ArticleVaccine2025
Tinnitus risk after COVID-19 XBB.1.5 vaccination: A self-controlled case series study.
Article in Vaccine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundWhile prior studies found no clear evidence of an association between COVID-19 vaccination and tinnitus, concerns about a potential link remain. This study assessed the risk of tinnitus following COVID-19 XBB.1.5 vaccination, administered alone or coadministered with influenza vaccine, using the event-dependent self-controlled case series (SCCS) design.
methodsWe conducted an SCCS study among individuals aged ≥12 years enrolled at Kaiser Permanente Southern California, with tinnitus events occurring between September 1, 2023, and March 31, 2024. The exposures included Pfizer-BioNTech and Moderna COVID-19 XBB.1.5 vaccines, with or without influenza vaccine coadministration. The primary outcome was first-ever tinnitus (no documented history before September 1, 2023), and the secondary outcome was first-in-1-year tinnitus, identified using ICD-10 code H93.1* in inpatient, emergency department, and outpatient settings. Risk intervals were pre-specified as 1-14 days and 1-28 days after vaccination, with person-time outside the risk interval serving as the control interval. Relative incidences (RI) and 95% confidence intervals (CI) were estimated, adjusting for seasonality by including tinnitus events among non-recipients of COVID-19 XBB.1.5 vaccines and by including calendar month in the SCCS models.
resultsWith 13,940 first-ever tinnitus events among recipients of COVID-19 XBB.1.5 vaccines, no increased risk was observed within 1-14 or 1-28 days following vaccination in overall analyses. The RI was 0.78 (95% CI: 0.67-0.90) for the 14-day risk interval and 0.87 (95% CI: 0.78-0.96) for the 28-day interval. Subgroup analyses by age and influenza vaccine coadministration status also showed no significant increase in RI. Similarly, no significantly elevated RI was found for first-in-1-year tinnitus in the overall analyses, age-specific analyses, or analyses by coadministration with influenza vaccine.
conclusionOur findings suggest no increased tinnitus risk following COVID-19 XBB.1.5 vaccination, either administered alone or coadministered with influenza vaccine. These results provide reassuring evidence of the safety of COVID-19 vaccines with respect to tinnitus risk.
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