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9.9 Resource AdverseEvent - Content

Patient Care Work GroupMaturity Level: 0 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 subject. The unintended effects may require additional monitoring, treatment or hospitalization or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects.

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. The form of the reporting is left to implementation guides based upon appropriate workflow patterns.

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.

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.

A potential adverse event may also be called a near miss or an error. These are also events but because 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.

The AdverseEvent resource is designed to represent events that have 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 including but not limited to Observation, Condition, MedicationAdminsitration, 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, and 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 Risk Assessment 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.

No resources refer to this resource directly.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent ΣTUDomainResourceMedical care, research study or other healthcare event causing physical injury
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the event
... actuality ?!Σ1..1codeactual | potential
AdverseEventActuality (Required)
... category Σ0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
AdverseEventCategory (Extensible)
... code Σ0..1CodeableConceptEvent or incident that occurred or was averted
AdverseEvent Type (Example)
... subject Σ1..1Reference(Patient | Group | Practitioner | RelatedPerson)Subject impacted by event
... encounter Σ0..1Reference(Encounter)The Encounter during which this AdverseEvent was created
... date Σ0..1dateTimeWhen the event occurred
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingCondition Σ0..*Reference(Condition)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
AdverseEventSeriousness (Example)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown
AdverseEventOutcome (Required)
... recorder Σ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
... detector Σ0..*Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Device)Who or what identified a change in physiological state or condition
... 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 | MedicationUsage | Device)
.... causality Σ0..*BackboneElementInformation on the possible cause of the event
..... assessmentMethod Σ0..1CodeableConceptMethod of evaluating the relatedness of the suspected entity to the event
AdverseEventCausalityMethod (Example)
..... entityRelatedness Σ0..1CodeableConceptResult of the assessment regarding the relatedness of the suspected entity to the event
AdverseEventCausalityAssessment (Example)
..... author Σ0..1Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)Author of the information on the possible cause of the event
... supportingInfo Σ0..*BackboneElementSupporting information relevant to the event
.... item Σ1..1Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference)Subject medical history or document relevant to this adverse event
.... contributingFactor Σ0..1booleanIf true, the item has been assessed to be a contributing factor of the adverse event
... study Σ0..*Reference(ResearchStudy)Research study that the subject is enrolled in

