Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Mar;134(3):1163-1168.
doi: 10.1002/lary.30923. Epub 2023 Aug 4.

Otolaryngologic Side Effects After COVID-19 Vaccination

Salma Ahsanuddin  1 , Ryan Jin  2 , Aatin K Dhanda  2 , Kirolos Georges  2 , Soly Baredes  2 , Jean Anderson Eloy  2   3   4   5   6 , Christina H Fang  1
Affiliations

Otolaryngologic Side Effects After COVID-19 Vaccination

Salma Ahsanuddin et al. Laryngoscope. 2024 Mar.

Abstract

Objectives: With widespread vaccination against COVID-19, concerns regarding side effects have been raised. We aim to assess the frequency of otolaryngologic adverse events (AEs) following COVID-19 vaccination as compared with other vaccines in a national database.

Study design: Retrospective analysis of national registry.

Methods: The Food and Drug Administration's Vaccine Adverse Event Reporting System (VAERS) database was queried from December 2020 to May 2021 for all COVID-19 vaccination AEs. Complaints were categorized as otolaryngologic and sub stratified into different anatomic components. Reporting odds ratios (ROR) and proportional reporting ratios (PRR) were determined for AEs of clinical significance.

Results: The total number of AEs reported from vaccination with the Moderna, Pfizer-BioNTech, and Janssen vaccines equaled 1,280,950. Of these, 62,660 (4.9%) were otolaryngologic in nature, with 32.6% associated with the oropharynx/larynx, 18.3% with the nasal cavity/sinuses, 17.1% with the ears/vestibular system, 10.0% with the oral cavity, and 21.9% miscellaneous. Signal ratios reached significance levels for dysgeusia (n = 2124, PRR: 17.33, ROR: 16.36), ageusia (n = 1376, PRR: 2.81, ROR: 2.81), anosmia (n = 983, PRR: 4.01, ROR: 4.01), rhinorrhea (n = 2203, PRR: 2.99, ROR: 3.00), throat tightness (n = 3666, PRR: 4.99, ROR: 5.00), throat irritation (n = 3313, PRR: 4.51, ROR: 4.52), dysphagia (n = 2538, PRR: 2.07, ROR: 2.07), tinnitus (n = 4377, PRR: 3.97, ROR: 3.98), and vertigo (n = 2887, PRR: 3.93, ROR: 3.93). Signal ratios were not significant for facial paralysis, Bell's palsy, anaphylaxis, sinusitis, hearing disability, and ear pain.

Conclusions: Although several otolaryngologic symptoms were reported, few were found to be clinically significant. Of note, facial paralysis, Bell's palsy, and anaphylaxis did not meet signal thresholds to be determined significant.

Level of evidence: 4 Laryngoscope, 134:1163-1168, 2024.

Keywords: COVID-19; adverse events; otolaryngology; pharmacovigilance; vaccination.

PubMed Disclaimer

Comment in

References

BIBLIOGRAPHY

    1. National Academies of Sciences, Engineering, and Medicine. National Academies Release Framework for Equitable Allocation of a COVID-19 Vaccine for Adoption by HHS, State, Tribal, Local, and Territorial Authorities. Published October 2, 2020 2020.
    1. Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403-416.
    1. Livingston EH, Malani PN, Creech CB. The Johnson & Johnson vaccine for COVID-19. JAMA. 2021;325(15):1575.
    1. Self WH, Tenforde MW, Rhoads JP, et al. Comparative effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) vaccines in preventing COVID-19 hospitalizations among adults without immunocompromising conditions-United States, March-August 2021. MMWR Morb Mortal Wkly Rep. 2021;70(38):1337-1343.
    1. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603-2615.

LinkOut - more resources