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June 29, 2021Heart Inflammation Warning Added to EUA Fact Sheets for Pfizer/BioNTech and Moderna COVID-19 Vaccines
June 25, 2021 – Emergency use authorization (EUA) fact sheets for the Pfizer/BioNTech and Moderna COVID-19 vaccines now include a warning about myocarditis and pericarditis following vaccination. According to the U.S. Centers for Disease Control and Prevention (CDC), there have been reports of increased cases of myocarditis and pericarditis occurring after vaccination with these products, particularly in adolescents and young adults.
Myocarditis and pericarditis are types of heart inflammation. In myocarditis, the heart muscle becomes inflamed. Pericarditis describes inflammation of the lining outside the heart. Symptoms may include chest pain, shortness of breath, or palpitations (the feeling that the heart is pounding, racing, fluttering, or missing beats).
In most reported instances, patients responded well to medication and rest, with prompt improvement in their symptoms. The cases occurred predominantly in male adolescents and young adults who were at least 16 years old, with onset of heart inflammation usually happening several days after administration of a second dose of the Pfizer/BioNTech or Moderna COVID-19 vaccine. The CDC continues to recommend COVID-19 vaccination for anyone who is at least 12 years old because of the risk presented by COVID-19 and potentially severe complications of the disease.
Heart inflammation in individuals receiving the Pfizer/BioNTech or Moderna vaccine is extremely rare. The rate of occurrence as of June 25, 2021, was 12.6 cases per million doses.