Reported adverse events following monovalent varicella vaccination in children aged 1–12 years: a VAERS disproportionality analysis, 1995-2026
- 1Department of Pharmacy, The Second Affiliated Hospital of Dalian Medical University
- 2Department of Pharmacy, Central Hospital of Dalian University of Technology
Abstract
Background: Varicella vaccines have been widely used in children, but comprehensive post-marketing safety evaluations in the pediatric population remain limited.
Methods: We analyzed 55,475 adverse event (AE) reports following varicella vaccination in children aged 1–12 years from the U.S. Vaccine Adverse Event Reporting System (VAERS) between 1995 and 2026. Descriptive analyses were performed for demographic and clinical characteristics. Disproportionality signals were detected using Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR), with false discovery rate controlled by Benjamini-Hochberg (BH) correction. Stratified analyses were conducted by age and sex.
Results: The most frequently reported adverse events were rash (a = 7,218, ROR = 2.09, PRR = 2.05), infection (a = 5,694, ROR = 10.76, PRR = 10.43), dermatitis bullous (a = 3,563, ROR = 37.28, PRR = 36.51), viral infection (a = 2,173, ROR = 9.67, PRR = 9.56) and rash vesicular (a = 2,137, ROR = 20.94, PRR = 20.68). Most cases (53.72%) resolved completely. Children aged 1–2 years accounted for 52.00% of reports. Initial analysis identified 135 positive signals at the Preferred Term level, which were reduced to 111 after multiplicity correction. Injection site reactions predominated in older children (3–6 and 7–12 years), while systemic events were more common in the youngest group. Sex differences were minimal. Serious adverse events occurred in 5.94% and deaths in 0.30% of reports.
Conclusion: This analysis of VAERS reports describes a generally non-serious and self-limiting reporting profile for varicella vaccines in children aged 1–12 years. These findings support continued pharmacovigilance to inform evidence-based vaccination policies and targeted risk communication, but they do not confirm a favorable safety profile or establish causality, incidence, or absolute risk. Further denominator-based studies are needed to validate these observations.
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BibTeX
@article{liu2026reported,
title = {{Reported adverse events following monovalent varicella vaccination in children aged 1–12 years: a VAERS disproportionality analysis, 1995-2026}},
author = {Meishen Liu and Yalin Xi and Le Yang and Miao Li and Depeng Zhao and Tangna Hao and Weijia Sun and Xinkuo Zheng},
journal = {Frontiers in Immunology},
year = {2026},
month = oct,
doi = {10.3389/fimmu.2026.1959638},
url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1959638/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Reported adverse events following monovalent varicella vaccination in children aged 1–12 years: a VAERS disproportionality analysis, 1995-2026
AU - Meishen Liu
AU - Yalin Xi
AU - Le Yang
AU - Miao Li
AU - Depeng Zhao
AU - Tangna Hao
AU - Weijia Sun
AU - Xinkuo Zheng
PY - 2026
DA - 2026/10/29
JO - Frontiers in Immunology
DO - 10.3389/fimmu.2026.1959638
UR - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1959638/full
AB - Background: Varicella vaccines have been widely used in children, but comprehensive post-marketing safety evaluations in the pediatric population remain limited. Methods: We analyzed 55,475 adverse event (AE) reports following varicella vaccination in children aged 1–12 years from the U.S. Vaccine Adverse Event Reporting System (VAERS) between 1995 and 2026. Descriptive analyses were performed for demographic and clinical characteristics. Disproportionality signals were detected using Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR), with false discovery rate controlled by Benjamini-Hochberg (BH) correction. Stratified analyses were conducted by age and sex. Results: The most frequently reported adverse events were rash (a = 7,218, ROR = 2.09, PRR = 2.05), infection (a = 5,694, ROR = 10.76, PRR = 10.43), dermatitis bullous (a = 3,563, ROR = 37.28, PRR = 36.51), viral infection (a = 2,173, ROR = 9.67, PRR = 9.56) and rash vesicular (a = 2,137, ROR = 20.94, PRR = 20.68). Most cases (53.72%) resolved completely. Children aged 1–2 years accounted for 52.00% of reports. Initial analysis identified 135 positive signals at the Preferred Term level, which were reduced to 111 after multiplicity correction. Injection site reactions predominated in older children (3–6 and 7–12 years), while systemic events were more common in the youngest group. Sex differences were minimal. Serious adverse events occurred in 5.94% and deaths in 0.30% of reports. Conclusion: This analysis of VAERS reports describes a generally non-serious and self-limiting reporting profile for varicella vaccines in children aged 1–12 years. These findings support continued pharmacovigilance to inform evidence-based vaccination policies and targeted risk communication, but they do not confirm a favorable safety profile or establish causality, incidence, or absolute risk. Further denominator-based studies are needed to validate these observations.
SN - 1664-3224
ER -