FHIR Release 3 (STU)

This page is part of the FHIR Specification (v3.0.2: STU 3). 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

Regulated Clinical Research Information Management Work GroupMaturity Level: 0 DraftCompartments: 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 may or may 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 may 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 ΣDomainResourceMedical 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
... category Σ0..1codeAE | PAE An adverse event is an event that caused harm to a patient, an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not
AdverseEventCategory (Required)
... type Σ0..1CodeableConceptactual | potential
SNOMED CT Clinical Findings (Example)
... subject Σ0..1Reference(Patient | ResearchSubject | Medication | Device)Subject or group impacted by event
... date Σ0..1dateTimeWhen the event occurred
... reaction Σ0..*Reference(Condition)Adverse Reaction Events linked to exposure to substance
... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptMild | Moderate | Severe
AdverseEventSeriousness (Example)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
AdverseEventOutcome (Required)
... recorder Σ0..1Reference(Patient | Practitioner | RelatedPerson)Who recorded the adverse event
... eventParticipant Σ0..1Reference(Practitioner | Device)Who was involved in the adverse event or the potential adverse event
... description Σ0..1stringDescription of the adverse event
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... instance Σ1..1Reference(Substance | Medication | MedicationAdministration | MedicationStatement | Device)Refers to the specific entity that caused the adverse event
.... causality Σ0..1codecausality1 | causality2
AdverseEventCausality (Required)
.... causalityAssessment Σ0..1CodeableConceptassess1 | assess2
AdverseEventCausalityAssessment (Example)
.... causalityProductRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
.... causalityMethod Σ0..1CodeableConceptmethod1 | method2
AdverseEventCausalityMethod (Example)
.... causalityAuthor Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
.... causalityResult Σ0..1CodeableConceptresult1 | result2
AdverseEventCausalityResult (Example)
... subjectMedicalHistory Σ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

UML Diagram (Legend)

