Surveillance of adverse events following immunisation in Australia annual report, 2014
DOI:
https://doi.org/10.33321/cdi.2016.40.41Keywords:
AEFI, adverse events, vaccines, surveillance, immunisation, vaccineAbstract
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2014 reported to the Therapeutic Goods Administration for 2014 and describes reporting trends over the 15-year period 1 January 2000 to 31 December 2014. There were 3,087 AEFI records for vaccines administered in 2014; an annual AEFI reporting rate of 13.2 per 100,000 population. There was a decline of 5% in the overall AEFI reporting rate in 2014 compared with 2013. This decline in reported adverse events in 2014 compared with the previous year was mainly attributable to fewer reports following the human papillomavirus (HPV) vaccine as it was the 2nd year of the extension of the National HPV Vaccination Program to males. AEFI reporting rates for most vaccines were lower in 2014 compared with 2013. The most commonly reported reactions were injection site reaction (27%), pyrexia (18%), rash (16%), vomiting (9%), headache (7%), and syncope (5%). The majority of AEFI reports described non-serious events while 7% (n=211) were classified as serious. There were 5 deaths reported with no clear causal relationship with vaccination found. Commun Dis Intell 2016;40(3):E377–E390.
Downloads
References
Council for International Organizations of Medical Sciences (CIOMS). World Health Organization. Definition and Application of Terms for Vaccine Pharmacovigilance: Report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance. 2012.
Lawrence G, Boyd I, McIntyre P, Isaacs D. Surveillance of adverse events following immunisation: Australia 2002 to 2003. Commun Dis Intell 2004;28(3):324–338.
Lawrence G, Boyd I, McIntyre P, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2005. Commun Dis Intell 2006;30(3):319–333.
Lawrence G, Gold MS, Hill R, Deeks S, Glasswell A, McIntyre PB. Annual report: surveillance of adverse events following immunisation in Australia, 2007. Commun Dis Intell 2008;32(4):371–387.
Lawrence G, Menzies R, Burgess M, McIntyre P, Wood N, Boyd I, et al. Surveillance of adverse events following immunisation: Australia, 2000–2002. Commun Dis Intell 2003;27(3):307–323.
Lawrence GL, Aratchige PE, Boyd I, McIntyre PB, Gold MS. Annual report on surveillance of adverse events following immunisation in Australia, 2006. Commun Dis Intell 2007;31(3):269–282.
Lawrence GL, Boyd I, McIntyre PB, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2004 [erratum appears in Commun Dis Intell 2005;29(4):416]. Commun Dis Intell 2005;29(3):248–262.
Mahajan D, Cook J, Dey A, Macartney K, Menzies R. Supplementary report: surveillance of adverse events following immunisation among children aged less than seven years in Australia, 1 January to 30 June 2012. Commun Dis Intell 2013;37(2):E130–E134.
Mahajan D, Cook J, Dey A, Macartney K, Menzies RI. Annual report: surveillance of adverse events following immunisation in Australia, 2011. Commun Dis Intell 2012;36(4):E315–E332.
Mahajan D, Cook J, McIntyre P, Macartney K, Menzies R. Supplementary report: surveillance of adverse events following immunisation among children aged less than seven years in Australia, 1 January to 30 June 2011. Commun Dis Intell 2012;36(1):114–119.
Mahajan D, Cook J, McIntyre PB, Macartney K, Menzies RI. Annual report: surveillance of adverse events following immunisation in Australia, 2010. Commun Dis Intell 2011;35(4):263–280.
Mahajan D, Roomiani I, Gold MS, Lawrence GL, McIntyre PB, Menzies RI. Annual report: surveillance of adverse events following immunisation in Australia, 2009. Commun Dis Intell 2010;34(3):259–276.
Menzies R, Mahajan D, Gold MS, Roomiani I, McIntyre P, Lawrence G. Annual report: surveillance of adverse events following immunisation in Australia, 2008. Commun Dis Intell 2009;33(4):365–381.
