Research Article

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

BMJ 1993; 307 doi: http://dx.doi.org/10.1136/bmj.307.6910.988 (Published 16 October 1993) Cite this as: BMJ 1993;307:988
  1. T M Govaert,
  2. G J Dinant,
  3. K Aretz,
  4. N Masurel,
  5. M J Sprenger,
  6. J A Knottnerus
  1. Department of General Practice, University of Limburg, Maastricht, Netherlands.

    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.