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
Report Drugs
This dataset provides the information about Canada Vigilance Adverse Reaction drugs associated with specific reports. This dataset includes data from 1965 to 2022-11-31.
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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 | 2023-03-03 |
Version | 2023-03-03 |
Update Frequency |
Annual |
Temporal Coverage |
1965 to 2022-11-31 |
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_Drug_ID | The adverse reaction identification number of the report assigned by Health Canada. | integer | level : Nominal |
Adverse_Reaction_Report_Number | The adverse reaction report number is the identification number of the report assigned by Health Canada. | integer | level : Nominal |
Drug_Product_ID | Drug Product Identifier | integer | level : Nominal |
Drug_Name | Name of the drug | string | - |
Health_Product_Role | The characterization of the role of the product as provided by the original reporter. The health product role represents the suspicion, opinion or observation of the individual reporter. | string | - |
Route_of_Administration | Indicates the part of the body on which, through which or into which the product is to be introduced | string | - |
Dose_Quantity | Dosage quantity taken by the patient | number | level : Nominal |
Dose_Unit | string | - | |
Frequency | Frequencey of the dose | string | - |
Therapy_Duration | The amount of time the health product has been taken by the patient. | string | - |
Therapy_Day | Day of therapy | string | - |
Dosage_Form | Form of the dosage used by the patient | string | - |
Data Preview
Report Drug ID | Adverse Reaction Report Number | Drug Product ID | Drug Name | Health Product Role | Route of Administration | Dose Quantity | Dose Unit | Frequency | Therapy Duration | Therapy Day | Dosage Form |
92 | 19112 | 21462 | MINIPRESS | Suspect | Oral | Tablets | |||||
93 | 19112 | 36143 | HYDROCHLOROTHIAZIDE | Concomitant | Oral | 50.0 | Milligram | 1.0 | 1.0 | Days | Tablets |
95 | 8371 | 21959 | HALDOL | Suspect | Oral | 5.0 | Milligram | 4.0 | 1.0 | Days | NOT SPECIFIED |
96 | 61206 | 3920 | MICRO-K EXTENCAPS | Concomitant | 2.0 | Dosage forms | 3.0 | 1.0 | Days | CAPSULE, SUSTAINED-RELEASE | |
100 | 61206 | 22598 | VANCOCIN | Suspect | Oral | 500.0 | Milligram | 4.0 | 1.0 | Days | NOT SPECIFIED |
101 | 205019 | 39852 | CHLOR-TRIPOLON | Drug used to treat AE | Tablets | ||||||
103 | 205019 | 21388 | TUBERCULIN PPD (MANTOUX) | Suspect | Unknown | LIQUID INTRADERMAL | |||||
104 | 205019 | 22822 | BENADRYL | Drug used to treat AE | NOT SPECIFIED | ||||||
105 | 82430 | 20979 | TAMOXIFEN | Concomitant | 20.0 | Milligram | Tablets | ||||
106 | 82430 | 38310 | ISOSORBIDE DINITRATE | Concomitant | Oral | 40.0 | Milligram | Tablets |