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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: Myocarditis; This is a spontaneous report from a non-contactable nurse via a Pfizer-sponsored program . An 18-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was admitted into the hospital with myocarditis after taking the Covid vaccine on an unspecified date. She was wondering when Pfizer would be reaching out to patient''s family as it was their vaccine that put the patient into the hospital. Also wondering if Pfizer was tracking this as a side effect. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the available information and known product information, the causal relationship between the reported myocarditis and use of BNT162B2 cannot be fully excluded. There is limited information with regards to medical history and clinical course thus precluding a more meaningful assessment. The case will be assessed further upon receipt of additional information. 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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