Canada Vigilance adverse reaction online database: Overview
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On this page
- What is the database
- What is the dashboard
- Alternative access to data (data extract)
- How information in the database is used
- About the data and its limitations
What is the database
Suspected adverse reactions (also known as side effects) to health products are collected through the Canada Vigilance Program (CVP). The CVP has a database called the Canada Vigilance Adverse Reaction Online Database. It contains reports of suspected adverse reactions to Canadian marketed health products that occur in Canada and are reported to Health Canada.
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
- hospitals, which are required to submit reports according to the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)
The Canada Vigilance Adverse Reaction Online Database includes data from January 1, 1965, to December 31, 2021 (2021-12-31). Information about cells, tissues and organs, and human blood and blood components has been included in the database since December 7, 2007, and September 1, 2015, respectively. Information about vaccines used for immunization has been included in the database since January 1, 2011.
The database is updated monthly to include reports received up to 90 days before the posting date. Reports involving treatments and vaccinations for COVID-19 are posted weekly due to the importance of this data for the pandemic. Health Canada uses this 90-day period to review the new reports submitted, code the information and perform quality assurance activities. Regular data updates will generate different results on different days.
The database should not be used on its own to evaluate a health product's safety profile as it does not provide conclusive information on the safety of health products. It should not be used as a substitute for medical advice. If you have a medical concern, consult a qualified health professional.
For more information, consult our Interpretation of suspected adverse reaction data page.
For general questions about the content of the Adverse Reaction Online Database or for technical support, please contact the Canada Vigilance Program.
Although medical devices fall under the scope of the Canada Vigilance Program, medical device incidents are not included in the database.
What is the dashboard
Health Canada has developed a new interface ("visualization") for the Canada Vigilance Adverse Reaction Online Database. This is an interactive, web-based tool (termed a "dashboard"). It makes it easier to search the data and it displays results in a user-friendly fashion.
Detailed documentation about the database and the dashboard, including search instructions, is available.
We welcome your feedback on this new tool. Please send any comments to: CVInterfaceFeedback.CommentairesInterfaceCV@hc-sc.gc.ca.
Alternative access to data (data extract)
The data set is updated on a monthly basis and currently covers the following time period: 1965 to 2021-10-31.
The data extract provides the full data set from the Canada Vigilance Adverse Reaction Online Database as a series of compressed ASCII text files. It's intended for users who are familiar with database structures and capable of setting up their own queries.
Get details about the data structure required to download the data. To use the data, the file must be loaded into an existing database or information system provided by the user.
Users who are less familiar with data extract requirements should search the Canada Vigilance Adverse Reaction Online Database.
How information in the database is used
Health Canada uses the information in the Canada Vigilance database to monitor the safety of health products after they have received market authorization. We update and maintain the database regularly.
The information in the database may change for a number of reasons. For example, we may:
- receive a follow-up report for an existing adverse reaction report
- identify a duplicate report or
- receive updates as a result of quality assurance activities
When we receive a follow-up report, we include only the latest version of the report in the output.
A reporter may request that a report be removed from the database if, for example, a reporter determines:
- the report was previously reported to Health Canada (that is, it is a duplicate report) or
- the adverse reaction was not due to the suspect product
Information about the identity of the patient and/or reporter of an adverse reaction is not included in the database. Details can be found in the section on "Privacy".
About the data and its limitations
To be entered into the database, information from the adverse reaction report is coded using key words. MedDRA reaction terms are used to represent the reaction(s) described in the case report and the indication for use of the suspect product. The Drug Product Database and Licensed Natural Health Products Database are used for the brand names and active ingredients of all products described in the case report.
Data for the following product lines are maintained in the database:
- biologics (including vaccines)
- natural health products
- cells, tissues and organs
- blood and blood components
- sperm and ova
Certain product lines have been added based upon when their regulations came into force or changes in responsibility for product lines occurred.
Adverse reactions following vaccination make up only a small portion of the reactions reported. This is because most vaccine reports are submitted to the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS).
Limitations of the data
Many factors influence the number of adverse reports in the Canada Vigilance Adverse Reaction Online Database. These factors include:
- the market share of the product
- the length of time the product is marketed
- publicity about a possible link between an adverse reaction and a product
- regulatory actions
In addition, Health Canada is aware that adverse reactions are often under-reported to both voluntary and mandatory spontaneous surveillance systems, such as the Canada Vigilance Program. Therefore, the data should not be used to determine the safety profile of 1 product compared to another.
As well, the total number of reactions occurring and the number of patients exposed to the health product are unknown. Therefore, the number of adverse reports in the database should also not be used to:
- determine the incidence of a reaction (how often the reaction has occurred in patients taking a given health product) or
- estimate the risk of a particular product
The database also contains duplicate reports, which refer to the same patient and adverse reaction received from more than 1 source (for example, pharmacist and consumer). Although the database is checked regularly for duplicate reports, it's not always possible to detect them, as the information in the reports may not exactly match or some information may be missing.
Each report represents the observations and opinions of the person reporting the adverse reaction (called a 'reporter'). It's not certain that a suspected product caused the reaction. The symptom or reaction may be related to the underlying illness being treated, to another product being taken at the same time or to other factors. A report involving death does not mean the health product caused the patient to die. A fatal outcome may occur due to the natural progression of the disease being treated.
This is raw data. No Health Canada assessment of association (causality) between the health product and the reaction(s) has been completed on this dataset. As well, the information contained in the report has not always been medically confirmed.
Because the database doesn't provide conclusive information on the safety of health products, it shouldn't be used on its own to evaluate a health product's safety profile. Further, the database doesn't contain any information on the benefits of a health product, so benefit-risk assessments are not possible.
The database should not be used as a substitute for medical advice. Patients should talk to a qualified health provider before stopping or changing how they take their medications.
The information is provided with the understanding that the data will be appropriately referenced and used understanding the limitations of the data.
Information on the identity of the patient and/or the person who reported an adverse reaction is protected under the Privacy Act and the Access to Information Act. Suspected health product-related adverse reaction information is submitted on a voluntary basis and is maintained in a computerized database.
The Canada Vigilance Program endeavours to use and disclose only de-identified information. However, it may use and disclose personal information that is not de-identified as permitted under the Privacy Act. An example is in response to an Access to Information and Privacy (ATIP) online request.
For more details on the personal information collected under the Canada Vigilance program, visit the Health Canada's Info Source page.
Every person has the right to access their own personal information and is entitled to request correction to ensure accuracy of their information. If you wish to exercise this right, contact the Treasury Board of Canada Secretariat.
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