Dataset Identification:
Resource Abstract:
- description: <p>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.</p>;
abstract: <p>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.</p>
Citation
- Title Adverse Event Reporting System (AERS).
-
- creation Date
2018-06-09T14:17:22.505433
Resource language:
Processing environment:
Back to top:
Metadata data stamp:
2018-08-06T19:35:42Z
Resource Maintenance Information
- maintenance or update frequency:
- notes: This metadata record was generated by an xslt transformation from a dc metadata record; Transform by Stephen M. Richard, based
on a transform by Damian Ulbricht. Run on 2018-08-06T19:35:42Z
Metadata contact
-
pointOfContact
- organisation Name
CINERGI Metadata catalog
-
- Contact information
-
-
- Address
-
- electronic Mail Address cinergi@sdsc.edu
Metadata language
eng
Metadata character set encoding:
utf8
Metadata standard for this record:
ISO 19139 Geographic Information - Metadata - Implementation Specification
standard version:
2007
Metadata record identifier:
urn:dciso:metadataabout:41029f70-9d51-4ca5-a29e-a722dd280f33
Metadata record format is ISO19139 XML (MD_Metadata)