As of November 2022, approximately 12.8 billion cumulative vaccine doses have been administered globally. Messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccines have been rapidly developed and widely utilized owing to organizations and government funding and technological collaborations in response to the COVID-19 pandemic.
Cardiac AEs showed a higher proportion of males and infection AEs a longer time to onset than other AEs (≥ 14 days).Įach cluster was distinguished by potential factors such as age group, gender, region, and time interval between vaccination date and start of reaction/event thus, our findings could contribute to enhancing understanding of safety profiles and establishing management strategies for serious AEs of special interest following mRNA COVID-19 vaccination. Thus far, myocarditis, anaphylaxis, Bell's palsy, and Guillain-Barré syndrome have been reported as AEs of mRNA COVID-19 vaccines however, the factors associated with unknown serious adverse events (AEs) following mRNA COVID-19 vaccines have not been established.įive clusters of AE reports were distinguished on LCA: infection AEs (cluster 1), cardiac AEs (cluster 2), respiratory/thrombotic AEs (cluster 3), systemic AEs (cluster 4), and nervous system AEs (cluster 5). Graphical AbstractĪs of November 2022, approximately 12.8 billion cumulative vaccine doses have been administered globally this administration of COVID-19 vaccines might be expanded in the future because of variants and booster doses. Our findings could contribute to enhancing understanding of safety profiles and establishing management strategies for serious AEs of special interest following mRNA COVID-19 vaccination. We suggest that monitoring should carefully consider the patterns of young males with cardiac AEs and elderly individuals with thrombosis after respiratory AEs. Each cluster was distinguished by potential factors such as age, gender, region, and time to onset. Using LCA, we found five clusters of serious AEs following mRNA COVID-19 vaccination. Compared to cluster 4, cluster 2 had a higher proportion of males (OR 2.98 95% confidence interval (CI) 2.87–3.09), and cluster 1 had a longer time to onset than other AEs (≥ 14 days) (OR 16.2 95% CI 15.5–16.9). Resultsįive clusters of AE reports were distinguished through LCA: infection AEs (cluster 1), cardiac AEs (cluster 2), respiratory/thrombotic AEs (cluster 3), systemic AEs (cluster 4), and nervous system AEs (cluster 5). We used a multinomial logistic regression model to estimate the association between potential factors and each cluster. The reporting characteristics in accordance with the cluster were described.
The Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) terms were selected for LCA. This study performed a latent class analysis (LCA) of reports of serious AEs following mRNA COVID-19 vaccination from VigiBase between Decem, and Febru( N = 312878). This study aimed to identify the patterns associated with serious AE reports after mRNA COVID-19 vaccination in the World Health Organization (WHO)’s global scale database (VigiBase). Although messenger RNA (mRNA) vaccines have been developed and widely utilized to mitigate the coronavirus disease (COVID-19) pandemic, it is essential to describe the adverse events (AEs) following immunization.
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