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Article History

Accepted: 20 November 2024

First Online: 8 February 2025

Declarations

:

: Open access funding provided by HEAL-Link Greece. This research was partially co-financed by the European Union and Greek national funds through the Operational Program Competitiveness, Entrepreneurship, and Innovation, under the call RESEARCH-CREATE-INNOVATE (project code: Τ2EDK-00640) and also by CERTH institutional funds.

: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. PN is an editorial board member of Drug Safety. PN was not involved in the selection of peer reviewers for the manuscript or any subsequent editorial decisions.

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

: This study includes only anonymized and publicly available patient-related data. These data were already published

: 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 already publicly available, and they are not sensitive because they are anonymized and cannot be linked to a patient.

: The authors have made the KG dataset publicly available in a GitHub repository. It should be noted that the raw PVSRs data are available under the CC BY-NC-SA 3.0 IGO license ().

: The SHACL scripts used for validation can be found in a GitHub repository ().

: The initial model and the deployment of the presented KG were designed by PN. GG performed the initial manual instantiation of the OpenPVSignal model for all PVSRs, and AK independently reviewed every PSVR instance and adjusted them when needed. The iteration of changes to the initial model was designed by PN, AC, GG, and AK and implemented by AC. AC performed a series of technical validations throughout this data conversion procedure and verified the shape conformity of the KG using SHACL tests designed by ADL. GG guided the design of the use-case scenario with the assistance of PN. MCJ also provided a significant contribution in terms of the definition of the COVID-19 use case. AC executed the analysis, and GG and AK evaluated the results. This article was written by AC with the help of PN, and all authors reviewed and approved the content of the manuscript. PN supervised the work as a whole.