Adverse Event Reporting System (AERS)

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.

General Information

• This data is described at

  http://catalog.data.gov/dataset/adverse-event-reporting-system-aers Do you think this data is incorrect? Let us know

• This data is published by

  U.S. Department of Health & Human Services Do you think this data is incorrect? Let us know

Legal Information

• The rights statement is at

  http://catalog.data.gov/dataset/adverse-event-reporting-system-aers Do you think this data is incorrect? Let us know

• Outside the US, this data is available under

  Creative Commons CCZero Do you think this data is incorrect? Let us know

• There are

  yes, and the rights are all held by the same person or organisation Do you think this data is incorrect? Let us know

• The content is available under

  Creative Commons CCZero Do you think this data is incorrect? Let us know

• The rights statement includes data about

  its data licence Do you think this data is incorrect? Let us know

• This data contains

  no data about individuals Do you think this data is incorrect? Let us know

Practical Information

• The data appears in this collection

  http://catalog.data.gov/organization/hhs-gov Do you think this data is incorrect? Let us know

• The accuracy or relevance of this data will

  go out of date but it is timestamped Do you think this data is incorrect? Let us know

• The data is

  backed up offsite Do you think this data is incorrect? Let us know

Technical Information

• This data is published at

  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm Do you think this data is incorrect? Let us know

Social Information

• The documentation includes machine-readable data for

  title Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  description Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  identifier Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  landing page Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  publisher Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  keyword(s) or tag(s) Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  theme(s) Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  distribution(s) Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  release date Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  modification date Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  temporal coverage Do you think this data is incorrect? Let us know

• The documentation includes machine-readable data for

  language Do you think this data is incorrect? Let us know

• The documentation about each distribution includes machine-readable data for

  title Do you think this data is incorrect? Let us know

• The documentation about each distribution includes machine-readable data for

  description Do you think this data is incorrect? Let us know

• The documentation about each distribution includes machine-readable data for

  release date Do you think this data is incorrect? Let us know

• The documentation about each distribution includes machine-readable data for

  a URL to access the data Do you think this data is incorrect? Let us know

• The documentation about each distribution includes machine-readable data for

  a URL to download the dataset Do you think this data is incorrect? Let us know

• The documentation about each distribution includes machine-readable data for

  type of download media Do you think this data is incorrect? Let us know

• Find out how to contact someone about this data at

  http://catalog.data.gov/dataset/adverse-event-reporting-system-aers Do you think this data is incorrect? Let us know

• Find out how to suggest improvements to publication at

  http://www.data.gov/issue/?media_url=http://catalog.data.gov/dataset/adverse-event-reporting-system-aers Do you think this data is incorrect? Let us know