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Write-up: Cerebellar infarction; This is a spontaneous report from a contactable pharmacist received via a Regulatory Authority. The patient was 56-year-old. Whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Whether the patient received any other medications within 2 weeks of vaccination was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. In May2021 of an unspecified date, the patient received the single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was unknown because of unable to read the details (as reported)) for COVID-19 immunization. On 03Jun2021 (2 weeks after the vaccination), the patient was hospitalized due to cerebral infarction. Details unknown because the inoculation facility and hospitalization facility were different. The reporter classified the event as serious (hospitalized) and stated the event result in Emergency room/department or urgent care. The outcome of the event was unknown with treatment including Hematoma removal surgery. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested; Sender''s Comments: Based on the information currently available, the reported event cerebral infarction 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.
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