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Adverse reactions to influenza vaccine in elderly people: randomised double blind placebo controlled trial
T M Govaert1, G J Dinant, K Aretz
1Department of General Practice, University of Limburg, Maastricht, Netherlands.
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 effects than women.
Conclusion:
Only local side effects were more common in vaccinated patients and all side effects were mild.