AdverseEvent (DomainResource)The identifier(s) of this adverse event that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itsefl is not appropriateidentifier : Identifier [0..1]The type of event which is important to characterize what occurred and caused harm to the subject, or had the potential to cause harm to the subjectcategory : code [0..1] Overall categorization of the event, e.g. real or potential (Strength=Required)AdverseEventCategory! This element defines the specific type of event that occurred or that was prevented from occurringtype : CodeableConcept [0..1] Detailed type of event (Strength=Example)SNOMED CT Clinical Findings?? This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was preventedsubject : Reference [0..1] Patient|ResearchSubject|Medication| Device 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)reaction : Reference [0..*] Condition The information about where the adverse event occurredlocation : Reference [0..1] Location Describes the seriousness or severity of the adverse eventseriousness : CodeableConcept [0..1] Overall seriousness of this event for the patient (Strength=Example)AdverseEventSeriousness?? Describes the type of outcome from the adverse eventoutcome : CodeableConcept [0..1] TODO (and should this be required?) (Strength=Required)AdverseEventOutcome! Information on who recorded the adverse event. May be the patient or a practitionerrecorder : Reference [0..1] Patient|Practitioner|RelatedPerson Parties that may or should contribute or have contributed information to the Act. Such information includes information leading to the decision to perform the Act and how to perform the Act (e.g. consultant), information that the Act itself seeks to reveal (e.g. informant of clinical history), or information about what Act was performed (e.g. informant witness)eventParticipant : Reference [0..1] Practitioner|Device Describes the adverse event in textdescription : string [0..1]AdverseEvent.subjectMedicalHistorysubjectMedicalHistory : Reference [0..*] Condition|Observation| AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure 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] Substance|Medication| MedicationAdministration|MedicationStatement|Device causality1 | causality2causality : code [0..1] TODO (Strength=Required)AdverseEventCausality! assess1 | assess2causalityAssessment : CodeableConcept [0..1] TODO (Strength=Example) AdverseEventCausalityAssessme...?? AdverseEvent.suspectEntity.causalityProductRelatednesscausalityProductRelatedness : string [0..1]method1 | method2causalityMethod : CodeableConcept [0..1] TODO (Strength=Example) AdverseEventCausalityMethod?? AdverseEvent.suspectEntity.causalityAuthorcausalityAuthor : Reference [0..1] Practitioner|PractitionerRole result1 | result2causalityResult : CodeableConcept [0..1] TODO (Strength=Example) AdverseEventCausalityResult?? 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>
 <category value="[code]"/><!-- 0..1 AE | PAE 
An adverse event is an event that caused harm to a patient,  an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not -->
 <type><!-- 0..1 CodeableConcept actual | potential --></type>
 <subject><!-- 0..1 Reference(Patient|ResearchSubject|Medication|Device) Subject or group impacted by event --></subject>
 <date value="[dateTime]"/><!-- 0..1 When the event occurred -->
 <reaction><!-- 0..* Reference(Condition) Adverse Reaction Events linked to exposure to substance --></reaction>
 <location><!-- 0..1 Reference(Location) Location where adverse event occurred --></location>
 <seriousness><!-- 0..1 CodeableConcept Mild | Moderate | Severe --></seriousness>
 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|RelatedPerson) Who recorded the adverse event --></recorder>
 <eventParticipant><!-- 0..1 Reference(Practitioner|Device) Who  was involved in the adverse event or the potential adverse event --></eventParticipant>
 <description value="[string]"/><!-- 0..1 Description of the adverse event -->
 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <instance><!-- 1..1 Reference(Substance|Medication|MedicationAdministration|
    MedicationStatement|Device) Refers to the specific entity that caused the adverse event --></instance>
  <causality value="[code]"/><!-- 0..1 causality1 | causality2 -->
  <causalityAssessment><!-- 0..1 CodeableConcept assess1 | assess2 --></causalityAssessment>
  <causalityProductRelatedness value="[string]"/><!-- 0..1 AdverseEvent.suspectEntity.causalityProductRelatedness -->
  <causalityMethod><!-- 0..1 CodeableConcept method1 | method2 --></causalityMethod>
  <causalityAuthor><!-- 0..1 Reference(Practitioner|PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor --></causalityAuthor>
  <causalityResult><!-- 0..1 CodeableConcept result1 | result2 --></causalityResult>
 </suspectEntity>
 <subjectMedicalHistory><!-- 0..* Reference(Condition|Observation|
   AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure) 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
  "category" : "<code>", // AE | PAE 
An adverse event is an event that caused harm to a patient,  an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not
  "type" : { CodeableConcept }, // actual | potential
  "subject" : { Reference(Patient|ResearchSubject|Medication|Device) }, // Subject or group impacted by event
  "date" : "<dateTime>", // When the event occurred
  "reaction" : [{ Reference(Condition) }], // Adverse Reaction Events linked to exposure to substance
  "location" : { Reference(Location) }, // Location where adverse event occurred
  "seriousness" : { CodeableConcept }, // Mild | Moderate | Severe
  "outcome" : { CodeableConcept }, // resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
  "recorder" : { Reference(Patient|Practitioner|RelatedPerson) }, // Who recorded the adverse event
  "eventParticipant" : { Reference(Practitioner|Device) }, // Who  was involved in the adverse event or the potential adverse event
  "description" : "<string>", // Description of the adverse event
  "suspectEntity" : [{ // The suspected agent causing the adverse event
    "instance" : { Reference(Substance|Medication|MedicationAdministration|
    MedicationStatement|Device) }, // R!  Refers to the specific entity that caused the adverse event
    "causality" : "<code>", // causality1 | causality2
    "causalityAssessment" : { CodeableConcept }, // assess1 | assess2
    "causalityProductRelatedness" : "<string>", // AdverseEvent.suspectEntity.causalityProductRelatedness
    "causalityMethod" : { CodeableConcept }, // method1 | method2
    "causalityAuthor" : { Reference(Practitioner|PractitionerRole) }, // AdverseEvent.suspectEntity.causalityAuthor
    "causalityResult" : { CodeableConcept } // result1 | result2
  }],
  "subjectMedicalHistory" : [{ Reference(Condition|Observation|
   AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure) }], // 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.category [ code ]; # 0..1 AE | PAE 
An adverse event is an event that caused harm to a patient,  an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not
  fhir:AdverseEvent.type [ CodeableConcept ]; # 0..1 actual | potential
  fhir:AdverseEvent.subject [ Reference(Patient|ResearchSubject|Medication|Device) ]; # 0..1 Subject or group impacted by event
  fhir:AdverseEvent.date [ dateTime ]; # 0..1 When the event occurred
  fhir:AdverseEvent.reaction [ Reference(Condition) ], ... ; # 0..* Adverse Reaction Events linked to exposure to substance
  fhir:AdverseEvent.location [ Reference(Location) ]; # 0..1 Location where adverse event occurred
  fhir:AdverseEvent.seriousness [ 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.eventParticipant [ Reference(Practitioner|Device) ]; # 0..1 Who  was involved in the adverse event or the potential adverse event
  fhir:AdverseEvent.description [ string ]; # 0..1 Description of the adverse event
  fhir:AdverseEvent.suspectEntity [ # 0..* The suspected agent causing the adverse event
    fhir:AdverseEvent.suspectEntity.instance [ Reference(Substance|Medication|MedicationAdministration|MedicationStatement|Device) ]; # 1..1 Refers to the specific entity that caused the adverse event
    fhir:AdverseEvent.suspectEntity.causality [ code ]; # 0..1 causality1 | causality2
    fhir:AdverseEvent.suspectEntity.causalityAssessment [ CodeableConcept ]; # 0..1 assess1 | assess2
    fhir:AdverseEvent.suspectEntity.causalityProductRelatedness [ string ]; # 0..1 AdverseEvent.suspectEntity.causalityProductRelatedness
    fhir:AdverseEvent.suspectEntity.causalityMethod [ CodeableConcept ]; # 0..1 method1 | method2
    fhir:AdverseEvent.suspectEntity.causalityAuthor [ Reference(Practitioner|PractitionerRole) ]; # 0..1 AdverseEvent.suspectEntity.causalityAuthor
    fhir:AdverseEvent.suspectEntity.causalityResult [ CodeableConcept ]; # 0..1 result1 | result2
  ], ...;
  fhir:AdverseEvent.subjectMedicalHistory [ Reference(Condition|Observation|AllergyIntolerance|FamilyMemberHistory|Immunization|
  Procedure) ], ... ; # 0..* AdverseEvent.subjectMedicalHistory
  fhir:AdverseEvent.referenceDocument [ Reference(DocumentReference) ], ... ; # 0..* AdverseEvent.referenceDocument
  fhir:AdverseEvent.study [ Reference(ResearchStudy) ], ... ; # 0..* AdverseEvent.study
]

