Adverse

The SHR Adverse domain contains definitions for describing adverse events and adverse reactions.

AdverseReaction [Entry]

Any noxious and unintended response to a medical product, procedure, or other intervention, for which a causal relationship to an intervention is at least a reasonable possibility i.e., the relationship cannot be ruled out. It is not necessarily associated with a previously-recorded SubstanceRisk. This entry could be used to record the occurrence or non-occurrence of an adverse reaction. C0559966

Based On Problem

Value:  CodeableConcept from MedDRAVS A set of codes drawn from different coding systems, representing the same concept.
ProblemCategory includes adverse_reaction 1 or more A categorization of the problem using common clinical categories.
NonOccurrenceModifier optional When true, indicates either that the event or action documented in the entry did not occur, or the the thing documented is absent or does not exist.
Manifestation 1 or more A complaint or observed (subjective) indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.
AdverseReactionAttribution 0 or more The cause of the adverse reaction (either known or theorized).
PatternOfEvent (TBD) optional Description TBD
AssociatedStudy (TBD) optional Description TBD
ActionTakenWithMedication (TBD) optional Description TBD
OtherActionTaken (TBD) optional Description TBD
Outcome (TBD) optional Description TBD
GeneralizedLikelihood optional Quantitative or qualitative measure of likelihood.
SupportingEvidenceQuality optional An assessment of the quality and/or quantity of the source information that supports judgment.
ClinicalStatus required A flag indicating whether the problem is active or inactive, recurring, in remission, or resolved.
IncludeOnProblemList optional Whether or not to include this problem on the subject's current problem list.
Onset optional The beginning or first appearance of a mental or physical disorder.
WhenClinicallyRecognized optional The time at which a condition or problem was first identified in a healthcare context.
Preexisting optional If the problem or condition existed before the current episode of care.
Abatement optional The end, remission or resolution.
BodySite 0 or more Location on or in the body.
Severity optional Degree of severity of a symptom, disorder, or problem.
Criticality optional A clinical judgment of potential clinical harm, or seriousness, of a condition. When the worst case result is assessed to have a life-threatening or organ system threatening potential, it is considered to be of high criticality.
GradeOrStage optional The stage or grade of a disease.

AdverseReactionAttribution

The cause of the adverse reaction (either known or theorized). Adverse Event Attribution to Product or Procedure (C1510821)

Choice required
         |  Substance required Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.
         |  Procedure (TBD) Description TBD
AttributionCertainty optional A specific identifiable level (defined qualitatively or quantitatively) of probability of adverse event being caused or associated with the product or procedure administration to a patient.

AttributionCertainty

A specific identifiable level (defined qualitatively or quantitatively) of probability of adverse event being caused or associated with the product or procedure administration to a patient.

Value:  CodeableConcept from http://hl7.org/fhir/reaction-event-certainty A set of codes drawn from different coding systems, representing the same concept.