Evidence map›Paper›PMID 39096568›Full record

ArticleAmerican journal of otolaryngology

Tinnitus after COVID-19 vaccination: Findings from the vaccine adverse event reporting system and the vaccine safety datalink.

W Katherine Yih, Jonathan Duffy, John R Su, Samaneh Bazel, Bruce Fireman, Laura Hurley, Judith C Maro, Paige Marquez, Pedro Moro, Narayan Nair and 7 more

Abstract read
In one paragraph

Article in American journal of otolaryngology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

W Katherine YihHarvard Pilgrim Health Care Institute and Department of Population Medicine, Harvard Medical School, Boston, MA, United States of America.
Jonathan DuffyImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States of America. Electronic address: jduffy@cdc.gov.
John R SuImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States of America.
Samaneh BazelOffice of Biostatistics and Pharmacovigilance, Food and Drug Administration, Silver Spring, MD, United States of America.
Bruce FiremanKaiser Permanente Northern California, Oakland, CA, United States of America.
Laura HurleyAmbulatory Care Services, Denver Health and Hospitals, Denver, CO, United States of America; Department of Medicine, University of Colorado School of Medicine, Aurora, CO, United States of America.
Judith C MaroHarvard Pilgrim Health Care Institute and Department of Population Medicine, Harvard Medical School, Boston, MA, United States of America.
Paige MarquezImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States of America.
Pedro MoroImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States of America.
Narayan NairOffice of Biostatistics and Pharmacovigilance, Food and Drug Administration, Silver Spring, MD, United States of America.
Jennifer NelsonKaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.
Ning SmithKaiser Permanente Northwest, Portland, OR, United States of America.
Maria SundaramMarshfield Clinic Research Institute, Marshfield, WI, United States of America.
Gabriela Vasquez-BenitezHealthPartners Institute, Bloomington, MN, United States of America.
Eric WeintraubImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States of America.
Stanley XuDepartment of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States of America.
Tom ShimabukuroImmunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States of America.

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

purposeTo assess the occurrence of tinnitus following COVID-19 vaccination using data mining and descriptive analyses in two U.S. vaccine safety surveillance systems.

methodsReports of tinnitus after COVID-19 vaccination to the Vaccine Adverse Event Reporting System (VAERS) from 2020 through 2024 were examined using empirical Bayesian data mining and by calculating reporting rates. In the Vaccine Safety Datalink (VSD) population, ICD-10 coded post-vaccination medical visits were examined using tree-based data mining, and tinnitus visit incidence rates during post-vaccination days 1-140 were calculated by age group for COVID-19 vaccines and for comparison, influenza vaccine.

resultsVAERS data mining did not find disproportionate reporting of tinnitus for any COVID-19 vaccine. VAERS received up to 84.82 tinnitus reports per million COVID-19 vaccine doses administered. VSD tree-based data mining found no signals for tinnitus. VSD tinnitus visit incidence rates after COVID-19 vaccines were similar to those after influenza vaccine except for the group aged ≥65 years (Moderna COVID-19 vaccine, 165 per 10,000 person-years; Pfizer-BioNTech COVID-19 vaccine, 154; influenza vaccine, 135).

conclusionsOverall, these findings do not support an increased risk of tinnitus following COVID-19 vaccination but cannot definitively exclude the possibility. Descriptive comparisons between COVID-19 and influenza vaccines were limited by lack of adjustment for potential confounding factors.

Indexed as

Adverse Drug Reaction Reporting SystemsCOVID-19 VaccinesData MiningTinnitusAdultAgedBayes TheoremCOVID-19FemaleHumansIncidenceInfluenza VaccinesMaleMiddle AgedUnited StatesVaccinationCOVID-19 VaccinesInfluenza VaccinesCOVID-19 vaccinationTinnitusVaccine safety

Identifiers

PMID39096568
PMCPMC11634645

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.