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9.9 Resource AdverseEvent - Content

Patient Care Work Group Maturity Level : 0   Draft Trial Use Security Category : Patient Compartments : Patient , Practitioner , RelatedPerson

Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.

AdverseEvent is an event resource from a FHIR workflow perspective - see Workflow Event

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

Name Flags Card. Type Description & Constraints doco
. . AdverseEvent Σ D TU DomainResource Medical care, research study or other healthcare event causing physical injury
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier Σ 0..1 0..* Identifier Business identifier for the event
. . . actuality ?! Σ 1..1 code actual | potential
AdverseEventActuality ( Required )
. . . category Σ 0..* CodeableConcept ProductProblem product-problem | ProductQuality product-quality | ProductUseError product-use-error | WrongDose wrong-dose | IncorrectPrescribingInformation incorrect-prescribing-information | WrongTechnique wrong-technique | WrongRouteOfAdministration wrong-route-of-administration | WrongRate wrong-rate | WrongDuration wrong-duration | WrongTime wrong-time | ExpiredDrug expired-drug | MedicalDeviceUseError medical-device-use-error | ProblemDifferentManufacturer problem-different-manufacturer | UnsafePhysicalEnvironment unsafe-physical-environment
AdverseEventCategory ( Extensible )
. . . event Σ 0..1 CodeableConcept Type of the event itself in relation to the subject
SNOMED CT Clinical Findings ( Example )
. . . subject Σ 1..1 Reference ( Patient | Group | Practitioner | RelatedPerson ) Subject impacted by event
. . . context encounter Σ 0..1 Reference ( Encounter | EpisodeOfCare ) The Encounter or episode of care that establishes the context for during which this AdverseEvent was created
. . . date Σ 0..1 dateTime When the event occurred
. . . detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
.. . resultingCondition Σ 0..* Reference ( Condition ) Effect on the subject due to this event
. . . location Σ 0..1 Reference ( Location ) Location where adverse event occurred
. . . seriousness Σ 0..1 CodeableConcept Seriousness of the event
AdverseEventSeriousness ( Example )
. . . severity Σ 0..1 CodeableConcept Mild mild | Moderate moderate | Severe severe
AdverseEventSeverity ( Required )
. . . outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
AdverseEventOutcome ( Required )
. . . recorder Σ 0..1 Reference ( Patient | Practitioner | PractitionerRole | RelatedPerson ) Who recorded the adverse event
. . . contributor Σ 0..* Reference ( Practitioner | PractitionerRole | Device ) Who was involved in the adverse event or the potential adverse event
. . . detector Σ 0..* Reference ( Patient | RelatedPerson | Practitioner | PractitionerRole | Device ) Who or what identified a change in physiological state or condition
. . . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
. . . instance . instance[x] Σ 1..1 Refers to the specific entity that caused the adverse event
..... instanceCodeableConcept CodeableConcept
..... instanceReference Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement MedicationUsage | Device ) Refers to the specific entity that caused the adverse event
. . . . causality Σ 0..* BackboneElement Information on the possible cause of the event
. . . . . assessment assessmentMethod Σ 0..1 CodeableConcept Assessment Method of if evaluating the relatedness of the suspected entity caused to the event
AdverseEventCausalityAssessment AdverseEventCausalityMethod ( Example )
. . . . productRelatedness . entityRelatedness Σ 0..1 string CodeableConcept AdverseEvent.suspectEntity.causalityProductRelatedness Result of the assessment regarding the relatedness of the suspected entity to the event
AdverseEventCausalityAssessment ( Example )
. . . . . author Σ 0..1 Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson ) AdverseEvent.suspectEntity.causalityAuthor Author of the information on the possible cause of the event
. . method . supportingInfo Σ 0..1 0..* CodeableConcept BackboneElement ProbabilityScale | Bayesian | Checklist Supporting information relevant to the event
AdverseEventCausalityMethod ( Example )
. . . . subjectMedicalHistory item Σ 0..* 1..1 Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference ) AdverseEvent.subjectMedicalHistory Subject medical history or document relevant to this adverse event
. . referenceDocument . . contributingFactor Σ 0..* 0..1 Reference ( DocumentReference boolean ) AdverseEvent.referenceDocument If true, the item has been assessed to be a contributing factor of the adverse event
