FAERS (raw)

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

Composite
91.1
Experimental validation
Retrospective
Stages
Post-market / RWE
Modalities
small-moleculebiologic-mab
Task types
pharmacovigilance
Size
reports: 19,000,000
License
Public domain
First release
1969
Last updated
2025-Q2
Official site
→ project page
Leaderboard
→ leaderboard
Dataset
→ dataset
Code / GitHub
→ repository
HuggingFace
→ HF
Paper
An assessment of the U.S. FDA Adverse Event Reporting System (FAERS) and the impact of quality reporting · Sakaeda T, Tamon A, Kadoyama K, Okuno Y · 2013 · paper · doi:10.3390/ijerph100300796 · 780 citations
Flags
none
Experts
Groups
FDA CDER
Hosted by
FAERS / SIDER / OffSides / TWOSIDES
Related benchmarks
OffSides / TWOSIDES, SIDER

Rubric (7-criterion)

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

Notes

Known under-/over-reporting biases.

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