Changes since DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent ΣDomainResourceMedical 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
... category Σ0..1codeAE | PAE An adverse event is an event that caused harm to a patient, an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not
AdverseEventCategory (Required)
... type Σ0..1CodeableConceptactual | potential
SNOMED CT Clinical Findings (Example)
... subject Σ0..1Reference(Patient | ResearchSubject | Medication | Device)Subject or group impacted by event
... date Σ0..1dateTimeWhen the event occurred
... reaction Σ0..*Reference(Condition)Adverse Reaction Events linked to exposure to substance
... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptMild | Moderate | Severe
AdverseEventSeriousness (Example)
... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
AdverseEventOutcome (Required)
... recorder Σ0..1Reference(Patient | Practitioner | RelatedPerson)Who recorded the adverse event
... eventParticipant Σ0..1Reference(Practitioner | Device)Who was involved in the adverse event or the potential adverse event
... description Σ0..1stringDescription of the adverse event
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... instance Σ1..1Reference(Substance | Medication | MedicationAdministration | MedicationStatement | Device)Refers to the specific entity that caused the adverse event
.... causality Σ0..1codecausality1 | causality2
AdverseEventCausality (Required)
.... causalityAssessment Σ0..1CodeableConceptassess1 | assess2
AdverseEventCausalityAssessment (Example)
.... causalityProductRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
.... causalityMethod Σ0..1CodeableConceptmethod1 | method2
AdverseEventCausalityMethod (Example)
.... causalityAuthor Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
.... causalityResult Σ0..1CodeableConceptresult1 | result2
AdverseEventCausalityResult (Example)
... subjectMedicalHistory Σ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