. . . study Σ 0..* Reference ( ResearchStudy ) AdverseEvent.study 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 server identifier : Identifier [0..1] [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 potential. (Strength=Required) AdverseEventActuality ! » The overall type of event, intended for search and filtering purposes category : CodeableConcept [0..*] « Overall categorization of the event, e.g. product related product-related or situational situational. (Strength=Extensible) AdverseEventCategory + » This element defines the specific type of event that occurred or that was prevented from occurring event : CodeableConcept [0..1] « Detailed type of event event. (Strength=Example) SNOMED CT Clinical Findings SNOMEDCTClinicalFindings ?? » This subject or group impacted by the event subject : Reference [1..1] « Patient | Group | Practitioner | RelatedPerson » The encounter Encounter during which AdverseEvent was created or episode of care that establishes to which the context for creation of this AdverseEvent record is tightly associated context encounter : Reference [0..1] « Encounter | EpisodeOfCare » The date (and perhaps time) when the adverse event occurred date : dateTime [0..1] Estimated or actual date the AdverseEvent began, in the opinion of the reporter detected : dateTime [0..1] The date on which the existence of the AdverseEvent was first recorded recordedDate : 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 occurred location : Reference [0..1] « Location » Assessment whether this event was of real importance seriousness : CodeableConcept [0..1] « Overall seriousness of this event for the patient patient. (Strength=Example) AdverseEventSeriousness ?? » Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.serious AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is severity : CodeableConcept [0..1] « The severity of the adverse event itself, in direct relation to the subject subject. (Strength=Required) AdverseEventSeverity ! » Describes the type of outcome from the adverse event outcome : CodeableConcept [0..1] « TODO (and should this be required?) required?). (Strength=Required) AdverseEventOutcome ! » Information on who recorded the adverse event. May be the patient or a practitioner recorder : 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 » AdverseEvent.subjectMedicalHistory Who or what identified a change in physiological state or condition subjectMedicalHistory detector : Reference [0..*] « Condition | Observation | AllergyIntolerance | FamilyMemberHistory Patient | Immunization RelatedPerson | Procedure Practitioner | Media PractitionerRole | DocumentReference » AdverseEvent.referenceDocument referenceDocument : Reference [0..*] « DocumentReference Device » AdverseEvent.study The research study that the subject is enrolled in study : Reference [0..*] « ResearchStudy » SuspectEntity Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device instance instance[x] : Reference Type [1..1] « CodeableConcept | Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement MedicationUsage | Device ) » Causality Assessment The method of if evaluating the relatedness of the suspected entity caused to the event assessment assessmentMethod : CodeableConcept [0..1] « TODO TODO. (Strength=Example) AdverseEventCausalityAssessme... AdverseEventCausalityMethod ?? » AdverseEvent.suspectEntity.causalityProductRelatedness The result of the assessment regarding the relatedness of the suspected entity to the event productRelatedness entityRelatedness : string CodeableConcept [0..1] « Codes for the assessment of whether the entity caused the event. (Strength=Example) AdverseEventCausalityAssessme... ?? » AdverseEvent.suspectEntity.causalityAuthor The author of the information on the possible cause of the event author : Reference [0..1] « Practitioner | PractitionerRole | Patient | RelatedPerson » SupportingInfo ProbabilityScale | Bayesian | Checklist Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following penciliin and the patient was given penicillin in the past. 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) method item : CodeableConcept Reference [0..1] [1..1] « Condition | Observation | AllergyIntolerance | TODO (Strength=Example) AdverseEventCausalityMethod FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference ?? » If true, the item has been assessed to be a contributing factor of the adverse event contributingFactor : boolean [0..1] Information on the possible cause of the event causality [0..*] Describes the entity that is suspected to have caused the adverse event suspectEntity [0..*] Supporting information relevant to the event supportingInfo [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>

 <identifier><!-- 0..* Identifier Business identifier for the event --></identifier>

