Clinical
Summary
This
page
is
part
of
the
FHIR
Specification
(v5.0.0:
R5
-
STU
v6.0.0-ballot2:
Release
6
Ballot
(2nd
Draft)
(see
Ballot
Notes
).
This
is
the
The
current
published
version
in
it's
permanent
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(it
will
always
be
available
at
this
URL).
is
5.0.0
.
For
a
full
list
of
available
versions,
see
the
Directory
of
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versions
.
Page
versions:
R5
R4B
R4
R3
|
Patient
Care
Work
Group
|
Maturity Level : 2 | Trial Use | Security Category : Patient | Compartments : Patient , Practitioner , RelatedPerson |
An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.
AdverseEvent
is
an
event
resource
from
a
FHIR
workflow
perspective
-
see
Workflow
Event
.
A
single
Adverse
Event
may
need
to
be
reported
in
multiple
ways.
Choosing
the
appropriate
form
of
the
reporting
is
dependent
upon
workflow
patterns.
In
particular,
the
implementation
guides
for
Clinical
Care
adverse
events
and
Clinical
Research
adverse
events
provide
important
extensions,
value-sets
and
examples
for
implementing
AdverseEvent.
The guides reflect that adverse event tracking in clinical care and clinical research settings can differ. In the former case, the event is tracked to meet business safety concerns and incident reporting. There is a strong interest in factors surrounding the event, if it was prevented, what happened, and if it occurred, how it was resolved or managed. In the clinical research setting, the event is additionally tracked and evaluated as part of the clinical research process for the research study, since the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment. In clinical research trials, serious adverse events are usually required to be reported to the respective health authorities (e.g., U.S. FDA). For Clinical Care or Clinical Research, the Vulcan accelerator project suggests two AdverseEvent Resource profiles.
This resource applies to events that occur during the course of medical care or medical research which may impact an individual as the recipient of care or the participant in a research study. There are also events that occur within a care setting that might or might not impact an individual but had the potential to cause an adverse event. Health care organizations monitor and report both adverse events as well as events that had the potential to cause patient harm. Data are often aggregated for reporting purposes and quality improvement initiatives.
An adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects. Examples of adverse events include the administration of an incorrect drug or an incorrect dose of a drug causing an adverse reaction, the use of an implanted device that causes an infection, or a biologic used during a research study that causes unanticipated renal failure. These events are characterized by the need to capture cause-and-effect (although they might not be known at the time of the event), severity, and outcome.
The context of an adverse event is also important. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause-and-effect relationship for an adverse event.
In clinical care, a potential adverse event may also be called a near miss or an error. These are also events but, since they were detected, did not cause harm to a subject. Examples of potential adverse events include a product problem such as a faulty pacemaker that is detected prior implantation, a doctor working simultaneously on two electronic health records realizing the order for a drug was entered on the incorrect patient and then canceling the order, or a patient with a peanut allergy notices that his hospital dinner tray includes peanuts, and he does not eat the peanuts.
For
examples
and
further
guidance,
it
is
strongly
suggested
that
an
implementer
consult
the
Clinical
Care
AdverseEvent
Implementation
Guide
and
the
Clinical
Research
AdverseEvent
Implementation
Guide
They
contain
valuable
extensions,
value
sets
and,
importantly,
examples.
The AdverseEvent resource is designed to represent events that had a harmful impact on a subject, or had the potential to cause harm to a subject but were avoided. In the course of medical care, there are many actions that may impact how a subject responds to a particular treatment impacting patient safety. Therefore, the AdverseEvent resource may reference multiple other resources to represent the context or details of an adverse event such as Observation, Condition, MedicationAdministration, Immunization, Procedure, or ResearchStudy.
A
DetectedIssue
reference
is
also
related
to
the
context
of
an
AdverseEvent
to
the
extent
that
a
known
risk
for
a
potential
issue,
such
as
a
drug-drug
interaction,
is
documented.
If,
in
the
context
of
a
known
issue,
an
adverse
event
occurs,
citing
this
relationship
is
important
for
preventing
such
an
occurrence
in
the
future.
The
AdverseEvent
resource
should
not
be
used
when
a
more
specific
resource
exists.
