Pharmacovigilance Analysis on Cerebrovascular Accidents and Coronavirus disease 2019 Vaccines
AbstractIntroductionRecently, there have been reports of cerebrovascular accidents (CVA) occurring in individuals who have received the Coronavirus disease 2019 (COVID-19) vaccine.ObjectiveThe objective of this analysis was to determine if a statistically significant signal exists in post-marketing safety reports between CVA and the three COVID-19 vaccines being administered in the United States of America (Pfizer, Moderna, Janssen).MethodsA pharmacovigilance disproportionality analysis on adverse events reported with COVID-19 vaccines was conducted using data from Vaccine Adverse Event Reporting System.ResultsA statistically significant signal was found between CVA events and each of the three COVID-19 vaccines (Pfizer/BioNTech’s, Moderna’s and Janssen’s) in the VAERS database. Females and individuals of age 65 or older had higher number of case reports of CVA events with the COVID-19 vaccines. Females had also more COVID-19 adverse event reports in which a CVA was reported and resulted in the patient having permanent disability or death.LimitationsRandomized controlled trials are needed to further analyze this signal.ConclusionPatients should be made aware of the risk-benefit and symptoms to watch out for that may indicate the onset of a CVA and informed to seek medical care as soon as possible if they develop these symptoms.