 <actuality value="[code]"/><!-- 1..1 actual | potential -->
 <</category>

 <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>

 <event><!-- 0..1 CodeableConcept Type of the event itself in relation to the subject --></event>
 <</subject>
 <</context>

 <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 of the event --></seriousness>
 <</severity>

 <severity><!-- 0..1 CodeableConcept mild | moderate | severe --></severity>

 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown --></outcome>
 <</recorder>
 <</contributor>

 <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>

  <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 -->
   <</assessment>
   <
   <</author>
   <</method>

   <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>
 <|
   |
   </subjectMedicalHistory>
 <</referenceDocument>
 <</study>

 <supportingInfo>  <!-- 0..* Supporting information relevant to the event -->
  <item><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Media|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

  "event" : { CodeableConcept }, // Type of the event itself in relation to the subject
  "
  "

  "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 of the event
  "

  "severity" : { CodeableConcept }, // mild | moderate | severe

  "outcome" : { CodeableConcept }, // resolved | recovering | ongoing | resolvedWithSequelae | 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|Media|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:

  fhir:AdverseEvent.identifier [ Identifier ], ... ; # 0..* Business identifier for the event

  fhir:AdverseEvent.actuality [ code ]; # 1..1 actual | potential
  fhir:

  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.event [ CodeableConcept ]; # 0..1 Type of the event itself in relation to the subject
  fhir:
  fhir:

  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 of the event
  fhir:

  fhir:AdverseEvent.severity [ CodeableConcept ]; # 0..1 mild | moderate | severe

  fhir:AdverseEvent.outcome [ CodeableConcept ]; # 0..1 resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
  fhir:
  fhir:

  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
    fhir:|
  

    # 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:
      fhir:
      fhir:
      fhir:

      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:|
  
  fhir:
  fhir:

  fhir:AdverseEvent.supportingInfo [ # 0..* Supporting information relevant to the event
    fhir:AdverseEvent.supportingInfo.item [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Media|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.actuality Added Element AdverseEvent.subjectMedicalHistory Type changed from Reference(Condition|Observation|AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure) to Reference(Condition|Observation|AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure|Media|DocumentReference) AdverseEvent.type deleted
AdverseEvent
AdverseEvent.category AdverseEvent.identifier
  • Max Cardinality changed from 1 to *
  • Type changed from code to CodeableConcept Change binding strength from required to extensible
AdverseEvent.event AdverseEvent.actuality
  • Added Element 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.subject AdverseEvent.severity
  • Min Cardinality changed from 0 to 1 Type changed Change value set from Reference(Patient|ResearchSubject|Medication|Device) http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.0 to Reference(Patient|Group|Practitioner|RelatedPerson) http://hl7.org/fhir/ValueSet/adverse-event-severity|4.1.0
AdverseEvent.context AdverseEvent.outcome
  • Added Element 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.resultingCondition AdverseEvent.detector
  • Added Element
AdverseEvent.severity AdverseEvent.suspectEntity.instance[x]
  • Added Mandatory Element
AdverseEvent.contributor AdverseEvent.suspectEntity.causality.assessmentMethod
  • Added Element
AdverseEvent.suspectEntity.instance AdverseEvent.suspectEntity.causality.entityRelatedness
  • Type changed from Reference(Substance|Medication|MedicationAdministration|MedicationStatement|Device) to Reference(Immunization|Procedure|Substance|Medication|MedicationAdministration|MedicationStatement|Device) Added Element
AdverseEvent.suspectEntity.causality AdverseEvent.suspectEntity.causality.author
  • Max Cardinality changed from 1 to * Type changed from code to BackboneElement Remove Binding http://hl7.org/fhir/ValueSet/adverse-event-causality (required) AdverseEvent.suspectEntity.causality.assessment Reference: Added Element Target Types Patient, RelatedPerson
AdverseEvent.suspectEntity.causality.productRelatedness AdverseEvent.supportingInfo
  • Added Element
AdverseEvent.suspectEntity.causality.author AdverseEvent.supportingInfo.item
  • Added Mandatory Element
AdverseEvent.suspectEntity.causality.method AdverseEvent.supportingInfo.contributingFactor
  • Added Element
AdverseEvent.reaction deleted AdverseEvent.eventParticipant deleted AdverseEvent.description AdverseEvent.suspectEntity.instance
  • deleted
AdverseEvent.suspectEntity.causalityAssessment AdverseEvent.suspectEntity.causality.assessment
  • deleted
AdverseEvent.suspectEntity.causalityProductRelatedness AdverseEvent.suspectEntity.causality.productRelatedness
  • deleted
AdverseEvent.suspectEntity.causalityMethod AdverseEvent.suspectEntity.causality.method
  • deleted
AdverseEvent.suspectEntity.causalityAuthor AdverseEvent.subjectMedicalHistory
  • deleted
AdverseEvent.suspectEntity.causalityResult 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

