Tinnitus after COVID-19 Vaccination: Findings from the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink

Details

• Alternative Title:
  Am J Otolaryngol
• Personal Author:
  Yih, W. Katherine ; Duffy, Jonathan ; Su, John R. ; Bazel, Samaneh ; Fireman, Bruce ; Hurley, Laura ; Maro, Judith C. ; Marquez, Paige ; Moro, Pedro ; Nair, Narayan ; Nelson, Jennifer ; Smith, Ning ; Sundaram, Maria ; Vasquez-Benitez, Gabriela ; Weintraub, Eric ; Xu, Stanley ; Shimabukuro, Tom
• Description:
  Purpose:
  
  To assess the occurrence of tinnitus following COVID-19 vaccination using data mining and descriptive analyses in two U.S. vaccine safety surveillance systems.
  
  Methods:
  
  Reports 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.
  
  Results:
  
  VAERS 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).
  
  Conclusions:
  
  Overall, 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.
  
  
• Subjects:
  Adult Adverse Drug Reaction Reporting Systems Aged Bayes Theorem COVID-19 COVID-19 Vaccines Data Mining Female Humans Incidence Influenza Vaccines Male Middle Aged Tinnitus United States Vaccination

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• Keywords:
  COVID-19 Vaccination Tinnitus Vaccine Safety
• Source:
  Am J Otolaryngol. 45(6):104448
• Pubmed ID:
  39096568
• Pubmed Central ID:
  PMC11634645
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHSUnited States/
• Volume:
  45
• Issue:
  6
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:c73c0f7b2370bbfae3ad9c55b07343012c51565ff870d6a320945d19074f5fa2473e72f4c9ae1d104c6ddfc2b790ce64d99844779fd0852a193d6adb3aef1c6a
• Download URL:
  https://stacks.cdc.gov/view/cdc/174807/cdc_174807_DS1.pdf
• File Type:
  [PDF - 951.38 KB ]