UML Diagram (Legend)

AdverseEvent (DomainResource)The identifier(s) of this adverse event that are assigned by business processes and/or used to refer to it when a direct URL reference to the resource itsefl is not appropriateidentifier : Identifier [0..1]The type of event which is important to characterize what occurred and caused harm to the subject, or had the potential to cause harm to the subjectcategory : code [0..1] Overall categorization of the event, e.g. real or potential (Strength=Required)AdverseEventCategory! This element defines the specific type of event that occurred or that was prevented from occurringtype : CodeableConcept [0..1] Detailed type of event (Strength=Example)SNOMED CT Clinical Findings?? This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was preventedsubject : Reference [0..1] Patient|ResearchSubject|Medication| Device 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)reaction : Reference [0..*] Condition The information about where the adverse event occurredlocation : Reference [0..1] Location Describes the seriousness or severity of the adverse eventseriousness : CodeableConcept [0..1] Overall seriousness of this event for the patient (Strength=Example)AdverseEventSeriousness?? Describes the type of outcome from the adverse eventoutcome : CodeableConcept [0..1] TODO (and should this be required?) (Strength=Required)AdverseEventOutcome! Information on who recorded the adverse event. May be the patient or a practitionerrecorder : Reference [0..1] Patient|Practitioner|RelatedPerson Parties that may or should contribute or have contributed information to the Act. Such information includes information leading to the decision to perform the Act and how to perform the Act (e.g. consultant), information that the Act itself seeks to reveal (e.g. informant of clinical history), or information about what Act was performed (e.g. informant witness)eventParticipant : Reference [0..1] Practitioner|Device Describes the adverse event in textdescription : string [0..1]AdverseEvent.subjectMedicalHistorysubjectMedicalHistory : Reference [0..*] Condition|Observation| AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure 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] Substance|Medication| MedicationAdministration|MedicationStatement|Device causality1 | causality2causality : code [0..1] TODO (Strength=Required)AdverseEventCausality! assess1 | assess2causalityAssessment : CodeableConcept [0..1] TODO (Strength=Example) AdverseEventCausalityAssessme...?? AdverseEvent.suspectEntity.causalityProductRelatednesscausalityProductRelatedness : string [0..1]method1 | method2causalityMethod : CodeableConcept [0..1] TODO (Strength=Example) AdverseEventCausalityMethod?? AdverseEvent.suspectEntity.causalityAuthorcausalityAuthor : Reference [0..1] Practitioner|PractitionerRole result1 | result2causalityResult : CodeableConcept [0..1] TODO (Strength=Example) AdverseEventCausalityResult?? 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>
 <category value="[code]"/><!-- 0..1 AE | PAE 
An adverse event is an event that caused harm to a patient,  an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not -->
 <type><!-- 0..1 CodeableConcept actual | potential --></type>
 <subject><!-- 0..1 Reference(Patient|ResearchSubject|Medication|Device) Subject or group impacted by event --></subject>
 <date value="[dateTime]"/><!-- 0..1 When the event occurred -->
 <reaction><!-- 0..* Reference(Condition) Adverse Reaction Events linked to exposure to substance --></reaction>
 <location><!-- 0..1 Reference(Location) Location where adverse event occurred --></location>
 <seriousness><!-- 0..1 CodeableConcept Mild | Moderate | Severe --></seriousness>
 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|RelatedPerson) Who recorded the adverse event --></recorder>
 <eventParticipant><!-- 0..1 Reference(Practitioner|Device) Who  was involved in the adverse event or the potential adverse event --></eventParticipant>
 <description value="[string]"/><!-- 0..1 Description of the adverse event -->
 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <instance><!-- 1..1 Reference(Substance|Medication|MedicationAdministration|
    MedicationStatement|Device) Refers to the specific entity that caused the adverse event --></instance>
  <causality value="[code]"/><!-- 0..1 causality1 | causality2 -->
  <causalityAssessment><!-- 0..1 CodeableConcept assess1 | assess2 --></causalityAssessment>
  <causalityProductRelatedness value="[string]"/><!-- 0..1 AdverseEvent.suspectEntity.causalityProductRelatedness -->
  <causalityMethod><!-- 0..1 CodeableConcept method1 | method2 --></causalityMethod>
