Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing.

Journal: Drug safety
Published Date: Dec 7, 2023

Abstract

INTRODUCTION: The Vaccine Adverse Event Reporting System (VAERS) has already been challenged by an extreme increase in the number of individual case safety reports (ICSRs) after the market introduction of coronavirus disease 2019 (COVID-19) vaccines. Evidence from scientific literature suggests that when there is an extreme increase in the number of ICSRs recorded in spontaneous reporting databases (such as the VAERS), an accompanying increase in the number of disproportionality signals (sometimes referred to as 'statistical alerts') generated is expected.

Authors

  • Guojun Dong
    Department of Drug Design and Pharmacology, University of Copenhagen, Jagtvej 160, 2100, Copenhagen, Denmark.
  • Andrew Bate
    Pfizer, London, UK.
  • François Haguinet
    GSK, Wavre, Belgium.
  • Gabriel Westman
    Swedish Medical Products Agency, Uppsala, Sweden.
  • Luise Dürlich
    Department of Linguistics and Philology, Uppsala University, Uppsala, Sweden.
  • Anders Hviid
    Department of Drug Design and Pharmacology, University of Copenhagen, Jagtvej 160, 2100, Copenhagen, Denmark.
  • Maurizio Sessa
    Department of Drug Design and Pharmacology, Drug Safety Group, University of Copenhagen, Copenhagen, Denmark.

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