R4 Ballot #1 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

9.9 Resource AdverseEvent - Content

Patient Care Work GroupMaturity Level: 0 Draft 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.

9.9.1 Scope and Usage

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.

9.9.2 Boundaries and Relationships

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.

9.9.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent ΣDDomainResourceMedical care, research study or other healthcare event causing physical injury
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!Σ1..1codeactual | potential
AdverseEventActuality (Required)
... category Σ0..*CodeableConceptProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironment
AdverseEventCategory (Extensible)
... event Σ0..1CodeableConceptType of the event itself in relation to the subject
SNOMED CT Clinical Findings (Example)
... subject Σ1..1Reference(Patient | Group | Practitioner | RelatedPerson)Subject impacted by event
... context Σ0..1Reference(Encounter | EpisodeOfCare)Encounter or episode of care that establishes the context for this AdverseEvent
... date Σ0..1dateTimeWhen the event occurred
... resultingCondition Σ0..*Reference(Condition)Effect on the subject due to this event
... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness of the event
AdverseEventSeriousness (Example)
... severity Σ0..1CodeableConceptMild | Moderate | Severe
AdverseEventSeverity (Required)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
AdverseEventOutcome (Required)
... recorder Σ0..1Reference(Patient | Practitioner | RelatedPerson)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | Device)Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... instance Σ1..1Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)Refers to the specific entity that caused the adverse event
.... causality Σ0..*BackboneElementInformation on the possible cause of the event
..... assessment Σ0..1CodeableConceptAssessment of if the entity caused the event
AdverseEventCausalityAssessment (Example)
..... productRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
AdverseEventCausalityMethod (Example)
... subjectMedicalHistory Σ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

