Surveillance of adverse events following immunisation in Australia, 2023
DOI:
https://doi.org/10.33321/cdi.2026.50.002Keywords:
AEFI, adverse events, vaccines, surveillance, immunisation, vaccineAbstract
This report summarises Australia’s spontaneous surveillance data for adverse events following immunisation (AEFI) for all vaccines administered in 2023, reported to the Therapeutic Goods Administration (TGA). This report combines coronavirus disease 2019 (COVID-19) and non-COVID-19 AEFI that were previously reported separately in 2022 and 2021.
Overall, there were 5,534 AEFI reports for vaccines administered in 2023. This represents an annual AEFI reporting rate of 20.8 per 100,000 population, compared with 79.2 per 100,000 population in 2022. The sharp decrease in the AEFI reporting rate in 2023 was likely driven by a change in COVID-19 vaccination policy. This included limiting COVID-19 vaccine booster dose recommendation to high-risk populations rather than to the wider community, resulting in a steep decline in both the number of administered doses and the number of AEFIs reported. The most commonly reported adverse events were medication errors, injection site reaction, hypersensitivity, pyrexia, and gastrointestinal nonspecific symptoms. The most commonly reported adverse events for new vaccines introduced in 2023 were medication errors and headache for COVID-19 vaccines; hypersensitivity and pyrexia for DTPa-HepB-IPV-Hib vaccine (Vaxelis); and injection site reaction and hypersensitivity for recombinant zoster vaccine (Shingrix). There was reduction in deaths reported following vaccination in 2023 compared to 2022 and 2021. None of the 34 reported deaths in 2023 were determined to be causally related to the vaccine(s) received.
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References
Council for International Organizations of Medical Sciences (CIOMS) c/o World Health Organization (WHO). Definition and Application of Terms for Vaccine Pharmacovigilance: Report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance. Geneva: CIOMS; 2012. Available from: https://www.who.int/vaccine_safety/initiative/tools/CIOMS_report_WG_vaccine.pdf.
Therapeutic Goods Administration (TGA). Reporting adverse events. [Webpage.] Canberra: Australian Government Department of Health and Aged Care, TGA; 2024. [Accessed during 2024.] Available from: https://www.tga.gov.au/safety/reporting-problems/reporting-adverse-events.
World Health Organization (WHO). Global manual on surveillance of adverse events following immunization: 2016 update. Geneva: WHO; 31 May 2016. Available from: https://www.who.int/publications/i/item/9789241507769.
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. doi: https://doi.org/10.33321/cdi.2003.27.56.
Glover C, Deng L, Larter C, Brogan C, Richardson O, Huang YA et al. Surveillance of adverse events following immunisation in Australia annual report, 2021. Commun Dis Intell (2018). 2024;48. doi: https://doi.org/10.33321/cdi.2024.48.1.
National Centre for Immunisation Research and Surveillance (NCIRS). History of immunisation in Australia. [Webpage.] Sydney: Sydney Children’s Hospitals Network, NCIRS; 2025. [Accessed in 2025.] Available from: https://ncirs.org.au/health-professionals/history-immunisation-australia.
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. doi: https://doi.org/10.33321/cdi.2004.28.37.
O’Moore M, Jones B, Hickie M, Glover C, Deng L, Huang Y et al. National pharmacovigilance of seasonal influenza vaccines in Australia. Med J Aust. 2024;221(4): 178–81. doi: https://doi.org/10.5694/mja2.52381.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Introductory Guide MedDRA Version 27.1. Brussels: ICH; September 2024. Available from: https://admin.meddra.org/sites/default/files/guidance/file/intguide_27_1_English.pdf.
Medical Dictionary for Regulatory Activities (MedDRA). Standardised MedDRA Queries. [Webpage.] Herndon VA: MedDRA: 2024. [Accessed during 2025.] Available from: https://www.meddra.org/standardised-meddra-queries.
MedDRA. Introductory Guide for Standardised MedDRA Queries (SMQs) (Version 27.1). Geneva: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, MedDRA; September 2024. Available from: https://admin.meddra.org/sites/default/files/guidance/file/SMQ_intguide_27_1_English.pdf.
Law B, Sturkenboom M, Safety Platform for Emergency vACcines (SPEAC). D2.3.1 Tier 1 AESI: ICD-9/10-CM and MedDRA Codes. Basel: Brighton Collaboration, SPEAC; 30 September 2020. [Accessed in 2025.] Available from: https://brightoncollaboration.org/wp-content/uploads/2023/05/SO2-D2.3.1_Tier-1-AESI-ICD-9-10-CM-and-MedDRA-Codes-.pdf.
Law B, Huang WT , Sturkenboom M. AESI Case Definition Companion Guide: Anaphylaxis Version 2. Basel: Brighton Collaboration, SPEAC; September 2022. Available from: https://zenodo.org/records/17086390.
Wise RP, Bonhoeffer J, Beeler J, Donato H, Downie P, Matthews D et al. Thrombocytopenia: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31): 5717–24. doi: https://doi.org/10.1016/j.vaccine.2007.02.067.
