Release 4 4B

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9.9 Resource AdverseEvent - Content

Patient Care Work Group Maturity Level : 0   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.

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 References

No resources refer to this resource directly.

This resource does not implement any patterns.

9.9.3 9.9.4 Resource Content

Structure

Name Flags Card. Type Description & Constraints doco
. . AdverseEvent Σ 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 Identifier Business identifier for the event
. . . actuality ?! Σ 1..1 code actual | potential
AdverseEventActuality ( Required )
. . . category Σ 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
AdverseEventCategory ( Extensible )
. . . subject Σ 1..1 Reference ( Patient | Group | Practitioner | RelatedPerson ) Subject impacted by event
. . . encounter Σ 0..1 Reference ( Encounter ) Encounter created as part of
. . . 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 | moderate | 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
. . . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
. . . . instance Σ 1..1 Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device ) Refers to the specific entity that caused the adverse event
. . . . causality Σ 0..* BackboneElement Information on the possible cause of the event
. . . . . assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
AdverseEventCausalityAssessment ( Example )
. . . . . productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
. . . . . author Σ 0..1 Reference ( Practitioner | PractitionerRole ) AdverseEvent.suspectEntity.causalityAuthor
. . . . . method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
AdverseEventCausalityMethod ( Example )
. . . subjectMedicalHistory Σ 0..* Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference ) AdverseEvent.subjectMedicalHistory
. . . referenceDocument Σ 0..* Reference ( DocumentReference ) AdverseEvent.referenceDocument
. . . study Σ 0..* 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 server identifier : 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 adverse event, e.g. real or potential. null (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 or situational. null (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. null (Strength=Example) SNOMEDCTClinicalFindings ?? » This subject or group impacted by the event subject : Reference [1..1] « Patient | Group | Practitioner | RelatedPerson » The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated encounter : Reference [0..1] « Encounter » 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. null (Strength=Example) AdverseEventSeriousness ?? » Describes the severity of the adverse event, in relation to the subject. Contrast to 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. null (Strength=Required) AdverseEventSeverity ! » Describes the type of outcome from the adverse event outcome : CodeableConcept [0..1] « TODO (and should this be required?). null (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 subjectMedicalHistory : Reference [0..*] « Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference » AdverseEvent.referenceDocument referenceDocument : Reference [0..*] « DocumentReference » AdverseEvent.study 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 : Reference [1..1] « Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device » Causality Assessment of if the entity caused the event assessment : CodeableConcept [0..1] « Codes for the assessment of whether the entity caused the event. null (Strength=Example) AdverseEventCausalityAssessme... ?? » AdverseEvent.suspectEntity.causalityProductRelatedness productRelatedness : string [0..1] AdverseEvent.suspectEntity.causalityAuthor author : Reference [0..1] « Practitioner | PractitionerRole » ProbabilityScale | Bayesian | Checklist method : CodeableConcept [0..1] « TODO. null (Strength=Example) AdverseEventCausalityMethod ?? » Information on the possible cause of the event causality [0..*] Describes the entity that is suspected to have caused the adverse event suspectEntity [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 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>

 <subject><!-- 1..1 Reference(Group|Patient|Practitioner|RelatedPerson) Subject impacted by event --></subject>

 <encounter><!-- 0..1 Reference(Encounter) Encounter created as part of --></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><!-- 0..1 CodeableConcept mild | moderate | severe --></severity>
 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <</contributor>

 <contributor><!-- 0..* Reference(Device|Practitioner|PractitionerRole) Who  was involved in the adverse event or the potential adverse event --></contributor>

 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <|
    </instance>

  <instance><!-- 1..1 Reference(Device|Immunization|Medication|
    MedicationAdministration|MedicationStatement|Procedure|Substance) 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>

 <subjectMedicalHistory><!-- 0..* Reference(AllergyIntolerance|Condition|
   DocumentReference|FamilyMemberHistory|Immunization|Media|Observation|
   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
  "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) }, // Encounter created as part of
  "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