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..1]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 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+ »This element defines the specific type of event that occurred or that was prevented from occurringevent : CodeableConcept [0..1] « Detailed type of event (Strength=Example)SNOMED CT Clinical Findings?? »This subject or group impacted by the eventsubject : Reference [1..1] « Patient|Group|Practitioner| RelatedPerson »The encounter or episode of care that establishes the context for this AdverseEventcontext : Reference [0..1] « Encounter|EpisodeOfCare »The date (and perhaps time) when the adverse event occurreddate : 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 was of real importanceseriousness : CodeableConcept [0..1] « Overall seriousness of this event for the patient (Strength=Example)AdverseEventSeriousness?? »Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.serious - a severe rash might not be serious, but a mild heart problem isseverity : CodeableConcept [0..1] « The severity of the adverse event itself, in direct relation to the subject (Strength=Required)AdverseEventSeverity! »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|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|Device »AdverseEvent.subjectMedicalHistorysubjectMedicalHistory : Reference [0..*] « Condition|Observation| AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure| Media|DocumentReference »AdverseEvent.referenceDocumentreferenceDocument : Reference [0..*] « DocumentReference »AdverseEvent.studystudy : 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 : Reference [1..1] « Immunization|Procedure|Substance| Medication|MedicationAdministration|MedicationStatement|Device »CausalityAssessment of if the entity caused the eventassessment : CodeableConcept [0..1] « TODO (Strength=Example) AdverseEventCausalityAssessme...?? »AdverseEvent.suspectEntity.causalityProductRelatednessproductRelatedness : string [0..1]AdverseEvent.suspectEntity.causalityAuthorauthor : Reference [0..1] « Practitioner|PractitionerRole »ProbabilityScale | Bayesian | Checklistmethod : CodeableConcept [0..1] « TODO (Strength=Example)AdverseEventCausalityMethod?? »Information on the possible cause of the eventcausality[0..*]Describes the entity that is suspected to have caused the adverse eventsuspectEntity[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..1 Identifier Business identifier for the event --></identifier>
 <actuality value="[code]"/><!-- 1..1 actual | potential -->
 <category><!-- 0..* CodeableConcept ProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironment --></category>
 <event><!-- 0..1 CodeableConcept Type of the event itself in relation to the subject --></event>
 <subject><!-- 1..1 Reference(Patient|Group|Practitioner|RelatedPerson) Subject impacted by event --></subject>
 <context><!-- 0..1 Reference(Encounter|EpisodeOfCare) Encounter or episode of care that establishes the context for this AdverseEvent --></context>
 <date value="[dateTime]"/><!-- 0..1 When the event occurred -->
 <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><!-- 0..1 CodeableConcept Mild | Moderate | Severe --></severity>
 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|RelatedPerson) Who recorded the adverse event --></recorder>
 <contributor><!-- 0..* Reference(Practitioner|Device) Who  was involved in the adverse event or the potential adverse event --></contributor>
 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <instance><!-- 1..1 Reference(Immunization|Procedure|Substance|Medication|
    MedicationAdministration|MedicationStatement|Device) Refers to the specific entity that caused the adverse event --></instance>
  <causality>  <!-- 0..* Information on the possible cause of the event -->
   <assessment><!-- 0..1 CodeableConcept Assessment of if the entity caused the event --></assessment>
   <productRelatedness value="[string]"/><!-- 0..1 AdverseEvent.suspectEntity.causalityProductRelatedness -->
   <author><!-- 0..1 Reference(Practitioner|PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor --></author>
   <method><!-- 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist --></method>
  </causality>
 </suspectEntity>
 <subjectMedicalHistory><!-- 0..* Reference(Condition|Observation|
   AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure|Media|
   DocumentReference) AdverseEvent.subjectMedicalHistory --></subjectMedicalHistory>
 <referenceDocument><!-- 0..* Reference(DocumentReference) AdverseEvent.referenceDocument --></referenceDocument>
 <study><!-- 0..* Reference(ResearchStudy) AdverseEvent.study --></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 }], // ProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironment
  "event" : { CodeableConcept }, // Type of the event itself in relation to the subject
  "subject" : { Reference(Patient|Group|Practitioner|RelatedPerson) }, // R!  Subject impacted by event
  "context" : { Reference(Encounter|EpisodeOfCare) }, // Encounter or episode of care that establishes the context for this AdverseEvent
  "date" : "<dateTime>", // When the event occurred
  "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|RelatedPerson) }, // Who recorded the adverse event
  "contributor" : [{ Reference(Practitioner|Device) }], // Who  was involved in the adverse event or the potential adverse event
  "suspectEntity" : [{ // The suspected agent causing the adverse event
    "instance" : { Reference(Immunization|Procedure|Substance|Medication|
    MedicationAdministration|MedicationStatement|Device) }, // R!  Refers to the specific entity that caused the adverse event
    "causality" : [{ // Information on the possible cause of the event
      "assessment" : { CodeableConcept }, // Assessment of if the entity caused the event
      "productRelatedness" : "<string>", // AdverseEvent.suspectEntity.causalityProductRelatedness
      "author" : { Reference(Practitioner|PractitionerRole) }, // AdverseEvent.suspectEntity.causalityAuthor
      "method" : { CodeableConcept } // ProbabilityScale | Bayesian | Checklist
    }]
  }],
  "subjectMedicalHistory" : [{ Reference(Condition|Observation|
   AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure|Media|
   DocumentReference) }], // AdverseEvent.subjectMedicalHistory
  "referenceDocument" : [{ Reference(DocumentReference) }], // AdverseEvent.referenceDocument
  "study" : [{ Reference(ResearchStudy) }] // AdverseEvent.study
}

