Release
4B
5
Clinical
Summary
This
page
is
part
of
the
FHIR
Specification
(v4.3.0:
R4B
(v5.0.0:
R5
-
STU
).
The
This
is
the
current
published
version
which
supercedes
in
it's
permanent
home
(it
will
always
be
available
at
this
version
is
5.0.0
.
URL).
For
a
full
list
of
available
versions,
see
the
Directory
of
published
versions
.
Page
versions:
R5
R4B
R5
R4B
R4
R3
|
Patient
Care
Work
Group
|
Maturity
Level
:
|
Trial Use | Security Category : Patient | Compartments : Patient , Practitioner , RelatedPerson |
Actual
or
potential/avoided
An
event
causing
unintended
physical
injury
resulting
from
or
contributed
(i.e.
any
change
to
by
medical
care,
current
patient
status)
that
may
be
related
to
unintended
effects
on
a
research
study
patient
or
other
healthcare
setting
factors
that
requires
research
participant.
The
unintended
effects
may
require
additional
monitoring,
treatment,
or
hospitalization,
or
that
results
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.
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
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
cause-and-effect
relationship
for
an
adverse
event.
A
In
clinical
care,
a
potential
adverse
event
may
also
be
called
a
near
miss
or
an
error.
These
are
also
events
but
because
but,
since
they
were
detected
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
have
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
care,
there
are
many
actions
that
may
impact
how
a
subject
responds
to
a
particular
treatment
impacting
patient
safety.
Therefore
Therefore,
the
AdverseEvent
resource
may
reference
multiple
other
resources
to
represent
the
context
or
details
of
an
adverse
event
including
but
not
limited
to
such
as
Observation,
Condition,
MedicationAdminsitration,
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
issue,
such
as
a
drug-drug
interaction
interaction,
is
documented.
If
If,
in
the
context
of
a
known
issue,
and
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 |
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension |
|
identifier
|
Σ |
|
Identifier |
Business
identifier
for
the
event
|
|
?! Σ | 1..1 | code |
|
|
actuality
|
?! Σ |
|
|
|
|
|
Σ |
|
CodeableConcept |
|
|
code
|
Σ |
|
CodeableConcept |
Event
or
incident
that
occurred
or
was
averted
Binding: AdverseEvent Type ( Example ) |
subject
| Σ | 1..1 | Reference ( Patient | Group | Practitioner | RelatedPerson | ResearchSubject ) |
Subject
impacted
by
event
|
|
encounter
|
Σ | 0..1 | Reference ( Encounter ) |
The
Encounter
|
occurrence[x]
|
Σ | 0..1 |
When
the
event
occurred
| |
occurrenceDateTime
| dateTime | |||
|
occurrencePeriod
| Period | |||
occurrenceTiming
|
|
Timing | ||
|
detected
|
Σ | 0..1 | dateTime |
When
the
event
was
detected
|
|
recordedDate
|
Σ | 0..1 | dateTime |
When
the
event
was
recorded
|
|
|
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: |
|
|
Σ |
|
CodeableConcept |
|
|
recorder
| Σ | 0..1 | Reference ( Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject ) |
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
|
|
|
Σ | 0..1 | CodeableConcept |
|
|
|
Σ |
|
Reference
(
|
Who
|
|
|
Σ | 0..* |
Reference
(
|
|
|
expectedInResearchStudy
| 0..1 | boolean |
Considered
likely
or
probable
or
anticipated
in
the
|
|
|
suspectEntity
|
Σ | 0..* | BackboneElement |
The
suspected
agent
causing
the
adverse
event
|
|
instance[x]
|
Σ | 1..1 |
Refers
to
the
specific
entity
that
caused
the
adverse
event
| |
|
instanceCodeableConcept
| CodeableConcept | |||
|
instanceReference
| Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy ) | |||
causality
|
Σ | 0..1 | BackboneElement |
Information
on
the
possible
cause
of
the
event
|
assessmentMethod
|
Σ | 0..1 | CodeableConcept |
Method
of
evaluating
the
relatedness
of
|
|
entityRelatedness
|
Σ | 0..1 |
|
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 | ResearchSubject ) |
Author
of
the
information
on
the
possible
cause
of
the
event
|
|
contributingFactor
|
| 0..* | BackboneElement |
Contributing
factors
suspected
to
have
increased
the
probability
or
severity
of
the
adverse
event
|
|
item[x]
|
Σ |
|
|
|
|
itemReference
|
|
Reference
