The U.S. Food and Drug Administration (FDA) on Friday added a warning about the risk of myocarditis and pericarditis to fact sheets for Moderna and Pfizer-BioNTech Covid-19 vaccines .
The warning notes that reports of adverse events following vaccination — particularly after the second dose — suggest increased risks of both types of heart inflammation.
As of June 11, more than 1,200 cases of myocarditis or pericarditis have been reported to the U.S. Vaccine Adverse Event Reporting System (VAERS), out of about 300 million mRNA vaccine doses administered.
The FDA is advising vaccine recipients to seek immediate medical attention if they experience “chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination.
“This update follows an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices meeting on Wednesday,” the FDA said.
“The data presented at this meeting reinforced the FDA’s decision to revise the fact sheets and further informed the specific revisions,” the FDA said in a statement.
The FDA and CDC, both agencies are monitoring the reports, collecting more information, and will follow-up to assess longer-term outcomes over several months.
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