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9.9 Resource AdverseEvent - Content

Patient Care icon

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.

9.9.1 Scope and Usage

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 icon and Clinical Research adverse events icon 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 icon and the Clinical Research AdverseEvent Implementation Guide icon They contain valuable extensions, value sets and, importantly, examples.

9.9.2 Boundaries and Relationships

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.

The AllergyIntolerance resource is a case specific means of capturing the condition of an allergy or intolerance and the criticality (or potential for future harm) based on the response of a particular individual.
The Clinical Reasoning module provides resources and operations to enable the representation, distribution, and evaluation of clinical knowledge artifacts, such as clinical decision support rules, quality measures, order sets, and protocols. The suite of resources within the clinical reasoning module should be used to capture clinical quality measures and clinical protocols that help drive clinical best practices.
The AdverseEvent resource is not intended to be used to capture potential subject risk in a prospective manner. A more appropriate resource for this purpose would be RiskAssessment which captures predicted outcomes for a patient or population on the basis of source information. Examples include a prognosis statement for a particular condition, risk of health outcome (heart attack, particular type of cancer) on the basis of lifestyle factors and/or family history, or list of potential health risks based on a patient's genetic analysis.

9.9.3 References to this Resource

Implements: Event

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 \| ResearchSubject)	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent
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
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 \| 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
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 \| ResearchSubject)	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[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 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 \| ResearchSubject)	Author of the information on the possible cause of the event
contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEvent Contributing Factor (Example)
itemReference			Reference(Condition \| Observation \| AllergyIntolerance \| FamilyMemberHistory \| Immunization \| Procedure \| Device \| DeviceUsage \| DocumentReference \| MedicationAdministration \| MedicationStatement)
itemCodeableConcept			CodeableConcept
preventiveAction	Σ	0..*	BackboneElement	Preventive actions that contributed to avoiding the adverse event
item[x]	Σ	1..1		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)
itemReference			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(Condition \| Observation \| AllergyIntolerance \| FamilyMemberHistory \| Immunization \| Procedure \| DocumentReference \| MedicationAdministration \| MedicationStatement \| QuestionnaireResponse)
itemCodeableConcept			CodeableConcept
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><!-- 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 -->
 <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|
   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[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>
 <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" : "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:AdverseEvent;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  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 from both R4 and R4B

AdverseEvent

AdverseEvent.identifier

Max Cardinality changed from 1 to *

AdverseEvent.status

Added Mandatory Element

AdverseEvent.category

Remove Binding `http://hl7.org/fhir/ValueSet/adverse-event-category` (extensible)

AdverseEvent.code

Renamed from event to code

AdverseEvent.subject

Type Reference: Added Target Type ResearchSubject

AdverseEvent.occurrence[x]

Added Element

AdverseEvent.resultingEffect

Renamed from resultingCondition to resultingEffect
Type Reference: Added Target Type Observation

AdverseEvent.outcome

Max Cardinality changed from 1 to *
Remove Binding `http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.0` (required)

AdverseEvent.recorder

Type Reference: Added Target Type ResearchSubject

AdverseEvent.participant

Added Element

AdverseEvent.participant.function

Added Element

AdverseEvent.participant.actor

Added Mandatory Element

AdverseEvent.expectedInResearchStudy

Added Element

AdverseEvent.suspectEntity.instance[x]

Renamed from instance to instance[x]
Add Type CodeableConcept

AdverseEvent.suspectEntity.causality

Max Cardinality changed from * to 1

AdverseEvent.suspectEntity.causality.assessmentMethod

Added Element

AdverseEvent.suspectEntity.causality.entityRelatedness

Renamed from productRelatedness to entityRelatedness
Type changed from string to CodeableConcept

AdverseEvent.suspectEntity.causality.author

Type Reference: Added Target Types Patient, RelatedPerson, ResearchSubject

AdverseEvent.contributingFactor

Added Element

AdverseEvent.contributingFactor.item[x]

Added Mandatory Element

AdverseEvent.preventiveAction

Added Element

AdverseEvent.preventiveAction.item[x]

Added Mandatory Element

AdverseEvent.mitigatingAction

Added Element

AdverseEvent.mitigatingAction.item[x]

Added Mandatory Element

AdverseEvent.supportingInfo

Added Element

AdverseEvent.supportingInfo.item[x]

Added Mandatory Element

AdverseEvent.note

Added Element

AdverseEvent.date

Deleted

AdverseEvent.severity

Deleted (AdverseEvent.severity is redundant with Condition.severity referenced via AdverseEvent.resultingEffect)

AdverseEvent.contributor

Deleted (-> AdverseEvent.participant.actor)

AdverseEvent.suspectEntity.causality.assessment

Deleted (-> AdverseEvent.suspectEntity.causality.assessmentMethod)

AdverseEvent.suspectEntity.causality.method

Deleted (-> AdverseEvent.suspectEntity.causality.assessmentMethod)

AdverseEvent.subjectMedicalHistory

Deleted (-> AdverseEvent.supportingInfo)

AdverseEvent.referenceDocument

Deleted (-> AdverseEvent.supportingInfo)

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

See R4 <--> R5 Conversion Maps (status = See Conversions Summary.)

