Surveillance of adverse events following immunisation in Australia annual report, COVID-19 vaccines, 2022

Authors

  • Yuanfei Anny Huang National Centre for Immunisation Research and Surveillance, Locked Bag 4001, Westmead NSW 2145, Sydney, Australia
  • Claire Larter Pharmacovigilance Branch, Therapeutic Goods Administration, Department of Health, Canberra, Australia
  • Megan Hickie Pharmacovigilance Branch, Therapeutic Goods Administration, Department of Health, Canberra, Australia
  • Megan O’Moore Pharmacovigilance Branch, Therapeutic Goods Administration, Department of Health, Canberra, Australia
  • Belinda Jones Pharmacovigilance Branch, Therapeutic Goods Administration, Department of Health, Canberra, Australia
  • Lucy Deng National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
  • Sophie Russell Pharmacovigilance Branch, Therapeutic Goods Administration, Department of Health, Canberra, Australia
  • Elspeth Kay Pharmacovigilance Branch, Therapeutic Goods Administration, Department of Health, Canberra, Australia
  • Kristine Macartney National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
  • Nicholas Wood 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.2025.49.044

Keywords:

AEFI, coronavirus disease 2019, COVID-19, adverse events, vaccines, surveillance, immunisation, vaccine

Abstract

This report summarises Australia’s spontaneous surveillance data for adverse events following immunisation (AEFI) for COVID-19 vaccines given in 2022 reported to the Therapeutic Goods Administration (TGA). The TGA strongly promoted and facilitated adverse event reporting in preparation for and during the COVID-19 vaccine rollout as a core component of the most intensive vaccine safety monitoring ever conducted in Australia.

There were 18,398 AEFI reports for COVID-19 vaccines administered in 2022, corresponding to an annual AEFI reporting rate of 89.6 per 100,000 doses of COVID-19 vaccines administered. The annual AEFI reporting rate for non-COVID-19 vaccines in 2022 was 18.8 per 100,000 doses administered to people of all ages.

Overall, the most frequently reported symptoms were adverse events consistent with the expected side effects from vaccines, as reported in clinical trials. These were classified as ‘gastrointestinal nonspecific symptoms and therapeutic procedures’, headache, chest pain, myalgia and pyrexia. The most frequently reported adverse events of special interest were myocarditis and/or pericarditis, followed by thrombosis and thromboembolism, and anaphylaxis. Of all COVID-19 vaccine AEFI reports, 160 (0.9%) included a fatal outcome, of which over 60% were in people aged ≥ 60 years. Of these 160 reports, only one was assessed by a Vaccine Safety Investigation Group (VSIG) as a death likely to be causally linked to vaccination.

This report confirms the value of spontaneous post-marketing vaccine pharmacovigilance, especially in the context of new vaccines using novel technologies and a near whole-of-population pandemic vaccination program. Ongoing safety monitoring continued to review and respond to reports of rare, unexpected conditions, such as myocarditis/pericarditis, with investigations resulting in changes to vaccine recommendations and product information. Overall, COVID-19 vaccine safety monitoring continued to demonstrate a reassuring safety profile for these vaccines, especially among children and adolescents aged 11 years and below, in whom COVID-19 vaccines were used for the first time in 2022 in Australia.

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References

Valeri M, Durrani S, Tran C, Chiu C, Macartney KK, Giles ML et al. ATAGI 2023 annual statement on immunisation. Commun Dis Intell (2018). 2023;47. doi: https://doi.org/10.33321/cdi.2023.47.42.

National Centre for Immunisation Research and Surveillance (NCIRS). Significant events in COVID-19 vaccination practice in Australia. Sydney: Sydney Children’s Hospital Network, NCIRS; 2024. [Accessed in 2024.] Available from: https://ncirs.org.au/sites/default/files/2025-04/COVID-19_March%202025.pdf.

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/publications/m/item/9789290360834.

Therapeutic Goods Administration (TGA). Reporting adverse events. [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing, TGA; 2024. [Accessed during 2024.] Available from: https://www.tga.gov.au/safety/reporting-problems/reporting-adverse-events.

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.

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.

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 26.1. Brussels: ICH; September 2023. Available from: https://admin.meddra.org/sites/default/files/guidance/file/intguide_26_1_English.pdf.

Medical Dictionary for Regulatory Activities (MedDRA). Standardised MedDRA Queries. [Webpage.] Herndon VA: MedDRA: 2023. [Accessed during 2024.] Available from: https://www.meddra.org/standardised-meddra-queries.

