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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: 1524484 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure decreased, Blood pressure measurement, Body temperature, Chills, Eating disorder, Heart rate, Heart rate increased, Hepatic function abnormal, Oedema, Oxygen saturation, Pallor, Pyrexia, Respiratory arrest, Somnolence
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (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), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Dysphagia; Fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: blood pressure; Result Unstructured Data: Test Result:126/77; Comments: before vaccination; Test Date: 20210708; Test Name: blood pressure; Result Unstructured Data: Test Result:110-120; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:67/46; Comments: at around 03:00; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:118/74; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Comments: at around 03:00; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:unable to measure; Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination; Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: in the moring; Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before report; Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: at night; Test Date: 20210707; Test Name: body temperature; Result Unstructured Data: Test Result:38 to 39 Centigrade; Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:40.1 Centigrade; Comments: at around 03:00; Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: at Periodic call; Test Date: 20210704; Test Name: pulse rate; Result Unstructured Data: Test Result:67; Test Date: 20210709; Test Name: pulse rate; Result Unstructured Data: Test Result:116; Comments: at around 03:00; Test Date: 20210709; Test Name: SpO2; Result Unstructured Data: Test Result:97 (RA) %; Comments: at around 03:00; Test Date: 20210709; Test Name: SpO2; Result Unstructured Data: Test Result:98 to 99 %
CDC Split Type: JPPFIZER INC202100927197

Write-up: respiratory arrest; blood pressure decreased/67/46; pulse rate was 116; oedema on the back; pallor facial; shivering; somnolence; Hepatic function disorder; Consciousness disturbed; Pyrexia/38 degrees Celsius; Eating disorder/unable to take meals; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority. Regulatory authority report number is v21120954. A 79-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot: EW0207, expiry: 30Sep2021) via an unspecified route of administration on 04Jul2021 at 13:31 (the day of vaccination) (at the age of 79-years-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.0 degrees centigrade. The family history was not provided. The patient had medical histories of after fracture, dementia, and dysphagia. Concomitant medications were not reported. On 05Jul2021 at 08:00 (18 hours/29 minutes after the vaccination), the patient experienced hepatic function disorder, pyrexia, eating disorder and disturbed consciousness. On 10Jul2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 04Jul2021 at 13:31, the body temperature was 36 degrees Celsius, the pulse rate was 67, and the blood pressure was 126/77. The condition was not poor, and meal intake was possible, and thus, the patient received the first dose of BNT162b2 vaccination. On 05Jul2021, at 10:20, it was reported that no change was observed in the blood pressure, and the body temperature was 37.2 degrees Celsius in the morning by the phone. However, the body temperature before the report was 36.8 degrees Celsius, and the patient was followed up. On 06Jul2021, at 09:48, in the morning, the patient was unable to have breakfast. The patient had pyrexia of 38 degrees Celsius last night, but the fever decreased to 36.8 degrees Celsius in this morning. Administration of fluid replacement was instructed, and BFLUID INJECTION 1000 mL was administered. On 07Jul2021, a phone call was made to confirm the situation. The patient tended to have somnolence, and she was unable to take meals. The effect of the vaccination was possibly potent. The body temperature was 38 to 39 degrees Celsius. It was difficult for the patient to orally take BFLUID INJECTION 1000 mL, and acetaminophen (ANHIBA) 400 mg was used twice. On 08Jul2021, at 15:47, the condition was reported. Although acetaminophen was used, the fever did not decrease. The blood pressure was 110 to 120s. The patient also had shivering, and administration of fluid replacement 1500 mL was instructed. Acetaminophen 400 mg was instructed to be used. On 09Jul2021, at around 03:00, since blood pressure decreased was noted, the physician visited the patient. The body temperature was 40.1 degrees Celsius, the blood pressure was 67/46, the pulse rate was 116, and the SpO2 was 97% (room air). The patient had pyrexia of 40 degrees Celsius, and no abnormalities were observed on the chest auscultation. The fever focus was unknown. On 09Jul2021, the physician visited the patient regularly. The body temperature was 37 degrees Celsius, the SpO2 was 98 to 99%, and the blood pressure was 118/74. The patient was slightly more active than the previous day. The blood examination was performed. Administration of hydrocortisone sodium succinate (SOLU-CORTEF) was instructed (at 16:00, a drip injection was performed). Since the patient had oedema on the back, a drip infusion was instructed to be decreased to 1000 mL. In the daytime, acetaminophen 400 mg was used twice. At 23:00 on the same day, the blood pressure was unable to be measured. It could be measured in a different way; however, the patient had pallor facial, and emergency call was made. Administration of fluid replacement of 500 mL was instructed. 15 minutes later, the respiratory condition tended to be aggravated, and house visit by a doctor was asked to the physician. On 10Jul2021, at around 00:00, when the patient arrived at the patient''s home, she had respiratory arrest. At 00:12, the patient was confirmed to die. The reporting other healthcare professional classified the event as serious (death) and assessed that the event was related to BNT162b2. Other possible causes of the event such as any other diseases were after fracture, dementia, and dysphagia. The outcome of the events altered state of consciousness, pyrexia, eating disorder, somnolence, chills, blood pressure decreased, heart rate increased, oedema and pallor was unknown. The patient died on 10Jun2021 due to hepatic function abnormal and respiratory arrest. It was unknown if autopsy was done.; Reported Cause(s) of Death: respiratory arrest; Hepatic function disorder


VAERS ID: 1524556 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Feeding disorder, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100935431

Write-up: unable to eat orally and hospitalized; felt ill; patient died; This is a spontaneous report from a contactable physician via a Pfizer sales representative. An elderly patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The course of the event was as follows: The patient received the vaccination at the facility for elderly by the reporting physician. Immediately after that, the patient felt ill and was unable to eat orally and hospitalized. After that, the patient was transferred to another hospital. On an unknown date (about one month after the vaccination), the patient died. Outcome of the event unable to eat was unknown. The reporting physician classified the event as serious (fatal) and the causality between the event and BNT162b2 was not reported.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.; Reported Cause(s) of Death: patient died


VAERS ID: 1524557 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID antigen test; Test Result: Negative
CDC Split Type: JPPFIZER INC202100935437

Write-up: Myocardial infarction; Cardiac arrest; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. An 85-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number was not reported), intramuscularly on 17Jul2021 (at the age of 85-years-old) as dose 2, single for COVID-19 immunisation. Medical history included Parkinson''s disease. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 COMIRNATY; lot number was not reported) on an unspecified date in 2021 for COVID-19 immunisation. On 18Jul2021 (1 day after the vaccination), the patient experienced myocardial infarction. The clinical course of the event was as follows: On 18Jul2021 (1 day after vaccination), the patient had cardiac arrest, and she was transferred to the reporting hospital. It was confirmed that the patient received the second dose of BNT162B2 vaccination on 17Jul2021 (the day of vaccination) by her family (according to her age, the vaccination was assumed to be BNT162b2 vaccination). The patient was confirmed to be alive until at 20:30 on 17Jul2021 (20 hours and 30 minutes after vaccination) by her family. On 18Jul2021 at around 06:30 (1 day, 6 hours, and 30 minutes after vaccination), the patient was emergently transferred. On the same day, COVID antigen test was performed (the result of negative was confirmed). On 18Jul2021 (1 day after the vaccination), the patient died due to myocardial infarction. It was not reported if an autopsy was performed or not. The outcome of the event cardiac arrest was unknown. The reporting pharmacist classified the event as serious (death) and assessed that the event was probably related to BNT162B2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on available information and the drug temporal relationship, the causality between the events myocardial infarction, cardiac arrest and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1524561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-24
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
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:
CDC Split Type: JPPFIZER INC202100952107

Write-up: Aortic dissection; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121151. A 65-year-old male patient received second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose of COVID-19 Vaccine on an unspecified date. The patient''s medical history and concomitant medications were not reported. On 24Jul2021 at 14:00 (unknown day(s) after the vaccination), the patient experienced aortic dissection. On 24Jul2021, the patient died of aortic dissection. The outcome of the event was Fatal. Clinical course of the event aortic dissection was as follows: The patient''s breath became hard, and he went into cardiac arrest. After transported to the hospital, the patient was diagnosed with aortic dissection. The reporting physician classified the event as serious (Death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Aortic dissection


VAERS ID: 1524563 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bronchiectasis, Condition aggravated, Mycobacterial infection, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Pseudomonas infection, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 29
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: Medical History/Concurrent Conditions: Bronchiectasis; Infection Pseudomonas aeruginosa; Mycobacterial infection
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210603; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210607; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210623; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Test Date: 20210623; Test Name: oxygen saturation; Test Result: 68 %
CDC Split Type: JPPFIZER INC202100967392

Write-up: pyrexia of 37.4 degree; Oxygen saturation decreased to 68%; pneumonia; pulmonary nontuberculous mycobacterial infection; bronchiectasis; Infection Pseudomonas aeruginosa chronic; pulmonary nontuberculous mycobacterial infection, bronchiectasis, and infection pseudomonas aeruginosa chronic; respiratory failure type 2; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120493. An 83-year-old female received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration on 02Jun2021 at 13:00 as 0.3mL single dose for COVID-19 immunization. Body temperature before vaccination was 36.8 degrees centigrade. The patient had no family history. The patient had medical histories of pulmonary nontuberculous mycobacterial infection from 2006, bronchiectasis, infection pseudomonas aeruginosa chronic from 2014. Concomitant medications were not reported. On 03Jun2021 (1 day after the vaccination), the patient developed a variety of symptoms that were diagnosed as pneumonia, pulmonary nontuberculous mycobacterial infection, bronchiectasis, and infection pseudomonas aeruginosa chronic. On 07Jun2021 (4 days after the vaccination), the patient was admitted to the hospital. On 23Jun2021 (20 days after the vaccination), the patient experienced pyrexia of 37.4 degree and oxygen saturation decreased of 68%, and was readmitted to the hospital. On unknown date (after the vaccination), the patient experienced respiratory failure type 2. On 02Jul2021 (one month after the vaccination), the outcome of the event was fatal. It was unknown if autopsy was performed. The clinical course was as follows: On 03Jun2021, the patient experienced pyrexia of 37.7 degrees Celsius. On 05Jun2021, the patient experienced sputum bloody. On 07Jun2021, the patient experienced pyrexia of 38 degrees Celsius and dyspnoea. On the same day, the patient was admitted to another hospital. The patient was diagnosed with pneumonia, pulmonary nontuberculous mycobacterial infection (pulmonary NTM infection), bronchiectasis, and infection Pseudomonas aeruginosa chronic on the detailed examination. From 07Jun2021 to 18Jun2021, tazobactam (TAZ) and piperacillin (PIPC) were administered. On 19Jun2021, the patient was recovering, and she was discharged. On 23Jun2021, the patient experienced pyrexia of 37.4 degrees Celsius again. Since the patient experienced oxygen saturation decreased to 68%, she was readmitted to the same hospital on the same day. After the hospitalization, meropenem (MEPM) was administered. However, although the pneumonia improved, the patient had respiratory failure type 2. On 02Jul2021, 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. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: From 2006, the patient had nontuberculous mycobacterial infection. From 2014, the patient had infection Pseudomonas aeruginosa chronic. Thus, the condition of respiratory function decreased. The possibility could not be ruled out that these diseases were aggravated triggered by the vaccination.; Reported Cause(s) of Death: Respiratory failure type 2; pneumonia; pulmonary nontuberculous mycobacterial infection; bronchiectasis; Infection Pseudomonas aeruginosa chronic; pneumonia, pulmonary nontuberculous mycobacterial infection, bronchiectasis, and infection pseudomonas


VAERS ID: 1524580 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: LBPFIZER INC202100955437

Write-up: Pulmonary embolism; This is a spontaneous report from a Pfizer colleague, who has seen this on social media, not sure how accurate it was. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was mentioned that Pulmonary embolism and death occurred to a patient after Pfizer BioNtech COVID-19 vaccine. Event took place after use of product. It was not reported if Autopsy Done. The 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: Pulmonary embolism


VAERS ID: 1524588 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
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: MXPFIZER INC202100956038

Write-up: 13-year-old dies after receiving Pfizer vaccine; This is a spontaneous report from a non-contactable consumer received via a Pfizer program. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), unknown dose number, via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. It was reported that the 13-year-old patient died after receiving the BNT162B2 vaccine on an unspecified date. It was not reported if an autopsy was performed and the cause of death was not provided. No follow-up attempts possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: 13-year-old dies after receiving Pfizer vaccine


