FDA requires updated warning about rare heart risk with COVID shots

Publication date: Jun 26, 2025

The Centers for Disease Control and Prevention previously concluded there was no increased risk of myocarditis detected in government vaccine injury databases for COVID-19 shots dating back to 2022. Officials also noted that cases tend to resolve quickly and are less severe that those associated with COVID-19 infection itself, which can also cause myocarditis. They’ve also suggested seasonal tweaks to match the latest circulating virus strains are new products that require extra testing. The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men. Myocarditis, a type of heart inflammation that is usually mild, emerged as a complication after the first shots became widely available in 2021. The FDA’s label update is the latest step by officials working under Kennedy to restrict or undercut use of vaccines. The label also notes that the problem has been most common among males ages 12 to 24.

Concepts Keywords
April Covid
Dating Fda
Fda Heart
Myocarditis Kennedy
Label
Myocarditis
Rare
Risk
Shots
Update
Vaccine
Vaccines
Warning
Warnings

Semantics

Type Source Name
drug DRUGBANK Coenzyme M
disease IDO site
disease IDO object
disease MESH PANIC
drug DRUGBANK Pirenzepine

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