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
|
|---|---|---|---|---|
AdverseEvent
|
TU | DomainResource |
An
event
that
may
be
related
to
unintended
effects
on
a
patient
or
research
participant
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension |
|
identifier
|
Σ | 0..* | Identifier |
Business
identifier
for
the
event
|
status
|
?! Σ | 1..1 | code |
in-progress
|
completed
|
entered-in-error
|
unknown
Binding: Adverse Event Status ( Required ) |
|
actuality
|
?! Σ | 1..1 | code |
actual
|
potential
Binding: Adverse Event Actuality ( Required ) |
|
category
|
Σ | 0..* | CodeableConcept |
wrong-patient
|
procedure-mishap
|
medication-mishap
|
device
|
unsafe-physical-environment
|
hospital-aquired-infection
|
wrong-body-site
Binding: Adverse Event Category ( Example ) |
|
code
|
Σ | 0..1 | CodeableConcept |
Event
or
incident
that
occurred
or
was
averted
Binding: AdverseEvent Type ( Example ) |
subject
|
Σ | 1..1 |
Reference
(
Patient
|
Group
|
Practitioner
|
RelatedPerson
|
Subject
impacted
by
event
|
|
encounter
|
Σ | 0..1 | Reference ( Encounter ) |
The
Encounter
associated
with
the
start
of
the
AdverseEvent
|
|
Σ | 0..1 |
When
the
|
|
|
dateTime | |||
|
Period | |||
|
effect[x]
| Σ | 0..1 |
When
the
effect
of
the
AdverseEvent
occurred
| |
|
effectDateTime
| dateTime | |||
|
|
|
|||
|
detected
|
Σ | 0..1 | dateTime |
When
the
event
was
detected
|
|
recordedDate
|
Σ | 0..1 | dateTime |
When
the
event
was
recorded
|
|
resultingEffect
|
Σ | 0..* | Reference ( Condition | Observation ) |
Effect
on
the
subject
due
to
this
event
|
|
location
|
Σ | 0..1 | Reference ( Location ) |
Location
where
adverse
event
occurred
|
|
seriousness
|
Σ | 0..1 | CodeableConcept |
Seriousness
or
gravity
of
the
event
Binding: Adverse Event Seriousness ( Example ) |
|
outcome
|
Σ | 0..* | CodeableConcept |
Type
of
outcome
from
the
adverse
event
Binding: AdverseEvent Outcome ( Example ) |
|
recorder
|
Σ | 0..1 |
Reference
(
Patient
|
Practitioner
|
PractitionerRole
|
RelatedPerson
|
Who
recorded
the
adverse
event
|
participant
|
Σ | 0..* | BackboneElement |
Who
was
involved
in
the
adverse
event
or
the
potential
adverse
event
and
what
they
did
|
|
function
|
Σ | 0..1 | CodeableConcept |
Type
of
involvement
Binding: AdverseEvent Participant Function ( Example ) |
|
actor
|
Σ | 1..1 |
Reference
(
Practitioner
|
PractitionerRole
|
Organization
|
CareTeam
|
Patient
|
Device
|
RelatedPerson
|
Who
was
involved
in
the
adverse
event
or
the
potential
adverse
event
|
|
study
|
Σ | 0..* | Reference ( ResearchStudy ) |
Research
study
that
the
subject
is
enrolled
in
|
|
expectedInResearchStudy
|
0..1 | boolean |
Considered
likely
or
probable
or
anticipated
in
the
research
study
|
|
|
suspectEntity
|
Σ | 0..* | BackboneElement |
The
suspected
agent
causing
the
adverse
event
|
|
instance
|
Σ | 1..1 |
|
Refers
to
the
specific
entity
that
caused
the
adverse
event
|
causality
|
Σ | 0..1 | BackboneElement |
Information
on
the
possible
cause
of
the
event
|
assessmentMethod
|
Σ | 0..1 | CodeableConcept |
Method
of
evaluating
the
relatedness
of
the
suspected
entity
to
the
event
Binding: Adverse Event Causality Method ( Example ) |
|
entityRelatedness
|
Σ | 0..1 | CodeableConcept |
Result
of
the
assessment
regarding
the
relatedness
of
the
suspected
entity
to
the
event
Binding: Adverse Event Causality Assessment ( Example ) |
|
author
|
Σ | 0..1 |
Reference
(
Practitioner
|
PractitionerRole
|
Patient
|
RelatedPerson
|
Author
of
the
information
on
the
possible
cause
of
the
event
|
|
contributingFactor
|
Σ | 0..* |
|
Binding: AdverseEvent Contributing Factor ( Example ) |
|
preventiveAction
|
Σ |
|
CodeableReference ( Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) |
Binding: AdverseEvent Preventive Action ( Example ) |
|
|
Σ | 0..* |
|
Ameliorating
actions
taken
after
the
adverse
event
Binding: AdverseEvent Mitigating Action ( Example ) |
|
supportingInfo
|
Σ | 0..* |
|
Binding: AdverseEvent Supporting Information ( Example ) |
|
note
|
Σ | 0..* | Annotation |
Comment
on
adverse
event
|
|
Documentation
for
this
format
|
||||
See the Extensions for this resource
UML Diagram ( Legend )
XML Template
<AdverseEvent xmlns="http://hl7.org/fhir"><!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier Business identifier for the event --></identifier> <status value="[code]"/><!-- 1..1 in-progress | completed | entered-in-error | unknown --> <actuality value="[code]"/><!-- 1..1 actual | potential --> <category><!-- 0..* CodeableConcept wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site --></category> <code><!-- 0..1 CodeableConcept Event or incident that occurred or was averted --></code>
<| </subject><subject><!-- 1..1 Reference(Group|Patient|Practitioner|RelatedPerson) Subject impacted by event --></subject> <encounter><!-- 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent --></encounter><</occurrence[x]><cause[x]><!-- 0..1 dateTime|Period When the cause of the AdverseEvent occurred --></cause[x]> <effect[x]><!-- 0..1 dateTime|Period When the effect of the AdverseEvent occurred --></effect[x]> <detected value="[dateTime]"/><!-- 0..1 When the event was detected --> <recordedDate value="[dateTime]"/><!-- 0..1 When the event was recorded --> <resultingEffect><!-- 0..* Reference(Condition|Observation) Effect on the subject due to this event --></resultingEffect> <location><!-- 0..1 Reference(Location) Location where adverse event occurred --></location> <seriousness><!-- 0..1 CodeableConcept Seriousness or gravity of the event --></seriousness> <outcome><!-- 0..* CodeableConcept Type of outcome from the adverse event --></outcome> <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|</recorder>RelatedPerson) Who recorded the adverse event --></recorder> <participant> <!-- 0..* Who was involved in the adverse event or the potential adverse event and what they did --> <function><!