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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||EX3617 / UNK||- / -|
Administered by: Other Purchased by: ??
Symptoms: Brain stem infarction
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: Cerebral infarction; Cerebration impaired; Dementia; Urinary tract infection
Diagnostic Lab Data:
CDC 'Split Type': JPPFIZER INC2021702695
Write-up: Brain stem infarction; This is a spontaneous report from a contactable other health professional received via a Pfizer sales representative. An 81-years-old male patient received unknown dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 20May2021 (Lot Number: EX3617; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. The patient was an 81-year-old male. Medical history included urinary tract infection, higher brain dysfunction, dementia, and cerebral infarction. Concomitant medications were not reported. On 20May2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Dose number was not reported, Lot number EX3617, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 26May2021 (6 days after the vaccination), the patient experienced brain stem infarction. The outcome of the event was fatal. The course of the event was as follows: On 20May2021, the patient was vaccinated. On 26May2021, the patient died. Brain stem infarction was reported in death certificate. Since the patient died 1 week after the vaccination, causality was considered low. The reporting other health professional classified the event as serious (death) and assessed that that the event was possibly related to BNT162B2. The outcome of the event was fatal. It was unknown if an autopsy was performed.; Sender''s Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the event brain stem infarction onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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: Brain stem infarction
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