Adverse reactions to influenza vaccine in elderly people: randomised double blind placebo controlled trial.
OBJECTIVE
To assess the frequency and type of side effects after influenza vaccination in elderly people.


METHODS
Randomised double blind placebo controlled study.


METHODS
15 general practices in the southern Netherlands.


METHODS
1806 patients aged 60 or older, of whom 904 received influenza vaccine and 902 placebo.


METHODS
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.


CONCLUSIONS
Only local side effects were more common in vaccinated patients and all side effects were mild.
Govaert
T M
TM
Department of General Practice, University of Limburg, Maastricht, Netherlands.
Dinant
G J
GJ
Aretz
K
K
Masurel
N
N
Sprenger
M J
MJ
Knottnerus
J A
JA
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D007252:Influenza Vaccines / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D012737:Sex Factors; D014611:Vaccination / Q000009:adverse effects
D007252:Influenza Vaccines