  "suspectEntity" : [{ // The suspected agent causing the adverse event
    "|
    

    "instance" : { Reference(Device|Immunization|Medication|
    MedicationAdministration|MedicationStatement|Procedure|Substance) }, // 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(AllergyIntolerance|Condition|
   DocumentReference|FamilyMemberHistory|Immunization|Media|Observation|
   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.actuality [ code ]; # 1..1 actual | potential
  fhir:AdverseEvent.category [ CodeableConcept ], ... ; # 0..* product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
  fhir:AdverseEvent.event [ CodeableConcept ]; # 0..1 Type of the event itself in relation to the subject
  fhir:

  fhir:AdverseEvent.subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ]; # 1..1 Subject impacted by event

  fhir:AdverseEvent.encounter [ Reference(Encounter) ]; # 0..1 Encounter created as part of
  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: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|PractitionerRole|RelatedPerson) ]; # 0..1 Who recorded the adverse event
  fhir:

  fhir:AdverseEvent.contributor [ Reference(Device|Practitioner|PractitionerRole) ], ... ; # 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:|
  

    fhir:AdverseEvent.suspectEntity.instance [ Reference(Device|Immunization|Medication|MedicationAdministration|MedicationStatement|
  Procedure|Substance) ]; # 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:|
  

  fhir:AdverseEvent.subjectMedicalHistory [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Media|Observation|Procedure) ], ... ; # 0..* AdverseEvent.subjectMedicalHistory
  fhir:AdverseEvent.referenceDocument [ Reference(DocumentReference) ], ... ; # 0..* AdverseEvent.referenceDocument
  fhir:AdverseEvent.study [ Reference(ResearchStudy) ], ... ; # 0..* AdverseEvent.study
]

Changes since R3 R4

AdverseEvent AdverseEvent.actuality Added Mandatory 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 Reference: Added Target Types Group, Practitioner, RelatedPerson Type Reference: Removed Target Types ResearchSubject, Medication, Device AdverseEvent.encounter Added Element AdverseEvent.detected Added Element AdverseEvent.recordedDate Added Element AdverseEvent.resultingCondition Added Element AdverseEvent.severity Added Element AdverseEvent.outcome Change value set from http://hl7.org/fhir/ValueSet/adverse-event-outcome to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 AdverseEvent.recorder Type Reference: Added Target Type PractitionerRole AdverseEvent.contributor Added Element AdverseEvent.suspectEntity.instance Type Reference: Added Target Types Immunization, Procedure 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 Reference: Added Target Types 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 No Changes

See the Full Difference for further information

This analysis is available as XML or JSON .

Conversions between R3 and R4

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 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 Identifier Business identifier for the event
. . . actuality ?! Σ 1..1 code actual | potential
AdverseEventActuality ( Required )
. . . category Σ 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
AdverseEventCategory ( Extensible )
. . . subject Σ 1..1 Reference ( Patient | Group | Practitioner | RelatedPerson ) Subject impacted by event
. . . encounter Σ 0..1 Reference ( Encounter ) Encounter created as part of
. . . 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 | moderate | 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
. . . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
. . . . instance Σ 1..1 Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device ) Refers to the specific entity that caused the adverse event
. . . . causality Σ 0..* BackboneElement Information on the possible cause of the event
. . . . . assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
AdverseEventCausalityAssessment ( Example )
. . . . . productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
. . . . . author Σ 0..1 Reference ( Practitioner | PractitionerRole ) AdverseEvent.suspectEntity.causalityAuthor
. . . . . method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
AdverseEventCausalityMethod ( Example )
. . . subjectMedicalHistory Σ 0..* Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference ) AdverseEvent.subjectMedicalHistory
. . . referenceDocument Σ 0..* Reference ( DocumentReference ) AdverseEvent.referenceDocument
. . . study Σ 0..* 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 server identifier : 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 adverse event, e.g. real or potential. null (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 or situational. null (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. null (Strength=Example) SNOMEDCTClinicalFindings ?? » This subject or group impacted by the event subject : Reference [1..1] « Patient | Group | Practitioner | RelatedPerson » The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated encounter : Reference [0..1] « Encounter » 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. null (Strength=Example) AdverseEventSeriousness ?? » Describes the severity of the adverse event, in relation to the subject. Contrast to 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. null (Strength=Required) AdverseEventSeverity ! » Describes the type of outcome from the adverse event outcome : CodeableConcept [0..1] « TODO (and should this be required?). null (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 subjectMedicalHistory : Reference [0..*] « Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference » AdverseEvent.referenceDocument referenceDocument : Reference [0..*] « DocumentReference » AdverseEvent.study 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 : Reference [1..1] « Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device » Causality Assessment of if the entity caused the event assessment : CodeableConcept [0..1] « Codes for the assessment of whether the entity caused the event. null (Strength=Example) AdverseEventCausalityAssessme... ?? » AdverseEvent.suspectEntity.causalityProductRelatedness productRelatedness : string [0..1] AdverseEvent.suspectEntity.causalityAuthor author : Reference [0..1] « Practitioner | PractitionerRole » ProbabilityScale | Bayesian | Checklist method : CodeableConcept [0..1] « TODO. null (Strength=Example) AdverseEventCausalityMethod ?? » Information on the possible cause of the event causality [0..*] Describes the entity that is suspected to have caused the adverse event suspectEntity [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 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>

