Others titles
- Indications Associated with Adverse Reports
- Canada Adverse Reaction Database
- Canada Vigilance Adverse Reaction Online Database
Keywords
- Adverse Event Reporting System Vaccine Information
- Adverse Reactions
- Adverse Reactions Database
- Canada Vigilance Adverse Reaction Database
- Vaccination Reporting System
- Suspected Adverse Reactions
- Drug Products
- Drug Report Indications
- Drug Product Ingredients
- Vaccine Side Effects
- Adverse Reaction Online Database
VAR Reports
This dataset provides the information about Canada Vigilance Adverse Reaction reports and patients. This dataset includes data from 1965 to 2022-10-31.
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Description
The Canada Vigilance Adverse Reaction dataset contains information about suspected adverse reactions (also known as side effects) to health products, captured from adverse reaction reports submitted to Health Canada by consumers and health professionals, who submit reports voluntarily, as well as by market authorization holders (manufacturers and distributors), who are required to submit reports according to the Food and Drugs Regulations. Information concerning vaccines used for immunization have only been included in the database since January 1, 2011.
Adverse reaction reports are submitted by:
– Consumers and health professionals, who submit reports voluntarily
– Manufacturers and distributors (also known as market authorization holders), who are required to submit reports according to the Food and Drugs Act.
This dataset has been collected primarily by a spontaneous surveillance system in which suspected adverse reactions to health products are reported to market authorization holders (manufacturers) and Health Canada on a voluntary basis.
Note: Inclusion of a particular reaction does not necessarily mean that it was caused by the suspected health product(s). Certain reported reactions may occur spontaneously. They provide a background rate in the general population and may have a temporal, but not necessarily a causal, relationship with the health product. The purpose of the Canada Vigilance Program is to detect possible signals of adverse reactions associated with health products. Additional scientific investigations are required to validate signals from the Canada Vigilance Program and to establish a cause and effect relationship between a health product and adverse reaction. The data provided do not represent all known safety information concerning the suspected health product(s) and should not be used in isolation to make decisions regarding an individual’s treatment regimen; other sources of information, including the prescribing information for the product, should be consulted.
About this Dataset
Data Info
Date Created | 2020-07-31 |
---|---|
Last Modified | 2023-10-02 |
Version | 2023-10-02 |
Update Frequency |
Annual |
Temporal Coverage |
1965 to 2022-10-31 |
Spatial Coverage |
Canada |
Source | John Snow Labs; Health Canada's Marketed Health Products Directorate; |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | Adverse Event Reporting System Vaccine Information, Adverse Reactions, Adverse Reactions Database, Canada Vigilance Adverse Reaction Database, Vaccination Reporting System, Suspected Adverse Reactions, Drug Products, Drug Report Indications, Drug Product Ingredients, Vaccine Side Effects, Adverse Reaction Online Database |
Other Titles | Indications Associated with Adverse Reports, Canada Adverse Reaction Database, Canada Vigilance Adverse Reaction Online Database |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Report_ID | The adverse reaction identification number of the report assigned by Health Canada. | integer | level : Ordinal |
Report_Number | The adverse reaction report number is the identification number of the report assigned by Health Canada. | string | - |
Version_No | The adverse reaction report version number of the report assigned by Health Canada. Version 0 is considered the initial version of the report. Subsequent version numbers refer to follow-up reports. | integer | level : Nominal |
Last_Received_Date | The date that the last follow-up report was received by Health Canada's Marketed Health Products Directorate. | date | - |
Initial_Received_Date | The date the first version (version 0) of the adverse reaction report was received by Health Canada's Marketed Health Products Directorate. | date | - |
MAH_No | Market Authorisation Holder (MAH) Adverse Reaction Report (AER) Number | string | - |