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 \| ResearchSubject)	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent
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
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 \| 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
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 \| ResearchSubject)	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[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 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 \| ResearchSubject)	Author of the information on the possible cause of the event
contributingFactor	Σ	0..*	BackboneElement	Contributing factors suspected to have increased the probability or severity of the adverse event
item[x]	Σ	1..1		Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEvent Contributing Factor (Example)
itemReference			Reference(Condition \| Observation \| AllergyIntolerance \| FamilyMemberHistory \| Immunization \| Procedure \| Device \| DeviceUsage \| DocumentReference \| MedicationAdministration \| MedicationStatement)
itemCodeableConcept			CodeableConcept
preventiveAction	Σ	0..*	BackboneElement	Preventive actions that contributed to avoiding the adverse event
item[x]	Σ	1..1		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)
itemReference			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(Condition \| Observation \| AllergyIntolerance \| FamilyMemberHistory \| Immunization \| Procedure \| DocumentReference \| MedicationAdministration \| MedicationStatement \| QuestionnaireResponse)
itemCodeableConcept			CodeableConcept
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><!-- 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 -->
 <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|
   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[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>
 <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" : "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:AdverseEvent;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  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 from both R4 and R4B

AdverseEvent

AdverseEvent.identifier

Max Cardinality changed from 1 to *

AdverseEvent.status

Added Mandatory Element

AdverseEvent.category

Remove Binding `http://hl7.org/fhir/ValueSet/adverse-event-category` (extensible)

AdverseEvent.code

Renamed from event to code

AdverseEvent.subject

Type Reference: Added Target Type ResearchSubject

AdverseEvent.occurrence[x]

Added Element

AdverseEvent.resultingEffect

Renamed from resultingCondition to resultingEffect
Type Reference: Added Target Type Observation

AdverseEvent.outcome

Max Cardinality changed from 1 to *
Remove Binding `http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.0` (required)

AdverseEvent.recorder

Type Reference: Added Target Type ResearchSubject

AdverseEvent.participant

Added Element

AdverseEvent.participant.function

Added Element

AdverseEvent.participant.actor

Added Mandatory Element

AdverseEvent.expectedInResearchStudy

Added Element

AdverseEvent.suspectEntity.instance[x]

Renamed from instance to instance[x]
Add Type CodeableConcept

AdverseEvent.suspectEntity.causality

Max Cardinality changed from * to 1

AdverseEvent.suspectEntity.causality.assessmentMethod

Added Element

AdverseEvent.suspectEntity.causality.entityRelatedness

Renamed from productRelatedness to entityRelatedness
Type changed from string to CodeableConcept

AdverseEvent.suspectEntity.causality.author

Type Reference: Added Target Types Patient, RelatedPerson, ResearchSubject

AdverseEvent.contributingFactor

Added Element

AdverseEvent.contributingFactor.item[x]

Added Mandatory Element

AdverseEvent.preventiveAction

Added Element

AdverseEvent.preventiveAction.item[x]

Added Mandatory Element

AdverseEvent.mitigatingAction

Added Element

AdverseEvent.mitigatingAction.item[x]

Added Mandatory Element

AdverseEvent.supportingInfo

Added Element

AdverseEvent.supportingInfo.item[x]

Added Mandatory Element

AdverseEvent.note

Added Element

AdverseEvent.date

Deleted

AdverseEvent.severity

Deleted (AdverseEvent.severity is redundant with Condition.severity referenced via AdverseEvent.resultingEffect)

AdverseEvent.contributor

Deleted (-> AdverseEvent.participant.actor)

AdverseEvent.suspectEntity.causality.assessment

Deleted (-> AdverseEvent.suspectEntity.causality.assessmentMethod)

AdverseEvent.suspectEntity.causality.method

Deleted (-> AdverseEvent.suspectEntity.causality.assessmentMethod)

AdverseEvent.subjectMedicalHistory

Deleted (-> AdverseEvent.supportingInfo)

AdverseEvent.referenceDocument

Deleted (-> AdverseEvent.supportingInfo)

See the Full Difference for further information

This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.

See R4 <--> R5 Conversion Maps (status = See Conversions Summary.)

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

9.9.4.1 Terminology Bindings

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	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.

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

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.

9.9.5 Search Parameters

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
code	token	Event or incident that occurred or was averted	AdverseEvent.code	22 Resources
date	date	When the event occurred	AdverseEvent.occurrence.ofType(dateTime) \| AdverseEvent.occurrence.ofType(Period) \| AdverseEvent.occurrence.ofType(Timing)	27 Resources
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)	66 Resources
recorder	reference	Who recorded the adverse event	AdverseEvent.recorder (Practitioner, Patient, PractitionerRole, ResearchSubject, RelatedPerson)
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, ResearchSubject, RelatedPerson)
substance	reference	Refers to the specific entity that caused the adverse event	(AdverseEvent.suspectEntity.instance as Reference) (Immunization, BiologicallyDerivedProduct, Device, Medication, Procedure, Substance, MedicationAdministration, MedicationStatement, ResearchStudy)