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Clinical Trial
. 1993 Oct 16;307(6910):988-90.
doi: 10.1136/bmj.307.6910.988.

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

T M Govaert  1 , G J Dinant, K Aretz, N Masurel, M J Sprenger, J A Knottnerus
Affiliations
Clinical Trial

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

T M Govaert et al. BMJ. .

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 effects than women.

Conclusion: Only local side effects were more common in vaccinated patients and all side effects were mild.

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