Adverse Event Reporting System (AERS)

Metadata Updated: April 25, 2021

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 November 10, 2020
Metadata Updated Date April 25, 2021

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date November 10, 2020
Metadata Updated Date April 25, 2021
Publisher U.S. Food and Drug Administration
Unique Identifier Unknown
Maintainer
Identifier b454bed2-730a-4e06-becb-0f599f2ad62a
Data First Published 2021-02-25
Data Last Modified 2004-01-01
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 6fd05fc5-db67-430c-8e7e-228e264e9584
Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
Harvest Source Title Healthdata.gov
Homepage URL http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm
License http://opendefinition.org/licenses/odc-odbl/
Program Code 009:000
Source Datajson Identifier True
Source Hash 4b442cf8013b00b7a50694490ae78efd318b28fe
Source Schema Version 1.1
Temporal 2004-01-01/2012-12-31

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