Hearing disorder following COVID ‐19 vaccination: A pharmacovigilance analysis using the Vaccine Adverse Event Reporting System

Abstract

What is known and objective Evidence on whether the coronavirus disease 2019 (COVID‐19) vaccination could cause hearing‐related adverse events is still conflicting. This study aims to access the association between COVID‐19 vaccine and hearing disorder. Methods The Vaccine Adverse Event Reporting System (VAERS) was queried between January 2020 to November 2021. The disproportionality pattern for hearing impairment of COVID‐19 vaccine was accessed by calculating the reporting odds ratio (ROR) and proportional reporting ratio (PRR). A further subgroup analysis based on the type of COVID‐19 vaccine and the doses administered was performed. In addition, the disproportionalities for hearing dysfunction between COVID‐19 and influenza vaccines were compared. Results and discussion A total of 14,956 reports of hearing‐related adverse events were identified with COVID‐19 vaccination and 151 with influenza vaccine during the analytic period in VAERS. The incidence of hearing disorder following COVID‐19 vaccination was 6.66 per 100,000. The results of disproportionality analysis revealed that the adverse events of hearing impairment, after administration of COVID‐19 vaccine, was significantly highly reported (ROR 2.38, 95% confidence interval [CI] 2.20–2.56; PRR: 2.35, χ 2 537.58), for both mRNA (ROR 2.37, 95% CI 2.20–2.55; PRR 2.34, χ 2 529.75) and virus vector vaccines (ROR 2.50, 95% CI 2.28–2.73; PRR 2.56, χ 2 418.57). While the disproportional level for hearing dysfunction was quite lower in influenza vaccine (ROR 0.36, 95% CI 0.30–0.42; PRR 0.36, χ 2 172.24). What is new and conclusion This study identified increased risk for hearing disorder following administration of both mRNA and virus vector COVID‐19 vaccines compared to influenza vaccination in real‐world settings.

Hearing Loss after COVID-19 and Non-COVID-19 Vaccination: A Systematic Review

“…This is largely due to reporting bias from electronic records, with minimal to no effort in reducing confounders in analysis. Larger observational studies utilize self-reporting systems, as seen with the Vaccine Adverse Event Reporting System (VAERS) in the United States [ 20 , 24 , 25 , 26 ] and national healthcare registries in Finland [ 28 ], Israel [ 27 ], and France [ 29 ]. Therefore, reporting bias remains a problem in interpreting the results.…”

“…The COVID-19 vaccines available use mRNA (e.g., manufactured by Pfizer or Moderna), viral vector-based (e.g., manufactured by Johnson and Johnson), or inactivated vaccine platforms (e.g., manufactured by Sinovac or AstraZeneca). A majority of studies evaluated mRNA-based vaccines only [ 11 , 27 , 29 ], while others also included viral vector-based vaccines [ 24 , 25 , 26 ] and inactivated virus vaccines [ 22 , 28 ] in their studies.…”

“…In large-scale observational studies, the incidence from all papers reviewed demonstrated that the incidence of SNHL was mostly compatible with the average annual incidence of 27 per 100,000 person-years for all causes, as reported by Alexander et al in 2013, studying 60 million patients from the United States (US) across 2006–2007 [ 16 ]. In nationwide studies conducted in the US, Formeister et al reported an incidence ranging from 0.6 to 28.0 cases per 100,000 person-years, whereas Chen reported an incidence of 6.66 per 100,000 person-years [ 24 , 25 ]. Similarly, the Finnish study by Nieminen et al shows an incidence of 21.2 to 22.1 cases per 100,000 person-years, depending on which vaccine was used [ 28 ].…”

Sudden Sensorineural Hearing Loss after COVID-19 Vaccination: A Review of the Available Evidence through the Prism of Causality Assessment

“…It should be noted that this risk, although documented, proved to be low (<1 per 100,000 vaccinated individuals). By the end of 2022, Chen et al published an analysis of the VAERS-registered hearing disorders and identified an increased risk of hearing impairment after administration of both mRNA and virus vector COVID-19 vaccines compared to influenza vaccination in a real-life context [ 50 ]. Following the Finnish publication, in July 2023, Thai-Van et al published data on all cases of SSNHL collected as part of the enhanced pharmacovigilance surveillance system set up in France [ 51 ].…”

“…In the French study, all SSNHL cases after mRNA COVID-19 vaccination were analysed by both pharmacovigilant and otolaryngologist, enabling the selection of only cases documented based on an audiogram or medical report, chronological data, and any additional data [ 50 ]. The authors were thus able to estimate the minimum rate of this adverse reaction based on “robust” cases, and we identified a few cases with a new positive rechallenge, suggesting a high probability of a causal relationship [ 93 ].…”