(
Condition
|
Observation
|
AllergyIntolerance
|
FamilyMemberHistory
|
Immunization
|
Procedure
|
|
||
|
itemCodeableConcept
| CodeableConcept | |||
|
preventiveAction
|
| 0..* | BackboneElement |
Preventive
actions
that
contributed
to
avoiding
the
adverse
event
|
|
item[x]
|
Σ |
|
Action
that
contributed
to
avoiding
the
adverse
event
Binding: AdverseEvent Preventive Action ( Example ) | |
|
itemReference
| Reference ( Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) | |||
|
itemCodeableConcept
|
|
CodeableConcept | ||
|
mitigatingAction
| Σ | 0..* | BackboneElement |
Ameliorating
actions
taken
after
the
adverse
event
occured
in
order
to
reduce
the
extent
of
harm
|
|
item[x]
| Σ | 1..1 |
Ameliorating
action
taken
after
the
adverse
event
occured
in
order
to
reduce
the
extent
of
harm
Binding: AdverseEvent Mitigating Action ( Example ) | |
|
| Reference ( Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) | |||
|
itemCodeableConcept
| CodeableConcept | |||
|
supportingInfo
|
Σ | 0..* | BackboneElement |
Supporting
information
relevant
to
the
event
|
|
item[x]
| Σ | 1..1 |
Subject
medical
history
or
document
relevant
to
this
adverse
event
Binding: AdverseEvent Supporting Information ( Example ) | |
|
itemReference
|
Reference
(
|
|||
|
itemCodeableConcept
| CodeableConcept | |||
|
note
|
| 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> < <</category> <</event> <</subject> <</encounter> <<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><!-- 1..1 Reference(Group|Patient|Practitioner|RelatedPerson| ResearchSubject) Subject impacted by event --></subject> <encounter><!-- 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent --></encounter> <occurrence[x]><!-- 0..1 dateTime|Period|Timing When the event occurred --></occurrence[x]> <detected value="[dateTime]"/><!-- 0..1 When the event was detected --> <recordedDate value="[dateTime]"/><!-- 0..1 When the event was recorded --><</resultingCondition><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> <</severity> <</outcome><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> <</contributor>RelatedPerson|ResearchSubject) 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| PractitionerRole|RelatedPerson|ResearchSubject) 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> < <</assessment> < <</author> <</method><instance[x]><!-- 1..1 CodeableConcept|Reference(BiologicallyDerivedProduct| Device|Immunization|Medication|MedicationAdministration|MedicationStatement| Procedure|ResearchStudy|Substance) Refers to the specific entity that caused the adverse event --></instance[x]> <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| RelatedPerson|ResearchSubject) Author of the information on the possible cause of the event --></author> </causality> </suspectEntity><| | </subjectMedicalHistory> <</referenceDocument> <</study><contributingFactor> <!-- 0..* Contributing factors suspected to have increased the probability or severity of the adverse event --> <item[x]><!-- 1..1 Reference(AllergyIntolerance|Condition|Device|DeviceUsage| DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration| MedicationStatement|Observation|Procedure)|CodeableConcept Item suspected to have increased the probability or severity of the adverse event --></item[x]> </contributingFactor> <preventiveAction> <!-- 0..* Preventive actions that contributed to avoiding the adverse event --> <item[x]><!-- 1..1 Reference(DocumentReference|Immunization| MedicationAdministration|MedicationRequest|Procedure)|CodeableConcept Action that contributed to avoiding the adverse event --></item[x]> </preventiveAction> <mitigatingAction> <!-- 0..* Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm --> <item[x]><!-- 1..1 Reference(DocumentReference|MedicationAdministration| MedicationRequest|Procedure)|CodeableConcept Ameliorating action taken after the adverse event occured in order to reduce the extent of harm --></item[x]> </mitigatingAction> <supportingInfo> <!-- 0..* Supporting information relevant to the event --> <item[x]><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference| FamilyMemberHistory|Immunization|MedicationAdministration| MedicationStatement|Observation|Procedure|QuestionnaireResponse)| CodeableConcept Subject medical history or document relevant to this adverse event --></item[x]> </supportingInfo> <note><!-- 0..* Annotation Comment on adverse event --></note> </AdverseEvent>
