FHIR Release 3 (STU) Current Build
This page is part of FHIR STU 3 (v3.0.1) in it's permanent home (it will always be available at this URL). It has been superceded by R4 . For a full list of available versions, see the Directory of published versions .

9.9 Resource AdverseEvent - Content

Regulated Clinical Research Information Management Patient Care Work Group Maturity Level : 0   Draft Trial Use Security Category : Patient Compartments : Patient , Practitioner , RelatedPerson

Actual or potential/avoided

An event causing unintended physical injury resulting from or contributed (i.e. any change to by medical care, current patient status) that may be related to unintended effects on a research study patient or other healthcare setting factors that requires research subject. The unintended effects may require additional monitoring, treatment, treatment or hospitalization, hospitalization or that results may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects.

AdverseEvent is an event resource from a FHIR workflow perspective - see Workflow Event . A single Adverse Event may need to be reported in multiple ways. The form of the reporting is left to implementation guides based upon appropriate workflow patterns.

This resource applies to events that occur during the course of medical care or medical research which may impact an individual as the recipient of care or the participant in a research study. There are also events that occur within a care setting that may might or may 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 may might not be known at the time of the event), severity, and outcome.

The context of an adverse event is also important. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause and effect relationship for an adverse event.

A potential adverse event may also be called a near miss or an error. These are also events but because they were detected did not cause harm to a subject. Examples of potential adverse events include a product problem such as a faulty pacemaker that is detected prior implantation, a doctor working simultaneously on two electronic health records realizing the order for a drug was entered on the incorrect patient and then canceling the order, or a patient with a peanut allergy notices that his hospital dinner tray includes peanuts, and he does not eat the peanuts.

The AdverseEvent resource is designed to represent events that have a harmful impact on a subject, or had the potential to cause harm to a subject but were avoided. In the course of medical care there are many actions that may impact how a subject responds to a particular treatment impacting patient safety. Therefore the AdverseEvent resource may reference multiple other resources to represent the context or details of an adverse event including but not limited to Observation, Condition, MedicationAdminsitration, Immunization, Procedure, or ResearchStudy.

A DetectedIssue reference is also related to the context of an AdverseEvent to the extent that a known risk for a potential issue such as a drug-drug interaction is documented. If in the context of a known issue, and adverse event occurs, citing this relationship is important for preventing such an occurrence in the future.

The AdverseEvent resource should not be used when a more specific resource exists.

  • The AllergyIntolerance resource is a case specific means of capturing the condition of an allergy or intolerance and the criticality (or potential for future harm) based on the response of a particular individual.
  • The Clinical Reasoning module provides resources and operations to enable the representation, distribution, and evaluation of clinical knowledge artifacts such as clinical decision support rules, quality measures, order sets, and protocols. The suite of resources within the clinical reasoning module should be used to capture clinical quality measures and clinical protocols that help drive clinical best practices.
  • The AdverseEvent resource is not intended to be used to capture potential subject risk in a prospective manner. A more appropriate resource for this purpose would be Risk Assessment which captures predicted outcomes for a patient or population on the basis of source information. Examples include a prognosis statement for a particular condition, risk of health outcome (heart attack, particular type of cancer) on the basis of lifestyle factors and/or family history or list of potential health risks based on a patient's genetic analysis.

No resources refer to this resource directly.

This resource does not implement any patterns.

