R6 Ballot (1st Draft)

This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

9.9 Resource AdverseEvent - Content

Patient Care icon Work GroupMaturity Level: 2 Trial UseSecurity 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.

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.
  • 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. DetectedIssue only applies to documenting a risk associated with a specific planned or ongoing action, or the lack of an action which should be planned - not a general propensity to risk.
  • Flags highlight highly condensed view of information found in other resources, which may include AdverseEvent. The purpose of these other resources is to provide detailed clinical information. The purpose of a Flag is to alert practitioners to information that is important to influence their interaction with a Patient prior to detailed review of the record.

9.9.3 References to this Resource

9.9.4 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent TUDomainResourceAn 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 Σ0..*IdentifierBusiness identifier for the event

... status ?!Σ1..1codein-progress | completed | entered-in-error | unknown
Binding: Adverse Event Status (Required)
... actuality ?!Σ1..1codeactual | potential
Binding: Adverse Event Actuality (Required)
... code Σ0..1CodeableConceptEvent or incident that occurred or was averted
Binding: AdverseEvent Type (Example)
... subject Σ1..1Reference(Patient | Group | Practitioner | RelatedPerson)Subject impacted by event
... encounter Σ0..1Reference(Encounter)The Encounter associated with the start of the AdverseEvent
... cause[x] Σ0..1When the cause of the AdverseEvent occurred
.... causeDateTimedateTime
.... causePeriodPeriod
... effect[x] Σ0..1When the effect of the AdverseEvent occurred
.... effectDateTimedateTime
.... effectPeriodPeriod
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingEffect Σ0..*Reference(Condition | Observation)Effect on the subject due to this event

... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness or gravity of the event
Binding: Adverse Event Seriousness (Example)
... outcome Σ0..*CodeableConceptType of outcome from the adverse event
Binding: AdverseEvent Outcome (Example)

... recorder Σ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... participant Σ0..*BackboneElementWho was involved in the adverse event or the potential adverse event and what they did

.... function Σ0..1CodeableConceptType of involvement
Binding: AdverseEvent Participant Function (Example)
.... actor Σ1..1Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson)Who was involved in the adverse event or the potential adverse event
... study Σ0..*Reference(ResearchStudy)Research study that the subject is enrolled in

... expectedInResearchStudy 0..1booleanConsidered likely or probable or anticipated in the research study
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event

.... instance[x] Σ1..1Refers to the specific entity that caused the adverse event
..... instanceCodeableConceptCodeableConcept
..... instanceReferenceReference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
.... causality Σ0..1BackboneElementInformation on the possible cause of the event
..... assessmentMethod Σ0..1CodeableConceptMethod of evaluating the relatedness of the suspected entity to the event
Binding: Adverse Event Causality Method (Example)
..... entityRelatedness Σ0..1CodeableConceptResult of the assessment regarding the relatedness of the suspected entity to the event
Binding: Adverse Event Causality Assessment (Example)
..... author Σ0..1Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)Author of the information on the possible cause of the event
... contributingFactor Σ0..*BackboneElementContributing factors suspected to have increased the probability or severity of the adverse event

.... item[x] Σ1..1Item suspected to have increased the probability or severity of the adverse event
Binding: AdverseEvent Contributing Factor (Example)
..... itemReferenceReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
..... itemCodeableConceptCodeableConcept
... preventiveAction Σ0..*BackboneElementPreventive actions that contributed to avoiding the adverse event

.... item[x] Σ1..1Action that contributed to avoiding the adverse event
Binding: AdverseEvent Preventive Action (Example)
..... itemReferenceReference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
..... itemCodeableConceptCodeableConcept
... mitigatingAction Σ0..*BackboneElementAmeliorating actions taken after the adverse event occured in order to reduce the extent of harm

.... item[x] Σ1..1Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
Binding: AdverseEvent Mitigating Action (Example)
..... itemReferenceReference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
..... itemCodeableConceptCodeableConcept
... supportingInfo Σ0..*BackboneElementSupporting information relevant to the event

