FDA Adverse Event Reporting System Quarterly Data Extract Files

Includes data files and supplemental information. Supplemental information includes a reproducible RMarkdown file, an Excel sheet with metadata, and complete webpage files.<br><br><br>From the FAERS Quarterly Data Extract Files Website:<br><br>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 FAERS data cannot be performed with these files by persons who are not familiar with creation of relational databases. However, you can get a summary FAERS report for a product by sending a Freedom of Information Act (FOIA) request to FDA. You can also request individual case reports by submitting a FOIA request listing case report numbers. 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.Additional fields will appear in the 2014 Q3 date files below.<br>For more details: Summary of Changes for the 2014 Q3 Quarterly Date Extract (PDF -71 KB)<br><br>***Microdata: Yes Level of Analysis: Groups - medications; Individuals - patients Variables Present: Unclear Based on the File Type File Layout: ascii, sgm Codebook: Yes Methods: Yes - <br>link: https://www.fda.gov/drugs/surveillance/postmarketing-adverse-event-reporting-compliance-programWeights (with appropriate documentation): n/a Publications: No Aggregate Data: No