Surveillance of adverse events following immunisation in Australia: annual report, 2018

Authors

  • Aditi Dey National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
  • Han Wang National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
  • Helen Quinn National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
  • Alexis Pillsbury National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
  • Catherine Glover National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
  • Megan Hickie Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, Department of Health, Canberra, Australia
  • Nicholas Wood National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
  • Frank Beard National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
  • Kristine Macartney National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia

DOI:

https://doi.org/10.33321/cdi.2020.44.12

Keywords:

AEFI, adverse events, vaccines, surveillance, immunisation, vaccine

Abstract

This report summarises Australian spontaneous surveillance data for adverse events following immunisation (AEFI) for 2018 reported to the Therapeutic Goods Administration and describes reporting trends over the 19-year period 1 January 2000 to 31 December 2018. There were 4221 AEFI records for vaccines administered in 2018, an annual AEFI reporting rate of 16.9 per 100,000 population. There was a 2.9% increase in the overall AEFI reporting rate in 2018 compared to 2017. This slight increase in reported adverse events in 2018 was likely due to new additions to the National Immunisation Program schedule, namely meningococcal ACWY vaccination for children aged 12 months, enhanced immunogenicity trivalent influenza vaccines for adults aged ≥65 years, and state- and territory-funded seasonal influenza vaccination programs for children aged 6 months to <5 years. AEFI reporting rates for most individual vaccines in 2018 were similar to 2017. The most commonly reported adverse events were injection site reaction (34%), pyrexia (15%), rash (15%), vomiting (8%), headache (6%) and pain (6%). Two deaths were reported to the TGA but no clear causal relationship with vaccination was found.

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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. Geneva: World Health Organization; 2012. Available from: https://www.who.int/vaccine_safety/initiative/tools/CIOMS_report_WG_vaccine.pdf

Dey A, Wang H, Quinn H, Hill R, Macartney K. Surveillance of adverse events following immunisation in Australia annual report, 2014. Commun Dis Intell Q Rep. 2016;40(3):E377–90.

Lawrence G, Boyd I, McIntyre P, Isaacs D. Surveillance of adverse events following immunisation: Australia 2002 to 2003. Commun Dis Intell Q Rep. 2004;28(3):324–38.

Lawrence G, Boyd I, McIntyre P, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2005. Commun Dis Intell Q Rep. 2006;30(3):319–33.

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 Q Rep. 2008;32(4):371–87.

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 Q Rep. 2003;27(3):307–23.

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 Q Rep. 2007;31(3):269–82.

Lawrence GL, Boyd I, McIntyre PB, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2004 Commun Dis Intell Q Rep. 2005;29(3):248–62.

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 Q Rep. 2013;37(2):E130–4.

Mahajan D, Cook J, Dey A, Macartney K, Menzies RI. Annual report: surveillance of adverse events following immunisation in Australia, 2011. Commun Dis Intell Q Rep. 2012;36(4):E315–32.

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 Q Rep. 2012;36(1):114–9.

Mahajan D, Cook J, McIntyre PB, Macartney K, Menzies RI. Annual report: surveillance of adverse events following immunisation in Australia, 2010. Commun Dis Intell Q Rep. 2011;35(4):263–80.

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 Q Rep. 2010;34(3):259–76.

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 Q Rep. 2009;33(4):365–81.

Mahajan D, Dey A, Cook J, Harvey B, Menzies R, Macartney K. Surveillance of adverse events following immunisation in Australia annual report, 2013. Commun Dis Intell Q Rep. 2015;39(3):E369–86.

Australian Technical Advisory Group on Immunisation (ATAGI). Australian Immunisation Handbook. [Internet.] Canberra: Australian Government Department of Health; 2018. [Accessed on 17 January 2019.] Available from: https://www.health.gov.au/resources/publications/the-australian-immunisation-handbook

Uppsala Monitoring Centre. [Internet.] 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):109–17.

National Health and Medical Research Council. The Australian Immunisation Handbook. 8th edn. Canberra: Australian Government Department of Health and Ageing; 2003.

Mahajan D, Dey A, Hill R, Harvey B, Menzies R, McIntyre P et al. Methodological framework for reporting of adverse events following immunisation (AEFI). [Conference presentation.] In: PHAA National Immunisation Conference, 17–19 June 2014; Melbourne, Australia.

