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Article History

Received: 30 September 2025

Accepted: 14 January 2026

First Online: 10 April 2026

Declarations

:

: The authors have declared that no conflict of interest exists.

: Access to SAEFVIC data conforms to the function as public health vaccine safety surveillance approved by the Royal Children’s Hospital Health Research Ethics Committee (HREC) as a registered database #96896. Ethics approval was granted by the Monash HREC (RES-18-0000-232A) for GP data, the RCH Melbourne HREC (79964) for linked data, and the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (RACGP NREEC) (17-008) for POLAR.

: A waiver of consent was granted by the respective health research ethics committees.

: De-identified information from the consumer who initiated this investigation is included with their consent. Data used in the three analyses were covered by ethics approvals granting a waiver of individual consent.

: The data used in the spontaneous reporting dataset, SCCS analysis for GP data hosted by Outcome Health and for the linked dataset by the Centre for Victorian Data Linkage were used under ethics for the current study and therefore are not publicly available, and authors are not permitted to share raw data.

: The codes are hosted in secure environments and cannot be publicly shared. It can be made available upon request.

: A.S., H.C. and J.B. conceptualised the study. A.S. had access to general practice data and J.M. to linked hospital data and took responsibility for the integrity of the data and the accuracy of the analysis. A.S., J.M. and D.H. were involved in statistical analysis. A.S., J.M. and D.H., along with all authors, contributed to data acquisition, analysis, and interpretation. A.S. wrote the initial draft of the manuscript. All authors critically revised the manuscript for important intellectual content. A.S. provided administrative, technical or material support. J.B. and H.C. supervised the study. All authors revised and approved the submitted version. A.S., H.C. and J.B. had final responsibility for the decision to submit for publication. All authors have read and approved the final version of the manuscript.