Surveillance of adverse events following immunisation in Australia annual report, 2013
DOI:
https://doi.org/10.33321/cdi.2015.39.42Keywords:
AEFI, adverse events, vaccines, surveillance, immunisation, vaccine safetyAbstract
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2013 reported to the Therapeutic Goods Administration (TGA) for 2013 and describes reporting trends over the 14-year period 1 January 2000 to 31 December 2013. There were 3,161 AEFI records for vaccines administered in 2013. This is an annual AEFI reporting rate of 13.9 per 100,000 population, the 2nd highest since 2000 and an increase of 59% compared with 2012 (1,994 AEFI records; 8.8 per 100,000 population). The increase was partly due to implementation of enhancements to vaccine safety reporting. This included stimulated reporting of AEFI as part of the extension of national human papillomavirus (HPV) vaccination under the National Immunisation Program to males aged 12–13 years, along with a catch-up program for males aged 14 and 15 years in February 2013 (n=785; includes males and females), in which certain events, such as syncope, were closely monitored. Eighty-two per cent (n=341/414) of the syncope reports were following HPV vaccination and of these 57% (n=195) were males and 43% (n=146) were females. In addition, reporting rates for most other the vaccines were higher in 2013 compared with 2012. The majority of AEFI reports described non-serious events while 5% (n=158) were classified as serious. There were 4 reports of death; however, all deaths were investigated by the TGA and no clear causal relationship with vaccination was found. The most commonly reported reactions were injection site reaction (13%), rash (10%), pyrexia (8%), and syncope (7%). Commun Dis Intell 2015;39(3):E369–E386.
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References
Council for International Organizations of Medical Sciences (CIOMS) c/o 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.
National Health and Medical Research Council. The Australian Immunisation Handbook, 8th edition. Canberra: Australian Government Department of Health and Ageing; 2003.
National Health and Medical Research Council. The Australian Immunisation Handbook. 9th edition. 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, K. B. 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 (AEFI) 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. In; 2012.
Australian Institute of Health and Welfare. 2009 Adult Vaccination Survey: summary results. Cat. No. PHE 135 Canberra: AIHW. 2011. Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=10737418286
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 II):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.
Buttery JP, Madin S, Crawford NW, Elia S, La Vincente S, Hanieh S, et al. Mass psychogenic response to human papillomavirus vaccination. Med J Aust 2008;189(5):261–262.
Clements CJ. Mass psychogenic illness after vaccination. Drug Saf 2003;26(9):599–604.
Crawford NW, Clothier H, Elia S, Lazzaro T, Royle J, Buttery JP. Syncope and seizures following human papillomavirus vaccination: a retrospective case series. Med J Aust 2011;194(1):16–18.
National Cancer Institute. Accelerating HPV Vaccine Uptake: Urgency for Action to Prevent Cancer. A Report to the President of the United States from the President’s Cancer Panel. Bethesda, MD. 2014. Accessed on 9 July 2014. Available from: http://deainfo.nci.nih.gov/advisory/pcp/annualReports/HPV/PDF/PCP_Annual_Report_2012–2013.pdf
Kids Research Institute. Paediatric Active Enhanced Disease Surveillance (PAEDS). Accessed on 9 July 2014. Available from: http://www.apsu.org.au/surveillance-systems/paeds/
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