disorder, Fall, Head injury, Pulmonary oedema, Skin laceration
SMQs:, Cardiac failure (narrow), 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), Accidents and injuries (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   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: PREDNISONE; AUSTELL-LISINOPRIL [LISINOPRIL DIHYDRATE]; VERAHEXAL; CIPLA SIMVASTATIN; RIDAQ; ECOTRIN; TREPILINE [AMITRIPTYLINE HYDROCHLORIDE]; DIAPHAGE; GLYGARD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid endarterectomy; Diabetes mellitus; Heart disease, unspecified; Hypercholesterolaemia; Hypertension; Penicillin allergy; Transient ischaemic attacks (3 previous)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021848107

Write-up: Lungs oedematous; possible head injury from a fall; possible head injury from a fall; laceration on his nasal bridge; Cerebrovascular disease; Cardiac disease; This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: F00927; Expiration Date: 30Sep2021), via an unspecified route of administration on 25Jun2021 14:35 (at the age of 76 years old) as dose number unknown, single for COVID-19 immunization. Medical history included hypercholesterolaemia, heart disease, diabetes mellitus, hypertension, and he also had three previous transient ischaemic attacks, penicillin allergy, and a right carotid endarterectomy. Concomitant medications included prednisone, lisinopril dihydrate (AUSTELL-LISINOPRIL), verapamil hydrochloride (VERAHEXAL), simvastatin (CIPLA SIMVASTATIN), hydrochlorothiazide (RIDAQ), acetylsalicylic acid (ECOTRIN), amitriptyline hydrochloride (TREPILINE), metformin hydrochloride (DIAPHAGE) and gliclazide (GLYGARD). The patient''s cause of death is reported to be cerebrovascular disease and cardiac disease on 26Jun2021. The patient was also found to have oedematous lungs on an unspecified date. The patient was found deceased on 26Jun2021 with rigor mortis partially set in. It is reported that the patient soon attempted to perform CPR, possible head injury from a fall, found in a pool of blood. As per the doctors communication mail, this deceased was a 76 year old man with a history of diabetes, hypertension, hypercholesterolaemia, and heart disease. He had also had three previous transient ischaemic attacks and a right carotid endarterectomy. The vaccine site was noted. There was no rash or oedema externally. He had a laceration on his nasal bridge (likely occurred when he collapsed). There was no intracranial injury. He had severe multifocal atherosclerosis in his Circle of Willis, with evidence of remote infarction. There was an ulcerated plaque at the bifurcation of the right carotid artery, with no fresh thrombus. The heart was dilated and very heavy (610g) with significant coronary artery disease and an old infarct in the posterior left ventricle. The lungs were oedematous. COD is natural: cerebrovascular and cardiac disease. This is not a Sudden/Unexpected death at all. It would have been best dealt with by conducting a ''verbal autopsy'', and signed out by his physician. The outcome of the events Cerebrovascular disease and Cardiac disease were fatal while the outcome of the rest of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. However, underlying medical conditions may provide the alternate explanations. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: Cardiac disease; Cerebrovascular disease


VAERS ID: 1489879 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-22
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Hypoxia, Oxygen saturation, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 0
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: FUROSEMIDE; SPIRONOLACTONE; AMLODIPINE; ATENOLOL; SIMVASTATIN; ALLOPURINOL; PARACETAMOL; TRAMADOL; PROCHLORPERAZINE; AQUEOUS BP
Current Illness: Dyslipidemia; Gout; Hyperglycemia; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoarthritis; Varicose veins; Vertigo
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: oxygen saturation; Test Result: 61 %; Test Date: 20210622; Test Name: PCR Swab test; Test Result: Positive
CDC Split Type: ZAPFIZER INC2021849798

Write-up: Severe shortness of breath; SARS-CoV-2 test positive; Severe hypoxia; This is a spontaneous report from a contactable physician. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FD0927; Expiration Date: 10Jun2021), via an unspecified route of administration on 10Jun2021 12:33 (at the age of 77years) as dose number unknown, single for Covid-19 immunization. Medical history included ongoing hypertension, ongoing gout, ongoing dyslipidaemia, ongoing raised BM (hyperglycaemia); vertigo, osteoarthritis, and varicose vein from an unknown date, not reported if ongoing or unknown. Concomitant medications included furosemide (FUROSEMIDE); spironolactone (SPIRONOLACTONE); amlodipine (AMLODIPINE); atenolol (ATENOLOL); simvastatin (SIMVASTATIN); allopurinol (ALLOPURINOL); paracetamol (PARACETAMOL); tramadol (TRAMADOL); prochlorperazine (PROCHLORPERAZINE); and emulsifying wax, paraffin, liquid, white soft paraffin (AQUEOUS BP); all taken for an unspecified indication from an unspecified start date and ongoing. On 22Jun2021, the patient experienced severe shortness of breath, Sars-cov-2 test positive, and severe hypoxia. The patient was hospitalized on 22Jun2021 in response to the events. The outcome of events was fatal. The patient underwent lab tests and procedures which included oxygen saturation: 61 % on 22Jun2021 and PCR Swab test: positive on 22Jun2021. The patient died on 22Jun2021 (as a result of the events). An autopsy was not performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information, there is not a reasonable possibility that the reported events are related to the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: Sars-cov-2 test positive; Severe hypoxia; severe shortness of breath


VAERS ID: 1489880 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cardiomegaly, Cholelithiasis, Liver disorder, Oedema peripheral, Pleural effusion
SMQs:, Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Angioedema (broad), Systemic lupus erythematosus (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIVETAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021854268

Write-up: heart failure; Flabby heart; bilateral pleural effusions; nutmeg liver; pedal oedema; Gallstones in the common bile duct; This is a spontaneous report from a contactable physician. A 78-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 22Jun2021 15:00 (at the age of 78 years old) as dose 1, single for covid-19 immunization. The patient''s medical history was not reported. The patient had no allergies and no chronic illness. It was unknown if patient was pregnant at the time of the event. Concomitant medication included valeriana officinalis root extract (LIVETAN) taken for an unspecified indication, start and stop date were not reported. Daughter said she bought the patient Livetan but not sure if she used it. It was reported the patient experienced sudden death on 23Jun2021 15:18 with main/chief autopsy findings were: body of elderly while female; no evidence of trauma to the body/features suggestive of heart failure, flabby heart, bilateral pleural effusions, nutmeg liver, pedal oedema (since unknown dates), gallstones in the common bile duct (since unknown dates); and no evidence of allergic reaction macroscopically. The patient died on 23Jun2021. The causes of death were heart failure, flabby heart, bilateral pleural effusions, nutmeg liver, pedal oedema and gallstones in the common bile duct. An autopsy was performed. Information on the batch/lot has been requested.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of cardiac failure,cardiomegaly,pleural effusion,nutmeg liver,gallstones in the common bile duct,oedema peripheral cannot be excluded.But also consider relevant medical history and concomittant drugs have contributory role.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: heart failure; flabby heart; bilateral pleural effusions; nutmeg liver; pedal oedema; gallstones in the common bile duct; Autopsy-determined Cause(s) of Death: heart failure; Flabby heart; bilateral pleural effusions; nutmeg liver; pedal oedema; Gallstones in the common bile duct


VAERS ID: 1489921 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-06-18
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epistaxis, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibrillation atrial; Hyperlipidemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Sudden death; Haemorrhage nasal; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) and EPISTAXIS (Haemorrhage nasal) in a 67-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Fibrillation atrial, Hypertension arterial and Hyperlipidemia. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Jun-2021, the patient experienced SUDDEN DEATH (Sudden death) (seriousness criteria death and medically significant) and EPISTAXIS (Haemorrhage nasal) (seriousness criterion death). The patient died on 18-Jun-2021. An autopsy was performed. The autopsy-determined cause of death was Sudden cardiac death. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information provided. Company Comment : Very limited information regarding these events has been provided at this time.Further information (translation) is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time.Further information (translation) is expected.; Autopsy-determined Cause(s) of Death: Sudden cardiac death


VAERS ID: 1490175 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 1 - / OT

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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 22
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Multimorbidity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021843829

Write-up: COVID-19; Drug ineffective; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number CZ-CZSUKL-21007677. A 77-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection: Lot/Batch number: EY7015) via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. Medical history included multimorbidity. The patient''s concomitant medications were not reported. On 12Mar2021, the patient experienced a COVID-19 infection 2 days after the vaccination with COMIRNATY vaccine. The outcome of the events was fatal. An autopsy was not performed and the reported cause of death was she died from complications of COVID-19 disease (at the hospital 22 days later), on 03Jun2021. No follow-up activities possible. No further information expected. ; Reported Cause(s) of Death: She died from complications of COVID-19 disease.


VAERS ID: 1490177 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea, Enteritis, Fatigue, Gastritis, Haematemesis, Infected skin ulcer, International normalised ratio, International normalised ratio increased, Multiple organ dysfunction syndrome, Peripheral swelling, Petechiae, Skin ulcer, Vascular pain
SMQs:, Cardiac failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARFARIN
Current Illness: Asthma (mild)
Preexisting Conditions: Medical History/Concurrent Conditions: Heart valve operation; Ulcus cruris (cured)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: International normalised ratio; Result Unstructured Data: Test Result:higher than usual
CDC Split Type: CZPFIZER INC2021847966

Write-up: Multi organ failure; leg ulcer inflammation worsened; gastritis; ileitis; digested blood vomiting; anticoagulated a lot with International normalized ration (INR) higher than usual; abdominal cramps; bloody spots on legs; diarrhoea; big fatigue; leg ulcer reopened; leg swelling / hand, leg and abdominal swelling; vessel burning; hand, leg and abdominal swelling; hand, leg and abdominal swelling; This is a spontaneous report received from contactable consumer downloaded via the Regulatory Authority-WEB: CZ-CZSUKL-21007962. This consumer reported different events with different doses of the same product; this case refers to dose 2; only this case is serious A female of unspecified age received the second dose of intramuscular BNT162b2 (COMIRNATY, solution for injection; Lot reported as unknown expiry information not provided) as a single dose on an unspecified date in 2021 for COVID-19 immunisation. Relevant medical history included Ulcus cruris (cured leg ulcer; not ongoing), ongoing Asthma (mild bronchial asthma), and Heart valve operation (valve surgery; not ongoing). Concomitant medications included warfarin from an unspecified date for an unspecified indication. The patient previously received COVID-19 immunisation with the first dose of intramuscular BNT162b2 (COMIRNATY, solution for injection; Lot reported as unknown expiry information not provided) as a single dose on an unspecified date in 2021 and experienced fatigue, joint pain, and mild nausea. On an unspecified date in 2021 after the second dose the patient experienced a severe reaction such as vessel burning, leg swelling, reopening of a leg ulcer, bloody spots appearing on legs, big fatigue, and then diarrhoea and abdominal spasms with digested blood vomiting. The patient was hospitalized where it was discovered she was anticoagulated a lot with International normalized ration (INR) higher than usual on an unspecified date in 2021. The patient then developed ileitis and gastritis and inflammation of the leg with ulcer worsened. The patient was given antibiotics and gastric wall calming drugs were administered. The warfarin was changed to intravenous heparin with two infusions daily. The patient then developed hand, leg and abdominal swelling. The patient subsequently died on an unspecified date in 2021 due to Multi organ failure /internal organ failure; There was no autopsy performed. The outcome of the events leg ulcer inflammation worsened, gastritis, ileitis, digested blood vomiting, abdominal cramps, bloody spots on legs, diarrhoea, big fatigue, leg ulcer reopened, leg swelling, vessel burning, and anticoagulated a lot with International normalized ration (INR) higher than usual was unknown. The reporter assessed the events Multi organ failure/internal organ failure, leg ulcer inflammation worsened, gastritis, and ileitis were assessed serious (hospitalization, life threatening and medically significant). The reporter assessed the event digested blood vomiting as serious (hospitalization and medically significant). The reporter assessed the events abdominal cramps, bloody spots on legs, diarrhoea, big fatigue, leg ulcer reopened, leg swelling, and vessel burning as non-serious. No follow-up attempts are possible. No further information expected, batch number already obtained; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-2021885729 Different events for 1st dose; Reported Cause(s) of Death: internal organ failure


VAERS ID: 1490180 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 9480 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis, Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021847958

Write-up: Sepsis; Soft tissue phlegmon left upper arm; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-DCGMA-21189746, Safety Report Unique Identifier-DE-PEI-202100081148. A 67-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: 9480, expiry date not reported), via an unspecified route of administration on 08Apr2021 (at the age of 67 years old) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of Comirnaty as covid-19 immunisation at 0.3 ml, on 18Mar2021. On 10Apr2021, the patient experienced sepsis and soft tissue phlegmon left upper arm. This report is serious - death. The patient died on 10Apr2021. The causes of death were sepsis and soft tissue phlegmon left upper arm. An autopsy was performed and results were not provided. Reporter''s Comments: left clinical Information probably reacted very strongly after the 2nd vaccination.; Reporter''s Comments: left clin. Information probably reacted very strongly after the 2nd vaccination; Reported Cause(s) of Death: soft tissue phlegmon left upper arm; Sepsis


VAERS ID: 1490192 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-04
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C007A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   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: Medical History/Concurrent Conditions: Cor pulmonale
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021848062

Write-up: Decompensation cardiac; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100121565. An 81-year-old female patient received bnt162b2 (COMIRNATY) (Strength: 0.3 ml) via an unspecified route of administration on 18May2021 (Batch/Lot Number: 1C007A) (at the age of 81 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included cor pulmonale. The patient''s concomitant medications were not reported. The patient experienced decompensation cardiac on 04Jun2021. This report was assessed serious (death) by regulatory authority. The patient died on 12Jun2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1490251 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-29
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypercholesterolaemia; Hypertension; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021847947

Write-up: Death 12 days after vaccination. Patient today, 29Jun2021 with me because of a psychological problem, according to own information with well-being. 5 hours later, the police reported that he had died.; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021123708, Sender''s (Case) Safety Report Unique Identifier-DE-PEI-202100118968. A 50-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: FD9234) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. Medical history included ongoing obesity, ongoing hypertension, and ongoing hypercholesterolaemia. The patient''s concomitant medications were not reported. On 29Jun2021, the patient experienced "death 12 days after vaccination. Patient today, 29Jun2021 with me because of a psychological problem, according to own information with well-being. 5 hours later, the police reported that he had died." The patient died on 29Jun2021. It was not reported if an autopsy was performed. Health Authority Comment: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses: Hypertension. Hypercholesterolemia. Obesity. / Police gave me no information, but apparently no apparent cause of death. I had to make a guess above, but I guess nothing. E.g. (asymptomatic?) Myocarditis. or e.g. sudden cardiac death. Inquiries are most likely possible at Criminal police PRIVACY, whom I pointed out to the timing of the vaccination. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death 12 days after vaccination. Pat ient today, 29Jun2021 with me because of a psychological problem, according to own information with well-being. 5 hours later, the police reported that he had died.


