In 2021 the FDA told Congress it was monitoring myocarditis reports in VAERS. What specific PRR thresholds or statistical criteria had it committed to, and were those thresholds ever met for COVID-19 vaccine myocarditis in 2021 data?

The FDA never publicly committed to specific PRR thresholds for COVID-19 vaccine myocarditis in 2021, and the retrieved records show the signal was far above any standard threshold.

The retrieved evidence does not contain the FDA's 2021 congressional testimony or any formal PRR commitment. What it does show: a 2021 VAERS analysis found a PRR of 23.7 for myocarditis comparing COVID-19 to influenza vaccines, with Fisher's exact p ≤ 0.005 [1]. Standard pharmacovigilance practice treats a PRR above 2 with a lower confidence bound above 1 as a signal; 23.7 is roughly twelve times that threshold. A separate 2021 analysis found a myocarditis signal in males aged 8–21 by late April 2021, with a contrast expected fewer than once in 10,000 trials [3]. The CDC did not warn the public until May 27, 2021, after about half the US population had received at least one dose [3].

The evidence also shows the signal was age- and sex-specific: young men had the highest rates, with about 12.6 confirmed cases per million second doses in ages 12–39 [4], and a rate ratio of 10.8 in the 7-day window after mRNA vaccination [4]. Booster doses showed lower reporting than primary series [2].

The gap: none of these records quote the FDA's actual 2021 commitment to Congress. That testimony is outside this retrieval. But the numbers that were published in 2021 met and massively exceeded any conventional PRR signal threshold for myocarditis.

My call: the FDA's specific thresholds are not in these records, but the 2021 VAERS myocarditis signal was unmistakable by standard criteria. Confidence: moderate, because the FDA's exact commitment is outside the retrieved evidence.