NSW Annual Adverse Events Following Immunisation Report, 2009.

AIM: This is the first annual report for NSW of adverse events following immunisation. It summarises Australian passive surveillance data for adverse events following immunisation for NSW for 2009. METHODS: Analysis of de-identified information on all adverse events following immunisation reported to the Therapeutic Goods Administration. RESULTS: 450 adverse events following immunisation were reported for vaccines administered in 2009; this is 32% higher than 2008 and the highest since 2003. The increase was almost entirely attributed to the commencement of the pandemic (H1N1) 2009 influenza vaccine in September 2009. Only 6% of the reported adverse events were serious in nature and the most commonly reported reactions were allergic reaction, injection site reaction, fever and headache. CONCLUSION: Reports of adverse events following immunisation in 2009 were dominated by the pandemic (H1N1) 2009 influenza vaccine. A large proportion of these adverse events were reported directly to the Therapeutic Goods Administration by members of the public. Reports were predominantly mild transient events, similar to those expected from the seasonal flu vaccine.

Annual report: surveillance of adverse events following immunisation in Australia, 2009.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2009, and describes reporting trends over the 10-year period 2000 to 2009. There were 2,396 AEFI records for vaccines administered in 2009, the highest number reported, a 46% increase over the 1,638 in 2008. The increase was almost entirely due to reports related to the introduction of pandemic H1N1 (pH1N1) 2009 influenza vaccine from September 2009 (n = 1,312) largely from the members of the public. The pH1N1 AEFI reporting rate for people aged > or = 18 years was 34.2 per 100,000 administered doses compared with 2.8 for seasonal influenza vaccine. The rates in > or = 65 year-olds were 28.0, 1.6 and 13.3 for pH1N1, seasonal influenza and polysaccharide pneumococcal, respectively. The high reporting rate for pH1N1 vaccine is likely to be at least partly due to enhanced reporting seen for all new vaccines and greater levels of reporting from members of the public in response to the implementation of strategies to encourage reporting, as part of the pH1N1 program. For children < 7 years, AEFI reporting rates in 2009 (14.1 per 100,000 administered doses) were similar to previous years. There were 193 (8%) AEFI reports classified as serious; 6 deaths temporally associated with immunisation were reported but none were judged to have a causal association. As in previous years, the most commonly reported reactions were allergic reaction, injection site reaction, fever, headache, malaise, nausea and myalgia. The most commonly reported reactions following pH1N1 influenza vaccine were allergic reaction (n = 381), headache (n = 289), fever (n = 235), pain (n = 186), nausea (n = 180) and injection site reaction (n = 178). The data within the limitation of passive surveillance provide a reference point for ongoing reporting of trends in AEFI by age group, severity and vaccine type and illustrate the value of the national TGA database as a surveillance tool for monitoring AEFI nationally.

Annual report: surveillance of adverse events following immunisation in Australia, 2008.

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2008, and describes reporting trends over the 9-year period 2000 to 2008. There were 1,542 AEFI records for vaccines administered in 2008. This was an annual AEFI reporting rate of 7.2 per 100,000 population, a 5% decrease compared with 2007. The majority of AEFI reports described non-serious events while 10% (n = 152) were classified as serious. Two deaths temporally associated with immunisation were reported; there was no evidence to suggest a causal association. The most commonly reported reactions were injection site reaction, allergic reaction, fever and headache. AEFI reporting rates in 2008 were 2.7 events per 100,000 administered doses of influenza vaccine for adults aged > or = 18 years, 18.9 per 100,000 administered doses of pneumococcal polysaccharide vaccine for those aged > or = 65 years, and 17.2 per 100,000 administered doses of scheduled vaccines for children aged < 7 years. Reports for infants increased in 2008, mainly related to gastrointestinal system events temporally associated with receipt of rotavirus vaccine in the 1st full year of the rotavirus immunisation program, while there was a substantial decrease in AEFI reports for human papilIoma virus vaccine in adolescents compared with 2007 when the program commenced. Increases in reports in children and adults were also partly attributed to the implementation of enhanced passive surveillance in Victoria. The consistently low reporting rate of serious AEFI highlights the safety of vaccines in Australia and illustrates the value of the national TGA database as a surveillance tool for monitoring AEFIs nationally.