Details about each adverse reaction event linked to exposure to the identified substance.
= Must Support, = Is Modifier, = QiCore defined extension
Field | Card. | Type | Description |
---|---|---|---|
substance | 0..1 | Concept | Identification of the specific substance (or pharmaceutical product) considered to be responsible for the Adverse Reaction event. Note: the substance for a specific reaction may be different from the substance identified as the cause of the risk, but it must be consistent with it. For instance, it may be a more specific substance (e.g. a brand medication) or a composite product that includes the identified substance. It must be clinically safe to only process the 'code' and ignore the 'reaction.substance'. If a receiving system is unable to confirm that AllergyIntolerance.reaction.substance falls within the semantic scope of AllergyIntolerance.code, then the receiving system should ignore AllergyIntolerance.reaction.substance. Binding: Codes defining the type of the substance (including pharmaceutical products). (example) |
manifestation | 1..* | List<Concept> | Clinical symptoms and/or signs that are observed or associated with the adverse reaction event. Binding: Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event. (example) |
description | 0..1 | String | Text description about the reaction as a whole, including details of the manifestation if required. |
onset | 0..1 | DateTime | Record of the date and/or time of the onset of the Reaction. |
severity | 0..1 | String | Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations. Binding: Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations. (required) |
exposureRoute | 0..1 | Concept | Identification of the route by which the subject was exposed to the substance. Binding: A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject. (example) |
note | 0..* | List<Annotation> | Additional text about the adverse reaction event not captured in other fields. |