FDA Adverse Event Reporting System Quarterly Data Extract Files
Principal Investigator(s): View help for Principal Investigator(s) United States Department of Health and Human Services. Food and Drug Administration
Version: View help for Version V1
| Name | File Type | Size | Last Modified |
|---|---|---|---|
| Data-Files | 03/16/2025 09:34:PM | ||
| Supplementary-Information | 03/16/2025 07:37:PM |
Project Citation:
United States Department of Health and Human Services. Food and Drug Administration. FDA Adverse Event Reporting System Quarterly Data Extract Files. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2025-03-16. https://doi.org/10.3886/E221501V1
Project Description
Project Title:
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FDA Adverse Event Reporting System Quarterly Data Extract Files
Summary:
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Includes data files and supplemental information. Supplemental information includes a reproducible RMarkdown file, an Excel sheet with metadata, and complete webpage files.
From the FAERS Quarterly Data Extract Files Website:
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:
From the FAERS Quarterly Data Extract Files Website:
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.
For more details: Summary of Changes for the 2014 Q3 Quarterly Date Extract (PDF -71 KB)
For more details: Summary of Changes for the 2014 Q3 Quarterly Date Extract (PDF -71 KB)
Original Distribution URL:
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https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html
Scope of Project
Time Period(s):
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2004 – 2024
Data Type(s):
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aggregate data
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This material is distributed exactly as it arrived from the data depositor. ICPSR has not checked or processed this material. Users should consult the investigator(s) if further information is desired.