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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||FA2453 / 1||- / -|
Administered by: Other Purchased by: ??
Symptoms: Body temperature, Urinary tract infection, Disease recurrence
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: Bedridden; Convulsion (the patient was taking anticonvulsant orally); Late effects of cerebral stroke (the patient was taking anticonvulsant orally); Pneumonia; Urinary tract infection
Diagnostic Lab Data: Test Date: 20210614; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination
CDC 'Split Type': JPPFIZER INC2021750228
Write-up: Urinary tract infection; Urinary tract infection; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21115416. An 86-year-old male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 14Jun2021 14:38 (Lot Number: FA2453; Expiration Date: 31Aug2021) at the age of 86 years old, as single dose for covid-19 immunisation. The patient was an 86-year and 9-month-old male. Body temperature before vaccination on 14Jun2021 was 36.8 degrees Celsius. The patient had no family history. Medical history included prior convulsion due to late effects of cerebral stroke (for which the patient was taking anticonvulsant orally), prior pneumonia, and prior urinary tract infection. On 14Jun2021 at 14:38 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 18Jun2021 (4 days after the vaccination), the patient experienced urinary tract infection. On 20Jun2021 (6 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 18Jun2021, the patient developed urinary tract infection, for which antibacterial agent and NSAID were administered. On 20Jun2021, the patient took a sudden turn for the worse and died. The patient had long been bedridden most of the time (nursing care level 4) and had history of pneumonia and urinary tract infection. The patient died on 20Jun2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases included neurogenic bladder due to late effects of cerebral stroke. The reporting physician commented as follows: It was presumed to be unrelated to the vaccination.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a role of BNT162B2 to the development of fatal urinary tract infection can be totally 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: Urinary tract infection; Urinary tract infection
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