VAERS ID: 1491073 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Vaccination site pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   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: METFOGAMMA; MILURIT; CARDURA; TRIFAS COR; BISOGAMMA; TEOTARD; XARELTO; SPIRONOLACTONE; SERETIDE; SORBIFER [ASCORBIC ACID;FERROUS SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Ankle fracture; Atrial fibrillation; Bronchial asthma; Diabetes mellitus; Enlarged prostate; Femoral neck fracture; Gout; Heart failure; Hypertension; Myocardial infarction (10 years ago); Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: BGPFIZER INC2021874456

Write-up: In the morning the patient died/ patient was found dead at home; Injection site pain; This is a spontaneous report from a contactable consumer (patient''s daugter) or other non-HCP downloaded from the Regulatory Agency WEB, regulatory authority number BG-BDA-20663. A 76-years-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EX3599) via an unspecified route of administration on 18May2021 as a single dose for covid-19 immunization. Medical history included myocardial infarction (10 years ago), two stent implantations in 2012, femoral neck fracture in 2014, ankle fracture, heart failure diagnosed in 2019, atrial fibrillation diagnosed in 2019, hypertension, anaemia, bronchial asthma, diabetes mellitus, gout, enlarged prostate. Month before vaccination the patient''s wife had Covid-19 but the patient did not developed symptoms of coronavirus disease. Concomitant medications included metformin hydrochloride (METFOGAMMA); allopurinol (MILURIT); doxazosin mesilate (CARDURA); torasemide (TRIFAS COR); bisoprolol fumarate (BISOGAMMA); theophylline (TEOTARD); rivaroxaban (XARELTO); spironolactone (SPIRONOLACTONE); fluticasone propionate, salmeterol xinafoate (SERETIDE); ascorbic acid, ferrous sulfate (SORBIFER [ASCORBIC ACID; FERROUS SULFATE]) all taken for an unspecified indication, start and stop date were not reported. The patient was vaccinated on 18May2021 after medical examination by his GP, who administered the vaccine, there were no contraindications for vaccination. The patient experienced injection site pain at night on 19May2021, after administration of the vaccine. According to patient''s daughter the patient was in overall good condition. In the morning before he died, he joked, laughed, and felt great. On 21May2021 the patient was found dead at home by his relatives, they called EMS, and an ambulance team established the death. The family refuses an autopsy. The outcome of the event vaccination site pain was recovered in 2021 and for another event was fatal. No follow-up attempts are possible, no further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1491092 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   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: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021874858

Write-up: Ventricular fibrillation; Cardiovascular collapse; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency WEB, regulatory authority number DE-PEI-202100129259. This spontaneous report was received from a Physician. A 68-year-old female patient received BNT162B2 (COMIRANTY; (mRNA TOZINAMERAN) Solution for injection; Lot Number: FD7958), via an unspecified route of administration on 23Jun2021 (at the age of 68-years-old) as dose number unknown, 0.3ml single for COVID-19 immunization. Medical history included hypertension. Concomitant medication was not reported. On 28Jun2021, the patient experienced Cardiovascular collapse, Ventricular fibrillation. Result of Assessment: Comirnaty/ all event(s):/ PEI: D. Unclassifiable. The outcome was fatal for Cardiovascular collapse, fatal for Ventricular fibrillation. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fibrillation ventricular


VAERS ID: 1491093 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-14
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), 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: DEPFIZER INC2021874886

Write-up: Drug ineffective; COVID-19 pneumonitis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency WEB, company number DE-PEI-202100129407. A 99-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: ET3045), via an unspecified route of administration (at the age of 99-year-old), on 03Apr2021 as single dose (dose number unknown) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. On 14Apr2021, the patient experienced COVID-19 pneumonitis. The patient experienced drug ineffective on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The clinical outcome of the events was reported as fatal. For event: COVID-19 pneumonitis: Relatedness of drug to reaction(s)/event(s):Result of Assessment: Unclassifiable. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Drug ineffective; COVID-19 pneumonitis


VAERS ID: 1491103 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Fall, Malaise, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 80
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: Arrhythmia
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021865037

Write-up: she fell; After the vaccination, persistent malaise and severe cardiac rhythm disturbances with admission to hospital on 09Mar2021; After the vaccination, persistent malaise and severe cardiac rhythm disturbances with admission to hospital on 09Mar2021; Cardiac arrest. Resuscitation, then cardiac arrest again; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency WEB (DE-PEI-CADR2021116907). This is first of two reports for same patient and it refers to the 2nd dose of the vaccine. A 87-years-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 08Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing arrhythmia, seasonal allergy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient received BNT162B2 (COMIRNATY), dose 1 on 05Feb2021 as single dose for covid-19 immunisation and experienced arrhythmia and malaise, both on 06Feb2021. The 2nd vaccination took place on 08Mar2021 despite the indisposition. On 09Mar2021 she was admitted to hospital because of strong heart rhythm disturbances with persistent malaise. After approx. 1 week later she was discharged. She continued to feel unwell. On 18May2021 she fell and was hospitalised again. She was put into an artificial coma and intubated. Then cardiac arrest, resuscitation, then cardiac arrest again and then the patient died on 29May2021 due to Infarct myocardial; an autopsy was not performed. At the time of death, the patient was not recovered from the event malaise while the outcome of the other events was unknown. Relatedness of drug to reaction(s)/event(s) performed; result of assessment: Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1491106 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   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: Hypercholesterolaemia; Hypertonus; Lumbar vertebral fracture L1
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021847954

Write-up: Found dead on 13May2021; Sweats after vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB: Worldwide unique case identification number-DE-PEI-CADR2021124290, Sender''s (Case) Safety Report Unique Identifier-DE-PEI-202100120436. A 71-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05May2021 (Batch/Lot Number: Unknown) as dose number unknown, 0.3 ml, single for covid-19 immunisation. The patient''s medical history included ongoing lumbar vertebral fracture L1 in Mar2021, ongoing hypercholesterolaemia and ongoing hypertonus. The patient experienced sweats after vaccination on 06May2021, and was found dead on 13May2021. The outcome of the event sweat was not recovered at the time of patient''s death. The patient died on 13May2021. An autopsy was not performed. Sender Comment: Information on risk factors or previous illnesses: hypertension, hypercholesterolemia, collapse of the LWK cover plate in Mar2021. Medication tilidine, pantoprazole, statin and antihypertensive agent. No follow-up attempts are possible, information on batch number cannot be obtained; Reported Cause(s) of Death: Found dead on 13May2021


VAERS ID: 1491130 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test, Body temperature, C-reactive protein, C-reactive protein increased, Dementia, Pneumonia, Pyrexia, Upper limb fracture, Urinary tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 42
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE; ARICEPT; EBIXA
Current Illness: Alzheimer''s disease (In treatment with Ebixa and Aricept.); Chronic obstructive lung disease (No inhalations meddication.); Dementia Alzheimer''s type; Depression (In treatment with Miazapin.); Low back pain (Lower back and back pain. The patient is not engaging in socail interaction. Increasing Mitrazapin); Tiredness
Preexisting Conditions: Medical History/Concurrent Conditions: Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Normal; Test Date: 202103; Test Name: Body temperature; Result Unstructured Data: Test Result:Sub febrile; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:No fever; Test Date: 20210203; Test Name: C-reactive protein; Result Unstructured Data: Test Result:65; Comments: unit not specified; Test Date: 202103; Test Name: C-reactive protein; Result Unstructured Data: Test Result:110; Comments: unit not specified
CDC Split Type: DKPFIZER INC2021848167

Write-up: pneumonia; possible shoulder fracture/ shoulder pain; possible shoulder fracture/ shoulder pain; suspected urinary tract infection; C-reactive protein was 65/ was 110; Change in dementia / Worsening of dementia; Fever; This is a spontaneous report from a contactable nurse and physician downloaded from the Regulatory Agency WEB, regulatory authority number DK-DKMA-WBS-0033567. A 73-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: EK9788; Expiration Date: 31May2021), via an unspecified route of administration on 29Jan2021 (at the age of 73-years-old) as dose 2, single for COVID-19 immunisation. Medical history included dementia Alzheimer''s type, tiredness from Jan2021 (Patient gets more tired. The dose of Mirtazapin was downregulated, but it had no effect), depression (in treatment with Mirtazapin), chronic obstructive lung disease (no inhalations medication), Alzheimer''s disease (In treatment with Ebixa and Aricept), and low back pain on Aug2020; all are ongoing and urinary tract infection from May2020 (Changed behavior, apathetic. Suspected infection treated with Imadrax. Responds well to treatment; not ongoing). Concomitant medications included mirtazapine taken for depression from 16Aug2016; donepezil hydrochloride (ARICEPT) taken for dementia Alzheimer''s type from 26Oct2016; and memantine hydrochloride (EBIXA) taken for dementia from 18Sep2018. The patient previously took amoxycillin trihydrate (IMADRAX) for urinary tract infection from May2020 and unspecified pain medications. The patient previously received the first dose of BNT162B2 (COMIRNATY; lot number EM0477 exp. date 30Apr2021), via an unspecified route of administration on 08Jan2021 as dose 1, single for COVID-19 immunisation. It was reported that there was an occurrence of dementia aggravated (change in dementia/worsening of dementia) and fever in a patient vaccinated with Comirnaty. On 29Jan2021 (the vaccination day of the second dose), the patient developed fever. On 30Jan2021, the patient developed dementia aggravated. The nurse reported that the outcome of dementia aggravated was fatal and that the patient died on 12Mar2021. It was also reported that the cause of death was dementia aggravated and pneumonia. In 2021, the patient had a blood tests and body temperature test; both were normal. On Mar2021, the patient''s body temperature was subfebrile. The patient''s C-reactive protein was 65 (unspecified unit) on 03Feb2021 and was 110 (unspecified unit) on Mar2021. On 03Feb2021, the patient had a suspected urinary tract infection. The nurse stated that the patient became significantly worse after the 2nd vaccination. The patient forgot how to talk, walk around, how to eat. The patient was in bed, and she did not get up again, and therefore nurse believed that Dementia aggravated can be the cause of death. The physician stated that the patient did not respond to the treatment for pneumonia and ended up dying. The physician stated that the patient was known to become tired and apathetic when she had an infection. The physician finds it difficult to say whether the increasing CRP was due to the possible shoulder fracture (also reported as shoulder pain) or pneumonia on Mar2021 (treated with Primcillin. No response to treatment). She was also unsure if it had a relation to the vaccine. The health authority assessed the events dementia aggravated and fever as serious (medically significant). The event possible shoulder fracture/ shoulder pain was treated with pain medications. The outcome of the event dementia aggravated and pneumonia was fatal; for fever was recovered on 03Feb2021; while for the other events was unknown. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dementia aggravated; Pneumonia


VAERS ID: 1491211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Infarction
SMQs:, Myocardial infarction (broad), 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: RIVOTRIL; DEPAKINE; SEROQUEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bipolar I disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210741810

Write-up: INFARCTION; This spontaneous report received from a physician via a Regulatory Authority (EMEA EVHUMAN NLP, ES-AEMPS-943210) concerned a 72 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included bipolar i disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21 C10-04 expiry: unknown) dose was not reported, 1 total, administered on 07-MAY-2021 for covid-19 vaccination. Concomitant medications included quetiapine fumarate for psychosis, clonazepam, and valproic acid. On unspecified date JUL-2021, the patient experienced infarction. The patient died from infarction. It was unknown whether the autopsy was done or not. The dose of covid-19 vaccine ad26.cov2.s was not changed. This report was serious (Death).; Sender''s Comments: V0: 20210741810-covid-19 vaccine ad26.cov2.s -Infarction. 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).


VAERS ID: 1491222 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cerebral infarction, Cerebral thrombosis, Cerebrovascular accident, Gait disturbance, Hypoaesthesia, Infarction, Peripheral coldness, Pulse absent, Subclavian artery dissection, Subclavian artery occlusion
SMQs:, Peripheral neuropathy (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 44
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELOCON
Current Illness: Coldness of limbs
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriasis
Allergies:
Diagnostic Lab Data: Test Name: angiography; Result Unstructured Data: Test Result:Right a. subclavia stem blocked
CDC Split Type: FIPFIZER INC2021874206

Write-up: Subclavian artery dissection; Subclavian artery occlusion; Cerebral thrombosis; Cerebral infarction; vaccine-induced infarction; had a cold right arm since the winter; feel numbness in the arm; not have a pulse in the right arm; appeared to be a right-sided stroke when the entire left side became limp and after 10 minutes resuscitation began.; appeared to be a right-sided stroke when the entire left side became limp and after 10 minutes resuscitation began.; This is a spontaneous report from a contactable physician, downloaded from the Agency-WEB regulatory authority number FI-FIMEA-20213484. A 63-years-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 28Apr2021 as single dose in left upper arm for COVID-19 immunization. The patient medical history include psoriasis and ongoing cold right arm since the winter. The patients concomitant medication include mometasone furoate (ELOCON). The patient experienced subclavian artery dissection, subclavian artery occlusion, cerebral thrombosis, cerebral infarction, vaccine-induced infarction, had a cold right arm since the winter, began to feel numbness in the arm on an unknown date in May2021, on the morning of Monday the 14.6. at hvc and did not have a pulse in the right arm and appeared to be a right-sided stroke when the entire left side became limp and after 10 minutes resuscitation began on an unknown date in May2021. The patient went to the hospital. Died in the evening. Given that the symptoms started during the winter, the physician thought the risk that it was ready about a side effect was small. In angiography statements, there was also talk of variation in the subclavian artery, which further reduces the risk that it is a vaccine-induced infarction. The suspicion arose when the symptoms apparently became worse in May and the patient received a dose of 28Apr. The patient underwent lab tests and procedures which included angiography: findings summary: Right a. subclavia stem blocked (dissection rather than thromboembolism?) Right a. vertebralis, almost all of a basilaris and right a. cerebri posterior completely unfilled / blocked (communicans posterior missing) explaining demarcated occipital infarction in the native CT. The carotid and cerebral arteries of the anterior circulation and the left circulation of them. cerebri posterior were open. The patient died on 14Jun2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible; batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Subclavian artery occlusion; Cerebral thrombosis; Cerebral infarction


