Annual report: surveillance of adverse events following immunisation in Australia, 2010.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2010, and describes reporting trends over the 11-year period 2000 to 2010. There were 3,894 AEFI records for vaccines administered in 2010, the highest number reported in any year, and a 63% increase over the 2,396 in 2009. The increase was almost entirely attributable to the large number of reports following seasonal influenza (n = 2,354) and pandemic H1N1 (pH1N1) influenza vaccines (n = 514). In children < 7 years of age, the number of reports following influenza vaccine increased almost 100-fold from 17 in 2009 to 1,693 in 2010 and, for people aged > or =18 years, from 135 to 496. For seasonal influenza vaccine, a disproportionate number of reports were from Western Australia (34%), consistent with more widespread influenza vaccination of children in that state, and 79% were identified as being associated with Fluvax or Fluvax junior (CSL Biotherapies). For pH1N1 vaccine, the number of reports in children < 7 years of age increased from 23 in 2009 to 329 in 2010, but was available for this age group for only 1 month (December) in 2009. In those aged > or = 18 years, for whom the pH1N1 vaccine was available from late September 2009, pH1N1 vaccine reports decreased from 1,209 in 2009 to 109 in 2010. For influenza vaccines, 79% of reports included fever, 45% allergic reactions and 15% malaise. In children aged < 7 years, there were 169 reports of convulsions (127 febrile), compared with 19 in 2009. In contrast, for non-influenza vaccines, reporting rates in children < 7 years of age increased only marginally from 14.1 per 100,000 in 2009 to 19.3 per 100,000 in 2010. Four deaths temporally associated with immunisation were reported but none were considered to have a causal association.