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

Abstract

To assess the frequency and type of side effects after influenza vaccination in elderly people. Randomised double blind placebo controlled study. 15 general practices in the southern Netherlands. 1806 patients aged 60 or older, of whom 904 received influenza vaccine and 902 placebo. Adverse reactions reported on postal questionnaire completed four weeks after vaccination. 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 effects than women. Only local side effects were more common in vaccinated patients and all side effects were mild.