The FDA and CDC said their safety monitoring system met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the bivalent Pfizer-BioNTech COVID-19 vaccine.
https://news.bloomberglaw.com/pharma-and-life-sciences/cdc-fda-identify-covid-vaccine-safety-signal-for-65-and-older
h/t Dogfood