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Safety of the BNT162b2 mRNA COVID-19 vaccine in a nationwide setting

New England Journal of Medicine Aug 30, 2021

Barda N, Dagan N, Ben-Shlomo Y, et al. - No correlation of receiving the BNT162b2 vaccine was observed with an elevated risk of most of the adverse events examined in this nationwide mass vaccination setting. Risk of myocarditis appeared high following the vaccination (1 to 5 events per 100,000 persons). SARS-CoV-2 infection results in a substantially increased risk of this potentially serious adverse event and of many other serious adverse events.

  • Nearly 884,828 persons were included in each of the vaccinated and control groups.

  • Association of vaccination was strongest with an increased risk of myocarditis, lymphadenopathy, appendicitis, and herpes zoster infection.

  • Risk of myocarditis and of additional serious adverse events, including pericarditis, arrhythmia, deep-vein thrombosis, pulmonary embolism, myocardial infarction, intracranial hemorrhage, and thrombocytopenia, was substantially increased in correlation with SARS-CoV-2 infection.

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