VAERS ID: 1491300 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Vaccination site pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   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: LEVOTHYROX; VENTOLINE [SALBUTAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Emphysema; Low weight (patient defined as fragile ++ by the doctor); Oral cancer stage unspecified (mandible and tongue cancer); Reduced general condition
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021847998

Write-up: Death unspecified/he was dead; fatigue; arm hurt at night; This is a spontaneous report from a contactable healthcare professional downloaded from the Agency-WEB with regulatory authority number FR-AFSSAPS-2021084082. A 59-year-old male patient received bnt162b2 (COMIRNATY), dose 1 at vaccination age of 59-year-old intramuscular in the arm on 26May2021 13:00 (Lot Number: FC3558) as dose 1, single for covid-19 immunisation. Medical history included reduced general condition, Oral cancer stage unspecified (mandible and tongue cancer) from 2006 to an unknown date, low weight (patient defined as fragile ++ by the doctor) and bronchoemphysema. The patient was considered at risk due to cancer. Concomitant medications included levothyroxine sodium (LEVOTHYROX), salbutamol (VENTOLINE) and analgesics, all indication, start and stop date were not reported. The patient received the injection of COMIRNATY on 26May2021 at 1 p.m. The patient was fine, he simply said that his arm hurt (vaccination site pain)at night (26May2021). The next day (27May2021), he slept all day but the doctor at the vaccination center had told the family that he might be tired (fatigue) so they didn''t worry and when they went to get him for dinner, he was dead. No autopsy planned. The outcome of the events ''his arm hurt'' and tired were unknown while the outcome of the other events was fatal. The patient died on 27May2021. An autopsy was not performed. CCl: death occurring less than 48 hours after the D1 of COMIRNATY in a person who exhibited significant fatigue following the vaccination which may have contributed to the death. NB: Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unspecified/he was dead


VAERS ID: 1491387 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-04-21
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood pressure measurement, Body mass index, Body temperature, COVID-19, Computerised tomogram, Drug ineffective, Dyspnoea, Heart rate, Oxygen saturation, SARS-CoV-2 antibody test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VALSARTAN; AMLODIPINE; KARDEGIC; LANSOPRAZOLE; CORTANCYL; CORDARONE; BISOCE; DOLIPRANE; CALCIPARINE; CIPROFLOXACIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia absoluta; Dialysis; Hypertension (treated); Kidney transplant rejection (acute then chronic rejection of the graft); Left ventricular hypertrophy; Nephropathy; Peripheral arterial disease (severe); Renal transplant; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:16/7 mmHg; Test Name: BMI; Result Unstructured Data: Test Result:23.78; Comments: kg/m2; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Name: Thoraco-abdominal-pelvic CT scan; Result Unstructured Data: Test Result:appearance suggestive of a Covid 19 infection with; Comments: appearance suggestive of a Covid 19 infection with 20% involvement of the pulmonary parenchyma; Test Date: 20210504; Test Name: Thoraco-abdominal-pelvic CT scan; Result Unstructured Data: Test Result:worsening of the lesions related to Covid 19. No p; Comments: worsening of the lesions related to Covid 19. No pulmonary embolism.; Test Name: Pulse; Result Unstructured Data: Test Result:80; Comments: /min; Test Name: O2 saturation; Test Result: 97 %; Comments: under 6 L of oxygen; Test Date: 20210429; Test Name: O2 saturation; Test Result: 87 %; Comments: desaturation in Ambient air at 87; Test Date: 20210501; Test Name: Covid-19 serology; Test Result: Negative
CDC Split Type: FRPFIZER INC2021857635

Write-up: COVID-19 INFECTION; Drug ineffective; severe right lumbar pain; dyspnea; This is a spontaneous report from a contactable pharmacist downloaded from the Agency-WEB FR-AFSSAPS-PS20211511, Safety Report Unique Identifier FR-AFSSAPS-2021086975. A 71-years-old male patient received second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported) intramuscular on 10Feb2021 as DOSE 2 SINGLE for COVID-19 immunization. The patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported) intramuscular on 01Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient''s medical history included kidney transplant rejection, acute then chronic rejection of the graft, renal transplant from 04Sep2012 to an unknown date, dialysis, hypertension from an unknown date and unknown if ongoing treated, peripheral arterial occlusive disease from an unknown date and unknown if ongoing severe, atrial fibrillation, urinary tract infection, left ventricular, nephropathy from an unknown date and unknown if ongoing. Concomitant medications included valsartan (VALSARTAN), amlodipine (AMLODIPINE), acetylsalicylate lysine (KARDEGIC), lansoprazole (LANSOPRAZOLE), prednisone (CORTANCYL), amiodarone hydrochloride, bisoprolol fumarate (BISOCE), paracetamol (DOLIPRANE), heparin calcium (CALCIPARINE), ciprofloxacin (CIPROFLOXACIN) taken for an unspecified indication. On 21Apr2021, the patient experienced dyspnea and severe right lumbar pain. Later, on 29Apr2021 the patient experienced COVID-19 infection (drug ineffective). It was reported that, the patient was unable to benefit from his 3rd vaccine dose due to hospitalization on 19Apr2021 for a scheduled amputation of an arteritic and diabetic left foot infected with pyocyanin and a dialysis session. On 21Apr2021, the patient had severe right lumbar pain. Started treatment with tramadol and Cortancyl (prednisone) 60 mg for 3 days. On 29Apr2021, resumption of dialysis. In the evening, transfer to the emergency room after an episode of dyspnea with desaturation in ambient air at 87. Usual treatment included: VALSARTAN 160 mg / day, AMLODIPINE 5 mg / day, ACETYLSALICYLIC ACID 75 mg (KARDEGIC *), 1 / d, LANSOPRAZOLE 30 mg / day, PREDNISONE 5 mg (CORTANCYL), scored tablet 10 mg, Morning, Oral use, AMIODARONE 200 mg (CORDARONE *), 1 / d, BISOPROLOL 5 mg (BISOCE), 5 mg / day, PARACETAMOL 500 mg (DOLIPRANE), 2 / d, CALCIUM HEPARIN 7,500 IU (CALCIPARINE *), sol injection, SC, SRG 0.3 mL 0.2 mL, at 6 a.m., 6 p.m., Subcutaneous use, for 15 days, CIPROFLOXACIN 750 mg / 1 day for 6 Weeks. The patient underwent lab tests and procedures which included blood pressure measurement: 16/7 mmhg, body mass index: 23.78 kg/m2, body temperature: 38 centigrade, computerized tomogram showed appearance suggestive of a COVID-19 infection with 20% involvement of the pulmonary parenchyma on unspecified dates. Later, on computerized tomogram showed worsening of the lesions related to COVID 19. no p on 04May2021 worsening of the lesions related to COVID-19. No pulmonary embolism, heart rate: 80 /min, oxygen saturation: 97 % under 6 L of oxygen on an unspecified dates and oxygen saturation: 87 % on 29Apr2021 desaturation in Ambient air at 87, SARS-COV-2 antibody test negative on 01May2021. The outcome of the event severe right lumbar pain and dyspnea was unknown. The patient was died on 04May2021 due to COVID-19 infection. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Drug ineffective; COVID-19 INFECTION


VAERS ID: 1492305 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-03-10
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 85
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: Diabetes mellitus (Diabetes mellitus)
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney transplant
Allergies:
Diagnostic Lab Data: Test Date: 20210314; Test Name: antigen test; Test Result: Positive
CDC Split Type: HRPFIZER INC2021885457

Write-up: Vaccination failure; Antigen testing-positive result; Pyrexia; Coughing; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory authority number HR-HALMED-300049278. A 67-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL0725), dose 1 intramuscular on 15Feb2021 as dose 1, 0.3ml single and received dose 2 intramuscular on 08Mar2021 (Batch/Lot Number: EP9598) as dose 2, 0.3ml single both for COVID-19 immunization. The patient''s medical history included ongoing diabetes mellitus and transplanted kidney. The patient''s concomitant medications were not reported. On 10Mar2021, the patient experienced pyrexia and coughing. On 14Mar2021, the patient had Antigen testing and showed positive result and was hospitalized on the same day. The patient died on 04Jun2021 due to COVID. It was not reported if an autopsy was performed. Conclusion received from PQC stated that, for this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the QC lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5736784, PR ID 5690881." Stop date for the events vaccination failure, pyrexia and cough was reported as 06Apr2021. The outcome of the events was fatal.; Reported Cause(s) of Death: Died from COVID-19


VAERS ID: 1492306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-04-06
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Headache, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 35
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: Sarcoidosis (Sarcoidosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: Antigen test; Test Result: Positive
CDC Split Type: HRPFIZER INC2021875669

Write-up: Died from COVID-19; Vaccination failure; Headache; Pyrexia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, Regulatory authority number HR-HALMED-300049279. A male patient of an unspecified age received his first dose of BNT162b2 (COMIRNATY, Batch/Lot Number: EJ6796), intramuscular on 16Jan2021 as dose 1, 0.3 ml single and a second dose of BNT162b2 (COMIRNATY, Batch/Lot Number: EL0725), intramuscular on 06Feb2021 as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included ongoing sarcoidosis Sarcoidosis. The patient concomitant medications were not reported. The patient died from COVID-19, Headache, Pyrexia, Vaccination failure on 14Apr2021. The events assessed as serious (death, hospitalization). The patient was hospitalized for headache and pyrexia from 14Apr2021 to an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Apr2021. The patient died on 11May2021. It was not reported if an autopsy was performed. The outcome of the events was reported as fatal. Conclusion of Previously Completed Investigation: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits.; Reported Cause(s) of Death: Died from COVID-19


VAERS ID: 1492401 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Hypertrophic cardiomyopathy; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100909744

Write-up: Ventricular fibrillation; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 92-year-old male received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number was not provided) via an intramuscularly on 02Jun2021 (the day of vaccination) at 0.3ml single dose for COVID-19 immunization. The patient medical history included hypertrophic cardiomyopathy, hypertension, diabetes mellitus and renal failure. Concomitant medication was not reported. On an unspecified date in Jun2021 (about ten days after the vaccination), the patient experienced ventricular fibrillation and was admitted to the hospital. The course of the event was as follows: about ten days after the vaccination, the patient fell down when he was working in the farm. The patient originally had the serious heart diseases such as hypertrophic cardiomyopathy. The patient was transported and admitted to a hospital. The physician of the hospital considered that ventricular fibrillation could be the cause of falling down. Considering the original underlying diseases, the physician judged the relationship between the event and the vaccination was almost none. The patient died about three days after the hospitalization. On an unspecified date in Jun2021 (about thirteen days after the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed and reported cause of death was ventricular fibrillation. The reporting physician classified the event as serious and assessed that the event was less likely related to BNT162b2.; Sender''s Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event 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: ventricular fibrillation


VAERS ID: 1492439 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021847686

Write-up: Death; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is v21117900. A 61-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: FC5947; Expiration Date: 30Sep2021), via an unspecified route of administration, on 01Jul2021 (reported as: in the afternoon) (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient experienced death on 05Jul2021 (4 days after the vaccination), which was reported as fatal. The clinical course was reported as follows: The body temperature before vaccination was 36.0 degrees centigrade on 01Jul2021. On 01Jul2021 (the day of vaccination), the patient received the first vaccination. On 05Jul2021 (4 days after the vaccination), the patient was found dead at the company''s warehouse. The details were unknown. The patient died on 05Jul2021. The cause of death was reported as unknown cause of death. It was not reported if an autopsy was performed. The reporting pharmacist assessed the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1492470 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 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: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bedridden; Cerebellar infarction; Debility (senile); Disuse syndrome; Gavage
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:37 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021849224

Write-up: Respiratory arrest; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21117945. A 98-year-old male patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: EY5423; Expiration Date: 31Aug2021), via an unspecified route of administration on 05Jul2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included cerebellar infarction on 13Mar2021, atrial fibrillation on 13Mar2021, tube feeding from 2021 to an unknown date, bedridden from 2021 to an unknown date, general debilitation (senile) from 2021 to an unknown date, and disuse syndrome from 2021 to an unknown date. Family history and concomitant medications were not reported. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 14Jun2021 for COVID-19 immunisation. On 06Jul2021 at 06:30, the patient experienced respiratory arrest, which was serious for death. The clinical course was as follows: on 13Mar2021, the patient experienced an onset (cerebellar infarction) and was admitted to the local hospital on the same day. Atrial fibrillation was noted. Because oral ingestion was impossible, tube feeding was performed. On 19May2021, the patient was transferred to the reporting hospital for his recuperation. The patient was bedridden and could hardly express his will for tube feeding. On 05Jul2021 at 14:00 (the day of vaccination), the patient received the second dose of BNT162b2 via an unspecified route of administration as a single dose for COVID-19 immunisation. Regarding his condition, he was being debilitated. On 06Jul2021at 06:30 (16 hours after the vaccination), the patient experienced respiratory arrest. At 07:57, his death was confirmed. The patient underwent lab tests and procedures which included body temperature: 37 degrees Centigrade on 05Jul2021 before vaccination. The clinical outcome of the event was fatal. The patient died on 06Jul2021 due to respiratory arrest. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause(s) of the event such as any other diseases was cerebellar infarction. The reporting physician commented as follows: the patient had general debilitation and was senile. He had disuse syndrome. About 16 hours had passed after the injection given this time. The physician considered unassesable or unrelated and reported this case.; Sender''s Comments: Based on the available information, the event respiratory arrest was unrelated to the suspect product BNT162B2 (COMIRNATY). the underlying medical history of cerebellar infarction may have played an important contributory role. This case will be re-assessed should additional information becomes available. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1492473 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Body temperature, Pneumonia, Sepsis
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   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: Corticobasal degeneration (underlying disease); Dehydration; Gastrostomy; Parkinson''s disease (father); Pneumonia aspiration; Pyrexia; Sputum increased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood culture; Result Unstructured Data: Test Result:revealed the onset of sepsis; Comments: after death; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210613; Test Name: Body temperature; Result Unstructured Data: Test Result:40 Centigrade
CDC Split Type: JPPFIZER INC2021849237