Therapeutic Goods Administration. Bexsero meningococcal B vaccine. 2014. Accessed on 23 October 2015. Available from: https://www.tga.gov.au/monitoring-communication/bexsero-meningococcal-b-vaccine
Australian Government Department of Health. Australian Technical Advisory Group on Immunisation Statement: Advice for immunisation providers regarding the use of Bexsero®. 2015. Accessed on 23 October 2015. Available from: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/atagi-advice-bexsero#full
National Health and Medical Research Council. The Australian Immunisation Handbook. 8th edn. Canberra; 2003.
National Health and Medical Research Council. The Australian Immunisation Handbook. 9th edn. Canberra: Australian Government Department of Health and Ageing; 2008.
Uppsala Monitoring Centre. WHO Collaborating Centre for International Drug Monitoring. Accessed on 9 July 2014. Available from: http://www.who-umc.org/
Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)—United States, 1991–2001. [erratum appears in MMWR Morb Mortal Wkly Rep 2003;52(06):113]. MMWR Surveill Summ 2003;52(1):1–24.
Brown EG. Using MedDRA: implications for risk management. Drug Saf 2004;27(8):591–602.
Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999;20(2):109–117.
Mahajan D, Dey A, Hill R, Harvey B, Menzies R, McIntyre P, et al. Methodological framework for reporting of adverse events following immunisation (AEFI) In: PHAA National Immunisation Conference, 17–19 June, 2014. Melbourne, Australia; 2014.
Leroy Z, Broder K, Menschik D, Shimabukuro T, Martin D. Febrile seizures after 2010–2011 influenza vaccine in young children, United States: a vaccine safety signal from the vaccine adverse event reporting system. Vaccine 2012;30(11):2020–2023.
Moro PL, Broder K, Zheteyeva Y, Revzina N, Tepper N, Kissin D, et al. Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System. Am J Obstet Gynecol 2011;205(473):e1–e9.
Zheteyeva Y, Moro PL, Yue X, Broder K. Safety of meningococcal polysaccharide-protein conjugate vaccine in pregnancy: a review of the Vaccine Adverse Event Reporting System. Am J Obstet Gynecol 2013;208(478):e1–e6.
Australian Government Department of Health, Therapeutic Goods Administration. National Adverse Events Following Immunisation reporting form. Accessed on 26 March 2013. Available from: http://www.tga.gov.au/safety/problem-medicine-aefi.htm
SAS Institute Inc. The SAS system for Windows [computer program]. Version 9.3. Cary, N.C. 2012.
Australian Bureau of Statistics. Australian Demographic Statistics. 2014. Accessed on. Available from: http://www.abs.gov.au/AUSSTATS/abs@.nsf/DetailsPage/3101.0Sep%202014?OpenDocument
Additional reports – Childhood immunisation coverage. Commun Dis Intell 2008;32(2):288–289.
Varricchio F, Iskander J, DeStefano F, Ball R, Pless R, Braun M, et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J 2004;23(4):287–294.
Australian Government Department of Health, Therapeutic Goods Administration. Database of Adverse Event Notifications. Accessed on 26 March 2013. Available from: http://www.tga.gov.au/safety/daen.htm
Simon LS. Pharmacovigilance: towards a better understanding of the benefit to risk ratio. Ann Rheum Dis 2002;61(Suppl 2):ii88–89.
Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, et al. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J 2007;26(3):201–209.
Therapeutic Goods Administration. Gardasil (quadrivalent human papillomavirus vaccine), update 2:– adverse event monitoring. 2015. Accessed on 26 May 2016. Available from: https://www.tga.gov.au/alert/gardasil-quadrivalent-human-papillomavirus-vaccine-update-2
Downloads
Published
How to Cite
License
Copyright (c) 2016 Communicable Diseases Intelligence

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
