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Article History

Accepted: 8 May 2025

First Online: 10 June 2025

Declarations

:

: This manuscript has not been funded by any party. This study has been developed in the context of the PhD research trajectory of the first study author (L.R.P.).

: Leonardo Roque-Pereira is an employee of Roche/Genentech. Nonetheless, this paper only reflects the personal views of the stated authors. Eugene Van Puijenbroek is an Editorial Board Member of the journal Drug Safety. Eugene Van Puijenbroek was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. The other authors have no conflicts of interest to declare.

: No ethics approval was required for this study as it includes essentially only public data transformation. It should be noted that the original data are either publicly available, or data are anonymized and cannot be linked to a patient. An independent quality check has been carried out by Utrecht Medical Centre University to ensure compliance with legislation and regulations (regarding informed consent procedure, data management, privacy aspects and legal aspects). This study does not fall under the scope of the Dutch Medical Research Involving Human Subjects Act (WMO) and therefore does not require approval from an accredited MREC in the Netherlands.

: This study includes only anonymized and publicly available patient-related data.

: Not applicable.

: The raw dataset from VAERS is available in the public domain. The raw data from EudraVigilance were provided by the European Medicines Agency (EMA) after a formal request. Therefore, the authors made some data available in the supplementary materials, omitting the report ID. The Electronic Supplementary Materials/Online Resources can be accessed in the following data repository: Roque-Pereira, L. (2025). Online Resources/Supplementary Materials for the article: Comparison of adverse events in pregnant persons receiving COVID-19 and influenza vaccines: a disproportionality analysis using combined data from US VAERS and EudraVigilance spontaneous report databases. Zenodo. .

: MedDRA Dictionary version 27.0 was used for the classification of Preferred Terms into the High-Level Group Terms. All data processing and statistical analysis were performed using R version 4.3.1, with the package ‘PhViD’ and OpenEBGM []. A virtual folder titled Digital Research Environment (DRE) was created on 30 January 2024.

: Conceptualization of the study—Leonardo Roque-Pereira, Malede Mequanent Sisay, Comfort K. Ogar, Carlos E. Durán, Daniel Weibel, Eugene Van Puijenbroek, Katia Verhamme, and Miriam Sturkenboom; dataset request/acquisition and handling—Leonardo Roque-Pereira and Malede Mequanent Sisay; codes/script creation in R—Malede Mequanent Sisay; data interpretation and data analysis—Leonardo Roque-Pereira, Malede Mequanent Sisay, Comfort K. Ogar, Carlos E. Durán, Daniel Weibel, Eugene Van Puijenbroek, Katia Verhamme, and Miriam Sturkenboom; draft of the manuscript—Leonardo Roque-Pereira; review and comments on the manuscript—all authors; all authors read and approved the final version.