Adverse Events Reporting System (AERS) > The Adverse Event Reporting System (AERS): Latest Quarterly Data Files

The Adverse Event Reporting System (AERS): Latest Quarterly Data Files

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. However, individual case reports from the AERS database can also be obtained by sending a Freedom of Information (FOI) request to FDA.

Instructions on how to send FDA an FOI request are available at this Web site: http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest 1.



The quarterly data files, which are available in ASCII or SGML formats, include:

. demographic and administrative information and the initial report image ID number (if available);
.. drug information from the case reports;
... reaction information from the reports;
.... patient outcome information from the reports;
..... information on the source of the reports;
...... a "README" file containing a description of the files.

open here to see the data files:
Adverse Events Reporting System (AERS) > The Adverse Event Reporting System (AERS): Latest Quarterly Data Files