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| Patient Care Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Group, Patient, Practitioner, RelatedPerson |
ShEx statement for adverseevent
PREFIX fhir: <http://hl7.org/fhir/>
PREFIX fhirvs: <http://hl7.org/fhir/ValueSet/>
PREFIX xsd: <http://www.w3.org/2001/XMLSchema#>
PREFIX rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#>
IMPORT <code.shex>
IMPORT <Group.shex>
IMPORT <Period.shex>
IMPORT <Device.shex>
IMPORT <Patient.shex>
IMPORT <boolean.shex>
IMPORT <dateTime.shex>
IMPORT <Location.shex>
IMPORT <CareTeam.shex>
IMPORT <Reference.shex>
IMPORT <Encounter.shex>
IMPORT <Identifier.shex>
IMPORT <Annotation.shex>
IMPORT <Practitioner.shex>
IMPORT <Organization.shex>
IMPORT <RelatedPerson.shex>
IMPORT <ResearchStudy.shex>
IMPORT <DomainResource.shex>
IMPORT <CodeableConcept.shex>
IMPORT <BackboneElement.shex>
IMPORT <PractitionerRole.shex>
IMPORT <CodeableReference.shex>
start=@<AdverseEvent> AND {fhir:nodeRole [fhir:treeRoot]}
# An event that may be related to unintended effects on a patient or research participant
<AdverseEvent> EXTENDS @<DomainResource> CLOSED {
a [fhir:AdverseEvent]?;fhir:nodeRole [fhir:treeRoot]?;
fhir:identifier @<OneOrMore_Identifier>?; # Business identifier for the event
fhir:status @<code> AND
{fhir:v @fhirvs:adverse-event-status}; # in-progress | completed |
# entered-in-error | unknown
fhir:actuality @<code> AND
{fhir:v @fhirvs:adverse-event-actuality}; # actual | potential
fhir:category @<OneOrMore_CodeableConcept>?; # wrong-patient | procedure-mishap |
# medication-mishap | device |
# unsafe-physical-environment |
# hospital-aquired-infection |
# wrong-body-site
fhir:code @<CodeableConcept>?; # Event or incident that occurred or
# was averted
fhir:subject @<Reference> AND {fhir:link
@<Group> OR
@<Patient> OR
@<Practitioner> OR
@<RelatedPerson> ? }; # Subject impacted by event
fhir:encounter @<Reference> AND {fhir:link
@<Encounter> ? }?; # The Encounter associated with the
# start of the AdverseEvent
fhir:effect @<dateTime> OR
@<Period> ?; # When the effect of the
# AdverseEvent occurred
fhir:detected @<dateTime>?; # When the event was detected
fhir:recordedDate @<dateTime>?; # When the event was recorded
fhir:resultingEffect @<OneOrMore_CodeableReference>?; # Effect on the subject due to this
# event
fhir:location @<Reference> AND {fhir:link
@<Location> ? }?; # Location where adverse event
# occurred
fhir:seriousness @<CodeableConcept>?; # Seriousness or gravity of the event
fhir:outcome @<OneOrMore_CodeableConcept>?; # Type of outcome from the adverse
# event
fhir:recorder @<Reference> AND {fhir:link
@<Patient> OR
@<Practitioner> OR
@<PractitionerRole> OR
@<RelatedPerson> ? }?; # Who recorded the adverse event
fhir:participant @<OneOrMore_AdverseEvent.participant>?; # Who was involved in the adverse
# event or the potential adverse
# event and what they did
fhir:study @<OneOrMore_Reference_ResearchStudy>?; # Research study that the subject is
# enrolled in
fhir:expectedInResearchStudy @<boolean>?; # Considered likely or probable or
# anticipated in the research study
fhir:suspectEntity @<OneOrMore_AdverseEvent.suspectEntity>?; # The suspected agent causing the
# adverse event
fhir:contributingFactor @<OneOrMore_CodeableReference>?; # Contributing factors suspected to
# have increased the probability or
# severity of the adverse event
fhir:preventiveAction @<OneOrMore_CodeableReference>?; # Preventive actions that
