FDA Adverse Events Reporting System Patient Outcome 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 patient outcome file contains information on patient outcomes for the event (0 or more).

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, FDA Adverse Events Reporting, FAERS Patient Outcome, FAERS Percentage Average, States Population

Other Titles

FDA Adverse Events Reporting System Outcome Report 2019, FDA Adverse Events Reporting System patent Outcome Reports 2019, FAERS Outcome Report 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 case.integerrequired : 1 level : Nominal
Patient_OutcomeDescription of patient outcome. The outcome from the latest version of a case is providedstring-
YearQuarterPrimary IdCase IdPatient Outcome
2019Q1100080859010008085Hospitalization -Initial or Prolonged
2019Q1100080859010008085Other Serious (Important Medical Event)
2019Q110010748410010748Other Serious (Important Medical Event)
2019Q110010748410010748Hospitalization -Initial or Prolonged
2019Q110017132810017132Other Serious (Important Medical Event)
2019Q110017231210017231Hospitalization -Initial or Prolonged
2019Q110018981410018981Hospitalization -Initial or Prolonged
2019Q110021472210021472Hospitalization -Initial or Prolonged
2019Q1100222154010022215Hospitalization -Initial or Prolonged
2019Q1100222154010022215Other Serious (Important Medical Event)