.... item[x] Σ1..1Subject medical history or document relevant to this adverse event
Binding: AdverseEvent Supporting Information (Example)
..... itemReferenceReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
..... itemCodeableConceptCodeableConcept
... note Σ0..*AnnotationComment on adverse event


doco Documentation for this format icon

See the Extensions for this resource

UML Diagram (Legend)

AdverseEvent (DomainResource)Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to serveridentifier : Identifier [0..*]The current state of the adverse event or potential adverse event (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)AdverseEventStatus! »Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely (this element modifies the meaning of other elements)actuality : code [1..1] « null (Strength=Required)AdverseEventActuality! »The overall type of event, intended for search and filtering purposescategory : CodeableConcept [0..*] « null (Strength=Example)AdverseEventCategory?? »Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfusedcode : CodeableConcept [0..1] « null (Strength=Example)AdverseEventType?? »This subject or group impacted by the eventsubject : Reference [1..1] « Patient|Group|Practitioner| RelatedPerson »The Encounter associated with the start of the AdverseEventencounter : Reference [0..1] « Encounter »The date (and perhaps time) when the cause of the AdverseEvent occurredcause[x] : DataType [0..1] « dateTime|Period »The date (and perhaps time) when the effect of the AdverseEvent occurredeffect[x] : DataType [0..1] « dateTime|Period »Estimated or actual date the AdverseEvent began, in the opinion of the reporterdetected : dateTime [0..1]The date on which the existence of the AdverseEvent was first recordedrecordedDate : dateTime [0..1]Information about the condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fallresultingEffect : Reference [0..*] « Condition|Observation »The information about where the adverse event occurredlocation : Reference [0..1] « Location »Assessment whether this event, or averted event, was of clinical importanceseriousness : CodeableConcept [0..1] « null (Strength=Example)AdverseEventSeriousness?? »Describes the type of outcome from the adverse event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fataloutcome : CodeableConcept [0..*] « null (Strength=Example)AdverseEventOutcome?? »Information on who recorded the adverse event. May be the patient or a practitionerrecorder : Reference [0..1] « Patient|Practitioner|PractitionerRole| RelatedPerson »The research study that the subject is enrolled instudy : Reference [0..*] « ResearchStudy »Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likelyexpectedInResearchStudy : boolean [0..1]Comments made about the adverse event by the performer, subject or other participantsnote : Annotation [0..*]ParticipantDistinguishes the type of involvement of the actor in the adverse event, such as contributor or informantfunction : CodeableConcept [0..1] « null (Strength=Example)AdverseEventParticipantFuncti...?? »Indicates who or what participated in the eventactor : Reference [1..1] « Practitioner|PractitionerRole| Organization|CareTeam|Patient|Device|RelatedPerson »SuspectEntityIdentifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a deviceinstance[x] : DataType [1..1] « CodeableConcept|Reference( Immunization|Procedure|Substance|Medication| MedicationAdministration|MedicationStatement|Device| BiologicallyDerivedProduct|ResearchStudy) »CausalityThe method of evaluating the relatedness of the suspected entity to the eventassessmentMethod : CodeableConcept [0..1] « null (Strength=Example) AdverseEventCausalityMethod?? »The result of the assessment regarding the relatedness of the suspected entity to the evententityRelatedness : CodeableConcept [0..1] « null (Strength=Example) AdverseEventCausalityAssessme...?? »The author of the information on the possible cause of the eventauthor : Reference [0..1] « Practitioner|PractitionerRole|Patient| RelatedPerson »ContributingFactorThe item that is suspected to have increased the probability or severity of the adverse eventitem[x] : DataType [1..1] « Reference(Condition|Observation| AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure| Device|DeviceUsage|DocumentReference|MedicationAdministration| MedicationStatement)|CodeableConcept; null (Strength=Example) AdverseEventContributingFactor?? »PreventiveActionThe action that contributed to avoiding the adverse eventitem[x] : DataType [1..1] « Reference(Immunization|Procedure| DocumentReference|MedicationAdministration|MedicationRequest)| CodeableConcept; null (Strength=Example)AdverseEventPreventiveAction?? »MitigatingActionThe ameliorating action taken after the adverse event occured in order to reduce the extent of harmitem[x] : DataType [1..1] « Reference(Procedure|DocumentReference| MedicationAdministration|MedicationRequest)|CodeableConcept; null (Strength=Example) AdverseEventMitigatingAction?? »SupportingInfoRelevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating actionitem[x] : DataType [1..1] « Reference(Condition|Observation| AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure| DocumentReference|MedicationAdministration|MedicationStatement| QuestionnaireResponse)|CodeableConcept; null (Strength=Example) AdverseEventSupportingInforat...?? »Indicates who or what participated in the adverse event and how they were involvedparticipant[0..*]Information on the possible cause of the eventcausality[0..1]Describes the entity that is suspected to have caused the adverse eventsuspectEntity[0..*]The contributing factors suspected to have increased the probability or severity of the adverse eventcontributingFactor[0..*]Preventive actions that contributed to avoiding the adverse eventpreventiveAction[0..*]The ameliorating action taken after the adverse event occured in order to reduce the extent of harmmitigatingAction[0..*]Supporting information relevant to the eventsupportingInfo[0..*]

