Others titles
- FDA Adverse Events Reporting System Demographics Quarterly Report 2021
- FDA Adverse Events Reporting System US Demographics 2021
- FAERS Demographics Report 2021
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 2021
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 2021. The Demographics dataset contains patient demographic and administrative information, a single record for each event report.
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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 | 2021-05-10 |
---|---|
Last Modified | 2022-03-09 |
Version | 2022-03-09 |
Update Frequency |
Quarterly |
Temporal Coverage |
2021 |
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 2021, FDA Adverse Events Reporting System US Demographics 2021, FAERS Demographics Report 2021 |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Year | The year in which the data was submitted | date | - |
Quarter | The quarter of the year in which the data was submitted | string | required : 1enum : Array ( [0] => Q1 [1] => Q2 [2] => Q3 [3] => Q4 ) |
Primary_Id | Number 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 manufacturer | integer | level : Nominalrequired : 1unique : 1 |
Case_Id | Number for identifying a FAERS case | integer | level : Nominalrequired : 1 |
Case_Version_Number | Safety 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.) | integer | level : Ordinalrequired : 1 |
Status_of_Report | Initial or follow-up status of report, as reported by manufacturer | string | required : 1 |
Event_Date | Date the adverse event occurred or began. If a complete date is not available, a partial date is provided | date | - |
Manufacturer_Date | Date 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_Date | Date 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_Date | Date 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_Report | Type of report submitted to FDA | string | - |
Authority_Number | Regulatory Authority’s case report number, when available | string | - |
Manufacturer_Number | Manufacturer's unique report identifier | string | - |
Manufacturer_Sender | Coded name of manufacturer sending report; if not found, then verbatim name of organization sending report is mentioned. | string | - |
Literature_Reference | Literature Reference information, when available | string | - |
Age_of_Patient | Numeric value of patient's age at event | integer | level : Ratio |
Age_Code | string | - | |
Age_Group | Patient age group, when available | string | - |
Gender_of_Patient | Patient's gender, when available | string | - |
Is_Electronically_Submitted | Whether or not this report was submitted under the electronic submissions procedure for manufacturers. Abbreviations: "true" means Yes, "false" means No | boolean | required : 1 |
Weight_of_Patient | Numeric value of patient's weight | number | level : Ratio |
Weight_Code | string | - | |
Report_Date | Date report was sent to FDA. If a complete date is not available, a partial date is provided | date | - |
Is_Notified_To_Manufacturer | Whether or not voluntary reporter also notified manufacturer (blank for manufacturer reports). Abbreviations: "true" means Yes, "false" means No | boolean | - |
Occupation_Code | Reporter's type of occupation in the latest version of a case | string | - |
Reporter_Country | Country of the reporter in the latest version of a case | string | - |
Occurrence_Country | Country where the event occurred | string | - |
Data Preview
Year | Quarter | Primary Id | Case Id | Case Version Number | Status of Report | Event Date | Manufacturer Date | Initial FDA Date | Subsequent FDA Date | Type of Report | Authority Number | Manufacturer Number | Manufacturer Sender | Literature Reference | Age of Patient | Age Code | Age Group | Gender of Patient | Is Electronically Submitted | Weight of Patient | Weight Code | Report Date | Is Notified To Manufacturer | Occupation Code | Reporter Country | Occurrence Country |
2021 | Q2 | 100042347 | 10004234 | 7 | F | 2010-01-29 | 2021-06-28 | 2014-03-12 | 2021-06-29 | EXP | FR-JNJFOC-20140304417 | JOHNSON AND JOHNSON | 81.0 | YR | E | True | 64.0 | KG | 2021-06-29 | MD | FR | FR | ||||
2021 | Q2 | 100108272 | 10010827 | 2 | F | 2021-04-12 | 2014-03-14 | 2021-04-27 | EXP | DE-RANBAXY-2014R1-79044 | RANBAXY | C | M | True | 2021-04-27 | MD | DE | DE | ||||||||
2021 | Q2 | 1001163937 | 10011639 | 37 | F | 1905-07-07 | 2021-05-03 | 2014-03-14 | 2021-05-14 | EXP | PHHY2012CA040051 | NOVARTIS | 49.0 | YR | F | True | 2021-05-14 | CN | CA | CA | ||||||
2021 | Q2 | 100144835 | 10014483 | 5 | F | 2021-06-15 | 2014-03-17 | 2021-06-21 | EXP | CA-009507513-1403CAN003893 | MERCK | 8.0 | WK | True | 2021-06-21 | HP | CA | CA | ||||||||
2021 | Q2 | 100148375 | 10014837 | 5 | F | 2021-05-28 | 2014-03-17 | 2021-06-10 | EXP | PHHY2014JP031472 | NOVARTIS | YAMAGUCHI T, HIROSAWA M, KAWAHARA A, KITAMURA K, NAKANISHI T AND KATSURAGI T ET AL.. SALVAGE IMATINIB THERAPY IN A HEMATOLOGICAL RELAPSE CML?BC PATIENT EARLY AFTER ALLOGENIC BMT. ANNUAL MEETING OF THE JAPAN SOCIETY FOR HAEMATOPOIETIC CELL TRANSPLANTATION. 2014?1?2 | 37.0 | YR | M | True | 2021-06-11 | HP | JP | JP | ||||||
2021 | Q2 | 100167816 | 10016781 | 6 | F | 2012-03-30 | 2021-06-16 | 2014-03-18 | 2021-06-24 | EXP | PHHY2012CA028320 | NOVARTIS | 45.0 | YR | F | True | 2021-06-24 | HP | CA | CA | ||||||
2021 | Q2 | 1002130533 | 10021305 | 33 | F | 2021-04-15 | 2021-04-15 | 2014-03-19 | 2021-04-23 | EXP | PHHY2014CA019281 | NOVARTIS | 43.0 | YR | M | True | 2021-04-23 | MD | CA | CA | ||||||
2021 | Q2 | 1002221560 | 10022215 | 60 | F | 2020-11-01 | 2021-06-11 | 2014-03-19 | 2021-06-24 | EXP | PHHY2011CA101736 | NOVARTIS | 74.0 | YR | F | True | 2021-06-24 | MD | CA | CA | ||||||
2021 | Q2 | 1002310547 | 10023105 | 47 | F | 2020-01-14 | 2021-06-08 | 2014-03-20 | 2021-06-23 | EXP | CA-ROCHE-1367988 | ROCHE | 66.0 | YR | F | True | 2021-06-23 | CN | CA | CA | ||||||
2021 | Q2 | 1002872121 | 10028721 | 21 | F | 2014-03-17 | 2021-04-28 | 2014-03-21 | 2021-05-10 | EXP | PHHY2014CA033801 | NOVARTIS | 57.0 | YR | F | True | 2021-05-10 | MD | CA | CA |