Active surveillance for adverse events of influenza vaccine safety in elderly cancer patients using self-controlled tree-temporal scan statistic analysis

Both cancer patients and the elderly are at high risk of developing flu complications, so influenza vaccination is recommended. We aimed to evaluate potential adverse events (AEs) following influenza vaccination in elderly cancer patients using the self-controlled tree-temporal scan statistic method. From a large linked database of Korea Disease Control and Prevention Agency vaccination data and the National Health Insurance Service claims data, we identified cancer patients aged over 65 who received flu vaccines during the 2016/2017 and 2017/2018 seasons. We included all the outcomes occurring on 1–84 days post-vaccination and evaluated all temporal risk windows, which started 1–28 days and ended 2–42 days. Patients who were diagnosed with the same disease during a year prior to vaccination were excluded. We used the hierarchy of ICD-10 to identify statistically significant clustering. This study included 431,276 doses of flu vaccine. We detected signals for 1 set: other dorsopathies on 1–15 days (attributable risk 16.5 per 100,000, P = 0.017). Dorsopathy is a known AE of influenza vaccine. No statistically significant clusters were found when analyzed by flu season. Therefore, influenza vaccination is more recommended for elderly patients with cancer and weakened immune systems.