Write-up: Pneumonia; Sepsis; This is a spontaneous report from a contactable physician received from the Agency. The regulatory authority report number is v21117956. An 88-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EY2173; Expiration Date: 31Aug2021), via an unspecified route of administration, on 01Jun2021 at 13:48 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included corticobasal degeneration from 2016 (underlying disease); repetitive aspiration pneumonia; dehydration and chronic aspiration pneumonia from 23Dec2020; gastrostomy from 17Feb2021; and usually had profuse sputum and occasionally experienced pyrexia. The patient had a family history of Parkinson''s disease (father). The patient''s concomitant medications were not reported. The patient experienced pneumonia and sepsis on 13Jun2021 at 18:00 (12 days after the vaccination), which were reported as fatal. The clinical course was reported as follows: The body temperature before vaccination was 36.5 degrees centigrade on 01Jun2021. On 13Jun2021 at 18:00 (12 days after the vaccination), the patient experienced pneumonia and sepsis. On 13Jun2021 at night, the patient experienced pyrexia with body temperature of 40 degrees centigrade, sputum increased, and hypoxaemia. He received transfusion, unspecified antibiotics, and oxygen but died on 15Jun2021 at 00:39 (14 days after the vaccination). After his death, the results of blood culture on in 2021 revealed the onset of sepsis. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 15Jun2021. The cause of death was reported as pneumonia and sepsis. It was not reported if an autopsy was performed. The reporting physician assessed that the events were unrelated to BNT162B2. Other possible causes of the events, such as any other diseases, were aspiration pneumonia and dysphagia. The reporting physician considered that there was no relation because the symptoms had developed about 2 weeks after the vaccination and aspiration pneumonia had been noted repetitively.; Reported Cause(s) of Death: Pneumonia; Sepsis


VAERS ID: 1492474 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Body temperature, Disease recurrence
SMQs:, Myocardial infarction (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   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: Medical History/Concurrent Conditions: Angina pectoris; Coronary angioplasty
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021849245

Write-up: recurrent acute coronary syndrome; recurrent acute coronary syndrome; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21117970. A 93-year-old female patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: FA5765; Expiration Date: 30Sep2021), via an unspecified route of administration on 02Jul2021 at 08:50 at a single dose for covid-19 immunisation. Medical history included angina pectoris, coronary angioplasty. Family history were not provided. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (Lot Number: EY5420; Expiration date: 31Aug2021) on 11Jun2021 via an unspecified route of administration as a single dose for COVID-19 immunization. After the first dose of vaccination, pyrexia or other symptoms were not present. On 03Jul2021 at 09:00, the patient experienced recurrent acute coronary syndrome, which was serious for death. The clinical course was as follows: on 02Jul2021 at 08:50 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5765, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 03Jul2021 at around 09:00 (1 day after the vaccination), the patient died of recurrent acute coronary syndrome. It was not reported if an autopsy was performed. The course of the events was as follows: On 02Jul2021, after the vaccination, the patient was observed until 09:20 and no symptoms were noted. Therefore, she returned home. She was living by herself. On 03Jul2021 at 08:30 (1 day after the vaccination), her family member (who was living separately) visited her and then she complained of poor physical condition, but her consciousness was clear and she could have a conversation normally. Thereafter, the family member cleaned around the house. Thirty minutes later, at around 9:00, the family member found her in a state of cardio-respiratory arrest in the room and asked for an emergency home visit. They were present at her deathbed at home. It was clinically diagnosed that she died of recurrent acute coronary syndrome. The patient underwent lab tests and procedures which included body temperature: 36.1 degrees Centigrade on 02Jul2021 before vaccination. The clinical outcome of the event was fatal. The patient died on 03Jul2021 due to recurrent acute coronary syndrome. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event was reported as follows: The patient had angina pectoris and underwent coronary angioplasty. The reporting physician commented as follows: It was assumed that she died of recurrent acute coronary syndrome. Since 24 hours passed after the vaccination, it was considered that there was no direct relationship with BNT162b2.; Reported Cause(s) of Death: recurrent acute coronary syndrome; recurrent acute coronary syndrome


VAERS ID: 1492476 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-08
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Diffuse large B-cell lymphoma, Disseminated intravascular coagulation, Endoscopy upper gastrointestinal tract
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignant lymphomas (narrow), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 27 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain upper; Inappetence
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: chest and abdomen CT scan; Result Unstructured Data: Test Result:enlarged lymph nodes and hepatic and pancreatic in; Comments: enlarged lymph nodes and hepatic and pancreatic infiltration were suspected; Test Date: 20210608; Test Name: Upper gastrointestinal tract endoscopy; Result Unstructured Data: Test Result:ulcerative lesions, tumour-like lesions, multiple; Comments: ulcerative lesions accompanied by bleeding in the anterior wall of the middle stomach, sparse tumour-like lesions and multiple masses in the duodenum
CDC Split Type: JPPFIZER INC2021849258

Write-up: diffuse large B-cell lymphoma (gastric and duodenal malignant lymphoma); Disseminated intravascular coagulation; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21117919. A 91-year-old male patient received second dose of BNT162B2 (COMIRNATY) on 04Jun2021 at single dose (at the age of 91-year-old) for COVID-19 immunisation. Medical history included upper abdominal pain and inappetence in late May2021. Concomitant medications were not reported. Body temperature before vaccination was not reported. On 14May2021 (the day of vaccination), the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 04Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) an unspecified route of administration as a single dose for COVID-19 immunization. On 08Jun2021 (4 days after the vaccination), the patient experienced diffuse large B-cell lymphoma (gastric and duodenal malignant lymphoma) and was hospitalized. On 06Jul2021 in the early hours (1 month and 2 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: In late May2021, since upper abdominal pain and inappetence appeared, the patient visited a nearby hospital. Acid secretion inhibitor medication was prescribed but it did not work. On 08Jun2021, the patient was referred to and seen at the reporting physician''s hospital. Upper gastrointestinal tract endoscopy was conducted and ulcerative lesions accompanied by bleeding in the anterior wall of the middle stomach and sparse tumour-like lesions was observed. As well as multiple masses in the duodenum (which were similar to those in the stomach) were observed. A biopsy of the lesions revealed that the patient had malignant lymphoma. On 09Jun2021, from the result of chest and abdomen CT scan, enlarged lymph nodes in the upper and lower parts of the diaphragm, and hepatic and pancreatic infiltration were suspected. The reporting physician referred the patient to a different hospital (hematology department), but the patient was not adaptable to definitive therapy. Thus, he was treated symptomatically. DIC (disseminated intravascular coagulation) concurrently occurred. However, since (his family) wished to be present at his deathbed at home and he was discharged from the hospital on 05Jul2021. The reporter was informed that the patient passed away in the early hours on 06Jul2021. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was possibly related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Regarding ADL (activities of daily living), he was considered dependent. Given his clinical course (above mentioned), involvement of BNT162b2 in the onset of the event could not be denied. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: diffuse large B-cell lymphoma (gastric and duodenal malignant lymphoma); Disseminated intravascular coagulation


VAERS ID: 1492484 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Breath sounds, Cerebral artery embolism, Computerised tomogram, Decreased appetite, Deep vein thrombosis, Echocardiogram, Endoscopy upper gastrointestinal tract, Haemorrhagic cerebral infarction, Headache, Heart rate, Magnetic resonance imaging head, Malaise, Myocardial infarction, Platelet count, Seizure, Thrombocytopenia, Thrombosis, Ultrasound scan
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210704; Test Name: breath sounds; Result Unstructured Data: Test Result:decreased; Test Date: 20210628; Test Name: coronary artery CT scan; Result Unstructured Data: Test Result:neither obstruction nor marked stenosis; Comments: neither obstruction nor marked stenosis; Test Date: 20210625; Test Name: CT scan of the whole body; Result Unstructured Data: Test Result:suspected breast cancer and metastases; Comments: suspected breast cancer and multiple metastases to liver; Test Date: 20210628; Test Name: Head CT scan; Result Unstructured Data: Test Result:extension of cerebral infarction; Comments: extension of cerebral infarction in the right occipital lobe; Test Date: 20210630; Test Name: Head CT scan; Result Unstructured Data: Test Result:cerebral infarction; Comments: cerebral infarction in the left occipital lobe; Test Date: 20210702; Test Name: Head CT scan; Result Unstructured Data: Test Result:extensive brain swelling; Comments: extensive brain swelling in the right cerebrum and cerebral infarction in a part of left frontal lobe and a part of the parietal lobe; Test Date: 20210704; Test Name: Head CT scan; Result Unstructured Data: Test Result:further worsening of brain swelling; Test Date: 20210701; Test Name: echocardiography; Result Unstructured Data: Test Result:no further extension of cerebral infarction; Comments: no further extension of cerebral infarction; Test Date: 20210701; Test Name: Endoscopy upper gastrointestinal tract; Result Unstructured Data: Test Result:advanced gastric carcinoma; Test Date: 20210704; Test Name: heart rate; Result Unstructured Data: Test Result:30; Comments: Unit:bpm; Test Date: 20210701; Test Name: brain MRI; Result Unstructured Data: Test Result:right middle cerebral artery occlusion; Comments: right middle cerebral artery occlusion and cerebral infarction in that area; Test Date: 20210624; Test Name: platelet; Result Unstructured Data: Test Result:decreased; Test Date: 20210701; Test Name: Lower extremity ultrasound; Result Unstructured Data: Test Result:deep vein thrombosis
CDC Split Type: JPPFIZER INC2021849333

Write-up: haemorrhagic venous infarction; multiple cerebral microembolism; myocardial infarction; thrombosis accompanied by thrombocytopenia; thrombosis accompanied by thrombocytopenia; Deep vein thrombosis; seizure; headache; malaise; appetite impaired; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21117930. The patient was a 77-year and 8-month-old female. Body temperature before vaccination was uncertain. Medical history included gastric cancer. Concomitant medications and family history were not provided. On 10Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 12Jun2021 (2 days after the vaccination), appetite impaired appeared. On 16Jun2021 (6 days after the vaccination), headache and malaise appeared. On 24Jun2021, (14 days after the vaccination), haemorrhagic venous infarction, multiple cerebral microembolism, myocardial infarction and thrombosis accompanied by thrombocytopenia occurred. On that day, the patient was hospitalized. On 30Jun2021 (20 days after the vaccination), seizure occurred. On 01Jul2021 (21 days after the vaccination), deep vein thrombosis occurred. On 04Jul2021 at 07:01 (24 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 12Jun2021, appetite impaired appeared. On 16Jun2021, headache and malaise appeared. On 24Jun2021, cerebral infarction was found at a different hospital, and the patient was transferred to the reporter''s hospital. She was hospitalized under diagnosis of haemorrhagic venous infarction in the right parietal occipital lobe, multiple cerebral microembolism and myocardial infarction. Administration of ARGATROBAN and anticonvulsant drugs was started. Blood test showed decreased platelets. Thrombosis accompanied by thrombocytopenia caused by vaccination was suspected. On 25Jun2021, as coagulopathy due to cancer was suggested as differential diagnoses, CT scan of the whole body was performed, and the result showed suspected breast cancer and multiple metastases to liver. On 28Jun2021, coronary artery CT scan showed neither obstruction nor marked stenosis. Head CT scan showed extension of cerebral infarction in the right occipital lobe. On 30Jun2021, anginal pain was noted but it disappeared in 2 hours. Seizure was noted. The dosage of anticonvulsant drugs was increased. From the result of head CT scan, it was found that cerebral infarction in the left occipital lobe occurred concurrently. On 01Jul2021, brain MRI (magnetic resonance imaging) showed right middle cerebral artery occlusion and cerebral infarction in that area. Further extension of myocardial infarction was not recognized on echocardiography. Lower extremity ultrasound showed the presence of deep vein thrombosis. Consciousness disturbed progressed. Appetite impaired was present. Nasogastric tube was inserted, and then regurgitation of blood was noted. Endoscopy upper gastrointestinal tract was urgently performed, which showed advanced gastric carcinoma. Since anaemia gradually advanced, red blood cell transfusion was performed. On 02Jul2021, head CT scan showed extensive brain swelling in the right cerebrum and cerebral infarction in a part of left frontal lobe and a part of the parietal lobe. On 03Jul2021, consciousness disturbed worsened and it led to severe consciousness disturbed. On 04Jul2021 at 06:00 in the morning, heart rate was 30 bpm. Decreased breath sounds were noted, and thereafter blood pressure decreased. Resuscitation was started. Head CT scan showed further worsening of brain swelling and this was determined to be brain herniation. At 07:01, the patient''s death was confirmed. The reporting physician classified the events as serious (fatal) and assessed that the events were related to BNT162b2. Gastric cancer was considered as another possible cause of the events. The reporting physician commented as follows: The patient experienced multi-organ thrombus accompanied by thrombocytopenia. As for cerebral infarction, after 2 weeks passed, extremely severe cerebral infarction (it would not be an exaggeration to say that this was status epilepticus) concurrently occurred. It was most likely to consider that the patient was susceptible to have abnormal coagulation due to gastric cancer, and then refractory thrombosis occurred as an adverse reaction of BNT162b2. The outcome of events haemorrhagic venous infarction, multiple cerebral microembolism, myocardial infarction and thrombosis accompanied by thrombocytopenia was fatal; outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: haemorrhagic venous infarction; multiple cerebral microembolism; myocardial infarction; thrombosis accompanied by thrombocytopenia; thrombosis accompanied by thrombocytopenia


VAERS ID: 1492486 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021852548

Write-up: died; This is a spontaneous report from a contactable pharmacist via Medical information group. A patient of unspecified age and gender received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first single dose of BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) for COVID-19 immunisation. Around 1 week after the patient received the second dose of COVID-19 vaccine, the patient died. The patient died on an unspecified date due to unknown cause of death. It was unknown whether an autopsy was performed. The event was classified as serious (death). Causality was unknow. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history, concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died


VAERS ID: 1492496 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Multiple cerebral infarction; Spinal cord injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021853887

Write-up: Cardiac failure acute; This is a spontaneous follow-up report from a physician via COVID-19 Adverse Event Self-Reporting Solution. A 93-years-old non-pregnant female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 15Jun2021(at age of 93 years old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The most recent COVID-19 vaccine was administered at the hospital. It was unknown whether the patient received other vaccines within 4 weeks prior to the COVID vaccine. There were multiple lists of other medications the patient received within 2 weeks of vaccination. Relevant past drug history was unknown. Allergies were unknown. Other medical history included cervical cord injury, diabetes mellitus, hypertension, and multiple cerebral infarction. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. In Jun2021 at unknown time, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported) via an unspecified route of administration for COVID-19 immunisation. The patient experienced cardiac failure acute (death) on 16Jun2021. Clinical course reported as below: On 16Jun2021 (1 day after the vaccination), the patient experienced cardiac failure acute. The reporter stated that the adverse event resulted in death. The patient died on 16Jun2021. The death cause was cardiac failure acute. No autopsy was performed. No treatment was given for the adverse event. The reporting physician assessed the event as serious (death). The causality of the event was not reported. The lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, the reported event cardiac failure acute 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 failure acute


