We aimed to analyze the characteristics of serious adverse events following immunizations (AEFIs) to identify potential safety information and prediction features. We screened the individual case safety reports (ICSRs) in adults who received mRNA-based COVID-19 vaccines using the Vaccine Adverse Event Reporting System until December 2021. We identified the demographic and clinical characteristics of ICSRs and performed signal detection. We developed prediction models for serious AEFIs and identified the prognostic features using logistic regression. Serious ICSRs and serious AEFIs were 51,498 and 271,444, respectively. Hypertension was the most common comorbidity (22%). Signal detection indicated that the reporting odds ratio of acute myocardial infarction (AMI) was more than 10 times. Those who had experienced myocardial infarction (MI) were 5.7 times more likely to suffer from MI as an AEFI (95% CI 5.28–6.71). Moreover, patients who had atrial fibrillation (AF), acute kidney injury (AKI), cardiovascular accident (CVA), or pulmonary embolism (PE) were 7.02 times, 39.09 times, 6.03 times, or 3.97 times more likely to suffer from each AEFI, respectively. Our study suggests that vaccine recipients who had experienced MI, AF, AKI, CVA, or PE could require further evaluation and careful monitoring to prevent those serious AEFIs.

Background: Rosuvastatin and atorvastatin are indicated for cardiovascular protection in patients with type 2 diabetes (T2D) but may differ in clinical effectiveness and safety. This study compared real-world cardiovascular and safety outcomes associated with rosuvastatin versus atorvastatin in patients with T2D, with an emphasis on older adults. Methods: This retrospective cohort study used electronic health records from 10 Korean hospitals standardized to the Common Data Model. Adults (≥18 years) with T2D who were newly prescribed rosuvastatin or atorvastatin were included. After propensity score matching, primary outcomes (myocardial infarction [MI], heart failure, stroke, cardiac arrest, and in-hospital death), secondary outcomes (peripheral arterial disease [PAD] and glaucoma), and safety outcomes (acute kidney injury, cataract, and myalgia) were compared. Subgroup and sensitivity analyses were conducted among patients aged ≥65 years. Results: Among 49,034 patients (rosuvastatin, 16,123; atorvastatin, 32,911), baseline characteristics were well balanced. Across all participating hospitals, the comparative analyses showed no meaningful differences in cardiovascular or safety outcomes between the two statins. However, among patients aged ≥65 years, rosuvastatin was associated with a higher risk of PAD (hazard ratio [HR] 1.19; 95% confidence interval [CI] 1.03–1.38), and this finding was consistent in sensitivity analysis (HR 1.31; 95% CI 1.01–1.70). Conclusions: Rosuvastatin and atorvastatin demonstrated comparable cardiovascular effectiveness and safety. Although rosuvastatin was associated with a modestly higher incidence of PAD in older adults, the difference was small. From a clinical perspective, these findings underscore the importance of individualized statin therapy tailored to patient-specific factors such as age, comorbidity, and vascular health. Overall, both statins provide overall therapeutic equivalence for cardiovascular prevention.