-- 0..1 CodeableConcept Type of involvement --></function> <actor><!-- 1..1 Reference(CareTeam|Device|Organization|Patient|Practitioner|</actor>PractitionerRole|RelatedPerson) Who was involved in the adverse event or the potential adverse event --></actor> </participant> <study><!-- 0..* Reference(ResearchStudy) Research study that the subject is enrolled in --></study> <expectedInResearchStudy value="[boolean]"/><!-- 0..1 Considered likely or probable or anticipated in the research study --> <suspectEntity> <!-- 0..* The suspected agent causing the adverse event --><| | </instance[x]><instance><!-- 1..1 CodeableReference(BiologicallyDerivedProduct|Device| Immunization|Medication|MedicationAdministration|MedicationStatement| Procedure|ResearchStudy|Substance) Refers to the specific entity that caused the adverse event --></instance> <causality> <!-- 0..1 Information on the possible cause of the event --> <assessmentMethod><!-- 0..1 CodeableConcept Method of evaluating the relatedness of the suspected entity to the event --></assessmentMethod> <entityRelatedness><!-- 0..1 CodeableConcept Result of the assessment regarding the relatedness of the suspected entity to the event --></entityRelatedness> <author><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|</author>RelatedPerson) Author of the information on the possible cause of the event --></author> </causality> </suspectEntity>< <| | </item[x]> </contributingFactor> < <| </item[x]> </preventiveAction> < <| </item[x]> </mitigatingAction> < <| | )| </item[x]> </supportingInfo><contributingFactor><!-- 0..* CodeableReference(AllergyIntolerance|Condition| Device|DeviceUsage|DocumentReference|FamilyMemberHistory|Immunization| MedicationAdministration|MedicationStatement|Observation|Procedure) Contributing factors suspected to have increased the probability or severity of the adverse event --></contributingFactor> <preventiveAction><!-- 0..* CodeableReference(DocumentReference|Immunization| MedicationAdministration|MedicationRequest|Procedure) Preventive actions that contributed to avoiding the adverse event --></preventiveAction> <mitigatingAction><!-- 0..* CodeableReference(DocumentReference| MedicationAdministration|MedicationRequest|Procedure) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm --></mitigatingAction> <supportingInfo><!-- 0..* CodeableReference(AllergyIntolerance|Condition| DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration| MedicationStatement|Observation|Procedure|QuestionnaireResponse) Subject medical history or document relevant to this adverse event --></supportingInfo> <note><!-- 0..* Annotation Comment on adverse event --></note> </AdverseEvent>
JSON Template
{
"resourceType" : "AdverseEvent",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Business identifier for the event
"status" : "<code>", // R! in-progress | completed | entered-in-error | unknown
"actuality" : "<code>", // R! actual | potential
"category" : [{ CodeableConcept }], // wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
"code" : { CodeableConcept }, // Event or incident that occurred or was averted
"|
"subject" : { Reference(Group|Patient|Practitioner|RelatedPerson) }, // R! Subject impacted by event
"encounter" : { Reference(Encounter) }, // The Encounter associated with the start of the AdverseEvent
">",
" },
" },
// cause[x]: When the cause of the AdverseEvent occurred. One of these 2:
"causeDateTime" : "<dateTime>",
"causePeriod" : { Period },
// effect[x]: When the effect of the AdverseEvent occurred. One of these 2:
"effectDateTime" : "<dateTime>",
"effectPeriod" : { Period },
"detected" : "<dateTime>", // When the event was detected
"recordedDate" : "<dateTime>", // When the event was recorded
"resultingEffect" : [{ Reference(Condition|Observation) }], // Effect on the subject due to this event
"location" : { Reference(Location) }, // Location where adverse event occurred
"seriousness" : { CodeableConcept }, // Seriousness or gravity of the event
"outcome" : [{ CodeableConcept }], // Type of outcome from the adverse event
"recorder" : { Reference(Patient|Practitioner|PractitionerRole|
RelatedPerson) }, // Who recorded the adverse event
"participant" : [{ // Who was involved in the adverse event or the potential adverse event and what they did
"function" : { CodeableConcept }, // Type of involvement
"actor" : { Reference(CareTeam|Device|Organization|Patient|Practitioner|
PractitionerRole|RelatedPerson) } // R! Who was involved in the adverse event or the potential adverse event
}],
"study" : [{ Reference(ResearchStudy) }], // Research study that the subject is enrolled in
"expectedInResearchStudy" : <boolean>, // Considered likely or probable or anticipated in the research study
"suspectEntity" : [{ // The suspected agent causing the adverse event
" },
"|
|
},
"instance" : { CodeableReference(BiologicallyDerivedProduct|Device|
Immunization|Medication|MedicationAdministration|MedicationStatement|
Procedure|ResearchStudy|Substance) }, // R! Refers to the specific entity that caused the adverse event
"causality" : { // Information on the possible cause of the event
"assessmentMethod" : { CodeableConcept }, // Method of evaluating the relatedness of the suspected entity to the event
"entityRelatedness" : { CodeableConcept }, // Result of the assessment regarding the relatedness of the suspected entity to the event
"author" : { Reference(Patient|Practitioner|PractitionerRole|
RelatedPerson) } // Author of the information on the possible cause of the event
}
}],
"
"|
|
},
" }
}],
"
"|
},
" }
}],
"
Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
"|
},
" }
}],
"
"|
|
},
" }
}],
"contributingFactor" : [{ CodeableReference(AllergyIntolerance|Condition|
Device|DeviceUsage|DocumentReference|FamilyMemberHistory|Immunization|