doco Documentation for this format

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..*]Whether the event actually happened, or just had the potential to. 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] « Overall nature of the adverse event, e.g. real or potential. (Strength=Required)AdverseEventActuality! »The overall type of event, intended for search and filtering purposescategory : CodeableConcept [0..*] « Overall categorization of the event, e.g. product-related or situational. (Strength=Extensible)AdverseEventCategory+ »Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfusedcode : CodeableConcept [0..1] « Detailed type of event. (Strength=Example)AdverseEvent Type?? »This subject or group impacted by the eventsubject : Reference [1..1] « Patient|Group|Practitioner| RelatedPerson »The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associatedencounter : Reference [0..1] « Encounter »The date (and perhaps time) when the adverse event occurreddate : dateTime [0..1]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]Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical)resultingCondition : Reference [0..*] « Condition »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] « Overall seriousness of this event for the patient. (Strength=Example)AdverseEventSeriousness?? »Describes the type of outcome from the adverse eventoutcome : CodeableConcept [0..1] « TODO (and should this be required?). (Strength=Required)AdverseEventOutcome! »Information on who recorded the adverse event. May be the patient or a practitionerrecorder : Reference [0..1] « Patient|Practitioner|PractitionerRole| RelatedPerson »Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness)contributor : Reference [0..*] « Practitioner|PractitionerRole| Device »Who or what identified a change in physiological state or conditiondetector : Reference [0..*] « Patient|RelatedPerson|Practitioner| PractitionerRole|Device »The research study that the subject is enrolled instudy : Reference [0..*] « ResearchStudy »SuspectEntityIdentifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a deviceinstance[x] : Type [1..1] « CodeableConcept|Reference(Immunization| Procedure|Substance|Medication|MedicationAdministration| MedicationUsage|Device) »CausalityThe method of evaluating the relatedness of the suspected entity to the eventassessmentMethod : CodeableConcept [0..1] « TODO. (Strength=Example) AdverseEventCausalityMethod?? »The result of the assessment regarding the relatedness of the suspected entity to the evententityRelatedness : CodeableConcept [0..1] « Codes for the assessment of whether the entity caused the event. (Strength=Example) AdverseEventCausalityAssessme...?? »The author of the information on the possible cause of the eventauthor : Reference [0..1] « Practitioner|PractitionerRole|Patient| RelatedPerson »SupportingInfoRelevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penciliin 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)item : Reference [1..1] « Condition|Observation|AllergyIntolerance| FamilyMemberHistory|Immunization|Procedure|DocumentReference »If true, the item has been assessed to be a contributing factor of the adverse eventcontributingFactor : boolean [0..1]Information on the possible cause of the eventcausality[0..*]Describes the entity that is suspected to have caused the adverse eventsuspectEntity[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>
 <actuality value="[code]"/><!-- 1..1 actual | potential -->
 <category><!-- 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment --></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 during which this AdverseEvent was created --></encounter>
 <date value="[dateTime]"/><!-- 0..1 When the event occurred -->
 <detected value="[dateTime]"/><!-- 0..1 When the event was detected -->
 <recordedDate value="[dateTime]"/><!-- 0..1 When the event was recorded -->
 <resultingCondition><!-- 0..* Reference(Condition) Effect on the subject due to this event --></resultingCondition>
 <location><!-- 0..1 Reference(Location) Location where adverse event occurred --></location>
 <seriousness><!-- 0..1 CodeableConcept Seriousness or gravity of the event --></seriousness>
 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <contributor><!-- 0..* Reference(Device|Practitioner|PractitionerRole) Who  was involved in the adverse event or the potential adverse event --></contributor>
 <detector><!-- 0..* Reference(Device|Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who or what identified a change in physiological state or condition --></detector>
 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <instance[x]><!-- 1..1 CodeableConcept|Reference(Device|Immunization|Medication|
    MedicationAdministration|MedicationUsage|Procedure|Substance) Refers to the specific entity that caused the adverse event --></instance[x]>
  <causality>  <!-- 0..* 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>
 <supportingInfo>  <!-- 0..* Supporting information relevant to the event -->
  <item><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure) Subject medical history or document relevant to this adverse event --></item>
  <contributingFactor value="[boolean]"/><!-- 0..1 If true, the item has been assessed to be a contributing factor of the adverse event -->
 </supportingInfo>
 <study><!-- 0..* Reference(ResearchStudy) Research study that the subject is enrolled in --></study>
</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
  "actuality" : "<code>", // R!  actual | potential
  "category" : [{ CodeableConcept }], // product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
  "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 during which this AdverseEvent was created
  "date" : "<dateTime>", // When the event occurred
  "detected" : "<dateTime>", // When the event was detected
  "recordedDate" : "<dateTime>", // When the event was recorded
  "resultingCondition" : [{ Reference(Condition) }], // 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 }, // resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown
  "recorder" : { Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) }, // Who recorded the adverse event
  "contributor" : [{ Reference(Device|Practitioner|PractitionerRole) }], // Who  was involved in the adverse event or the potential adverse event
  "detector" : [{ Reference(Device|Patient|Practitioner|PractitionerRole|
   RelatedPerson) }], // Who or what identified a change in physiological state or condition
  "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(Device|Immunization|Medication|
    MedicationAdministration|MedicationUsage|Procedure|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
    }]
  }],
  "supportingInfo" : [{ // Supporting information relevant to the event
    "item" : { Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure) }, // R!  Subject medical history or document relevant to this adverse event
    "contributingFactor" : <boolean> // If true, the item has been assessed to be a contributing factor of the adverse event
  }],
  "study" : [{ Reference(ResearchStudy) }] // Research study that the subject is enrolled in
}