JSON Template
{
"resourceType" : "",
"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|
ResearchSubject) }, // R! Subject impacted by event
"encounter" : { Reference(Encounter) }, // The Encounter associated with the start of the AdverseEvent
// occurrence[x]: When the event occurred. One of these 3:
"occurrenceDateTime" : "<dateTime>",
"occurrencePeriod" : { Period },
"occurrenceTiming" : { Timing },
"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|ResearchSubject) }, // 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|ResearchSubject) } // 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[x]: Refers to the specific entity that caused the adverse event. One of these 2:
"instanceCodeableConcept" : { CodeableConcept },
"instanceReference" : { Reference(BiologicallyDerivedProduct|Device|Immunization|
Medication|MedicationAdministration|MedicationStatement|Procedure|
ResearchStudy|Substance) },
"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|ResearchSubject) } // Author of the information on the possible cause of the event
}
}],
"|
|
"
"
"contributingFactor" : [{ // Contributing factors suspected to have increased the probability or severity of the adverse event
// item[x]: Item suspected to have increased the probability or severity of the adverse event. One of these 2:
"itemReference" : { Reference(AllergyIntolerance|Condition|Device|DeviceUsage|
DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration|
MedicationStatement|Observation|Procedure) },
"itemCodeableConcept" : { CodeableConcept }
}],
"preventiveAction" : [{ // Preventive actions that contributed to avoiding the adverse event
// item[x]: Action that contributed to avoiding the adverse event. One of these 2:
"itemReference" : { Reference(DocumentReference|Immunization|
MedicationAdministration|MedicationRequest|Procedure) },
"itemCodeableConcept" : { CodeableConcept }
}],
"mitigatingAction" : [{ // Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
// item[x]:
Ameliorating action taken after the adverse event occured in order to reduce the extent of harm. One of these 2:
"itemReference" : { Reference(DocumentReference|MedicationAdministration|
MedicationRequest|Procedure) },
"itemCodeableConcept" : { CodeableConcept }
}],
"supportingInfo" : [{ // Supporting information relevant to the event
// item[x]: Subject medical history or document relevant to this adverse event. One of these 2:
"itemReference" : { Reference(AllergyIntolerance|Condition|DocumentReference|
FamilyMemberHistory|Immunization|MedicationAdministration|
MedicationStatement|Observation|Procedure|QuestionnaireResponse) },
"itemCodeableConcept" : { CodeableConcept }
}],
"note" : [{ Annotation }] // Comment on adverse event
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .[ a fhir:;[ a fhir:AdverseEvent; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtensionfhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir:| fhir: fhir: fhir: fhir: fhir: ], ...; ], ...; fhir:| fhir: fhir:fhir:identifier ( [ Identifier ] ... ) ; # 0..* Business identifier for the event fhir:status [ code ] ; # 1..1 in-progress | completed | entered-in-error | unknown fhir:actuality [ code ] ; # 1..1 actual | potential fhir:category ( [ CodeableConcept ] ... ) ; # 0..* wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site fhir:code [ CodeableConcept ] ; # 0..1 Event or incident that occurred or was averted fhir:subject [ Reference(Group|Patient|Practitioner|RelatedPerson|ResearchSubject) ] ; # 1..1 Subject impacted by event fhir:encounter [ Reference(Encounter) ] ; # 0..1 The Encounter associated with the start of the AdverseEvent # occurrence[x] : 0..1 When the event occurred. One of these 3 fhir:occurrence [ a fhir:dateTime ; dateTime ] fhir:occurrence [ a fhir:Period ; Period ] fhir:occurrence [ a fhir:Timing ; Timing ] 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 event fhir:recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson|ResearchSubject) ] ; # 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 involvement fhir:actor [ Reference(CareTeam|Device|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson| ResearchSubject) ] ; # 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 # instance[x] : 1..1 Refers to the specific entity that caused the adverse event. One of these 2 fhir:instance [ a fhir:CodeableConcept ; CodeableConcept ] fhir:instance [ a fhir:Reference ; Reference(BiologicallyDerivedProduct|Device|Immunization|Medication| MedicationAdministration|MedicationStatement|Procedure|ResearchStudy|Substance) ] 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 event fhir:author [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson|ResearchSubject) ] ; # 0..1 Author of the information on the possible cause of the event ] ; ] ... ) ; fhir:contributingFactor ( [ # 0..* Contributing factors suspected to have increased the probability or severity of the adverse event # item[x] : 1..1 Item suspected to have increased the probability or severity of the adverse event. One of these 2 fhir:item [ a fhir:Reference ; Reference(AllergyIntolerance|Condition|Device|DeviceUsage|DocumentReference| FamilyMemberHistory|Immunization|MedicationAdministration|MedicationStatement| Observation|Procedure) ] fhir:item [ a fhir:CodeableConcept ; CodeableConcept ] ] ... ) ; fhir:preventiveAction ( [ # 0..* Preventive actions that contributed to avoiding the adverse event # item[x] : 1..1 Action that contributed to avoiding the adverse event. One of these 2 fhir:item [ a fhir:Reference ; Reference(DocumentReference|Immunization|MedicationAdministration|MedicationRequest| Procedure) ] fhir:item [ a fhir:CodeableConcept ; CodeableConcept ] ] ... ) ; fhir:mitigatingAction ( [ # 0..* Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm # item[x] : 1..1 Ameliorating action taken after the adverse event occured in order to reduce the extent of harm. One of these 2 fhir:item [ a fhir:Reference ; Reference(DocumentReference|MedicationAdministration|MedicationRequest|Procedure) ] fhir:item [ a fhir:CodeableConcept ; CodeableConcept ] ] ... ) ; fhir:supportingInfo ( [ # 0..* Supporting information relevant to the event # item[x] : 1..1 Subject medical history or document relevant to this adverse event. One of these 2 fhir:item [ a fhir:Reference ; Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization| MedicationAdministration|MedicationStatement|Observation|Procedure| QuestionnaireResponse) ] fhir:item [ a fhir:CodeableConcept ; CodeableConcept ] ] ... ) ; fhir:note ( [ Annotation ] ... ) ; # 0..* Comment on adverse event ]
Changes
since
from
both
R4
and
R4B
| AdverseEvent | |
| AdverseEvent.identifier |
|
| AdverseEvent.status |
|
| AdverseEvent.category |
|
| AdverseEvent.code |
|
| AdverseEvent.subject |
|
| AdverseEvent.occurrence[x] |
|
| AdverseEvent.resultingEffect |
|
| AdverseEvent.outcome |
|
| AdverseEvent.recorder |
|
| AdverseEvent.participant |
|
| AdverseEvent.participant.function |
|
| AdverseEvent.participant.actor |
|
| AdverseEvent.expectedInResearchStudy |
|
| AdverseEvent.suspectEntity.instance[x] |
|
| AdverseEvent.suspectEntity.causality |
|
| AdverseEvent.suspectEntity.causality.assessmentMethod |
|
| AdverseEvent.suspectEntity.causality.entityRelatedness |
|
| AdverseEvent.suspectEntity.causality.author |
|
| AdverseEvent.contributingFactor |
|
| AdverseEvent.contributingFactor.item[x] |
|
| AdverseEvent.preventiveAction |
|
| AdverseEvent.preventiveAction.item[x] |
|
| AdverseEvent.mitigatingAction |
|
| AdverseEvent.mitigatingAction.item[x] |
|
| AdverseEvent.supportingInfo |
|
| AdverseEvent.supportingInfo.item[x] |
|
| 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
.
Conversions
between
R3
and
R4
for
R4B
as
XML
or
JSON
.
See
R3
<-->
R4
<-->
R5
Conversion
Maps
(status
=
1
test
that
all
execute
ok.
1
fail
round-trip
testing
and
1
r3
resources
are
invalid
(0
errors).
)
See
Conversions
Summary
.)
