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U.S. Department of Health and Human Services

Drugs

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Instructions for Requesting Individual Case Reports

The initial reporter provides a narrative describing the event in the report submitted to FDA. The narrative is not included in the FAERS (formerly AERS) quarterly data files. The narrative may contain personal identifiers or other information that cannot be disclosed. The narrative information must be reviewed prior to public disclosure to remove information that may, for example, identify the person using the product or another person involved in the event. Individual case reports that include a redacted narrative can be obtained by sending a FOIA request to FDA. We provide the most current case information available at the time your request is processed.


The request must identify each case report you are interested in receiving. The case report number is included in the field/data element labeled: (1) “CASE” in the AERS ASCII format, (2) "CASE_ID" in the FAERS ASCII format (data files starting the 4th quarter 2012), or (3) “safetyreportid” in the SGML/XML format of the quarterly data files.

To facilitate processing your request, please include the following in your FOIA request: 

  1. identify the suspect drug(s) associated with the cases you are requesting;
  2. identify the source of the case numbers (e.g., FAERS quarterly data files); and
  3. use case numbers (do not use individual safety report (ISR) numbers or image numbers) and list the 7 digit case numbers in ascending order in a column. An example is shown below: 

3394619
3394646
3394655
3492174

Please retain an electronic copy of your case list (EXCEL preferred). At the time we begin processing your request we may contact you and ask for the electronic case list. This will allow us to import your electronic case list into our query rather than having to manually enter the case numbers.
 

Using other sources of information for case identification: If you are not using the FAERS quarterly data files as a reference for your case identification, identify the source you are using (e.g., FAERS FOIA Detailed Report). Identification of the information source may help facilitate processing of your FOIA request, should there be any questions about the numbers you have provided to us. Please avoid citing various tracking numbers from the Spontaneous Reporting System (SRS) data extract sold through the National Technical Information Service (NTIS) or image numbers that may be available from other sources. The SRS tracking numbers have changed numerous times over the years. Trying to link SRS tracking numbers or image numbers to the current case number is very difficult. We cannot enter these numbers directly into FAERS and easily retrieve case information.
 

Fees: You may have to pay fees to cover some or all of the cost of processing your request. You can use an estimate of 15 minutes processing time per case report to assist you in estimating the fees you may incur. Instructions on how to make a FOIA request and information about fees are available on FDA’s website:
http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm