Abstract
Background: China has a high incidence rate of varicella yet a low coverage rate of the varicella vaccine (VarV), with safety concerns being a leading cause of the lack of vaccination willingness. This study aimed to describe VarV-related adverse events following immunization (AEFIs) and analyze their characteristics in Zhejiang, China, 2020-2022. Methods: VarV-related AEFIs in Zhejiang Province from 1 January 2020 to 31 December 2022 were collected through the Chinese National AEFI Information System (CNAEFIS) for a descriptive epidemiological analysis. Results: From 2020 to 2022, a total of 1477 VarV-related AEFI cases were reported (incidence rate: 34.79/100,000). The three most frequently reported clinical symptoms of common adverse reactions were fever, redness, and induration at the vaccination site. The distribution of VarV-related AEFIs varied significantly by age, dose, severity, and season. VarV-related AEFIs were more likely to be non-severe adverse events that occurred in the summer and winter seasons following the first dose of vaccine and among those under 3 years old. The top three regions with the highest incidence rates were Lishui City (59.53/100,000), Quzhou City (41.05/100,000), and Jinhua City (40.43/100,000). Most of the cases achieved full recovery without treatment (96.21%), and the rest were successfully treated without any sequelae. Conclusions: VarV demonstrates a safe profile in Zhejiang Province. Most VarV-related AEFIs are common reactions without requiring treatment, and the rates of rare and severe AEFIs remain low. Consistent monitoring, investigation, and diagnosis are needed to guide future VarV research and vaccination strategy adjustment. Our findings call for more policy changes, such as integrating VarV into China's National Immunization Program and conducting more trials to evaluate the safety and effectiveness of VarV.