Structure
| Name | Flags | Card. | Type |
Description
&
Constraints
|
|---|---|---|---|---|
|
AdverseEvent
|
TU | DomainResource |
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension |
|
|
identifier
|
Σ |
|
Identifier |
Business
identifier
for
the
event
|
|
|
?! Σ | 1..1 | code |
|
|
actuality
|
?! Σ |
|
|
|
|
|
Σ |
|
CodeableConcept |
|
|
code
|
Σ |
|
CodeableConcept |
Event
or
incident
that
occurred
or
was
averted
Binding: AdverseEvent Type ( Example ) |
|
subject
| Σ | 1..1 | Reference ( Patient | Group | Practitioner | RelatedPerson | ResearchSubject ) |
Subject
impacted
by
event
|
|
encounter
|
Σ | 0..1 | Reference ( Encounter ) |
The
Encounter
|
|
occurrence[x]
|
Σ | 0..1 |
When
the
event
occurred
| |
|
occurrenceDateTime
| dateTime | |||
|
occurrencePeriod
| Period | |||
|
occurrenceTiming
|
|
Timing | ||
|
detected
|
Σ | 0..1 | dateTime |
When
the
event
was
detected
|
|
recordedDate
|
Σ | 0..1 | dateTime |
When
the
event
was
recorded
|
|
|
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: |
|
|
Σ |
|
CodeableConcept |
|
|
recorder
| Σ | 0..1 | Reference ( Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject ) |
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
|
|
|
Σ | 0..1 | CodeableConcept |
|
|
|
Σ |
|
Reference
(
|
Who
|
|
|
Σ | 0..* |
Reference
(
|
|
|
expectedInResearchStudy
| 0..1 | boolean |
Considered
likely
or
probable
or
anticipated
in
the
|
|
|
suspectEntity
|
Σ | 0..* | BackboneElement |
The
suspected
agent
causing
the
adverse
event
|
|
instance[x]
|
Σ | 1..1 |
Refers
to
the
specific
entity
that
caused
the
adverse
event
| |
|
instanceCodeableConcept
| CodeableConcept | |||
|
instanceReference
| Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy ) | |||
|
causality
|
Σ | 0..1 | BackboneElement |
Information
on
the
possible
cause
of
the
event
|
|
assessmentMethod
|
Σ | 0..1 | CodeableConcept |
Method
of
evaluating
the
relatedness
of
|
|
entityRelatedness
|
Σ | 0..1 |
|
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 | ResearchSubject ) |
Author
of
the
information
on
the
possible
cause
of
the
event
|
|
contributingFactor
|
| 0..* | BackboneElement |
Contributing
factors
suspected
to
have
increased
the
probability
or
severity
of
the
adverse
event
|
|
item[x]
|
Σ |
|
|
|
|
itemReference
|
|
Reference
(
Condition
|
Observation
|
AllergyIntolerance
|
FamilyMemberHistory
|
Immunization
|
Procedure
|
|
||
|
itemCodeableConcept
| CodeableConcept | |||
|
preventiveAction
|
| 0..* | BackboneElement |
Preventive
actions
that
contributed
to
avoiding
the
adverse
event
|
|
item[x]
|
Σ |
|
Action
that
contributed
to
avoiding
the
adverse
event
Binding: AdverseEvent Preventive Action ( Example ) | |
|
itemReference
| Reference ( Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) | |||
|
itemCodeableConcept
|
|
CodeableConcept | ||
|
mitigatingAction
| Σ | 0..* | BackboneElement |
Ameliorating
actions
taken
after
the
adverse
event
occured
in
order
to
reduce
the
extent
of
harm
|
|
item[x]
| Σ | 1..1 |
Ameliorating
action
taken
after
the
adverse
event
occured
in
order
to
reduce
the
extent
of
harm
Binding: AdverseEvent Mitigating Action ( Example ) | |
|
| Reference ( Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) | |||
|
itemCodeableConcept
| CodeableConcept | |||
|
supportingInfo
|
Σ | 0..* | BackboneElement |
Supporting
information
relevant
to
the
event
|
|
item[x]
| Σ | 1..1 |
Subject
medical
history
or
document
relevant
to
this
adverse
event
Binding: AdverseEvent Supporting Information ( Example ) | |
|
itemReference
|
Reference
(
|
|||
|
itemCodeableConcept
| CodeableConcept | |||
|
note
|
| 0..* | Annotation |
Comment
on
adverse
event
|
|
Documentation
for
this
format
|
||||
See the Extensions for this resource
XML Template
<<AdverseEvent xmlns="http://hl7.org/fhir"><</identifier> < <</category> <</event> <</subject> <</encounter> <<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><!-- 1..1 Reference(Group|Patient|Practitioner|RelatedPerson| ResearchSubject) Subject impacted by event --></subject> <encounter><!-- 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent --></encounter> <occurrence[x]><!-- 0..1 dateTime|Period|Timing When the event occurred --></occurrence[x]> <detected value="[dateTime]"/><!-- 0..1 When the event was detected --> <recordedDate value="[dateTime]"/><!-- 0..1 When the event was recorded --><</resultingCondition><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> <</severity> <</outcome><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> <</contributor>RelatedPerson|ResearchSubject) 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| PractitionerRole|RelatedPerson|ResearchSubject) 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> < <</assessment> < <</author> <</method><instance[x]><!