Heart Inflammation Risk: FDA Expands Side Effects of COVID-19 Vaccines

On Friday, June 25, the US Food and Drug Administration (FDA) added a myocarditis and pericarditis risk warning to the Moderna and Pfizer-BioNTech COVID-19 vaccine fact sheets. The edition told in more detail CNN.

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The warning notes that reports of side effects after vaccination—especially after the second dose—suggest an increased risk of both types of heart inflammation.

Recently, the US Centers for Disease Control and Prevention (CDC) stated that agency received about 1200 heart disease reports after 300 million doses of two vaccines... The CDC has confirmed about 300 of these cases, many in young men and adolescents.

But patients are recovering quickly, said pediatric cardiologist Dr. Matthew Oster.

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The FDA recommends that vaccine recipients seek immediate medical attention if they experience "chest pain, shortness of breath, or a feeling of rapid heartbeat, flutter, or pounding after vaccination."

“This update follows extensive review and discussion at the CDC's Advisory Committee on Immunization Practices (ACIP),” the FDA said. “The data presented at this meeting supported the FDA's decision to review its COVID-19 vaccine fact sheets.”

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ACIP members agreed that there is a likely link between mRNA vaccines for COVID-19 and rare cases of heart inflammation in adolescents and young adults. Almost all cases resolved with little treatment, and patients recovered quickly. The consultants said the benefits of vaccinations outweigh the risks.

The FDA said it will update the fact sheets to reflect the findings.

Both the FDA and CDC are tracking reports of vaccine side effects and will monitor their long-term results, the FDA noted.

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