Adverse Food Events 2004 to 2018

$447.50 / year

This dataset is a quarterly updated file that contains data extracted from the US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) for the years 2004 to 2018.

Complexity

US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) is a post-market surveillance system that collects reports about adverse events involving CFSAN-regulated products.The CAERS database receives both mandatory reports for dietary supplements as well as voluntary reports from both consumers and health care practitioners for dietary supplements, cosmetics, foods, and other products regulated by CFSAN. CAERS receives reports through MedWatch, emails, telephone calls, faxes, letters, and electronic transfers from the Office of Regulatory Affairs (ORA) District Offices’ Field Accomplishments and Compliance Tracking System (FACTS).

Each data extract covers reports received by CAERS through the previous quarter of the year. The posted data extracts contain information from adverse event reports associated with CFSAN-regulated products (foods, dietary supplements, and cosmetics). The CAERS extract provides a file of data in CSV format (delimiter separated text).

Date Created

2004-01-01

Last Modified

2018-08-20

Version

1

Update Frequency

Quarterly

Temporal Coverage

2004-01-01 to 2018-03-31

Spatial Coverage

World

Source

John Snow Labs; US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Adverse Event Reporting System (CAERS), Center for Food Safety and Applied Nutrition (CFSAN), FDA Adverse Events, FDA Adverse Reports, Adverse Event Reporting FDA, Adverse Reactions to Food, Food Adverse Events, Food Adverse Reports, Food Adverse Reactions, Adverse Event Reporting System

Other Titles

US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS), US FDA Adverse Event Reporting System, Food Adverse Event Reporting, Food Adverse Event Surveillance, Food Adverse Event Monitoring, Adverse Events Caused by Food

NameDescriptionTypeConstraints
Report_NumberThe unique number that identifies each case.string-
Created_DateThe date on which the data were first entered into Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) from an adverse event report.string-
Event_Start_DateThe reported date on which the consumer first experience the adverse event.string-
Product_RoleSuspect or concomitant (as reported)string-
Reported_Brand_Product_NameThe verbatim brands and/or product names indicated to have been used by the consumer reported having experienced the adverse event. An adverse event report may specify the consumption of a single product or multiple products.string-
Industry_CodeThe US Food and Drug Administration (FDA) industry code associated with the type of product reported.string-
Industry_NameThe FDA industry description associated with the type of product reported (ice cream products, cosmetics, coffee/tea).string-
Age_At_Adverse_EventThe age of the consumer reported having experienced the adverse event.numberlevel : Nominal
Age_UnitThe time unit (day, week, month, year) of the age provided in the Age of Adverse Event data field for the consumer reported having experienced the adverse event.string-
GenderThe sex of the individual reported having experienced the adverse event.string-
One_Row_OutcomesOutcomes of the adverse event experienced by the injured consumer as specified by the reported; each report may indicate one or more outcomes.string-
One_Row_SymptomsThe symptoms experienced by the injured consumer as specified by the reporter and coded by FDA according to the Medical Data Dictionary for Regulatory Activities (MedDRA). Each adverse event report may indicate one or more symptoms.string-
Report_NumberCreated_DateEvent_Start_DateProduct_RoleReported_Brand_Product_NameIndustry_CodeIndustry_NameAge_At_Adverse_EventAge_UnitGenderOne_Row_OutcomesOne_Row_Symptoms
2018-CFS-0058254/13/2018CONCOMITANTTurmeric
2018-CFS-0058254/13/2018CONCOMITANTProbiotic
2018-CFS-0058254/13/2018CONCOMITANTAmino Acids
2018-CFS-0063694/26/2018CONCOMITANTDIMAlopecia
2018-CFS-0063694/26/2018CONCOMITANTDHEAAlopecia
2018-CFS-0075405/29/2018CONCOMITANTVITAMINSRash
2018-CFS-0072825/22/2018SUSPECTMONAT53 Cosmetics
2018-CFS-0080666/13/2018SUSPECTMonat53 Cosmetics
9071401/19/2007ConcomitantSOUP38 SoupMaleHEADACHE
2018-CFS-00666105/03/2018CONCOMITANTIRONEpistaxis