# contributed to avoiding the
# adverse event
fhir:mitigatingAction @<OneOrMore_CodeableReference>?; # Ameliorating actions taken after
# the adverse event occurred in
# order to reduce the extent of harm
fhir:supportingInfo @<OneOrMore_CodeableReference>?; # Subject medical history or
# document relevant to this adverse
# event
fhir:note @<OneOrMore_Annotation>?; # Comment on adverse event
}
# The suspected agent causing the adverse event
<AdverseEvent.suspectEntity> EXTENDS @<BackboneElement> CLOSED {
fhir:instance @<CodeableReference>; # Refers to the specific entity that
# caused the adverse event
fhir:causality @<AdverseEvent.suspectEntity.causality>?; # Information on the possible cause
# of the event
fhir:occurrence @<dateTime> OR
@<Period> ?; # When the suspect entity occurred
}
# Information on the possible cause of the event
<AdverseEvent.suspectEntity.causality> EXTENDS @<BackboneElement> CLOSED {
fhir:assessmentMethod @<CodeableConcept>?; # Method of evaluating the
# relatedness of the suspected
# entity to the event
fhir:entityRelatedness @<CodeableConcept>?; # Result of the assessment regarding
# the relatedness of the suspected
# entity to the event
fhir:author @<Reference> AND {fhir:link
@<Patient> OR
@<Practitioner> OR
@<PractitionerRole> OR
@<RelatedPerson> ? }?; # Author of the information on the
# possible cause of the event
}
# Who was involved in the adverse event or the potential adverse event and what they did
<AdverseEvent.participant> EXTENDS @<BackboneElement> CLOSED {
fhir:function @<CodeableConcept>?; # Type of involvement
fhir:actor @<Reference> AND {fhir:link
@<CareTeam> OR
@<Device> OR
@<Group> OR
@<Organization> OR
@<Patient> OR
@<Practitioner> OR
@<PractitionerRole> OR
@<RelatedPerson> ? }; # Who was involved in the adverse
# event or the potential adverse
# event
}
#---------------------- Cardinality Types (OneOrMore) -------------------
<OneOrMore_Identifier> CLOSED {
rdf:first @<Identifier> ;
rdf:rest [rdf:nil] OR @<OneOrMore_Identifier>
}
<OneOrMore_CodeableConcept> CLOSED {
rdf:first @<CodeableConcept> ;
rdf:rest [rdf:nil] OR @<OneOrMore_CodeableConcept>
}
<OneOrMore_CodeableReference> CLOSED {
rdf:first @<CodeableReference> ;
rdf:rest [rdf:nil] OR @<OneOrMore_CodeableReference>
}
<OneOrMore_AdverseEvent.participant> CLOSED {
rdf:first @<AdverseEvent.participant> ;
rdf:rest [rdf:nil] OR @<OneOrMore_AdverseEvent.participant>
}
<OneOrMore_Reference_ResearchStudy> CLOSED {
rdf:first @<Reference> AND {fhir:link
@<ResearchStudy> } ;
rdf:rest [rdf:nil] OR @<OneOrMore_Reference_ResearchStudy>
}
<OneOrMore_AdverseEvent.suspectEntity> CLOSED {
rdf:first @<AdverseEvent.suspectEntity> ;
rdf:rest [rdf:nil] OR @<OneOrMore_AdverseEvent.suspectEntity>
}
<OneOrMore_Annotation> CLOSED {
rdf:first @<Annotation> ;
rdf:rest [rdf:nil] OR @<OneOrMore_Annotation>
}
#---------------------- Value Sets ------------------------
# Overall nature of the adverse event, e.g. real or potential.
fhirvs:adverse-event-actuality ["actual" "potential"]
# Codes identifying the lifecycle stage of an adverse event.
fhirvs:adverse-event-status ["in-progress" "completed" "entered-in-error" "unknown"]
Usage note: every effort has been made to ensure that the ShEx files are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot3 generated on Thu, Oct 23, 2025 19:45+0000.
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