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:AdverseEvent.identifier [ Identifier ], ... ; # 0..* Business identifier for the event
  fhir:AdverseEvent.actuality [ code ]; # 1..1 actual | potential
  fhir:AdverseEvent.category [ CodeableConcept ], ... ; # 0..* product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
  fhir:AdverseEvent.code [ CodeableConcept ]; # 0..1 Event or incident that occurred or was averted
  fhir:AdverseEvent.subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ]; # 1..1 Subject impacted by event
  fhir:AdverseEvent.encounter [ Reference(Encounter) ]; # 0..1 The Encounter during which this AdverseEvent was created
  fhir:AdverseEvent.date [ dateTime ]; # 0..1 When the event occurred
  fhir:AdverseEvent.detected [ dateTime ]; # 0..1 When the event was detected
  fhir:AdverseEvent.recordedDate [ dateTime ]; # 0..1 When the event was recorded
  fhir:AdverseEvent.resultingCondition [ Reference(Condition) ], ... ; # 0..* Effect on the subject due to this event
  fhir:AdverseEvent.location [ Reference(Location) ]; # 0..1 Location where adverse event occurred
  fhir:AdverseEvent.seriousness [ CodeableConcept ]; # 0..1 Seriousness or gravity of the event
  fhir:AdverseEvent.outcome [ CodeableConcept ]; # 0..1 resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown
  fhir:AdverseEvent.recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 0..1 Who recorded the adverse event
  fhir:AdverseEvent.contributor [ Reference(Device|Practitioner|PractitionerRole) ], ... ; # 0..* Who  was involved in the adverse event or the potential adverse event
  fhir:AdverseEvent.detector [ Reference(Device|Patient|Practitioner|PractitionerRole|RelatedPerson) ], ... ; # 0..* Who or what identified a change in physiological state or condition
  fhir:AdverseEvent.suspectEntity [ # 0..* The suspected agent causing the adverse event
    # AdverseEvent.suspectEntity.instance[x] : 1..1 Refers to the specific entity that caused the adverse event. One of these 2
      fhir:AdverseEvent.suspectEntity.instanceCodeableConcept [ CodeableConcept ]
      fhir:AdverseEvent.suspectEntity.instanceReference [ Reference(Device|Immunization|Medication|MedicationAdministration|MedicationUsage|
  Procedure|Substance) ]
    fhir:AdverseEvent.suspectEntity.causality [ # 0..* Information on the possible cause of the event
      fhir:AdverseEvent.suspectEntity.causality.assessmentMethod [ CodeableConcept ]; # 0..1 Method of evaluating the relatedness of the suspected entity to the event
      fhir:AdverseEvent.suspectEntity.causality.entityRelatedness [ CodeableConcept ]; # 0..1 Result of the assessment regarding the relatedness of the suspected entity to the event
      fhir:AdverseEvent.suspectEntity.causality.author [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 0..1 Author of the information on the possible cause of the event
    ], ...;
  ], ...;
  fhir:AdverseEvent.supportingInfo [ # 0..* Supporting information relevant to the event
    fhir:AdverseEvent.supportingInfo.item [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Observation|Procedure) ]; # 1..1 Subject medical history or document relevant to this adverse event
    fhir:AdverseEvent.supportingInfo.contributingFactor [ boolean ]; # 0..1 If true, the item has been assessed to be a contributing factor of the adverse event
  ], ...;
  fhir:AdverseEvent.study [ Reference(ResearchStudy) ], ... ; # 0..* Research study that the subject is enrolled in
]