VAERS ID: 1524632 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   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: FLUVOXAMINE; IRBESARTAN; PANTOPRAZOLE; CLOZAPINE; LORAZEPAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:no thrombocytopenia; Test Name: CT scan; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC202100973243

Write-up: Lung embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number NL-LRB-00640152. A 61-year-old male patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 19Jul2021, as single dose (Batch/Lot Number was unknown) for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fluvoxamine tablet taken withdrawal for an unspecified indication on an unspecified date; irbesartan (tablet strength 75 mg) taken for an unspecified indication on an unspecified date; pantoprazole (gastro resistant tablet strength 20 mg) taken for an unspecified indication on an unspecified date; clozapine taken for an unspecified indication on an unspecified date; lorazepam taken for an unspecified indication on an unspecified date. The patient had not gotten COVID-19 infection previously. The patient experienced lung embolism on 24Jul2021. The patient underwent lab tests and procedures which included blood test: no thrombocytopenia and CT scan with unknown results on an unspecified date. Lung embolism was treated with heparine. The patient died on 26Jul2021. It was not unknown if an autopsy was performed. The outcome of event was fatal. Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no; pulmonary embolism. Additional information ADR: there was no question of thrombocytopenia. BSN available: yes. COVID-19. Previous COVID-19 infection: No. Other, diagnostic procedures: CT scan, blood test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no; pulmonary embolism. Additional information ADR: there was no question of thrombocytopenia. BSN available: yes. COVID-19. Previous COVID-19 infection: No. Other, diagnostic procedures: CT scan, blood test.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1524668 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Polymerase chain reaction, Pyrexia, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: RT-PCR TEST; Result Unstructured Data: Test Result:negative; Test Date: 20210717; Test Name: RT-PCR TEST; Result Unstructured Data: Test Result:postive
CDC Split Type: PHPFIZER INC202100970918

Write-up: difficulty breathing/shortness of breath; fever; Vaccination site pain; RT-PCR test positive, oxygen level down; RT-PCR test postive, oxygen level down; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300093266. A 75-year-old male patient received second dose of bnt162b2 (COMIRNATY Solution for injection Batch/Lot Number: FD5996) via intramuscularly on 08Jul2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY Solution for injection Batch/Lot Number: FD5996) via intramuscularly on 17Jun2021 as dose 1, single (at the age of 75-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. In 2021 03:00, the patient experienced rt-pcr test postive, oxygen level down. On 10Jul2021 18:00, patient experienced difficulty breathing/shortness. Patient was hospitalized on 12Jul2021. The patient underwent lab tests and procedures which included RT-PCR test resulted negative on 13Jul2021, RT-PCR test resulted as positive on 17Jul2021. The clinical outcome of the event RT-PCR test positive, oxygen level down was fatal, and rest of the events was unknown. The patient died on 17Jul2021 around 3-4am. It was not reported if an autopsy was performed. Cremated on 18Jul2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: RT-PCR test postive, oxygen level down; RT-PCR test postive, oxygen level down


VAERS ID: 1524717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
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: ROPFIZER INC202100931820

Write-up: died 3 days later; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The doctor mentioned that after the vaccination, the patient died 3 days later on an unspecified date. The doctor also specified that they would have preferred the vaccine to be in the form of a pre-filled syringe, so that there would be no dosing errors and mentioned that sometimes 6 doses could not be withdrawn from a vial. In addition, they added that it was complicated to dilute and considered this issue to be a problem, especially when the room might be more than 30 degrees Celsius. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : RO-PFIZER INC-202100931821 same reporter, suspect product, and event; different patient; Reported Cause(s) of Death: died 3 days later


VAERS ID: 1524718 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202100931821

Write-up: died; This is a spontaneous report from a contactable physician. This report was received via a sales representative. This physician reported the same event under the same suspect product for two patients. This is the second of two reports. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The doctor mentioned that after the vaccination one patient died 3 days later, and another patient died in the time between the two doses. The doctor also specified that they would have preferred the vaccine to be in the form of a pre-filled syringe so that there would be no dosing errors and mentioned that sometimes 6 doses could not be withdrawn from a vial. In addition, they added that it is complicated to dilute and considers this issue to be a problem, especially when the room may be more than 30 degrees Celsius. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: 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.,Linked Report(s) : RO-PFIZER INC-202100931820 same reporter, suspect product, and event; different patient; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1524743 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Incorrect route of product administration, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   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: TRPFIZER INC202100960058

Write-up: heart attack; Inappropriate route of vaccination, subcutaneous; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number E-54398317-510.01.05-490739. A 25-year-old male patient (reporter''s relative) received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), via subcutaneous on 18Jun2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on 18Jun2021 and had no health problems, passed away on 21Jun2021 with a heart attack at his home. The patient experienced heart attack (death) on 21Jun2021, inappropriate route of vaccination (subcutaneous) on 18Jun2021. The patient died on 21Jun2021. It was not reported if an autopsy was performed. The outcome of the event heart attack was fatal. The outcome of the event inappropriate route of vaccination was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart attack


VAERS ID: 1525235 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-05-10
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001652 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lung disorder, Lung opacity
SMQs:, Interstitial lung disease (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   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:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Ground glass opacity in thoracic CT; Pneumopathy; This regulatory authority case was reported by a physician and describes the occurrence of LUNG OPACITY (Ground glass opacity in thoracic CT) and LUNG DISORDER (Pneumopathy) in an 82-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001652) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced LUNG DISORDER (Pneumopathy) (seriousness criterion death). On 25-May-2021, the patient experienced LUNG OPACITY (Ground glass opacity in thoracic CT) (seriousness criterion death). The patient died on 02-Jun-2021. The reported cause of death was Ground glass opacity in thoracic CT and Pneumopathy. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-NC20212962 Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per assessment by Authority. Both events retained as resulting in death as per Authority report, although the specific cause of death is not clear from the Regulatory Authority; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per assessment by Authority. Both events retained as resulting in death as per Authority report, although the specific cause of death is not clear from the ; Reported Cause(s) of Death: Ground glass opacity in thoracic CT; Pneumopathy


VAERS ID: 1525417 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood glucose increased, Condition aggravated, Death, Investigation
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210416; Test Name: blood glucose; Result Unstructured Data: Test Result:strongly elevated; Test Date: 20210414; Test Name: infection test; Result Unstructured Data: Test Result:free of infections
CDC Split Type: ATPFIZER INC202100954816

Write-up: Condition worsened on the 4th day of stay at the hospital; Blood sugar levels greatly increased; deceased; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number AT-BASGAGES-2021-38112. A 99-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing renal failure and ongoing diabetes mellitus. The patient''s weight was not reported, and height was not reported. The patient''s concomitant medications were not reported. Patient was free of infection at time of vaccination. On 16Apr2021, blood glucose levels strongly elevated, hospitalization. Treatment of the side effect included rapid insulin and fluid administration in hospital, condition improved the next day, condition deteriorated on the 4th day of hospitalisation on 19Apr2021 and died on 20Apr2021. The patient underwent lab tests and procedures which included infection test: free of infections on 14Apr2021. The patient died on 20Apr2021. It was not reported if an autopsy was performed. Cause of death not known. The patient''s outcome was recovering/resolving for blood glucose increased, fatal for death, not recovered/not resolved for condition worsened. Senders comments: Agency-comment: Follow-up information has been requested. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: deceased


VAERS ID: 1525419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypertensive heart disease, Ischaemia
SMQs:, Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100924286

Write-up: Hypertensive heart disease; Ischaemia; Hypertensive heart disease; Ischaemia; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is 584834. A 71-year-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hypertensive heart disease and ischaemia on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Pfizer is a marketing authorization holder of COVID-19 VACCINE in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 VACCINE has submitted the same report to the regulatory authorities. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Hypertensive heart disease; Ischaemia


VAERS ID: 1525433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-04
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: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100957885

Write-up: passed away; This is a spontaneous report from a contactable consumer (Pfizer colleague). A 35-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Advised by phone from a Pfizer colleague that he had received a phone call earlier on 27Jul2021 from an industry colleague that a friend (of the industry colleague) had passed away. It was noted that the patient was a 35yo female and had received what the industry colleague thought was the bnt162b2 vaccine yesterday (26Jul2021) and had passed away in their sleep sometime between the evening of the 26Jul2021 morning of 27Jul2021. The Pfizer colleague noted that the reporter had mentioned the patient was otherwise well and did not note any pre-existing conditions. The patient died on Jul2021. 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: passed away


VAERS ID: 1525516 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100929854

Write-up: anaphylactic reaction; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The reporter stated she has a relative and she had an anaphylactic reaction to the vaccine, and she died on an unspecified date. The outcome of the event was fatal. It was unknown if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: anaphylactic reaction


VAERS ID: 1525526 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-05-09
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9093 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal growth abnormality, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-10
   Days after onset: 62
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202100991812

Write-up: Missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks; Missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks; This is a spontaneous report from a contactable consumer (patient''s mother). This consumer reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), transplacental, administered in Arm Left on 16Jun2021 17:15 (Batch/Lot Number: FA9093) as dose 2, single, transplacental, administered in Arm Right on 09May2021 17:30 (Batch/Lot Number: EW0193) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The mother is a 37-year-old female, last menstrual period date (22Apr2021), Pregnancy Due Date (27Jan2022). Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic Administration facility. Mother had missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment was given. The patient died on 10Jul2021. It was not reported if an autopsy was performed.; Sender''s Comments: Linked Report(s) : CA-PFIZER INC-202100941550 baby case; Reported Cause(s) of Death: Missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks; Missed miscarriage - fetal growth stopped at 7 weeks and was diagnosed at 11 weeks


VAERS ID: 1525533 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Low density lipoprotein, Sudden death, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRADIF; VALSARTAN/HCT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (treated, well-controlled); Low density lipoprotein increased; Nicotine abuse; Overweight
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:29; Test Name: LDL; Result Unstructured Data: Test Result:4.44
CDC Split Type: CHPFIZER INC202100961682

Write-up: pain in the area of the injection site on the left arm; unclear case of death; This is a spontaneous report. A 69-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown), at the age of 69 years old, via intramuscular in left arm on 25May2021 at 11:25 at single dose for COVID-19 immunisation. Medical history (cardiovascular risk factors, CVRF) included body mass index (BMI) 29, nicotine abuse, low density lipoprotein (LDL) 4.44, arterial hypertension (treated, well-controlled). Concomitant medications included tamsulosin hydrochloride (PRADIF) and hydrochlorothiazide, valsartan (VALSARTAN/HCT). The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 69 years old, via intramuscular on 27Apr2021 at single dose for COVID-19 immunisation and was tolerated without complications. External anamnesis showed pain in the area of the injection site on the left arm on 26May2021. The patient died during the night between 26May2021 21:00 and 27May2021 8:00. The patient experienced sudden death; death treated as potentially unnatural; autopsy ordered by coroner; unexplained death. Swissmedic assessed this case as serious (results in death). The patient underwent lab tests and procedures which included BMI: 29, LDL: 4.44 on an unspecified date. An autopsy was performed and results were not provided. The outcome of the event unclear case of death was fatal. The outcome of the event pain in the area of the injection site was unknown. A causal relationship between BNT162B2 and "sudden death, cause unknown" and "injection site pain" was assessed by Swissmedic according to WHO as being possible. Sender''s comment (Swissmedic): In this unclear death, which was designated as sudden death according to the primary reporter and which was treated as potentially unnatural, there was suspected drug-induced reaction after 2nd vaccination with COVID-19 mRNA vaccine (BNT162B2). The Swiss SPC for BNT162B2 did not list death of unknown cause or a fatal course of event listed under various organ classes. In the WHO database on single case reports (VigiBase, accessed via VigiLyze), 887 reports were found (accessed 22Jun2021) on the association of "TN: BNT162B2" with preferred term "death", of which 203 reports were on low level term "unknown cause of death". The number of reports was lower than statistically expected. In this case, an autopsy had been ordered by the forensic medicine. No further data are available in this regard. Evidence for the presence of other possible drug triggers was not reported. The causal relationship for death of unknown cause was judged as possible for BNT162B2 according to the criteria of Swissmedic in case of plausible temporal correlation and missing data on the findings of the ordered autopsy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: unclear case of death