-- 1..1 CodeableConcept|Reference(BiologicallyDerivedProduct| Device|Immunization|Medication|MedicationAdministration|MedicationStatement| Procedure|ResearchStudy|Substance) Refers to the specific entity that caused the adverse event --></instance[x]> <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| RelatedPerson|ResearchSubject) Author of the information on the possible cause of the event --></author> </causality> </suspectEntity><| | </subjectMedicalHistory> <</referenceDocument> <</study><contributingFactor> <!-- 0..* Contributing factors suspected to have increased the probability or severity of the adverse event --> <item[x]><!-- 1..1 Reference(AllergyIntolerance|Condition|Device|DeviceUsage| DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration| MedicationStatement|Observation|Procedure)|CodeableConcept Item suspected to have increased the probability or severity of the adverse event --></item[x]> </contributingFactor> <preventiveAction> <!-- 0..* Preventive actions that contributed to avoiding the adverse event --> <item[x]><!-- 1..1 Reference(DocumentReference|Immunization| MedicationAdministration|MedicationRequest|Procedure)|CodeableConcept Action that contributed to avoiding the adverse event --></item[x]> </preventiveAction> <mitigatingAction> <!-- 0..* Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm --> <item[x]><!-- 1..1 Reference(DocumentReference|MedicationAdministration| MedicationRequest|Procedure)|CodeableConcept Ameliorating action taken after the adverse event occured in order to reduce the extent of harm --></item[x]> </mitigatingAction> <supportingInfo> <!-- 0..* Supporting information relevant to the event --> <item[x]><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference| FamilyMemberHistory|Immunization|MedicationAdministration| MedicationStatement|Observation|Procedure|QuestionnaireResponse)| CodeableConcept Subject medical history or document relevant to this adverse event --></item[x]> </supportingInfo> <note><!-- 0..* Annotation Comment on adverse event --></note> </AdverseEvent>
JSON Template
{
"resourceType" : "",
"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|
ResearchSubject) }, // R! Subject impacted by event
"encounter" : { Reference(Encounter) }, // The Encounter associated with the start of the AdverseEvent
// occurrence[x]: When the event occurred. One of these 3:
"occurrenceDateTime" : "<dateTime>",
"occurrencePeriod" : { Period },
"occurrenceTiming" : { Timing },
"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|ResearchSubject) }, // 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|ResearchSubject) } // 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[x]: Refers to the specific entity that caused the adverse event. One of these 2:
"instanceCodeableConcept" : { CodeableConcept },
"instanceReference" : { Reference(BiologicallyDerivedProduct|Device|Immunization|
Medication|MedicationAdministration|MedicationStatement|Procedure|
ResearchStudy|Substance) },
"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|ResearchSubject) } // Author of the information on the possible cause of the event
}
}],
"|
|
"
"
"contributingFactor" : [{ // Contributing factors suspected to have increased the probability or severity of the adverse event
// item[x]: Item suspected to have increased the probability or severity of the adverse event. One of these 2:
"itemReference" : { Reference(AllergyIntolerance|Condition|Device|DeviceUsage|
DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration|
MedicationStatement|Observation|Procedure) },
"itemCodeableConcept" : { CodeableConcept }
}],
"preventiveAction" : [{ // Preventive actions that contributed to avoiding the adverse event
// item[x]: Action that contributed to avoiding the adverse event. One of these 2:
"itemReference" : { Reference(DocumentReference|Immunization|
MedicationAdministration|MedicationRequest|Procedure) },
"itemCodeableConcept" : { CodeableConcept }
}],
"mitigatingAction" : [{ // Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
// item[x]:
Ameliorating action taken after the adverse event occured in order to reduce the extent of harm. One of these 2:
"itemReference" : { Reference(DocumentReference|MedicationAdministration|
MedicationRequest|Procedure) },
"itemCodeableConcept" : { CodeableConcept }
}],
"supportingInfo" : [{ // Supporting information relevant to the event
// item[x]: Subject medical history or document relevant to this adverse event. One of these 2:
"itemReference" : { Reference(AllergyIntolerance|Condition|DocumentReference|
FamilyMemberHistory|Immunization|MedicationAdministration|
MedicationStatement|Observation|Procedure|QuestionnaireResponse) },
"itemCodeableConcept" : { CodeableConcept }
}],
"note" : [{ Annotation }] // Comment on adverse event