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..1 Business identifier for the event
  fhir:AdverseEvent.actuality [ code ]; # 1..1 actual | potential
  fhir:AdverseEvent.category [ CodeableConcept ], ... ; # 0..* ProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironment
  fhir:AdverseEvent.event [ CodeableConcept ]; # 0..1 Type of the event itself in relation to the subject
  fhir:AdverseEvent.subject [ Reference(Patient|Group|Practitioner|RelatedPerson) ]; # 1..1 Subject impacted by event
  fhir:AdverseEvent.context [ Reference(Encounter|EpisodeOfCare) ]; # 0..1 Encounter or episode of care that establishes the context for this AdverseEvent
  fhir:AdverseEvent.date [ dateTime ]; # 0..1 When the event occurred
  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:AdverseEvent.severity [ CodeableConcept ]; # 0..1 Mild | Moderate | Severe
  fhir:AdverseEvent.outcome [ CodeableConcept ]; # 0..1 resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
  fhir:AdverseEvent.recorder [ Reference(Patient|Practitioner|RelatedPerson) ]; # 0..1 Who recorded the adverse event
  fhir:AdverseEvent.contributor [ Reference(Practitioner|Device) ], ... ; # 0..* Who  was involved in the adverse event or the potential adverse event
  fhir:AdverseEvent.suspectEntity [ # 0..* The suspected agent causing the adverse event
    fhir:AdverseEvent.suspectEntity.instance [ Reference(Immunization|Procedure|Substance|Medication|MedicationAdministration|
  MedicationStatement|Device) ]; # 1..1 Refers to the specific entity that caused the adverse event
    fhir:AdverseEvent.suspectEntity.causality [ # 0..* Information on the possible cause of the event
      fhir:AdverseEvent.suspectEntity.causality.assessment [ CodeableConcept ]; # 0..1 Assessment of if the entity caused the event
      fhir:AdverseEvent.suspectEntity.causality.productRelatedness [ string ]; # 0..1 AdverseEvent.suspectEntity.causalityProductRelatedness
      fhir:AdverseEvent.suspectEntity.causality.author [ Reference(Practitioner|PractitionerRole) ]; # 0..1 AdverseEvent.suspectEntity.causalityAuthor
      fhir:AdverseEvent.suspectEntity.causality.method [ CodeableConcept ]; # 0..1 ProbabilityScale | Bayesian | Checklist
    ], ...;
  ], ...;
  fhir:AdverseEvent.subjectMedicalHistory [ Reference(Condition|Observation|AllergyIntolerance|FamilyMemberHistory|Immunization|
  Procedure|Media|DocumentReference) ], ... ; # 0..* AdverseEvent.subjectMedicalHistory
  fhir:AdverseEvent.referenceDocument [ Reference(DocumentReference) ], ... ; # 0..* AdverseEvent.referenceDocument
  fhir:AdverseEvent.study [ Reference(ResearchStudy) ], ... ; # 0..* AdverseEvent.study
]

Changes since R3

AdverseEvent
AdverseEvent.actuality
  • Added Element
AdverseEvent.category
  • Max Cardinality changed from 1 to *
  • Type changed from code to CodeableConcept
  • Change binding strength from required to extensible
AdverseEvent.event
  • Added Element
AdverseEvent.subject
  • Min Cardinality changed from 0 to 1
  • Type changed from Reference(Patient|ResearchSubject|Medication|Device) to Reference(Patient|Group|Practitioner|RelatedPerson)
AdverseEvent.context
  • Added Element
AdverseEvent.resultingCondition
  • Added Element
AdverseEvent.severity
  • Added Element
AdverseEvent.contributor
  • Added Element
AdverseEvent.suspectEntity.instance
  • Type changed from Reference(Substance|Medication|MedicationAdministration|MedicationStatement|Device) to Reference(Immunization|Procedure|Substance|Medication|MedicationAdministration|MedicationStatement|Device)
AdverseEvent.suspectEntity.causality
  • 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
  • Added Element
AdverseEvent.suspectEntity.causality.productRelatedness
  • Added Element
AdverseEvent.suspectEntity.causality.author
  • Added Element
AdverseEvent.suspectEntity.causality.method
  • 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.eventParticipant
  • deleted
AdverseEvent.description
  • deleted
AdverseEvent.suspectEntity.causalityAssessment
  • deleted
AdverseEvent.suspectEntity.causalityProductRelatedness
  • deleted
AdverseEvent.suspectEntity.causalityMethod
  • deleted
AdverseEvent.suspectEntity.causalityAuthor
  • deleted
AdverseEvent.suspectEntity.causalityResult
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent ΣDDomainResourceMedical care, research study or other healthcare event causing physical injury
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!Σ1..1codeactual | potential
AdverseEventActuality (Required)
... category Σ0..*CodeableConceptProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironment
AdverseEventCategory (Extensible)
... event Σ0..1CodeableConceptType of the event itself in relation to the subject
SNOMED CT Clinical Findings (Example)
... subject Σ1..1Reference(Patient | Group | Practitioner | RelatedPerson)Subject impacted by event
... context Σ0..1Reference(Encounter | EpisodeOfCare)Encounter or episode of care that establishes the context for this AdverseEvent
... date Σ0..1dateTimeWhen the event occurred
... resultingCondition Σ0..*Reference(Condition)Effect on the subject due to this event
... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness of the event
AdverseEventSeriousness (Example)
... severity Σ0..1CodeableConceptMild | Moderate | Severe
AdverseEventSeverity (Required)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
AdverseEventOutcome (Required)
... recorder Σ0..1Reference(Patient | Practitioner | RelatedPerson)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | Device)Who was involved in the adverse event or the potential adverse event
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... instance Σ1..1Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device)Refers to the specific entity that caused the adverse event
.... causality Σ0..*BackboneElementInformation on the possible cause of the event
..... assessment Σ0..1CodeableConceptAssessment of if the entity caused the event
AdverseEventCausalityAssessment (Example)
..... productRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
AdverseEventCausalityMethod (Example)
... subjectMedicalHistory Σ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

