Surveillance of adverse events following immunisation in Australia, 2024

Authors

  • Thuy Nguyen National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia; The University of Sydney Children's Hospital Westmead Clinical School, Westmead, New South Wales, Australia
  • Nicholas Wood National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia; The University of Sydney Children's Hospital Westmead Clinical School, Westmead, New South Wales, Australia
  • Kristine Macartney National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia; The University of Sydney Children's Hospital Westmead Clinical School, Westmead, New South Wales, Australia
  • Lucy Deng National Centre for Immunisation Research and Surveillance, Westmead, New South Wales, Australia; The University of Sydney Children's Hospital Westmead Clinical School, Westmead, New South Wales, Australia

DOI:

https://doi.org/10.33321/cdi.2026.50.046

Keywords:

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

Abstract

This report summarises Australia’s spontaneous surveillance data for adverse events following immunisation (AEFI) for all vaccines administered in 2024, reported to the Therapeutic Goods Administration (TGA). An adverse event(s) following immunisation is defined as any untoward medical occurrence which follows immunisation but does not necessarily have a causal relationship with use of the vaccine. Analyses of AEFI data are done continuously and also annually to detect new potential safety issues or changes to known safety issues.

Overall, there were 6,232 AEFI reports for vaccines administered in 2024. This represents an annual AEFI reporting rate of 22.9 per 100,000 population and 25.7 per 100,000 vaccine doses, compared with 20.8 per 100,000 population and 24.1 per 100,000 doses in 2023. The slight increase in the AEFI reporting rates observed in 2024 was likely driven by the introduction of a new recombinant zoster vaccine (RZV, Shingrix) which replaced the live attenuated zoster vaccine (ZLV, Zostavax) on the National Immunisation Program (NIP) from November 2023, along with the expansion of the eligible population for zoster vaccination. In 2024, RZV (Shingrix) was associated with the highest number of reported AEFIs.

The most frequently reported adverse events following immunisation were medication errors; hypersensitivity; gastrointestinal nonspecific symptoms; pyrexia; and injection site reaction. Among vaccines newly introduced in 2024, the most commonly reported adverse events were medication errors and nonspecific gastrointestinal symptoms for COVID-19 vaccines (Comirnaty XBB.1.5 and Spikevax XBB.1.5); hypersensitivity and pyrexia for the DTPa-HepB-IPV-Hib vaccine (Vaxelis); medication errors and exposure during pregnancy for the adjuvanted recombinant respiratory syncytial virus (RSV) pre-fusion F protein vaccine (Arexvy); and hypersensitivity and nonspecific gastrointestinal symptoms for RZV (Shingrix). Fewer deaths were reported following vaccination in 2024 (28 reports) than in 2023 (34 reports). None of the 28 reported deaths in 2024 indicated an emerging safety signal.

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Published

16/11/26

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Nguyen, Thuy, Nicholas Wood, Kristine Macartney, and Lucy Deng. 2026. “Surveillance of Adverse Events Following Immunisation in Australia, 2024”. Communicable Diseases Intelligence 50 (November). https://doi.org/10.33321/cdi.2026.50.046.

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