Surveillance of adverse events following immunisation in Australia, 2012.
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2012. It also describes reporting trends over the 13-year period 1 January 2000 to 31 December 2012. There were 1,897 AEFI records for vaccines administered in 2012, a decrease of 22% from 2,417 in 2011. The decrease in 2012 compared with 2011 was mainly attributable to a drop in the reports following receipt of the 23-valent pneumococcal polysaccharide vaccine (405 reduced to 133). However, reporting rates for some other vaccines such as rotavirus and varicella vaccines were higher in 2012 than 2011. Although an increase was observed in estimated reporting rates for rotavirus and varicella in children aged < 7 years in 2012 compared with 2011, it was not statistically significant. There were 370 AEFI records (37.2 per 100,000 doses) for the pneumococcal conjugate vaccine in 2012, which was fewer than in 2011 (43.4 per 100,000 doses). The most commonly reported reactions were injection site reactions (40%), fever (22%), allergic reactions (19%) and rash (10%). Only 7% of all the reported adverse events were categorised as serious. There were 2 reports of death, which were investigated by the TGA and no clear causal relationship with vaccination was found.
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, University of Sydney and The Children's Hospital at Westmead, Sydney, New South Wales.
Deepika
D
Mahajan
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, University of Sydney and The Children's Hospital at Westmead, Sydney, New South Wales.
Aditi
A
Dey
Office of Product Review, Therapeutic Goods Administration, Canberra, Australian Capital Territory.
Jane
J
Cook
Office of Product Review, Therapeutic Goods Administration, Canberra, Australian Capital Territory.
Bronwen
B
Harvey
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, University of Sydney and The Children's Hospital at Westmead, Sydney, New South Wales.
Rob I
RI
Menzies
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, University of Sydney and The Children's Hospital at Westmead, Sydney, New South Wales.
Kristine M
KM
Macartney
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001315:Australia / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D003140:Communicable Disease Control / Q000266:history / Q000706:statistics & numerical data*; D005260:Female; D062306:Geography, Medical; D049674:History, 21st Century; D006801:Humans; D017589:Immunization Programs; D007115:Immunization Schedule; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011159:Population Surveillance; D014611:Vaccination / Q000009:adverse effects*; D014612:Vaccines / Q000009:adverse effects; D055815:Young Adult
D014612:Vaccines