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..1]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 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+ »This element defines the specific type of event that occurred or that was prevented from occurringevent : CodeableConcept [0..1] « Detailed type of event (Strength=Example)SNOMED CT Clinical Findings?? »This subject or group impacted by the eventsubject : Reference [1..1] « Patient|Group|Practitioner| RelatedPerson »The encounter or episode of care that establishes the context for this AdverseEventcontext : Reference [0..1] « Encounter|EpisodeOfCare »The date (and perhaps time) when the adverse event occurreddate : 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 was of real importanceseriousness : CodeableConcept [0..1] « Overall seriousness of this event for the patient (Strength=Example)AdverseEventSeriousness?? »Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.serious - a severe rash might not be serious, but a mild heart problem isseverity : CodeableConcept [0..1] « The severity of the adverse event itself, in direct relation to the subject (Strength=Required)AdverseEventSeverity! »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|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|Device »AdverseEvent.subjectMedicalHistorysubjectMedicalHistory : Reference [0..*] « Condition|Observation| AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure| Media|DocumentReference »AdverseEvent.referenceDocumentreferenceDocument : Reference [0..*] « DocumentReference »AdverseEvent.studystudy : 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 : Reference [1..1] « Immunization|Procedure|Substance| Medication|MedicationAdministration|MedicationStatement|Device »CausalityAssessment of if the entity caused the eventassessment : CodeableConcept [0..1] « TODO (Strength=Example) AdverseEventCausalityAssessme...?? »AdverseEvent.suspectEntity.causalityProductRelatednessproductRelatedness : string [0..1]AdverseEvent.suspectEntity.causalityAuthorauthor : Reference [0..1] « Practitioner|PractitionerRole »ProbabilityScale | Bayesian | Checklistmethod : CodeableConcept [0..1] « TODO (Strength=Example)AdverseEventCausalityMethod?? »Information on the possible cause of the eventcausality[0..*]Describes the entity that is suspected to have caused the adverse eventsuspectEntity[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..1 Identifier Business identifier for the event --></identifier>
 <actuality value="[code]"/><!-- 1..1 actual | potential -->
 <category><!-- 0..* CodeableConcept ProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironment --></category>
 <event><!-- 0..1 CodeableConcept Type of the event itself in relation to the subject --></event>
 <subject><!-- 1..1 Reference(Patient|Group|Practitioner|RelatedPerson) Subject impacted by event --></subject>
 <context><!-- 0..1 Reference(Encounter|EpisodeOfCare) Encounter or episode of care that establishes the context for this AdverseEvent --></context>
 <date value="[dateTime]"/><!-- 0..1 When the event occurred -->
 <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><!-- 0..1 CodeableConcept Mild | Moderate | Severe --></severity>
 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|RelatedPerson) Who recorded the adverse event --></recorder>
 <contributor><!-- 0..* Reference(Practitioner|Device) Who  was involved in the adverse event or the potential adverse event --></contributor>
 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <instance><!-- 1..1 Reference(Immunization|Procedure|Substance|Medication|
    MedicationAdministration|MedicationStatement|Device) Refers to the specific entity that caused the adverse event --></instance>
  <causality>  <!-- 0..* Information on the possible cause of the event -->
   <assessment><!-- 0..1 CodeableConcept Assessment of if the entity caused the event --></assessment>
   <productRelatedness value="[string]"/><!-- 0..1 AdverseEvent.suspectEntity.causalityProductRelatedness -->
   <author><!-- 0..1 Reference(Practitioner|PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor --></author>
   <method><!-- 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist --></method>
  </causality>
 </suspectEntity>
 <subjectMedicalHistory><!-- 0..* Reference(Condition|Observation|
   AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure|Media|
   DocumentReference) AdverseEvent.subjectMedicalHistory --></subjectMedicalHistory>
 <referenceDocument><!-- 0..* Reference(DocumentReference) AdverseEvent.referenceDocument --></referenceDocument>
 <study><!-- 0..* Reference(ResearchStudy) AdverseEvent.study --></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 }], // ProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironment
  "event" : { CodeableConcept }, // Type of the event itself in relation to the subject
  "subject" : { Reference(Patient|Group|Practitioner|RelatedPerson) }, // R!  Subject impacted by event
  "context" : { Reference(Encounter|EpisodeOfCare) }, // Encounter or episode of care that establishes the context for this AdverseEvent
  "date" : "<dateTime>", // When the event occurred
  "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|RelatedPerson) }, // Who recorded the adverse event
  "contributor" : [{ Reference(Practitioner|Device) }], // Who  was involved in the adverse event or the potential adverse event
  "suspectEntity" : [{ // The suspected agent causing the adverse event
    "instance" : { Reference(Immunization|Procedure|Substance|Medication|
    MedicationAdministration|MedicationStatement|Device) }, // R!  Refers to the specific entity that caused the adverse event
    "causality" : [{ // Information on the possible cause of the event
      "assessment" : { CodeableConcept }, // Assessment of if the entity caused the event
      "productRelatedness" : "<string>", // AdverseEvent.suspectEntity.causalityProductRelatedness
      "author" : { Reference(Practitioner|PractitionerRole) }, // AdverseEvent.suspectEntity.causalityAuthor
      "method" : { CodeableConcept } // ProbabilityScale | Bayesian | Checklist
    }]
  }],
  "subjectMedicalHistory" : [{ Reference(Condition|Observation|
   AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure|Media|
   DocumentReference) }], // AdverseEvent.subjectMedicalHistory
  "referenceDocument" : [{ Reference(DocumentReference) }], // AdverseEvent.referenceDocument
  "study" : [{ Reference(ResearchStudy) }] // AdverseEvent.study
}