VAERS ID: 1525534 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Cold sweat, Decreased appetite, Dyspnoea, General physical health deterioration, Nausea, Oxygen saturation decreased, Pyrexia, Respiratory rate increased, Restlessness, Somnolence, Unresponsive to stimuli, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   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: ELIQUIS; MARCOUMAR; ALDACTONE [SPIRONOLACTONE]; BILOL; DEXILANT; DONEPEZIL; LEFLUNOMIDE; ALLOPURINOL; TORASEMIDE; VITAMIN D3; VITARUBIN [CYANOCOBALAMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic; Chronic renal failure; COVID-19; Deep vein thrombosis; Dementia (development); Gastroesophageal reflux disease; Gout; Granulomatous liver disease; Heart failure; Pneumonia; Seronegative rheumatoid arthritis; Thromboembolic event (unprovoked thromboembolic events with pneumonia both sides and 3-story deep vein thrombosis); Upper gastrointestinal bleeding (for gastroesophageal reflux ulcer (under anticoagulant with Marcoumar)); Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210520; Test Name: auscultatory; Result Unstructured Data: Test Result:breath sounds variable in- and expiratory; Comments: breath sounds variable in- and expiratory (a.e. secretion), no obstruction, no definite infiltrate; Test Date: 20210423; Test Name: temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: status subfebrilis; Test Date: 202105; Test Name: temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: In the night, dropped; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: morning; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: around 16:00; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:40.2 Centigrade; Comments: 18:00; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: 19:00; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Comments: 21:15; Test Date: 20210520; Test Name: temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Comments: 21:30; Test Date: 20210520; Test Name: Heart rate; Result Unstructured Data: Test Result:115/min; Comments: 18:00; Test Date: 20210520; Test Name: Heart rate; Result Unstructured Data: Test Result:98/min; Comments: 19:00; Test Date: 20210520; Test Name: Heart rate; Result Unstructured Data: Test Result:45/min; Comments: 21:15, during few minutes according to nurses; Test Date: 20210520; Test Name: Heart rate; Result Unstructured Data: Test Result:85/min; Comments: 21:30; Test Date: 202105; Test Name: SpO2; Result Unstructured Data: Test Result:81-88 %; Comments: In the night; Test Date: 20210520; Test Name: SpO2; Test Result: 57 %; Comments: approximately 17:20; Test Date: 20210520; Test Name: SpO2; Test Result: 66 %; Comments: below 6l/min O2 administration via mask; Test Date: 20210520; Test Name: SpO2; Test Result: 80 %; Comments: 19:00, under 9L O2 administration via mask; Test Date: 20210520; Test Name: SpO2; Test Result: 88 %; Comments: 21:15; Test Date: 20210520; Test Name: Respiratory rate; Result Unstructured Data: Test Result:$g40/min; Comments: 18:00; Test Date: 20210520; Test Name: Respiratory rate; Result Unstructured Data: Test Result:36/min; Comments: 19:00; Test Date: 20210520; Test Name: Respiratory rate; Result Unstructured Data: Test Result:28/min; Comments: 21:30
CDC Split Type: CHPFIZER INC202100961646

Write-up: restlessness; cold sweaty; unresponsive; Respiratory rate $g 40/min, 36/min, 28/min; dyspnea/rapidly increasing dyspnea; saturation drop to SpO2 57%/66%/80% (under 9l O2 administration via mask)/88%/from 88% to 81%; temperature 38.3C/40.2C/39C/38.8C/38.2C; vomiting of previously drunk fluid; mild general condition decrease; loss of appetite (lunch); somnolent, unable to awaken; nausea; This is a spontaneous report received from a contactable physician via Regulatory Agency, the regulatory authority. Regulatory authority report number CH-SM-2021-16726. This physician reported different dose and events for the same patient. This is the first of two reports-regarding the second dose. A 87-year-old male patient (resident of a nursing home) received the second dose of BNT162B2 (COMIRNATY, lot number: unknown), at the age of 87 years old, via intramuscular on 19May2021 at 11:00 at 0.3 ml single dose for COVID-19 immunisation. Prior to vaccination, the patient had been in good general health. Medical history included unprovoked thromboembolic events from 2014 (Status after unprovoked thromboembolic events with pneumonia both sides and 3-story deep vein thrombosis 2014), pneumonia both sides from 2014, 3-story deep vein thrombosis from 2014, heart failure, gastroesophageal reflux ulcer, anemic upper gastrointestinal bleed from 23Apr2021 (for gastroesophageal reflux ulcer ,under anticoagulant with Marcoumar), seronegative erosive rheumatoid arthritis, granulomatous sclerosing hepatitis of unclear etiology, gout, chronic renal failure, vitamin B12 deficiency, dementia (development), COVID-19 from Dec2020 and allergies: Co-Amoxi (diarrhea immediately). Concomitant medications included apixaban (ELIQUIS, strength: 5 mg) orally at 5mg 2x/d from 02May2021 to 20May2021; phenprocoumon (MARCOUMAR) orally until 24Apr2021; spironolactone (ALDACTONE, strength: 25 mg) orally at 25mg 1x/d from 11Aug2020 to 20May2021; bisoprolol fumarate (BILOL, strength: 1.25 mg) orally at 1.25mg 1x/d from 12Dec2018 to 20May2021; dexlansoprazole (DEXILANT, strength: 60 mg) orally at 60mg 1x/d from 02May2021 to 20May2021; donepezil (strength: 10 mg) orally at 10mg 1x/d from 16Sep2018 to 20May2021; leflunomide (strength: 10 mg) orally at 10mg 1x/d from 17Sep2018 to 20May2021; allopurinol (strength: 150 mg) orally at 150mg 1x/d from 16Sep2018 to 20May2021; torasemide (strength: 10 mg) orally at 10mg 1x/d from 20Oct2020 to 20May2021; colecalciferol (VITAMIN D3, strength: 10 drop) orally at 10drop 1x/d from 18Oct2018 to 20May2021; cyanocobalamin (VITARUBIN , strength: 1000 ug, also reported as 1000 mcg) subcutaneously at 1000ug every 3 months from 03Jul2019 to 20May2021. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 87 years old, via intramuscular on 22Apr2021 at 0.3 ml single dose for COVID-19 immunisation. Approximately 3 to 4 days after vaccination, on 23Apr2021, the patient occurred emesis (with fresh blood, under Marcoumar) with gastroesophageal ulcer and status subfebrilis (37.8C). According to the primary reporter, these complaints could also be interpreted as a vaccination reaction, since the symptoms (status febrilis and emesis) occurred within 24 hours after the first and second administration of BNT162B2, respectively. On 20May2021 morning, temperature 35.6C. Late morning on 20May2021, nurses noticed mild general condition decrease and loss of appetite (lunch); around 16:00, temperature 38.3C and vomiting of previously drunk fluid. Administration of paracetamol (DAFALGAN) 600mg supp. around 15:30. In the course dyspnea and saturation drop to SpO2 57%, gray color, cool periphery approximately at 17:20. Administration of 6L O2 via mask. At 18:00 (first home visit), temperature 40.2C, respiratory rate $g 40/min, heart rate 115/min; SpO2 66% below 6l/min O2 administration via mask; auscultatory breath sounds variable in- and expiratory (a.e. secretion), no obstruction, no definite infiltrate. Patient experienced somnolent, unable to awaken and integument without evidence of exanthem. Patient positioning (cardiac position), covering patient. Physical fever reduction by cool wash down, cool compresses groin/calf; O2 increased to 9l/min. Fractionated 2 x 2.5mg morphine subcutaneous and 0.5mg haloperidol (HALDOL) subcutaneous for nausea. 500 ml NaCl subcutaneous with 44 ml/h infusomat (500 ml/12h). At 19:00 (reported as 09:00), temperature 39C; respiratory rate 36/min; heart rate 98/min; SpO2 80% (under 9l O2 administration via mask); patient briefly wakeable (open eyes). At 21:15, the patient experienced cold sweaty, unresponsive; temperature 38.8C; heart rate 45/min (during few minutes according to nurses); SpO2 88%. At 21:30 (second home visit), temperature 38.2?; respiratory rate 28/min; heart rate 85/min; patient briefly wakeable (open eyes with facial expression); dyspnea objectively better (fewer subcostal retractions, deeper breaths, calmer rate). In the night of May2021 according to night nurse, temperatures dropped (to 37.2C) and SpO2 saturations from 88% to 81%, wakeability documented. On 21May2021 around 04:45, the patient experienced restlessness, rapidly increasing dyspnea. Rapid death with onset of death on 21May2021 at 05:20. Fatal adverse event according to primary notifier: General condition decrease and appetite loss, within a few hours status febrilis to maximum temperature 40.2 degree celcius, vomiting, dyspnea. Autopsy determination of cause of death was refused by relatives. Sender''s Comment: The causal relationship for the fatal complaints (status febrilis, vomiting, dyspnea) after the second administration of BNT162B2 was judged to be possible according to Regulatory Agency criteria with plausible temporal correlation, unreported evidence for the presence of clinical causes and no autopsy determination of the cause of death. The causal relationship for the complaints (vomiting, status subfebrilis) after the first administration of BNT162B2 was also judged to be possible with plausible temporal correlation and the presence of a clinical cause that cannot be ruled out (gastrointestinal bleeding with known gastroesophageal reflux ulcer). The extent to which the chronology suggests the presence of immune-mediated reactions remains speculative. A causal relationship between BNT162B2 and reduced general condition, appetite lost, vomiting, fever and dyspnea was assessed as possible. Regulatory Authority assessed this case as serious (medically significant and fatal outcome). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : CH-PFIZER INC-202100962493 Same reporter, same patient, different event, different drug/dose; Reported Cause(s) of Death: loss of appetite (lunch); vomiting of previously drunk fluid; temperature 38.3C/40.2C/39C/38.8C/38.2C; mild general condition decrease; dyspnea/rapidly increasing dyspnea


VAERS ID: 1526404 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic stenosis, Cardiogenic shock, Dyspnoea, Electrocardiogram, International normalised ratio, International normalised ratio increased, Platelet count, Platelet count decreased, Thrombosis
SMQs:, Cardiac failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: TEE; Result Unstructured Data: Test Result:Malfunction of the mechanical aortic valve with ao; Comments: Malfunction of the mechanical aortic valve with aortic stenosis (grade III) and aortic insufficiency (grade III); Test Name: INR; Result Unstructured Data: Test Result:18,081; Test Name: platelets; Result Unstructured Data: Test Result:low
CDC Split Type: DEPFIZER INC202100928187

Write-up: Dyspnea two days after vaccination; Malfunction of the mechanical aortic valve with aortic stenosis (grade III) and aortic insufficiency (grade III); suspicion of thrombosis of the aortic replacement; laboratory INR $g 7; low normal platelets; progressive cardiogenic shock; This is a literature spontaneous report 2021, 7; 52-55 entitled INR Changes after COVID-19 VACCINATION. An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. In an 80-year-old woman hospitalized with suspected myocardial infarction. Five days and two weeks after vaccination with the mRNA vaccine from BioNTech/Pfizer (BNT162b2; COMIRNATY) an INR of greater than 7 was determined at admission (18,081). To what extent the acute diseases may have influenced the INR value remains unclear. Reported adverse events for this patient:- Dyspnea two days after vaccination- Hospital admission five days after vaccination, here echocardiographic (TEE) Malfunction of the mechanical aortic valve with aortic stenosis (grade III) and aortic insufficiency (grade III), - suspicion of thrombosis of the aortic replacement - laboratory INR $g 7 - low normal platelets - in the course progressive cardiogenic shock - Exitus lethalis six days after vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed. This information on side effect originates from a spontaneous reporting system (NETWORK OF MUTUAL INFORMATION). The reports show, from the point of view of the reporter, abnormal or unexpected events of the treatment, which are associated with drug therapy. Therefore, events associated with drug therapy are recorded, without causality having been proven or verified (suspected reports). It is also not possible to draw conclusions from these data regarding the frequency of occurrence of these adverse effects assigned to the drugs. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The Company cannot completely exclude the possible causality between the reported events Dyspnoea, Aortic stenosis, Thrombosis, International normalised ratio increased, Platelet count decreased, Cardiogenic shock and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. Additional information is needed to better assess the case, including complete medical history, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: progressive cardiogenic shock; Platelet count decreased; INR increased; Thrombosis; Aortic stenosis; Dyspnea


