Instructions for the Canada Vigilance Adverse Reaction Online Database
The Canada Vigilance Adverse Reaction Online Database contains information on suspected adverse reaction reports related to marketed health products that were 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.
- Health Canada receives adverse reaction reports daily, including new reports and additional information for reports previously submitted. This database is updated monthly to reflect this new information.
- Only suspected adverse reactions to Canadian marketed health products that occur in Canada and are reported to Health Canada are found in the database.
- All search criteria entry errors (e.g. missing date) will result in an error message being displayed at the top of the page, explaining the problem and the affected field will be highlighted.
- For assistance while using the database, select the "Help with this Section" links throughout the database to return to specific sections of this page. You may also select the purple buttons with question marks to learn more about particular terms.
- Please note, the database times out if there is no activity for 30 minutes. Any criteria entered or results retrieved will be lost.
Report Search Criteria
This section allows you to narrow down your search based on certain report elements, including dates received, whether or not the reports are considered serious and source of reports.
An Initial Received Date range OR Latest Received Date range must be entered for the search to be executed. The date range is defaulted to include all the reports in the database. You may adjust the dates in these fields to obtain fewer reports. Be sure to use the format YYYY-MM-DD.
Patient Search Criteria
This section allows you to specify criteria related to the patient(s) who experienced the adverse reaction(s) described in each report, including gender, age and outcome.
If originally provided by the reporter, age is displayed by number of years, which has been rounded up to the closest year. For example, when searching for patients less than 1 year of age, select the age range 0-1 year.
Suspected Health Product Search Criteria
In order to specify health product search criteria, you may either select all health products or perform a keyword search by brand name or active ingredient. The keyword search by brand name is most common among users.
For brand name or active ingredient keyword searches, simply enter a minimum three letters of the brand name or active ingredient you would like to retrieve. Upon selecting the "Find Health Products" button, a list of brand names or active ingredients will appear. You may either "Select All Below" or select specific items from the list, holding down the Ctrl key for multiple selections. The selected brand names or active ingredients, highlighted in blue, will be included in your search criteria. Once you have made your selection, proceed to the Adverse Reaction Term Search Criteria.
When conducting a keyword search by brand name or by active ingredient in this database, the English version of a brand name or active ingredient should be used. International characters, such as accents and symbols, are not recognized in the database and should be avoided as part of keywords. The sources for brand name and active ingredient are the Drug Product Database (DPD) and Licensed Natural Health Products Database (LNHPD). Product information found within the DPD and LNHPD databases originates from organizations that are not subject to the Official Languages Act.
In addition, a keyword search by brand name retrieves adverse reactions specific to the product's brand name selected. However, there may be multiple brand names for the same active ingredient. To expand the scope of a search, consider a keyword search by active ingredient.
For additional information concerning the brand names and active ingredients of health products marketed in Canada, please visit Health Canada's Drug Product Database and Licensed Natural Health Products Database.
Adverse Reaction Term Search Criteria
Adverse reaction information is coded in the database using terminology from the Medical Dictionary of Regulatory Activities (MedDRA), which includes standardized terms for symptoms, signs, diseases, syndromes and diagnoses.
In order to specify adverse reaction term criteria when searching the database, you may either select all adverse reaction terms or perform a keyword search by adverse reaction term or System Organ Class (SOC).
It is most common for users to select all adverse reaction terms for their search. To select all adverse reaction terms for a search, simply choose "Select All Adverse Reaction Terms" and proceed to select the "Search" button at the bottom of the page to retrieve the results of your search.
To search for a single adverse reaction term or System Organ Class, simply choose the appropriate selection "By Adverse Reaction Term" or "By System Organ Class" and then enter a minimum three letters of the adverse reaction term or System Organ Class you would like to retrieve. Upon selecting the "Find Terms" button, a list of adverse reaction terms or System Organ Classes will appear. You may either "Select All Below" or select specific items from the list, holding down the control (Ctrl) key for multiple selections. The selected adverse reaction terms or System Organ Classes, highlighted in blue, will be included in your search criteria. Once you have made your selection, you may proceed to select the "Search" button at the bottom of the page to retrieve the results of your search. To start over, simply select the "Reset" button.
Searching by system organ class can be useful when searching for reports associated with a set of similar adverse reaction terms (i.e. Cardiac arrest and Heart attack). Alternatively, a single adverse reaction term can be selected when searching for one specific adverse reaction. However, it should be noted that, since MedDRA contains over 18,000 unique adverse reaction terms, it may be difficult to retrieve all the cases associated with one broad medical concept without using an SOC or by performing multiple searches using a variety of similar adverse reaction terms. Depending on the number of cases included in the search results, it may be advantageous to search "All Adverse Reaction Terms" and then review the resulting cases individually.
Note: Searching of all health products AND all adverse reactions terms is not possible. If "Select All Health Products" was chosen in section 3, a keyword search must be done in Section 4 and if "Select All Adverse Reaction Terms" is chosen in Section 4, a keyword search would have to be done in Section 3.
Once your search has been executed, you will be prompted to select the type of view to display the search results. The "Standard View" results table, which is adequate for most users, includes the following columns: Adverse Reaction Report (AER) Number, Market Authorization Holder (MAH) AER Number, Initial Received Date, Age, Gender, Suspected Brand Name and Adverse Reaction Terms.
The "Custom View" allows you to choose which fields you would like to see when the results of your search are displayed. In addition to AER Number, a maximum of 6 elements can be selected for the initial results display. Standard View report elements have been preselected below. To replace a standard report element with one of your choice, simply select a new element and deselect the one you do not wish to include.
Complete information on specific reports is available by selecting corresponding AER Numbers in the results table on the next page.
This section displays a table of adverse reaction reports submitted to Health Canada that correspond to the search criteria specified and the view selected. A summary of the search criteria specified is displayed at the top of the page. Search criteria can be modified by selecting the "Modify Search Criteria" button located above and below the results table.
The total number of reports retrieved is also displayed in the "Search Result" table. A maximum of 20 matching records will be displayed per page; select "next result" for the next 20 results.
Table results are sorted by Adverse Reaction Report (AER) Number. The following underlined titles allow you to sort the results according to a specific column, in ascending order: Market Authorization Holder (MAH) AER Number, Initial Received Date, Age and Gender.
Blank fields mean that no information was provided by the reporter for a particular field.
To access complete information for a specific report, select the corresponding AER Number in the first column of the results table.
Export/Save Search Results
This section allows you to export and save the search results to your computer. Results can be saved in Portable Document Format (PDF) or Microsoft Excel (XLS) format. Help on using these formats can be obtained by visiting the Alternate Format Help Section of the Health Canada Web site.
Exported files are limited to 1,000 adverse reaction reports. For search results that exceed this limit, it is recommended to return to the Search Criteria, to specify additional criteria or reduce the time period of the reports requested, in order to obtain fewer results. Alternatively, a request for a summary of adverse reaction information can be made by contacting the Canada Vigilance Program or users who are familiar with database structures can download data extract files.
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