Canada Vigilance adverse reaction online database: Glossary

Active ingredient: Any component that has medicinal properties and supplies pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of a human or other animals. The name and strength of each active ingredient contained in a health product is indicated on its packaging or label. Health products can contain multiple active ingredients. The same active ingredient(s) may be marketed under different brand names.

Adverse event report (AER) number: Identification number of the report assigned by Health Canada.

Adverse event report (AER) version number: 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.

Adverse reaction term (MedDRA-preferred term): A distinct descriptor (single medical concept) for a symptom, sign, disease, diagnosis, therapeutic indication, investigation, surgical or medical procedure and medical, social or family history characteristic.

The list of adverse reaction terms in MedDRA is extensive. For example, in version 15 of MedDRA, there are over 18,000 unique preferred terms. Therefore, when searching adverse reaction data, it may be difficult to retrieve all the cases associated with a single broad medical concept without using a system organ class (SOC) or by performing multiple searches using a variety of similar adverse reaction terms.

Age: Age of the patient when the adverse effect occurred.

Age group: Age group of the patient when the adverse effect occurred. The age group values are as follows:

• adolescent: greater or equal to 13 and less than 18 years
• adult: greater or equal to 18 and up to 65 years, inclusively
• child: greater or equal to 1 and less than 13 years
• elderly: greater than 65
• infant: greater than 25 days and less than 1 year
• neonate: greater than zero and up to 25 days, inclusively

Brand name: The name assigned by the manufacturer under which the product is sold or advertised. A health product's brand name is indicated on its packaging or label. Multiple brand names may exist for products containing the same active ingredient. This ingredient may be marketed under a different brand name.

Concomitant health product: The health product is not suspected, but the patient was taking it at the time of the adverse reaction. This represents the suspicion, opinion or observation of the individual reporter. Cause-and-effect relationships have not been established.

COVID product: Defined as true or false. A COVID product is any health product used to treat COVID-19 or is a COVID-19 vaccine.

Date received (initial): Date that the first version (version 0) of the adverse event report was received by the Canada Vigilance Program.

Date received (latest): Date that the last follow-up report was received by the Canada Vigilance Program. Latest received date is the same date as initial received date if no follow-up reports have been received.

Duplicate report: Related to the same patient and event received from more than one source (for example, pharmacist and consumer).

Sex: Biological sex of the patient as it was provided by the reporter.

Health product: This category includes the following products:

• prescription and non-prescription medications
• natural health products
• biologics, such as:
  • biotechnology products
  • vaccines
  • fractionated blood products
  • human blood and blood components
  • human cells, tissues and organs
• radiopharmaceuticals
• disinfectants and sanitizers with disinfectant claims

Height: Height of the patient when the adverse effect occurred, in centimetres or inches.

Indication: Refers to the particular condition for which a health product was taken.

Market authorization holder (MAH) adverse event report (AER) number: The version identification number assigned by the MAH for reports originating from an MAH.

Medical Dictionary for Regulatory Activities (MedDRA) terminology and updates: The adverse reaction data contained in this online database is coded using MedDRA terminology. MedDRA is composed of standardized terms for symptoms, signs, diseases, syndromes and diagnoses. The terminology is organized into 5 distinct levels of hierarchy ranging from system organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), to low-level term (LLT). These groupings help when retrieving, evaluating and presenting adverse reaction data coded with MedDRA.

This terminology is updated at the same times twice a year (May and November). Following each new version release of MedDRA, the adverse reaction data are reviewed and updated to reflect any changes made to the terminology. Therefore, some adverse reaction reports previously contained in this online database may reflect some of these changes.

MedDRA system organ class (SOC): The highest level of the hierarchy that provides the broadest concept for data retrieval. An SOC contains several similar adverse reaction terms that relate to 1 specific organ system of the body (for example, cardiac disorders). SOCs are useful when searching for a set of similar adverse reaction terms (such as cardiac arrest and heart attack).

There are 27 SOCs in MedDRA, including:

• blood and lymphatic system disorders
• cardiac disorders
• congenital, familial and genetic disorders
• ear and labyrinth disorders
• endocrine disorders
• eye disorders
• gastrointestinal disorders
• general disorders and administration site conditions
• hepatobiliary disorders
• immune system disorders
• infections and infestations
• injury, poisoning and procedural complications
• investigations
• metabolism and nutrition disorders
• musculoskeletal and connective tissue disorders
• neoplasms benign, malignant and unspecified (including cysts and polyps)
• nervous system disorders
• pregnancy, puerperium and perinatal conditions
• psychiatric disorders
• renal and urinary disorders
• reproductive system and breast disorders
• respiratory, thoracic and mediastinal disorders
• skin and subcutaneous tissue disorders
• social circumstances
• surgical and medical procedures
• vascular disorders
• product issues

Reason for seriousness: Represented by one of the following:

• congenital anomaly
• death
• disability
• hospitalization
• life-threatening
• other medically important condition

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. The report outcome is not based on a scientific evaluation by Health Canada. It represent one of the following:

• death: the patient died
• not recovered/not resolved: the patient has not yet recovered
• recovered/resolved with sequelae: the patient recovered, but with an after effect possibly due to disease, injury, treatment or procedure
• recovering/resolving: the patient is continuing to recover
• unknown: the reporter did not know the outcome at the time the report was submitted

Reporter type: Indicates who reported the adverse reaction and their relationship to the patient.

Serious report (defined as true or false): Contains a serious adverse reaction, determined by the reporter of the report at the time of reporting. Health Canada defines a serious adverse reaction as:

A noxious and unintended response to a drug, which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above, may also be considered serious.

Source of report: Indicates the location through which the reporter sent the report:

• community: report received from the community (for example, pharmacy)
• hospital: report received directly from a hospital
• market authorization holder (MAH): report received from an MAH
• other: reports received from other source

Suspected health product: The reporter suspects that the health product caused the adverse reaction. This represents the suspicion, opinion or observation of the individual reporter. Cause-and-effect relationships have not been established.

Type of report: Represented by 1 of the following:

• other: the report originates from another program or source
• published: the report originates from an article published in health professional literature
• safety update report: the report originates from a safety update report
• Special Access Program (SAP): the report concerns a product that is not marketed in Canada, but is available through SAP
• spontaneous: an unsolicited communication by a health care professional or consumer to Health Canada that describes 1 or more adverse drug reactions in a patient who was given 1 or more medicinal products and that does not derive from a study or any organized data collection scheme
• study: the report was received as part of a post-marketing study
• unknown: the report originates from an unknown program or source

Weight: Weight of the patient when the adverse effect occurred, in kilograms or pounds.