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<p>VigiBase, the WHO global database of adverse event reports for medicines and vaccines, receives information on suspected adverse effects of medicinal products from countries, regions and territories that are members of the WHO Programme for International Drug Monitoring. The database serves as a global resource for pharmacovigilance signal management and scientific development. Its initial establishment through the programme in 1968 has also contributed to the international harmonisation of adverse event report data. As of 31 December 2024, the database includes over 40 million individual case reports coded in standard terminologies (WHODrug and MedDRA<sup>®</sup>). These reports, of which ~ 80% relate to medicines and ~ 20% to vaccines, come from over 160 countries. This profile paper aims to provide an update on the database infrastructure including data capture, management and analysis tools. It also presents a summary of global patterns and trends of key report characteristics, as well as strengths and limitations of the data to offer context to users and the global pharmacovigilance community.</p>

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VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月30日

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  • Judith S. Brand,
  • Oskar Gauffin,
  • Daniele Sartori,
  • Michele Fusaroli,
  • Helena Sköld,
  • Tomas Bergvall,
  • Lovisa Sandberg,
  • Magnus Wallberg,
  • Peter Hjelmström,
  • G. Niklas Norén

摘要

VigiBase, the WHO global database of adverse event reports for medicines and vaccines, receives information on suspected adverse effects of medicinal products from countries, regions and territories that are members of the WHO Programme for International Drug Monitoring. The database serves as a global resource for pharmacovigilance signal management and scientific development. Its initial establishment through the programme in 1968 has also contributed to the international harmonisation of adverse event report data. As of 31 December 2024, the database includes over 40 million individual case reports coded in standard terminologies (WHODrug and MedDRA®). These reports, of which ~ 80% relate to medicines and ~ 20% to vaccines, come from over 160 countries. This profile paper aims to provide an update on the database infrastructure including data capture, management and analysis tools. It also presents a summary of global patterns and trends of key report characteristics, as well as strengths and limitations of the data to offer context to users and the global pharmacovigilance community.