FDA Adverse Event Reporting System
E1199973
UNEXPLORED
The FDA Adverse Event Reporting System is a U.S. Food and Drug Administration database that collects and analyzes reports of adverse events and medication errors associated with drugs and therapeutic biologic products.
All labels observed (1)
| Label | Occurrences |
|---|---|
| FDA Adverse Event Reporting System canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T16185382 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: FDA Adverse Event Reporting System Context triple: [Office of Surveillance and Epidemiology, usesDataSource, FDA Adverse Event Reporting System]
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A.
Vaccine Adverse Event Reporting System
The Vaccine Adverse Event Reporting System (VAERS) is a U.S. national surveillance program that collects and analyzes reports of possible side effects following vaccination to monitor vaccine safety.
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B.
FDA Risk Evaluation and Mitigation Strategies authority
The FDA Risk Evaluation and Mitigation Strategies authority is the U.S. Food and Drug Administration’s power to require special safety measures and monitoring programs for certain high-risk prescription drugs to ensure their benefits outweigh their risks.
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C.
Food and Drug Administration
The Food and Drug Administration is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other consumer products.
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D.
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is the U.S. regulatory body responsible for overseeing the safety, efficacy, and quality of biological products such as vaccines, blood products, and gene therapies.
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E.
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research is the U.S. FDA division responsible for overseeing the safety, effectiveness, and quality of prescription and over-the-counter drugs.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: FDA Adverse Event Reporting System Target entity description: The FDA Adverse Event Reporting System is a U.S. Food and Drug Administration database that collects and analyzes reports of adverse events and medication errors associated with drugs and therapeutic biologic products.
-
A.
Vaccine Adverse Event Reporting System
The Vaccine Adverse Event Reporting System (VAERS) is a U.S. national surveillance program that collects and analyzes reports of possible side effects following vaccination to monitor vaccine safety.
-
B.
FDA Risk Evaluation and Mitigation Strategies authority
The FDA Risk Evaluation and Mitigation Strategies authority is the U.S. Food and Drug Administration’s power to require special safety measures and monitoring programs for certain high-risk prescription drugs to ensure their benefits outweigh their risks.
-
C.
Food and Drug Administration
The Food and Drug Administration is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other consumer products.
-
D.
Center for Biologics Evaluation and Research
The Center for Biologics Evaluation and Research is the U.S. regulatory body responsible for overseeing the safety, efficacy, and quality of biological products such as vaccines, blood products, and gene therapies.
-
E.
Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research is the U.S. FDA division responsible for overseeing the safety, effectiveness, and quality of prescription and over-the-counter drugs.
- F. None of above. chosen
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.