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Life Threatening? No
Write-up: Myocarditis; Arrhythmia; Chillblains; This is a spontaneous report received from a contactable other Health Care Professional. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2, intramuscular, administered in left deltoid on 08Feb2021 (Lot Number: EL9265), at the age of 70 years, as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications taken within two weeks of vaccination included vitamins nos, acetylsalicylic acid (ASPIRIN (E.C.), Vitamin D nos, metoprolol tartrate (LOPRESSOR), atorvastatin calcium (LIPITOR). Historical vaccine included BNT162b2, dose 1 on 14Jan2021, lot # EL3216, intramuscular in right deltoid. On an unspecified date, the patient experienced myocarditis, arrhythmia, and chilblains. The patient had lab tests which included haematology test: normal on 17Feb2021, clinical chemistry: normal on 17Feb2021, sars-cov-2 test negative: negative on 22Feb2021. The clinical outcome of the events myocarditis, arrhythmia, and chilblains was unknown.; Sender''s Comments: Based on an implied vaccine-event chronological association, a causal relationship between reported events and PFIZER-BIONTECH COVID-19 mRNA VACCINE cannot be completely excluded. The case will be reevaluated should additional information become 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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