Others titles

  • FDA Adverse Events Reporting System Demographics Quarterly Report 2022
  • FDA Adverse Events Reporting System US Demographics 2022
  • FAERS Demographics Report 2022

Keywords

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

FDA Adverse Events Reporting System Demographics 2022

The FDA Adverse Event Reporting System (FAERS) contains information on medication errors, quality complaints and drug-related adverse events that were submitted to the FDA (U.S. Food and Drug Administration) in 2022. The Demographics dataset contains patient demographic and administrative information, a single record for each event report.

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Last updated:January 20, 2021

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Description

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 the 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 the 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 the FDA.

About this Dataset

Data Info

Date Created

2022-04-29

Last Modified

2023-01-30

Version

2023-01-30

Update Frequency

Quarterly

Temporal Coverage

2022-01 to 2022-12

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 2022, FDA Adverse Events Reporting System US Demographics 2022, FAERS Demographics Report 2022

Data Fields

Name Description Type Constraints
YearThe year in which the data was submitteddate-
QuarterThe quarter of the year in which the data was submittedstringrequired : 1enum : Array ( [0] => Q1 [1] => Q2 [2] => Q3 [3] => Q4 )
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 manufacturerintegerlevel : Nominalrequired : 1unique : 1
Case_IdNumber for identifying a FAERS caseintegerlevel : Nominalrequired : 1
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.)integerlevel : Ordinalrequired : 1
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 FDAstring-
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 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). 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-

Data Preview

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
2022Q110005972101000597210F2014-02-212022-02-022014-03-132022-02-06EXPPHHO2014DE003546NOVARTIS66.0YRFTrue74.0KG2022-02-03MDDEDE
2022Q110014432441001443244F2022-02-162014-03-172022-02-25EXPCA-009507513-1403CAN006934MERCK64.0YRFTrue69.0KG2022-02-25HPCACA
2022Q1100144836100144836F2022-01-062014-03-172022-01-11EXPCA-009507513-1403CAN003893MERCKJaworsky D, Thompson C, Yudin MH, Bitnun A, Brophy J, Samson L, et al. Use of newer antiretroviral agents, darunavir and etravirine with or without raltegravir, in pregnancy, a report of two cases. Antiviral therapy. 2010;15 (4):585-88.0WKTrue2022-01-11HPCACA
2022Q110016781101001678110F2012-03-302021-12-292014-03-182022-01-06EXPPHHY2012CA028320NOVARTIS45.0YRFTrue2022-01-06HPCACA
2022Q110022215661002221566F2011-01-012022-02-162014-03-192022-02-22EXPPHHY2011CA101736NOVARTISFTrue2022-02-22CNCACA
2022Q1100235912100235912F2022-03-142014-03-202022-03-24EXPGB-PERRIGO-14GB002712PERRIGO25.0YRFTrue67.0KG2022-03-24MDGBGB
2022Q1100235992100235992F2022-03-142014-03-202022-03-24EXPGB-PERRIGO-14GB002710PERRIGO48.0YRFTrue49.0KG2022-03-24MDGBGB
2022Q1100236002100236002F2022-03-142014-03-202022-03-24EXPGB-PERRIGO-14GB002711PERRIGO20.0YRFTrue54.0KG2022-03-24MDGBGB
2022Q1100236012100236012F2019-01-042014-03-202022-03-23EXPGB-PERRIGO-14GB002703PERRIGO37.0YRFTrue60.0KG2022-03-23MDGBGB
2022Q1100236022100236022F2019-01-042014-03-202022-03-23EXPGB-PERRIGO-14GB002705PERRIGO25.0YRFTrue58.0KG2022-03-23MDGBGB