Hypothesis: This study investigates whether U.S. Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System (VAERS) data suggest an association between vertigo, tinnitus, hearing loss, Bell's palsy and the COVID-19 vaccines administered in the United States. Background: Published case reports suggest a possible association between various otologic symptoms and the COVID-19 vaccines, but the only published analysis of VAERS data, which did not account for underreporting of late-appearing adverse events, found no association between hearing loss and the vaccines. Methods: The incidence in VAERS of vertigo, tinnitus, hearing loss, and Bell's palsy associated with COVID-19 vaccinations administered between December 14, 2020 and June 7, 2021 was compared with published rates for the general population. To account for underreporting of late-appearing adverse events, incidences were calculated using only the initial part of the observation period, during which reported events spike above expected events. Results: The COVID-19 vaccines were associated with statistically significant increases in the incidence of vertigo, tinnitus, hearing loss, and Bell's palsy of 1877, 50, 12, and 14 cases per 100,000, respectively. In relation to the mRNA-1273 or BNT162b2 vaccines, the Ad26.COV2.S vaccine was associated with a statistically significant excess incidence of vertigo, tinnitus, and hearing loss of at least 723, 57, and 55 cases per 100,000, respectively. Conclusion: These results suggest an association between the COVID-19 vaccines and vertigo, tinnitus, hearing loss, and Bell's palsy. They also suggest that, with respect to vertigo, tinnitus, and hearing loss, the association is relatively strong for the Ad26.COV2.S vaccine.

Ramsi A. Woodcock suffers from otologic symptoms that he believes to have been caused by COVID-19 vaccination. He is Loren J. Bartels' patient.

This study did not receive any funding.

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Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study uses data from the Vaccine Adverse Event Reporting System (VAERS) that is publicly available on the CDC website at https://wonder.cdc.gov/vaers.html.

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Yes

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