Surveillance of adverse events following immunisation in Australia, 2023.

Abstract

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.