Pharmacovigilance Analysis on Cerebrovascular Accidents and Coronavirus disease 2019 Vaccines

Abstract

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.