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .[ a fhir:;[ a fhir:AdverseEvent; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtensionfhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir: fhir:| fhir: fhir: fhir: fhir: fhir: ], ...; ], ...; fhir:| fhir: fhir:fhir:identifier ( [ Identifier ] ... ) ; # 0..* Business identifier for the event fhir:status [ code ] ; # 1..1 in-progress | completed | entered-in-error | unknown fhir:actuality [ code ] ; # 1..1 actual | potential fhir:category ( [ CodeableConcept ] ... ) ; # 0..* wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site fhir:code [ CodeableConcept ] ; # 0..1 Event or incident that occurred or was averted fhir:subject [ Reference(Group|Patient|Practitioner|RelatedPerson|ResearchSubject) ] ; # 1..1 Subject impacted by event fhir:encounter [ Reference(Encounter) ] ; # 0..1 The Encounter associated with the start of the AdverseEvent # occurrence[x] : 0..1 When the event occurred. One of these 3 fhir:occurrence [ a fhir:dateTime ; dateTime ] fhir:occurrence [ a fhir:Period ; Period ] fhir:occurrence [ a fhir:Timing ; Timing ] 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 event fhir:recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson|ResearchSubject) ] ; # 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 involvement fhir:actor [ Reference(CareTeam|Device|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson| ResearchSubject) ] ; # 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 # instance[x] : 1..1 Refers to the specific entity that caused the adverse event. One of these 2 fhir:instance [ a fhir:CodeableConcept ; CodeableConcept ] fhir:instance [ a fhir:Reference ; Reference(BiologicallyDerivedProduct|Device|Immunization|Medication| MedicationAdministration|MedicationStatement|Procedure|ResearchStudy|Substance) ] 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 event fhir:author [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson|ResearchSubject) ] ; # 0..1 Author of the information on the possible cause of the event ] ; ] ... ) ; fhir:contributingFactor ( [ # 0..* Contributing factors suspected to have increased the probability or severity of the adverse event # item[x] : 1..1 Item suspected to have increased the probability or severity of the adverse event. One of these 2 fhir:item [ a fhir:Reference ; Reference(AllergyIntolerance|Condition|Device|DeviceUsage|DocumentReference| FamilyMemberHistory|Immunization|MedicationAdministration|MedicationStatement| Observation|Procedure) ] fhir:item [ a fhir:CodeableConcept ; CodeableConcept ] ] ... ) ; fhir:preventiveAction ( [ # 0..* Preventive actions that contributed to avoiding the adverse event # item[x] : 1..1 Action that contributed to avoiding the adverse event. One of these 2 fhir:item [ a fhir:Reference ; Reference(DocumentReference|Immunization|MedicationAdministration|MedicationRequest| Procedure) ] fhir:item [ a fhir:CodeableConcept ; CodeableConcept ] ] ... ) ; fhir:mitigatingAction ( [ # 0..* Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm # item[x] : 1..1 Ameliorating action taken after the adverse event occured in order to reduce the extent of harm. One of these 2 fhir:item [ a fhir:Reference ; Reference(DocumentReference|MedicationAdministration|MedicationRequest|Procedure) ] fhir:item [ a fhir:CodeableConcept ; CodeableConcept ] ] ... ) ; fhir:supportingInfo ( [ # 0..* Supporting information relevant to the event # item[x] : 1..1 Subject medical history or document relevant to this adverse event. One of these 2 fhir:item [ a fhir:Reference ; Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization| MedicationAdministration|MedicationStatement|Observation|Procedure| QuestionnaireResponse) ] fhir:item [ a fhir:CodeableConcept ; CodeableConcept ] ] ... ) ; fhir:note ( [ Annotation ] ... ) ; # 0..* Comment on adverse event ]
Changes
since
Release
4
from
both
R4
and
R4B
| AdverseEvent | |
| AdverseEvent.identifier |
|
| AdverseEvent.status |
|
| AdverseEvent.category |
|
| AdverseEvent.code |
|
| AdverseEvent.subject |
|
| AdverseEvent.occurrence[x] |
|
| AdverseEvent.resultingEffect |
|
| AdverseEvent.outcome |
|
| AdverseEvent.recorder |
|
| AdverseEvent.participant |
|
| AdverseEvent.participant.function |
|
| AdverseEvent.participant.actor |
|
| AdverseEvent.expectedInResearchStudy |
|
| AdverseEvent.suspectEntity.instance[x] |
|
| AdverseEvent.suspectEntity.causality |
|
| AdverseEvent.suspectEntity.causality.assessmentMethod |
|
| AdverseEvent.suspectEntity.causality.entityRelatedness |
|
| AdverseEvent.suspectEntity.causality.author |
|
| AdverseEvent.contributingFactor |
|
| AdverseEvent.contributingFactor.item[x] |
|
| AdverseEvent.preventiveAction |
|
| AdverseEvent.preventiveAction.item[x] |
|
| AdverseEvent.mitigatingAction |
|
| AdverseEvent.mitigatingAction.item[x] |
|
| AdverseEvent.supportingInfo |
|
| AdverseEvent.supportingInfo.item[x] |
|
| 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
.
