Adverse reactions to influenza vaccine in elderly people: Randomised double blind placebo controlled trial

Abstract

Objective - To assess the frequency and type of side effects after influenza vaccination in elderly people. Design - Randomised double blind placebo controlled study. Setting - 15 general practices in the southern Netherlands. Subjects - 1806 patients aged 60 or older, of whom 904 received influenza vaccine and 902 placebo. Main outcome measures - Adverse reactions reported on postal questionnaire completed four weeks after vaccination. Results - 210 (23%) patients given vaccine reported one or more adverse reactions compared with 127 (14%) given placebo. The frequency of local adverse reactions were 17.5% in the vaccine group and 7.3% in the placebo group (p < 0.001). There was no difference in systemic adverse reactions (11% v 9.4%; p = 0.34). In general, men reported fewer side effets than women. Conclusion - Only local side effects were more common in vaccinated patients and all side effects were mild.