Structure

Name Flags Card. Type Description & Constraints doco
. . AdverseEvent Σ TU DomainResource Medical care, research study or other healthcare event causing physical injury
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier Σ 0..1 0..* Identifier Business identifier for the event
. . . category actuality ?! Σ 0..1 1..1 code AE actual | 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 AdverseEventActuality ( Required )
. . . type category Σ 0..1 0..* CodeableConcept actual product-problem | potential 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 )
... event Σ 0..1 CodeableConcept Type of the event itself in relation to the subject
SNOMED CT Clinical Findings ( Example )
. . . subject Σ 0..1 1..1 Reference ( Patient | ResearchSubject Group | Medication Practitioner | Device RelatedPerson ) Subject or group impacted by event
. . . encounter Σ 0..1 Reference ( Encounter ) The Encounter during which this AdverseEvent was created
.. . date Σ 0..1 dateTime When the event occurred
. . . detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
.. . reaction resultingCondition Σ 0..* Reference ( Condition ) Adverse Reaction Events linked to exposure Effect on the subject due to substance this event
. . . location Σ 0..1 Reference ( Location ) Location where adverse event occurred
. . . seriousness Σ 0..1 CodeableConcept Mild | Moderate | Severe Seriousness or gravity of the event
AdverseEventSeriousness ( Example )
. . . severity Σ 0..1 CodeableConcept mild | moderate | severe
AdverseEventSeverity ( Required )
... outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae resolved-with-sequelae | fatal | unknown
AdverseEventOutcome ( Required )
. . . recorder Σ 0..1 Reference ( Patient | Practitioner | PractitionerRole | RelatedPerson ) Who recorded the adverse event
. . . eventParticipant contributor Σ 0..1 0..* Reference ( Practitioner | PractitionerRole | Device ) Who was involved in the adverse event or the potential adverse event
. . description . detector Σ 0..1 0..* string Reference ( Patient | RelatedPerson | Practitioner | PractitionerRole | Device ) Description of the adverse event Who or what identified a change in physiological state or condition
. . . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
. . . instance . instance[x] Σ 1..1 Reference ( Substance | Medication | MedicationAdministration | MedicationStatement | Device ) Refers to the specific entity that caused the adverse event
. . . . causality . instanceCodeableConcept Σ CodeableConcept 0..1
. . . . . instanceReference code causality1 | causality2 AdverseEventCausality Reference ( Required Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationUsage | Device )
. . . causalityAssessment . causality Σ 0..1 0..* CodeableConcept BackboneElement assess1 | assess2 Information on the possible cause of the event
AdverseEventCausalityAssessment ( Example )
. . . . causalityProductRelatedness . assessmentMethod Σ 0..1 string CodeableConcept AdverseEvent.suspectEntity.causalityProductRelatedness Method of evaluating the relatedness of the suspected entity to the event
AdverseEventCausalityMethod ( Example )
. . . . . causalityMethod entityRelatedness Σ 0..1 CodeableConcept method1 | method2 Result of the assessment regarding the relatedness of the suspected entity to the event
AdverseEventCausalityMethod AdverseEventCausalityAssessment ( Example )
. . . . . causalityAuthor author Σ 0..1 Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson ) AdverseEvent.suspectEntity.causalityAuthor Author of the information on the possible cause of the event
. . causalityResult . supportingInfo Σ 0..1 0..* CodeableConcept BackboneElement result1 | result2 Supporting information relevant to the event
AdverseEventCausalityResult ( Example )
. . . . subjectMedicalHistory item Σ 0..* 1..1 Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference ) AdverseEvent.subjectMedicalHistory Subject medical history or document relevant to this adverse event
. . referenceDocument . . contributingFactor Σ 0..* 0..1 Reference ( DocumentReference boolean ) AdverseEvent.referenceDocument If true, the item has been assessed to be a contributing factor of the adverse event
. . . study Σ 0..* Reference ( ResearchStudy ) AdverseEvent.study Research study that the subject is enrolled in

doco Documentation for this format

UML Diagram ( Legend )

AdverseEvent ( DomainResource ) The identifier(s) of Business identifiers assigned to this adverse event that are assigned by business processes and/or used to refer to it when a direct URL reference to the performer or other systems which remain constant as the resource itsefl is not appropriate updated and propagates from server to server identifier : Identifier [0..1] [0..*] The type of event which is important to characterize what occurred and caused harm to Whether the subject, event actually happened, or just had the potential to cause harm to to. Note that this is independent of whether anyone was affected or harmed or how severely (this element modifies the subject meaning of other elements) category actuality : code [0..1] [1..1] « Overall categorization nature of the adverse event, e.g. real or potential potential. (Strength=Required) AdverseEventCategory 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. (Strength=Extensible) AdverseEventCategory + » This element defines the specific type of event that occurred or that was prevented from occurring type event : CodeableConcept [0..1] « Detailed type of event event. (Strength=Example) SNOMED CT Clinical Findings SNOMEDCTClinicalFindings ?? » This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented subject : Reference [0..1] [1..1] « Patient | ResearchSubject Group | Medication Practitioner | Device 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) reaction resultingCondition : Reference [0..*] « Condition » The information about where the adverse event occurred location : Reference [0..1] « Location » Describes the seriousness or severity of the adverse Assessment whether this event was of real importance seriousness : CodeableConcept [0..1] « Overall seriousness of this event for the patient patient. (Strength=Example) AdverseEventSeriousness ?? » Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.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. (Strength=Required) AdverseEventSeverity ! » Describes the type of outcome from the adverse event outcome : CodeableConcept [0..1] « TODO (and should this be required?) required?). (Strength=Required) AdverseEventOutcome ! » Information on who recorded the adverse event. May be the patient or a practitioner recorder : Reference [0..1] « Patient | Practitioner | PractitionerRole | RelatedPerson » Parties that may or should contribute or have contributed information to the Act. adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the Act activity and how to perform the Act activity (e.g. consultant), information that the Act activity itself seeks to reveal (e.g. informant of clinical history), or information about what Act activity was performed (e.g. informant witness) eventParticipant contributor : Reference [0..1] [0..*] « Practitioner | Device PractitionerRole | Describes the adverse event in text description : string Device [0..1] » AdverseEvent.subjectMedicalHistory Who or what identified a change in physiological state or condition subjectMedicalHistory detector : Reference [0..*] Condition | Observation | AllergyIntolerance « Patient | FamilyMemberHistory RelatedPerson | Immunization Practitioner | Procedure AdverseEvent.referenceDocument referenceDocument : Reference PractitionerRole [0..*] DocumentReference | Device » AdverseEvent.study The research study that the subject is enrolled in study : Reference [0..*] « ResearchStudy » SuspectEntity Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device instance instance[x] : Reference Type [1..1] Substance « CodeableConcept | Medication Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement MedicationUsage | Device ) » Causality causality1 | causality2 The method of evaluating the relatedness of the suspected entity to the event causality assessmentMethod : code CodeableConcept [0..1] « TODO (Strength=Required) TODO. (Strength=Example) AdverseEventCausality ! AdverseEventCausalityMethod ?? » assess1 | assess2 The result of the assessment regarding the relatedness of the suspected entity to the event causalityAssessment entityRelatedness : CodeableConcept [0..1] « TODO Codes for the assessment of whether the entity caused the event. (Strength=Example) AdverseEventCausalityAssessme... ?? » AdverseEvent.suspectEntity.causalityProductRelatedness The author of the information on the possible cause of the event causalityProductRelatedness author : string Reference [0..1] « Practitioner | PractitionerRole | Patient | RelatedPerson » method1 | method2 causalityMethod : CodeableConcept [0..1] TODO (Strength=Example) AdverseEventCausalityMethod ?? SupportingInfo AdverseEvent.suspectEntity.causalityAuthor Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penciliin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS) causalityAuthor item : Reference [0..1] Practitioner [1..1] « Condition | PractitionerRole Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference » result1 | result2 If true, the item has been assessed to be a contributing factor of the adverse event causalityResult contributingFactor : CodeableConcept boolean [0..1] TODO (Strength=Example) Information on the possible cause of the event causality AdverseEventCausalityResult ?? [0..*] Describes the entity that is suspected to have caused the adverse event suspectEntity [0..*] Supporting information relevant to the event supportingInfo [0..*]