MedDRA. Introductory Guide for Standardised MedDRA Queries (SMQs) (Version 26.1). Geneva: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, MedDRA; September 2023. Available from: https://admin.meddra.org/sites/default/files/guidance/file/SMQ_intguide_26_1_English.pdf.

Safety Platform for Emergency vACcines (SPEAC). Updated (October 2022) COVID-19 AESI including status of associated Brighton case definitions. Basel: Brighton Collaboration, SPEAC; 31 October 2022. [Accessed during 2023–2024.] Available from: https://brightoncollaboration.us/wp-content/uploads/2022/11/Updated-COVID-19-AESI-list_Oct2022.pdf.

Law B, SPEAC. SO2 – D2.5.2.1 – AESI Case Definition Companion Guide for 1st Tier AESI: Acute Disseminated Encephalomyelitis (ADEM). Basel: Brighton Collaboration, SPEAC; 11 February 2021. Available from: https://brightoncollaboration.us/wp-content/uploads/2021/03/SPEAC_D2.5.2.1_ADEM-Case-Definition-Companion-Guide_V1.0_format12063-1.pdf.

Law B, SPEAC. SO2 – D2.5.2.1 – AESI Case Definition Companion Guide for 1st Tier AESI: Anaphylaxis. Basel: Brighton Collaboration, SPEAC; 5 February 2021. Available from: https://brightoncollaboration.us/wp-content/uploads/2021/03/SPEAC_D2.5.2.1_Anaphylaxis-Case-Definition-Companion-Guide_V1.0-12070-1.pdf.

Law B, Rojo Villaescusa M, SPEAC. SO2 – D2.5.2.2 – AESI Case Definition Companion Guide: Acute Respiratory Distress Syndrome (ARDS). Basel: Brighton Collaboration, SPEAC; 17 October 2022. Available from: https://brightoncollaboration.org/wp-content/uploads/2023/06/SPEAC_D2.5.2.2_ARDS-Case-Definition-Companion-Guide-V1.0-17Oct2022-1.pdf.

Law B, SPEAC. SO2 – D2.5.2.1 – AESI Case Definition Companion Guide for 1st Tier AESI: Aseptic Meningitis. Basel: Brighton Collaboration, SPEAC; 21 February 2021. Available from: https://brightoncollaboration.us/wp-content/uploads/2021/03/SPEAC_D2.5.2.1_Aseptic-Meningitis-Case-Definition-Companion-Guide_V1.0_format12069-1.pdf.

Law B, SPEAC. SO2 – D2.5.2.1 – AESI Case Definition Companion Guide for 1st Tier AESI: Facial Nerve Palsy. Basel: Brighton Collaboration; 11 February 2021. Available from: https://brightoncollaboration.us/wp-content/uploads/2021/10/SPEAC_D2.5.2.1_Facial-Nerve-Palsy-Case-Definition-Companion-Guide_V1.0_format12067-1.pdf.

Law B, SPEAC. SO2 – D2.5.2.1 – AESI Case Definition Companion Guide for 1st Tier AESI: Acute Encephalitis. Basel: Brighton Collaboration, SPEAC; 21 February 2021. Available from: https://brightoncollaboration.us/wp-content/uploads/2021/03/SPEAC_D2.5.2.1_Encephalitis-Case-Definition-Companion-Guide_V1.0_format12064-1.pdf.

Law B, SPEAC. SO2 – D2.5.2.1 – AESI Case Definition Companion Guide for 1st Tier AESI: Generalized Convulsion. Basel: Brighton Collaboration, SPEAC; 15 February 2021. Available from: https://brightoncollaboration.us/wp-content/uploads/2021/03/SPEAC_D2.5.2.1_Generalised-Convulsion-Case-Definition-Companion-Guide-V1.0_format12068-1.pdf.

Law B, SPEAC. SO2 – D2.5.2.1 – AESI Case Definition Companion Guide for 1st Tier AESI: Guillain Barré and Miller Fisher Syndromes. Basel: Brighton Collaboration, SPEAC; 9 February 2021. Available from: https://brightoncollaboration.us/wp-content/uploads/2021/03/SPEAC_D2.5.2.1-GBS-Case-Definition-Companion-Guide_V1.0_format12062-1.pdf.

Law B, SPEAC. AESI Case Definition Companion Guide: Multisystem Inflammatory Syndrome In Children and Adults (MIS-C/A). Basel: Brighton Collaboration, SPEAC; 19 October 2022. Not available online.