Conversions
between
R3
and
R4
for
R4B
as
XML
or
JSON
.
See
R3
<-->
R4
<-->
R5
Conversion
Maps
(status
=
1
test
that
all
execute
ok.
1
fail
round-trip
testing
and
1
r3
resources
are
invalid
(0
errors).
)
See
Conversions
Summary
.)
See
the
Profiles
&
Extensions
and
the
alternate
Additional
definitions:
Master
Definition
XML
+
JSON
,
XML
Schema
/
Schematron
+
JSON
Schema
,
ShEx
(for
Turtle
)
+
see
the
extensions
,
the
spreadsheet
version
&
the
dependency
analysis
| Path |
|
Type |
|
|---|---|---|---|
| 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 |
|
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 |
|
This value set includes codes that describe the type of outcome from the adverse event. |
| AdverseEvent.participant.function | AdverseEventParticipantFunction |
|
This value set includes codes that describe the type of involvement of the actor in the adverse event. |
| AdverseEvent.suspectEntity.causality.assessmentMethod | AdverseEventCausalityMethod | Example |
TODO. |
| AdverseEvent.suspectEntity.causality.entityRelatedness | AdverseEventCausalityAssessment | Example | Codes for the assessment of whether the entity caused the event. |
| AdverseEvent.contributingFactor.item[x] | AdverseEventContributingFactor | Example |
This value set includes codes that describe the contributing factors suspected to have increased the probability or severity of the adverse event. |
| AdverseEvent.preventiveAction.item[x] | AdverseEventPreventiveAction | Example | This value set includes codes that describe the preventive actions that contributed to avoiding the adverse event. |
| AdverseEvent.mitigatingAction.item[x] | AdverseEventMitigatingAction | Example | This value set includes codes that describe the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. |
| AdverseEvent.supportingInfo.item[x] | 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 |
|
AdverseEvent.category | |
| code | token | Event or incident that occurred or was averted | AdverseEvent.code | 22 Resources |
| date | date | When the event occurred |
|
27 Resources |
|
|
token |
|
|
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 ) | 66 Resources |
| recorder | reference | Who recorded the adverse event |
AdverseEvent.recorder
( Practitioner , Patient , PractitionerRole , ResearchSubject , RelatedPerson ) |
|
|
|
reference | Effect on the subject due to this event |
( Condition , Observation ) |
|
| seriousness | token | Seriousness or gravity of the event | AdverseEvent.seriousness | |
|
|
token |
|
|
|
| study | reference |
|
AdverseEvent.study
( ResearchStudy ) |
|
| subject | reference | Subject impacted by event |
AdverseEvent.subject
( Practitioner , Group , Patient , ResearchSubject , RelatedPerson ) |
|
| substance | reference | Refers to the specific entity that caused the adverse event |
( Immunization , BiologicallyDerivedProduct , Device , Medication , Procedure , Substance , MedicationAdministration , MedicationStatement , ResearchStudy ) |
FHIR
®©
HL7.org
2011+.
FHIR
Release
4B
(v4.3.0)
hl7.fhir.r4b.core#4.3.0
R5
hl7.fhir.core#5.0.0
generated
on
Sat,
May
28,
2022
12:53+1000.
Sun,
Mar
26,
2023
15:24+1100.
Links:
Search
|
Version
History
|
Table
of
Contents
|
Glossary
|
QA
Page
|
Compare
to
R4
|
Compare
to
R4B
|
|
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a
change