MedicationAdministration|MedicationStatement|Observation|Procedure) }], // Contributing factors suspected to have increased the probability or severity of the adverse event
"preventiveAction" : [{ CodeableReference(DocumentReference|Immunization|
MedicationAdministration|MedicationRequest|Procedure) }], // Preventive actions that contributed to avoiding the adverse event
"mitigatingAction" : [{ CodeableReference(DocumentReference|
MedicationAdministration|MedicationRequest|Procedure) }], // Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm
"supportingInfo" : [{ CodeableReference(AllergyIntolerance|Condition|
DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration|
MedicationStatement|Observation|Procedure|QuestionnaireResponse) }], // Subject medical history or document relevant to this adverse event
"note" : [{ Annotation }] // Comment on adverse event
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .fhir:fhir:subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ] ; # 1..1 Subject impacted by event fhir:encounter [ Reference(Encounter) ] ; # 0..1 The Encounter associated with the start of the AdverseEvent# . One of these 3 fhir: ] fhir: ] fhir: ]# cause[x] : 0..1 When the cause of the AdverseEvent occurred. One of these 2 fhir:cause [ a fhir:dateTime ; dateTime ] fhir:cause [ a fhir:Period ; Period ] # effect[x] : 0..1 When the effect of the AdverseEvent occurred. One of these 2 fhir:effect [ a fhir:dateTime ; dateTime ] fhir:effect [ a fhir:Period ; Period ] fhir:detected [ dateTime ] ; # 0..1 When the event was detected fhir:recordedDate [ dateTime ] ; # 0..1 When the event was recorded fhir:resultingEffect ( [ Reference(Condition|Observation) ] ... ) ; # 0..* Effect on the subject due to this event fhir:location [ Reference(Location) ] ; # 0..1 Location where adverse event occurred fhir:seriousness [ CodeableConcept ] ; # 0..1 Seriousness or gravity of the event fhir:outcome ( [ CodeableConcept ] ... ) ; # 0..* Type of outcome from the adverse eventfhir:fhir:recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 Who recorded the adverse event fhir:participant ( [ # 0..* Who was involved in the adverse event or the potential adverse event and what they did fhir:function [ CodeableConcept ] ; # 0..1 Type of involvementfhir:|fhir:actor [ Reference(CareTeam|Device|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 1..1 Who was involved in the adverse event or the potential adverse event ] ... ) ; fhir:study ( [ Reference(ResearchStudy) ] ... ) ; # 0..* Research study that the subject is enrolled in fhir:expectedInResearchStudy [ boolean ] ; # 0..1 Considered likely or probable or anticipated in the research study fhir:suspectEntity ( [ # 0..* The suspected agent causing the adverse event# . One of these 2 fhir: ] fhir:| ) ]fhir:instance [ CodeableReference(BiologicallyDerivedProduct|Device|Immunization|Medication| MedicationAdministration|MedicationStatement|Procedure|ResearchStudy|Substance) ] ; # 1..1 Refers to the specific entity that caused the adverse event fhir:causality [ # 0..1 Information on the possible cause of the event fhir:assessmentMethod [ CodeableConcept ] ; # 0..1 Method of evaluating the relatedness of the suspected entity to the event fhir:entityRelatedness [ CodeableConcept ] ; # 0..1 Result of the assessment regarding the relatedness of the suspected entity to the eventfhir:fhir:author [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 Author of the information on the possible cause of the event ] ; ] ... ) ;fhir: # . One of these 2 fhir:|fhir:contributingFactor ( [ CodeableReference(AllergyIntolerance|Condition|Device|DeviceUsage|DocumentReference| FamilyMemberHistory|Immunization|MedicationAdministration|MedicationStatement|) ] fhir: ] ] ... ) ; fhir: # . One of these 2 fhir:| ) ] fhir: ] ] ... ) ; fhir: # . One of these 2 fhir:) ] fhir: ] ] ... ) ; fhir: # . One of these 2 fhir:|Observation|Procedure) ] ... ) ; # 0..* Contributing factors suspected to have increased the probability or severity of the adverse event fhir:preventiveAction ( [ CodeableReference(DocumentReference|Immunization|MedicationAdministration|MedicationRequest| Procedure) ] ... ) ; # 0..* Preventive actions that contributed to avoiding the adverse event fhir:mitigatingAction ( [ CodeableReference(DocumentReference|MedicationAdministration|MedicationRequest|Procedure) ] ... ) ; # 0..* Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm fhir:supportingInfo ( [ CodeableReference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization| MedicationAdministration|MedicationStatement|Observation|Procedure|) ] fhir: ] ] ... ) ;QuestionnaireResponse) ] ... ) ; # 0..* Subject medical history or document relevant to this adverse event fhir:note ( [ Annotation ] ... ) ; # 0..* Comment on adverse event ]
Changes from both R4 and R4B
| AdverseEvent | |
| AdverseEvent.identifier |
|
| AdverseEvent.status |
|
| AdverseEvent.category |
|
| AdverseEvent.code |
|
|
|
|
|
|
|
| AdverseEvent.resultingEffect |
|
| AdverseEvent.outcome |
|
| AdverseEvent.participant |
|
| AdverseEvent.participant.function |
|
| AdverseEvent.participant.actor |
|
| AdverseEvent.expectedInResearchStudy |
|
|
|
|
| AdverseEvent.suspectEntity.causality |
|
| AdverseEvent.suspectEntity.causality.assessmentMethod |
|
| AdverseEvent.suspectEntity.causality.entityRelatedness |
|
| AdverseEvent.suspectEntity.causality.author |
|
| AdverseEvent.contributingFactor |
|
| AdverseEvent.preventiveAction |
|
| AdverseEvent.mitigatingAction |
|
| AdverseEvent.supportingInfo |
|
| AdverseEvent.note |
|
| AdverseEvent.date |
|
| AdverseEvent.severity |
|
| AdverseEvent.contributor |
|
| AdverseEvent.suspectEntity.causality.assessment |
|
| AdverseEvent.suspectEntity.causality.method |
|
| AdverseEvent.subjectMedicalHistory |
|
| AdverseEvent.referenceDocument |
|
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON .
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
|
|---|---|---|---|---|
|
AdverseEvent
|
TU | DomainResource |
An
event
that
may
be
related
to
unintended
effects
on
a
patient
or
research
participant
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension |
|
|
identifier
|
Σ | 0..* | Identifier |
Business
identifier
for
the
event
|
|
status
|
?! Σ | 1..1 | code |
in-progress
|
completed
|
entered-in-error
|
unknown
Binding: Adverse Event Status ( Required ) |
|
actuality
|
?! Σ | 1..1 | code |
actual
|
potential
Binding: Adverse Event Actuality ( Required ) |
|
category
|
Σ | 0..* | CodeableConcept |
wrong-patient
|
procedure-mishap
|
medication-mishap
|
device
|
unsafe-physical-environment
|
hospital-aquired-infection
|
wrong-body-site
Binding: Adverse Event Category ( Example ) |
|
code
|
Σ | 0..1 | CodeableConcept |
Event
or
incident
that
occurred
or
was
averted
Binding: AdverseEvent Type ( Example ) |
|
subject
|
Σ | 1..1 |
Reference
(
Patient
|
Group
|
Practitioner
|
RelatedPerson
|
Subject
impacted
by
event
|
|
encounter
|
Σ | 0..1 | Reference ( Encounter ) |
The
Encounter
associated
with
the
start
of
the
AdverseEvent
|
|
|
Σ | 0..1 |
When
the
|
|
|
|
dateTime | |||
|
|
Period | |||
|
effect[x]
| Σ | 0..1 |
When
the
effect
of
the
AdverseEvent
occurred
| |
|
effectDateTime
| dateTime | |||
|
|
|
|||
|
detected
|
Σ | 0..1 | dateTime |
When
the
event
was
detected
|
|
recordedDate
|
Σ | 0..1 | dateTime |
When
the
event
was
recorded
|
|
resultingEffect
|
Σ | 0..* | Reference ( Condition | Observation ) |
Effect
on
the
subject
due
to
this
event
|
|
location
|
Σ | 0..1 | Reference ( Location ) |
Location
where
adverse
event
occurred
|
|
seriousness
|
Σ | 0..1 | CodeableConcept |
Seriousness
or
gravity
of
the
event
Binding: Adverse Event Seriousness ( Example ) |
|
outcome
|
Σ | 0..* | CodeableConcept |
Type
of
outcome
from
the
adverse
event
Binding: AdverseEvent Outcome ( Example ) |
|
recorder
|
Σ | 0..1 |
Reference
(
Patient
|
Practitioner
|
PractitionerRole
|
RelatedPerson
|
Who
recorded
the
adverse
event
|
|
participant
|
Σ | 0..* | BackboneElement |
Who
was
involved
in
the
adverse
event
or
the
potential
adverse
event
and
what
they
did
|
|
function
|
Σ | 0..1 | CodeableConcept |
Type
of
involvement
Binding: AdverseEvent Participant Function ( Example ) |
|
actor
|
Σ | 1..1 |
Reference
(
Practitioner
|
PractitionerRole
|
Organization
|
CareTeam
|
Patient
|
Device
|
RelatedPerson
|
Who
was
involved
in
the
adverse
event
or
the
potential
adverse
event
|
|
study
|
Σ | 0..* | Reference ( ResearchStudy ) |
Research
study
that
the
subject
is
enrolled
in
|
|
expectedInResearchStudy
|
0..1 | boolean |
Considered
likely
or
probable
or
anticipated
in
the
research
study
|
|
|
suspectEntity
|
Σ | 0..* | BackboneElement |
The
suspected
agent
causing
the
adverse
event
|
|
instance
|
Σ | 1..1 |
|
Refers
to
the
specific
entity
that
caused
the
adverse
event
|
|
causality
|
Σ | 0..1 | BackboneElement |
Information
on
the
possible
cause
of
the
event
|
|
assessmentMethod
|
Σ | 0..1 | CodeableConcept |
Method
of
evaluating
the
relatedness
of
the
suspected
entity
to
the
event
Binding: Adverse Event Causality Method ( Example ) |
|
entityRelatedness
|
Σ | 0..1 | CodeableConcept |
Result
of
the
assessment
regarding
the
relatedness
of
the
suspected
entity
to
the
event
Binding: Adverse Event Causality Assessment ( Example ) |
|
author
|
Σ | 0..1 |
Reference
(
Practitioner
|
PractitionerRole
|
Patient
|
RelatedPerson
|
Author
of
the
information
on
the
possible
cause
of
the
event
|
|
contributingFactor
|
Σ | 0..* |
|
Binding: AdverseEvent Contributing Factor ( Example ) |
|
preventiveAction
|
Σ |
|
CodeableReference ( Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) |
Binding: AdverseEvent Preventive Action ( Example ) |
|
|
Σ | 0..* |
|
Ameliorating
actions
taken
after
the
adverse
event
Binding: AdverseEvent Mitigating Action ( Example ) |
|
supportingInfo
|
Σ | 0..* |
|
Binding: AdverseEvent Supporting Information ( Example ) |
|
note
|
Σ | 0..* | Annotation |
Comment
on
adverse
event
|
|
Documentation
for
this
format
|
||||
See the Extensions for this resource
XML Template
<AdverseEvent xmlns="http://hl7.org/fhir"><| </subject><subject><!-- 1..1 Reference(Group|Patient|Practitioner|RelatedPerson) Subject impacted by event --></subject> <encounter><!-- 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent --></encounter><</occurrence[x]><cause[x]><!-- 0..1 dateTime|Period When the cause of the AdverseEvent occurred --></cause[x]> <effect[x]><!-- 0..1 dateTime|Period When the effect of the AdverseEvent occurred --></effect[x]> <detected value="[dateTime]"/><!-- 0..1 When the event was detected --> <recordedDate value="[dateTime]"/><!-- 0..1 When the event was recorded --> <resultingEffect><!-- 0..* Reference(Condition|Observation) Effect on the subject due to this event --></resultingEffect> <location><!-- 0..1 Reference(Location) Location where adverse event occurred --></location> <seriousness><!-- 0..1 CodeableConcept Seriousness or gravity of the event --></seriousness> <outcome><!-- 0..* CodeableConcept Type of outcome from the adverse event --></outcome> <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|</recorder>RelatedPerson) Who recorded the adverse event --></recorder> <participant> <!-- 0..