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Administered by: Pharmacy Purchased by: ?
Life Threatening? Yes
Write-up: stroke; This is a spontaneous report from a non-contactable pharmacist. A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at the age of 71-years, at single dose in right arm on 02Apr2021 09:00 (Lot number: EP7533) for COVID-19 immunisation. The patient medical history was not reported and there were no known allergies. Concomitant medications included rivaroxaban (XARELTO); empagliflozin (JARDIANCE); lisinopril all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at the age of 71-years, at single dose in right arm on 05Mar2021 09:00 (Lot number: EN6199) for COVID-19 immunisation. The patient experienced stroke on 11Apr2021 (Stroke 7 days after injection (as reported)), it resulted in "Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event) and Disability or permanent damage". The patient was hospitalized for stroke for 2 days. The patient was not diagnosed with COVID prior to vaccination and he had not been tested for COVID since the vaccination. Event outcome was not recovered. No follow up attempts are possible. No further information is expected.; Sender''s Comments: The reported stroke is likely due to an underlying medical condition and unrelated to BNT162B2. Although temporally related, there is no sufficient evidence that the reported stroke is related to BNT162B2. Note that the patient''s medical history was not reported, however, patient is taking rivaroxaban and lisinopril for unspecified indication. 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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