XML Template

<AdverseEvent xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>
 <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>
 <</subject>

 <identifier><!-- 0..* Identifier Business identifier for the event --></identifier>
 <actuality value="[code]"/><!-- 1..1 actual | potential -->
 <category><!-- 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment --></category>
 <event><!-- 0..1 CodeableConcept Type of the event itself in relation to the subject --></event>
 <subject><!-- 1..1 Reference(Group|Patient|Practitioner|RelatedPerson) Subject impacted by event --></subject>
 <encounter><!-- 0..1 Reference(Encounter) The Encounter during which this AdverseEvent was created --></encounter>

 <date value="[dateTime]"/><!-- 0..1 When the event occurred -->
 <</reaction>

 <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>
 <</outcome>
 <</recorder>
 <</eventParticipant>
 <

 <seriousness><!-- 0..1 CodeableConcept Seriousness or gravity of the event --></seriousness>
 <severity><!-- 0..1 CodeableConcept mild | moderate | severe --></severity>
 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <contributor><!-- 0..* Reference(Device|Practitioner|PractitionerRole) Who  was involved in the adverse event or the potential adverse event --></contributor>
 <detector><!-- 0..* Reference(Device|Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who or what identified a change in physiological state or condition --></detector>
 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <|
    </instance>
  <
  <</causalityAssessment>
  <
  <</causalityMethod>
  <</causalityAuthor>
  <</causalityResult>

  <instance[x]><!-- 1..1 CodeableConcept|Reference(Device|Immunization|Medication|
    MedicationAdministration|MedicationUsage|Procedure|Substance) Refers to the specific entity that caused the adverse event --></instance[x]>
  <causality>  <!-- 0..* Information on the possible cause of the event -->
   <assessmentMethod><!-- 0..1 CodeableConcept Method of evaluating the relatedness of the suspected entity to the event --></assessmentMethod>
   <entityRelatedness><!-- 0..1 CodeableConcept Result of the assessment regarding the relatedness of the suspected entity to the event --></entityRelatedness>
   <author><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
     RelatedPerson) Author of the information on the possible cause of the event --></author>
  </causality>

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

 <supportingInfo>  <!-- 0..* Supporting information relevant to the event -->
  <item><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Media|Observation|Procedure) Subject medical history or document relevant to this adverse event --></item>
  <contributingFactor value="[boolean]"/><!-- 0..1 If true, the item has been assessed to be a contributing factor of the adverse event -->
 </supportingInfo>
 <study><!-- 0..* Reference(ResearchStudy) Research study that the subject is enrolled in --></study>

</AdverseEvent>

JSON Template

{doco
  "resourceType" : "",

  "resourceType" : "AdverseEvent",

  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "
  "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
  "
  "

  "identifier" : [{ Identifier }], // Business identifier for the event
  "actuality" : "<code>", // R!  actual | potential
  "category" : [{ CodeableConcept }], // product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
  "event" : { CodeableConcept }, // Type of the event itself in relation to the subject
  "subject" : { Reference(Group|Patient|Practitioner|RelatedPerson) }, // R!  Subject impacted by event
  "encounter" : { Reference(Encounter) }, // The Encounter during which this AdverseEvent was created