* Who was involved in the adverse event or the potential adverse event and what they did --> <function><!-- 0..1 CodeableConcept Type of involvement --></function> <actor><!-- 1..1 Reference(CareTeam|Device|Organization|Patient|Practitioner|</actor>PractitionerRole|RelatedPerson) Who was involved in the adverse event or the potential adverse event --></actor> </participant> <study><!-- 0..* Reference(ResearchStudy) Research study that the subject is enrolled in --></study> <expectedInResearchStudy value="[boolean]"/><!-- 0..1 Considered likely or probable or anticipated in the research study --> <suspectEntity> <!-- 0..* The suspected agent causing the adverse event --><| | </instance[x]><instance><!-- 1..1 CodeableReference(BiologicallyDerivedProduct|Device| Immunization|Medication|MedicationAdministration|MedicationStatement| Procedure|ResearchStudy|Substance) Refers to the specific entity that caused the adverse event --></instance> <causality> <!-- 0..1 Information on the possible cause of the event --> <assessmentMethod><!-- 0..1 CodeableConcept Method of evaluating the relatedness of the suspected entity to the event --></assessmentMethod> <entityRelatedness><!-- 0..1 CodeableConcept Result of the assessment regarding the relatedness of the suspected entity to the event --></entityRelatedness> <author><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|</author>RelatedPerson) Author of the information on the possible cause of the event --></author> </causality> </suspectEntity>< <| | </item[x]> </contributingFactor> < <| </item[x]> </preventiveAction> < <| </item[x]> </mitigatingAction> < <| | )| </item[x]> </supportingInfo><contributingFactor><!-- 0..* CodeableReference(AllergyIntolerance|Condition| Device|DeviceUsage|DocumentReference|FamilyMemberHistory|Immunization| MedicationAdministration|MedicationStatement|Observation|Procedure) Contributing factors suspected to have increased the probability or severity of the adverse event --></contributingFactor> <preventiveAction><!-- 0..* CodeableReference(DocumentReference|Immunization| MedicationAdministration|MedicationRequest|Procedure) Preventive actions that contributed to avoiding the adverse event --></preventiveAction> <mitigatingAction><!-- 0..* CodeableReference(DocumentReference| MedicationAdministration|MedicationRequest|Procedure) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm --></mitigatingAction> <supportingInfo><!-- 0..* CodeableReference(AllergyIntolerance|Condition| DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration| MedicationStatement|Observation|Procedure|QuestionnaireResponse) Subject medical history or document relevant to this adverse event --></supportingInfo> <note><!-- 0..* Annotation Comment on adverse event --></note> </AdverseEvent>
JSON Template
{
"resourceType" : "AdverseEvent",
// from Resource: id, meta, implicitRules, and language
// from DomainResource: text, contained, extension, and modifierExtension
"identifier" : [{ Identifier }], // Business identifier for the event
"status" : "<code>", // R! in-progress | completed | entered-in-error | unknown
"actuality" : "<code>", // R! actual | potential
"category" : [{ CodeableConcept }], // wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
"code" : { CodeableConcept }, // Event or incident that occurred or was averted
"|
"subject" : { Reference(Group|Patient|Practitioner|RelatedPerson) }, // R! Subject impacted by event
"encounter" : { Reference(Encounter) }, // The Encounter associated with the start of the AdverseEvent
">",
" },
" },
// cause[x]: When the cause of the AdverseEvent occurred. One of these 2:
"causeDateTime" : "<dateTime>",
"causePeriod" : { Period },
// effect[x]: When the effect of the AdverseEvent occurred. One of these 2:
"effectDateTime" : "<dateTime>",
"effectPeriod" : { Period },
"detected" : "<dateTime>", // When the event was detected
"recordedDate" : "<dateTime>", // When the event was recorded
"resultingEffect" : [{ Reference(Condition|Observation) }], // Effect on the subject due to this event
"location" : { Reference(Location) }, // Location where adverse event occurred
"seriousness" : { CodeableConcept }, // Seriousness or gravity of the event
"outcome" : [{ CodeableConcept }], // Type of outcome from the adverse event
"recorder" : { Reference(Patient|Practitioner|PractitionerRole|
RelatedPerson) }, // Who recorded the adverse event
"participant" : [{ // Who was involved in the adverse event or the potential adverse event and what they did
"function" : { CodeableConcept }, // Type of involvement
"actor" : { Reference(CareTeam|Device|Organization|Patient|Practitioner|
PractitionerRole|RelatedPerson) } // R! Who was involved in the adverse event or the potential adverse event
}],
"study" : [{ Reference(ResearchStudy) }], // Research study that the subject is enrolled in
"expectedInResearchStudy" : <boolean>, // Considered likely or probable or anticipated in the research study
"suspectEntity" : [{ // The suspected agent causing the adverse event
" },
"|
|
},
"instance" : { CodeableReference(BiologicallyDerivedProduct|Device|
Immunization|Medication|MedicationAdministration|MedicationStatement|
Procedure|ResearchStudy|Substance) }, // R! Refers to the specific entity that caused the adverse event
"causality" : { // Information on the possible cause of the event