XML Template

<AdverseEvent xmlns="http://hl7.org/fhir"> doco
 <!-- 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) Subject impacted by event --></subject>
 <encounter><!-- 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent --></encounter>
 <cause[x]><!-- 0..1 dateTime|Period When the cause of the AdverseEvent occurred --></cause[x]>
 <effect[x]><!-- 0..1 dateTime|Period When the effect of the AdverseEvent occurred --></effect[x]>
 <detected value="[dateTime]"/><!-- 0..1 When the event was detected -->
 <recordedDate value="[dateTime]"/><!-- 0..1 When the event was recorded -->
 <resultingEffect><!-- 0..* Reference(Condition|Observation) Effect on the subject due to this event --></resultingEffect>
 <location><!-- 0..1 Reference(Location) Location where adverse event occurred --></location>
 <seriousness><!-- 0..1 CodeableConcept Seriousness or gravity of the event --></seriousness>
 <outcome><!-- 0..* CodeableConcept Type of outcome from the adverse event --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <participant>  <!-- 0..* Who was involved in the adverse event or the potential adverse event and what they did -->
  <function><!-- 0..1 CodeableConcept Type of involvement --></function>
  <actor><!-- 1..1 Reference(CareTeam|Device|Organization|Patient|Practitioner|
    PractitionerRole|RelatedPerson) Who was involved in the adverse event or the potential adverse event --></actor>
 </participant>
 <study><!-- 0..* Reference(ResearchStudy) Research study that the subject is enrolled in --></study>
 <expectedInResearchStudy value="[boolean]"/><!-- 0..1 Considered likely or probable or anticipated in the research study -->
 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <instance[x]><!-- 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) 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

