The safety of seasonal influenza vaccines in Australian children in 2013.
OBJECTIVE
To examine influenza vaccine safety in Australian children aged under 10 years in 2013.


METHODS
Active prospective surveillance study conducted with parents or carers of children who received influenza vaccine in outpatient clinics at six tertiary paediatric hospitals or from selected primary health care providers between 18 March and 19 July 2013.


METHODS
Parental-reported frequency of systemic reactions (fever, headache, nausea, abdominal symptoms, convulsions, rash, rigors and fatigue), injection site reactions (erythema, swelling and/or pain at the injection site), use of antipyretics or analgesics, and medical attendance or advice within 72 hours after vaccination.


RESULTS
Of 981 children enrolled in the surveillance, 893 children aged 6 months to < 10 years were eligible for inclusion. These children received 1052 influenza vaccine doses. Fever was reported in 5.5% (95% CI, 4.1%-7.3%) and 6.5% (95% CI, 3.5%-10.9%) of children after Doses 1 and 2, respectively. One febrile convulsion occurred in a child with a known seizure disorder. Injection site reactions occurred in 21.2% (95% CI, 18.5%-24.1%) and 6.0% (95% CI, 3.1%-10.2%) after Doses 1 and 2, respectively; most were mild. Very few parents sought medical follow-up for their child's reaction: 22 (2.6%; 95% CI, 1.6%-3.9%) after Dose 1, and 11 (5.5%; 95% CI, 2.8%-9.6%) after Dose 2.


CONCLUSIONS
These results are consistent with clinical trials and other observational studies of influenza vaccines currently registered for use in young children in Australia and can reassure parents and health care providers that influenza vaccination is safe and well tolerated.
National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Sydney, NSW, Australia. nicholas.wood@health.nsw.gov.au.
Nicholas J
NJ
Wood
Department of Paediatric and Adolescent Medicine, Princess Margaret Hospital for Children, Perth, WA, Australia.
Chris C
CC
Blyth
Vaccine Trials Group, Telethon Institute for Child Health Research, Perth, WA, Australia.
Gabriela A
GA
Willis
Department of Paediatric and Adolescent Medicine, Princess Margaret Hospital for Children, Perth, WA, Australia.
Peter
P
Richmond
Discipline of Paediatrics, University of Adelaide, Adelaide, SA, Australia.
Michael S
MS
Gold
SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community), Murdoch Childrens Research Institute, Melbourne, VIC, Australia.
Jim P
JP
Buttery
Department of General Medicine, Royal Children's Hospital, Melbourne, VIC, Australia.
Nigel
N
Crawford
WentWest (Western Sydney Medicare Local), Sydney, NSW, Australia.
Michael
M
Crampton
National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Sydney, NSW, Australia.
J Kevin
JK
Yin
National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Sydney, NSW, Australia.
Maria Yui Kwan
MY
Chow
National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Sydney, NSW, Australia.
Kristine
K
Macartney
D001315:Australia; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines; D008297:Male; D061214:Patient Safety; D011159:Population Surveillance; D018570:Risk Assessment; D015164:Vaccines, Inactivated
D007252:Influenza Vaccines; D015164:Vaccines, Inactivated; C478242:vaxigrip