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Life Threatening? No
Write-up: early stages of pericarditis or the shingles; severe chest pain; early stages of pericarditis or the shingles; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL1283, unknown expiration), via an unspecified route of administration in left arm on 13Jan2021 at 13:00 (01:00 PM; at the age of 48 years old) at a single dose for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient has no known allergies. The patient also received first dose of BNT162B2 (Brand: Pfizer; Lot number: EJ1685, unknown expiration) on 23Dec2020 at 01:00 PM in left arm (at the age of 48 years old) for COVID-19 immunization. The patient went to the ER with severe chest pain. After many tests were run, doctors believed that the patient was in early stages of pericarditis or the shingles on 17Feb2021 at 04:00 AM. The patient confirmed that she never developed shingles but have had all symptoms of pericarditis. The events resulted in emergency room/department or urgent care visit. The patient received NSAIDs and pain meds as treatment for the events. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information, the Company considers the reported event pericarditis is unrelated to BNT162B2 vaccine, but more likely an inter-current medical condition. 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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