{doco
  "resourceType" : "AdverseEvent",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for the event
  "status" : "<code>", // R!  in-progress | completed | entered-in-error | unknown
  "actuality" : "<code>", // R!  actual | potential
  "category" : [{ CodeableConcept }], // wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
  "code" : { CodeableConcept }, // Event or incident that occurred or was averted
  "subject" : { Reference(Group|Patient|Practitioner|RelatedPerson) }, // R!  Subject impacted by event
  "encounter" : { Reference(Encounter) }, // The Encounter associated with the start of the AdverseEvent
  // cause[x]: When the cause of the AdverseEvent occurred. One of these 2:
  "causeDateTime" : "<dateTime>",
  "causePeriod" : { Period },
  // effect[x]: When the effect of the AdverseEvent occurred. One of these 2:
  "effectDateTime" : "<dateTime>",
  "effectPeriod" : { Period },
  "detected" : "<dateTime>", // When the event was detected
  "recordedDate" : "<dateTime>", // When the event was recorded
  "resultingEffect" : [{ Reference(Condition|Observation) }], // Effect on the subject due to this event
  "location" : { Reference(Location) }, // Location where adverse event occurred
  "seriousness" : { CodeableConcept }, // Seriousness or gravity of the event
  "outcome" : [{ CodeableConcept }], // Type of outcome from the adverse event
  "recorder" : { Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) }, // Who recorded the adverse event
  "participant" : [{ // Who was involved in the adverse event or the potential adverse event and what they did
    "function" : { CodeableConcept }, // Type of involvement
    "actor" : { Reference(CareTeam|Device|Organization|Patient|Practitioner|
    PractitionerRole|RelatedPerson) } // R!  Who was involved in the adverse event or the potential adverse event
  }],
  "study" : [{ Reference(ResearchStudy) }], // Research study that the subject is enrolled in
  "expectedInResearchStudy" : <boolean>, // Considered likely or probable or anticipated in the research study
  "suspectEntity" : [{ // The suspected agent causing the adverse event
    // instance[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) } // 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/> .doco


[ 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) ] ; # 1..1 Subject impacted by event
  fhir:encounter [ Reference(Encounter) ] ; # 0..1 The Encounter associated with the start of the AdverseEvent
  # cause[x] : 0..1 When the cause of the AdverseEvent occurred. One of these 2
    fhir:cause [  a fhir:dateTime ; dateTime ]
    fhir:cause [  a fhir:Period ; Period ]
  # effect[x] : 0..1 When the effect of the AdverseEvent occurred. One of these 2
    fhir:effect [  a fhir:dateTime ; dateTime ]
    fhir:effect [  a fhir:Period ; Period ]
  fhir:detected [ dateTime ] ; # 0..1 When the event was detected
  fhir:recordedDate [ dateTime ] ; # 0..1 When the event was recorded
  fhir:resultingEffect  ( [ Reference(Condition|Observation) ] ... ) ; # 0..* Effect on the subject due to this event
  fhir:location [ Reference(Location) ] ; # 0..1 Location where adverse event occurred
  fhir:seriousness [ CodeableConcept ] ; # 0..1 Seriousness or gravity of the event
  fhir:outcome  ( [ CodeableConcept ] ... ) ; # 0..* Type of outcome from the adverse event
  fhir:recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 Who recorded the adverse event
  fhir:participant ( [ # 0..* Who was involved in the adverse event or the potential adverse event and what they did
    fhir:function [ CodeableConcept ] ; # 0..1 Type of involvement
    fhir:actor [ Reference(CareTeam|Device|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 1..1 Who was involved in the adverse event or the potential adverse event
  ] ... ) ;
  fhir:study  ( [ Reference(ResearchStudy) ] ... ) ; # 0..* Research study that the subject is enrolled in
  fhir:expectedInResearchStudy [ boolean ] ; # 0..1 Considered likely or probable or anticipated in the research study
  fhir:suspectEntity ( [ # 0..* The suspected agent causing the adverse event
    # 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) ] ; # 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.cause[x]
  • Added Element
AdverseEvent.effect[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.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
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

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent TUDomainResourceAn 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 Σ0..*IdentifierBusiness identifier for the event

... status ?!Σ1..1codein-progress | completed | entered-in-error | unknown
Binding: Adverse Event Status (Required)
... actuality ?!Σ1..1codeactual | potential
Binding: Adverse Event Actuality (Required)
... code Σ0..1CodeableConceptEvent or incident that occurred or was averted
Binding: AdverseEvent Type (Example)
... subject Σ1..1Reference(Patient | Group | Practitioner | RelatedPerson)Subject impacted by event
... encounter Σ0..1Reference(Encounter)The Encounter associated with the start of the AdverseEvent
... cause[x] Σ0..1When the cause of the AdverseEvent occurred
.... causeDateTimedateTime
.... causePeriodPeriod
... effect[x] Σ0..1When the effect of the AdverseEvent occurred
.... effectDateTimedateTime
.... effectPeriodPeriod
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingEffect Σ0..*Reference(Condition | Observation)Effect on the subject due to this event

... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness or gravity of the event
Binding: Adverse Event Seriousness (Example)
... outcome Σ0..*CodeableConceptType of outcome from the adverse event
Binding: AdverseEvent Outcome (Example)

... recorder Σ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... participant Σ0..*BackboneElementWho was involved in the adverse event or the potential adverse event and what they did

.... function Σ0..1CodeableConceptType of involvement
Binding: AdverseEvent Participant Function (Example)
.... actor Σ1..1Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson)Who was involved in the adverse event or the potential adverse event
... study Σ0..*Reference(ResearchStudy)Research study that the subject is enrolled in

... expectedInResearchStudy 0..1booleanConsidered likely or probable or anticipated in the research study
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event

.... instance[x] Σ1..1Refers to the specific entity that caused the adverse event
..... instanceCodeableConceptCodeableConcept
..... instanceReferenceReference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)
.... causality Σ0..1BackboneElementInformation on the possible cause of the event
..... assessmentMethod Σ0..1CodeableConceptMethod of evaluating the relatedness of the suspected entity to the event
Binding: Adverse Event Causality Method (Example)
..... entityRelatedness Σ0..1CodeableConceptResult of the assessment regarding the relatedness of the suspected entity to the event
Binding: Adverse Event Causality Assessment (Example)
..... author Σ0..1Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)Author of the information on the possible cause of the event
... contributingFactor Σ0..*BackboneElementContributing factors suspected to have increased the probability or severity of the adverse event

.... item[x] Σ1..1Item suspected to have increased the probability or severity of the adverse event
Binding: AdverseEvent Contributing Factor (Example)
..... itemReferenceReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement)
..... itemCodeableConceptCodeableConcept
... preventiveAction Σ0..*BackboneElementPreventive actions that contributed to avoiding the adverse event

.... item[x] Σ1..1Action that contributed to avoiding the adverse event
Binding: AdverseEvent Preventive Action (Example)
..... itemReferenceReference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
..... itemCodeableConceptCodeableConcept
... mitigatingAction Σ0..*BackboneElementAmeliorating actions taken after the adverse event occured in order to reduce the extent of harm

.... item[x] Σ1..1Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
Binding: AdverseEvent Mitigating Action (Example)
..... itemReferenceReference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest)
..... itemCodeableConceptCodeableConcept
... supportingInfo Σ0..*BackboneElementSupporting information relevant to the event

.... item[x] Σ1..1Subject medical history or document relevant to this adverse event
Binding: AdverseEvent Supporting Information (Example)
..... itemReferenceReference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
..... itemCodeableConceptCodeableConcept
... note Σ0..*AnnotationComment on adverse event


doco Documentation for this format icon

See the Extensions for this resource

UML Diagram (Legend)

