ABSTRACT
OBJECTIVE: To investigate how often patients are diagnosed with new-onset tinnitus within 21 days after COVID-19 vaccination in comparison to after three other common vaccinations: influenza, Tdap (tetanus, diphtheria, and acellular pertussis), and polysaccharide pneumococcus. METHODS: The TriNetX Analytics Network, a federated health research network that aggregates the de-identified electronic health record (EHR) data of over 78 million patients, was queried for patients receiving each vaccination. Instances of new-onset tinnitus within 21 days of vaccination were recorded and reported. RESULTS: Out of 2,575,235 patients receiving a first dose of the mRNA COVID-19 vaccine without any prior tinnitus diagnosis, 0.038% (95% CI: 0.036%-0.041%) of patients had a new diagnosis of tinnitus within 21 days. There was a higher risk of a new tinnitus diagnosis after the influenza vaccine (RR: 1.95, 95% CI: 1.72-2.21), Tdap vaccine (RR: 2.36, 95% CI: 1.93-2.89), and pneumococcal vaccine (RR: 1.97, 95% CI: 1.48-2.64) than after the first dose of the COVID-19 vaccine. There was a lower risk of a new tinnitus diagnosis after the second dose of COVID-19 than after the first dose (RR: 0.80, 95% CI: 0.71-0.91). CONCLUSION: The rate of newly diagnosed tinnitus acutely after the first dose of the COVID-19 vaccine is very low. There was a higher risk of newly diagnosed tinnitus after influenza, Tdap, and pneumococcal vaccinations than after the COVID-19 vaccine. The present findings can help to address COVID-19 vaccine hesitancy during the ongoing pandemic. LEVEL OF EVIDENCE: Level 3 Laryngoscope, 2022.
ABSTRACT
Importance: New-onset retinal vascular occlusion (RVO) occurring acutely after messenger RNA (mRNA) COVID-19 vaccination has been described in recent literature. Because RVO can cause vision loss or blindness, an epidemiologic investigation evaluating this potential association is of great importance to public health. Objective: To investigate how often patients are diagnosed with new RVO acutely after the mRNA COVID-19 vaccine compared with influenza and tetanus, diphtheria, pertussis (Tdap) vaccines. Design, Setting, and Participants: A retrospective population-based cohort design using the TriNetX Analytics platform, a federated, aggregated electronic health record (EHR) research network containing the deidentified EHR data of more than 103 million patients, was used to examine aggregate EHR data. Data were collected and analyzed on October 20, 2022. Data on patients within the TriNetX Analytics platform were searched for the presence of vaccination Common Procedural Technology codes, and instances of newly diagnosed RVO within 21 days of vaccination were recorded and reported. Propensity score matching based on demographic characteristics (age, sex, race and ethnicity) and comorbidities (diabetes, hypertension, and hyperlipidemia) was performed between vaccination groups for evaluation of relative risks (RRs). Main Outcomes and Measures: The appearance of a new-encounter diagnosis of RVO within 21 days of the mRNA COVID-19 vaccination was the primary outcome. Historical comparison cohorts of patients receiving influenza and Tdap vaccinations allowed for evaluation of the RRs for RVO. Results: Of 3â¯108â¯829 patients (mean [SD] age at vaccination, 50.7 [20.4] years; 56.4% women) who received the mRNA COVID-19 vaccine, 104 (0.003%; 95% CI, 0.003%-0.004%) patients had a new diagnosis of RVO within 21 days of vaccination. After propensity score matching, the RR for new RVO diagnosis after the first dose of COVID-19 vaccination was not significantly different from that after influenza (RR, 0.74; 95% CI, 0.54-1.01) or Tdap (RR, 0.78; 95% CI, 0.44-1.38) vaccinations, but was greater when compared with the second dose of the COVID-19 vaccination (RR, 2.25; 95% CI, 1.33-3.81). Conclusions and Relevance: The findings of this study suggest that RVO diagnosed acutely after mRNA COVID-19 vaccination occurs extremely rarely at rates similar to those of 2 different historically used vaccinations, the influenza and Tdap vaccines. No evidence suggesting an association between the mRNA COVID-19 vaccination and newly diagnosed RVO was found.