Name Flags Card. Type Description & Constraints doco
. . AdverseEvent Σ D TU DomainResource Medical care, research study or other healthcare event causing physical injury
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier Σ 0..1 0..* Identifier Business identifier for the event
. . . actuality ?! Σ 1..1 code actual | potential
AdverseEventActuality ( Required )
. . . category Σ 0..* CodeableConcept ProductProblem product-problem | ProductQuality product-quality | ProductUseError product-use-error | WrongDose wrong-dose | IncorrectPrescribingInformation incorrect-prescribing-information | WrongTechnique wrong-technique | WrongRouteOfAdministration wrong-route-of-administration | WrongRate wrong-rate | WrongDuration wrong-duration | WrongTime wrong-time | ExpiredDrug expired-drug | MedicalDeviceUseError medical-device-use-error | ProblemDifferentManufacturer problem-different-manufacturer | UnsafePhysicalEnvironment unsafe-physical-environment
AdverseEventCategory ( Extensible )
. . . event Σ 0..1 CodeableConcept Type of the event itself in relation to the subject
SNOMED CT Clinical Findings ( Example )
. . . subject Σ 1..1 Reference ( Patient | Group | Practitioner | RelatedPerson ) Subject impacted by event
. . . context encounter Σ 0..1 Reference ( Encounter | EpisodeOfCare ) The Encounter or episode of care that establishes the context for during which this AdverseEvent was created
. . . date Σ 0..1 dateTime When the event occurred
. . . detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
.. . resultingCondition Σ 0..* Reference ( Condition ) Effect on the subject due to this event
. . . location Σ 0..1 Reference ( Location ) Location where adverse event occurred
. . . seriousness Σ 0..1 CodeableConcept Seriousness of the event
AdverseEventSeriousness ( Example )
. . . severity Σ 0..1 CodeableConcept Mild mild | Moderate moderate | Severe severe
AdverseEventSeverity ( Required )
. . . outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
AdverseEventOutcome ( Required )
. . . recorder Σ 0..1 Reference ( Patient | Practitioner | PractitionerRole | RelatedPerson ) Who recorded the adverse event
. . . contributor Σ 0..* Reference ( Practitioner | PractitionerRole | Device ) Who was involved in the adverse event or the potential adverse event
. . . detector Σ 0..* Reference ( Patient | RelatedPerson | Practitioner | PractitionerRole | Device ) Who or what identified a change in physiological state or condition
. . . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
. . . instance . instance[x] Σ 1..1 Refers to the specific entity that caused the adverse event
..... instanceCodeableConcept CodeableConcept
..... instanceReference Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement MedicationUsage | Device ) Refers to the specific entity that caused the adverse event
. . . . causality Σ 0..* BackboneElement Information on the possible cause of the event
. . . . . assessment assessmentMethod Σ 0..1 CodeableConcept Assessment Method of if evaluating the relatedness of the suspected entity caused to the event
AdverseEventCausalityAssessment AdverseEventCausalityMethod ( Example )
. . . . productRelatedness . entityRelatedness Σ 0..1 string CodeableConcept AdverseEvent.suspectEntity.causalityProductRelatedness Result of the assessment regarding the relatedness of the suspected entity to the event
AdverseEventCausalityAssessment ( Example )
. . . . . author Σ 0..1 Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson ) AdverseEvent.suspectEntity.causalityAuthor Author of the information on the possible cause of the event
. . method . supportingInfo Σ 0..1 0..* CodeableConcept BackboneElement ProbabilityScale | Bayesian | Checklist Supporting information relevant to the event
AdverseEventCausalityMethod ( Example )
. . . . subjectMedicalHistory item Σ 0..* 1..1 Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference ) AdverseEvent.subjectMedicalHistory Subject medical history or document relevant to this adverse event
. . referenceDocument . . contributingFactor Σ 0..* 0..1 Reference ( DocumentReference boolean ) AdverseEvent.referenceDocument If true, the item has been assessed to be a contributing factor of the adverse event
