• Nicholas J Wood, Chris C Blyth, Gabriela A Willis, Peter Richmond, Michael S Gold, Jim P Buttery, Nigel Crawford, Michael Crampton, J Kevin Yin, Maria Yui Kwan Chow, and Kristine Macartney.
• National Centre for Immunisation Research and Surveillance, The Children's Hospital at Westmead, Sydney, NSW, Australia. nicholas.wood@health.nsw.gov.au.
• Med. J. Aust. 2014 Nov 17; 201 (10): 596-600.

ObjectiveTo examine influenza vaccine safety in Australian children aged under 10 years in 2013.Design, Participants And SettingActive 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.Main Outcome MeasuresParental-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.ResultsOf 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.ConclusionsThese 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.

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