Clinical Relatedness and Stability of vigiVec Semantic Vector Representations of Adverse Events and Drugs in Pharmacovigilance.

Introduction: Individual case reports are essential to identify and assess previously unknown adverse effects of medicines. On these reports, information on adverse events (AEs) and drugs are encoded in hierarchical terminologies. Encoding differences may hinder the retrieval and analysis of clinically related reports relevant to a topic of interest.

A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review.

Introduction And Objective: The European Medicines Agency (EMA) maintains a list of designated medical events (DMEs), events that are inherently serious and are prioritized for signal detection, irrespective of statistical criteria. We have analysed the results of our previously published scoping review to determine whether DME signals differ from those of other adverse events in terms of time to communication and characteristics of supporting reports of suspected adverse drug reactions.

Methods: For all signals, we obtained the launch year of medicinal products from textbooks or regulatory agencies, extracted the year of the first report in VigiBase and calculated the interval between the first report and communication (time to communication, TTC).

Global safety monitoring of COVID-19 vaccines: how pharmacovigilance rose to the challenge.

Unlabelled: Pharmacovigilance (PV) came suddenly into the spotlight when several new vaccines, developed as a response to the COVID-19 pandemic, received emergency authorisation and were rolled out on a large scale in late 2020. The vaccines underwent stringent clinical trials and evaluation from regulatory authorities, but with the use of novel technology and an anticipated rapid and vast deployment of the vaccines, the importance of a well-functioning international post marketing safety surveillance system was stressed. International PV stakeholders were faced with several challenges due to the extent of the global vaccination campaign.