FDA Warns of Heart Risk With Pfizer, Moderna COVID-19 Vaccines

Safety Monitoring Continues

Continuous monitoring and assessment of the safety of all  vaccines, including the mRNA  COVID-19 vaccines, is an FDA priority and we remain committed to informing the public when we learn new information about these vaccines.

Vaccines& Immunizations

In addition, as part of the approvals of Comirnaty and Spikevax, each manufacturer is required by FDA to conduct a study to assess if there are long-term heart effects in people who have had myocarditis after receiving an mRNA  COVID-19 vaccine. These studies are underway.

How to Report a Suspected Adverse Event After Vaccination

Suspected adverse events may be reported to the Vaccine Adverse Event Reporting System (VAERS), which is co-managed by the FDA and the CDC.

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