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- 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
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
Adverse Food Events 2004 to 2020
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 2020.
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Description
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).
About this Dataset
Data Info
| Date Created | 2004-01-01 |
|---|---|
| Last Modified | 2022-02-06 |
| Version | 2022-02-06 |
| Update Frequency |
Quarterly |
| Temporal Coverage |
2004-01-01 to 2020-02-03 |
| 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 |
Data Fields
| Name | Description | Type | Constraints |
|---|---|---|---|
| Report_Number | The unique number that identifies each case. | string | - |
| Created_Date | The 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_Date | The reported date on which the consumer first experience the adverse event. | string | - |
| Product_Role | Suspect or concomitant (as reported) | string | - |
| Reported_Brand_Product_Name | The 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_Code | The US Food and Drug Administration (FDA) industry code associated with the type of product reported. | string | - |
| Industry_Name | The FDA industry description associated with the type of product reported (ice cream products, cosmetics, coffee/tea). | string | - |
| Age_At_Adverse_Event | The age of the consumer reported having experienced the adverse event. | number | level : Nominal |
| Age_Unit | The 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 | - |
| Gender | The sex of the individual reported having experienced the adverse event. | string | - |
| One_Row_Symptoms | The 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 | - |
| One_Row_Outcomes | Outcomes of the adverse event experienced by the injured consumer as specified by the reported; each report may indicate one or more outcomes. | string | - |