 <subject><!-- 1..1 Reference(Group|Patient|Practitioner|RelatedPerson) Subject impacted by event --></subject>

 <encounter><!-- 0..1 Reference(Encounter) Encounter created as part of --></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><!-- 0..1 CodeableConcept mild | moderate | severe --></severity>
 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <</contributor>

 <contributor><!-- 0..* Reference(Device|Practitioner|PractitionerRole) Who  was involved in the adverse event or the potential adverse event --></contributor>

 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <|
    </instance>

  <instance><!-- 1..1 Reference(Device|Immunization|Medication|
    MedicationAdministration|MedicationStatement|Procedure|Substance) 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>

 <subjectMedicalHistory><!-- 0..* Reference(AllergyIntolerance|Condition|
   DocumentReference|FamilyMemberHistory|Immunization|Media|Observation|
   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
  "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) }, // Encounter created as part of
  "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

  "suspectEntity" : [{ // The suspected agent causing the adverse event
    "|
    

    "instance" : { Reference(Device|Immunization|Medication|
    MedicationAdministration|MedicationStatement|Procedure|Substance) }, // 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(AllergyIntolerance|Condition|
   DocumentReference|FamilyMemberHistory|Immunization|Media|Observation|
   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.actuality [ code ]; # 1..1 actual | potential
  fhir:AdverseEvent.category [ CodeableConcept ], ... ; # 0..* product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
  fhir:AdverseEvent.event [ CodeableConcept ]; # 0..1 Type of the event itself in relation to the subject
  fhir:

  fhir:AdverseEvent.subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ]; # 1..1 Subject impacted by event

  fhir:AdverseEvent.encounter [ Reference(Encounter) ]; # 0..1 Encounter created as part of
  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: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|PractitionerRole|RelatedPerson) ]; # 0..1 Who recorded the adverse event
  fhir:

  fhir:AdverseEvent.contributor [ Reference(Device|Practitioner|PractitionerRole) ], ... ; # 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:|
  

    fhir:AdverseEvent.suspectEntity.instance [ Reference(Device|Immunization|Medication|MedicationAdministration|MedicationStatement|
  Procedure|Substance) ]; # 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:|
  

  fhir:AdverseEvent.subjectMedicalHistory [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Media|Observation|Procedure) ], ... ; # 0..* AdverseEvent.subjectMedicalHistory
  fhir:AdverseEvent.referenceDocument [ Reference(DocumentReference) ], ... ; # 0..* AdverseEvent.referenceDocument
  fhir:AdverseEvent.study [ Reference(ResearchStudy) ], ... ; # 0..* AdverseEvent.study
]

Changes since Release 3 4

AdverseEvent AdverseEvent.actuality Added Mandatory 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 Reference: Added Target Types Group, Practitioner, RelatedPerson Type Reference: Removed Target Types ResearchSubject, Medication, Device AdverseEvent.encounter Added Element AdverseEvent.detected Added Element AdverseEvent.recordedDate Added Element AdverseEvent.resultingCondition Added Element AdverseEvent.severity Added Element AdverseEvent.outcome Change value set from http://hl7.org/fhir/ValueSet/adverse-event-outcome to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 AdverseEvent.recorder Type Reference: Added Target Type PractitionerRole AdverseEvent.contributor Added Element AdverseEvent.suspectEntity.instance Type Reference: Added Target Types Immunization, Procedure 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 Reference: Added Target Types 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 No Changes

See the Full Difference for further information

This analysis is available as XML or JSON .

Conversions between R3 and R4

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

 

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

9.9.3.1 9.9.4.1 Terminology Bindings

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

9.9.4 9.9.5 Search Parameters

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 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 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 | moderate | severe AdverseEvent.severity
study reference AdverseEvent.study 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
( Immunization , Device , Medication , Procedure , Substance , MedicationAdministration , MedicationStatement )