Changes since R3

AdverseEvent
AdverseEvent.identifier
  • Max Cardinality changed from 1 to *
AdverseEvent.actuality
  • Change value set from http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.0 to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.1.0
AdverseEvent.code
  • Added Element
AdverseEvent.outcome
  • Change value set from http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.0 to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.1.0
AdverseEvent.detector
  • Added Element
AdverseEvent.suspectEntity.instance[x]
  • Added Mandatory Element
AdverseEvent.suspectEntity.causality.assessmentMethod
  • Added Element
AdverseEvent.suspectEntity.causality.entityRelatedness
  • Added Element
AdverseEvent.suspectEntity.causality.author
  • Type Reference: Added Target Types Patient, RelatedPerson
AdverseEvent.supportingInfo
  • Added Element
AdverseEvent.supportingInfo.item
  • Added Mandatory Element
AdverseEvent.supportingInfo.contributingFactor
  • Added Element
AdverseEvent.event
  • deleted
AdverseEvent.severity
  • deleted
AdverseEvent.suspectEntity.instance
  • deleted
AdverseEvent.suspectEntity.causality.assessment
  • deleted
AdverseEvent.suspectEntity.causality.productRelatedness
  • deleted
AdverseEvent.suspectEntity.causality.method
  • deleted
AdverseEvent.subjectMedicalHistory
  • deleted
AdverseEvent.referenceDocument
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. 1 fail round-trip testing and 1 r3 resources are invalid (0 errors).)

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent ΣTUDomainResourceMedical care, research study or other healthcare event causing physical injury
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the event
... actuality ?!Σ1..1codeactual | potential
AdverseEventActuality (Required)
... category Σ0..*CodeableConceptproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
AdverseEventCategory (Extensible)
... code Σ0..1CodeableConceptEvent or incident that occurred or was averted
AdverseEvent Type (Example)
... subject Σ1..1Reference(Patient | Group | Practitioner | RelatedPerson)Subject impacted by event
... encounter Σ0..1Reference(Encounter)The Encounter during which this AdverseEvent was created
... date Σ0..1dateTimeWhen the event occurred
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingCondition Σ0..*Reference(Condition)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
AdverseEventSeriousness (Example)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown
AdverseEventOutcome (Required)
... recorder Σ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
... detector Σ0..*Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Device)Who or what identified a change in physiological state or condition
... 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 | MedicationUsage | Device)
.... causality Σ0..*BackboneElementInformation on the possible cause of the event
..... assessmentMethod Σ0..1CodeableConceptMethod of evaluating the relatedness of the suspected entity to the event
AdverseEventCausalityMethod (Example)
..... entityRelatedness Σ0..1CodeableConceptResult of the assessment regarding the relatedness of the suspected entity to the event
AdverseEventCausalityAssessment (Example)
..... author Σ0..1Reference(Practitioner | PractitionerRole | Patient | RelatedPerson)Author of the information on the possible cause of the event
... supportingInfo Σ0..*BackboneElementSupporting information relevant to the event
.... item Σ1..1Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference)Subject medical history or document relevant to this adverse event
.... contributingFactor Σ0..1booleanIf true, the item has been assessed to be a contributing factor of the adverse event
... study Σ0..*Reference(ResearchStudy)Research study that the subject is enrolled in