. . . study Σ 0..* Reference ( ResearchStudy ) AdverseEvent.study 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 server identifier : Identifier [0..1] [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 potential. (Strength=Required) AdverseEventActuality ! » The overall type of event, intended for search and filtering purposes category : CodeableConcept [0..*] « Overall categorization of the event, e.g. product related product-related or situational situational. (Strength=Extensible) AdverseEventCategory + » This element defines the specific type of event that occurred or that was prevented from occurring event : CodeableConcept [0..1] « Detailed type of event event. (Strength=Example) SNOMED CT Clinical Findings SNOMEDCTClinicalFindings ?? » This subject or group impacted by the event subject : Reference [1..1] « Patient | Group | Practitioner | RelatedPerson » The encounter Encounter during which AdverseEvent was created or episode of care that establishes to which the context for creation of this AdverseEvent record is tightly associated context encounter : Reference [0..1] « Encounter | EpisodeOfCare » The date (and perhaps time) when the adverse event occurred date : dateTime [0..1] Estimated or actual date the AdverseEvent began, in the opinion of the reporter detected : dateTime [0..1] The date on which the existence of the AdverseEvent was first recorded recordedDate : 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 occurred location : Reference [0..1] « Location » Assessment whether this event was of real importance seriousness : CodeableConcept [0..1] « Overall seriousness of this event for the patient patient. (Strength=Example) AdverseEventSeriousness ?? » Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.serious AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is severity : CodeableConcept [0..1] « The severity of the adverse event itself, in direct relation to the subject subject. (Strength=Required) AdverseEventSeverity ! » Describes the type of outcome from the adverse event outcome : CodeableConcept [0..1] « TODO (and should this be required?) required?). (Strength=Required) AdverseEventOutcome ! » Information on who recorded the adverse event. May be the patient or a practitioner recorder : 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 » AdverseEvent.subjectMedicalHistory Who or what identified a change in physiological state or condition subjectMedicalHistory detector : Reference [0..*] « Condition | Observation | AllergyIntolerance | FamilyMemberHistory Patient | Immunization RelatedPerson | Procedure Practitioner | Media PractitionerRole | DocumentReference » AdverseEvent.referenceDocument referenceDocument : Reference [0..*] « DocumentReference Device » AdverseEvent.study The research study that the subject is enrolled in study : Reference [0..*] « ResearchStudy » SuspectEntity Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device instance instance[x] : Reference Type [1..1] « CodeableConcept | Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement MedicationUsage | Device ) » Causality Assessment The method of if evaluating the relatedness of the suspected entity caused to the event assessment assessmentMethod : CodeableConcept [0..1] « TODO TODO. (Strength=Example) AdverseEventCausalityAssessme... AdverseEventCausalityMethod ?? » AdverseEvent.suspectEntity.causalityProductRelatedness The result of the assessment regarding the relatedness of the suspected entity to the event productRelatedness entityRelatedness : string CodeableConcept [0..1] « Codes for the assessment of whether the entity caused the event. (Strength=Example) AdverseEventCausalityAssessme... ?? » AdverseEvent.suspectEntity.causalityAuthor The author of the information on the possible cause of the event author : Reference [0..1] « Practitioner | PractitionerRole | Patient | RelatedPerson » SupportingInfo ProbabilityScale | Bayesian | Checklist Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following penciliin and the patient was given penicillin in the past. 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) method item : CodeableConcept Reference [0..1] [1..1] « Condition | Observation | AllergyIntolerance | TODO (Strength=Example) AdverseEventCausalityMethod FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference ?? » If true, the item has been assessed to be a contributing factor of the adverse event contributingFactor : boolean [0..1] Information on the possible cause of the event causality [0..*] Describes the entity that is suspected to have caused the adverse event suspectEntity [0..*] Supporting information relevant to the event supportingInfo [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>