VAERS ID: 1526434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-11
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100956137

Write-up: stroke; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported), at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced stroke on 11Apr2021 and died on 26Apr2021. The outcome of event stroke was fatal. It was unknown if the autopsy was done. The event stroke 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. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: stroke


VAERS ID: 1526436 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-05
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D018A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100962389

Write-up: sinus vein thrombosis; This is a spontaneous report received by Pfizer from Biontech (manufacturer control number: 76161), license party for COMIRNATY. Contactable reporter reported for a 36-years-old male patient, received COMIRNATY (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 2 (Lot Number: 1D018A expiry date was not reported) via an unspecified route of administration on 11Jun2021 as a dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine COMIRNATY (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection dose 1 (Lot number EX8680 and expiry date not reported) via unspecified route of administration on 12May2021 as a single dose for covid-19 immunisation.On 05Jul2021 the patient experienced fulminant sinus venous thrombosis without thrombocytopenia, The patient died on 09Jul2021 and the cause of death was sinus vein thrombosis, It was not reported if an autopsy was unknown. No follow-up attempts are possible. No further information is expected. ; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Cerebral Venous Sinus thrombosis and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: sinus vein thrombosis


VAERS ID: 1526457 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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: Medical History/Concurrent Conditions: Hypertension arterial (HTA)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100960420

Write-up: death, there is no other clinic; Overdose vaccine administered; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, ES-AEMPS-836109 via RA. A 78-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EW2246) via intramuscular on 13Apr2021 at age of 78 years old as 0.5 ml single for COVID-19 immunisation. Medical history included hypertension arterial (HTA). Concomitant medications were unknown. The patient experienced death, there is no other clinic on the 16Apr2021. Overdose vaccine administered. It was communicated for knowledge purposes. The ultimate cause of death (judicial autopsy) was being studied. The patient suffered sudden death on 16Apr2021, when the medical services arrived, the patient was lying in bed. No vital signs on examination. Presented lividities on exploration. Rhythm strip was performed. Outcome of the event death, there is no other clinic was fatal.; Reported Cause(s) of Death: sudden death


VAERS ID: 1526646 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   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: ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cholecystectomy; Tobacco user; Comments: tabac hta cholecystectomie
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100948996

Write-up: Death sudden; chest pain; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-MA20212801. A 66-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly on 15Jul2021 (Lot Number: FE2296) as DOSE 2, SINGLE at age of 66-year-old for COVID-19 immunisation. Medical history included tobacco user, arterial hypertension, cholecystectomy, from an unknown date. Concomitant medication(s) included enalapril (ENALAPRIL) taken for an unspecified indication, start and stop date were not reported, doubt about ENALAPRIL (patient has not consulted from more than 12 months). The patient experienced death sudden on 19Jul2021. According to his partner patient complained to chest pain since the day before (18Jul2021). The patient died on 19Jul2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1526647 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-07-09
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / UNK LA / OT

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: 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: Ex-tobacco user (for 20 years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100948999

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB [FR-AFSSAPS-MA20212804]. A 58 years old male patient of an unspecified age received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 26May2021 at the age of 57 years old (Batch/Lot Number: FA5831) as single dose for covid-19 immunisation. Medical history included Smoking cessation for 20 years, no current treatment, no known cardiovascular history. The patient''s concomitant medications were not reported. The patient vaccinated with bnt162b2 on 25Jun2021 (as reported), and presented on 09Jul2021 i.e. 6 weeks after vaccination, a cardiorespiratory arrest. Death occurred suddenly at work, no etiology found. Cyanotic patient. 2 electric shocks by DSA (semi-automatic defibrillator). Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number) 45 days (as reported). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1526665 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Pulmonary malformation, Ultrasound scan
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-05-28
   Days after onset: 45
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: 20210528; Test Name: echography; Result Unstructured Data: Test Result:pulmonary malformation/2 pulmonary spots/lung spot
CDC Split Type: FRPFIZER INC202100948992

Write-up: pulmonary malformation/2 pulmonary spots/lung spot; 3 weeks of amenorrhea +2 days exposed of vaccination with the COMIRNATY vaccine in its mother; This is a spontaneous report from a contactable nurse downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NY20212786. This nurse reported information for both mother and fetus/baby. This is a fetus report. Spontaneous Report (regulatory authority Local Reference number: 2021093455), Initial information received on 11Jul2021, from an health professional (nurse) to the regulatory authority. A fetus of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 transplacental on 13Apr2021 (Lot Number: EW2239) as single dose for immunisation against sars-cov-2. The fetus medical history was not specified. Concomitant medications were not reported. The mother was pregnant while receiving bnt162b2. The mother''s last menstrual period date was 20Mar2021, and the mother was due to deliver on 25Dec2021. The fetus was exposed of vaccination with the comirnaty vaccine in its mother on 13Apr2021, at 3 weeks and 2 days of amenorrhea (first-trimester). On 28May2021, the fetus had a pulmonary malformation on echography (pulmonary malformation/2 pulmonary spots/lung spot), which resulted in fetus''s congenital anomaly and death. Lab tests and procedures included ultrasound: pulmonary malformation/2 pulmonary spots/lung spot on 28May2021. Miscarriage of the mother on the same day (28May2021) which required the mother''s hospitalization. The fetus died on 28May2021. It was unknown if an autopsy was performed. The outcome of the event pulmonary malformation/2 pulmonary spots/lung spot (also reported malformation foetale) was fatal. Reporter comment: Discovery on ultrasound of 2 pulmonary spots in a fetus of 9 weeks of amenorrhea + 6 days, 3 weeks of amenorrhea +2 days exposed of vaccination with the COMIRNATY vaccine in its mother (1st vaccination, batch not specified). Miscarriage the same day. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Discovery on ultrasound of 2 pulmonary spots in a fetus of 9 weeks of amenorrhea + 6 days, at 3 weeks of amenorrhea + 2 days exposed to the vaccination with the COMIRNATY vaccine in its mother (1st vaccination, batch not specified). Miscarriage the same day.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202100949216 fetus/mother case, same vaccine, different events; Reported Cause(s) of Death: pulmonary malformation/2 pulmonary spots/lung spot


VAERS ID: 1526683 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood creatinine, Cardiac arrest, Electrocardiogram, Troponin
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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; LANSOPRAZOLE; ATORVASTATIN; AMLODIPINE; AMIODARONE; BISOPROLOL; RAMIPRIL; FUROSEMIDE; DIFFU K; PAROXETINE; ZYMAD; BROMAZEPAM; TOVIAZ; DITROPAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Atrial fibrillation; Cholecystectomy; Chronic renal insufficiency; Claudication; Coronary stent user; Diphtheria; Dyslipidaemia; Ex-tobacco user; Horton''s disease; Hypertension arterial (HTA); Ischaemic heart disease (ACS (acute coronary syndrome) ST- ischemic heart disease in the lower territory in 2011); Lower urinary tract infection; Lung edema; Peripheral arterial disease; Total knee replacement; Type 2 diabetes mellitus; Umbilical hernia repair
Allergies:
Diagnostic Lab Data: Test Name: coronary angiography; Result Unstructured Data: Test Result:intra-stent thrombosis of the right coronary...; Comments: ...artery balloon dilation then loading dose + heparin therapy + cangrelor + tirofiban; Test Name: baseline creatinemia; Result Unstructured Data: Test Result:158 umol/l; Test Name: ECG; Result Unstructured Data: Test Result:no clear signs of ischemia; Test Name: Troponinemia; Result Unstructured Data: Test Result:0.13 ng/ml
CDC Split Type: FRPFIZER INC202100948978

Write-up: Arrest cardiac; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number FR-AFSSAPS-PP20211057. A 75-years-old female patient received bnt162b2 (COMIRNATY), intramuscularly on 07Jul2021 at age of 75 years old (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, single for covid-19 immunisation. Medical history included weaned tobacco, Hypertension arterial (HTA), Dyslipidemia, Type 2 diabetes since 2014, SCA ST- ischemic heart disease in the lower territory in 2011, bare stent on the right coronary artery, Peripheral arterial disease (PAD) known since 2017 with vascular claudication on exertion, Chronic renal insufficiency (CRI) on probable nephroangiosclerosis with baseline creatinemia at 158 micro-mol / L, Atypical Horton''s disease with thoracic aortitis diagnosed in 2015, Repeated lower urinary tract infections, Diphtheria at 3 years, Total knee replacement Sep2020, Appendectomy in 1963, Umbilical hernia treatment in 1995, Cholecystectomy in 2000, ALE (acute lung edema) on transition to rapid atrial fibrillation, minimal ischemic part probable in Apr2021. Concomitant medication(s) included apixaban (ELIQUIS); lansoprazole; atorvastatin; amlodipine; amiodarone; bisoprolol; ramipril; furosemide; potassium chloride (DIFFU K); paroxetine; colecalciferol (ZYMAD); bromazepam; fesoterodine fumarate (TOVIAZ); oxybutynin hydrochloride (DITROPAN), all taken for an unspecified indication, start and stop date were not reported. Patient presenting with cardiac arrest due to intrastent coronary stenosis immediately after (5 min) on 07Jul2021 of a COVID 19 vaccine booster. The same day, immediately after the injection (delay = 5 min), discomfort without prodrome then cardio-respiratory arrest quickly recovered after injection of adrenaline (1 mg) and the installation of a DSA (1 shock delivered initially)On 12Jul2021, the patient died of Multiple organ failure (multivisceral complications) and massive hemoptysis secondary to cardiogenic and vasoplegic shock. Discussion/conclusion of our analysis: Chronological, semiological and bibliographical data are not very suggestive of the role of vaccination against covid19 in the occurrence of this intrastent thrombosis of the right coronary artery in this polyvascular context. However, the very short time between the event and the injection (5 min) does not formally rule out the participation (coincidence?) Of the vaccination as a factor that may have favored this intra-stent thrombosis complicated by cardiac arrest. (arterial hypotension?). The patient underwent lab tests and procedures which included Electrocardiogram (ECG): no clear signs of ischemia, Troponinemia: 0.13 ng / mL, Coronary angiography: intra-stent thrombosis of the right coronary artery balloon dilation then loading dose + heparin therapy + cangrelor + tirofiban, baseline creatinemia at 158 micro-mol / L. The patient died on 12Jul2021. An autopsy was not performed. Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures" Official Bulletin of the Minister in charge of Health n ? 84/50, 24 January 1985. Published in Therapy 1985; 40: 111-8 No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Multiple organ failure; massive hemoptysis; cardiogenic shock; vasoplegic shock; cardiac arrest


VAERS ID: 1527131 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Brain injury, Cardiac arrest, Circulatory collapse, Computerised tomogram head, Computerised tomogram spine, Computerised tomogram thorax, Electrocardiogram, Lung consolidation, Post cardiac arrest syndrome, Rib fracture, SARS-CoV-2 antibody test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (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), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Osteoporosis/osteopenia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Head CT; Result Unstructured Data: Test Result:Showed hypoxic ischaemic brain injury*; Test Name: Computerised tomogram spine; Result Unstructured Data: Test Result:Unknown; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:Unknown; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Suspicious of acute myocardial infarction; Test Name: Covid-19 test; Test Result: Negative ; Comments: Negative
CDC Split Type: GBPFIZER INC202100962182

Write-up: Brain injury; Bilateral chest consolidation; rib fractures; suspicious of acute myocardial infarction; cardiac arrest; Post cardiac arrest syndrome; Circulatory collapse; This is a spontaneous report from a contactable physician. This report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107261205489830-B4UXP. Safety Report Unique Identifier GB-MHRA-ADR 25706684. A 53-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 19Jul2021 with unspecified Batch/Lot number was not reported as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Patient previously well. Not known to have sought any medical assistance from general practitioner (GP) or secondary care in last few years. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced cardiac arrest (cardiac arrest) (death) on 22Jul2021, post cardiac arrest syndrome (post cardiac arrest syndrome) (death) on 22Jul2021, circulatory collapse (circulatory collapse) (death) on 22Jul2021, brain injury (brain injury) (death) on an unspecified date. The patient died on 23Jul2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included computerised tomogram head: showed hypoxic ischaemic brain injury*, computerised tomogram spine, computerised tomogram thorax: unknown, electrocardiogram: suspicious of acute myocardial infarction, SARS-CoV-2 antibody test: negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient had possibly first COVID vaccination on 19th July. Found collapsed at work on 22nd July in cardiac arrest. Electrocardiogram (ECG) suspicious of acute myocardial infarction but remained too unstable for angiogram for definitive diagnosis or treatment. CT head showed hypoxic ischaemic brain injury. (Bilateral chest consolidation likely secondary to aspiration and rib fractures likely due to CPR). The report did not consider the report relate to possible blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. .; Reported Cause(s) of Death: Post cardiac arrest syndrome; suspicious of acute myocardial infarction; Brain injury; Circulatory collapse; cardiac arrest


