Global Burden of Vaccine-Associated Chronic Urticaria, 2010-2023: From the Global Pharmacovigilance Database

Abstract

Purpose: The etiology and pathophysiology of vaccine-associated chronic urticaria (CU) remain unclear, particularly during the coronavirus disease 2019 (COVID-19) pandemic. Thus, this study aimed to comprehensively investigate the global burden and long-term trends of vaccine-associated CU, with a focus on the associated vaccines and the distribution of cases across different age groups and sexes.

Methods: Using data from the World Health Organization international pharmacovigilance database (VigiBase), which encompasses reports from 156 countries and territories between 1968 and 2023, we systematically analyzed the global burden and long-term trends in vaccine-associated CU reports (total individual case safety reports = 131,255,418). We estimated the global and regional reports, information component (IC) with IC_0.25 using disproportionality analyses, and reporting odds ratio (ROR) with 95% confidence interval (CI) to investigate the potential associations between 27 vaccines and CU.

Results: Among the 3,474 reports of all-cause CU, 1,898 vaccine-associated CU reports were identified between 2010 and 2023. A dramatic surge in vaccine-associated CU reports has been observed since 2020, primarily driven by the COVID-19 mRNA vaccines. The COVID-19 mRNA vaccines were associated with the most CU reports (ROR, 26.52 [95% CI, 24.33-28.90]; IC, 3.18 [IC_0.25, 3.10]), followed by papillomavirus (ROR, 4.23 [95% CI, 2.55-7.03]; IC, 1.93 [IC_0.25, 1.06]), influenza (ROR, 3.09 [95% CI, 2.16-4.43]; IC, 1.57 [IC_0.25, 0.96]), Ad5-vectored COVID-19 (ROR, 2.82 [95% CI, 2.40-3.31]; IC, 1.42 [IC_0.25, 1.16]), and zoster vaccines (ROR, 2.28 [95% CI, 1.32-3.93]; IC, 1.12 [IC_0.25, 0.18]). These increased risks were particularly pronounced for males and older adults. No fatal outcomes have been reported in vaccine-associated CU.

Conclusions: This study underscores the importance of clinicians considering the potential risk factors associated with vaccine-associated CU, especially in the context of COVID-19-related vaccines. Ongoing pharmacovigilance efforts facilitated by robust reporting systems are required to further validate our findings.

Keywords: Pharmacovigilance; World Health Organization; urticaria; vaccines.

Fig. 1. Study population.

Fig. 2. Temporal trends (A) and global distribution (B) of vaccine-associated CU adverse events by continent.

CU, chronic urticaria.

Fig. 3. Cumulative number of CU reports per year association with COVID-19 vaccines (A), other vaccines (B) and all vaccines with the proportion reported by period (C).

CU, chronic urticaria; COVID-19, coronavirus disease 2019; DTP, diphtheria, tetanus, and pertussis.