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HHS Office of the Chief Data Officer
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.
Tags
adverse event, human drugs
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Data Provided By
open.fda.gov
Profile Picture HHS Office of the Chief Data Officer

created Feb 25 2021

updated Jul 25 2023

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(none)
Permissions
Public
Tags
adverse event, human drugs
Licensing and Attribution
Data Provided By
open.fda.gov
Source Link
(none)
Common Core
Publisher
U.S. Food and Drug Administration
Contact Name
FDA Enterprise Data Inventory
Contact Email
FDA_Enterprise_Data_Inventory@fda.hhs.gov
Bureau Code
009:10
Program Code
009:000
Public Access Level
public
Temporal Applicability
2004-01-01/2012-12-31
Homepage
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm
License
http://opendefinition.org/licenses/odc-odbl/
Last Update
2004-01-01
Unique Identifier
b454bed2-730a-4e06-becb-0f599f2ad62a
Harvest Source
Is Harvested Data
Yes
Harvest Source URI
https://open.fda.gov/data.json
Last Harvest Performed
2021-02-25T06:38:40.905869Z
Harvest Source Title
open.fda.gov
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