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.

Law B, SPEAC. SO2 – D2.5.2.1 – AESI Case Definition Companion Guide for 1st Tier AESI: Thrombocytopenia. Basel: Brighton Collaboration, SPEAC; 8 February 2021. Available from: https://brightoncollaboration.us/wp-content/uploads/2021/03/SPEAC_D2.5.2.1-Thrombocytopenia-Case-Definition-Companion-Guide_V1.0_format12065-1.pdf.

Law B, Villaescusa MR, SPEAC. AESI Case Definition Companion Guide: Thrombosis and Thromboembolism. Basel: Brighton Collaboration, SPEAC; 10 October 2022. Available from: https://zenodo.org/records/7181081.

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.

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, Disability and Ageing, 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 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 National Immunisation Program vaccines to the Australian Immunisation Register began on 1 July 2021. [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing; 8 July 2021. [Accessed during 2024.] Available from: https://www.health.gov.au/news/mandatory-reporting-of-national-immunisation-program-vaccines-to-the-australian-immunisation-register-began-on-1-july-2021.

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.

Australian Bureau of Statistics. National, state and territory population. Reference period: June 2022. [Webpage.] Canberra: Australian Bureau of Statistics; 15 December 2022. [Accessed during 2023.] Available from: https://www.abs.gov.au/statistics/people/population/national-state-and-territory-population/jun-2022.

R Core Team. R: A Language and Environment for Statistical Computing. [Application.] Vienna: R Foundation for Statistical Computing; 2020. Available from: https://www.R-project.org/.

TGA. Database of Adverse Event Notifications (DAEN). [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing, TGA; 2023. [Accessed during 2024.] Available from: https://www.tga.gov.au/safety/database-adverse-event-notifications-daen.

TGA. DAEN - medicines: Information for consumers. [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing, TGA; 2023. [Accessed during 2025.] Available from: https://www.tga.gov.au/resources/resource/reference-material/daen-medicines-information-consumers#what-the-tga-does-with-information-in-the-database.

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.

TGA. COVID-19 vaccine weekly safety report - 23-09-2022. [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing, TGA; 23 September 2022. [Accessed during 2025.] Available from: https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-23-09-2022.

TGA. COVID-19 vaccine weekly safety report - 19-05-2022. [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing, TGA; 19 May 2022. [Accessed during 2025.] Available from: https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-weekly-safety-report-19-05-2022.

Australian Institute of Health and Welfare (AIHW). COVID-19. [Webpage.] Canberra: Australian Government, AIHW; 16 July 2024. [Accessed during 2025.] Available from: https://www.aihw.gov.au/reports/australias-health/covid-19.

Australian Government Department of Health, Disability and Ageing. ATAGI recommendations on COVID-19 vaccine use in children aged 6 months to < 5 years. [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing; 3 August 2022. [Accessed during 2025.] Available from: https://www.health.gov.au/news/atagi-recommendations-on-covid-19-vaccine-use-in-children-aged-6-months-to.

Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG). COVID-19 vaccination in pregnant and breastfeeding women and those planning pregnancy. [Webpage.] Melbourne: RANZCOG; 10 July 2024. [Accessed during 2024.] Available from: https://ranzcog.edu.au/news/covid-19-vaccination-pregnant-breastfeeding/.

Australian Government Department of Health, Disability and Ageing. COVID-19 vaccination decision guide for women who are pregnant, breastfeeding or planning pregnancy (Version 8.8). Canberra: Australian Government Department of Health, Disability and Ageing; 12 January 2024. [Accessed during 2024.] Available from: https://www.health.gov.au/sites/default/files/2024-01/covid-19-vaccination-shared-decision-making-guide-for-women-who-are-pregnant-breastfeeding-or-planning-pregnancy.pdf.

Australian Government Department of Health, Disability and Ageing, Australian Immunisation Handbook. Vaccinated pregnant women may consider a further dose during pregnancy. [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing; 22 November 2024. Available from: https://immunisationhandbook.health.gov.au/recommendations/vaccinated-pregnant-women-may-consider-a-further-dose-during-pregnancy.

Hause AM, Baggs J, Marquez P, Myers TR, Su JR, Hugueley B et al. Safety monitoring of Pfizer-BioNTech COVID-19 vaccine booster doses among children aged 5–11 years – United States. MMWR Morb Mortal Wkly Rep. 2022;71(33):1047–51. doi: https://doi.org/10.15585/mmwr.mm7133a3.

