Munjal Tina, Batts Shelley, Gombar Saurabh, Stankovic Konstantina M
Department of Otolaryngology - Head and Neck Surgery, Stanford University School of Medicine, Stanford, CA, United States.
Department of Otolaryngology, Head and Neck Surgery, Massachusetts Eye and Ear, Boston, MA, United States.
Front Neurol. 2025 Aug 7;16:1637870. doi: 10.3389/fneur.2025.1637870. eCollection 2025.
Otologic adverse events (AEs) have been occasionally reported as sequalae of COVID-19 vaccination, although their incidence in comparison with that of preexisting vaccines with high uptake remains unclear. This study compared the rates of new-onset otologic AEs among matched adults receiving mRNA COVID-19 vaccination versus influenza vaccination.
This retrospective cohort study used electronic health records (EHR) data from Stanford Health Care to identify adults aged 50-89 years with no history of otologic disorders prior to first Pfizer/Moderna COVID-19 vaccine (December 2020-January 2022) or any pre-pandemic influenza vaccine (January 2016-December 2019). Patients were categorized by vaccination into FluVax or COVIDVax cohorts. A 90-day history pre-vaccination (baseline period) and ≥6 months follow-up post-vaccination were required. Event rates of new-onset hearing loss (HL), sudden HL, tinnitus, vertigo/dizziness, aural fullness, and otalgia in the 6 months post-vaccination were compared between groups after high-dimensional propensity score (hdPS) matching. A sensitivity analysis was conducted among patients with no COVID-19 infection at any time. Odds ratios (ORs) were calculated using logistic regression for the hdPS matched cohorts.
After hdPS matching, 20,325 patients were included into the FluVax and COVIDVax cohorts, respectively (mean age: 65.5 and 65.2 years; 53.1 and 53.8% females). The rates of otologic AEs in the 6 months post-vaccination were similarly low for the FluVax and COVIDVax cohorts: 1.16% vs. 1.16% for any HL, 0.01% vs. 0.02% for sudden HL, 0.41% vs. 0.47% for tinnitus, 1.96% vs. 1.59% for vertigo, 0.27% vs. 0.25% for otalgia, and 0.09% vs. 0.2% for aural fullness. COVIDVax patients had lower odds of vertigo [OR 95% CI: 0.81 (0.70, 0.94)] and higher odds of aural fullness [2.16 (1.25-3.72)] than the FluVax patients (both < 0.05). The results of the sensitivity analysis limited to patients with no COVID-19 infection at any time ( = 17,530 each cohort) were consistent with the primary results, but aural fullness was the only AE with statistically higher risk in the COVIDVax vs. FluVax cohort [OR (95% CI): 1.90 (1.09-3.31); = 0.021].
New-onset otologic AEs were rare among a large cohort of hdPS-matched patients who received mRNA COVID-19 or pre-pandemic flu vaccination at a single institution. Although aural fullness was statistically more common in the COVIDVax vs. FluVax cohort, regardless of COVID-19 infection status, it remained extremely rare (<0.22%) in any cohort. These results indicate a similar otologic safety profile of the two vaccines, although future research is recommended in larger EHR databases to corroborate the findings.
耳科不良事件（AEs）偶尔被报道为新冠病毒疫苗接种的后遗症，尽管与高接种率的现有疫苗相比，其发生率尚不清楚。本研究比较了接种mRNA新冠疫苗与流感疫苗的匹配成年人中新发耳科不良事件的发生率。
这项回顾性队列研究使用了斯坦福医疗保健公司的电子健康记录（EHR）数据，以识别50-89岁、在首次接种辉瑞/莫德纳新冠疫苗（2020年12月至2022年1月）或任何大流行前流感疫苗（2016年1月至2019年12月）之前无耳科疾病史的成年人。患者按疫苗接种情况分为流感疫苗接种组（FluVax）或新冠疫苗接种组（COVIDVax）。需要接种前90天的病史（基线期）和接种后≥6个月的随访。在进行高维倾向评分（hdPS）匹配后，比较两组在接种后6个月内新发听力损失（HL）、突发性HL、耳鸣、眩晕/头晕、耳闷和耳痛的事件发生率。对任何时候都未感染新冠病毒的患者进行了敏感性分析。使用逻辑回归计算hdPS匹配队列的比值比（OR）。
在进行hdPS匹配后，分别有20325名患者被纳入流感疫苗接种组和新冠疫苗接种组（平均年龄：65.5岁和65.2岁；女性分别为53.1%和53.8%）。流感疫苗接种组和新冠疫苗接种组在接种后6个月的耳科不良事件发生率同样较低：任何HL的发生率分别为1.16%和1.16%，突发性HL的发生率分别为0.01%和0.02%，耳鸣的发生率分别为0.41%和0.47%，眩晕的发生率分别为1.96%和1.59%，耳痛的发生率分别为0.27%和0.25%，耳闷的发生率分别为0.09%和0.2%。与流感疫苗接种组患者相比，新冠疫苗接种组患者眩晕的几率较低[OR 95% CI：0.81（0.70，0.94）]，耳闷的几率较高[2.16（1.25-3.72）]（均P<0.05）。仅限于任何时候都未感染新冠病毒的患者（每组n=17530）的敏感性分析结果与主要结果一致，但耳闷是新冠疫苗接种组与流感疫苗接种组相比唯一具有统计学上更高风险的不良事件[OR（95% CI）：1.90（1.09-3.31）；P=0.021]。
在一家机构接受mRNA新冠疫苗或大流行前流感疫苗接种的大量hdPS匹配患者中，新发耳科不良事件很少见。尽管与流感疫苗接种组相比，新冠疫苗接种组中耳闷在统计学上更常见，但无论新冠病毒感染状况如何，在任何队列中其发生率仍然极低（<0.22%）。这些结果表明两种疫苗在耳科安全性方面相似，尽管建议在更大的EHR数据库中进行进一步研究以证实这些发现。
