FDA Adverse Events Reporting System Demographics 2018

$716 / year

The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to FDA (U.S. Food and Drug Administration) in 2018. The Demographics dataset contains patient demographic and administrative information, a single record for each event report.

Complexity

FAERS (FDA Adverse Event Reporting System) is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. It is a useful tool for FDA (U.S. Food and Drug Administration) 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.

The reports in FAERS are submitted to FDA by 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 to the products’ manufacturers who then send these reports to FDA.

Date Created

2018-05-12

Last Modified

2019-02-07

Version

2019-02-07

Update Frequency

Quarterly

Temporal Coverage

2018-01-01 to 2018-12-31

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

US Demographics, FAERS Database, Adverse Reaction, Adverse Events of Medication, Adverse Event Reporting Form, FAERS, Serious Adverse Event, Adverse Events Reporting System

Other Titles

FDA Adverse Events Reporting System Demographics Quarterly Report 2018, FDA Adverse Events Reporting System US Demographics 2018, FAERS Demographics Report 2018

NameDescriptionTypeConstraints
YearThe year in which the data was submitteddaterequired : 1
QuarterThe quarter of the year in which the data was submittedstringrequired : 1 enum : Array
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 eventintegerlevel : 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 Nobooleanrequired : 1
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). Abbreviations: "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
2018Q1100035813100035813Follow-up2014-01-102018-01-162014-03-122018-01-23Expedited (15-Day)CN-ELI_LILLY_AND_COMPANY-CN201801014052ELI LILLY AND CO64.0YEARMaleTrue2018-01-23ConsumerCanadaChina
2018Q1100048965100048965Follow-up2018-02-012014-03-122018-02-09Expedited (15-Day)PHHY2017AU020915NOVARTISMaleTrue69.0Kilograms2018-02-09ConsumerCOUNTRY NOT SPECIFIEDAustralia
2018Q1100054258100054258Follow-up2013-07-012018-01-052014-03-122018-01-11Expedited (15-Day)JP-BAUSCH-BL-2018-004001BAUSCH AND LOMB65.0YEARMaleTrue2018-01-11PhysicianJapanJapan
2018Q1100058884100058884Follow-up20112018-03-022014-03-132018-03-07Periodic (Non-Expedited)US-ASTRAZENECA-2015SE68374ASTRAZENECA775.0MONTHFemaleTrue61.2Kilograms2018-03-07ConsumerUnited States of America (the)United States of America (the)
2018Q1100060834100060834Follow-up20142017-12-042014-03-132018-01-26Expedited (15-Day)JP-ASTELLAS-2018JP005660ASTELLAS60.0YEARFemaleTrue2018-01-26ConsumerJapanJapan
2018Q1100065478100065478Follow-up2012-03-292018-01-302014-03-132018-02-09Expedited (15-Day)JP-ROCHE-2070545ROCHE82.0YEARMaleTrue59.0Kilograms2018-02-09PhysicianJapanJapan
2018Q1100066292100066292Follow-up2018-02-192014-03-132018-02-22Periodic (Non-Expedited)US-MUNDIPHARMA DS AND PHARMACOVIGILANCE-USA-2017-0138515PURDUEAdultFemaleTrue2018-02-22ConsumerUnited States of America (the)United States of America (the)
2018Q1100071964100071964Follow-up2013-06-142018-03-052014-03-132018-03-08Periodic (Non-Expedited)US-PFIZER INC-2018064046PFIZERTrue2018-03-08Other health-professionalUnited States of America (the)United States of America (the)
2018Q1100100246100100246Follow-up2008-052018-03-122014-03-132018-03-19Periodic (Non-Expedited)US-MYLANLABS-2018M1012089MYLANFemaleTrue2018-03-19ConsumerUnited States of America (the)United States of America (the)
2018Q1100113852100113852Follow-up2013-102018-01-092014-03-142018-01-15Expedited (15-Day)CA-ROCHE-2081977ROCHEFemaleTrue2018-01-15PhysicianCanadaCanada