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..1 Business identifier for the event
  fhir:AdverseEvent.actuality [ code ]; # 1..1 actual | potential
  fhir:AdverseEvent.category [ CodeableConcept ], ... ; # 0..* ProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironment
  fhir:AdverseEvent.event [ CodeableConcept ]; # 0..1 Type of the event itself in relation to the subject
  fhir:AdverseEvent.subject [ Reference(Patient|Group|Practitioner|RelatedPerson) ]; # 1..1 Subject impacted by event
  fhir:AdverseEvent.context [ Reference(Encounter|EpisodeOfCare) ]; # 0..1 Encounter or episode of care that establishes the context for this AdverseEvent
  fhir:AdverseEvent.date [ dateTime ]; # 0..1 When the event occurred
  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:AdverseEvent.severity [ CodeableConcept ]; # 0..1 Mild | Moderate | Severe
  fhir:AdverseEvent.outcome [ CodeableConcept ]; # 0..1 resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
  fhir:AdverseEvent.recorder [ Reference(Patient|Practitioner|RelatedPerson) ]; # 0..1 Who recorded the adverse event
  fhir:AdverseEvent.contributor [ Reference(Practitioner|Device) ], ... ; # 0..* Who  was involved in the adverse event or the potential adverse event
  fhir:AdverseEvent.suspectEntity [ # 0..* The suspected agent causing the adverse event
    fhir:AdverseEvent.suspectEntity.instance [ Reference(Immunization|Procedure|Substance|Medication|MedicationAdministration|
  MedicationStatement|Device) ]; # 1..1 Refers to the specific entity that caused the adverse event
    fhir:AdverseEvent.suspectEntity.causality [ # 0..* Information on the possible cause of the event
      fhir:AdverseEvent.suspectEntity.causality.assessment [ CodeableConcept ]; # 0..1 Assessment of if the entity caused the event
      fhir:AdverseEvent.suspectEntity.causality.productRelatedness [ string ]; # 0..1 AdverseEvent.suspectEntity.causalityProductRelatedness
      fhir:AdverseEvent.suspectEntity.causality.author [ Reference(Practitioner|PractitionerRole) ]; # 0..1 AdverseEvent.suspectEntity.causalityAuthor
      fhir:AdverseEvent.suspectEntity.causality.method [ CodeableConcept ]; # 0..1 ProbabilityScale | Bayesian | Checklist
    ], ...;
  ], ...;
  fhir:AdverseEvent.subjectMedicalHistory [ Reference(Condition|Observation|AllergyIntolerance|FamilyMemberHistory|Immunization|
  Procedure|Media|DocumentReference) ], ... ; # 0..* AdverseEvent.subjectMedicalHistory
  fhir:AdverseEvent.referenceDocument [ Reference(DocumentReference) ], ... ; # 0..* AdverseEvent.referenceDocument
  fhir:AdverseEvent.study [ Reference(ResearchStudy) ], ... ; # 0..* AdverseEvent.study
]