Report_Type_Code | The date the first version (version 0) of the adverse reaction report was received by Health Canada's Marketed Health Products Directorate. | integer | level : Nominal |
Report_Type_Description | Type of Report Description | string | - |
Gender | Gender of the patient as it was provided by the reporter. | string | - |
Age | Age of the patient as it was provided by the reporter. | number | level : Nominal |
Outcome_Code | The Report Outcome Code | integer | level : Nominal |
Outcome_Description | The report outcome represents the outcome of the reported case as described by the reporter at the time of reporting and does not infer a causal relationship. | string | - |
Weight | Weight of the patient when the adverse effect occurred in kilograms or pounds. | number | level : Ratio |
Weight_Unit | Weight measures in units | string | - |
Height | Height of the patient when the adverse effect occurred in centimetres or inches. | number | level : Ratio |
Height_Unit | Height measures in units | string | - |
Seriousness_Code | Serious Adverse Reaction Code | integer | level : Ratio |
Seriousness_Description | The reason for seriousness is represented by (Congenital Anomaly, Death, Disability, Hospitalization, Life Threatening, Other Medically Important Condition) | string | - |
Is_Death | The drug may have contributed to the death. (1=true and 2=false) | boolean | - |
Is_Disability | The drug may have contributed to the disability. (1=true and 2=false) | boolean | - |
Is_Congenital_Anomaly | The drug may have contributed to the Congenital Anomaly. (1=true and 2=false) | boolean | - |
Is_Life_Threatening | The drug may have contributed to the Life Threatening. (1=true and 2=false) | boolean | - |
Is_Hospitalization_Required | The drug may have contributed to the Hospitalization. (1=true and 2=false) | boolean | - |
Is_Other_Medically_Important_Condition | The drug may have contributed to the Other Medically Important Condition. (1=true and 2=false) | boolean | - |
Reporter_Type | Reporter type | string | - |
Report_Source_Description | The type of report is represented by (Other, Published, Safety Update Report, Special Access Program, Spontaneous, Study, Unknown) | string | - |
E2B_Safety_Report_ID | This unique identifier is the complete safety report identification number assigned to the case by the sender. | string | - |
Authority_Number | When a regulator is the initial sender this number should populated with their unique identifier. | string | - |
Company_Number | Name of the Vaccination | string | - |
Data Preview
Report ID | Report Number | Version No | Last Received Date | Initial Received Date | MAH No | Report Type Code | Report Type Description | Gender | Age | Outcome Code | Outcome Description | Weight | Weight Unit | Height | Height Unit | Seriousness Code | Seriousness Description | Is Death | Is Disability | Is Congenital Anomaly | Is Life Threatening | Is Hospitalization Required | Is Other Medically Important Condition | Reporter Type | Report Source Description | E2B Safety Report ID | Authority Number | Company Number |
1 | 1 | 0 | 1973-06-05 | 1973-06-05 | 7 | Spontaneous | Female | 62.0 | 6 | Unknown | 66.0 | Kilogram | 155.0 | Centimeter | 2 | Not Serious | ||||||||||||
2 | 2 | 0 | 1973-06-05 | 1973-06-05 | 7 | Spontaneous | Female | 70.0 | 6 | Unknown | 2 | Not Serious | 3.0 | Hospital | ||||||||||||||
3 | 3 | 0 | 1973-06-05 | 1973-06-05 | 7 | Spontaneous | Male | 83.0 | 6 | Unknown | 44.0 | Kilogram | 173.0 | Centimeter | 1 | Serious | 3.0 | Hospital | ||||||||||
4 | 4 | 0 | 1973-06-05 | 1973-06-05 | 7 | Spontaneous | Female | 78.0 | 6 | Unknown | 1 | Serious | 3.0 | Hospital | ||||||||||||||
5 | 5 | 0 | 1973-06-05 | 1973-06-05 | 7 | Spontaneous | Female | 55.0 | 6 | Unknown | 2 | Not Serious | 1.0 | Community | ||||||||||||||
6 | 6 | 0 | 1973-06-05 | 1973-06-05 | 7 | Spontaneous | Female | 69.0 | 6 | Unknown | 2 | Not Serious | 1.0 | Community | ||||||||||||||
7 | 7 | 0 | 1973-06-05 | 1973-06-05 | 7 | Spontaneous | Male | 43.0 | 6 | Unknown | 2 | Not Serious | ||||||||||||||||
8 | 8 | 0 | 1973-06-05 | 1973-06-05 | 7 | Spontaneous | Male | 6 | Unknown | 2 | Not Serious | 1.0 | Community | |||||||||||||||
9 | 9 | 0 | 1973-06-05 | 1973-06-05 | 7 | Spontaneous | Female | 22.0 | 6 | Unknown | 2 | Not Serious | 1.0 | Community | ||||||||||||||
10 | 10 | 0 | 1973-06-05 | 1973-06-05 | 7 | Spontaneous | Male | 6 | Unknown | 2 | Not Serious | 1.0 | Community |