Bonhoeffer J, Menkes J, Gold MS, de Souza-Brito G, Fisher MC, Halsey N et al. Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004;22(5–6):557–62. doi: https://doi.org/10.1016/j.vaccine.2003.09.008.
Tapiainen T, Prevots R, Izurieta HS, Abramson J, Bilynsky R, Bonhoeffer J et al. Aseptic meningitis: case definition and guidelines for collection, analysis and presentation of immunization safety data. Vaccine. 2007;25(31):5793–802. doi: https://doi.org/10.1016/j.vaccine.2007.04.058.
Sejvar JJ, Kohl KS, Bilynsky R, Blumberg D, Cvetkovich T, Galama J et al. Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5771–92. doi: https://doi.org/10.1016/j.vaccine.2007.04.060.
Sejvar JJ, Kohl KS, Gidudu J, Amato A, Bakshi N, Baxter R et al. Guillain–Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2011;29(3):599–612. doi: https://doi.org/10.1016/j.vaccine.2010.06.003.
Rath B, Gidudu JF, Anyoti H, Bollweg B, Caubel P, Chen YH et al. Facial nerve palsy including Bell's palsy: case definitions and guidelines for collection, analysis, and presentation of immunisation safety data. Vaccine. 2017;35(15):1972–83. doi: https://doi.org/10.1016/j.vaccine.2016.05.023.
Law B, SPEAC. SO2 – D2.5.2.2 – AESI Case Definition Companion Guide for 2nd Tier AESI: Myocarditis and Pericarditis. Basel: Brighton Collaboration, SPEAC; 13 May 2022. Available from: https://brightoncollaboration.us/wp-content/uploads/2022/05/SPEAC_D2.5.2.2_Myocarditis-companion-guide_codes-updated_BL_2022_May12.pdf.
WHO. Causality assessment of an adverse event following immunization (AEFI): user manual for the revised WHO classification, 2nd ed., 2019 update. Geneva: WHO; 16 April 2021. Available from: https://www.who.int/publications/i/item/9789241516990.
TGA. Third Australian case of thrombosis likely linked to AstraZeneca ChAdOx1-S COVID-19 vaccine. [Webpage.] Canberra: Australian Government Department of Health and Aged Care, TGA; 16 April 2021. [Accessed during 2025.] Available from: https://www.tga.gov.au/news/safety-alerts/third-australian-case-thrombosis-likely-linked-astrazeneca-chadox1-s-covid-19-vaccine.
Australian Bureau of Statistics. National, state and territory population. Reference period: June 2023. [Webpage.] Canberra: Australian Bureau of Statistics; 14 December 2023. [Accessed during 2024.] Available from: https://www.abs.gov.au/statistics/people/population/national-state-and-territory-population/jun-2023.
Australian Government: Services Australia. Australian Immunisation Register. [Webpage.] Canberra: Services Australia; 2024. [Accessed during 2024.] Available from: https://www.servicesaustralia.gov.au/australian-immunisation-register.
Australian Government Department of Health, Disability and Ageing. Mandatory reporting of Japanese encephalitis virus vaccines to the Australian Immunisation Register began on 21 December 2022. [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing; 13 January 2022. [Accessed during 2024.] Available from: https://www.health.gov.au/news/mandatory-reporting-of-japanese-encephalitis-virus-vaccines-to-the-australian-immunisation-register-began-on-21-december-2022.
Hull B, Hendry A, Dey A, Brotherton J, Macartney K, Beard F. Annual Immunisation Coverage Report 2022. Commun Dis Intell (2018). 2025;49. doi: https://doi.org/10.33321/cdi.2025.49.023.
TGA. Database of Adverse Event Notifications (DAEN). [Webpage.] Canberra: Australian Government Department of Health and Aged Care, TGA; 2023. [Accessed during 2024.] Available from: https://www.tga.gov.au/safety/database-adverse-event-notifications-daen.
Huang YA, Larter C, Hickie M, O’Moore M, Jones B, Deng L et al. Surveillance of adverse events following immunisation in Australia, COVID-19 vaccines, 2022. Commun Dis Intell (2018). 2025;49. doi: https://doi.org/10.33321/cdi.2025.49.044.
Huang YA, Larter C, Hickie M, O’Moore M, Jones B, Deng L et al. Surveillance of adverse events following immunisation in Australia, 2022. Commun Dis Intell (2018). 2025;49. doi: https://doi.org/10.33321/cdi.2025.49.043.
Glover C, Deng L, Larter C, Brogan C, Richardson O, Huang YA et al. Surveillance of adverse events following immunisation in Australia, COVID-19 vaccines, 2021. Commun Dis Intell (2018). 2024;48. doi: https://doi.org/10.33321/cdi.2024.48.2.
NCIRS. Significant events in COVID-19 vaccination practice in Australia. Sydney: Sydney Children’s Hospitals Network, NCIRS; 2025. [Accessed in 2025.] Available from: https://ncirs.org.au/sites/default/files/2025-09/COVID-19_July%202025%20update.pdf.