AdverseEvent (DomainResource)Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to serveridentifier : Identifier [0..*]The current state of the adverse event or potential adverse event (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)AdverseEventStatus! »Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely (this element modifies the meaning of other elements)actuality : code [1..1] « null (Strength=Required)AdverseEventActuality! »The overall type of event, intended for search and filtering purposescategory : CodeableConcept [0..*] « null (Strength=Example)AdverseEventCategory?? »Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfusedcode : CodeableConcept [0..1] « null (Strength=Example)AdverseEventType?? »This subject or group impacted by the eventsubject : Reference [1..1] « Patient|Group|Practitioner| RelatedPerson »The Encounter associated with the start of the AdverseEventencounter : Reference [0..1] « Encounter »The date (and perhaps time) when the cause of the AdverseEvent occurredcause[x] : DataType [0..1] « dateTime|Period »The date (and perhaps time) when the effect of the AdverseEvent occurredeffect[x] : DataType [0..1] « dateTime|Period »Estimated or actual date the AdverseEvent began, in the opinion of the reporterdetected : dateTime [0..1]The date on which the existence of the AdverseEvent was first recordedrecordedDate : dateTime [0..1]Information about the condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fallresultingEffect : Reference [0..*] « Condition|Observation »The information about where the adverse event occurredlocation : Reference [0..1] « Location »Assessment whether this event, or averted event, was of clinical importanceseriousness : CodeableConcept [0..1] « null (Strength=Example)AdverseEventSeriousness?? »Describes the type of outcome from the adverse event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fataloutcome : CodeableConcept [0..*] « null (Strength=Example)AdverseEventOutcome?? »Information on who recorded the adverse event. May be the patient or a practitionerrecorder : Reference [0..1] « Patient|Practitioner|PractitionerRole| RelatedPerson »The research study that the subject is enrolled instudy : Reference [0..*] « ResearchStudy »Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likelyexpectedInResearchStudy : boolean [0..1]Comments made about the adverse event by the performer, subject or other participantsnote : Annotation [0..*]ParticipantDistinguishes the type of involvement of the actor in the adverse event, such as contributor or informantfunction : CodeableConcept [0..1] « null (Strength=Example)AdverseEventParticipantFuncti...?? »Indicates who or what participated in the eventactor : Reference [1..1] « Practitioner|PractitionerRole| Organization|CareTeam|Patient|Device|RelatedPerson »SuspectEntityIdentifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a deviceinstance[x] : DataType [1..1] « CodeableConcept|Reference( Immunization|Procedure|Substance|Medication| MedicationAdministration|MedicationStatement|Device| BiologicallyDerivedProduct|ResearchStudy) »CausalityThe method of evaluating the relatedness of the suspected entity to the eventassessmentMethod : CodeableConcept [0..1] « null (Strength=Example) AdverseEventCausalityMethod?? »The result of the assessment regarding the relatedness of the suspected entity to the evententityRelatedness : CodeableConcept [0..1] « null (Strength=Example) AdverseEventCausalityAssessme...?? »The author of the information on the possible cause of the eventauthor : Reference [0..1] « Practitioner|PractitionerRole|Patient| RelatedPerson »ContributingFactorThe item that is suspected to have increased the probability or severity of the adverse eventitem[x] : DataType [1..1] « Reference(Condition|Observation| AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure| Device|DeviceUsage|DocumentReference|MedicationAdministration| MedicationStatement)|CodeableConcept; null (Strength=Example) AdverseEventContributingFactor?? »PreventiveActionThe action that contributed to avoiding the adverse eventitem[x] : DataType [1..1] « Reference(Immunization|Procedure| DocumentReference|MedicationAdministration|MedicationRequest)| CodeableConcept; null (Strength=Example)AdverseEventPreventiveAction?? »MitigatingActionThe ameliorating action taken after the adverse event occured in order to reduce the extent of harmitem[x] : DataType [1..1] « Reference(Procedure|DocumentReference| MedicationAdministration|MedicationRequest)|CodeableConcept; null (Strength=Example) AdverseEventMitigatingAction?? »SupportingInfoRelevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating actionitem[x] : DataType [1..1] « Reference(Condition|Observation| AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure| DocumentReference|MedicationAdministration|MedicationStatement| QuestionnaireResponse)|CodeableConcept; null (Strength=Example) AdverseEventSupportingInforat...?? »Indicates who or what participated in the adverse event and how they were involvedparticipant[0..*]Information on the possible cause of the eventcausality[0..1]Describes the entity that is suspected to have caused the adverse eventsuspectEntity[0..*]The contributing factors suspected to have increased the probability or severity of the adverse eventcontributingFactor[0..*]Preventive actions that contributed to avoiding the adverse eventpreventiveAction[0..*]The ameliorating action taken after the adverse event occured in order to reduce the extent of harmmitigatingAction[0..*]Supporting information relevant to the eventsupportingInfo[0..*]

