FDA Adverse Events Reporting System Demographics 2016

$395 / year

FAERS database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.
The Demographics data file contains patient demographic and administrative information, a single record for each event report.

Complexity

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

FAERS is used for the spontaneous reporting of adverse events and medication errors involving human drugs and therapeutic biological products. FAERS began on September 10, 2012, and replaced the Adverse Event Reporting System (also known as Legacy AERS), which was decommissioned on August 27, 2012.

FAERS is a useful tool for FDA for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer’s compliance to reporting regulations and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor the safety of products after they are approved by FDA. If a potential safety concern is identified in FAERS, further evaluation is performed. Further evaluation might include conducting studies using other large databases, such as those available in the Sentinel System. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.

Reporting of adverse events and medication errors by healthcare professionals and consumers is voluntary in the United States. FDA receives some adverse event and medication error reports directly from healthcare 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 adverse events and/or medication errors 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 reports received directly and the reports from manufacturers are entered into FAERS.

Date Created

2012-09-10

Last Modified

2017-02-25

Version

2017-02-25

Update Frequency

Quarterly

Temporal Coverage

2016-01-01 to 2016-12-31

Spatial Coverage

United States

Source

John Snow Labs => U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Percentage Average, US Demographics, States Population, AERS database

Other Titles

Percentage Average FDA Adverse Events Reporting System Demographics 2016, FDA Adverse Events Reporting System US Demographics 2016, States Population FDA Adverse Events Reporting System Demographics 2016

NameDescriptionTypeConstraints
YearThe year in which the data was submitteddaterequired : 1
QuarterThe quarter of the year in which the data was submittedstringrequired : 1
Primary_idUnique number for identifying a FAERS report. This is the primary link field (primary key) between data files. This is a concatenated key of Case ID and Case Version Number. It is the Identifier for the case sequence (version) number as reported by the manufacturer.integerunique : 1 required : 1 level : Nominal
Case_idNumber for identifying a FAERS case. A case consists of one or more versions. A follow-up version (that is, the newest/latest version received by FDA) will have the same CASE number as the initial/oldest version.integerrequired : 1 level : Nominal
Case_VersionSafety Report Version Number. The Initial Case will be version 1; follow-ups to the case will have sequentially incremented version numbers (for example, 2, 3, 4, etc.).integerrequired : 1 level : Ordinal
I_F_CodeCode for initial or follow-up status of report, as reported by manufacturer. Abbreviations: I means Initial, F means Followupstringrequired : 1
Event_DateDate the adverse event occurred or began. (YYYY-MM-DD format) – If a complete date is not available, a partial date is provided.date-
Manufacturer_DateDate manufacturer first received initial information. In subsequent versions of a case, the latest manufacturer received date will be provided (YYYY-MM-DD format). If a complete date is not available, a partial date will be provided.date-
Initial_FDA_DateDate FDA received first version (Initial) of Case (YYYY-MM-DD format)date-
FDA_DateDate FDA received Case. In subsequent versions of a case, the latest manufacturer received date will be provided (YYYY-MM-DD format).date-
Report_CodeCode for the type of report submitted. Abbreviations: EXP means Expedited (15-Day), PER means Periodic, DIR means Directstringrequired : 1
Authority_NumberRegulatory Authority’s case report number, when available.string-
Manufacturer_NumberManufacturer's unique report identifier.string-
Manufacturer_SenderCoded name of manufacturer sending report; if not found, then verbatim name of organization sending report.string-
Literature_ReferenceLiterature Reference information, when available.string-
AgeNumeric value of patient's age at event.numberlevel : Nominal
Age_Codestring-
Age_GroupPatient Age Group code, when available. Abbreviations: N means Neonate, I means Infant, C means Child, T means Adolescent, A means Adult, E means Elderlystring-
Gender_CodeCode for patient's sex. Abbreviations: UNK means Unknown, M means Male, F means Female, NS means Not Specifiedstring-
Is_E_SubWhether or not this report was submitted under the electronic submissions procedure for manufacturers. Abbreviations: true means Yes, false means Nobooleanrequired : 1
WeightNumeric value of patient's weight.numberlevel : Nominal
Weight_CodeAbbreviation of the unit of patient's weight. Abbreviations: KG means Kilograms, LBS means Pounds, GMS means Gramsstring-
Report_DateDate report was sent (YYYY-MM-DD format). If a complete date is not available, a partial date is provided. See the NOTE on dates at the end of this section.date-
To_ManufacturerWhether or not voluntary reporter also notified manufacturer (blank for manufacturer reports). Abbreviatiosn: Y means Yes, N means No, U means Unknownstring-
Occupation_CodeAbbreviation for the reporter's type of occupation in the latest version of a case. Abbreviations: , MD means Physician, PH means Pharmacist, OT means Other health-professional, LW means Lawyer, CN means Consumerstring-
Reporter_CountryA 2 letter country code representing the country of the reporter in the latest version of a casestring-
Occurrence_CountryA 2 letter country code representing the country where the event occurred.string-
YearQuarterPrimary_idCase_idCase_VersionI_F_CodeEvent_DateManufacturer_DateInitial_FDA_DateFDA_DateReport_CodeAuthority_NumberManufacturer_NumberManufacturer_SenderLiterature_ReferenceAgeAge_CodeAge_GroupGender_CodeIs_E_SubWeightWeight_CodeReport_DateTo_ManufacturerOccupation_CodeReporter_CountryOccurrence_Country
2016Q1119298421119298421I2016-01-192016-01-19DIRfalseNUS
2016Q1121407221121407221I2016-03-022016-03-02DIRfalseNUS
2016Q1121442351121442351I2016-03-032016-03-03DIRfalseNUS
2016Q1121801501121801501I2016-03-142016-03-14DIRfalseNUS
2016Q1121834731121834731I2016-03-152016-03-15DIRfalseNUS
2016Q2124675281124675281I2016-06-142016-06-14DIRfalseNUS
2016Q3126064371126064371I2016-07-282016-07-28DIRfalseNUS
2016Q3126762461126762461I2016-08-222016-08-22DIRfalseNUS
2016Q1118977921118977921I2016-01-072016-01-07DIRFfalseNUS
2016Q1119336741119336741I2016-01-202016-01-20DIRFfalseNUS