ABSTRACT
Background Vaccines are considered one of the milestones of modern medicine that promoted health and curbed morbidity and mortality. However, with the rapid development and approval of various vaccines, various thrombotic events have been reported. Yet, a comprehensive analysis of vaccine and stroke and other thrombotic events is not well-characterized. Methods To investigate the relationship between vaccines and thrombotic disorders, we utilized vaccine adverse event reporting system (VAERS) database between 1990-2021 using key medical terms. The data was stratified based on sex and age, and type of vaccine. The COVID-19 vaccine was additionally stratified based on manufacturer. Disproportionality signal analysis was conducted by measuring reporting odds ratio (ROR) with 95% confidence interval (CI). Results More than 1,300,000 adverse events reported between 1990-2021 in FAERS database. Over 6000 cases of stroke have been reported between 1990-2021. As expected, most of the reported stroke (70%) occurred in older patients (>50 years old). Interestingly, the incidence of vaccine-associated stroke is slightly more in females (52%) compared to males (44%). Among all the vaccine-related stoke, COVID-19 vaccines were associated with over 80% of all stroke reported with ROR (CI 95%) of 13.3 (CI 12.4-14.3, p<0.0001). Subclassification analysis of COVID-19 vaccines revealed that Pfizer/Biontech COVID-19 vaccine was associated with 46%, Moderna (40%), and Janssen (12%) of all COVID-19 associated stroke. Finally, our data revealed that prothrombic diseases of various vascular beds were reported the most among patients who have received COVID-19 vaccines. Among these thrombotic events, deep vein thrombosis, pulmonary embolism, and cerebral venous sinus thrombosis were the most predominant. Conclusion Thrombotic events related to vaccines are rare but still feared due to their high morbidity and mortality. In this study, ischemic stroke was most reported among the COVID-19, Zoster, and Influenza trivalent injected vaccine. This retrospective study highlights the urgent need for further longitudinal studies to examine the safety of vaccines in patient with high risk for thrombosis.Copyright © 2023 American College of Cardiology Foundation