XML Template

<AdverseEvent xmlns="http://hl7.org/fhir"> doco
 <!-- 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) Subject impacted by event --></subject>
 <encounter><!-- 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent --></encounter>
 <cause[x]><!-- 0..1 dateTime|Period When the cause of the AdverseEvent occurred --></cause[x]>
 <effect[x]><!-- 0..1 dateTime|Period When the effect of the AdverseEvent occurred --></effect[x]>
 <detected value="[dateTime]"/><!-- 0..1 When the event was detected -->
 <recordedDate value="[dateTime]"/><!-- 0..1 When the event was recorded -->
 <resultingEffect><!-- 0..* Reference(Condition|Observation) Effect on the subject due to this event --></resultingEffect>
 <location><!-- 0..1 Reference(Location) Location where adverse event occurred --></location>
 <seriousness><!-- 0..1 CodeableConcept Seriousness or gravity of the event --></seriousness>
 <outcome><!-- 0..* CodeableConcept Type of outcome from the adverse event --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <participant>  <!-- 0..* Who was involved in the adverse event or the potential adverse event and what they did -->
  <function><!-- 0..1 CodeableConcept Type of involvement --></function>
  <actor><!-- 1..1 Reference(CareTeam|Device|Organization|Patient|Practitioner|
    PractitionerRole|RelatedPerson) Who was involved in the adverse event or the potential adverse event --></actor>
 </participant>
 <study><!-- 0..* Reference(ResearchStudy) Research study that the subject is enrolled in --></study>
 <expectedInResearchStudy value="[boolean]"/><!-- 0..1 Considered likely or probable or anticipated in the research study -->
 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <instance[x]><!-- 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) 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

{doco
  "resourceType" : "AdverseEvent",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for the event
  "status" : "<code>", // R!  in-progress | completed | entered-in-error | unknown
  "actuality" : "<code>", // R!  actual | potential
  "category" : [{ CodeableConcept }], // wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
  "code" : { CodeableConcept }, // Event or incident that occurred or was averted
  "subject" : { Reference(Group|Patient|Practitioner|RelatedPerson) }, // R!  Subject impacted by event
  "encounter" : { Reference(Encounter) }, // The Encounter associated with the start of the AdverseEvent
  // cause[x]: When the cause of the AdverseEvent occurred. One of these 2:
  "causeDateTime" : "<dateTime>",
  "causePeriod" : { Period },
  // effect[x]: When the effect of the AdverseEvent occurred. One of these 2:
  "effectDateTime" : "<dateTime>",
  "effectPeriod" : { Period },
  "detected" : "<dateTime>", // When the event was detected
  "recordedDate" : "<dateTime>", // When the event was recorded
  "resultingEffect" : [{ Reference(Condition|Observation) }], // Effect on the subject due to this event
  "location" : { Reference(Location) }, // Location where adverse event occurred
  "seriousness" : { CodeableConcept }, // Seriousness or gravity of the event
  "outcome" : [{ CodeableConcept }], // Type of outcome from the adverse event
  "recorder" : { Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) }, // Who recorded the adverse event
  "participant" : [{ // Who was involved in the adverse event or the potential adverse event and what they did
    "function" : { CodeableConcept }, // Type of involvement
    "actor" : { Reference(CareTeam|Device|Organization|Patient|Practitioner|
    PractitionerRole|RelatedPerson) } // R!  Who was involved in the adverse event or the potential adverse event
  }],
  "study" : [{ Reference(ResearchStudy) }], // Research study that the subject is enrolled in
  "expectedInResearchStudy" : <boolean>, // Considered likely or probable or anticipated in the research study
  "suspectEntity" : [{ // The suspected agent causing the adverse event
    // instance[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) } // 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/> .doco


