Previous studies have shown controversial results on the risk of Bell’s palsy after influenza vaccination. Since the antigenic components of influenza vaccine can vary from season to season, continuous safety monitoring is required. The aim of the present study was to determine whether there was an increased risk of Bell’s palsy in the elderly after influenza vaccination between the 2015/2016 and 2017/2018 flu seasons. This study included the elderly who received influenza vaccinations for three flu seasons using a large-linked database of vaccination registration data from the Korea Disease Control and Prevention Agency and the National Health Insurance Service claims data. We used a self-controlled risk interval design with a risk interval of 1 to 42 days and a control interval of 57 to 98 days postvaccination and calculated the incidence rate ratio. To ensure the robustness of the results, sensitivity analyses were also carried out with different risk and control intervals. Of 4,653,440 elderly people who received the influenza vaccine, there was no statistically significant increase in the risk of Bell’s palsy (IRR: 0.99, 95% CI: 0.92–1.07). Similar results were found in analysis results for each season and the results of the sensitivity analyses excluding the 2017/2018 season. In conclusion, we found no evidence of an increased risk of Bell’s palsy after influenza vaccination. The results of our study provide reassurance about the safety of the influenza vaccine NIP program. However, it is necessary to continuously monitor the risk of Bell’s palsy during future flu seasons.
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© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
- Adverse events
- Bell’s palsy
- Elderly people
- Influenza vaccine
- Large-linked database
- Self-controlled risk interval design