Post-marketing safety surveillance of tetanus, diphtheria, and acellular pertussis (Tdap) vaccine: a disproportionality analysis of the vaccine adverse event reporting system (2015–2025)
Frontiers in Cellular and Infection Microbiology·
- DOI
- 10.3389/fcimb.2026.1831548
- PMID
- —
- PMCID
- —
- OpenAlex
- —
- Study type
- Journal article
- Publisher
- Frontiers Media SA
- Article type
- journal-article
- Integrity
- current
Why this research matters now
The paper addresses post-marketing vaccine safety surveillance for a routinely recommended vaccine. Its relevance is strongest for safety signal detection and hypothesis generation in Tdap vaccination programs.
Structured evidence summary
Research question
The study examined adverse event reports associated with Tdap vaccination in VAERS from 2015 through May 2025, with attention to overall safety patterns and selected subgroups.
Study design
This was a retrospective disproportionality analysis of U.S. VAERS reports. The abstract describes use of ROR, PRR, BCPNN, and MGPS methods, with false discovery rate control and Weibull analysis for timing of onset.
Population and setting
The setting was the United States VAERS database. Subgroup analyses included adolescents aged 10 to 18 years, adults aged 65 years or older, pregnant individuals, males, and non-pregnant females.
Main findings
The abstract reports 20,128 Tdap-related adverse event reports, with most categorized as non-serious. Frequently reported positive signals included injection-site redness, injection-site swelling, and erythema, and most events were reported within one day after vaccination. The abstract also reports no unexpected signals in the overall population, older adults, males, or pregnancy-related reports, while noting subgroup signals including opisthotonus in adolescents and radiculitis brachial and bursal fluid accumulation in non-pregnant females.
Public-health relevance
The paper addresses post-marketing vaccine safety surveillance for a routinely recommended vaccine. Its relevance is strongest for safety signal detection and hypothesis generation in Tdap vaccination programs.
Important limitations
The abstract indicates that some subgroup findings are hypothesis-generating and require formal testing in active surveillance systems. The study is also limited, for this summary, to information available in the supplied single-article abstract and metadata; the full paper would be needed for decision-grade interpretation.
GIDS interpretation
For indexing and discoverability, this article fits vaccine safety surveillance in the United States, with relevance to Tdap and the diseases pertussis, diphtheria, and tetanus. The classifier context supports editorial routing under surveillance, vaccination, and vaccine safety topics.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 11 auditable classifier relationships to diseases, places, topics, and study design.