doco Documentation for this format

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..*]Whether the event actually happened, or just had the potential to. 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] « Overall nature of the adverse event, e.g. real or potential. (Strength=Required)AdverseEventActuality! »The overall type of event, intended for search and filtering purposescategory : CodeableConcept [0..*] « Overall categorization of the event, e.g. product-related or situational. (Strength=Extensible)AdverseEventCategory+ »Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfusedcode : CodeableConcept [0..1] « Detailed type of event. (Strength=Example)AdverseEvent Type?? »This subject or group impacted by the eventsubject : Reference [1..1] « Patient|Group|Practitioner| RelatedPerson »The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associatedencounter : Reference [0..1] « Encounter »The date (and perhaps time) when the adverse event occurreddate : dateTime [0..1]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]Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical)resultingCondition : Reference [0..*] « Condition »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] « Overall seriousness of this event for the patient. (Strength=Example)AdverseEventSeriousness?? »Describes the type of outcome from the adverse eventoutcome : CodeableConcept [0..1] « TODO (and should this be required?). (Strength=Required)AdverseEventOutcome! »Information on who recorded the adverse event. May be the patient or a practitionerrecorder : Reference [0..1] « Patient|Practitioner|PractitionerRole| RelatedPerson »Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness)contributor : Reference [0..*] « Practitioner|PractitionerRole| Device »Who or what identified a change in physiological state or conditiondetector : Reference [0..*] « Patient|RelatedPerson|Practitioner| PractitionerRole|Device »The research study that the subject is enrolled instudy : Reference [0..*] « ResearchStudy »SuspectEntityIdentifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a deviceinstance[x] : Type [1..1] « CodeableConcept|Reference(Immunization| Procedure|Substance|Medication|MedicationAdministration| MedicationUsage|Device) »CausalityThe method of evaluating the relatedness of the suspected entity to the eventassessmentMethod : CodeableConcept [0..1] « TODO. (Strength=Example) AdverseEventCausalityMethod?? »The result of the assessment regarding the relatedness of the suspected entity to the evententityRelatedness : CodeableConcept [0..1] « Codes for the assessment of whether the entity caused the event. (Strength=Example) AdverseEventCausalityAssessme...?? »The author of the information on the possible cause of the eventauthor : Reference [0..1] « Practitioner|PractitionerRole|Patient| RelatedPerson »SupportingInfoRelevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penciliin 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)item : Reference [1..1] « Condition|Observation|AllergyIntolerance| FamilyMemberHistory|Immunization|Procedure|DocumentReference »If true, the item has been assessed to be a contributing factor of the adverse eventcontributingFactor : boolean [0..1]Information on the possible cause of the eventcausality[0..*]Describes the entity that is suspected to have caused the adverse eventsuspectEntity[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>
 <actuality value="[code]"/><!-- 1..1 actual | potential -->
 <category><!-- 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment --></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 during which this AdverseEvent was created --></encounter>
 <date value="[dateTime]"/><!-- 0..1 When the event occurred -->
 <detected value="[dateTime]"/><!-- 0..1 When the event was detected -->
 <recordedDate value="[dateTime]"/><!-- 0..1 When the event was recorded -->
 <resultingCondition><!-- 0..* Reference(Condition) Effect on the subject due to this event --></resultingCondition>
 <location><!-- 0..1 Reference(Location) Location where adverse event occurred --></location>
 <seriousness><!-- 0..1 CodeableConcept Seriousness or gravity of the event --></seriousness>
 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <contributor><!-- 0..* Reference(Device|Practitioner|PractitionerRole) Who  was involved in the adverse event or the potential adverse event --></contributor>
 <detector><!-- 0..* Reference(Device|Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who or what identified a change in physiological state or condition --></detector>
 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <instance[x]><!-- 1..1 CodeableConcept|Reference(Device|Immunization|Medication|
    MedicationAdministration|MedicationUsage|Procedure|Substance) Refers to the specific entity that caused the adverse event --></instance[x]>
  <causality>  <!-- 0..* 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>
 <supportingInfo>  <!-- 0..* Supporting information relevant to the event -->
  <item><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure) Subject medical history or document relevant to this adverse event --></item>
  <contributingFactor value="[boolean]"/><!-- 0..1 If true, the item has been assessed to be a contributing factor of the adverse event -->
 </supportingInfo>
 <study><!-- 0..* Reference(ResearchStudy) Research study that the subject is enrolled in --></study>
</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
  "actuality" : "<code>", // R!  actual | potential
  "category" : [{ CodeableConcept }], // product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
  "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 during which this AdverseEvent was created
  "date" : "<dateTime>", // When the event occurred
  "detected" : "<dateTime>", // When the event was detected
  "recordedDate" : "<dateTime>", // When the event was recorded
  "resultingCondition" : [{ Reference(Condition) }], // 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 }, // resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown
  "recorder" : { Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) }, // Who recorded the adverse event
  "contributor" : [{ Reference(Device|Practitioner|PractitionerRole) }], // Who  was involved in the adverse event or the potential adverse event
  "detector" : [{ Reference(Device|Patient|Practitioner|PractitionerRole|
   RelatedPerson) }], // Who or what identified a change in physiological state or condition
  "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(Device|Immunization|Medication|
    MedicationAdministration|MedicationUsage|Procedure|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
    }]
  }],
  "supportingInfo" : [{ // Supporting information relevant to the event
    "item" : { Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure) }, // R!  Subject medical history or document relevant to this adverse event
    "contributingFactor" : <boolean> // If true, the item has been assessed to be a contributing factor of the adverse event
  }],
  "study" : [{ Reference(ResearchStudy) }] // Research study that the subject is enrolled in
}

