FDA to add warning to COVID-19 vaccine on rare heart inflammation risk

Cases seen in people vaccinated with Pfizer, Moderna

FILE - In this Wednesday, May 19, 2021 file photo, a licensed practical nurse draws a Moderna COVID-19 vaccine into a syringe at a mass vaccination clinic at Gillette Stadium in Foxborough, Mass. On Wednesday, June 23, 2021, federal officials said they plan to strengthen cautions about a rare side effect of some COVID-19 vaccines chest pain and heart inflammation, mostly among teenagers and young adults. But in an unusual joint statement, top U.S. government health officials, medical organizations, laboratory and hospital associations and others stressed the overriding benefit of the vaccines. (AP Photo/Steven Senne) (Steven Senne, Copyright 2021 The Associated Press. All rights reserved)

The Food and Drug Administration said it is planning to add a warning to COVID-19 mRNA vaccines about the risk of heart inflammation and chest pain.

Officials discussed the vaccine’s benefits and risks of myocarditis and pericarditis, both terms referring to inflammation of the heart muscle and tissue surrounding the heart.

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The two-dose Pfizer and Moderna vaccines are both mRNA vaccines.

This all comes after reports of inflammatory heart conditions among some young adults and teens who were recently vaccinated.

In general, the cases appeared to be rare and mild, and they resolved quickly. There have been 323 confirmed reports of the inflammation in people younger than 30, and the vast majority recovered from their symptoms.

Dr. Raul Pino with the Florida Department of Health in Orange County said Wednesday that there have 28 reported cases of these side effects in Florida, so far.

Health experts emphasized the benefits of the mRNA COVID-19 vaccines outweigh the risks.