  "date" : "<dateTime>", // When the event occurred
  "

  "detected" : "<dateTime>", // When the event was detected
  "recordedDate" : "<dateTime>", // When the event was recorded
  "resultingCondition" : [{ Reference(Condition) }], // Effect on the subject due to this event

  "location" : { Reference(Location) }, // Location where adverse event occurred
  "
  "
  "
  "
  "

  "seriousness" : { CodeableConcept }, // Seriousness or gravity of the event
  "severity" : { CodeableConcept }, // mild | moderate | severe
  "outcome" : { CodeableConcept }, // resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown
  "recorder" : { Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) }, // Who recorded the adverse event
  "contributor" : [{ Reference(Device|Practitioner|PractitionerRole) }], // Who  was involved in the adverse event or the potential adverse event
  "detector" : [{ Reference(Device|Patient|Practitioner|PractitionerRole|
   RelatedPerson) }], // Who or what identified a change in physiological state or condition
  "suspectEntity" : [{ // The suspected agent causing the adverse event
    "|
    
    "
    "
    "
    "
    "
    "

    // instance[x]: Refers to the specific entity that caused the adverse event. One of these 2:
    "instanceCodeableConcept" : { CodeableConcept },
    "instanceReference" : { Reference(Device|Immunization|Medication|
    MedicationAdministration|MedicationUsage|Procedure|Substance) },
    "causality" : [{ // Information on the possible cause of the event
      "assessmentMethod" : { CodeableConcept }, // Method of evaluating the relatedness of the suspected entity to the event
      "entityRelatedness" : { CodeableConcept }, // Result of the assessment regarding the relatedness of the suspected entity to the event
      "author" : { Reference(Patient|Practitioner|PractitionerRole|
     RelatedPerson) } // Author of the information on the possible cause of the event
    }]

  }],
  "|
   
  "
  "

  "supportingInfo" : [{ // Supporting information relevant to the event
    "item" : { Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Media|Observation|Procedure) }, // R!  Subject medical history or document relevant to this adverse event
    "contributingFactor" : <boolean> // If true, the item has been assessed to be a contributing factor of the adverse event
  }],
  "study" : [{ Reference(ResearchStudy) }] // Research study that the subject is enrolled in

}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco
[ a fhir:;

[ a fhir:AdverseEvent;

  fhir:nodeRole fhir:treeRoot; # if this is the parser root
  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:
  fhir: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:
  fhir:

  fhir:AdverseEvent.identifier [ Identifier ], ... ; # 0..* Business identifier for the event
  fhir:AdverseEvent.actuality [ code ]; # 1..1 actual | potential
  fhir:AdverseEvent.category [ CodeableConcept ], ... ; # 0..* product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
  fhir:AdverseEvent.event [ CodeableConcept ]; # 0..1 Type of the event itself in relation to the subject
  fhir:AdverseEvent.subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ]; # 1..1 Subject impacted by event
  fhir:AdverseEvent.encounter [ Reference(Encounter) ]; # 0..1 The Encounter during which this AdverseEvent was created

  fhir:AdverseEvent.date [ dateTime ]; # 0..1 When the event occurred
  fhir:

  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:
  fhir:
  fhir:
  fhir:
  fhir:

  fhir:AdverseEvent.seriousness [ CodeableConcept ]; # 0..1 Seriousness or gravity of the event
  fhir:AdverseEvent.severity [ CodeableConcept ]; # 0..1 mild | moderate | severe
  fhir:AdverseEvent.outcome [ CodeableConcept ]; # 0..1 resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown
  fhir:AdverseEvent.recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 0..1 Who recorded the adverse event
  fhir:AdverseEvent.contributor [ Reference(Device|Practitioner|PractitionerRole) ], ... ; # 0..* Who  was involved in the adverse event or the potential adverse event
  fhir:AdverseEvent.detector [ Reference(Device|Patient|Practitioner|PractitionerRole|RelatedPerson) ], ... ; # 0..* Who or what identified a change in physiological state or condition

  fhir:AdverseEvent.suspectEntity [ # 0..* The suspected agent causing the adverse event
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:

    # AdverseEvent.suspectEntity.instance[x] : 1..1 Refers to the specific entity that caused the adverse event. One of these 2
      fhir:AdverseEvent.suspectEntity.instanceCodeableConcept [ CodeableConcept ]
      fhir:AdverseEvent.suspectEntity.instanceReference [ Reference(Device|Immunization|Medication|MedicationAdministration|MedicationUsage|
  Procedure|Substance) ]
    fhir:AdverseEvent.suspectEntity.causality [ # 0..* Information on the possible cause of the event
      fhir:AdverseEvent.suspectEntity.causality.assessmentMethod [ CodeableConcept ]; # 0..1 Method of evaluating the relatedness of the suspected entity to the event
      fhir:AdverseEvent.suspectEntity.causality.entityRelatedness [ CodeableConcept ]; # 0..1 Result of the assessment regarding the relatedness of the suspected entity to the event
      fhir:AdverseEvent.suspectEntity.causality.author [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 0..1 Author of the information on the possible cause of the event
    ], ...;

