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Authors
Sandberg, Lovisa https://orcid.org/0000-0001-6982-5244
Vidlin, Sara Hedfors https://orcid.org/0000-0003-1619-3751
K-Pápai, Levente https://orcid.org/0000-0002-2586-8960
Savage, Ruth https://orcid.org/0000-0002-8932-0849
Raemaekers, Boukje C. https://orcid.org/0009-0008-3946-3340
Taavola-Gustafsson, Henric https://orcid.org/0000-0002-2604-2810
Rudolph, Annette https://orcid.org/0000-0003-2360-7174
Quirant, Lucy https://orcid.org/0009-0008-5779-5066
Bergvall, Tomas https://orcid.org/0000-0003-4394-3431
Wallberg, Magnus https://orcid.org/0009-0003-2681-2226
Ellenius, Johan https://orcid.org/0000-0001-6447-8415
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Article History
Accepted: 8 May 2025
First Online: 23 June 2025
Declarations
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: The authors received no financial support for the research, authorship and/or publication of this article.
: Lovisa Sandberg, Sara Hedfors Vidlin, Levente K-Pápai, Ruth Savage, Boukje C. Raemaekers, Henric Taavola-Gustafsson, Annette Rudolph, Lucy Quirant, Tomas Bergvall, Magnus Wallberg and Johan Ellenius have no conflicts of interest that are directly related to the content of this article. Ruth Savage is an Editorial Board member of Drug Safety. She was not involved in the selection of peer reviewers nor any of the subsequent editorial decisions. Lucy Quirant, as of May 2023, is no longer employed by the Uppsala Monitoring Centre. However, her contributions to the study were completed prior to the time of departure, as part of her employment at the Uppsala Monitoring Centre.
: Not applicable. This study did not use personal data.
: Not applicable.
: Not applicable.
: The data that support the findings of this study are not publicly available. Access to the data is restricted based on the conditions for access within the WHO Programme for International Drug Monitoring. Subject to these conditions, data are available from the authors on reasonable request. For further inquiries, please contact Uppsala Monitoring Centre via .The VigiBase pregnancy algorithm is implemented in VigiLyze, the tool for searching and analysing VigiBase data, which is available to national pharmacovigilance centres as members of the WHO Programme for International Drug Monitoring. An initial version of the algorithm was implemented in November 2022. The version evaluated in the study, which includes some minor updates, was implemented in February 2024. VigiBase data, including output of the VigiBase pregnancy algorithm, are also available through VigiBase Custom Searches.
: The code used for this study is not provided. The implementation of the VigiBase Pregnancy Algorithm in R will be made available at .
: All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by LS, SHV, LK-P, HT and RS. Manual annotations were performed by LS, AR, BCR and RS. The first draft of the manuscript was written by LS, SHV, LK-P and RS, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
