FDA confirms increased risk of heart swelling with vaccine
FDA confirms increased risk of heart swelling with vaccine the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks. fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine http://web.archive.org/web/20210823134524/fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
