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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||FA7338 / 1||LA / OT|
Administered by: Other Purchased by: ??
Symptoms: Cardio-respiratory arrest, Sudden death
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure; Influenza A virus infection; Rhabdomyolysis; Schizophrenia
Diagnostic Lab Data:
CDC 'Split Type': JPPFIZER INC2021718074
Write-up: confirmed dead/Sudden death with unknown cause of death; found in a state of cardio-respiratory arrest in the toilet; This is a spontaneous report from a contactable physician via a company representative via the Agency. The patient was a non-pregnant 71-year-old female. Underlying disease/complication included schizophrenia. Other medical history included influenza A, rhabdomyolysis, and acute renal failure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included antipsychotic drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. On 15Jun2021 at 11:10 (at age of 71 years old, no pregnant, the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) intramuscularly into the left arm as a single dose for COVID-19 immunization. On 16Jun2021 at 15:30 (1 day after the vaccination), the patient was found in a state of cardio-respiratory arrest in the toilet. On 16Jun2021 at 15:45 (1 day after the vaccination), the patient experienced sudden death with unknown cause of death. Autopsy was performed with unknown results. The outcome of the event was fatal. The course of the event was as follows: On 16Jun2021 at 15:30 (1 day after the vaccination), the patient was found in a state of cardio-respiratory arrest in the toilet. Cardiac massage was immediately started. A transfusion route was secured, and oxygen was administered. The patient was placed with an automated external defibrillator (AED) but was unresponsive, and at 15:45, she was confirmed dead. As it was considered as sudden death with unknown cause of death, a contact was made to the police. After a questioning, the corpse was transported. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unknown.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events cardiorespiratory arrest (Fatal) and sudden death and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: found in a state of cardio-respiratory arrest in the toilet; confirmed dead/Sudden death with unknown cause of death
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