FDA Adverse Events Reporting System Demographics 2015

$716 / 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

2016-03-15

Version

2016-03-15

Update Frequency

Quarterly

Temporal Coverage

2015-01-01 to 2015-12-31

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

Source License Requirements

N/A

Source Citation

N/A

Keywords

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

Other Titles

Percentage Average FDA Adverse Events Reporting System Demographics 2015, FDA Adverse Events Reporting System US Demographics 2015, States Population FDA Adverse Events Reporting System Demographics 2015

NameDescriptionTypeConstraints
YearThe year in which the data was submitteddaterequired : 1
QuarterThe quarter of the year in which the data was submittedstringrequired : 1
Primary_IdNumber 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. It is the Identifier for the case sequence (version) number as reported by the manufacturerintegerunique : 1 required : 1 level : Nominal
Case_IdNumber for identifying a FAERS caseintegerrequired : 1 level : Nominal
Case_Version_NumberSafety Report Case 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
Status_of_ReportInitial or follow-up status of report, as reported by manufacturerstringrequired : 1
Event_DateDate the adverse event occurred or began. If a complete date is not available, a partial date is provideddate-
Manufacturer_DateDate manufacturer first received initial information. In subsequent versions of a case, the latest manufacturer received date will be provided. FAERS extracts will provide only the exact data submitted in the case. Therefore, if a complete date is not available, a partial date will be provided.date-
Initial_FDA_DateDate FDA received first version (Initial) of Case. FAERS extracts will provide only the exact data submitted in the case. Therefore, if a complete date is not available, a partial date will be provided.date-
Subsequent_FDA_DateDate FDA received Case. In subsequent versions of a case, the latest manufacturer received date will be provided (YYYY-MM-DD format). FAERS extracts will provide only the exact data submitted in the case. Therefore, if a complete date is not available, a partial date will be provided.date-
Type_of_ReportType of report submitted to FDAstringrequired : 1
Authority_NumberRegulatory Authority’s case report number, when availablestring-
Manufacturer_NumberManufacturer's unique report identifierstring-
Manufacturer_SenderCoded name of manufacturer sending report; if not found, then verbatim name of organization sending report is mentioned.string-
Literature_ReferenceLiterature Reference information, when availablestring-
Age_of_PatientNumeric value of patient's age at eventnumberlevel : Ratio
Age_Codestring-
Age_GroupPatient age group, when availablestring-
Gender_of_PatientPatient's gender, when availablestring-
Is_Electronically_SubmittedWhether or not this report was submitted under the electronic submissions procedure for manufacturers. Abbreviations: "true" means Yes, "false" means Noboolean-
Weight_of_PatientNumeric value of patient's weightnumberlevel : Ratio
Weight_Codestring-
Report_DateDate report was sent to FDA. If a complete date is not available, a partial date is provideddate-
Is_Notified_To_ManufacturerWhether or not voluntary reporter also notified manufacturer (blank for manufacturer reports). Abbreviatiosn: "true" means Yes, "false" means Noboolean-
Occupation_CodeReporter's type of occupation in the latest version of a casestring-
Reporter_CountryCountry of the reporter in the latest version of a casestring-
Occurrence_CountryCountry where the event occurredstring-
YearQuarterPrimary IdCase IdCase Version NumberStatus of ReportEvent DateManufacturer DateInitial FDA DateSubsequent FDA DateType of ReportAuthority NumberManufacturer NumberManufacturer SenderLiterature ReferenceAge of PatientAge CodeAge GroupGender of PatientIs Electronically SubmittedWeight of PatientWeight CodeReport DateIs Notified To ManufacturerOccupation CodeReporter CountryOccurrence Country
2015Q1100036412100036412F2013-042014-04-162014-03-122015-03-12PERUS-ABBVIE-13P-163-1090373-00ABBVIE42YRMTrue118.04KG2015-03-12FalseCNUSUS
2015Q1100038593100038593F2013-07-172014-12-102014-03-122015-03-12PERUS-INCYTE CORPORATION-2013IN001676INCYTE64YRMTrue92.06KG2015-03-12FalseCNUSUS
2015Q1100038603100038603F2008-072015-03-192014-03-122015-03-31EXPUS-BAYER-2014-035493BAYER25YRAFTrue49.89KG2015-03-31FalseCNUSUS
2015Q1100039823100039823F2013-07-012014-03-252014-03-122015-01-22EXPUS-INCYTE CORPORATION-2014IN000187INCYTE79YRMTrue2015-01-22FalseCNUSUS
2015Q1100039882100039882F2013-102014-08-112014-03-122015-03-12PERUS-ABBVIE-13P-163-1177683-00ABBVIE43YRFTrue54.48KG2015-03-12FalseCNUSUS
2015Q1100039973100039973F2013-12-302014-11-202014-03-122015-03-12PERUS-INCYTE CORPORATION-2014IN000035INCYTE81YRFTrue63.04KG2015-03-12FalseCNUSUS
2015Q1100040603100040603F2008-012015-03-172014-03-122015-03-27PERUS-BAYER-2014-036236BAYER33YRAFTrue68.27KG2015-03-27FalseLWUSUS
2015Q1100040674100040674F2011-102015-03-172014-03-122015-03-27PERUS-BAYER-2014-036172BAYER40YRAFTrue56.69KG2015-03-27FalseCNUSUS
2015Q1100041104100041104F2012-07-232014-12-222014-03-122015-01-05EXPPHHY2014CA028965NOVARTIS40YRMTrue2015-01-06FalseCNCOUNTRY NOT SPECIFIEDCA
2015Q1100041203100041203F2014-01-172015-03-162014-03-122015-03-17EXPPHHO2014PL003565NOVARTIS61YRMTrue74.0KG2015-03-17FalseMDPLPL