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Life Threatening? No
Write-up: Patient developed documented endocarditis on day 7 post administration; This is a spontaneous report from a contactable pharmacist. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 intramuscular, administered in left arm on 13Sep2021 (Batch/Lot Number: EC0179) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on an unspecified date (Batch/Lot Number: EC0179) as dose 2, single for COVID-19 immunisation. The patient experienced patient developed documented endocarditis on day 7 post administration on 19Sep2021. The event led to hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient been tested for COVID-19. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of endocarditis cannot be fully 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 to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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