 <identifier><!-- 0..* Identifier Business identifier for the event --></identifier>

 <actuality value="[code]"/><!-- 1..1 actual | potential -->
 <</category>

 <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>

 <event><!-- 0..1 CodeableConcept Type of the event itself in relation to the subject --></event>
 <</subject>
 <</context>

 <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 of the event --></seriousness>
 <</severity>

 <severity><!-- 0..1 CodeableConcept mild | moderate | severe --></severity>

 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown --></outcome>
 <</recorder>
 <</contributor>

 <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>

  <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 -->
   <</assessment>
   <
   <</author>
   <</method>

   <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>
 <|
   |
   </subjectMedicalHistory>
 <</referenceDocument>
 <</study>

 <supportingInfo>  <!-- 0..* Supporting information relevant to the event -->
  <item><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Media|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

  "event" : { CodeableConcept }, // Type of the event itself in relation to the subject
  "
  "

  "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 of the event
  "

  "severity" : { CodeableConcept }, // mild | moderate | severe

  "outcome" : { CodeableConcept }, // resolved | recovering | ongoing | resolvedWithSequelae | 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|Media|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:

  fhir:AdverseEvent.identifier [ Identifier ], ... ; # 0..* Business identifier for the event

  fhir:AdverseEvent.actuality [ code ]; # 1..1 actual | potential
  fhir:

  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.event [ CodeableConcept ]; # 0..1 Type of the event itself in relation to the subject
  fhir:
  fhir:

  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 of the event
  fhir:

  fhir:AdverseEvent.severity [ CodeableConcept ]; # 0..1 mild | moderate | severe

  fhir:AdverseEvent.outcome [ CodeableConcept ]; # 0..1 resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
  fhir:
  fhir:

  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
    fhir:|
  

    # 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:
      fhir:
      fhir:
      fhir:

      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:|
  
  fhir:
  fhir:

  fhir:AdverseEvent.supportingInfo [ # 0..* Supporting information relevant to the event
    fhir:AdverseEvent.supportingInfo.item [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Media|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 DSTU2 Release 3

AdverseEvent.actuality Added Element AdverseEvent.subjectMedicalHistory Type changed from Reference(Condition|Observation|AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure) to Reference(Condition|Observation|AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure|Media|DocumentReference) AdverseEvent.type deleted AdverseEvent.reaction deleted
AdverseEvent
AdverseEvent.category AdverseEvent.identifier
  • Max Cardinality changed from 1 to *
  • Type changed from code to CodeableConcept Change binding strength from required to extensible
AdverseEvent.event AdverseEvent.actuality
  • Added Element 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.subject AdverseEvent.severity
  • Min Cardinality changed from 0 to 1 Type changed Change value set from Reference(Patient|ResearchSubject|Medication|Device) http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.0 to Reference(Patient|Group|Practitioner|RelatedPerson) http://hl7.org/fhir/ValueSet/adverse-event-severity|4.1.0
AdverseEvent.context AdverseEvent.outcome
  • Added Element 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.resultingCondition AdverseEvent.detector
  • Added Element
AdverseEvent.severity AdverseEvent.suspectEntity.instance[x]
  • Added Mandatory Element
AdverseEvent.contributor AdverseEvent.suspectEntity.causality.assessmentMethod
  • Added Element
AdverseEvent.suspectEntity.instance AdverseEvent.suspectEntity.causality.entityRelatedness
  • Type changed from Reference(Substance|Medication|MedicationAdministration|MedicationStatement|Device) to Reference(Immunization|Procedure|Substance|Medication|MedicationAdministration|MedicationStatement|Device) Added Element
AdverseEvent.suspectEntity.causality AdverseEvent.suspectEntity.causality.author
  • Max Cardinality changed from 1 to * Type changed from code to BackboneElement Remove Binding http://hl7.org/fhir/ValueSet/adverse-event-causality (required) AdverseEvent.suspectEntity.causality.assessment Reference: Added Element Target Types Patient, RelatedPerson
AdverseEvent.suspectEntity.causality.productRelatedness AdverseEvent.supportingInfo
  • Added Element
AdverseEvent.suspectEntity.causality.author AdverseEvent.supportingInfo.item
  • Added Mandatory Element
AdverseEvent.suspectEntity.causality.method AdverseEvent.supportingInfo.contributingFactor
  • Added Element
AdverseEvent.eventParticipant deleted AdverseEvent.description AdverseEvent.suspectEntity.instance
  • deleted
AdverseEvent.suspectEntity.causalityAssessment AdverseEvent.suspectEntity.causality.assessment
  • deleted
AdverseEvent.suspectEntity.causalityProductRelatedness AdverseEvent.suspectEntity.causality.productRelatedness
  • deleted
AdverseEvent.suspectEntity.causalityMethod AdverseEvent.suspectEntity.causality.method
  • deleted
AdverseEvent.suspectEntity.causalityAuthor AdverseEvent.subjectMedicalHistory
  • deleted
AdverseEvent.suspectEntity.causalityResult 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). )