VAERS ID: 1527174 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-05-31
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ischaemia, Multiple organ dysfunction syndrome, Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100961730

Write-up: Multiple organ failure; Heart attack; Ischaemia; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number [GB-MHRA-WEBCOVID-202107262018076890-ZV5BM], Safety Report Unique Identifier [GB-MHRA-ADR 25710182]. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced heart attack on 31May2021, ischaemia on 31May2021, multiple organ failure on 01Jun2021. Case narrative: Heart attack, ischaemia and multiple organ failure. Patient was not enrolled in clinical trial. The events were reported as serious due to death. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on unknown date. The patient died on 01Jun2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Heart attack; Ischaemia; Multiple organ failure


VAERS ID: 1527200 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound foetal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   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 Name: pregnancy scans; Result Unstructured Data: Test Result:embreo stopped growing; Comments: 2 weeks after vaccination
CDC Split Type: GBPFIZER INC202100962151

Write-up: vaginal bleeding; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107271445109040-AIR2K. Safety Report Unique Identifier (GB-MHRA-ADR 25714872). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jun2021 (Batch/Lot number was not reported) single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced vaginal bleeding on an unspecified date, miscarriage of pregnancy on 24Jun2021. One week post Covid-19 Pfizer vaccination, vaginal bleeding occurred, and based on pregnancy scans, the embreo stopped growing 2 weeks after vaccination subsequently causing a missed miscarriage. Outcome of vaginal bleeding was resolved. The patient died on 24Jun2021 due to miscarriage of pregnancy. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: miscarriage of pregnancy


VAERS ID: 1527306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Alcohol poisoning, Myocardial ischaemia
SMQs:, Depression (excl suicide and self injury) (broad), Other ischaemic heart disease (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: HKPFIZER INC202100949591

Write-up: ACUTE INTOXICATION; ISCHAEMIC HEART DISEASE; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS002821), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. The 50-year-old male patient received the Tozinameran (COMIRNATY, solution for injection) (lot number: unknown) via unspecified route of administration on an unknown date at unspecified dosing frequency for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient died on an unknown date. The patient had received COVID-19 vaccines within 14 days before passing away. There was no clinical evidence that the incident arose from vaccination. The preliminary autopsy revealed that the cause of death could potentially be acute intoxication or ischaemic heart disease. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: ISCHAEMIC HEART DISEASE; acute intoxication


VAERS ID: 1527352 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Dyspnoea, Hypopnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 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: HRPFIZER INC202100955417

Write-up: shortness of breath / shortness of breath; abdominal pain; fever / temperature; fever; shallow breathing; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number HR-HALMED-300049644. A 76-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 03Jul2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shortness of breath / shortness of breath (dyspnoea) (death) on 07Jul2021, abdominal pain (abdominal pain upper) (death) on 07Jul2021 , fever / temperature (pyrexia) (death) on 07Jul2021, fever (chills) (death) on 07Jul2021, shallow breathing (hypopnoea) (death) on 07Jul2021. The patient died on 08Jul2021. It was not reported if an autopsy was performed. Causality was unassessable/Unclassifiable. Senders comment: 23Jul2021: Additional documentation will be requested. Information on the lot/batch number has been requested.; Reporter''s Comments: 23Jul2021: Additional documentation will be requested.; Reported Cause(s) of Death: Unknown cause of death; Shortness of breath; Stomach pain; fever; Rigors; Breathing shallow


VAERS ID: 1527638 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac failure, Dizziness, Headache, Pneumonia aspiration, Vertigo
SMQs:, Cardiac failure (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Parkinson''s disease; Polyneuropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100948905

Write-up: After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis/vertigo; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-759514. An 80-years-old male patient received BNT162B2 (COMIRNATY; formulation: Solution for injection, Lot Number: EW2246 expiry date was not reported) dose 1 via intramuscular route of administration on 09Apr2021 as dose 1, single dose for covid-19 immunisation. Medical history included polyneuropathy, hypertension, Parkinson''s disease from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 16Apr2021 (after 7 days vaccination), the patient experienced dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis/vertigo. The patient died on 14May2021. The patient died due to events dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis and vertigo. It was not reported if an autopsy was performed. Sender''s comments: request report. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After 7 days vaccination dizziness, asthenia, headache, severe heart failure and hospitalization, polomonitis abingestis; After


VAERS ID: 1527643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain
SMQs:, Retroperitoneal fibrosis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100954753

Write-up: Started having back pain after vaccination; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-759801. A 88-year-old female patient received bnt162b2 (COMIRNATY), via intramuscular, administered in right arm (right shoulder) on 01Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included osteoporosis. The patient had no history of Covid-19. The patient''s concomitant medications were not reported. The patient experienced started having back pain on 06Apr2021 after vaccination. The condition was notified treating physician and impact on quality of life (10/10). Vaccine done on 01Apr2021. No major pathology. The patient lived alone, 100% autonomous. The reporter did not know if there are any contributing causes. The patient''s family doctor, by telephone, had prescribed DICLOFENAC for these severe pains that had come to her a few days after the vaccination. The ''autopsy examination'' was not performed. The lot/batch number was unknown. The patient died in Apr2021. An autopsy was not performed. The outcome of event back pain was fatal. Senders comment: Follow-up in progress: date of vaccine administration, batch number, clinical report, autopsy examination No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Osteoporosis; Reported Cause(s) of Death: Started having back pain after vaccination


VAERS ID: 1527650 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-06-12
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7065 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Apraxia, Coma, Microbiology test, Myocarditis, Sepsis, Ventricular dysfunction
SMQs:, Cardiac failure (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 30
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: Amyloidosis; Hypertension arterial; IGG myeloma
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Infectious findings; Test Result: Negative ; Comments: Infectious findings were negative
CDC Split Type: ITPFIZER INC202100954732

Write-up: septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction; septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction; septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction; septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction; septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction; This is a spontaneous report from a contactable physician downloaded from the Agency EudraVigilance-WEB, regulatory authority number IT-MINISAL02-760101. A 59-year-old male patient received bnt162b2 (COMIRNATY) (also reported "COVID 19 Comirnaty vaccine Pfizer"), dose 1 intramuscular, administered in Arm Left (also reported left shoulder) on 17May2021 12:10 (Lot Number: EY7065) as single dose for covid-19 immunisation. Medical history included hypertension arterial from an unknown date and unknown if ongoing; amyloidosis from 01Nov2020 and unknown if ongoing; and IGG myeloma from 01Nov2020 and unknown if ongoing. Concomitant medications were not reported. On 12Jun2021, the patient experienced septic state of unknown cause followed by ideomotor slowing and coma and lymphocytic myocarditis with severe contractile ventricular dysfunction, which reported as resulted in death. Contacted the reporter for the clinical report that will be attached in a Network. Therapeutic measures were taken as a result of the events: inotropic support, antimicrobial therapy, mechanical circulatory support, ventilatory support. The patient died on 12Jul2021. It was unknown if an autopsy was performed. Sender comment: updated on 22Jul2021: the referring physician who provides the attached clinical report contacted. Reporter comment: The patient died in privacy after a prolonged hospitalization at the privacy hospital. Infectious findings were negative and no clear cause for severe neurological impairment and subsequent myocarditis was identified. The vaccine (we only know that it was mRNA) was administered on 17May2021 probably in privacy. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The patient died in PRIVACY after a prolonged hospitalization at the privacy hospital. Infectious findings were negative and no clear cause for severe neurological impairment and subsequent myocarditis was identified. The vaccine (we only know that it was mRNA) was administered on 17May2021 probably in privacy.; Reported Cause(s) of Death: Myocarditis; Coma; Ideomotor apraxia; Ventricular dysfunction; septic state of unknown cause


VAERS ID: 1527655 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-06-07
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Ascites, Asthenia, Cardiac failure, Diarrhoea, Hepatic failure, Oedema peripheral, Pleural effusion, Pyrexia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 39
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: Cirrhosis liver; Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100955000

Write-up: Violent diarrhoea; fever; asthenia; renal failure; cardiac and hepatic decompensation; hepatic decompensation; limb oedema; ascites; pleural effusion; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-760679. A 77-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Apr2021 (at unknown age) as single dose for COVID-19 immunisation. Medical history included Cirrhosis, cardiopathic. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY), as single dose for COVID-19 immunisation, After 48 hours from the first dose he has a bellyache, nausea, tremors and diarrhoea. On 07Jun2021, The patient experienced violent diarrhoea with fever and asthenia, followed by hospitalization with renal failure, cardiac and hepatic decompensation as well as limb oedema, ascites and pleural effusion (death, hospitalization). It was unknown if Autopsy Done. The patient died on 16Jul2021. Actions taken (Admissions to different hospitals without any improvement.) No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202100960191 same patient, different events for 1st dose of Comirnaty; Reported Cause(s) of Death: violent diarrhoea; fever; asthenia; renal failure; cardiac and hepatic decompensation; cardiac and hepatic decompensation; limb oedema; ascites; pleural effusion


VAERS ID: 1527657 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004499 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Sudden death
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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dercum''s disease; Diabetes mellitus; Hypertension; Renal dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH and CARDIAC ARREST in a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004499) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Dercum''s disease, Renal dialysis and Diabetes mellitus. On 16-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 20-Jul-2021, the patient experienced SUDDEN DEATH (seriousness criteria death and medically significant) and CARDIAC ARREST (seriousness criteria death and medically significant). The patient died on 20-Jul-2021. The reported cause of death was. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. This a report of dead 4 days after receiving the product in a 57-years old patient with concomitant Hypertension, Diabetes mellitus, Dercum''s disease and Renal dialysis. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This a report of dead 4 days after receiving the product in a 57-years old patient with concomitant Hypertension, Diabetes mellitus, Dercum''s disease and Renal dialysis. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death.


