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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: Pericarditis; This is a spontaneous report from a contactable physician. A 75-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown), via an unspecified route of administration, on 12Mar2021 at the age of 75 years old as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 15Mar2021, the patient had experienced pericarditis. Treatment drug NSAIDs colchicine was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the event was recovering. Follow-up activities closed as no follow-up attempts required.; Sender''s Comments: Based on the close temporal relationship, A possible contributory role of the suspect product to the development of Pericarditis cannot be 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.
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