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 oflocal 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=034). In general, men reported fewer side effects than women.Conclusion-Only local side effects were more common in vaccinated patients and all side effects were mild.

Guidelines for the management of adult lower respiratory tract infections

“…Systemic symptoms or disability are seen as often in persons receiving placebo as in those who have received inactivated influenza vaccine. Mild local reactions, such as a ''sore arm'', are less common after placebo than after active substance, 5-10% versus 15-20%, respectively [265][266][267]. The inactivated vaccine is also safe to administer to patients with asthma, including those with severe asthma [268].…”

Influenza and Cardiovascular Disease

“…In a randomized, double-blind, crossover trial in the elderly, Margolis and colleagues 57 reported no significant systemic symptoms. In another randomized clinical trial, Govaert et al 58 found no increase in systemic adverse reactions, only an increase in local side effects.…”

Sex differences in injection site reactions with human vaccines

“…F > M. Govaert et al 43 1,806 responded to questionnaire; 16 non-responders in each group, 904 vaccine, 902 placebo.…”