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Life Threatening? No
Write-up: acute pericarditis; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 23Dec2020 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if other vaccines were given in four weeks and unknown if patient had Covid prior vaccination. The patient experienced acute pericarditis on 24Dec2020. Clinical course as follows: Doctor colleagues at the institution admitted (at Emergency room/department or urgent care) and treated a patient with acute pericarditis who received his first dose of Pfizer SARS-CoV-2 EUA vaccine on 23Dec2020. The physician (reporter) considered the event as non-serious. The outcome of the event was recovering. Information about batch/lot number has been requested.; Sender''s Comments: The causal relationship between BNT162B2 and the event acute pericarditis cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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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