VAERS ID: 1527661 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-09
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Sudden death
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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction (10 years ago); Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100954662

Write-up: death. Unexpected death. Cardiocirculatory arrest. Before, he was fit and well.; Cardiocirculatory arrest; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-760951. A 83-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 29Apr2021 09:46 (Batch/Lot Number: EX7389; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included prostate cancer, acute myocardial infarction 10 years ago. The patient''s concomitant medications were not reported. The patient experienced death. unexpected death. cardiocirculatory arrest. before, he was fit and well on 09May2021.The patient died on 09May2021. It was not reported if an autopsy was performed. Outcome of events was fatal. Sender comment: Dr. PRIVACY reports death in the kitchen during a meal. No family members present. She will send any death certificates and a report of her in the next week. It also refers to Acute myocardial infarction (10 years ago) and prostate cancer. A report for the precise medical history is awaited. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiocirculatory arrest


VAERS ID: 1527663 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214003 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Bradycardia, Hypotension, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   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: RANEXA; PRADAXA; CRESTOR; TRITTICO; SILODYX; LANOXIN; CIPROXIN [CIPROFLOXACIN HYDROCHLORIDE]; TOUJEO; DOBETIN [CYANOCOBALAMIN]; APIDRA; BINOCRIT
Current Illness:
Preexisting Conditions: Comments: No relevant medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of BRADYCARDIA, ASTHENIA, VOMITING, PYREXIA, and HYPOTENSION in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214003) for COVID-19 vaccination. No relevant medical history was reported. Concomitant products included RANOLAZINE (RANEXA) from 10-Jun-2021 to 16-Jul-2021, DABIGATRAN ETEXILATE MESILATE (PRADAXA) from 10-Jun-2021 to 16-Jul-2021, ROSUVASTATIN CALCIUM (CRESTOR) from 10-Jun-2021 to 16-Jul-2021, TRAZODONE HYDROCHLORIDE (TRITTICO) from 10-Jun-2021 to 16-Jul-2021, SILODOSIN (SILODYX) from 10-Jun-2021 to 16-Jul-2021, DIGOXIN (LANOXIN) from 10-Jun-2021 to 10-Jun-2021, CIPROFLOXACIN HYDROCHLORIDE (CIPROXIN [CIPROFLOXACIN HYDROCHLORIDE]) from 09-Jul-2021 to 15-Jul-2021, INSULIN GLARGINE (TOUJEO), CYANOCOBALAMIN (DOBETIN [CYANOCOBALAMIN]) from 05-Jul-2021 to 16-Jul-2021, INSULIN GLULISINE (APIDRA) and EPOETIN ALFA (BINOCRIT) from 10-Jun-2021 to 16-Jul-2021 for an unknown indication. On 07-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milligram in total. On 15-Jul-2021, the patient experienced BRADYCARDIA (seriousness criteria death and medically significant), ASTHENIA (seriousness criterion death), VOMITING (seriousness criterion death), PYREXIA (seriousness criterion death) and HYPOTENSION (seriousness criterion death). The patient died on 16-Jul-2021. The reported cause of death was Asthenia, Vomiting, Fever chills, Bradycardia and Hypotension. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Company Comment : This a regulatory/spontaneous report of fatal events, 9 days after receiving an unknown dose of the product in a 85 years old female with multiple concomitant medications, whose medical history was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Sender''s Comments: This a regulatory/spontaneous report of fatal events, 9 days after receiving an unknown dose of the product in a 85 years old female with multiple concomitant medications, whose medical history was not provided. Autopsy was not provided. Very limited information regarding the event has been provided for inferring causality. Further information is not expected; Reported Cause(s) of Death: Asthenia; Vomiting; Fever chills; Bradycardia; Hypotension


VAERS ID: 1527744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Delirium, Generalised tonic-clonic seizure, Hyperhidrosis, Pyrexia, Tachycardia, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral palsy; Excitement; Hospitalization NOS; Psychogenic disorder NOS; Unrest
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: Before vaccination; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:39s Centigrade; Test Date: 20210715; Test Name: Heart rate; Result Unstructured Data: Test Result:130; Comments: Unit: beat per minute
CDC Split Type: JPPFIZER INC202100952096

Write-up: fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority report. A 52-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FC5947; Expiration Date: 30Sep2021), via an unspecified route of administration on 14Jul2021 11:11 (at unknown age) as single dose for COVID-19 immunisation. Medical history included Cerebral palsy, psychogenic response, Unrest, Excitement, hospitalized from 06Oct2014. The patient''s concomitant medications were not reported. The patient was a 52-year and 11-month-old female. Body temperature before vaccination was 35.9 degrees centigrade. The patient''s family history was not reported. On 23Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY3860, Expiration date 31Aug2021). On 14Jul2021 at 11:11 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 15Jul2021 at 16:20 (1 day after the vaccination), the patient experienced fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state) and cardio-respiratory arrest. The course of the event was as follows: The patient had been seen for many years by the reporting physician for the treatment of cerebral palsy and psychogenic response since the patient visited the outpatient department. Since 06Oct2014, the patient had been hospitalized although she was repeatedly discharged from the hospital for a short period. On 15Apr2021, she made 13th admission to the hospital. She was physically in good health with no changes noted in her symptoms for years but sometimes became unrest and excited. From around 16:20 of 15Jul2021, the patient experienced fever-tension syndrome with the symptoms including pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating, and confusional and delirium state. While the symptoms persisted, the patient experienced cardio-respiratory arrest. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The number of drugs administered to the patient tended to be rather large, but that was inevitable considering the patient''s condition. On 15Jul2021 (1 day after the vaccination), the outcome of the event was fatal. It was unknown if Autopsy Done.; Reported Cause(s) of Death: fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 beats per minute, tremor limb, tonic-clonic convulsion, excess sweating and confusional and delirium state); fever-tension syndrome (pyrexia of 39s degrees C, tachycardia of 130 bea


VAERS ID: 1527749 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-20
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENIDIPINE; TIAPRIDE; RISPERIDONE; QUETIAPINE; RIVASTIGMINE ACINO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100952748

Write-up: Platelets decreased; This is a spontaneous report from a contactable physician received via regulatory authority. A 98-year-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 15Jul2021 14:00 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) (at the age of 98-year-old) as dose 1, single for covid-19 immunisation. Medical history included angina pectoris and dementia from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient received the following concomitant medications within 2 weeks of vaccination: benidipine (BENIDIPINE), tiapride (TIAPRIDE), risperidone (RISPERIDONE), quetiapine (QUETIAPINE), and rivastigmine (RIVASTIGMINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jul2021 (5 days after the vaccination), the patient experienced platelets decreased. On 26Jul2021 (11 days after the vaccination), the patient died. The patient received no treatment for the event. The reporting physician assessed the event as serious (Death). Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the close temporal association there is possibility of causal association between the fatal event platelet decreased and the suspect drug BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Platelets decreased


VAERS ID: 1527751 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body temperature, Cardiac failure, Fall, Movement disorder
SMQs:, Cardiac failure (narrow), Retroperitoneal fibrosis (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Accidents and injuries (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100957938

Write-up: Cardiac failure; Falling down the stairs; Low back pain; Inability to move lower limbs as intended; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is V21121311. An 87-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 16Jul2021 10:00 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 16Jul2021 at 10:00 (the day of vaccination), the patient received?the first dose of bnt162b2 (Solution for injection, Lot number FD0889, Expiration date 30Sep2021) via an unspecified route of administration as the first single dose for COVID-19 immunization. On 20Jul2021 (4 days after the vaccination), the patient experienced low back pain, which caused inability to move lower limbs as intended. On 21Jul2021 at 03:30 (5 days after the vaccination), the patient got out of bed, experienced cardiac failure, and then fell down the stairs. The outcome of the cardiac failure was fatal, and the outcome of the other events was not reported. It was not reported if an autopsy was performed. The reporting physician classified the event, cardiac failure, as serious (death) and assessed that the causality between the event and bnt162b2 was unassessable. Other possible cause of the event such as any other diseases was not reported. The patient died on Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1527752 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100957961

Write-up: Pyrexia; patient was unable to take meals; This is a spontaneous report from a contactable pharmacist communicated to Pfizer sales representative. A 92-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 20Jul2021 (the day of vaccination), as Dose 1 single, for COVID-19 immunisation. The patient medical history and the patient''s concomitant medications were not reported. On an unspecified date in Jul2021, the patient was unable to take meals and admitted at the reporting hospital. That was almost in the stage before death-watch. On 21Jul2021 (1 day after the vaccination), the patient experienced pyrexia. On 23Jul2021 (3 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The outcome for the event pyrexia was fatal, while the outcome for the other event was unknown. The seriousness was reported as serious (death), but causality assessment was not reported. Information regarding lot/batch number has been requested.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, Comirnaty vaccine, cannot be excluded for the reported events of Fever, unable take meals and death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Pyrexia


VAERS ID: 1527753 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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: 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: Interstitial pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100957966

Write-up: Interstitial pneumonia aggravated; This is a spontaneous case from a contactable physician received via a sales representative. A 9-decade-old patient (in his/her 80s) of an unspecified gender received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. First dose received on an unknown date for covid-19 immunisation. Medical history included interstitial pneumonia. The patient''s concomitant medications were not reported. On unknown date in 2021 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On unknown date in 2021 (7 days after the vaccination), the patient experienced interstitial pneumonia aggravated. On unknown date in 2021 (10 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: 7 days after the second dose of bnt162b2 vaccination, it was confirmed that interstitial pneumonia which the patient originally had was aggravated. After the patient was referred to another hospital (10 days after vaccination), the patient died. The patient was usually visiting the reporting hospital and another hospital. Since the interstitial pneumonia was aggravated this time, the patient was referred to the third hospital. The patient died on 2021. It was not reported if an autopsy was performed. The causality between the event and bnt162b2 was not provided. Information on the lot/batch number has been requested.; Sender''s Comments: based on the available information ,the strong temporal relationship between the fatal event aggravated interstitial pneumonia and the suspect vaccine BNT162B2 the causality cannot be complete4ly ruled out .; Reported Cause(s) of Death: Interstitial pneumonia aggravated


VAERS ID: 1527755 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Intractable pain; Paralysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100957978

Write-up: Sudden death; This is a spontaneous report from a non-contactable pharmacist received via the Regulatory Authority. The patient was a 71-year-old male. On 30Jun2021 at 18:15 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) at 71-year-old via intramuscular in the left arm for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Medical history included hypertension, residual paralysis from cerebral haemorrhage, and intractable pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescribed drug within 2 weeks of vaccination. On 09Jun2021 at 15:15, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) at 71-year-old via intramuscular in the left arm for COVID-19 immunization. On 09Jul2021 (9 days after the vaccination), the patient was confirmed to be alive until noon. On unknown date in Jul2021 (within 2 weeks after the vaccination), the patient suddenly died. This was a sudden death within 2 weeks of the vaccination. The patient was confirmed to be alive until noon on 09Jul2021, but the exact date of death was unknown. On 12Jul2021 (12 days after the vaccination), the patient was found dead at home. The cause of death was reported as "Unknown". The patient received no treatments for the event. The reporting physician assessed the event as serious (Death). It was unknown if autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: sudden death


VAERS ID: 1527756 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Computerised tomogram, Headache
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: 2021-07-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; Dyslipidaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: CT; Result Unstructured Data: Test Result:No abnormalities
CDC Split Type: JPPFIZER INC202100957980

Write-up: Cardio-respiratory arrest; Headache; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 56-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included dyslipidaemia, and bronchitis chronic. Concomitant medication included rosuvastatin calcium (CRESTOR) taken for an unspecified indication from Aug2020 and ongoing. On 25Jun2021, the patient previously received the first dose of bnt162b2 (Lot# unknown, Expiration date unknown). On 16Jul2021 (the day of vaccination), the patient received?the second dose of bnt162b2 (Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On around 21Jul2021 (5 days after the vaccination), the patient experienced headache. On 24Jul2021, the patient experienced cardio-respiratory arrest. On 24Jul2021 (8 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had underlying diseases such as dyslipidaemia and chronic bronchitis and had continuously received oral rosuvastatin calcium tablet 2.5 mg since Aug2020. For the profilaxis of novel coronavirus infection, the patient would like to receive bnt162b2 as a patient with underlying diseases and then received the vaccination at the site. On 25Jun2021, she received the first dose of bnt162b2. On 16Jul2021, she received the second dose of bnt162b2. From around 21Jul2021, the patient experienced the symptom of headache, and therefore on 23Jul2021, she visited a medical center, where computed tomography was performed. However, no abnormalities were found, and drip infusion was administered. On 24Jul2021, early in the morning, the patient was confirmed to be in cardio-respiratory arrest at her home and then died. The outcome of event headache was unknown. The patient died on 24Jul2021. It was not reported if an autopsy was performed. The reporting physician did not provide the seriousness and causality of the events. Information on the lot/batch number has been requested.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of cardio-respiratory arrest due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1527757 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cerebral infarction, Coma scale, Computerised tomogram head, Dehydration, Depressed level of consciousness, Feeding disorder, Pyrexia, Thrombosis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JANUVIA; LUVOX [FLUVOXAMINE MALEATE]; TORASEMIDE OD; URSODEOXYCHOLIC ACID; MAGMITT; TRAMAL; AZULFIDINE EN; PREDNISOLONE; LANSOPRAZOLE; THYRADIN S; ALFACALCIDOL; CLOPIDOGREL SULFATE; DAI-KENCHU-TO; MOSAPRIDE CITRATE; BETANIS
Current Illness: Arteriosclerosis obliterans; Carotid artery stenosis; Dementia; Diabetes mellitus (Since 68-year-old); Hip surgery; Hypertension; Hypothyroidism; Lumbar disc herniation; Primary sclerosing cholangitis; Rheumatoid arthritis (Since 30-year-old)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: blood pressure; Result Unstructured Data: Test Result:78/46 mmHg; Comments: at 18:00; Test Date: 20210719; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: Before vaccination; Test Date: 20210719; Test Name: body temperature; Result Unstructured Data: Test Result:39.9 Centigrade; Comments: at 14:30; Test Date: 20210720; Test Name: body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: at 04:00; Test Date: 20210721; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: at 06:00; Test Date: 20210721; Test Name: CS; Result Unstructured Data: Test Result:200-300; Comments: at 11:00; Test Date: 20210721; Test Name: Head CT; Result Unstructured Data: Test Result:Low density area in the right occipital lobe; Comments: Low density area was confirmed in the right occipital lobe (cerebral infarction).
CDC Split Type: JPPFIZER INC202100958016

