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Life Threatening? No
Write-up: Pericarditis; This is a spontaneous report from a non-contactable physician (patient). A female patient of unknown age received the second dose of bnt162b2 on 25Jan2021 (lot number: unknown) via unknown route of administration in Arm Right at single dose for COVID-19 immunization. Medical history and concomitant medications were reported none. Historical vaccine included the first dose of bnt162b2 on 04Jan2021 around 2Pm -3PM (lot number: unknown) for Covid-19 Immunization. Prior Vaccinations (within 4 weeks) there were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. AE following prior vaccinations were reported as None. Family Medical History Relevant to AE was reported as None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported None. Patient Had a problem and doctor told her to report this, did not know if it was related to the vaccine or not, wanted to know if there had been any other reports like this. Patient got pericarditis in mid Jun2021 that lasted until or around Aug2021. She did not know, maybe lasted until the second week in Aug2021. Clarified pericarditis started middle of Jul2021 on 16Jul2021. Patient did not have Pericarditis at the moment. Patient wanted to know whether it was ok to get the booster. Patient had No new medications, nothing changed in her life. Investigations included: Developed a positive Antinuclear Antibody, the autoimmune marker, around that time period after the pericarditis. First test was positive on 15Jun2021, repeat test was negative on 15Jun2021. The adverse event required a visit to Physician Office and Had tests done. The causality assessment between the event Pericarditis and the suspect drug was reported as unknown. The outcome of the event was recovered on 10Aug2021. No follow-up attempts are possible; information about lot batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on current available information, a possible contributory role of BNT162B2 cannot be completely excluded for event Pericarditis due to temporal relationship. However, current information is limited and does not allow a full 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.
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