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:AdverseEvent.identifier [ Identifier ], ... ; # 0..* Business identifier for the event
  fhir:AdverseEvent.actuality [ code ]; # 1..1 actual | potential
  fhir:AdverseEvent.category [ CodeableConcept ], ... ; # 0..* product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
  fhir:AdverseEvent.code [ CodeableConcept ]; # 0..1 Event or incident that occurred or was averted
  fhir:AdverseEvent.subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ]; # 1..1 Subject impacted by event
  fhir:AdverseEvent.encounter [ Reference(Encounter) ]; # 0..1 The Encounter during which this AdverseEvent was created
  fhir:AdverseEvent.date [ dateTime ]; # 0..1 When the event occurred
  fhir:AdverseEvent.detected [ dateTime ]; # 0..1 When the event was detected
  fhir:AdverseEvent.recordedDate [ dateTime ]; # 0..1 When the event was recorded
  fhir:AdverseEvent.resultingCondition [ Reference(Condition) ], ... ; # 0..* Effect on the subject due to this event
  fhir:AdverseEvent.location [ Reference(Location) ]; # 0..1 Location where adverse event occurred
  fhir:AdverseEvent.seriousness [ CodeableConcept ]; # 0..1 Seriousness or gravity of the event
  fhir:AdverseEvent.outcome [ CodeableConcept ]; # 0..1 resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown
  fhir:AdverseEvent.recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 0..1 Who recorded the adverse event
  fhir:AdverseEvent.contributor [ Reference(Device|Practitioner|PractitionerRole) ], ... ; # 0..* Who  was involved in the adverse event or the potential adverse event
  fhir:AdverseEvent.detector [ Reference(Device|Patient|Practitioner|PractitionerRole|RelatedPerson) ], ... ; # 0..* Who or what identified a change in physiological state or condition
  fhir:AdverseEvent.suspectEntity [ # 0..* The suspected agent causing the adverse event
    # AdverseEvent.suspectEntity.instance[x] : 1..1 Refers to the specific entity that caused the adverse event. One of these 2
      fhir:AdverseEvent.suspectEntity.instanceCodeableConcept [ CodeableConcept ]
      fhir:AdverseEvent.suspectEntity.instanceReference [ Reference(Device|Immunization|Medication|MedicationAdministration|MedicationUsage|
  Procedure|Substance) ]
    fhir:AdverseEvent.suspectEntity.causality [ # 0..* Information on the possible cause of the event
      fhir:AdverseEvent.suspectEntity.causality.assessmentMethod [ CodeableConcept ]; # 0..1 Method of evaluating the relatedness of the suspected entity to the event
      fhir:AdverseEvent.suspectEntity.causality.entityRelatedness [ CodeableConcept ]; # 0..1 Result of the assessment regarding the relatedness of the suspected entity to the event
      fhir:AdverseEvent.suspectEntity.causality.author [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 0..1 Author of the information on the possible cause of the event
    ], ...;
  ], ...;
  fhir:AdverseEvent.supportingInfo [ # 0..* Supporting information relevant to the event
    fhir:AdverseEvent.supportingInfo.item [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Observation|Procedure) ]; # 1..1 Subject medical history or document relevant to this adverse event
    fhir:AdverseEvent.supportingInfo.contributingFactor [ boolean ]; # 0..1 If true, the item has been assessed to be a contributing factor of the adverse event
  ], ...;
  fhir:AdverseEvent.study [ Reference(ResearchStudy) ], ... ; # 0..* Research study that the subject is enrolled in
]