  ], ...;
  fhir:|
  
  fhir:
  fhir:

  fhir:AdverseEvent.supportingInfo [ # 0..* Supporting information relevant to the event
    fhir:AdverseEvent.supportingInfo.item [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Media|Observation|Procedure) ]; # 1..1 Subject medical history or document relevant to this adverse event
    fhir:AdverseEvent.supportingInfo.contributingFactor [ boolean ]; # 0..1 If true, the item has been assessed to be a contributing factor of the adverse event
  ], ...;
  fhir:AdverseEvent.study [ Reference(ResearchStudy) ], ... ; # 0..* Research study that the subject is enrolled in

]

Changes since DSTU2 R3

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

This resource did not exist in Release 2 See the Full Difference for further information

This analysis is available as XML or JSON .

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

Structure

Name Flags Card. Type Description & Constraints doco
. . AdverseEvent Σ TU DomainResource Medical care, research study or other healthcare event causing physical injury
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier Σ 0..1 0..* Identifier Business identifier for the event
. . . category actuality ?! Σ 0..1 1..1 code AE actual | 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 AdverseEventActuality ( Required )
. . . type category Σ 0..1 0..* CodeableConcept actual product-problem | potential 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 )
... event Σ 0..1 CodeableConcept Type of the event itself in relation to the subject
SNOMED CT Clinical Findings ( Example )
. . . subject Σ 0..1 1..1 Reference ( Patient | ResearchSubject Group | Medication Practitioner | Device RelatedPerson ) Subject or group impacted by event
. . . encounter Σ 0..1 Reference ( Encounter ) The Encounter during which this AdverseEvent was created
.. . date Σ 0..1 dateTime When the event occurred
. . . detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
.. . reaction resultingCondition Σ 0..* Reference ( Condition ) Adverse Reaction Events linked to exposure Effect on the subject due to substance this event
. . . location Σ 0..1 Reference ( Location ) Location where adverse event occurred
. . . seriousness Σ 0..1 CodeableConcept Mild | Moderate | Severe Seriousness or gravity of the event
AdverseEventSeriousness ( Example )
. . . severity Σ 0..1 CodeableConcept mild | moderate | severe
AdverseEventSeverity ( Required )
... outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae resolved-with-sequelae | fatal | unknown
AdverseEventOutcome ( Required )
. . . recorder Σ 0..1 Reference ( Patient | Practitioner | PractitionerRole | RelatedPerson ) Who recorded the adverse event
. . . eventParticipant contributor Σ 0..1 0..* Reference ( Practitioner | PractitionerRole | Device ) Who was involved in the adverse event or the potential adverse event
. . description . detector Σ 0..1 0..* string Reference ( Patient | RelatedPerson | Practitioner | PractitionerRole | Device ) Description of the adverse event Who or what identified a change in physiological state or condition
. . . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
. . . instance . instance[x] Σ 1..1 Reference ( Substance | Medication | MedicationAdministration | MedicationStatement | Device ) Refers to the specific entity that caused the adverse event
. . . . causality . instanceCodeableConcept Σ CodeableConcept 0..1
. . . . . instanceReference code causality1 | causality2 AdverseEventCausality Reference ( Required Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationUsage | Device )
. . . causalityAssessment . causality Σ 0..1 0..* CodeableConcept BackboneElement assess1 | assess2 Information on the possible cause of the event
AdverseEventCausalityAssessment ( Example )
. . . . causalityProductRelatedness . assessmentMethod Σ 0..1 string CodeableConcept AdverseEvent.suspectEntity.causalityProductRelatedness Method of evaluating the relatedness of the suspected entity to the event
AdverseEventCausalityMethod ( Example )
. . . . . causalityMethod entityRelatedness Σ 0..1 CodeableConcept method1 | method2 Result of the assessment regarding the relatedness of the suspected entity to the event
AdverseEventCausalityMethod AdverseEventCausalityAssessment ( Example )
. . . . . causalityAuthor author Σ 0..1 Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson ) AdverseEvent.suspectEntity.causalityAuthor Author of the information on the possible cause of the event
. . causalityResult . supportingInfo Σ 0..1 0..* CodeableConcept BackboneElement result1 | result2 Supporting information relevant to the event
AdverseEventCausalityResult ( Example )
. . . . subjectMedicalHistory item Σ 0..* 1..1 Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference ) AdverseEvent.subjectMedicalHistory Subject medical history or document relevant to this adverse event
. . referenceDocument . . contributingFactor Σ 0..* 0..1 Reference ( DocumentReference boolean ) AdverseEvent.referenceDocument If true, the item has been assessed to be a contributing factor of the adverse event
. . . study Σ 0..* Reference ( ResearchStudy ) AdverseEvent.study Research study that the subject is enrolled in

doco Documentation for this format

UML Diagram ( Legend )

