Post-marketing safety surveillance of pneumococcal vaccines: a real-world pharmacovigilance study using the U.S. vaccine adverse event reporting system (VAERS) database.

ABSTRACT:

Background

Pneumococcal vaccines have been utilized in the United States for decades with extensive clinical safety records. However, comprehensive post-marketing 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 b

SUBMITTER: Zheng X 

PROVIDER: S-EPMC12417412 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature