Serious Safety Signals and Prediction Features Following COVID-19 mRNA Vaccines Using the Vaccine Adverse Event...

Area of Science:

• Vaccinology
• Pharmacovigilance
• Cardiovascular Medicine

Background:

• mRNA COVID-19 vaccines have been widely administered.
• Monitoring adverse events following immunizations (AEFIs) is crucial for vaccine safety.
• Understanding risk factors for serious AEFIs can improve patient outcomes.

Purpose of the Study:

• To analyze the characteristics of serious AEFIs in adults receiving mRNA COVID-19 vaccines.
• To identify potential safety signals and predictive features for serious AEFIs.
• To develop prediction models for serious AEFIs.

Main Methods:

• Screening of individual case safety reports (ICSRs) from the Vaccine Adverse Event Reporting System (VAERS) until December 2021.
• Analysis of demographic and clinical characteristics of ICSRs.
• Signal detection and logistic regression modeling to identify prognostic features for serious AEFIs.

Main Results:

• Over 51,000 serious ICSRs and 271,000 serious AEFIs were identified.
• Hypertension was the most common comorbidity (22%).
• Significant reporting odds ratios were observed for acute myocardial infarction (AMI), myocardial infarction (MI), atrial fibrillation (AF), acute kidney injury (AKI), cardiovascular accident (CVA), and pulmonary embolism (PE).
• Individuals with prior MI, AF, AKI, CVA, or PE showed significantly higher likelihoods of experiencing these as AEFIs.

Conclusions:

• Vaccine recipients with a history of MI, AF, AKI, CVA, or PE may require enhanced evaluation and monitoring.
• Identifying individuals at higher risk can aid in preventing serious AEFIs.
• This study provides valuable safety information for mRNA COVID-19 vaccine pharmacovigilance.