AdverseEvent ( DomainResource ) The identifier(s) of Business identifiers assigned to this adverse event that are assigned by business processes and/or used to refer to it when a direct URL reference to the performer or other systems which remain constant as the resource itsefl is not appropriate updated and propagates from server to server identifier : Identifier [0..1] [0..*] The type of event which is important to characterize what occurred and caused harm to Whether the subject, event actually happened, or just had the potential to cause harm to to. Note that this is independent of whether anyone was affected or harmed or how severely (this element modifies the subject meaning of other elements) category actuality : code [0..1] [1..1] « Overall categorization nature of the adverse event, e.g. real or potential potential. (Strength=Required) AdverseEventCategory 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. (Strength=Extensible) AdverseEventCategory + » This element defines the specific type of event that occurred or that was prevented from occurring type event : CodeableConcept [0..1] « Detailed type of event event. (Strength=Example) SNOMED CT Clinical Findings SNOMEDCTClinicalFindings ?? » This subject or group impacted by the event. With a prospective adverse event, there will be no subject as the adverse event was prevented subject : Reference [0..1] [1..1] « Patient | ResearchSubject Group | Medication Practitioner | Device 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) reaction resultingCondition : Reference [0..*] « Condition » The information about where the adverse event occurred location : Reference [0..1] « Location » Describes the seriousness or severity of the adverse Assessment whether this event was of real importance seriousness : CodeableConcept [0..1] « Overall seriousness of this event for the patient patient. (Strength=Example) AdverseEventSeriousness ?? » Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.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. (Strength=Required) AdverseEventSeverity ! » Describes the type of outcome from the adverse event outcome : CodeableConcept [0..1] « TODO (and should this be required?) required?). (Strength=Required) AdverseEventOutcome ! » Information on who recorded the adverse event. May be the patient or a practitioner recorder : Reference [0..1] « Patient | Practitioner | PractitionerRole | RelatedPerson » Parties that may or should contribute or have contributed information to the Act. adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the Act activity and how to perform the Act activity (e.g. consultant), information that the Act activity itself seeks to reveal (e.g. informant of clinical history), or information about what Act activity was performed (e.g. informant witness) eventParticipant contributor : Reference [0..1] [0..*] « Practitioner | Device PractitionerRole | Describes the adverse event in text description : string Device [0..1] » AdverseEvent.subjectMedicalHistory Who or what identified a change in physiological state or condition subjectMedicalHistory detector : Reference [0..*] Condition | Observation | AllergyIntolerance « Patient | FamilyMemberHistory RelatedPerson | Immunization Practitioner | Procedure AdverseEvent.referenceDocument referenceDocument : Reference PractitionerRole [0..*] DocumentReference | Device » AdverseEvent.study The research study that the subject is enrolled in study : Reference [0..*] « ResearchStudy » SuspectEntity Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device instance instance[x] : Reference Type [1..1] Substance « CodeableConcept | Medication Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement MedicationUsage | Device ) » Causality causality1 | causality2 The method of evaluating the relatedness of the suspected entity to the event causality assessmentMethod : code CodeableConcept [0..1] « TODO (Strength=Required) TODO. (Strength=Example) AdverseEventCausality ! AdverseEventCausalityMethod ?? » assess1 | assess2 The result of the assessment regarding the relatedness of the suspected entity to the event causalityAssessment entityRelatedness : CodeableConcept [0..1] « TODO Codes for the assessment of whether the entity caused the event. (Strength=Example) AdverseEventCausalityAssessme... ?? » AdverseEvent.suspectEntity.causalityProductRelatedness The author of the information on the possible cause of the event causalityProductRelatedness author : string Reference [0..1] « Practitioner | PractitionerRole | Patient | RelatedPerson » method1 | method2 causalityMethod : CodeableConcept [0..1] TODO (Strength=Example) AdverseEventCausalityMethod ?? SupportingInfo AdverseEvent.suspectEntity.causalityAuthor Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penciliin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS) causalityAuthor item : Reference [0..1] Practitioner [1..1] « Condition | PractitionerRole Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference » result1 | result2 If true, the item has been assessed to be a contributing factor of the adverse event causalityResult contributingFactor : CodeableConcept boolean [0..1] TODO (Strength=Example) Information on the possible cause of the event causality AdverseEventCausalityResult ?? [0..*] Describes the entity that is suspected to have caused the adverse event suspectEntity [0..*] Supporting information relevant to the event supportingInfo [0..*]

XML Template

<AdverseEvent xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>
 <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>
 <</subject>

 <identifier><!-- 0..* Identifier Business identifier for the event --></identifier>
 <actuality value="[code]"/><!-- 1..1 actual | potential -->
 <category><!-- 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment --></category>
 <event><!-- 0..1 CodeableConcept Type of the event itself in relation to the subject --></event>
 <subject><!-- 1..1 Reference(Group|Patient|Practitioner|RelatedPerson) Subject impacted by event --></subject>
 <encounter><!-- 0..1 Reference(Encounter) The Encounter during which this AdverseEvent was created --></encounter>