Dey A, Wang H, Quinn H, Pillsbury A, Hickey M, Deng L et al. Surveillance of adverse events following immunisation in Australia annual report, 2020. Commun Dis Intell (2018). 2022;46. doi: https://doi.org/10.33321/cdi.2022.46.47.
Dey A, Wang H, Quinn H, Pillsbury A, Glover C, Hickey M et al. Surveillance of adverse events following immunisation in Australia annual report, 2019. Commun Dis Intell (2018). 2021;45. doi: https://doi.org/10.33321/cdi.2021.45.23.
Dey A, Wang H, Quinn H, Pillsbury A, Glover C, Hickey M et al. Surveillance of adverse events following immunisation in Australia: annual report, 2018. Commun Dis Intell (2018). 2020;44. doi: https://doi.org/10.33321/cdi.2020.44.12.
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. doi: https://doi.org/10.33321/cdi.2019.43.29.
Hull B, Hendry A, Macartney K, Beard F. Annual Immunisation Coverage Report 2023. Commun Dis Intell (2018). 2026;50. doi: https://doi.org/10.33321/cdi.2026.50.001.
Phillips A, Hickie M, Totterdell J, Brotherton J, Dey A, Hill R et al. Adverse events following HPV vaccination: 11 years of surveillance in Australia. Vaccine. 2020;38(38):6038–46. doi: https://doi.org/10.1016/j.vaccine.2020.06.039.
Egoavil CM, Tuells J, Carreras JJ, Montagud E, Pastor-Villalba E, Caballero E et al. Trends of adverse events following immunization (AEFI) reports of human papillomavirus vaccine in the Valencian community—Spain (2008–2018). Vaccines (Basel). 2020;8(1):117. doi: https://doi.org/10.3390/vaccines8010117.
Tricco AC, Zarin W, Cardoso R, Veroniki AA, Khan PA, Nincic V et al. Efficacy, effectiveness, and safety of herpes zoster vaccines in adults aged 50 and older: systematic review and network meta-analysis. BMJ. 2018;363:k4029. doi: https://doi.org/10.1136/bmj.k4029.
López-Fauqued M, Campora L, Delannois F, El Idrissi M, Oostvogels L, De Looze FJ et al. Safety profile of the adjuvanted recombinant zoster vaccine: pooled analysis of two large randomised phase 3 trials. Vaccine. 2019;37(18):2482–93. doi: https://doi.org/10.1016/j.vaccine.2019.03.043.
Therapeutic Goods Administration - TGA. [‘Facebook’ social media post.] Facebook; 5 October 2021. Available from: https://www.facebook.com/TGAgovau/posts/pfbid0SUHvJqCSfi1tTNJTWjgVnasjVeDmgL6MzrSHPrH6M32zZXSFVn2rncDmjsaHNxBcl.
Therapeutic Goods Administration - TGA. [‘Facebook’ social media post.] Facebook; 1 March 2022. Available from: https://www.facebook.com/TGAgovau/posts/pfbid02t48T1Ft8zoetjAkvUt6o8mK7TqUt4bf3vfE1S6oagGPhc2W1swftEgCa1jtRTbC1l.
Australian Government Department of Health, Disability and Ageing, Australian Technical Advisory Group on Immunisation (ATAGI). ATAGI advice on seasonal influenza vaccines in 2023. Canberra: Australian Government Department of Health, Disability and Ageing; 28 February 2023. [Accessed during 2025.] Available from: https://www.health.gov.au/resources/publications/atagi-advice-on-seasonal-influenza-vaccines-in-2023.
Australian Government Department of Health, Disability and Ageing, ATAGI. ATAGI Update on the COVID-19 Vaccination Program. [Media release.] Canberra: Australian Government Department of Health, Disability and Ageing; 1 September 2023. [Accessed during 2025.] Available from: https://www.health.gov.au/news/atagi-update-on-the-covid-19-vaccination-program.
Australian Government Department of Health, Disability and Ageing. Vaccine safety in Australia AusVaxSafety – Summary report 2023. Canberra: Australian Government Department of Health, Disability and Ageing; 20 November 2024. [Accessed during 2025.] Available from: https://www.health.gov.au/resources/publications/vaccine-safety-in-australia-ausvaxsafety-summary-report-2023.
Censi S, Bisaccia G, Gallina S, Tomassini V, Uncini A. Guillain-Barré syndrome and COVID-19 vaccination: a systematic review and meta-analysis. J Neurol. 2024;271(3):1063–71. doi: https://doi.org/10.1007/s00415-024-12186-7.
Goud R, Lufkin B, Duffy J, Whitaker B, Wong HL, Liao J et al. Risk of Guillain-Barré syndrome following recombinant zoster vaccine in Medicare beneficiaries. JAMA Intern Med. 2021;181(12):1623–30. doi: https://doi.org/10.1001/jamainternmed.2021.6227.
Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015;33(36):4398–405. doi: https://doi.org/10.1016/j.vaccine.2015.07.035.
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