Surveillance of adverse events following immunisation in Australia annual report, 2016.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2016 reported to the Therapeutic Goods Administration and describes reporting trends over the 17-year period 1 January 2000 to 31 December 2016. There were 3,407 AEFI records for vaccines administered in 2016; an annual AEFI reporting rate of 14.1 per 100,000 population. There was a 14% increase in the overall AEFI reporting rate in 2016 compared with 2015. This increase in reported adverse events in 2016, compared to the previous year, was mainly attributable to introduction of the booster dose of the diphtheria, tetanus, and acellular pertussis-containing vaccine (DTPa) at 18 months of age in March 2016 and the zoster vaccine for those aged 70-79 years in November 2016. AEFI reporting rates for most other individual vaccines in 2016 were similar to 2015. The most commonly reported reactions were injection site reaction (29%), pyrexia (19%), rash (17%), vomiting (8%) and headache (7%). The majority of AEFI reports (90%) were described as non-serious events and a 24% decline was observed in events classified as 'serious' in this reporting period compared to the previous reporting period. There were 2 deaths reported but no clear causal relationship with vaccination found.