Changes since Release 3

AdverseEvent
AdverseEvent.identifier
  • Max Cardinality changed from 1 to *
AdverseEvent.actuality
  • Change value set from http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.0 to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.1.0
AdverseEvent.code
  • Added Element
AdverseEvent.outcome
  • Change value set from http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.0 to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.1.0
AdverseEvent.detector
  • Added Element
AdverseEvent.suspectEntity.instance[x]
  • Added Mandatory Element
AdverseEvent.suspectEntity.causality.assessmentMethod
  • Added Element
AdverseEvent.suspectEntity.causality.entityRelatedness
  • Added Element
AdverseEvent.suspectEntity.causality.author
  • Type Reference: Added Target Types Patient, RelatedPerson
AdverseEvent.supportingInfo
  • Added Element
AdverseEvent.supportingInfo.item
  • Added Mandatory Element
AdverseEvent.supportingInfo.contributingFactor
  • Added Element
AdverseEvent.event
  • deleted
AdverseEvent.severity
  • deleted
AdverseEvent.suspectEntity.instance
  • deleted
AdverseEvent.suspectEntity.causality.assessment
  • deleted
AdverseEvent.suspectEntity.causality.productRelatedness
  • deleted
AdverseEvent.suspectEntity.causality.method
  • deleted
AdverseEvent.subjectMedicalHistory
  • deleted
AdverseEvent.referenceDocument
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. 1 fail round-trip testing and 1 r3 resources are invalid (0 errors).)

 

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis a

PathDefinitionTypeReference
AdverseEvent.actuality Overall nature of the adverse event, e.g. real or potential.RequiredAdverseEventActuality
AdverseEvent.category Overall categorization of the event, e.g. product-related or situational.ExtensibleAdverseEventCategory
AdverseEvent.code Detailed type of event.ExampleAdverseEvent Type
AdverseEvent.seriousness Overall seriousness of this event for the patient.ExampleAdverseEventSeriousness
AdverseEvent.outcome TODO (and should this be required?).RequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessmentMethod TODO.ExampleAdverseEventCausalityMethod
AdverseEvent.suspectEntity.causality.entityRelatedness Codes for the assessment of whether the entity caused the event.ExampleAdverseEventCausalityAssessment

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
actualitytokenactual | potentialAdverseEvent.actuality
categorytokenproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environmentAdverseEvent.category
codetokenEvent or incident that occurred or was avertedAdverseEvent.code
datedateWhen the event occurredAdverseEvent.date
identifiertokenBusiness identifier for the eventAdverseEvent.identifier
locationreferenceLocation where adverse event occurredAdverseEvent.location
(Location)
patientreferenceSubject impacted by eventAdverseEvent.subject
(Practitioner, Group, Patient, RelatedPerson)
recorderreferenceWho recorded the adverse eventAdverseEvent.recorder
(Practitioner, Patient, PractitionerRole, RelatedPerson)
resultingconditionreferenceEffect on the subject due to this eventAdverseEvent.resultingCondition
(Condition)
seriousnesstokenSeriousness or gravity of the eventAdverseEvent.seriousness
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, Device, Medication, Procedure, Substance, MedicationAdministration, MedicationUsage)