Adverse Event Reporting System (AERS)

Metadata Updated: August 20, 2018

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.

Access & Use Information

Public: This dataset is intended for public access and use. License: See this page for license information.

Downloads & Resources

Dates

Metadata Created Date April 6, 2016
Metadata Updated Date August 20, 2018

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date April 6, 2016
Metadata Updated Date August 20, 2018
Publisher U.S. Food and Drug Administration
Unique Identifier b454bed2-730a-4e06-becb-0f599f2ad62a
Maintainer
FDA Enterprise Data Inventory
Maintainer Email
Public Access Level public
Bureau Code 009:10
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Harvest Object Id d3046e89-d663-4ba1-baec-9ab82f67376e
Harvest Source Id 15c538b5-31a0-474e-8ba5-c85ee421cb4d
Harvest Source Title Healthdata.gov
License http://opendefinition.org/licenses/odc-odbl/
Data Last Modified 2004-01-01
Program Code 009:000
Source Datajson Identifier True
Source Hash 3521d6fa07f1a3891192c8e663b3843edf42f9d8
Source Schema Version 1.1
Temporal 2004-01-01T05:00:00-05:00/2012-12-31T05:00:00-05:00

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