Abstract
IMPORTANCE: Annual administration of the influenza vaccine (fluVc) is currently the most effective method of preventing the influenza virus in older adults. However, half of adults older than 65 years remain unvaccinated in Taiwan, possibly because of concern about adverse events, such as Bell palsy (BP). Currently, studies on the association between fluVc and risk of BP are inconsistent. OBJECTIVE: To determine whether the incidence of BP increases following fluVc in older adults. DESIGN, SETTING, AND PARTICIPANTS: A self-controlled case series study design was used. Days 1 through 7, days 8 through 14, days 15 through 30, and days 31 through 60 following fluVc were identified as risk intervals, and days 61 through 180 were considered the control interval. A total of 4367 vaccinated individuals aged 65 years or older who developed BP within 6 months following fluVc were enrolled. Population-based retrospective claims data were obtained between 2010 and 2017; data were analyzed from April 2022 through September 2022. EXPOSURE: Government-funded seasonal fluVc. MAIN OUTCOMES AND MEASURES: The outcome of interest was BP onset in risk intervals compared with control intervals. Three or more consecutive diagnoses of BP within 60 days following fluVc were used as the definition of a patient with BP. Poisson regression was used to analyze the incidence rate ratio (IRR) of risk intervals compared with control intervals. RESULTS: In total, 13 261 521 patients who received the fluVc were extracted from the National Health Insurance Research Database in Taiwan from January 1, 2010, to December 31, 2017. Of those, 7 581 205 patients older than 65 years old met the inclusion criteria. The number of patients with BP diagnosed within 6 months following fluVc enrolled for risk analysis was 4367 (mean [SD] age, 74.19 [5.97] years; 2349 [53.79%] female patients). The incidence rate of BP among all observed fluVc older adults was 57.87 per 100 000 person-years. The IRRs for BP on days 1 through 7, days 8 through 14, and days 15 through 30 were 4.18 (95% CI, 3.82-4.59), 2.73 (95% CI, 2.45-3.05), and 1.67 (95% CI, 1.52-1.84), respectively. However, there was no increase during days 31 through 60 (IRR, 1.06; 95% CI, 0.97-1.16). The postvaccination risk of BP was consistent across all subgroups stratified by sex, age group, and baseline conditions. CONCLUSIONS AND RELEVANCE: The present self-controlled case series indicated that the risk of BP in individuals older than 65 years increased within the first month, especially within the first week, following fluVc. But overall, the adverse event rate of BP was low, and considering the morbidity and mortality of influenza infection, the benefits of fluVc still outweigh the risks.