Write-up: consciousness decreased; Cerebral infarction; pyrexia; meal intake was difficult; dehydration and thrombosis caused by pyrexia; dehydration and thrombosis caused by pyrexia; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). And from the same contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21122036. A non-pregnant 76-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm right on 19Jul2021 10:00 (Batch/Lot Number: FC9909; Expiration Date: 30Sep2021) as dose 2, single at the age of 76-year-old for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis chronic (since 30-year-old), primary schlerosing cholangitis from Jan2020 and ongoing, ongoing diabetes mellitus (since 68-year-old), ongoing hypertension, ongoing hypothyroidism, ongoing carotid artery stenosis, ongoing arteriosclerosis obliterans, ongoing lumbar disc herniation, ongoing after hip surgery right, ongoing dementia. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included sitagliptin phosphate (JANUVIA); fluvoxamine maleate (LUVOX); torasemide (TORASEMIDE OD); ursodeoxycholic acid; magnesium oxide (MAGMITT); tramadol hydrochloride (TRAMAL); sulfasalazine (AZULFIDINE EN); prednisolone; lansoprazole; levothyroxine sodium (THYRADIN S); alfacalcidol; clopidogrel sulfate from an unspecified start date and ongoing; dai-kenchu-to; mosapride citrate; mirabegron (BETANIS). On 28Jun2021 at 10:30, the patient previously received the first dose of bnt162b2 (Lot# EY3860, Expiration date 31Aug2021) via intramuscular route of administration in the arm left for COVID-19 immunization. On 19Jul2021 at 10:00 (the day of vaccination), the patient received the second single dose of bnt162b2 (Solution for injection, Lot number FC9909, Expiration date 30Sep2021) via intramuscular route of administration in the arm right for COVID-19 immunization. On 19Jul2021 at 14:30 (4 hours and 30 minutes after the vaccination), the patient experienced cerebral infarction. The event resulted in prolongation of hospitalization (the patient received vaccination during hospitalization) and death. The outcome of the event was fatal with treatment as follows: 1. On 19Jul2021, at 14:45 (4 hours and 45 minutes after vaccination), and on 20Jul2021, at 04:00 (18 hours after vaccination), diclofenac sodium (DICLOFENAC NA SUPP) 25 mg was inserted into the anus. 2. On 21Jul2021, and 22Jul2021, a drip infusion of edaravone 30 mg 1A was administered 2 times per day. 3. On 21Jul2021 and 22Jul2021, a drip infusion of fructose, glycerol (GLYCEOL) 200 mL was administered once per day. The reporting physician assessed the event as serious (prolonged hospitalization and death). Since the vaccination, the patient has not been tested for COVID-19. The cause of death was cerebral infarction. Autopsy was not performed. The reported event was as follows: On 19Jul2021 at 14:30 (4 hours and 30 minutes after the vaccination), the body temperature was 39.9 degrees celsius, and meal intake was difficult after the patient received the second dose of bnt162b2 vaccination. On 20Jul2021, at 04:00 (18 hours after vaccination), the body temperature was 39.4 degrees Celsius, and at 18:00 (32 hours after vaccination), the blood pressure was 78/46 mmHg. On 21Jul2021, at 06:00 (2 days after vaccination), the body temperature was 36.5 degrees Celsius. At 11:00 (2 days after vaccination), the patient had consciousness decreased (JCS: Japan Coma Scale was 200 to 300). Head CT showed low density area in the right occipital lobe (cerebral infarction). On 22Jul2021, at 19:19 (3 days, 9 hours, and 19 minutes after vaccination), the patient was confirmed to die. The body temperature before vaccination was 37.0 degrees Celsius. The reporting term was cerebral infarction and pyrexia. The course of the event was as follows: On 19Jul2021 (the day of vaccination), at 10:00, the patient received the second dose of bnt162b2 vaccination (at the age of 76-year-old). At 14:30 (4 hours and 30 minutes after vaccination), the body temperature was 39.9 degrees Celsius, and meal intake was difficult. At 14:45 (4 hours and 45 minutes after vaccination), diclofenac 25 mg, one suppository was inserted into the anus. On 20Jul2021, at 04:00 (18 hours after vaccination), the body temperature was 39.4 degrees Celsius, and diclofenac 25 mg, one suppository was inserted into the anus. At 18:00 (32 hours after vaccination), the blood pressure was 78/46 mmHg. On 21Jul2021, at 06:00 (2 days after vaccination), the body temperature was 36.5 degrees Celsius. At 11:00 (2 days after vaccination), the patient had consciousness decreased (Coma Scale was 200 to 300). Head CT showed low density area in the right occipital lobe (cerebral infarction). A drip infusion of edaravone 30 mg 1A was administered 2 times, and a drip infusion of fructose, glycerol 200 mL was administered once. On 22Jul2021 (3 days after vaccination), a drip infusion of edaravone 30 mg 1A was administered 2 times, and a drip infusion of fructose, glycerol 200 mL was administered once. At 19:19 (3 days, 9 hours, and 19 minutes after vaccination), the patient was confirmed to die. 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 as follows: Since the patient had underlying diseases of carotid artery stenosis and arteriosclerosis obliterans, it was unknown that cerebral infarction occurred directly caused by the vaccination. The cause of death was cerebral infarction. The outcome of other event was unknown. The patient died on 22Jul2021. An autopsy was not performed. The reporting physician commented as follows: After the vaccination, the patient had pyrexia of 39.9 degrees Celsius as a side reaction. Thereafter, the patient had consciousness decreased, and she was diagnosed with cerebral infarction on the imaging examination. Since the causes of cerebral infarction were dehydration and thrombosis caused by pyrexia other than a side reaction to the vaccination, and the patient had underling diseases of carotid artery stenosis and arteriosclerosis obliterans, the causality between the event and bnt162b2 vaccination was unknown.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1527758 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: BLOPRESS; TENORMIN; NORVASC; TAKEPRON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Internal carotid artery stenosis; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100958113

Write-up: cerebral infarction caused by right internal carotid artery stenosis; cerebral infarction caused by right internal carotid artery stenosis; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121317. A 73-year and 2-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EW0201, Expiration date: 30Sep2021), at the age of 73-year and 2-month-old, on 08Jul2021 at 09:30 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.0 degrees Centigrade. Medical history included hypertension, stroke, and right internal carotid artery stenosis. The patient family history was not reported. Concomitant medications included candesartan cilexetil (BLOPRESS, strength: 4 mg) taken for hypertension orally at 12 mg daily, 1 tablet in the evening/8 mg, 1 tablet in the morning; atenolol (TENORMIN, strength: 25 mg) taken for hypertension orally at 1 tablet in the morning; amlodipine besilate (NORVASC, strength: 5 mg) taken for hypertension orally at 1 tablet in the morning; and lansoprazole (TAKEPRON, formulation: orodispersible tablet, strength: 15 mg) orally at 1 tablet in the evening. On 08Jul2021 at 09:30 (the day of vaccination), the patient received the first dose of BNT162B2. On 12Jul2021 at 03:00 (3 days 17 hrs 30 min after the vaccination), the patient experienced cerebral infarction caused by right internal carotid artery stenosis. The patient was admitted to the reporter''s clinic, and then transferred to hospital B. On an unknown date, the patient died. It was not reported if an autopsy was performed. The outcome of the events was fatal. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was stroke. The reporting physician commented as follows: Existence of internal carotid artery stenosis had been confirmed before vaccination. Thus, the causal relationship was unknown.; Reporter''s Comments: Existence of internal carotid artery stenosis had been confirmed before vaccination. Thus, the causal relationship was unknown.; Reported Cause(s) of Death: cerebral infarction caused by right internal carotid artery stenosis; cerebral infarction caused by right internal carotid artery stenosis


VAERS ID: 1527759 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Chest X-ray, International normalised ratio, Respiratory arrest
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   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: WARFARIN POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Name: Chest X-ray; Test Result: 58.2 %; Comments: CTR; Test Name: PT-INR; Result Unstructured Data: Test Result:1.7
CDC Split Type: JPPFIZER INC202100958392

Write-up: acute exacerbation of cardiac failure; Respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121417. An 84-year-old female patient (reported as 84-year and 3-month-old) received bnt162b2 (COMIRNATY), dose 1 intramuscular on 26Jul2021 13:50 (Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation. The patient had no family history. Concomitant medication included warfarin potassium for atrial fibrillation. On 27Jul2021 at 05:20 (15 hours and 30 minutes after the vaccination), the patient experienced respiratory arrest. On 27Jul2021 at 06:27 (16 hours and 37 minutes after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 26Jul2021 at 20:00, the patient went to bed with no significant changes from the day before. On 27Jul2021 at 05:20, the patient was found to be in respiratory arrest. The patient was transported to Hospital A by ambulance. On the same day at 06:27, the death was confirmed. Event respiratory arrest caused emergency room visit and treatment was received. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was acute exacerbation of cardiac failure. The patient underwent lab tests and procedures which included body temperature: 36.3 centigrade before vaccination on 26Jul2021, chest x-ray: 58.2 % CTR on unspecified date, PT-INR (international normalised ratio): 1.7 on unspecified date. The patient died on 27Jul2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Respiratory arrest; acute exacerbation of cardiac failure


VAERS ID: 1527760 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Death
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: 2021-06-24
   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: FEBURIC; ZAFATEK; ATELEC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Hyperuricaemia; Prostatic hyperplasia; Small cell lung cancer (complete remission); Thoracic aortic aneurysm (48 mm)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100958415

Write-up: The postmortem certificate reported that Unknown cause, time of death, June 24th 22:04; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122028. A 76-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Jun2021 18:20 (Batch/Lot Number: FA5765; Expiration Date: 30Sep2021), at same age, as DOSE 2, SINGLE for covid-19 immunisation. Medical history included thoracic aortic aneurysm (48 mm), small cell lung cancer (complete remission), hyperuricaemia, hypertension, prostatic hyperplasia and diabetes mellitus. Concomitant medications included febuxostat (FEBURIC); trelagliptin succinate (ZAFATEK); and cilnidipine (ATELEC). The patient previously received the first dose of BNT162b2 (COMIRNATY) on an unknown date for covid-19 immunisation. The patient experienced cardio-respiratory arrest on 24Jun2021 with outcome of fatal. The patient died on 24Jun2021. An autopsy was performed that revealed unknown cause of death. On 24Jun2021 at unknown time (one day after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: On 23Jun2021, there was no problem. On 24Jun2021 after 20:00, the patient returned home and then spent time alone. On 25Jun2021 in the morning, the patient was in the state of cardio-respiratory arrest in the bathroom at home. Ambulance team confirmed the death and reported to the local police. It was not incidental, but the patient was alone at the time of death, therefore the body was placed at the local police until the medical examiner visit on the following day. On 26Jun2021, an internal examination was performed at the facility of medical examination. No traumatic injury, no rupture of known aortic aneurysm. The postmortem certificate reported that Unknown cause, time of death, June 24th 22:04. On 30Jun2021, the private funeral was completed. Tissue examination was performed at the facility of medical examination, but the result was not received. The reporting physician classified the event as serious (fatal) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had many primary diseases, but each of them was stabilized, and the postmortem could not indicate the organic cause of death. The primary physician reported the case because there were many unknown parts in the cause of death and there could be a causal relationship with the vaccination.; Reported Cause(s) of Death: The postmortem certificate reported that Unknown cause, time of death, June 24th 22:04; Cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: The postmortem certificate reported that Unknown cause, time of death, June 24th 22:04


