Adverse Food Events 2004 to 2019

$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 2019.

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

2019-03-01

Version

2019-03-01

Update Frequency

Quarterly

Temporal Coverage

2004-01-01 to 2019-03-31

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
1729402014-01-01SUSPECTDANNON DANNON LITE & FIT GREEK YOGURT CHERRY9 Milk/Butter/Dried Milk ProdNAUSEAOther Outcome
1729452014-01-01SUSPECTSAVORITZ ORIGINAL BUTTERY ROUND CRACKERS3 Bakery Prod/Dough/Mix/IcingVOMITINGOther Outcome
1729442014-01-01SUSPECTWELCH'S 100% GRAPE JUICE, FROM CONCENTRATE WITH ADDED VITAMIN C20 Fruit/Fruit ProdSLEEP DISORDER, SALIVARY GLAND DISORDER, ANXIETYOther Outcome
1729372014-01-01SUSPECTDAVID'S SUNFLOWER SEEDS, RANCH FLAVORED23 Nuts/Edible SeedTENDERNESS, PAIN, MUCOSAL ULCERATION, CAUSTIC INJURY, BURNING SENSATIONHospitalization, Patient Visited Healthcare Provider
1729342014-01-012013-12-05SUSPECTVALUED NATIONAL PINE NUTS23 Nuts/Edible SeedHYPERSENSITIVITY, DYSGEUSIAOther Outcome
1729392014-01-01SUSPECTKASHI WHOLE WHEAT BISCUITS, ISLAND VANILLA5 Cereal Prep/Breakfast FoodVOMITING, MALAISE, GASTROINTESTINAL DISORDER, FLUSHING, FEELING OF BODY TEMPERATURE CHANGE, FEELING HOT, DYSPEPSIA, BODY TEMPERATURE INCREASED, ABDOMINAL PAINOther Outcome
1729412014-01-012013-12-16SUSPECTCOPPER RIVER KIPPERED ALASKA SILVER SALMON16 Fishery/Seafood ProdLACERATIONOther Outcome
1729472014-01-02CONCOMITANTVITAMIN C (ASCORBIC ACID)54 Vit/Min/Prot/Unconv Diet(Human/Animal)64.0year(s)FFOREIGN BODY TRAUMA, CHOKINGMedically Important
1729602014-01-02SUSPECTNUTRILITE GLUCOSAMINE-754 Vit/Min/Prot/Unconv Diet(Human/Animal)INFECTION, DISCOMFORT, ABDOMINAL PAIN UPPERHospitalization
1729472014-01-02SUSPECTCITRACAL MAXIMUM (CHOLECALCIFEROL + CALCLIUM CITRATE) FILM-COATED TABLET54 Vit/Min/Prot/Unconv Diet(Human/Animal)64.0year(s)FFOREIGN BODY TRAUMA, CHOKINGMedically Important