Incidence of outcomes relevant to vaccine safety monitoring in the general population, after influenza vaccination, and after respiratory infections: a descriptive analysis of four US claims databases, 2022–2023
Vaccine·
- DOI
- 10.1016/j.vaccine.2026.128821
- PMID
- 42296834
- PMCID
- —
- OpenAlex
- W7164806039
- Study type
- Cohort study
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
Contemporaneous incidence estimates for 30 safety outcomes across five organ systems can inform benefit-risk framing for new and existing respiratory vaccines during the COVID-19 endemic era and highlight the need to account for age and sex when interpreting expected rates.
Structured evidence summary
Research question
The study aimed to estimate background incidence rates of vaccine safety outcomes overall, after influenza vaccination, and after respiratory infections, to support benefit-risk contextualization for respiratory vaccines during the COVID-19 endemic period.
Study design
Retrospective descriptive cohort analysis using four US administrative claims databases covering 1 August 2022 to 31 July 2023, with analyses stratified by age and sex across five defined cohorts.
Population and setting
The general US population plus four defined subcohorts (influenza vaccine recipients and those with medically attended SARS-CoV-2, RSV, or influenza infection), analyzed within HealthVerity, Optum Clinformatics, Humana, and Medicare Fee-For-Service claims data.
Main findings
Incidence rates after influenza vaccination were generally similar to or lower than general-population rates, while rates following respiratory infections were generally higher. Adults ≥65 showed the highest rates for cardiovascular and thromboembolic outcomes across cohorts, while adults 18–64 most frequently experienced seizures, anaphylaxis, and cardiovascular outcomes after infection. In children, febrile seizures (≤5 years) and seizures were among the highest reported rates.
Public-health relevance
Contemporaneous incidence estimates for 30 safety outcomes across five organ systems can inform benefit-risk framing for new and existing respiratory vaccines during the COVID-19 endemic era and highlight the need to account for age and sex when interpreting expected rates.
Important limitations
The authors note that elevated rates after infection were confounded by marked baseline differences and that more rigorous adjusted analyses are still needed; this summary is also limited to the supplied single-article abstract/metadata and would require the original paper for decision-grade interpretation.
GIDS interpretation
The study provides methodological context for vaccine safety surveillance by describing expected rates across outcomes and exposure groups; it does not by itself confirm any surveillance signal and is best used as background reference for future benefit-risk assessments of respiratory vaccines.
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 15 auditable classifier relationships to diseases, places, topics, and study design.