FDA Adverse Events Reporting System Report Source 2019

$179 / 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 2019. The report source dataset contains report sources for event.

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

2019-04-26

Last Modified

2019-04-26

Version

2019-04-26

Update Frequency

Quarterly

Temporal Coverage

2019-01-01 to 2019-03-01

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

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 Data Reporting System Report Source 2019, Evaluating Evidence FDA Adverse Events Reporting System Report Source 2019, FAERS Report Source 2019

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_Number. It is the Identifier for the case sequence (version) number as reported by the manufacturerintegerrequired : 1 level : Nominal
Case_IdCase number for identifying a FAERS caseintegerrequired : 1 level : Nominal
Report_SourceSource of the report (the source from the latest version of a case is provided)string-
YearQuarterPrimary IdCase IdReport Source
2019Q115431328115431328Health Professional
2019Q115450783315450783Health Professional
2019Q115450783315450783Study
2019Q115781402115781402Consumer
2019Q115785129115785129Consumer
2019Q115785135115785135Health Professional
2019Q115785142115785142Health Professional
2019Q115785243115785243Health Professional
2019Q115785250115785250Consumer
2019Q115785256115785256Consumer