Lee MT, et al. Yonsei Med J. 2020 Sep;61(9):741-749. https://doi.org/10.3349/ymj.2020.61.9.741

It is important to detect signals of abrupt changes in adverse event reporting in order to notice public safety concerns and take prompt action, especially for vaccines under national immunization programs. In this study, we assessed the applicability of change point analysis (CPA) for signal detection in vaccine safety surveillance. The performances of three CPA methods, namely Bayesian change point analysis, Taylor’s change point analysis (Taylor-CPA), and environmental time series change point detection (EnvCpt), were assessed via simulated data with assumptions for the baseline number of events and degrees of change. The analysis was validated using the Korea Adverse Event Reporting System (KAERS) database. In the simulation study, the Taylor-CPA method exhibited better results for the detection of a change point (accuracy of 96% to 100%, sensitivity of 7% to 100%, specificity of 98% to 100%, positive predictive value of 25% to 85%, negative predictive value of 96% to 100%, and balanced accuracy of 53% to 100%) than the other two CPA methods. When the CPA methods were applied to reports of syncope or dizziness following human papillomavirus (HPV) immunization in the KAERS database, Taylor-CPA and EnvCpt detected a change point (Q2/2013), which was consistent with actual public safety concerns. CPA can be applied as an efficient tool for the early detection of vaccine safety signals.

Introduction 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. 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). Methods This study performed a latent class analysis (LCA) of reports of serious AEs following mRNA COVID-19 vaccination from VigiBase between December 28, 2020 , and February 28, 2022 (N = 312878). The Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) terms were selected for LCA. The reporting characteristics in accordance with the cluster were described. We used a multinomial logistic regression model to estimate the association between potential factors and each cluster. Results Five 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). 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). Conclusion Using LCA, we found five clusters of serious AEs following mRNA COVID-19 vaccination. Each cluster was distinguished by potential factors such as age, gender, region, and time to onset. We suggest that monitoring should carefully consider the patterns of young males with cardiac AEs and elderly individuals with thrombosis after respiratory AEs. 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. Graphical Abstract

This study investigated the effectiveness of early vitamin C, hydrocortisone, and thiamine among patients with septic cardiomyopathy. In total, 91 patients with septic cardiomyopathy received a vitamin C protocol in September 2018–February 2020. These patients were compared to 75 patients with septic cardiomyopathy who did not receive a vitamin C protocol in September 2016–February 2018. Relative to the control patients, the treated patients were older and more likely to require mechanical ventilation. The vitamin C protocol was associated with a lower risk of intensive care unit mortality in the propensity score (PS)-matched cohort (aHR: 0.55, 95% CI: 0.30–0.99) and inverse probability of treatment weighting-matched cohort (aHR: 0.67, 95% CI: 0.45–1.00). In the PS-matched cohort (59 patients per group), the vitamin C protocol was associated with decreased values for vasopressor dosage, C-reactive protein concentration, and the Sequential Organ Failure Assessment score during the 4-day treatment period. Patients who started the vitamin C protocol within 2 h after diagnosis (vs. 2–8 h or ≥8 h) had the highest vasopressor weaning rate and the lowest mortality rate. These results suggest that early treatment using a vitamin C protocol might improve organ dysfunction and reduce mortality among patients with septic cardiomyopathy.

Jong Gyun Ahn, M.D., Ph.D., Min-Taek Lee, Ph.D., Daye Lee, Pharm.D., R.Ph., Eun Jeong Min, Ph.D., Dae Chul Jeong, M.D., Ph.D.. J Rheum Dis -0001;0:. https://doi.org/10.4078/jrd.2025.0101