Annual report: surveillance of adverse events following immunisation in Australia, 2007.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration for 2007, and describes reporting trends over the 8-year period 2000 to 2007. There were 1,538 AEFI records for vaccines administered in 2007. This is an annual AEFI reporting rate of 7.3 per 100,000 population, the highest since 2003 and an 85% increase compared with 2006 (835 AEFI records; 4.0 records per 100,000 population). The increase was almost entirely due to reports following the commencement of the national 3-dose human papillomavirus (HPV) vaccine program for females aged 12 to 26 years in April 2007 (n = 705 reports) and the national infant rotavirus vaccine program in July 2007 (n = 72 reports). AEFI reporting rates in 2007 were 2.3 per 100,000 administered doses of influenza vaccine for adults aged > or = 18 years, 18.6 per 100,000 administered doses of pneumococcal polysaccharide vaccine for those aged > or = 65 years and 12.7 per 100,000 administered doses of scheduled vaccines for children aged < 7 years. The majority of the 1,538 AEFI reports for 2007 described non-serious events while 9% (n = 141) were classified as serious. Two deaths temporally associated with immunisation were reported; there was no evidence to suggest a causal association. The most significant AEFI reported following HPV vaccine were anaphylaxis (n = 11) and convulsion (n = 18), mostly associated with syncope. The most commonly reported reactions were allergic reaction, injection site reaction, headache and nausea. The data confirm that, despite the low rate of AEFI reporting in Australia, the passive surveillance system is sufficiently robust to detect safety signals which are expected following changes in the immunisation program, allowing these to be investigated further.