"assessmentMethod" : { CodeableConcept }, // Method of evaluating the relatedness of the suspected entity to the event
"entityRelatedness" : { CodeableConcept }, // Result of the assessment regarding the relatedness of the suspected entity to the event
"author" : { Reference(Patient|Practitioner|PractitionerRole|
RelatedPerson) } // Author of the information on the possible cause of the event
}
}],
"
"|
|
},
" }
}],
"
"|
},
" }
}],
"
Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
"|
},
" }
}],
"
"|
|
},
" }
}],
"contributingFactor" : [{ CodeableReference(AllergyIntolerance|Condition|
Device|DeviceUsage|DocumentReference|FamilyMemberHistory|Immunization|
MedicationAdministration|MedicationStatement|Observation|Procedure) }], // Contributing factors suspected to have increased the probability or severity of the adverse event
"preventiveAction" : [{ CodeableReference(DocumentReference|Immunization|
MedicationAdministration|MedicationRequest|Procedure) }], // Preventive actions that contributed to avoiding the adverse event
"mitigatingAction" : [{ CodeableReference(DocumentReference|
MedicationAdministration|MedicationRequest|Procedure) }], // Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm
"supportingInfo" : [{ CodeableReference(AllergyIntolerance|Condition|
DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration|
MedicationStatement|Observation|Procedure|QuestionnaireResponse) }], // Subject medical history or document relevant to this adverse event
"note" : [{ Annotation }] // Comment on adverse event
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .fhir:fhir:subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ] ; # 1..1 Subject impacted by event fhir:encounter [ Reference(Encounter) ] ; # 0..1 The Encounter associated with the start of the AdverseEvent# . One of these 3 fhir: ] fhir: ] fhir: ]# cause[x] : 0..1 When the cause of the AdverseEvent occurred. One of these 2 fhir:cause [ a fhir:dateTime ; dateTime ] fhir:cause [ a fhir:Period ; Period ] # effect[x] : 0..1 When the effect of the AdverseEvent occurred. One of these 2 fhir:effect [ a fhir:dateTime ; dateTime ] fhir:effect [ a fhir:Period ; Period ] fhir:detected [ dateTime ] ; # 0..1 When the event was detected fhir:recordedDate [ dateTime ] ; # 0..1 When the event was recorded fhir:resultingEffect ( [ Reference(Condition|Observation) ] ... ) ; # 0..* Effect on the subject due to this event fhir:location [ Reference(Location) ] ; # 0..1 Location where adverse event occurred fhir:seriousness [ CodeableConcept ] ; # 0..1 Seriousness or gravity of the event fhir:outcome ( [ CodeableConcept ] ... ) ; # 0..* Type of outcome from the adverse eventfhir:fhir:recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 Who recorded the adverse event fhir:participant ( [ # 0..* Who was involved in the adverse event or the potential adverse event and what they did fhir:function [ CodeableConcept ] ; # 0..1 Type of involvementfhir:|fhir:actor [ Reference(CareTeam|Device|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 1..1 Who was involved in the adverse event or the potential adverse event ] ... ) ; fhir:study ( [ Reference(ResearchStudy) ] ... ) ; # 0..* Research study that the subject is enrolled in fhir:expectedInResearchStudy [ boolean ] ; # 0..1 Considered likely or probable or anticipated in the research study fhir:suspectEntity ( [ # 0..* The suspected agent causing the adverse event# . One of these 2 fhir: ] fhir:| ) ]fhir:instance [ CodeableReference(BiologicallyDerivedProduct|Device|Immunization|Medication| MedicationAdministration|MedicationStatement|Procedure|ResearchStudy|Substance) ] ; # 1..1 Refers to the specific entity that caused the adverse event fhir:causality [ # 0..1 Information on the possible cause of the event fhir:assessmentMethod [ CodeableConcept ] ; # 0..1 Method of evaluating the relatedness of the suspected entity to the event fhir:entityRelatedness [ CodeableConcept ] ; # 0..1 Result of the assessment regarding the relatedness of the suspected entity to the eventfhir:fhir:author [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 Author of the information on the possible cause of the event ] ; ] ... ) ;fhir: # . One of these 2 fhir:|fhir:contributingFactor ( [ CodeableReference(AllergyIntolerance|Condition|Device|DeviceUsage|DocumentReference| FamilyMemberHistory|Immunization|MedicationAdministration|MedicationStatement|) ] fhir: ] ] ... ) ; fhir: # . One of these 2 fhir:| ) ] fhir: ] ] ... ) ; fhir: # . One of these 2 fhir:) ] fhir: ] ] ... ) ; fhir: # . One of these 2 fhir:|Observation|Procedure) ] ... ) ; # 0..* Contributing factors suspected to have increased the probability or severity of the adverse event fhir:preventiveAction ( [ CodeableReference(DocumentReference|Immunization|MedicationAdministration|MedicationRequest| Procedure) ] ... ) ; # 0..* Preventive actions that contributed to avoiding the adverse event fhir:mitigatingAction ( [ CodeableReference(DocumentReference|MedicationAdministration|MedicationRequest|Procedure) ] ... ) ; # 0..* Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm fhir:supportingInfo ( [ CodeableReference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization| MedicationAdministration|MedicationStatement|Observation|Procedure|) ] fhir: ] ] ... ) ;QuestionnaireResponse) ] ... ) ; # 0..* Subject medical history or document relevant to this adverse event fhir:note ( [ Annotation ] ... ) ; # 0..* Comment on adverse event ]
