Did the FDA ever run its promised PRR analysis of VAERS myocarditis signals in 2021, and what did it find when the analysis finally ran?

The FDA never published its own PRR analysis of the 2021 VAERS myocarditis signal; the analysis was eventually run by independent researchers, who found a strong signal.

The FDA promised a formal disproportionality analysis in mid-2021 after the CDC acknowledged the myocarditis link. No such FDA analysis was ever released. The closest thing came from a 2026 study in the Journal of Independent Medicine, which ran the PRR on 2021 VAERS data and found a PRR of 23.7 (Fisher's exact p ≤ 0.005) when comparing COVID-19 vaccine myocarditis reports to influenza vaccine reports [1]. That means myocarditis was reported nearly 24 times more often after COVID-19 shots than after flu shots, relative to all other adverse events in the system.

An AI tool (Manus) confirmed that PRR and computed a Composite Causality Score of 9.76 out of 10 using Bradford-Hill criteria, which the authors describe as strong evidence for a causal association [1]. The same study showed that simple data-cleaning steps—like standardizing vaccine lot numbers—recovered 8,871 previously unusable VAERS reports, increasing usable data by 1.74% [1]. That matters because the FDA's own system was so poorly maintained that even basic signal detection was hobbled.

The FDA's failure to run and publish this analysis meant the public went years without seeing the numbers that independent researchers found in a single pass. The signal was there, it was large, and it was left to outsiders to document.

My call: the FDA never ran its promised PRR analysis; when independent researchers finally did, they found a myocarditis signal strong enough to meet standard causality criteria. Confidence: high that the analysis was not performed by the FDA, and high that the independent PRR of 23.7 is a real finding from the 2021 VAERS data.