Student Manipal College of Pharmaceutical Sciences Manipal, India
Background: COVID-19 spread globally following its breakout in December 2019. In response, vaccinations for severe acute respiratory syndrome coronavirus SARS-CoV-2 were rapidly designed, tested, and introduced. Since the beginning of the pandemic, thromboembolic events have been a well-known severe consequence of SARSCoV2 infection. Ever since the introduction of COVID 19 vaccinations, there have been a significant increase in the number of adverse occurrences which significantly increased. We aimed at analyzing the association of COVID 19 vaccine and thromboembolic events using data from Vaccine Adverse Events Reporting System(VAERS).
Objectives: To evaluate the association of COVID 19 vaccines and Thromboembolic events using VAERS
Methods: We have conducted a retrospective study using Vaccine adverse event reporting system(VAERS) to retrieve the raw data and analyze the same. Duplicates were removed and the symptoms were filtered using MS Excel. VAERS ID and symptoms were merged using MS access. Demographic data of each year was calculated to get the mean, median and mode of each year. Disproportionality analysis was conducted using 2x2 contingency table and Reporting odds ratio (ROR). A threshold of ROR>1, with number of cases of adverse events (N>3) and lower limit of 95% Confidence Interval CI>1 is used to establish the significance of disproportionality to find out the association of COVID 19 and thromboembolic events.
Results: After deduplication, a total of 300466 adverse events were extracted for COVID 19 vaccines, out of which 8141 thromboembolic events were found. The ROR values were calculated for each year; 2021 (5.36),2022 (18.02), 2023 (1.75) clearly showed a significant relationship between COVID 19 and thromboembolic events with a lower limit of 95% Cl.
Conclusions: The results of the study could help in detecting and preventing new and emerging adverse events. Since there was a significant association, the data could help suspect similar adverse events due to COVID 19 vaccines and help the physicians to take better decisions and treatment regimen for the patients.