  <causalityAuthor><!-- 0..1 Reference(Practitioner|PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor --></causalityAuthor>
  <causalityResult><!-- 0..1 CodeableConcept result1 | result2 --></causalityResult>
 </suspectEntity>
 <subjectMedicalHistory><!-- 0..* Reference(Condition|Observation|
   AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure) 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
  "category" : "<code>", // AE | PAE 
An adverse event is an event that caused harm to a patient,  an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not
  "type" : { CodeableConcept }, // actual | potential
  "subject" : { Reference(Patient|ResearchSubject|Medication|Device) }, // Subject or group impacted by event
  "date" : "<dateTime>", // When the event occurred
  "reaction" : [{ Reference(Condition) }], // Adverse Reaction Events linked to exposure to substance
  "location" : { Reference(Location) }, // Location where adverse event occurred
  "seriousness" : { CodeableConcept }, // Mild | Moderate | Severe
  "outcome" : { CodeableConcept }, // resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
  "recorder" : { Reference(Patient|Practitioner|RelatedPerson) }, // Who recorded the adverse event
  "eventParticipant" : { Reference(Practitioner|Device) }, // Who  was involved in the adverse event or the potential adverse event
  "description" : "<string>", // Description of the adverse event
  "suspectEntity" : [{ // The suspected agent causing the adverse event
    "instance" : { Reference(Substance|Medication|MedicationAdministration|
    MedicationStatement|Device) }, // R!  Refers to the specific entity that caused the adverse event
    "causality" : "<code>", // causality1 | causality2
    "causalityAssessment" : { CodeableConcept }, // assess1 | assess2
    "causalityProductRelatedness" : "<string>", // AdverseEvent.suspectEntity.causalityProductRelatedness
    "causalityMethod" : { CodeableConcept }, // method1 | method2
    "causalityAuthor" : { Reference(Practitioner|PractitionerRole) }, // AdverseEvent.suspectEntity.causalityAuthor
    "causalityResult" : { CodeableConcept } // result1 | result2
  }],
  "subjectMedicalHistory" : [{ Reference(Condition|Observation|
   AllergyIntolerance|FamilyMemberHistory|Immunization|Procedure) }], // 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.category [ code ]; # 0..1 AE | PAE 
An adverse event is an event that caused harm to a patient,  an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did not
  fhir:AdverseEvent.type [ CodeableConcept ]; # 0..1 actual | potential
  fhir:AdverseEvent.subject [ Reference(Patient|ResearchSubject|Medication|Device) ]; # 0..1 Subject or group impacted by event
  fhir:AdverseEvent.date [ dateTime ]; # 0..1 When the event occurred
  fhir:AdverseEvent.reaction [ Reference(Condition) ], ... ; # 0..* Adverse Reaction Events linked to exposure to substance
  fhir:AdverseEvent.location [ Reference(Location) ]; # 0..1 Location where adverse event occurred
  fhir:AdverseEvent.seriousness [ 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.eventParticipant [ Reference(Practitioner|Device) ]; # 0..1 Who  was involved in the adverse event or the potential adverse event
  fhir:AdverseEvent.description [ string ]; # 0..1 Description of the adverse event
  fhir:AdverseEvent.suspectEntity [ # 0..* The suspected agent causing the adverse event
    fhir:AdverseEvent.suspectEntity.instance [ Reference(Substance|Medication|MedicationAdministration|MedicationStatement|Device) ]; # 1..1 Refers to the specific entity that caused the adverse event
    fhir:AdverseEvent.suspectEntity.causality [ code ]; # 0..1 causality1 | causality2
    fhir:AdverseEvent.suspectEntity.causalityAssessment [ CodeableConcept ]; # 0..1 assess1 | assess2
    fhir:AdverseEvent.suspectEntity.causalityProductRelatedness [ string ]; # 0..1 AdverseEvent.suspectEntity.causalityProductRelatedness
    fhir:AdverseEvent.suspectEntity.causalityMethod [ CodeableConcept ]; # 0..1 method1 | method2
    fhir:AdverseEvent.suspectEntity.causalityAuthor [ Reference(Practitioner|PractitionerRole) ]; # 0..1 AdverseEvent.suspectEntity.causalityAuthor
    fhir:AdverseEvent.suspectEntity.causalityResult [ CodeableConcept ]; # 0..1 result1 | result2
  ], ...;
  fhir:AdverseEvent.subjectMedicalHistory [ Reference(Condition|Observation|AllergyIntolerance|FamilyMemberHistory|Immunization|
  Procedure) ], ... ; # 0..* AdverseEvent.subjectMedicalHistory
  fhir:AdverseEvent.referenceDocument [ Reference(DocumentReference) ], ... ; # 0..* AdverseEvent.referenceDocument
  fhir:AdverseEvent.study [ Reference(ResearchStudy) ], ... ; # 0..* AdverseEvent.study
]

