Key result
COVID-19 vaccination linked to ~164% higher reporting of early-onset arrhythmias, most frequently tachycardia.
Why the study?
Although COVID-19 vaccines are highly effective, their cardiovascular safety, particularly regarding arrhythmic risk, continues to raise concerns.
What are the characteristics and signal strengths of cardiac arrhythmias following COVID-19 vaccination reported in the U.S. VAERS database?
Observational (n=52,518)
What are the characteristics and signal strengths of cardiac arrhythmias following COVID-19 vaccination reported in the U.S. VAERS database?
Odds Ratio: 2.64 (95% CI 2.46–2.83)
Cardiac arrhythmias following COVID-19 vaccination, primarily tachycardia and atrial fibrillation, typically occur within 1 day post-vaccination and show platform-specific patterns, though overall risk remains low.
Highlights a potential early post-vaccination arrhythmia signal requiring clinical awareness; leaves open true incidence and.
Background Although COVID-19 vaccines are highly effective in preventing infection and severe disease, their cardiovascular safety, particularly regarding arrhythmic risk, continues to raise concerns. Methods A disproportionality analysis was conducted using the U.S. Vaccine Adverse Event Reporting System (VAERS) to evaluate arrhythmia-related AEs reported between December 2020 and January 2025. Adverse events (AEs) were identified using MedDRA Preferred Terms, and signal strength was assessed by Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Results A total of 52,518 reports were identified, with a median onset interval of 1 day after vaccination. The most frequent AEs were tachycardia (40.5%) and atrial fibrillation (16.9%). Atrial flutter, extrasystoles, and atrioventricular block exhibited the strongest signals. Severe events primarily involved ventricular and conduction abnormalities, particularly among older adults and male individuals. Reports involving mRNA vaccines were predominantly characterized by tachyarrhythmia-related events, whereas findings for bradyarrhythmia- and conduction-related events after adenoviral vector vaccination should be interpreted cautiously. Conclusions Cardiac arrhythmias following COVID-19 vaccination typically occurred within the early post-vaccination period and demonstrated clear platform- and population-specific differences. Although the overall risk is low, enhanced early monitoring and stratified pharmacovigilance are warranted to optimize vaccine safety.
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Lu et al. (2026) conducted an observational in Cardiac arrhythmias (n=52,518). COVID-19 vaccination vs. Reports without target vaccines was evaluated on Tachycardia reporting signal (ROR 2.64, 95% CI 2.46-2.83). COVID-19 vaccination was associated with early-onset cardiac arrhythmias, most frequently tachycardia, which demonstrated a significant reporting signal (ROR 2.64).
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