 <date value="[dateTime]"/><!-- 0..1 When the event occurred -->
 <</reaction>

 <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>
 <</outcome>
 <</recorder>
 <</eventParticipant>
 <

 <seriousness><!-- 0..1 CodeableConcept Seriousness or gravity of the event --></seriousness>
 <severity><!-- 0..1 CodeableConcept mild | moderate | severe --></severity>
 <outcome><!-- 0..1 CodeableConcept resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <contributor><!-- 0..* Reference(Device|Practitioner|PractitionerRole) Who  was involved in the adverse event or the potential adverse event --></contributor>
 <detector><!-- 0..* Reference(Device|Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who or what identified a change in physiological state or condition --></detector>
 <suspectEntity>  <!-- 0..* The suspected agent causing the adverse event -->
  <|
    </instance>
  <
  <</causalityAssessment>
  <
  <</causalityMethod>
  <</causalityAuthor>
  <</causalityResult>

  <instance[x]><!-- 1..1 CodeableConcept|Reference(Device|Immunization|Medication|
    MedicationAdministration|MedicationUsage|Procedure|Substance) Refers to the specific entity that caused the adverse event --></instance[x]>
  <causality>  <!-- 0..* Information on the possible cause of the event -->
   <assessmentMethod><!-- 0..1 CodeableConcept Method of evaluating the relatedness of the suspected entity to the event --></assessmentMethod>
   <entityRelatedness><!-- 0..1 CodeableConcept Result of the assessment regarding the relatedness of the suspected entity to the event --></entityRelatedness>
   <author><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
     RelatedPerson) Author of the information on the possible cause of the event --></author>
  </causality>

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

 <supportingInfo>  <!-- 0..* Supporting information relevant to the event -->
  <item><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Media|Observation|Procedure) Subject medical history or document relevant to this adverse event --></item>
  <contributingFactor value="[boolean]"/><!-- 0..1 If true, the item has been assessed to be a contributing factor of the adverse event -->
 </supportingInfo>
 <study><!-- 0..* Reference(ResearchStudy) Research study that the subject is enrolled in --></study>

</AdverseEvent>

JSON Template

{doco
  "resourceType" : "",

  "resourceType" : "AdverseEvent",

  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "
  "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
  "
  "

  "identifier" : [{ Identifier }], // Business identifier for the event
  "actuality" : "<code>", // R!  actual | potential
  "category" : [{ CodeableConcept }], // product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
  "event" : { CodeableConcept }, // Type of the event itself in relation to the subject
  "subject" : { Reference(Group|Patient|Practitioner|RelatedPerson) }, // R!  Subject impacted by event
  "encounter" : { Reference(Encounter) }, // The Encounter during which this AdverseEvent was created

  "date" : "<dateTime>", // When the event occurred
  "

  "detected" : "<dateTime>", // When the event was detected
  "recordedDate" : "<dateTime>", // When the event was recorded
  "resultingCondition" : [{ Reference(Condition) }], // Effect on the subject due to this event

  "location" : { Reference(Location) }, // Location where adverse event occurred
  "
  "
  "
  "
  "

  "seriousness" : { CodeableConcept }, // Seriousness or gravity of the event
  "severity" : { CodeableConcept }, // mild | moderate | severe
  "outcome" : { CodeableConcept }, // resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown
  "recorder" : { Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) }, // Who recorded the adverse event
  "contributor" : [{ Reference(Device|Practitioner|PractitionerRole) }], // Who  was involved in the adverse event or the potential adverse event
  "detector" : [{ Reference(Device|Patient|Practitioner|PractitionerRole|
   RelatedPerson) }], // Who or what identified a change in physiological state or condition
  "suspectEntity" : [{ // The suspected agent causing the adverse event
    "|
    
    "
    "
    "
    "
    "
    "

    // instance[x]: Refers to the specific entity that caused the adverse event. One of these 2:
    "instanceCodeableConcept" : { CodeableConcept },
    "instanceReference" : { Reference(Device|Immunization|Medication|
    MedicationAdministration|MedicationUsage|Procedure|Substance) },
    "causality" : [{ // Information on the possible cause of the event
      "assessmentMethod" : { CodeableConcept }, // Method of evaluating the relatedness of the suspected entity to the event
      "entityRelatedness" : { CodeableConcept }, // Result of the assessment regarding the relatedness of the suspected entity to the event
      "author" : { Reference(Patient|Practitioner|PractitionerRole|
     RelatedPerson) } // Author of the information on the possible cause of the event
    }]

  }],
  "|
   
  "
  "

  "supportingInfo" : [{ // Supporting information relevant to the event
    "item" : { Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Media|Observation|Procedure) }, // R!  Subject medical history or document relevant to this adverse event
    "contributingFactor" : <boolean> // If true, the item has been assessed to be a contributing factor of the adverse event
  }],
  "study" : [{ Reference(ResearchStudy) }] // Research study that the subject is enrolled in

}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco
[ a fhir:;