Changes since DSTU2

AdverseEvent
AdverseEvent.actuality
  • Added Element
AdverseEvent.category
  • Max Cardinality changed from 1 to *
  • Type changed from code to CodeableConcept
  • Change binding strength from required to extensible
AdverseEvent.event
  • Added Element
AdverseEvent.subject
  • Min Cardinality changed from 0 to 1
  • Type changed from Reference(Patient|ResearchSubject|Medication|Device) to Reference(Patient|Group|Practitioner|RelatedPerson)
AdverseEvent.context
  • Added Element
AdverseEvent.resultingCondition
  • Added Element
AdverseEvent.severity
  • Added Element
AdverseEvent.contributor
  • Added Element
AdverseEvent.suspectEntity.instance
  • Type changed from Reference(Substance|Medication|MedicationAdministration|MedicationStatement|Device) to Reference(Immunization|Procedure|Substance|Medication|MedicationAdministration|MedicationStatement|Device)
AdverseEvent.suspectEntity.causality
  • 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
  • Added Element
AdverseEvent.suspectEntity.causality.productRelatedness
  • Added Element
AdverseEvent.suspectEntity.causality.author
  • Added Element
AdverseEvent.suspectEntity.causality.method
  • 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.eventParticipant
  • deleted
AdverseEvent.description
  • deleted
AdverseEvent.suspectEntity.causalityAssessment
  • deleted
AdverseEvent.suspectEntity.causalityProductRelatedness
  • deleted
AdverseEvent.suspectEntity.causalityMethod
  • deleted
AdverseEvent.suspectEntity.causalityAuthor
  • deleted
AdverseEvent.suspectEntity.causalityResult
  • deleted

See the Full Difference for further information

This analysis is available as XML or JSON.

 

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

9.9.3.1 Terminology Bindings

PathDefinitionTypeReference
AdverseEvent.actuality Overall nature of the event, e.g. real or potentialRequiredAdverseEventActuality
AdverseEvent.category Overall categorization of the event, e.g. product related or situationalExtensibleAdverseEventCategory
AdverseEvent.event Detailed type of eventExampleSNOMED CT Clinical Findings
AdverseEvent.seriousness Overall seriousness of this event for the patientExampleAdverseEventSeriousness
AdverseEvent.severity The severity of the adverse event itself, in direct relation to the subjectRequiredAdverseEventSeverity
AdverseEvent.outcome TODO (and should this be required?)RequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessment TODOExampleAdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.method TODOExampleAdverseEventCausalityMethod

9.9.4 Search Parameters

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
categorytokenProductProblem | ProductQuality | ProductUseError | WrongDose | IncorrectPrescribingInformation | WrongTechnique | WrongRouteOfAdministration | WrongRate | WrongDuration | WrongTime | ExpiredDrug | MedicalDeviceUseError | ProblemDifferentManufacturer | UnsafePhysicalEnvironmentAdverseEvent.category
datedateWhen the event occurredAdverseEvent.date
eventtokenType of the event itself in relation to the subjectAdverseEvent.event
locationreferenceLocation where adverse event occurredAdverseEvent.location
(Location)
recorderreferenceWho recorded the adverse eventAdverseEvent.recorder
(Practitioner, Patient, RelatedPerson)
resultingconditionreferenceEffect on the subject due to this eventAdverseEvent.resultingCondition
(Condition)
seriousnesstokenSeriousness of the eventAdverseEvent.seriousness
severitytokenMild | Moderate | SevereAdverseEvent.severity
studyreferenceAdverseEvent.studyAdverseEvent.study
(ResearchStudy)
subjectreferenceSubject impacted by eventAdverseEvent.subject
(Practitioner, Group, Patient, RelatedPerson)
substancereferenceRefers to the specific entity that caused the adverse eventAdverseEvent.suspectEntity.instance
(Immunization, Device, Medication, Procedure, Substance, MedicationAdministration, MedicationStatement)