[ 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) ] ; # 1..1 Subject impacted by event
  fhir:encounter [ Reference(Encounter) ] ; # 0..1 The Encounter associated with the start of the AdverseEvent
  # cause[x] : 0..1 When the cause of the AdverseEvent occurred. One of these 2
    fhir:cause [  a fhir:dateTime ; dateTime ]
    fhir:cause [  a fhir:Period ; Period ]
  # effect[x] : 0..1 When the effect of the AdverseEvent occurred. One of these 2
    fhir:effect [  a fhir:dateTime ; dateTime ]
    fhir:effect [  a fhir:Period ; Period ]
  fhir:detected [ dateTime ] ; # 0..1 When the event was detected
  fhir:recordedDate [ dateTime ] ; # 0..1 When the event was recorded
  fhir:resultingEffect  ( [ Reference(Condition|Observation) ] ... ) ; # 0..* Effect on the subject due to this event
  fhir:location [ Reference(Location) ] ; # 0..1 Location where adverse event occurred
  fhir:seriousness [ CodeableConcept ] ; # 0..1 Seriousness or gravity of the event
  fhir:outcome  ( [ CodeableConcept ] ... ) ; # 0..* Type of outcome from the adverse event
  fhir:recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 Who recorded the adverse event
  fhir:participant ( [ # 0..* Who was involved in the adverse event or the potential adverse event and what they did
    fhir:function [ CodeableConcept ] ; # 0..1 Type of involvement
    fhir:actor [ Reference(CareTeam|Device|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 1..1 Who was involved in the adverse event or the potential adverse event
  ] ... ) ;
  fhir:study  ( [ Reference(ResearchStudy) ] ... ) ; # 0..* Research study that the subject is enrolled in
  fhir:expectedInResearchStudy [ boolean ] ; # 0..1 Considered likely or probable or anticipated in the research study
  fhir:suspectEntity ( [ # 0..* The suspected agent causing the adverse event
    # 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) ] ; # 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.cause[x]
  • Added Element
AdverseEvent.effect[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.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
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

PathValueSetTypeDocumentation
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.

NameTypeDescriptionExpressionIn Common
actualitytokenactual | potentialAdverseEvent.actuality
categorytokenwrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-siteAdverseEvent.category
causedateWhen the cause of the event occurredAdverseEvent.cause.ofType(dateTime) | AdverseEvent.cause.ofType(Period)
codetokenEvent or incident that occurred or was avertedAdverseEvent.code22 Resources
effectdateWhen the effect of the event occurredAdverseEvent.effect.ofType(dateTime) | AdverseEvent.effect.ofType(Period)
identifiertokenBusiness identifier for the eventAdverseEvent.identifier65 Resources
locationreferenceLocation where adverse event occurredAdverseEvent.location
(Location)
patientreferenceSubject impacted by eventAdverseEvent.subject.where(resolve() is Patient)
(Patient)		66 Resources
recorderreferenceWho recorded the adverse eventAdverseEvent.recorder
(Practitioner, Patient, PractitionerRole, RelatedPerson)
resultingeffectreferenceEffect on the subject due to this eventAdverseEvent.resultingEffect
(Condition, Observation)
seriousnesstokenSeriousness or gravity of the eventAdverseEvent.seriousness
statustokenin-progress | completed | entered-in-error | unknownAdverseEvent.status
studyreferenceResearch study that the subject is enrolled inAdverseEvent.study
(ResearchStudy)
subjectreferenceSubject impacted by eventAdverseEvent.subject
(Practitioner, Group, Patient, RelatedPerson)
substancereferenceRefers to the specific entity that caused the adverse event(AdverseEvent.suspectEntity.instance as Reference)
(Immunization, BiologicallyDerivedProduct, Device, Medication, Procedure, Substance, MedicationAdministration, MedicationStatement, ResearchStudy)