 

Alternate 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

AdverseEvent.suspectEntity.causality.assessment AdverseEvent.suspectEntity.causality.method
Path Definition Type Reference
AdverseEvent.actuality Overall nature of the adverse event, e.g. real or potential potential. Required AdverseEventActuality
AdverseEvent.category Overall categorization of the event, e.g. product related product-related or situational situational. Extensible AdverseEventCategory
AdverseEvent.event Detailed type of event event. Example SNOMED CT Clinical Findings SNOMEDCTClinicalFindings
AdverseEvent.seriousness Overall seriousness of this event for the patient patient. Example AdverseEventSeriousness
AdverseEvent.severity The severity of the adverse event itself, in direct relation to the subject subject. Required AdverseEventSeverity
AdverseEvent.outcome TODO (and should this be required?) required?). Required AdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessmentMethod TODO TODO. Example AdverseEventCausalityAssessment AdverseEventCausalityMethod
AdverseEvent.suspectEntity.causality.entityRelatedness TODO Codes for the assessment of whether the entity caused the event. Example AdverseEventCausalityMethod AdverseEventCausalityAssessment

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

Name Type Description Expression In Common
actuality token actual | potential AdverseEvent.actuality
category token ProductProblem product-problem | ProductQuality product-quality | ProductUseError product-use-error | WrongDose wrong-dose | IncorrectPrescribingInformation incorrect-prescribing-information | WrongTechnique wrong-technique | WrongRouteOfAdministration wrong-route-of-administration | WrongRate wrong-rate | WrongDuration wrong-duration | WrongTime wrong-time | ExpiredDrug expired-drug | MedicalDeviceUseError medical-device-use-error | ProblemDifferentManufacturer problem-different-manufacturer | UnsafePhysicalEnvironment unsafe-physical-environment AdverseEvent.category
date date When the event occurred AdverseEvent.date
event token Type of the event itself in relation to the subject AdverseEvent.event
location reference Location where adverse event occurred AdverseEvent.location
( Location )
recorder reference Who recorded the adverse event AdverseEvent.recorder
( Practitioner , Patient , PractitionerRole , RelatedPerson )
resultingcondition reference Effect on the subject due to this event AdverseEvent.resultingCondition
( Condition )
seriousness token Seriousness of the event AdverseEvent.seriousness
severity token Mild mild | Moderate moderate | Severe severe AdverseEvent.severity
study reference AdverseEvent.study Research study that the subject is enrolled in AdverseEvent.study
( ResearchStudy )
subject reference Subject impacted by event AdverseEvent.subject
( Practitioner , Group , Patient , RelatedPerson )
substance reference Refers to the specific entity that caused the adverse event AdverseEvent.suspectEntity.instance (AdverseEvent.suspectEntity.instance as Reference)
( Immunization , Device , Medication , Procedure , Substance , MedicationAdministration , MedicationStatement MedicationUsage )