Adverse Event Reporting System (AERS)

Metadata Updated: March 1, 2019

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: No license information was provided. If this work was prepared by an officer or employee of the United States government as part of that person's official duties it is considered a U.S. Government Work.

Downloads & Resources

Dates

Metadata Created Date April 6, 2016
Metadata Updated Date March 1, 2019

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date April 6, 2016
Metadata Updated Date March 1, 2019
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 43087509-cd9d-4a61-b4a5-05a5fdc3d403
Harvest Source Id 15c538b5-31a0-474e-8ba5-c85ee421cb4d
Harvest Source Title Healthdata.gov
Data Last Modified 2004-01-01
Program Code 009:000
Source Datajson Identifier True
Source Hash 3437e26b4fc2b1e0be63a9638014ed645294e931
Source Schema Version 1.1
Temporal 2004-01-01T05:00:00-05:00/2012-12-31T05:00:00-05:00

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