Tinnitus risk after COVID-19 XBB.1.5 vaccination: A self-controlled case series study

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-07-26 DOI:10.1016/j.vaccine.2025.127548

Stanley Xu , Lina S. Sy , Vennis Hong , Lei Qian , Kimberly J. Holmquist , Katia J. Bruxvoort , Bing Han , Bruno Lewin

{"title":"Tinnitus risk after COVID-19 XBB.1.5 vaccination: A self-controlled case series study","authors":"Stanley Xu , Lina S. Sy , Vennis Hong , Lei Qian , Kimberly J. Holmquist , Katia J. Bruxvoort , Bing Han , Bruno Lewin","doi":"10.1016/j.vaccine.2025.127548","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>While 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.</div></div><div><h3>Methods</h3><div>We 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.</div></div><div><h3>Results</h3><div>With 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.</div></div><div><h3>Conclusion</h3><div>Our 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.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"62 ","pages":"Article 127548"},"PeriodicalIF":4.5000,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vaccine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0264410X2500845X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

While 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.

Methods

We 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.

Results

With 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.

Conclusion

Our 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.

查看原文本刊更多论文

COVID-19 XBB.1.5疫苗接种后耳鸣风险的自我对照病例系列研究

虽然之前的研究没有发现明确的证据表明COVID-19疫苗接种与耳鸣之间存在关联，但人们仍然担心存在潜在的联系。本研究采用事件依赖的自我控制病例系列（SCCS）设计，评估单独接种或与流感疫苗联合接种COVID-19 XBB.1.5疫苗后耳鸣的风险。方法：我们在Kaiser Permanente Southern California注册的年龄≥12岁的个体中进行了一项SCCS研究，这些个体在2023年9月1日至2024年3月31日期间发生耳鸣事件。暴露包括辉瑞- biontech和Moderna COVID-19 XBB.1.5疫苗，联合或不联合使用流感疫苗。主要结局是首次耳鸣（在2023年9月1日之前没有记录的病史），次要结局是1年内首次耳鸣，使用ICD-10代码H93.1*在住院、急诊和门诊环境中确定。预先确定接种后1-14天和1-28天的风险间隔，以超出风险间隔的人数作为对照间隔。通过纳入未接种COVID-19 XBB.1.5疫苗的耳鸣事件和在SCCS模型中纳入日历月，对季节性因素进行调整，估计了相对发病率（RI）和95%置信区间（CI）。结果在接种COVID-19 XBB.1.5疫苗的人群中有13940例首次耳鸣事件，在接种后1-14天和1-28天内未观察到风险增加。14天风险间隔的RI为0.78 (95% CI: 0.67-0.90)， 28天风险间隔的RI为0.87 （95% CI: 0.78 - 0.96）。按年龄和流感疫苗联合使用情况进行的亚组分析也显示，RI没有显著增加。同样，在总体分析、年龄特异性分析或与流感疫苗联合使用的分析中，1年内首次耳鸣的RI未发现显著升高。结论：单独或与流感疫苗联合接种COVID-19 XBB.1.5疫苗均未增加耳鸣风险。这些结果为COVID-19疫苗在耳鸣风险方面的安全性提供了令人放心的证据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

期刊介绍： Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.