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Adverse Event Reporting System (AERS)

Dataset Summary

Agency	Department of Health and Human Services
Sub-Agency/Organization	US Food and Drug Administration
Category	Health and Nutrition
Date Released	01/01/2004
Date Updated	http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm082193
Time Period	2004-2012
Frequency	quarterly
Description	The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products. Reporting of adverse events from the point of care is voluntary in the United States. FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report these events to the products' manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations. The files listed on this page contain raw data extracted from the AERS database for the indicated time ranges and are not cumulative. Users of these files need to be familiar with creation of relational databases using applications such as ORACLE, Microsoft Office Access, MySQL and IBM DB2 or the use of ASCII files with SAS analytic tools. A simple search of AERS data cannot be performed with these files by persons who are not familiar with creation of relational databases.

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Dataset Metrics

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Dataset Information

Data.gov Data Category Type	Raw Data Catalog
Specialized Data Category Designation	Surveillance
Keywords	Human drugs, adverse drug reaction, human drug side effects, adverse event, biological product adverse event, human biological products
Unique ID	6223

Contributing Agency Information

Citation	http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveil...
Agency Program Page	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPa...
Agency Data Series Page	http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveil...

Dataset Coverage

Unit of Analysis	adverse drug event
Granularity	country
Geographic Coverage	Many reports are from the United States but the system accepts reports from all countries

Data Description

Collection Mode	Paper, MedWatch Website, electronic submission with E2B standard
Data Collection Instrument	http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/u...
Data Dictionary/Variable List	http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveil...

Additional Dataset Documentation

Technical Documentation	Each downloaded file set included full technical documentation
Additional Metadata

OMB Control No. 3090-0284