ORIGINAL RESEARCH article
Front. Cell. Infect. Microbiol.
Sec. Microbial Vaccines
Volume 15 - 2025 | doi: 10.3389/fcimb.2025.1635180
This article is part of the Research TopicVaccine and Infectious Disease InformaticsView all 7 articles
Post-Marketing Safety Surveillance of Pneumococcal Vaccines: A Real-World Pharmacovigilance Study Using the U.S. Vaccine Adverse Event Reporting System (VAERS) Database
Provisionally accepted
Xinkuo Zheng1*
Meishen Liu2Aili Ding1Shihong Zhang1Ling Wu1Fanli Kong1Weijia Sun1Yuchen Peng1Yalin Xi1*- 1Central Hospital of Dalian University of Technology, Dalian, China
- 2The Second Hospital of Dalian Medical University, Dalian, China
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Pneumococcal vaccines have been utilized in the United States for decades with extensive clinical safety records. However, comprehensive postmarketing pharmacovigilance evaluations for all available types remain lacking. This study aimed to assess adverse events following immunization (AEFI) using the VAERS database and analyze potential associations between adverse events (AEs) and vaccine administration based on VAERS data. Methods: We retrieved all AEs associated with pneumococcal vaccines recorded in the VAERS database from 1990 through March 2025. Descriptive analyses were conducted to summarize the demographics, clinical characteristics, and vaccination profiles of reported cases. Disproportionality analysis was performed to detect potential safety signals between AEs and vaccine administration.The VAERS database documented 157,244 individuals receiving pneumococcal vaccines, with 158,778 doses administered, capturing 632,481 AE reports following vaccination during the study period. Females showed higher AE reporting rates (54.29%) compared to males (36.88%), with the majority of cases (38.20%) occurring in individuals aged < 18 years. Complete recovery (44.20%) and hospitalization (14.94%) were the most common outcomes. Most AEs (77.11%) occurred within 0 -30 days post-vaccination (median onset: 0 day). Pneumococcal polysaccharide vaccine (PPSV, 48.92%) and 13-valent pneumococcal conjugate vaccine (PCV13, 27.57%) constituted the predominant vaccine types. Disproportionality analysis identified 929 positive AE signals across 24 system organ classes (SOCs), with injection site erythema [reporting odds ratio (ROR) = 4.24], injection site swelling (ROR = 4.19), and injection site pain (ROR = 2.75) being the most frequent. DME screening revealed erythema multiforme (n = 398) and product contamination microbial (ROR = 11.25) as key safety signals. General disorders (ROR = 1.73) and skin conditions (ROR = 1.69) were the predominant SOC categories. Conclusions: This post-marketing surveillance has revealed predominantly nonserious AEs, with most adverse events clustered within 30 days post-vaccination. These observations reinforce the established safety profile of pneumococcal vaccines while emphasizing temporal risk patterns to guide post-vaccination monitoring protocols and risk-benefit evaluations.
Keywords: Pneumococcal Vaccines, Pharmacovigilance, Post-marketing safety surveillance, Vaccine Adverse Event Reporting System, adverse events, Safety
Received: 26 May 2025; Accepted: 06 Aug 2025.
Copyright: © 2025 Zheng, Liu, Ding, Zhang, Wu, Kong, Sun, Peng and Xi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xinkuo Zheng, Central Hospital of Dalian University of Technology, Dalian, China
Yalin Xi, Central Hospital of Dalian University of Technology, Dalian, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.