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FAERS (raw)

FDA Adverse Event Reporting System — 19M+ reports used as substrate for signal-detection ML.
Composite score: 91.1

Rubric (1–5 per criterion)

rigor
4/5
coverage
5/5
maintenance
5/5
adoption
5/5
quality
3/5
accessibility
5/5
industry_relevance
5/5

Metadata

Stages
Post-market / RWE
Modalities
small-moleculebiologic-mab
Task types
pharmacovigilance
License
Public domain
First release
1969
Last updated
2025-Q2
Flags
none

Size & scope

Primary paper

Title
An assessment of the U.S. FDA Adverse Event Reporting System (FAERS) and the impact of quality reporting
Authors
Sakaeda T, Tamon A, Kadoyama K, Okuno Y
Year
2013
DOI / arXiv
10.3390/ijerph100300796
Citations
780

Links

Hosted by (initiatives)

Experts (primary authors / maintainers)

Groups (host labs / companies / consortia)

Related benchmarks

Notes (honest caveats)

Known under-/over-reporting biases.