CDC’s Vaccine Safety Datalink (VSD) 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 Pfizer-BioNTech COVID-19 Vaccine,
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Bivalent. To date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal. No change is recommended in COVID-19 vaccination practice.