Serious adverse events following receipt of trivalent inactivated influenza vaccine in Korea, 2003-2010.

Background: Vaccination is very important for the control and prevention of influenza, yet no vaccine is perfectly safe. Little is known, however, about influenza vaccination-associated serious adverse events following immunization (AEFI). This study aimed to identify background information on influenza vaccination-related serious AEFI in Korea. Methods: Retrospective review of data from Korea National Vaccine Injury Compensation Program from 2003 to 2010. Results: Distribution of approximately 75 million doses of influenza vaccine by end of 2010 gave rise to 42 potentially serious AEFI. In all, nine Guillain-Barre syndrome, eighteen other neurologic events, eight local events, and seven miscellaneous events were included. 62% of these events were identified to have unlike causal association with the vaccine. The reporting rate of serious AEFI ranged from 0.006 to 0.07 cases per 100,000 distributed doses of the vaccine. Conclusion: GBS was the most common influenza vaccination-related serious AEFI. Enhancing post-vaccination GBS surveillance may increase public confidence in future routine and pandemic influenza vaccination. (C) 2011 Elsevier Ltd. All rights reserved.