VAERS ID: 1492512 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Body temperature, Hypoxia, Oxygen saturation, Vomiting
SMQs:, Acute pancreatitis (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (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: Medical History/Concurrent Conditions: Disuse syndrome; Pneumonia aspiration; Vomiting
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210628; Test Name: SpO2; Test Result: 88 %
CDC Split Type: JPPFIZER INC2021855563

Write-up: Vomiting; hypoxaemia (SpO2 was 88%) due to aspiration; hypoxaemia (SpO2 was 88%) due to aspiration; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118191. A 92-year and 6-month-old male patient received bnt162b2 (COMIRNATY Solution for injection), dose 1 via an unspecified route of administration on 28Jun2021 14:43 (Batch/Lot Number: FC5295; Expiration Date: 30Sep2021) at the age of 92-years-old, as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pneumonia aspiration, disuse, vomiting. The patient had no particular family history. The patient''s concomitant medications were not reported. The patient experienced vomiting on 28Jun2021 18:25, hypoxaemia (spo2 was 88%) due to aspiration on 28Jun2021. The patient underwent lab tests and procedures which included body temperature: 36.9 centigrade on 28Jun2021 Before vaccination, oxygen saturation: 88 % on 28Jun2021. The course of the event was as follows: On 28Jun2021 (the day of vaccination), at 14:43, the patient received the first dose of BNT162b2 vaccination. However, while the patient was followed up for approximately 15 minutes after the vaccination, no abnormalities were observed. At around 18:00 (3 hours and 17 minutes after vaccination), the patient had a large amount of vomiting during dinner. He had hypoxaemia (SpO2 was 88%) due to aspiration. A suction of vomit and oxygen administration were performed; however, the patient was confirmed to die at 22:59 (8 hours and 16 minutes after vaccination). On 28Jun2021 (the day of the vaccination), the outcome of the event was fatal. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient was being admitted to the hospital for the rehabilitation for disuse after the treatment of pneumonia aspiration. The patient had medical history of aspiration due to vomiting after meals and pneumonia aspiration in the past. It was highly likely that the patient had vomiting incidentally on the day of vaccination.; Reported Cause(s) of Death: Vomiting; hypoxaemia (SpO2 was 88%) due to aspiration; hypoxaemia (SpO2 was 88%) due to aspiration


VAERS ID: 1492513 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cardiac failure congestive
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure congestive (On 15Nov/unknown year, the patient was being admitted to the hospital); Dementia (On 15Nov/unknown year, the patient was being admitted to the hospital); Type 2 diabetes mellitus (On 15Nov/unknown year, the patient was being admitted to the hospital)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021855566

Write-up: Suspicion of congestive heart failure acutely aggravated; cardiac arrest; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority. Regulatory authority report number is v21117932. A 77-year and 4-month-old male patient received bnt162b2 (COMIRNATY Solution for injection), dose 1 via an unspecified route of administration on 22Jun2021 14:00 (Batch/Lot Number: FA5765; Expiration Date: 30Sep2021) at the age of 77-year-old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included On 15Nov/unknown year, the patient was being admitted to the hospital for cardiac failure congestive, type 2 diabetes mellitus, and dementia. He was bedridden. The family history was not provided. The patient''s concomitant medications were not reported. On 23Jun2021 at 01:40 (11 hours/40 minutes after the vaccination), the patient experienced suspicion of congestive heart failure acutely aggravated and cardiac arrest. On 23Jun2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 23Jun2021, at 01:40 (11 hours and 40 minutes after vaccination), the patient had cardiac arrest face down under the bed. At 03:23 (13 hours and 23 minutes after vaccination), the patient died. The other healthcare professional reported cause of death was suspected acute aggravation of cardiac failure. It was not reported if an autopsy was performed. The reporting other healthcare professional classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: cardiac arrest; Suspicion of congestive heart failure acutely aggravated


VAERS ID: 1492514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood creatine phosphokinase, Blood creatinine, Blood glucose, Blood potassium, Body temperature, C-reactive protein, Cardio-respiratory arrest, Imaging procedure, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 1
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:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: CPK; Result Unstructured Data: Test Result:2453; Test Date: 20210706; Test Name: CRE; Result Unstructured Data: Test Result:1.75; Test Date: 20210706; Test Name: Glucose; Result Unstructured Data: Test Result:26; Test Date: 20210706; Test Name: K; Result Unstructured Data: Test Result:7.1; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:41 Centigrade; Test Date: 20210706; Test Name: CRP; Result Unstructured Data: Test Result:0.05; Test Date: 202107; Test Name: Ai-CT; Result Unstructured Data: Test Result:pulmonary oedema-like finding
CDC Split Type: JPPFIZER INC2021855569

Write-up: Cardiopulmonary arrest (CPA); Consciousness disturbed; Pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21118189. A 68-year-old female received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose on 03Jul2021 at 15:02 (the day of vaccination), for COVID-19 immunization. Medical history and concomitant medication were not reported.Body temperature before vaccination was 36.5 degrees centigrade. On 05Jul2021 (2 days after the vaccination), the patient experienced pyrexia. On 06Jul2021 (3 days after the vaccination), the patient experienced cardiopulmonary arrest (CPA) and consciousness disturbed.On 06Jul2021 (3 days after the vaccination), Outcome of Cardio-respiratory arrest was fatal, others was unknown.The course of the events was as follows:On 03Jul2021, the patient received the first dose of the vaccine. On 05Jul2021, the patient developed pyrexia. On 06Jul2021, family member noticed that the patient had consciousness disturbed and pyrexia of 41 degrees centigrade, for which ambulance was requested. When emergency medical service arrived, the patient was in CPA and cardiopulmonary resuscitation was performed until the patient arrived at the hospital. However, the patient died. Autopsy imaging (AI) CT revealed pulmonary oedema-like finding. During resuscitation, blood test showed creatine phosphokinase (CPK) 2453, creatinine (CRE) 1.75, Potassium (K) 7.1, C-reactive protein (CRP) 0.05, and glucose 26. Pathological autopsy was conducted; however, cause of death could not be identified macroscopically.Therapeutic measures were taken as a result of Cardio-respiratory arrest.The reporting physician classified the events 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 could not be judged.The cause of death was unknown. The reporting physician commented as follows:At the time of this report, there was no clear evidence for causality between the event and the vaccine. Result of pathological autopsy was awaited. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1492532 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-14
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: 2021-06-25
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARBOCISTEINE; TAFLUPROST; HACHIMIJIOGAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure chronic; Glaucoma; Interstitial pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021856322

Write-up: Interstitial pneumonia aggravated acute; This is a spontaneous case from a non-contactable physician communicated to a Pfizer sales representative. An 82-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot# unknown, Expiration date unknown) via an unspecified route of administration on 26May2021 (the day of vaccination) [at the age of 82-year-old] as dose 1, 0.3 ml single for COVID-19 immunization. The family history was not provided. The patient had medical histories of cardiac failure chronic, atrial fibrillation, interstitial pneumonia, and glaucoma. The concomitant medications included ongoing carbocisteine, aconitum spp. processed root/alisma orientale tuber/cinnamomum cassia bark/cornus officinalis fruit/dioscorea spp. Rhizome/paeonia x suffruticosa root bark/poria cocos sclerotium/rehmannia glutinosa root (HACHIMIJIOGAN) and ongoing tafluprost ophthalmic solution 0.0015% (Ear drops). On 14Jun2021 (19 days after the vaccination), the patient experienced interstitial pneumonia aggravated acute suspected due to the onset of sputum bloody and cough. On 16Jun2021, the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration at a dose of 0.3 mL, single for COVID-19 immunization. On 17Jun2021, the patient was admitted to the hospital for treatment. the patient experienced pneumonia. Outcome of the clinical event was fatal. On 25Jun2021, the patient died due to interstitial pneumonia aggravated acute. It was unknown if an autopsy was performed. The events were unrelated to BNT162B2 vaccination.; Sender''s Comments: Based on possible dose-event relationship the causal role of event interstitial pneumonia aggravated cannot be excluded with BNT162B2 vaccine. 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 aggravated acute


VAERS ID: 1492543 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose abnormal, Blood glucose increased, Blood test, Cardioversion, Dyspnoea, Heart rate, Investigation, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), 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: Test Date: 20210707; Test Name: blood sugar; Result Unstructured Data: Test Result:286; Comments: At 03:52; Test Name: blood examination; Result Unstructured Data: Test Result:Unknown results; Test Name: cardioversion; Result Unstructured Data: Test Result:Unknown results; Comments: direct current cardioversion (DC) was performed 3 times; Test Name: heart rate; Result Unstructured Data: Test Result:Unknown results; Comments: The heart rate did not recover; Test Name: pulse; Result Unstructured Data: Test Result:unknown results; Comments: pulse was not palpable; Test Name: lab examination; Result Unstructured Data: Test Result:unknown results; Comments: common carotid artery and the radial artery were palpable
CDC Split Type: JPPFIZER INC2021865659

Write-up: The blood sugar level was 286; Loss of consciousness; stertorous breathing; vomiting; This is a spontaneous report from a contactable other healthcare professional received from the Regulatory Authority. Regulatory authority report number is v21118508. A 51-year and 8-month-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, on 06Jul2021 at 11:00 (at the age of 51 years), as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The family history was not provided. Body temperature before vaccination was not provided. The 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) was not reported. On 07Jul2021 at 03:30 (16 hours and 30 minutes after the vaccination), the patient experienced loss of consciousness. The course of the event was reported as, on 06Jul2021 (the day of vaccination), at 11:00, the patient received the first dose of BNT162B2 vaccination. The patient had a normal life without a large change until going to bed. At 22:00 (11 hours after vaccination), the patient was confirmed to have a normal life. At 03:30 (16 hours and 30 minutes after vaccination), the patient had loss of consciousness in the left lateral decubitus position in the futon (Japanese bedding), and no response was obtained. Thus, an ambulance was called. At 03:42 (16 hours and 42 minutes after vaccination), an ambulance service arrived. There were marks of vomiting. The patient had stertorous breathing. The consciousness level was 3 digits. The common carotid artery and the radial artery were palpable. The airway was secured manually. At 03:52 (16 hours and 52 minutes after vaccination), the patient was put into the ambulance. The blood sugar level was 286. At 03:53 (16 hours and 53 minutes after vaccination), the stertorous breathing disappeared. The pulse was not palpable. A cardiac massage was initiated. At 04:32 (17 hours and 32 minutes after vaccination), the patient arrived in the hospital. The intravenous route was secured. A blood examination was performed. Adrenalin was intravenously administered (the total of 7A), and direct current cardioversion (DC) was performed 3 times. The heart rate did not recover. At 05:10 (18 hours and 10 minutes after vaccination), the patient was confirmed to die. The dead body was transferred by the police (the subsequent situation was unknown). It was not reported if an autopsy was performed. Therapeutic measures were taken as a result of all events. The patient underwent lab tests and procedures which included blood glucose abnormal: 286. The outcome of the event vomiting was unknown and rest of the events were fatal. The reporting other healthcare professional classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was not reported about other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Loss of consciousness; stertorous breathing; The blood sugar level was 286


VAERS ID: 1492551 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Acute coronary syndrome, Blood pressure measurement, Cerebrovascular disorder, Chest pain, Echocardiogram, Electrocardiogram, Fall, Heart rate, Hypoxic-ischaemic encephalopathy, Loss of consciousness, Myocardial infarction, Pulmonary embolism, Respiratory distress, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FERROUS CITRATE; EZETIMIBE; AMLODINE [AMLODIPINE BESILATE]; TRICHLORMETHIAZIDE; FEBURIC; TRAZENTA; CLOPIDOGREL; VOGLIBOSE; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE]; BETANIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Bladder cancer; Cancer of sigmoid colon (excl rectosigmoid); Chronic kidney disease; Colectomy; Diabetes mellitus; Hypertension; Hyperuricaemia; Transurethral resection of bladder tumour
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: BP; Result Unstructured Data: Test Result:91/74 mmHg; Test Date: 20210630; Test Name: Echocardiography; Result Unstructured Data: Test Result:no apparent infarction; Test Date: 20210630; Test Name: ECG; Result Unstructured Data: Test Result:ST-T change; Test Date: 20210711; Test Name: HR; Result Unstructured Data: Test Result:60/minute; Test Date: 20210630; Test Name: Antigen quantitative test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC2021885357

Write-up: fell at the time of urination; unconscious; myocardial infarction; hypoxic encephalopathy; suspected acute coronary syndrome; epigastric pain; respiratory distress; chest pain; pulmonary embolism; cerebrovascular disorder; This is a spontaneous report from a contactable nurse received via COVID-19 Adverse Event Self-Reporting Solution and from the Regulatory Authority. Regulatory authority report number is v21119822. An 88-year and 4-month-old male patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA7338, Expiration date: 30Sep2021) intramuscularly on 29Jun2021 at 13:00 (the day of vaccination) (at the age of 88-year-old) for COVID-19 immunization. Medical history included diabetes mellitus (DM), chronic kidney disease (CKD), hypertension (HT), hyperuricaemia (HUA), sigmoid colon cancer, bladder cancer, angina pectoris, colectomy and transurethral resection of bladder tumour (TTUR-Bt). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, which included antigen quantitative test by nasal swab on 30Jun2021 and result was negative. The patient received ferrous citrate, ezetimibe, amlodipine besilate (AMLODINE), trichlormethiazide, febuxostat (FEBURIC), linagliptin (TRAZENTA), clopidogrel, voglibose, esomeprazole magnesium (NEXIUM), tamsulosin hydrochloride (TAMSULOSIN), and mirabegron (BETANIS) within 2 weeks of vaccination. On 04Jun2021 at 12:30, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number: FA7338, Expiration date: 30Sep2021) intramuscularly for COVID-19 immunization. The course of the event was as follows: On 30Jun2021 the patient was admitted to the hospital due to chest pain. Electrocardiogram (ECG) showed ST-T change. The patient gradually had poor oxygenation, for which bilevel positive airway pressure (BIBAP) was used. The patient had respiratory distress and chest pain intermittently. On 11Jul2021 at 23:45, the patient was found to lie face up on bedside. There was no pupillary reflex, 4 mm in size, and no bilateral difference. Blood pressure (BP) was 91/74 mmHg, heart rate (HR) was 60/minute, and SpO2 could not be measured. Cardiopulmonary resuscitation (CPR) was initiated. On 12Jul2021 at 00:10, endotracheal intubation was performed. On 12Jul2021 at 00:34, death was confirmed. The events resulted in emergency room/department or urgent care, hospitalization, and death. The reporting nurse classified the event as serious (death and hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were as follows: The patient said to have epigastric pain since the day before the vaccination; thus, there was a possibility of myocardial infarction. The patient seemed to fell at the time of urination and was unconscious; thus, it was possible that the patient had pulmonary embolism (PE), cerebrovascular disorder, etc. The outcome of the event was fatal with treatment including oxygen administration and infusion. Cause of death was reported that myocardial infarction and hypoxic encephalopathy.; Reported Cause(s) of Death: myocardial infarction; hypoxic encephalopathy; suspected acute coronary syndrome; epigastric pain; respiratory distress; chest pain; fell at the time of urination; unconscious; pulmonary embolism; cerebrovascular disorder