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):2020–3.

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(5):473.e1–9.

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(6):478.e1–6.

Australian Government Department of Health, Therapeutic Goods Administration. National Adverse Events Following Immunisation (AEFI) reporting form. [Internet.] Canberra: Australian Government Department of Health. [Accessed on 26 March 2013.] Available from: https://www.tga.gov.au/form/national-adverse-events-following-immunisation-aefi-reporting-form

SAS Institute Inc. The SAS system for Windows [computer program]. Version 9.4. Cary, N.C. 2012.

Australian Bureau of Statistics. Australian Demographic Statistics, Jun 2015. [Internet.] Available from: https://www.abs.gov.au/AUSSTATS/abs@.nsf/allprimarymainfeatures/6CBA90A25BAC951DCA257F7F001CC559?opendocument

Australian Government Department of Human Services. Australian Immunisation Register. [Internet.] Canberra: Australian Government Department of Human Services. [Accessed on 21 October 2016.] Available from: https://www.humanservices.gov.au/individuals/services/medicare/australian-immunisation-register

Australian Government Department of Health. UPDATE: Expansion of Australia’s Immunisation Registers. [Accessed on 21 October 2016.] Available from: https://sydneynorthhealthnetwork.org.au/wp-content/uploads/2015/12/Factsheet-Immunisation-Registers-Expansion-23102015.pdf

Varricchio F, Iskander J, DeStefano F, Ball R, Pless R, Braun MM et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. 2004;23(4):287–94.

Australian Government Department of Health, Therapeutic Goods Administration. Database of Adverse Event Notifications. [Internet.] Canberra: Australian Government Department of Health. [Accessed on 26 March 2013.] Available from: http://www.tga.gov.au/safety/daen.htm

Rouse CE, Eckert LO, Babarinsa I, Fay E, Gupta M, Harrison MS et al. Spontaneous abortion and ectopic pregnancy: Case definition & guidelines for data collection, analysis, and presentation of maternal immunization safety data. Vaccine. 2017;35(48A):6563–74.

Ammon Avalos L, Galindo C, Li DK. A systematic review to calculate background miscarriage rates using life table analysis. Birth Defects Res A Clin Mol Teratol. 2012;94(6):417–23.

Dey A, Wang H, Quinn H, Cook J, Macartney K. Surveillance of adverse events following immunisation in Australia annual report, 2015. Commun Dis Intell Q Rep. 2017;41(3):E264–278.

Dey A, Wang H, Quinn H, Cook J, Macartney K. Surveillance of adverse events following immunisation in Australia annual report, 2016. Commun Dis Intell (2018). 2018;42. pii: S2209-6051(18)00011-8

Dey A, Wang H, Quinn H, Hiam R, Wood N, Beard F et al. Surveillance of adverse events following immunisation in Australia annual report, 2017. Commun Dis Intell (2018). 2019;43. https://doi.org/10.33321/cdi.2019.43.29.

Simon LS. Pharmacovigilance: towards a better understanding of the benefit to risk ratio. Ann Rheum Dis. 2002;61(Suppl II):ii88–9.

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):201–9.

Mahajan D, Dey A, Cook J, Harvey B, Menzies RI, Macartney KM. Surveillance of adverse events following immunisation in Australia, 2012. Commun Dis Intell Q Rep. 2014;38(3):E232–46.

National Centre for Immunisation Research and Surveillance. AusVaxSafety. [Internet.] Sydney: National Centre for Immunisation Research and Surveillance; 2019. [Accessed on 1 November 2019.] Available from: http://www.ausvaxsafety.org.au/

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Published

16/03/20

How to Cite

Dey, Aditi, Han Wang, Helen Quinn, Alexis Pillsbury, Catherine Glover, Megan Hickie, Nicholas Wood, Frank Beard, and Kristine Macartney. 2020. “Surveillance of Adverse Events Following Immunisation in Australia: Annual Report, 2018”. Communicable Diseases Intelligence 44 (March). https://doi.org/10.33321/cdi.2020.44.12.

Issue

Vol. 44 (2020)

Section

Annual report

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