Changes from both R4 and R4B
| AdverseEvent | |
| AdverseEvent.identifier |
|
| AdverseEvent.status |
|
| AdverseEvent.category |
|
| AdverseEvent.code |
|
|
|
|
|
|
|
| AdverseEvent.resultingEffect |
|
| AdverseEvent.outcome |
|
| AdverseEvent.participant |
|
| AdverseEvent.participant.function |
|
| AdverseEvent.participant.actor |
|
| AdverseEvent.expectedInResearchStudy |
|
|
|
|
| AdverseEvent.suspectEntity.causality |
|
| AdverseEvent.suspectEntity.causality.assessmentMethod |
|
| AdverseEvent.suspectEntity.causality.entityRelatedness |
|
| AdverseEvent.suspectEntity.causality.author |
|
| AdverseEvent.contributingFactor |
|
| AdverseEvent.preventiveAction |
|
| AdverseEvent.mitigatingAction |
|
| AdverseEvent.supportingInfo |
|
| AdverseEvent.note |
|
| AdverseEvent.date |
|
| AdverseEvent.severity |
|
| AdverseEvent.contributor |
|
| AdverseEvent.suspectEntity.causality.assessment |
|
| AdverseEvent.suspectEntity.causality.method |
|
| AdverseEvent.subjectMedicalHistory |
|
| AdverseEvent.referenceDocument |
|
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON .
Additional definitions: Master Definition XML + JSON , XML Schema / Schematron + JSON Schema , ShEx (for Turtle ) + see the extensions , the spreadsheet version & the dependency analysis
| Path | ValueSet | Type | Documentation |
|---|---|---|---|
| AdverseEvent.status | AdverseEventStatus | Required |
Codes identifying the lifecycle stage of an adverse event. |
| AdverseEvent.actuality | AdverseEventActuality | Required |
Overall nature of the adverse event, e.g. real or potential. |
| AdverseEvent.category | AdverseEventCategory | Example |
Overall categorization of the event, e.g. product-related or situational. |
| AdverseEvent.code | AdverseEventType | Example |
This value set includes codes that describe the adverse event or incident that occurred or was averted. |
| AdverseEvent.seriousness | AdverseEventSeriousness | Example |
Overall seriousness of this event for the patient. |
| AdverseEvent.outcome | AdverseEventOutcome | Example |
This value set includes codes that describe the type of outcome from the adverse event. |
| AdverseEvent.participant.function | AdverseEventParticipantFunction | Example |
This value set includes codes that describe the type of involvement of the actor in the adverse event. |
| AdverseEvent.suspectEntity.causality.assessmentMethod | AdverseEventCausalityMethod | Example |
|
| AdverseEvent.suspectEntity.causality.entityRelatedness | AdverseEventCausalityAssessment | Example |
Codes for the assessment of whether the entity caused the event. |
|
|
AdverseEventContributingFactor | Example |
This value set includes codes that describe the contributing factors suspected to have increased the probability or severity of the adverse event. |
|
|
AdverseEventPreventiveAction | Example |
This value set includes codes that describe the preventive actions that contributed to avoiding the adverse event. |
|
|
AdverseEventMitigatingAction | Example |
This
value
set
includes
codes
that
describe
the
ameliorating
actions
taken
after
the
adverse
event
|
|
|
AdverseEventSupportingInforation | Example |
This value set includes codes that describe the supporting information relevant to the event. |
Search parameters for this resource. See also the full list of search parameters for this resource , and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
| Name | Type | Description | Expression | In Common |
| actuality | token | actual | potential | AdverseEvent.actuality | |
| category | token | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site | AdverseEvent.category | |
| cause | date | When the cause of the event occurred | AdverseEvent.cause.ofType(dateTime) | AdverseEvent.cause.ofType(Period) | |
| code | token | Event or incident that occurred or was averted | AdverseEvent.code |
|
|
|
date | When the effect of the event occurred |
|
|
| identifier | token | Business identifier for the event | AdverseEvent.identifier | 65 Resources |
| location | reference | Location where adverse event occurred |
AdverseEvent.location
( Location ) |
|
| patient | reference | Subject impacted by event |
AdverseEvent.subject.where(resolve()
is
Patient)
( Patient ) |
|
| recorder | reference | Who recorded the adverse event |
AdverseEvent.recorder
( Practitioner , Patient , PractitionerRole , |
|
| resultingeffect | reference | Effect on the subject due to this event |
AdverseEvent.resultingEffect
( Condition , Observation ) |
|
| seriousness | token | Seriousness or gravity of the event | AdverseEvent.seriousness | |
| status | token | in-progress | completed | entered-in-error | unknown | AdverseEvent.status | |
| study | reference | Research study that the subject is enrolled in |
AdverseEvent.study
( ResearchStudy ) |
|
| subject | reference | Subject impacted by event |
AdverseEvent.subject
( Practitioner , Group , Patient , |
|
| substance | reference | Refers to the specific entity that caused the adverse event |
|
FHIR
®©
HL7.org
2011+.
FHIR
R5
hl7.fhir.core#5.0.0
R6
hl7.fhir.core#6.0.0-ballot2
generated
on
Sun,
Mar
26,
2023
15:24+1100.
Mon,
Aug
12,
2024
16:57+0800.
Links:
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