VAERS ID: 1527761 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Abscess, Bedridden, Blood test, Computerised tomogram, Dysphonia, Ear disorder, Fatigue, Feeling abnormal, Gait disturbance, Physical deconditioning, Pneumomediastinum, Speech disorder
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 3
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: 20210718; Test Name: Blood test; Result Unstructured Data: Test Result:No renal or hepatic findings; Test Date: 20210718; Test Name: CT; Result Unstructured Data: Test Result:Mediastinal emphysema; Comments: mediastinal emphysema and abscess in the mediastinum of the head
CDC Split Type: JPPFIZER INC202100958441

Write-up: Mediastinal emphysema; abscess in the mediastinum of the head; Difficulty in walking; Inability to say words other than "tired"; tired; Strange feeling in the right ear and the head; Strange feeling in the right ear and the head; Difficulty in emiting a voice; Physical deconditioning; Tendency to stay in bed during the daytime; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21121413.?A 69-year and 2-month-old female patient received?the first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration in the right arm on 13Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. Body temperature before vaccination was unknown. It was unknown whether there were 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''s medical history and concomitant medications were not provided. On 16Jul2021 (3 days after the vaccination), the patient claimed strange feeling in the right ear and the head, hard to emit a voice, physical deconditioning, and tendency to stay in bed during the daytime. On 18Jul2021 (5 days after the vaccination), the patient experienced difficulty in walking, inability to say words other than "tired," and mediastinal emphysema. On 19Jul2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 16Jul2021, about 3 days after the vaccination, the patient complained of strange feeling in the right ear and the head as well as difficulty in emitting a voice. Thereafter, the patient''s physical conditions worsened and tended to stay in bed even during the daytime. On 18Jul2021, in the morning, the patient experienced difficulty in walking and inability to say words other than "tired." At around 12:00, she visited the reporting hospital, where computed comography (CT) showed mediastinal emphysema and abscess in the mediastinum of the head. Blood test was also performed and no renal or hepatic findings observed. Therapeutic measures were taken as a result of the event mediastinal emphysema included the patient was managed with tracheal intubation. (Abbreviations with no details) but her condition did not improve. At 15:20, the patient died. Events resulted in physician office visit. Outcome of the event mediastinal emphysema was fatal, while of the other events was unknow. 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 was unassessable. Other possible cause of the event such as any other diseases was illegible from illegible was also possible. Reporter comment: Because the vaccine was administered to the right arm and the emphysema was strong near the right clavicle, the pathway of vaccination site (illegible) was also unclear and could not be estimated. The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up. ; Reported Cause(s) of Death: Mediastinal emphysema


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

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Body temperature, Cardio-respiratory arrest, Dyspnoea, Fall, Fibrin D dimer, Loss of consciousness, Malaise, Platelet count, Sudden cardiac death, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer stage I (Regular hospital visits for lung cancer (stage IA, resection in 2019, passed without recurrence)); Pulmonary resection (Regular hospital visits for lung cancer (stage IA, resection in 2019, passed without recurrence)); Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: K; Test Result: 8.8 meq; Comments: increased; Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210727; Test Name: D-dimer; Result Unstructured Data: Test Result:1174 ug/ml; Comments: increased; Test Date: 20210727; Test Name: Plt; Result Unstructured Data: Test Result:65000 /mm3
CDC Split Type: JPPFIZER INC202100958723

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


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

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

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

Write-up: lying with no consciousness; Consciousness disturbed due to Subarachnoid haemorrhage; Consciousness disturbed due to Subarachnoid haemorrhage; Respiratory arrest; Cardiac arrest; This is a spontaneous report from a contactable primary physician received from the Regulatory authority. Regulatory authority report number is v21121566. The patient was a 76-year and 2-month-old male. Body temperature before vaccination was 35.5 degrees centigrade. The patient family history was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY5420, Expiration date 31Aug2021). On 24Jul2021 at 15:20 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 27Jul2021 at unknown time (three days after the vaccination), the patient experienced Consciousness disturbed due to Subarachnoid haemorrhage. On 28Jul2021 (four days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27Jul2021 at about 11:00, the family of patient confirmed that the patient was doing well, and left home. On 27Jul2021 at about 11:45, the patient was found lying with no consciousness, and ambulance was called. The patient was transported to hospital of the reporter. The detailed examination was performed and the patient was diagnosed with Subarachnoid haemorrhage. After the diagnosis, Respiratory arrest and Cardiac arrest occurred. On 28Jul2021 at 00:48, the patient was confirmed dead. The reporting physician did not report the seriousness of the event and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was not reported. The reporting physician did not report any further comment.; Reported Cause(s) of Death: Consciousness disturbed; Respiratory arrest; Cardiac arrest; lying with no consciousness; Subarachnoid haemorrhage


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

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

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

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


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

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

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

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


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

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

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

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


VAERS ID: 1527773 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100960971

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EPADEL [EICOSAPENTAENOIC ACID ETHYL ESTER]; AMLODIPINE; AZILVA; MAGMITT; LOXONIN PAP
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100963308

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bedridden; Cardiac failure (Pulmonary fibrosis and cardiac failure were progressing gradually.); Circulatory instability; Hospitalisation (discharge to home became difficult); Oral intake reduced; Oxygen therapy; Pulmonary fibrosis (Pulmonary fibrosis and cardiac failure were progressing gradually.); Respiratory failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100963309

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100963311

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


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100963351

Write-up: possibility of a thrombotic disease was likely; Death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 86-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 22Jun2021 (Lot Number: FA5765; Expiration Date: 30Sep2021) (at age of 86-year-old) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EY5420, Expiration date 31Aug2021) for covid-19 immunization. The family history, medical history and concomitant medications were not provided. On 28Jun2021 (6 days after the vaccination), the patient experienced death. On 28Jun2021 (6 days after vaccination), the patient died at his home. The cause of death was unknown (no autopsy was performed). The causality between the event and BNT162b2 vaccination was unknown at all. However, since the patient was undergoing a catheter, the possibility of a thrombotic disease was likely. The causality between the event and BNT162b2 was not provided. The patient died on 28Jun2021. An autopsy was not performed.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The reported thrombotic disease is likely an intercurrent medical condition and unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death; possibility of a thrombotic disease was likely


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

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

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

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


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

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

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

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


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic (NT-pro BNP was 1186 pg/mL)
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: blood pressure; Result Unstructured Data: Test Result:96/57; Test Date: 20210709; Test Name: blood pressure; Result Unstructured Data: Test Result:72/43; Test Date: 20210624; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210625; Test Name: body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Date: 20210626; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210630; Test Name: body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210705; Test Name: body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:39.0 Centigrade; Test Date: 20210708; Test Name: pulse rate; Result Unstructured Data: Test Result:102; Test Name: SpO2; Result Unstructured Data: Test Result:90s %; Comments: SpO2 was maintained at 90s% (it was 92 to 98% until 08Jul2021); Test Date: 20210708; Test Name: SpO2; Test Result: 92 %; Test Date: 20210709; Test Name: SpO2; Test Result: 82 %; Comments: at 15:00
CDC Split Type: JPPFIZER INC202100967306

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100970127

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Regulatory Authority. A 73-years-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot number FC9909, Expiration date 30 Sept, 2021) via intramuscular route of administration in the arm left on 07Jul2021 at 10:45 (at the age of 73-years-old) at single dose for covid-19 immunisation. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient medical history included rheumatoid arthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient concomitant medication was none. The patient previously took carbamazepine and experienced drug eruption. the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot number EY3860, Expiration date 31Aug2021) via intramuscular route of administration in the arm left on 16Jun2021 at 10:45 (at the age of 73-years-old) at single dose for covid-19 immunization. On 14Jul2021 (7 days after the vaccination), the patient experienced death. The reported event was as follows: On 07Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. After the vaccination, the patient did not visit a hospital or consult with a physician. On 14Jul2021 at 14:33 (7 days, 3 hours, and 48 minutes after vaccination), the patient was found lying down at her home. The patient had postmortem rigidity, and her death was confirmed. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (death). The cause of the death was unknown. An autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE; LANSOPRAZOLE; FUROSEMIDE; NITRODERM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Cardiac failure chronic; Endoscopic submucosal dissection; Gastric cancer; Gastric ulcer haemorrhage; Spinal cord injury
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: PCR (Nasal Swab); Test Result: Negative
CDC Split Type: JPPFIZER INC202100976123

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


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatic disease; Renal disease
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100979105

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperlipidaemia; Hypertension (Mild (150s/80s))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.7 degrees Celsius; Test Name: Postmortem examination; Result Unstructured Data: Cause of death was suspected heart disease and the etiology was unclear. As per additional note, bilateral pleural effusions were noted on autopsy imaging (AI)
CDC Split Type: JPTAKEDA2021TJP065313

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 49
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMOXICILLINE/CLAVULAANZUUR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:no results reported; Test Name: Thorax X; Result Unstructured Data: Test Result:no results reported
CDC Split Type: NLPFIZER INC202100954761

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


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

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

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

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


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

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

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

Write-up: PASSED AWAY/DEATH; FLU-LIKE SYMPTOMS INCLUDING FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included obese. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) .5 ml, 1 total, administered on 24-JUL-2021 for Prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUL-2021, the patient experienced flu-like symptoms including fever. The patient was able to disclose adverse events he experienced to his friends and family members and the last they heard from patient was on 26 Jul 2021.The patient passed away on 01-AUG-2021, a week after the vaccination. On 01-AUG-2021, the patient died from unknown cause of death. An autopsy was not performed. The patient was cremated immediately after death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of passed away/death on 01-AUG-2021, and the outcome of flu-like symptoms including fever was not reported. This report was serious (Death).; Sender''s Comments: V0:20210801333- passed away/death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1527969 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: left sided body weakness; slurred speech; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority report. A 71-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Jun2021 (at the age of 71-years-old) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Jun2021, the patient experienced slurred speech and was hospitalized. The hospitalization was prolonged as a result of slurred speech. On the same day, the patient experienced left sided body weakness. The patient died due to slurred speech and left sided body weakness on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: left sided body weakness; slurred speech


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: PTPFIZER INC202100955104

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100960255

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


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

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

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

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


VAERS ID: 1528289 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100969792

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


VAERS ID: 1528290 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100969820

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


VAERS ID: 1528291 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100969821

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


VAERS ID: 1528292 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100969822

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


VAERS ID: 1528480 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-07-04
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202100966818

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 50
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: several exams; Result Unstructured Data: Test Result:all possible causes were discarded; Test Date: 20210721; Test Name: karyotype exam; Result Unstructured Data: Test Result:which exam was collected in the material in the on; Comments: which exam was collected in the material in the on 21Jul2021 when the patient died, that is: all tests that would identify genetic causes have already been done, and it was possible to discard all known causes; Test Date: 202106; Test Name: Ultrasound; Result Unstructured Data: Test Result:had hydrops fetalis/Anasarca
CDC Split Type: BRPFIZER INC202100950671

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


VAERS ID: 1528525 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210806312

Write-up: UNKNOWN CAUSE OF DEATH; This spontaneous report received from a physician via a Regulatory Authority [NLP] concerned a 43 year old male of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974 expiry: unknown) dose was not reported, 1 total administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210806312-Covid-19 vaccine ad26.cov2.s -UNKNOWN CAUSE OF DEATH. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1528571 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100974100

Write-up: sudden cardiac death; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 76914], license party for Comirnaty. A contactable physician reported that a 50-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sudden cardiac death on an unspecified date. However, the reporter is not sure whether the patient was vaccinated. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: As there is limited information in the case provided, the causal association between the event Sudden cardiac death and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: sudden cardiac death


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

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Intracardiac thrombus, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN 1A FARMA; ENALAPRIL KRKA; AMLODIPIN ACTAVIS [AMLODIPINE MESILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202100948619

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


VAERS ID: 1529455 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COPFIZER INC202100970198

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


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

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

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

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


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

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100948612

Write-up: Pulmonary thromboembolism; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-949006. A 56-year-old female patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot number was not reported) via an unspecified route of administration on 12Jun2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Historical vaccine includes first dose of bnt162b2 (COMIRNATY; Batch/Lot number was not reported) on 22May2021 for COVID-19 immunization. On 07Jul2021, patient experienced pulmonary thromboembolism, she was hospitalized and died on an unspecified date. The event was reported as serious (death, hospitalization, life threatening). It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pulmonary thromboembolism


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cesarean section (x2)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100948617

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

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

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

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


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

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardiac arrest, Cataplexy, Gastrointestinal disorder, Immune system disorder, Sepsis, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100973516

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


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202100985235

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


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