FDA Issues New Heart Risk Alert for COVID Vaccines
If you have received a COVID-19 vaccine or are due for another dose, the FDA has just issued an update you should know before committing.
In June 2025, the Food and Drug Administration quietly updated the fact sheets for both Pfizer and Moderna's mRNA COVID-19 vaccines.
What Changed?
The risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) has been on the FDA's radar since 2021. However, until now, the fact sheets have not alerted people with a history of these conditions.
That's changed.
The new guidance says anyone who's had myocarditis or pericarditis before should talk to their doctor before getting another mRNA COVID shot.
In plain terms, If you've had heart inflammation before, don't roll up your sleeve without a conversation with your healthcare provider first.
Who's Most at Risk?
The update does not change who's statistically most likely to experience this rare side effect. The highest risk still falls on:
Young males (ages 12 to 29)
Especially after their second mRNA vaccine dose
Cases have mostly appeared within a few days post-shot, with symptoms like:
Chest pain
Shortness of breath
A racing or pounding heartbeat
If any of these effects kick in after your vaccine, call your doctor immediately.
How Serious Is This?
These cases are still extremely rare, considering the millions of doses that have been delivered. Most people who've developed post-vaccine heart inflammation had mild cases and recovered quickly with rest and treatment.
The FDA is not saying to stop vaccinating but to be aware, especially if you've had heart issues before.
Why Issue This Update Now?
Short answer: Ongoing safety monitoring.
The FDA and CDC have been tracking post-vaccine side effects for years, utilizing systems such as VAERS (Vaccine Adverse Event Reporting System). The new label update reflects continued data showing a pattern of risk, particularly for young males and individuals with a history of heart inflammation.
Should You Still Get Vaccinated?
For most people, the FDA and CDC are still saying yes.
Both organizations state that the benefits of COVID-19 vaccines still outweigh the risks, especially when considering the higher risk of heart complications associated with contracting COVID-19.
But suppose you've had myocarditis or pericarditis in the past. In that case, this is your cue to pause and have an honest conversation with your doctor first.
What's Next?
If you're getting a COVID-19 shot (or thinking about it), know your personal health history and pay attention to new guidance.
And if you've had heart inflammation before?
Consult with your healthcare provider before scheduling an mRNA COVID-19 vaccine.
Report any post-vaccine symptoms to the VAERS system for national monitoring.
Public health agencies continue to recommend staying up to date on COVID-19 vaccinations, particularly with the emergence of new variants.
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