Epidemiological Characteristics and Clinical Outcomes of Vaccine-associated Urticaria: A Retrospective Cross-sectional Analysis of the Vaccine Adverse Event Reporting System Database (1990–2025)
Chetan Chandrashekar, Poornima Andal Peachiappan, Herrieth Jandwa, Mansiben Patel, Amardeepsinh JadejaAbstract
Introduction:
Urticaria is a commonly reported cutaneous adverse event following vaccination, which may range from mild self-limiting reactions to more severe hypersensitivity manifestations. Monitoring vaccine-associated urticaria is important for ongoing vaccine safety surveillance and pharmacovigilance. However, large-scale population-based analyses evaluating demographic characteristics, vaccine associations, onset intervals, and severity patterns remain limited.
Aim:
The aim of the study was to analyze reports of urticaria in the Vaccine Adverse Event Reporting System (VAERS) database between 1990 and 2025 and evaluate demographic characteristics, vaccine type distribution, onset intervals, temporal trends, and seriousness patterns.
Methodology:
A retrospective observational study was conducted using data from the VAERS database. Reports of urticaria submitted between January 1990 and March 2025 were included. The variables analyzed included age, sex, vaccine type, onset interval, and seriousness classification. Descriptive statistics were generated using frequencies and percentages, and comparative analyses were performed between serious and nonserious reports.
Results:
A total of 61,996 urticaria reports were identified during the study period. Most reports occurred among adults aged 18–49 years and females. Most reports were classified as nonserious and occurred within the early postvaccination period. COVID-19 vaccines accounted for the highest proportion of reports, followed by influenza and measles, mumps, and rubella vaccines. Temporal analysis demonstrated a marked increase in reporting during 2021, followed by declining trends thereafter. Comparative analysis identified differences in demographic and clinical characteristics between serious and nonserious reports.
Conclusion:
Urticaria is a frequently reported adverse event following vaccination, with identifiable demographic, temporal, and clinical patterns. Most reports were nonserious and occurred shortly after vaccination, although differences were observed between serious and nonserious reports. Continued pharmacovigilance and future studies incorporating detailed clinical data are needed to better understand factors associated with vaccine-related urticaria.