COVID-19 vaccines associated vestibular disorders: A case series and disproportionality analysis in Vigibase®

ABSTRACT

Introduction: Reports of vestibular syndrome have been associated with COVID vaccination in the recent literature. In this study, we aimed to evaluate the association between COVID-19 vaccines and vestibular disorders using Vigibase®, the WHO pharmacovigilance database. Material and methods: On January 5th, 2022, we extracted in a deduplicated dataset of VigiBase® reports of vestibular disorders for tozinameran (Pfizer®), elasomeran (Moderna®), Ad26.COV2.S (Janssen®) and ChadOx1nCov-19 (Astra-Zeneca®), using MedDRA preferred terms neuronitis vestibular, acute vestibular syndrome, vestibular disorder and the low level term vestibular vertigo. Seriousness was analyzed and reported odds ratio (ROR) were calculated. We also reviewed the management of COVID-vaccine associated vestibular disorders reported in Caen Regional Pharmacovigilance Center. Results: In Vigibase®, 226 reports of vestibular disorders were found for ChadOx1nCov-19, 40 for Ad26.COV2.S, 254 for elasomeran and 1,050 for tozinameran. The ROR were respectively 2.5 (2.2-2.8), 2.5 (1.8-3.2), 3.6 (3.2-4.0) and 7.0 (6.6-7.4). Reports were considered serious in 74.3% for ChadOx1nCov-19, 70.0% for Ad26.COV2.S, 60.6% for elasomeran and 56.01% for tozinameran. Finally, we collected 13 reports of COVID-19 vaccines associated vestibular disorders in our pharmacovigilance center. Concerning the management of those vestibular disorders, 4 patients received antiemetics, 1 received betahistine, 7 received acetylleucine, 2 received corticoids and 6 had vestibular physiotherapy sessions. After 1 month of follow-up, only one patient had recovered. Discussion/Conclusion: The Vigibase® analysis showed a statistically significant association between the 4 COVID-19 vaccines under study and vestibular disorders. Short-term anticholinergics, antiemetics, antihistamines or benzodiazepines, and a corticosteroid burst with rapid taper as well as vestibular rehabilitation are usually recommended treatments. In our case series we noticed the long duration of the symptoms despite the treatments received and the heterogeneity of the adopted therapeutic strategy. Physicians should be aware and careful of the potential association of COVID-19 vaccines and vestibular disorders. Management guidelines are needed given the wide exposure to COVID-19 vaccines.