[ a fhir:AdverseEvent;

  fhir:nodeRole fhir:treeRoot; # if this is the parser root
  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:
  fhir: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:
  fhir:

  fhir:AdverseEvent.identifier [ Identifier ], ... ; # 0..* Business identifier for the event
  fhir:AdverseEvent.actuality [ code ]; # 1..1 actual | potential
  fhir:AdverseEvent.category [ CodeableConcept ], ... ; # 0..* product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
  fhir:AdverseEvent.event [ CodeableConcept ]; # 0..1 Type of the event itself in relation to the subject
  fhir:AdverseEvent.subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ]; # 1..1 Subject impacted by event
  fhir:AdverseEvent.encounter [ Reference(Encounter) ]; # 0..1 The Encounter during which this AdverseEvent was created

  fhir:AdverseEvent.date [ dateTime ]; # 0..1 When the event occurred
  fhir:

  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:
  fhir:
  fhir:
  fhir:
  fhir:

  fhir:AdverseEvent.seriousness [ CodeableConcept ]; # 0..1 Seriousness or gravity of the event
  fhir:AdverseEvent.severity [ CodeableConcept ]; # 0..1 mild | moderate | severe
  fhir:AdverseEvent.outcome [ CodeableConcept ]; # 0..1 resolved | recovering | ongoing | resolved-with-sequelae | fatal | unknown
  fhir:AdverseEvent.recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 0..1 Who recorded the adverse event
  fhir:AdverseEvent.contributor [ Reference(Device|Practitioner|PractitionerRole) ], ... ; # 0..* Who  was involved in the adverse event or the potential adverse event
  fhir:AdverseEvent.detector [ Reference(Device|Patient|Practitioner|PractitionerRole|RelatedPerson) ], ... ; # 0..* Who or what identified a change in physiological state or condition

  fhir:AdverseEvent.suspectEntity [ # 0..* The suspected agent causing the adverse event
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:
    fhir:

    # AdverseEvent.suspectEntity.instance[x] : 1..1 Refers to the specific entity that caused the adverse event. One of these 2
      fhir:AdverseEvent.suspectEntity.instanceCodeableConcept [ CodeableConcept ]
      fhir:AdverseEvent.suspectEntity.instanceReference [ Reference(Device|Immunization|Medication|MedicationAdministration|MedicationUsage|
  Procedure|Substance) ]
    fhir:AdverseEvent.suspectEntity.causality [ # 0..* Information on the possible cause of the event
      fhir:AdverseEvent.suspectEntity.causality.assessmentMethod [ CodeableConcept ]; # 0..1 Method of evaluating the relatedness of the suspected entity to the event
      fhir:AdverseEvent.suspectEntity.causality.entityRelatedness [ CodeableConcept ]; # 0..1 Result of the assessment regarding the relatedness of the suspected entity to the event
      fhir:AdverseEvent.suspectEntity.causality.author [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 0..1 Author of the information on the possible cause of the event
    ], ...;

  ], ...;
  fhir:|
  
  fhir:
  fhir:

  fhir:AdverseEvent.supportingInfo [ # 0..* Supporting information relevant to the event
    fhir:AdverseEvent.supportingInfo.item [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Media|Observation|Procedure) ]; # 1..1 Subject medical history or document relevant to this adverse event
    fhir:AdverseEvent.supportingInfo.contributingFactor [ boolean ]; # 0..1 If true, the item has been assessed to be a contributing factor of the adverse event
  ], ...;
  fhir:AdverseEvent.study [ Reference(ResearchStudy) ], ... ; # 0..* Research study that the subject is enrolled in

]

Changes since DSTU2 Release 3

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

This resource did not exist in Release 2 See the Full Difference for further information

This analysis is available as XML or JSON .

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

 

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

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

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

type token actual | potential AdverseEvent.type
Name Type Description Expression In Common
actuality token actual | potential AdverseEvent.actuality
category token AE product-problem | 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 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
identifier token Business identifier for the event AdverseEvent.identifier
location reference Location where adverse event occurred AdverseEvent.location
( Location )
reaction patient reference Adverse Reaction Events linked to exposure to substance Subject impacted by event AdverseEvent.reaction AdverseEvent.subject
( Condition Practitioner , Group , Patient , RelatedPerson )
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 Mild Seriousness or gravity of the event AdverseEvent.seriousness
severity token mild | Moderate moderate | Severe severe AdverseEvent.seriousness AdverseEvent.severity
study reference AdverseEvent.study Research study that the subject is enrolled in AdverseEvent.study
( ResearchStudy )
subject reference Subject or group impacted by event AdverseEvent.subject
( Device Practitioner , Medication Group , Patient , ResearchSubject RelatedPerson )
substance reference Refers to the specific entity that caused the adverse event AdverseEvent.suspectEntity.instance (AdverseEvent.suspectEntity.instance as Reference)
( Immunization , Device , Medication , Procedure , Substance , MedicationAdministration , MedicationStatement MedicationUsage )