VAERS ID: 1492652 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-23
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cerebral infarction, Computerised tomogram abnormal, Computerised tomogram head, Echocardiogram, Electrocardiogram, Investigation, Magnetic resonance imaging head
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:not reported; Test Name: CT thorax/abdomen; Result Unstructured Data: Test Result:not reported; Test Name: CT-scan brain; Result Unstructured Data: Test Result:not reported; Test Name:; Result Unstructured Data: Test Result:not reported; Test Name: ECG; Result Unstructured Data: Test Result:not reported; Test Name: Duplex carotiden; Result Unstructured Data: Test Result:not reported; Test Name: MRI brain; Result Unstructured Data: Test Result:not reported
CDC Split Type: NLPFIZER INC2021874178

Write-up: Cerebral infarction; This is a spontaneous report from a contactable physician. This report is received downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00613091. A 73-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection, Lot No: unknown), via an unspecified route of administration on 13May2021 as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. There was no history of previous COVID-19 infection. The patient previously received BNT162b2 (COMIRNATY, Solution for injection, Lot No: unknown) via an unspecified route of administration on 08Apr2021 as dose 1, single for COVID-19 immunisation and had no adverse reaction. On 23May2021 (10-days after the vaccination), the patient experienced cerebral infarction. The event was serious (fatal and medically significant). The patient underwent lab tests and procedures which included blood test, CT thorax/abdomen, CT-scan brain, echocardiogram, electrocardiogram (ECG), Duplex carotids, MRI brain; results for all the tests were not reported, on unspecified date. Therapeutic measures were taken as a result of cerebral infarction with supporting care. The outcome of cerebral infarction was fatal. The patient died on 15Jun2021. It was not reported if an autopsy was performed. Case summary and Reporter comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: No Date: 8Apr2021. BSN available: yes. Previous COVID-19 infection: No. diagnostic procedures: Including multiple CT-cerebrums, MRI-cerebrum, CT-thorax/abdomen, extensive blood tests, ECGs, echo cor, duplex carotids. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: /Cerebral infarction


VAERS ID: 1492683 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
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 INC2021847157

Write-up: Death; This is a spontaneous report from a contactable other health professional through the Regulatory Authority.(Regulatory Authority report number was unknown). A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) as dose number unknown, single, with route of administration and therapy date unspecified date, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had died on an unspecified date. It was unknown if an autopsy was performed. The cause of death was not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the death and the suspect drug comirnaty vaccine , cannot be excluded. The case will be reassessed once new information is available. ; Reported Cause(s) of Death: Death


VAERS ID: 1492684 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
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 INC2021847162

Write-up: death; This is a spontaneous report from a contactable other healthcare professional via the Regulatory Authority. Regulatory authority report number is unknown. A patient of unspecified age and gender received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. 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: death


VAERS ID: 1492715 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021848116

Write-up: Hemorrhagic stroke - death in hospital; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. The Regulatory Authority report number is PL-URPL-3-737-2021. The PL-URPL-3-737-2021 application was sent to Regulatory Authority on 25May2021 by the district sanitary and epidemiological station. A 69-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EY3014; Expiration Date: 01May2021), intramuscular, administered in left arm on 28Apr2021 18:30 (at the age of 69 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced hemorrhagic stroke on 30Apr2021 at 09:30. On 27May2021, an epidemiological inquiry was carried out. The duration of the patient''s stay in the hospital has been agreed with the epidemiological nurse: from 30Apr2021 to 09May2021. on 09May2021, the patient was dead. According to the information obtained from the doctor, the patient''s hospital treatment information card shows the following: condition after vaccination covid - 1 dose. Additional information: In the past, the patient did not develop any post-vaccination reaction. Result: death (date: 09May2021, cause: hemorrhagic stroke) The reporting person (doctor) classified it as severe. Due to the nature of the side effects, hospitalization and death of the patient, classified the report as severe. The data contained in the electronic report are all available to Regulatory Authority - in the case of obtaining additional information, another version will be sent. It was not reported if an autopsy was performed. Sender comments: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides) The reported side effects are unexpected in the Summary of Product Characteristics. Until 12May2021 in the Regulatory Authority database, 16 cases of haemorrhagic stroke were reported with the result of the patient''s death. The reporting person (doctor) classified them as severe. Due to the nature of the side effects, hospitalization and death of the patient, Regulatory Authority classified the report as severe. Regulatory Authority turned to the relevant sanitary and epidemiological station with a request for additional information in the form of the patient''s medical history (possible chronic diseases, medications used, etc.) and with a question whether an autopsy was performed. The NCA assessed the relatedness of drug to all reactions/events by method of assessment WHO scale as possible.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1492736 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-06-03
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   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: BROMFENAC; TRITICUM AC; DIPLEXIL; EUTIROX; DIAZEPAM; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Goiter (in surgery); Meningioma; Tear disorder (waiting for an ophthalmic hosp consultation to clean the lenses)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021848240

Write-up: Large ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, Safety Report Unique Identifier PT-INFARMED-T202106-1974. A 77-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY, Batch/Lot Number: EX8680), intramuscular on 18May2021 as dose 2, 0.3 ml, single for COVID-19 immunisation. Medical history included anxiety, goiter (in surgery) and tear disorder (waiting for an ophthalmic hosp consultation to clean the lenses) from an unknown date and unknown if ongoing; meningioma from 2004 to an unknown date and unknown if ongoing. Concomitant medications included bromfenac, trazodone (TRITICUM AC), valproate sodium (DIPLEXIL), levothyroxine sodium (EUTIROX), diazepam and omeprazole, all taken for an unspecified indication, start and stop dates were not reported. The patient previously received the first dose of COMIRNATY on 20Apr2021 as 1st dose, 0.3mL, single for COVID-19 immunisation. The patient experienced large ischemic stroke on 03Jun2021. Clinical course was as follows: The adverse reaction (ADR) appeared 44 and 16 days after the administration, respectively, of the 1st and 2nd dose of the suspected drug, with a duration of 2 days. ADR motivated the patient''s death. There was no reduction in dosage, suspension or reintroduction of the suspected drug, once the vaccination schedule was complete. There is no suspicion of drug interactions. There are no data on a history of previous drug/vaccine reactions or allergies, or on the nature of treatment for the reaction. There is reference to the use of the following usual medications: Valproic acid 500 mg once a day po, Trazodone 150 + 50 mg/day po, Levothyroxine sodium 0.05 mg, Bromofenac eye drops, Omeprazole 20 mg and Diazepam. Additional data: No laboratory, echographic or other data were available. The date of death was 05Jun2021 and there is no information about the autopsy. The outcome of the event was fatal. The patient died on 05Jun2021. It was unknown if an autopsy was performed. Reporter''s comments: Other Information- Personal Background: eye tearing - waiting for an ophthalmic hosp consultation to clean the lenses; goiter - in surgery; meningioma in 2004; anxiety MH: Diplexil 500 1id; triticum AC 150mg 1cp + medium; euthyrox 50mg; bromfenac eye drops; omeprazole 20mg; absorbit smart plus; diazepam No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Reporter''s Comments: Other Information- Personal Background: eye tearing - waiting for an ophthalmic hosp consultation to clean the lenses; goiter - in surgery; meningioma in 2004; anxiety MH: Diplexil 500 1id; triticum AC 150mg 1cp + medium; euthyrox 50mg; bromfenac eye drops; omeprazole 20mg; absorbit smart plus; diazepam; Reported Cause(s) of Death: Ischaemic stroke


VAERS ID: 1492752 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-06-21
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / OT

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: 2021-06-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021849805

Write-up: Stroke; This is a spontaneous report from a contactable consumer (patient''s niece). A 69-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EY2172), intramuscular, on 07May2021 (at the age of 69 years), 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: EW2243) on 09Apr2021 (at the age of 69 years) for COVID-19 immunization (intramuscular, single). On 21Jun2021, the patient experienced stroke. The outcome of the event was fatal. The patient died on 24Jun2021 as a result of stroke (cause of death). It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Stroke


VAERS ID: 1492771 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Defaecation disorder, Loss of consciousness, Nausea, Pupillary disorder, Respiratory depression, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cognitive impairment; Diastolic heart failure; Hypothyroidism; Kidney failure; Prostate cancer (Hormone-treated silent prostate cancer for many years, chronic.); Welander distal myopathy
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia (unknown genesis); Hypertension (Previously treated hypertension, treatment withdrawn 2017.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021848111

Write-up: suspected acute cerebral vascular event; sudden nausea, vomiting, fecal discharge, lost consciousness and developed respiratory depression; sudden nausea, vomiting, fecal discharge, lost consciousness and developed respiratory depression; sudden nausea, vomiting, fecal discharge, lost consciousness and developed respiratory depression; sudden nausea, vomiting, fecal discharge, lost consciousness and developed respiratory depression; sudden nausea, vomiting, fecal discharge, lost consciousness and developed respiratory depression; rigid left pupil and then also rigid right pupil; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-050754. A 97-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EP2166), via an unspecified route of administration on Mar2021 as dose 2, single for COVID-19 immunization. Medical history included ongoing cognitive impairment, diastolic heart failure from Jun2020 and ongoing, anaemia from 2017 to an unknown date unknown genesis (not ongoing), hypertension from an unknown date to an unknown date (not ongoing) previously treated hypertension - treatment withdrawn 2017, ongoing hypothyroidism, ongoing prostate cancer (Hormone-treated silent prostate cancer for many years, chronic), kidney failure from Jun2020 and ongoing, and ongoing Welander distal myopathy. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot Number: EJ6790) on an unspecified date in Feb2021 for COVID-19 immunization. On an unspecified date in Apr2021, 22 days after the second vaccination, the patient had a sudden nausea, vomiting, fecal discharge, lost consciousness and developed respiratory depression. Ambulance was called and ambulance personnel noted light rigid left pupil and then also light rigid right pupil. The patient was sent to the emergency room. The man never recovered from the events. The patient died in the emergency room, given the man''s old age, no resuscitation attempts were made. Cause of death is stated as probably an acute cerebral vascular event. More likely caused by natural aging than vaccination. The patient died on Apr2021. An autopsy will not be performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on known disease pathophysiology, the event of cerebrovascular accident is assessed as not related to BNT162B2 and more likely due to underlying patient''s old age and underlying medical conditions. 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: suspected acute cerebral vascular event


VAERS ID: 1492778 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021848084

Write-up: UNCLEAR DEATH; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [SE-MPA-2021-055669]. A 95-year-old female patient received her first dose of BNT162B2 (COMIRNATY; lot number: unknown), via an unspecified route of administration on 03Mar2021 (at an unspecified age) at dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was said to be healthy before. It was reported that the suspected adverse reactions were unclear. On Mar2021, the patient was found dead at home with unclear death. It was unknown of autopsy was performed. Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: UNCLEAR DEATH


VAERS ID: 1492795 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-04-01
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial thrombosis, Intracardiac thrombus, Portal vein thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; XANOR; DAIVOBET [BETAMETHASONE DIPROPIONATE;CALCIPOTRIOL]; METOPROLOL; OLANZAPINE; DIPRODERM [BETAMETHASONE DIPROPIONATE]; ALVEDON; LEVAXIN; ETALPHA;
Current Illness: Multimorbidity
Preexisting Conditions: Medical History/Concurrent Conditions: Bowel movement irregularity (Medication: Movicol); Depression (Medication: Citalopram); Folate deficiency (Patient was taking folic acid); Hypocalcaemia (Patient was taking Kalcipos); Pain (Medication: Alvedon); Psoriasis (Medication: Daivobet and Conoderm)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021883248

Write-up: portal vein thrombosis with fresh bleeding in the surroundings; thrombosis alt embolization right atrium; thrombosis alt embolization valvula tricuspidalis; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number SE-MPA-2021-058516. A 65-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot Number: EP2166), via an intramuscular route of administration on 19Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history included ongoing multi-disease (among other things investigated in 2019 due to suspected osteomyelofibrosis/MDS, but no evidence for this), depression, bowel movement irregularity, psoriasis, folate deficiency, hypocalcaemia, and pain. The patient concomitant medications included alprazolam (XANOR), betamethasone dipropionate (DIPRODERM 0.5%), olanzapine, levothyroxine sodium (LEVAXIN), and methotrexate, all from 27Oct2016; metoprolol, omeprazole (OMEPRAZOL), and furosemide (FURIX [FUROSEMIDE]), all from 28Oct2016; betamethasone dipropionate, calcipotriol (DAIVOBET) taken for psoriasis from 17May2018, paracetamol (ALVEDON) taken for pain from 30May2018, alfacalcidol (ETALPHA) from 31May2018, alimemazine from 27Oct2019, citalopram Film-coated tablet 3 tablets at 08:00 via oral for Depression on 21Jan2019, pregabalin taken for anxiety from 11Nov2019, prednisolone taken for arthritis from 12Nov2019, macrogol 3350; potassium chloride; sodium bicarbonate; sodium chloride (MOVICOL) taken for bowel movement irregularity from 07Jan2020, sodium fluoride (DENTAN) from 07Jan2020, urea (CANODERM) taken for psoriasis from 02Oct2020, folic acid (FOLSYRA ACTAVIS) taken for folate deficiency from 25Jan2021, calcium carbonate (KALCIPOS) taken for hypocalcaemia from 26Jan2021; Furix Retard, and Predanalinol from unknown start date; all concomitant medications with an unspecified stop date. The patient previously received BNT162B2 (COMIRNATY, solution for injection, Lot Number: EP2163), via an unspecified route of administration on 26Feb2021 as dose 1, single for COVID-19 immunisation. On an unspecified date in Apr2021, the patient experienced portal vein thrombosis with fresh bleeding in the surroundings, thrombosis alt embolization to the valvula tricuspidalis and right atrium. The events were assessed as serious (death). Patient died suddenly because of events in Apr2021. The underlying genesis was unknown. The outcome of the events was fatal. On an unspecified date, autopsy demonstrated portal vein thrombosis with fresh bleeding in the surroundings and thrombosis or embolization to the valvula tricuspidlis and right atrium. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: portal vein thrombosis with fresh bleeding in the environment; thrombosis or embolization to the valvula tricuspidalis and right atrium.; thrombosis alt embolization valvula tricuspidalis