Changes since DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.

 

Alternate definitions: Master Definition (XML, JSON), XML Schema/Schematron (for ) + JSON Schema, ShEx (for Turtle)

9.9.3.1 Terminology Bindings

PathDefinitionTypeReference
AdverseEvent.category Overall categorization of the event, e.g. real or potentialRequiredAdverseEventCategory
AdverseEvent.type Detailed type of eventExampleSNOMED CT Clinical Findings
AdverseEvent.seriousness Overall seriousness of this event for the patientExampleAdverseEventSeriousness
AdverseEvent.outcome TODO (and should this be required?)RequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causality TODORequiredAdverseEventCausality
AdverseEvent.suspectEntity.causalityAssessment TODOExampleAdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causalityMethod TODOExampleAdverseEventCausalityMethod
AdverseEvent.suspectEntity.causalityResult TODOExampleAdverseEventCausalityResult

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
categorytokenAE | PAE An adverse event is an event that caused harm to a patient, an adverse reaction is a something that is a subject-specific event that is a result of an exposure to a medication, food, device or environmental substance, a potential adverse event is something that occurred and that could have caused harm to a patient but did notAdverseEvent.category
datedateWhen the event occurredAdverseEvent.date
locationreferenceLocation where adverse event occurredAdverseEvent.location
(Location)
reactionreferenceAdverse Reaction Events linked to exposure to substanceAdverseEvent.reaction
(Condition)
recorderreferenceWho recorded the adverse eventAdverseEvent.recorder
(Practitioner, Patient, RelatedPerson)
seriousnesstokenMild | Moderate | SevereAdverseEvent.seriousness
studyreferenceAdverseEvent.studyAdverseEvent.study
(ResearchStudy)
subjectreferenceSubject or group impacted by eventAdverseEvent.subject
(Device, Medication, Patient, ResearchSubject)
substancereferenceRefers to the specific entity that caused the adverse eventAdverseEvent.suspectEntity.instance
(Device, Medication, Substance, MedicationAdministration, MedicationStatement)
typetokenactual | potentialAdverseEvent.type