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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: myocarditis; This is a spontaneous report from a contactable nurse reported for a patient via a Pfizer company representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on an unspecified date (batch/lot number and expiry date unknown) as dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The nurse reported "Verbatim question: for the covid vaccine, 12 and up, they encountered myocarditis. Can you please send/call her about this. She''s a pediatrician. She would like more info.". The outcome of the event was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on available information and known drug profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and the reported event myocarditis. 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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