VAERS ID: 1493269 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   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: GLYGARD; JALRA; LISINOPRIL; PREDNISONE; SIMVASTATIN; VERAHEXAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic; Hyperlipidaemia; Hypertension; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021853868

Write-up: The patient died; This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (CORMINATY, Batch/Lot Number: FD0927; Expiration Date: 30Sep2021), via an unspecified route of administration, on 25Jun2021 14:35 (at the age of 76 years old), as dose 1, single, for COVID-19 immunisation. Medical history included being allergic to Penicillin, hypertension, diabetic, and hyperlipidaemia. Concomitant medications included gliclazide (GLYGARD); vildagliptin (JALRA); lisinopril; prednisone; simvastatin; and verapamil hydrochloride (VERAHEXAL). It was reported that the patient died on 26Jun2021. An autopsy was performed, and results were 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: Deceased/The patient died


VAERS ID: 1493303 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-07
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Sudden death, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COJNJFOC20210731982

Write-up: SUDDEN DEATH; FAINT; INTENSE HEADACHE; This spontaneous report received from a consumer concerned a 47 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021, the day of vaccination during night, the patient had intense headache. By the early morning of 08-JUL-2021, the patient fainted and had sudden death. On 08-JUL-2021, the patient died from unknown cause of death. The reporter stated that, the patient received a single dose vaccine, reason why reporter assumed it was the Janssen covid-19 vaccine. An autopsy was performed on an unspecified date reported sudden death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had sudden death on 08-JUL-2021, and the outcome of intense headache and faint was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0: 20210731982- Covid-19 vaccine ad26.cov2.s- Sudden death, Faint. 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: 1493329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-12
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Blood pressure diastolic, Blood pressure systolic, Body mass index, Death, Dyspnoea, Echocardiogram
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRONOLACTONE; ATORVASTATIN; KVENTIAX; PERINDOPRIL ARGININE/INDAPAMIDE/AMLODIPINE; METFORMIN
Current Illness: Coronary heart disease; Heart failure NYHA class II; Insomnia; Obesity (1. stage BMI 34.02 on 2021/07/08); Primary hypertension (start year around 2011, well controlled with medication); Type II diabetes mellitus (Start year 2019 last blood test in 2020 diabetes well controlled with diet and medication)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20181206; Test Name: Echocardiogram; Result Unstructured Data: Dyskinesia in left ventricle septal wall; Test Date: 20190108; Test Name: Coronary angiogram; Result Unstructured Data: No stenoses found; Test Date: 20210708; Test Name: Blood pressure systolic; Result Unstructured Data: 120 mmHg; Test Date: 20210708; Test Name: Blood pressure diastolic; Result Unstructured Data: 70 mmHg; Test Date: 20210708; Test Name: Body mass index; Result Unstructured Data: BMI = 34.02
CDC Split Type: LVJNJFOC20210741803

Write-up: DEATH; LABOURED BREATHING; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, LV-SAM-2021076266] concerned a 67 year old female. The patient''s weight was 86 kilograms, and height was not reported. The patient''s concurrent conditions included primary hypertension, heart failure HA (Heart Association) class II, coronary heart disease, type 2 diabetes mellitus, obesity, and insomnia. On 06-DEC-2018, Laboratory data included: echocardiogram showed dyskinesia in left ventricle septal wall. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-01) 0.5 ml, 1 total, administered on 08-JUL-2021 for prophylactic vaccination in left deltoid as 1st immunization dose. Concomitant medications included atorvastatin for coronary heart disease, quetiapine fumarate for insomnia, amlodipine besilate/indapamide/perindopril arginine for primary hypertension, spironolactone for primary hypertension, and metformin for type 2 diabetes mellitus. On 08-JAN-2019, laboratory data included Coronary angiogram which showed no stenoses found. On 08-JUL-2021, laboratory data included blood pressure diastolic which showed 70 mm[Hg], blood pressure systolic which showed 120 mm[Hg], and Body mass index showed BMI equals to 34.02. On 12-JUL-2021, the patient had laboured breathing. On the same date, the patient died. The cause of death was unknown. It was unknown whether the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of laboured breathing on 12-JUL-2021. This report was serious (Death).; Sender''s Comments: V0-20210741803- covid-19 vaccine ad26.cov2.s -Death and laboured breathing . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: DEATH


VAERS ID: 1493433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Nasopharyngitis
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: AUPFIZER INC202100924288

Write-up: Nasopharyngitis; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 586732. A 51-year-old female patient received BNT162B2 (COMIRNATY) 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 nasopharyngitis on an unspecified date. The outcome of the event was fatal. The 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: Nasopharyngitis


VAERS ID: 1493434 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Immune system disorder, Lymphadenopathy, Neoplasm malignant, Pericardial effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
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: AUPFIZER INC2021857309

Write-up: Water on his heart; Enlarged lymph nodes; Immune system was so suppressed; One of the lymph turned into cancer; This is a spontaneous report from a contactable consumer (patient''s relative). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose number unknown via an unspecified route of administration on an unspecified date at unspecified age of vaccination (Batch/Lot number was not reported) as single dose for COVID-19 immunisation . The patient medical history and concomitant medications were not reported. He was a fit, healthy, young man. He ha no issues. The patient experienced water on his heart (pericardial effusion) (death, hospitalization) on an unspecified date , enlarged lymph nodes (lymphadenopathy) (death, hospitalization) on an unspecified date, immune system was so suppressed (immune system disorder) (death, hospitalization) on an unspecified date, one of the lymph turned into cancer (neoplasm malignant) (death, hospitalization, medically significant) on an unspecified date. The patient was battling in hospital 6 weeks, he passed away on 07Jul2021 (day before reporting date) from complications, including water on his heart., enlarged lymph nodes, one of the lymph turned into cancer, immune system was so suppressed. It was not reported if an autopsy was performed. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.; Reported Cause(s) of Death: Enlarged lymph nodes; Immune system was so suppressed; Pericardial effusion; One of the lymph turned into cancer


VAERS ID: 1493435 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Dyspnoea, Gait disturbance, Headache, Immune system disorder, Lymphadenopathy, Neoplasm malignant, Pancreatitis, Pericardial effusion
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
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: AUPFIZER INC2021861485

Write-up: difficulty breathing! He could not get upstairs, could not even walk and so was hospitalized.; difficulty breathing! He could not get upstairs, could not even walk and so was hospitalized.; cancer was suspected; inflammation of pancreas; complications with the immune system/went down; enlarged lymph nodes; headache; there was water in the heart, the heard could not pump effectively this is why he died.; there was water in the heart, the heard could not pump effectively this is why he died.; This is spontaneous report from a contactable consumer or other non-professional (reporting for her uncle) received via a Pfizer colleague. A 50-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on unspecified date in Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was always exercising and running, previously was completely healthy, no history of any diseases. on unspecified date in 2021, the patient experienced headache, difficulty breathing, he could not get upstairs, could not even walk and so was hospitalized. In the hospital, he was found with inflammation of pancreas, enlarged lymph nodes, there was water in the heart, the heard could not pump effectively this was why he died. As for the enlarged lymph nodes, a cancer was suspected, and he received chemotherapy. The patient died on 07Jul2021. It was not reported if an autopsy was performed. The reporter thought the vaccine had bad complications with the immune system of the uncle, which went down and caused all problems. The patient was hospitalized for difficulty breathing, not get upstairs, could not even walk. The outcome of events water in the heart, the heard could not pump effectively was fatal; outcome of other events was unknown. The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. The lot/batch number has been requested. ; Reported Cause(s) of Death: the heard could not pump effectively; there was water in the heart


VAERS ID: 1493437 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-26
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intestinal ischaemia, Platelet count, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Ischaemic colitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210626; Test Name: platelet count; Result Unstructured Data: Test Result:decreased
CDC Split Type: AUPFIZER INC2021862392

Write-up: Intestinal ischaemia; Platelet count decreased; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 577131. A 94-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced intestinal ischaemia and platelet count decreased on 26Jun2021. The outcome of the events 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.; Reported Cause(s) of Death: Intestinal ischaemia; Platelet count decreased


VAERS ID: 1493438 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-31
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intestinal ischaemia, Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Ischaemic colitis (narrow), Sepsis (narrow), Opportunistic infections (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: AUPFIZER INC2021862460

Write-up: Intestinal ischaemia; Septic shock; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 577565. A 78-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced intestinal ischaemia and septic shock on 31Mar2021. 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: Intestinal ischaemia; Septic shock


VAERS ID: 1493439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-22
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Delirium, Dyspnoea, Fatigue, Hypophagia, Parainfluenzae virus infection, Pyrexia, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Opportunistic infections (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: AUPFIZER INC2021862468

Write-up: Delirium; Dyspnoea; Fatigue; Hypophagia; Parainfluenzae virus infection; Pyrexia; Tachycardia; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 579121. A 94-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose of bnt162b2 on unknown date. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced delirium; dyspnoea; fatigue; hypophagia; parainfluenzae virus infection; pyrexia; tachycardia on 22Jun2021. 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: Delirium; Dyspnoea; Fatigue; Hypophagia; Parainfluenzae virus infection; Pyrexia; Tachycardia


VAERS ID: 1493492 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   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: BEPFIZER INC202100920603

Write-up: Death; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the regulatory authority BE-FAMHP-DHH-N2021-101750 received by the Belgian authorities. A 61-year-old female patient received bnt162b2 (COMIRNATY) second dose at the age of 61-year-old on 06Jul2021 (lot: FE2625) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced Death on 06Jul2021. No side effect per se. Death on the same day as second vaccination. It was unknown if Autopsy Done. The outcome of the event was Fatal. Reporters comments: Treatment - Evolution of the ADR - ADR description - No side effect per se. Death on the same day as second vaccination. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - Evolution of the ADR - ADR description - No side effect per se. Death on the same day as second vaccination.; Reported Cause(s) of Death: death


VAERS ID: 1493520 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-29
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cell death, Extramedullary haemopoiesis, Extremity contracture, Histology, Joint range of motion decreased, Maternal exposure timing unspecified, Musculoskeletal disorder, Placental disorder, Premature baby, Scoliosis, Visceral oedema
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METHYLFOLATE; VITAMIN D [COLECALCIFEROL]; OGESTAN [COLECALCIFEROL;DOCOSAHEXAENOIC ACID;FOLIC ACID;IODINE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: Placental histopathology; Result Unstructured Data: Test Result:placentitis; Comments: immaturity, autolysis, polyvisceral edema, diffuse extramedullary hemopoiesis, mild lumbar scoliosis, extension of the left arm and right leg, flexion of the left thigh over the abdomen. Feet with internal rotation
CDC Split Type: BRPFIZER INC202100929299

