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Life Threatening? No
Write-up: nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report 2021, 1-4; entitled Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. A 44-year-old woman was hospitalized for nausea, vomiting and chest pain on the day that she received the Pfizer vaccine (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) at single dose (at 44-year-old) for COVID-19 immunization. Her laboratory values included a platelet count of 85 x 109/L and a peak troponin level of 4 ng/mL (normal < = 0.04 ng/mL). The patient was diagnosed with myocarditis but did not require treatment for thrombocytopenia. Her platelets were 61 x 109/L on discharge, but subsequent platelet counts were not reported. The outcome of the events was unknown. No follow-up attempts are needed. Information on Lot/batch number cannot be obtained.; Sender''s Comments: The causal association cannot be excluded between the reported events and BNT162B2 vaccine use. 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 AE. 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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