The warning notes that reports of side effects after vaccination — especially after the second dose — indicate an increased risk of both types of heart inflammation.
Earlier this week, vaccine advisers from the U.S. Centers for Disease Control and Prevention learned that the agency had received about 1,200 reports of such heart inflammation after 300 million doses of the two vaccines were given. CDC has confirmed about 300 of those cases, many of them among young men and adolescents.
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But patients recover quickly, Dr. Matthew Oster, a pediatric cardiologist, told advisers.
The FDA advises vaccine recipients to seek immediate medical attention if they experience “chest pain, shortness of breath, or feelings of a fast beating, fluttering, or pounding heart after vaccination.”
“This update follows a comprehensive review of information and discussion by CDC’s Advisory Committee on Immunization Practices meeting Wednesday,” the FDA said.
“The data presented at this meeting reinforced the FDA’s decision to revise the factsheets and further informed the specific revisions.”
The FDA said at the time it would update the fact sheets to reflect the findings.
Both the FDA and CDC are monitoring reports of these side effects and will follow up on them to assess longer-term results, the FDA noted.