Write-up: polyvisceral edema; marked immaturity; autolysis; diffuse extramedullary hemopoiesis; mild lumbar scoliosis; extension of the left arm and right leg; flexion of the left thigh over the abdomen. Feet with internal rotation; camptodactyly of the 2nd right finger and the 3rd left finger; maternal drug exposure; active, low-grade, parenchymal and basal hematogenous placentitis; This is a spontaneous report from a contactable physician. This contactable physician reported events for the mother and fetus. This is the fetus report. A 36-year-old female (mother) received BNT162B2 (COMIRNATY Solution for injection), intramuscular, administered in the arm, on 06May2021 09:10 (Batch/Lot number: EX2405), as dose 1, single, for COVID-19 immunisation. Concomitant medications taken by mother included influenza vaccine (FLUARIX, Manufacturer: GSK, batch/lot number: AF1BA 534AA), on 09Apr2021; Methylfolate as prenatal from 28Oct2020 and ongoing; Vitamin D 2000 IU for hypovitaminosis D from 2020 (reported as 28Oct2020 and Dec2020) and ongoing; and colecalciferol, docosahexaenoic acid, folic acid, iodine (OGESTAN) for an unknown indication, from Mar2021 and ongoing. The pregnant woman physician accompany with prenatal care applied the first dose of Pfizer vaccine against COVID-19 on 06May2021. The pregnancy was of low risk and without any complications until then. However, on 27May2021, fetal death was identified at around 19 weeks of gestational age. On 07Jul2021, it was reported that the first day of the last menstrual period was 30Dec2020, estimated date of conception was 13Jan2021, estimated delivery date was 06Oct2021 and gestational period at the time of the initial exposure was 18 weeks (second quarter). The mother was asymptomatic. She did not have any infectious symptoms. In a routine consultation at 21 weeks, the diagnosis of fetal death between 19/20 weeks was made. Subsequent laboratory tests were normal, including for infectious screening. The histopathological examination of the fetus was normal, as was the genetic analysis. Placental histopathology on 29May2021 showed placentitis with intense villositis. When talking to the pathologist, she says that the findings are more compatible with an immune reaction than an infectious one. Results of serology tests (e.g., rubella, toxoplasmosis, etc) were negative and Ante-natal check-up (e.g., fetal ultrasound, serum markers, etc) were normal and without alteration. There were no problems before, during and after delivery. The mode of delivery was vaginal, but the outcome of pregnancy was stillbirth on 29May2021 with gestational age at birth of 21 weeks. It was reported that the reason of termination was "late abortion-no heartbeat fetus on 21-week ultrasound". The result of physical examination and pathology was that the fetus had no anomalies. Anatomopathological examination (necropsy report) of the fetus, placenta, umbilical cord and placental membranes was performed. Macroscopy of the fetus stated "Fetus sent fixed in formalin, in an advanced state of maceration, female with brownish skin with detachment areas weighing 230g, measuring 25.2cm in total length and 19.0cm in craniocaudal length. Feet with 3.3cm. Perimeters: Head collapsed and partially damaged by maceration measuring 13.0cm, thoracic 15.5cm and abdominal 15.0cm. Deformed head, elongated with a flattened occiput with disjointed and slightly overlapping bones, covered by a scalp with discreet fluff. Anterior fontanelle measuring 2.5x2.0cm and posterior fontanelle 1.0x1.0cm. Face with eyes showing closed eyelid slits and in a discreet oblique position, measuring 0.8 cm and interocular distance of 1.1 cm. Conjunctiva and sclera brownish, grayish-brown iris, pupils in mydriasis and opacified corneas. Flat nose with pervious choanas and no secretion. Filtrum 0.4cm. Mouth with thin lips, palate and tongue without particularities. Mento with slight microretrognathism. Membranous ears, anteverted helices and implanted below eyeline level; pervious auditory canals, free of secretions. Centered and elongated neck. Chest with little evident and symmetrical breast papillae. The abdomen is centered by a segment of umbilical cord measuring 19.0x1.0cm with 2 areas of constriction and curling with a diameter of 0.5cm, one of them at the level of the insertion in the abdominal wall and the other 2.5cm away from the margin closest to the placental disc. The jelly is brownish and, when cut, shows 3 vases. Female external genitalia with age-appropriate development. Perforated and relaxed anus without content. Back with mild lumbar scoliosis, covered by intact skin. Upper and lower limbs showing extension of the left arm and right leg; flexion of the left thigh over the abdomen. Feet with internal rotation. Presence of five fingers, palm and plantar creases not very evident and difficult to assess. Evident articular folds, with apparent single fold on the 5th finger(s) bilaterally. Note camptodactyly of the 2nd right finger and the 3rd left finger. Internal examination: Retracted scalp, scarce subcutaneous cellular tissue. Smooth and congested periosteum; slender, slender skull bones. The skull is open, the supporting elements are intact, and the meninges are not very congested. The brain is markedly softened, represented by grayish and pasty material weighing about 50g, crumbling under handling, undefined turns. Optical chiasma and olfactory bulbs present. Pituitary in the store, brownish-brown and soft. Base of skull with usual appearance. Thoraco-dominal cavity: sparse subcutaneous cellular tissue; intact diaphragmatic domes located in the fifth intercostal spaces. Abdominal viscera: Liver exceeds the right costal margin, the xiphoid appendix and the left costal margin by 1.2cm, 1.1cm and 0.8cm respectively. Spleen in the store. Bladder exceeding 1.2 cm from the pubic symphysis. Intestinal loops poorly rotated with ileocecal appendix at the hepatic angle. Removed the rib cage, absence of liquid collections; the lungs do not fill the pleural cavities. They are brownish, smooth and homogeneous, weighing together 6.5g; the right with 3 lobes and the left with 2 lobes. Cardiac area measures 2.5x1.5 cm and the vessels at the base have normal exit and implantation. Aorta and pulmonary with 0.3cm in diameter and patent ductus arteriosus with 0.4x0.2cm. Smooth and thin pericardium. Smooth and shiny epicardium and endocardium. Brownish and soft myocardium. Oval foramen covered in about 50% by thin membrane. Right and left ventricles 0.2cm thick. Heart weight 3.8. Thymus covers the vessels at the base and part of the heart, it is lobulated and soft. Brownish, soft, topical salivary glands. Trachea centered without content. Esophagus of usual trajectory and caliber with brownish-brown and smooth mucosa, without content. Stomach filled with scant liquefied content; flattened mucosa. Small and large intestines with smooth, thin and brownish serous containing greenish-brown material, sometimes liquefied, sometimes semi-pasty. Spleen weighs 0.15g and is soft, dark brown and homogeneous. Liver weighs 8.6g, has a smooth and transparent capsule and when cut, the parenchyma is dark brown and soft. Bile tract with impaired permeability assessment. Gallbladder measuring 1.0x0.3cm. Lobulated, brownish and soft pancreas. The adrenals together weigh 0.55g with a brownish-yellow cut surface. Topical kidneys weighing together 1.3g, outer surface lobulated and covered by a thin capsule. In the cuts, dark brown and soft parenchyma, not evident cortical-medullary border and a pielo-calicial system without any particularities. Ureters on their usual route. Bladder with slightly pleated mucosa, no content. Ovaries, fallopian tubes and pelvic uterus with development in accordance with age." Macroscopy of the placenta stated "Racket-shaped placenta weighing 100.4g and measuring .5x7.0cm with somewhat jagged edges. Fetal face covered by a grayish-brown membrane, slightly hypotransparent, without subchorionic fibrin deposits, absent trabeculation and three main vascular trunks, magisterial and not congested. The maternal face is light brown with brownish areas, pale, with poorly delimited lobes and intact with some superficially adhered clots. In sections, brownish-brown parenchyma, spongy aspect, area of subchorial thrombosis measuring about 3.5 cm in length, not evident lobar design and thickness varies between 1.5 and 2.5 cm. Light brownish and hypotransparent chorion, with a shorter distance of impaired rupture. Umbilical cord measuring a total of 29.0x1.0cm of paramarginal insertion at 1.0cm from the margin, with areas of hyperspiral and constriction previously described with. For cuts, browned jelly with three vases." Microscopy of the fetus stated "Fetal viscera showing marked generalized autolysis, edema, vascular congestion and general characteristics of immaturity, such as a thick renal nephrogenic zone represented by about 3 layers of nephrons, lungs in the canalicular stage of development and extramedullary hemopoiesis, mainly in the liver." Microscopy of the placenta, umbilical cord and placental membrane stated "Placenta with flattened to cuboidal-type amniotic epithelium. Corion showing some congested vessels, with foci of extramedullary hemopoiesis and others with obliterated light. Slight chronic focal inflammatory infiltrate in the chorion. The villi, in general, are voluminous and swollen, some of them hypercellular (at the expense of apparent Hofbauer cell hyperplasia), with foci of mild extramedullary hemopoiesis. Presence of areas of acute and chronic intervillositis with multifocal clusters of villi with proliferative vilositis and areas of trophoblastic necrosis and others with cicatricial vilositis; presence of areas of marked increase in deposition of peri and intervillous fibrin, with intervillous and subchorial thrombosis, some of them containing groups of degenerated neutrophils and involving peripheral degenerated villi. Deciduous with increased fibrin deposition, foci of vascular thrombosis and areas of mild to moderate chronic and acute deciduitis at baseline. Villous trunks and their proximal and distal branches and villi with fibromuscular hypertrophy, areas of stromal fibrosis, some vessels reveal fibrinoleukocyte microthrombi and recanalization foci. Other villi reveal stromal fibrosis, stromato-vascular karyorrhexis and avascular villi ("avascular villi"), noting peripheral focal areas of hypotrophic / hypoplastic and degenerate villi (ghosts) with areas of dystrophic mineralization amidst fibrin configuring rare and small infarcts . Basal decidua with deposition of fibrinoid material. Placental membranes also show mild to moderate mixed inflammatory infiltrate in the reflex decidua and vessels show vascular congestion, in addition to focal lamellar deciduous necrosis. Umbilical cord with three congested vessels amid autolyzed Wharton''s jelly." Diagnosis for the fetus was "fetus in an advanced state of maceration, female, weighing 230g, measuring 25.2cm in total length and feet measuring 3.3cm, with slightly reduced weight for gestational age with i.g. anthropometric around 19/20 weeks. Main diagnosis: fetal (with chronic and acute intervillositis and proliferative villositis with areas of trophoblastic necrosis) associated with changes in severe maternal and fetal vascular hypoperfusion (see placental report). Other diagnoses: marked immaturity, autolysis and polyvisceral edema; diffuse extramedullary hemopoiesis; mild lumbar scoliosis; extension of the left arm and right leg; flexion of the left thigh over the abdomen. feet with internal rotation; and camptodactyly of the 2nd right finger and the 3rd left finger." Diagnosis for the placenta, umbilical cord and placental membrane was "2nd trimester placenta, slightly reduced weight for gestational age exhibiting: active, low-grade, parenchymal and basal hematogenous placentitis (proliferative villitis with areas of trophoblastic necrosis, chronic and acute intervillositis with intervillous and deciduous microabscess); Maternal vascular hypoperfusion alterations represented by subchorial and intervillous thrombosis, increased deposition of peri and intervillous fibrin in the basal decidua, small peripheral foci of villous ischemic alterations outlining tiny old infarcts with intervillous hemorrhage; changes in chronic fetal vascular hypoperfusion (fibromuscular hypertrophy of villous trunks, microthrombi and recanalization foci, stromato-vascular karyorrhexis and avascular villi); immature villi with diffuse stromal edema and mild extramedullary hemopoiesis in fetal vessels." On 29May2021 the patient experienced active, low-grade, parenchymal and basal hematogenous placentitis (fatal). On an unspecified date the patient experienced polyvisceral edema, marked immaturity, autolysis, diffuse extramedullary hemopoiesis, mild lumbar scoliosis, extension of the left arm and right leg, flexion of the left thigh over the abdomen. Feet with internal rotation, camptodactyly of the 2nd right finger and the 3rd left finger. The outcome of the event low-grade, parenchymal and basal hematogenous placentitis was fatal. The outcome of the other events was unknown. Autopsy was performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the temporal relationship, the association between the reported events with COMIRNATY use can not be fully 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.,Linked Report(s) : BR-PFIZER INC-2021627894 Maternal case; Reported Cause(s) of Death: placentitis; Autopsy-determined Cause(s) of Death: placentitis


VAERS ID: 1493521 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0574 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Maternal exposure during pregnancy, Stillbirth
SMQs:, Congenital and neonatal arrhythmias (broad), 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: 2021-06-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2021840467

Write-up: that my baby''s heart had stopped; baby was born without life with 3.3 kg; I received the vaccine on 17Jun/ I was with 37 weeks and 4 days of gestation; This is a spontaneous report from a contactable consumer or other health care professional (Parent) reported information for both mother and foetus/baby received from the Medical Information Team. This is a foetus/baby report. A foetus female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number and expiration date was not reported), via transplacental route of administration on 17Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Mother of patient received the vaccine on 17Jun and was 41 years old with 37 weeks and 4 days of gestation. On the day after the vaccination, Mother of patient felt very tired and unfortunately on the day 20Jun (Day in which 38 weeks of gestation would be completed) found out that her baby heart had stopped, probably from Friday to Saturday even she had a perfect gestation, baby was born without life with 3.3 kg. The placental analysis signals thrombus and waiting for the health plan to release my genetic exams of thrombophilia, but she believes it is important to report the case to you, so other pregnant women does not take risk, because in her heart the vaccine could have caused the reported issue. At the moment Mother of patient was using anticoagulant, for safety as well, due to the placental condition, and she was super insecure regarding receiving the second dose and hopes that soon she can have a better clarification about this fact, but she leaves here report, with a lot of pain in the heart. It was not reported if an autopsy was performed. The outcome of events baby heart had stopped and baby was born without life with 3.3 k was fatal and outcome of maternal exposure during pregnancy, third trimester was unknown.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-2021830714 Mother-Baby Case; Reported Cause(s) of Death: that my baby''s heart had stopped/ my baby born without life


VAERS ID: 1493579 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   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:
CDC Split Type: DEPFIZER INC2021857701

Write-up: Unknown cause of death; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100125814. A 67-year-old female patient received bnt162b2 (COMIRNATY; 0.3 ml strength), via an unspecified route of administration on 24Jun2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 30Jun2021, the patient experienced unknown cause of death. An autopsy was planned. Causality assessment from the HA was D. Unclassifiable. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1493583 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-06-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6975 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021865084

Write-up: Unknown cause of death; This is a spontaneous report downloaded from the Medicines Agency (MA) regulatory authority-WEB number DE-PEI-202100126094 from a non-contactable Physician. An 81-year-old male patient received bnt162b2 (COMIRNATY) second dose at the age of 81-year-old on 29Jun2021 (lot: FE6975) as 0.3 ml single dose for COVID-19 immunisation. No relevant medical history and concomitant medication reported. The patient previously received bnt162b2 (COMIRNATY) first dose at the age of 81-year-old on 08Jun2021 (batch unknown) as 0.3 ml single dose for COVID-19 immunisation. On 29Jun2021 the patient experienced Unknown cause of death. This report was serious due to death. Event assessment: COMIRNATY/ event/PEI /Result of Assessment: D. Unclassifiable. It was unknown if Autopsy Done. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1494459 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Dyspnoea, Myocardial infarction, Myocarditis
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Infarct myocardial
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrhythmia NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021857658

Write-up: A few days after vaccination, pressing pain in the shoulder area. Death according to medical suspicion of heart attack and/or myocarditis.; A few days after vaccination, pressing pain in the shoulder area. Death according to medical suspicion of heart attack and/or myocarditis.; Arrhythmia; Dyspnoea; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency-WEB, regulatory authority number DE-PEI-CADR2021105509. A 67-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05May2021 (Batch/Lot Number: EY2172) as a single dose, for covid-19 immunisation . Medical history included Infarct myocardial and cardiac arrhythmia NOS; (Myocardial infarction ca 1996 Cardiac arrhythmias successfully treated by ablation 2019 since then no arrhythmias occurred, only immediately after vaccination again Patient was under very close cardiological supervision and always well adjusted. Last cather control showed no acute cardiac or vascular problems). Concomitant medications were not reported. On 07May2021 the patient experienced Arrhythmia, Dyspnoea, Infarct myocardial, Myocarditis. Clinical course as follows: Two days after vaccination, pain in the shoulder area and cardiac arrhythmias occurred that were not there before. Patient had a catheter examination a few weeks earlier which showed no abnormalities. Thus, the situation must have been triggered by the vaccination. Patient died, despite immediate treatment by the emergency physician and intensive care unit, no rescue was possible.The patient''s outcome was: not recovered/not resolved for Arrhythmia, not recovered/not resolved for Dyspnoea, fatal for Infarct myocardial, fatal for Myocarditis.The patient died on 01Jun2021. It was not reported if an autopsy was performed No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: myocarditis; Infarct myocardial


VAERS ID: 1494460 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dizziness, Fall, Gait inability, Incorrect route of product administration
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac insufficiency; Geromarasmus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021857663

Write-up: Dizziness/Light headedness; she needed a wheelchair and was no longer able to walk; intravenous; died in her sleep during the night; fell; This is a spontaneous report from a non-contactable consumer (patient''s daughter) downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021107290. A 91-year-old female patient received second dose of BNT162b2 (COMIRNATY), intravenous on 28Apr2021 (Batch/Lot Number was no reported) as 0.3 mL single dose for COVID-19 immunisation. Medical history included ongoing cardiac insufficiency and ongoing geromarasmus. No known allergies. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162b2 (COMIRNATY) on 08Mar2021 as 0.3 mL single dose for COVID-19 immunisation and experienced no adverse reaction. The reported stated that: the night after the vaccination (on 29Apr2021), the patient fell while going to the toilet. The reporter called 911. Dizziness/Light headedness. In the meantime, she needed a wheelchair and was no longer able to walk on her own. On 14May2021 she died in her sleep during the night. Cause of death unknown. An autopsy was not performed. The patient outcome of the other events was not recovered. Causality between COMIRNATY and all events was assessed by HA as unclassifiable. The information on the lot/batch number has been requested.; Reported Cause(s) of Death: Unknown cause of death


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