Hause AM, Shay DK, Klein NP, Abara WE, Baggs J, Cortese MM et al. Safety of COVID-19 vaccination in United States children ages 5 to 11 years. Pediatrics. 2022;150(2):e2022057313. doi: https://doi.org/10.1542/peds.2022-057313.

Piechotta V, Siemens W, Thielemann I, Toews M, Koch J, Vygen-Bonnet S et al. Safety and effectiveness of vaccines against COVID-19 in children aged 5–11 years: a systematic review and meta-analysis. Lancet Child Adolesc Health. 2023;7(6):379–91. doi: https://doi.org/10.1016/S2352-4642(23)00078-0.

WHO. GACVS statement regarding COVID-19 immunization errors in children. [Webpage.] Geneva: WHO; 30 August 2022. [Accessed during 2025.] Available from: https://www.who.int/news/item/30-08-2022-statement-covid-19-immunization-errors-children.

TGA. COVID-19 vaccine weekly safety report - 10-02-2022. [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing, TGA; 10 February 2022. [Accessed during 2025.] Available from: https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-weekly-safety-report-10-02-2022#vaccination-errors-in-children.

Australian Government Department of Health, Disability and Ageing. COVID-19 vaccination (as of 14 November 2024). Canberra: Australian Government Department of Health, Disability and Ageing; 14 November 2024. [Accessed during 2025.] Available from: https://www.health.gov.au/sites/default/files/2024-11/covid-19-vaccines-in-australia-a3-poster.pdf.

Australian Government Department of Health, Disability and Ageing, ATAGI. ATAGI Clinical Guidance on COVID-19 Vaccine Administration Errors (Version 2.2). Canberra: Australian Government Department of Health, Disability and Ageing, ATAGI; 8 August 2024. Available from: https://www.health.gov.au/sites/default/files/2024-08/atagi-clinical-guidance-on-covid-19-vaccine-administration-errors.pdf.

State Government of Western Australia Department of Health (WA Health), Communicable Disease Control Directorate. Western Australian Vaccine Safety Surveillance – Annual Report 2022. Perth: WA Health; 2023. Available from: https://www.health.wa.gov.au/~/media/Corp/Documents/Health-for/Immunisation/Western-Australia-Vaccine-Safety-Surveillance-Annual-Report-2022.pdf.

TGA. COVID-19 vaccine safety report - 29-06-2023. [Webpage.] Canberra: Australian Government Department of Health, Disability and Ageing, TGA; 29 June 2023. [Accessed during 2025.] Available from: https://www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-29-06-2023.

Australian Bureau of Statistics. Causes of Death, Australia. Reference period: 2022. [Webpage.] Canberra: Australian Bureau of Statistics; 29 September 2023. [Accessed during 2024.] Available from: https://www.abs.gov.au/statistics/health/causes-death/causes-death-australia/2022.

Australian Government Department of Health, Disability and Ageing. Vaccine safety in Australia AusVaxSafety – Summary report 2022. Canberra: Australian Government Department of Health, Disability and Ageing; 23 February 2024. Available from: https://www.health.gov.au/resources/publications/vaccine-safety-in-australia-ausvaxsafety-summary-report-2022.

Reynolds R, Tay E, Dymock M, Deng L, Glover C, Lopez LK et al. Short-term active safety surveillance of the Spikevax and Nuvaxovid priming doses in Australia. Vaccines. 2024;12(9):971. doi: https://doi.org/10.3390/vaccines12090971.

Shimabukuro T, 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.

Tuckerman J, Blyth CC, Beard FH, Danchin MH. COVID-19 and changes in the National Immunisation Program: a unique opportunity to optimise the Australian Immunisation Register (AIR). Med J Aust. 2021;214(6):247–9. doi: https://doi.org/10.5694/mja2.50971.

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Published

17/12/25

How to Cite

Huang, Yuanfei Anny, Claire Larter, Megan Hickie, Megan O’Moore, Belinda Jones, Lucy Deng, Sophie Russell, Elspeth Kay, Kristine Macartney, and Nicholas Wood. 2025. “Surveillance of Adverse Events Following Immunisation in Australia Annual Report, COVID-19 Vaccines, 2022”. Communicable Diseases Intelligence 49 (December). https://doi.org/10.33321/cdi.2025.49.044.

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Vol. 49 (2025)

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Annual report

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