FHIR Release 3 (STU) 5 Preview #2
This page is part of the FHIR Specification (v3.0.2: STU 3). The current version which supercedes this version is 4.0.1 . 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 status ?! Σ 0..1 1..1 code AE in-progress | completed | entered-in-error | unknown
Adverse Event Status ( Required )
... actuality ?! Σ 1..1 code 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 )
. . . code Σ 0..1 CodeableConcept Event or incident that occurred or was averted
AdverseEvent Type ( 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 associated with the start of the AdverseEvent
... occurrence[x] Σ 0..1 When the event occurred
.... occurrenceDateTime dateTime
.... occurrencePeriod Period
.... occurrenceTiming Timing
. . . date detected Σ 0..1 dateTime When the event occurred 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 )
. . . outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Type of outcome from the adverse event
AdverseEventOutcome AdverseEvent Outcome ( Required Example )
. . . recorder Σ 0..1 Reference ( Patient | Practitioner | PractitionerRole | RelatedPerson ) Who recorded the adverse event
. . eventParticipant . participant Σ 0..1 0..* Reference ( Practitioner | Device BackboneElement ) Who was involved in the adverse event or the potential adverse event and what they did
. . . description . function Σ 0..1 string CodeableConcept Description Type of involvement
AdverseEvent Participant Function ( Example )
.... actor Σ 1..1 Reference ( Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson ) Who was involved in the adverse event or the potential adverse event
. . . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
. . . instance . instance[x] Σ 1..1 Refers to the specific entity that caused the adverse event
..... instanceCodeableConcept 1..1 CodeableConcept
..... instanceReference Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement MedicationUsage | Device ) Refers to the specific entity that caused the adverse event
. . . . causality Σ 0..1 code BackboneElement causality1 | causality2 Information on the possible cause of the event
..... assessmentMethod Σ 0..1 CodeableConcept Method of evaluating the relatedness of the suspected entity to the event
AdverseEventCausality AdverseEventCausalityMethod ( Required Example )
. . . . . causalityAssessment entityRelatedness Σ 0..1 CodeableConcept assess1 | assess2 Result of the assessment regarding the relatedness of the suspected entity to the event
AdverseEventCausalityAssessment ( Example )
. . . causalityProductRelatedness . . author Σ 0..1 Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson ) Author of the information on the possible cause of the event
... contributingFactor Σ 0..1 0..* string BackboneElement AdverseEvent.suspectEntity.causalityProductRelatedness Contributing factors suspected to have increased the probability or severity of the adverse event
. . . causalityMethod . item[x] Σ 1..1 Item suspected to have increased the probability or severity of the adverse event
AdverseEvent Contributing Factor ( Example )
.... . itemReference 0..1 Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference )
..... itemCodeableConcept CodeableConcept
. . . preventiveAction method1 | method2 Σ 0..* BackboneElement Preventive actions that contributed to avoiding the adverse event
AdverseEventCausalityMethod
. . . . item[x] Σ 1..1 Action that contributed to avoiding the adverse event
AdverseEvent Preventive Action ( Example )
. . . . . causalityAuthor itemReference Σ 0..1 Reference ( Practitioner Immunization | PractitionerRole Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) AdverseEvent.suspectEntity.causalityAuthor
. . . . causalityResult . itemCodeableConcept CodeableConcept
. . . mitigatingAction Σ 0..1 0..* CodeableConcept BackboneElement result1 | result2 Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
AdverseEventCausalityResult
. . . . item[x] Σ 1..1 Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
AdverseEvent Mitigating Action ( Example )
. . . . . subjectMedicalHistory itemReference Reference ( Procedure | DocumentReference | MedicationAdministration | MedicationRequest )
. . . . . itemCodeableConcept CodeableConcept
... supportingInfo Σ 0..* BackboneElement Supporting information relevant to the event
.... item[x] Σ 1..1 Subject medical history or document relevant to this adverse event
AdverseEvent Supporting Information ( Example )
..... itemReference Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference ) AdverseEvent.subjectMedicalHistory
. referenceDocument . . . Σ . itemCodeableConcept 0..* Reference ( DocumentReference CodeableConcept ) AdverseEvent.referenceDocument
. . . 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 current state of the adverse event which is important to characterize what occurred and caused harm to or potential adverse event (this element modifies the subject, meaning of other elements) status : code [1..1] « Codes identifying the lifecycle stage of an event. (Strength=Required) AdverseEventStatus ! » Whether the 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 ! » This element defines the specific 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=Example) AdverseEventCategory ?? » Specific event that occurred or that was prevented from occurring averted, such as patient fall, wrong organ removed, or wrong blood transfused type code : CodeableConcept [0..1] « Detailed type of event event. (Strength=Example) SNOMED CT Clinical Findings AdverseEvent Type ?? » 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 associated with the start of the AdverseEvent encounter : Reference [0..1] « Encounter » The date (and perhaps time) when the adverse event occurred occurrence[x] : DataType [0..1] « dateTime | Period | Timing » 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 Assessment whether this event, or severity averted event, was of the adverse event clinical importance seriousness : CodeableConcept [0..1] « Overall seriousness of this event for the patient patient. (Strength=Example) AdverseEventSeriousness ?? » Describes the type of outcome from the adverse event event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal outcome : CodeableConcept [0..1] « TODO (and should this be required?) (Strength=Required) Codes describing the type of outcome from the adverse event. (Strength=Example) AdverseEventOutcome ! AdverseEvent Outcome ?? » 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. Such information includes information leading to the decision to perform the Act and how to perform the Act (e.g. consultant), information The research study that the Act itself seeks to reveal (e.g. informant of clinical history), or information about what Act was performed (e.g. informant witness) subject is enrolled in eventParticipant study : Reference [0..1] Practitioner | Device [0..*] « ResearchStudy » Participant Describes Distinguishes the adverse event type of involvement of the actor in text the adverse event, such as contributor or informant description function : string CodeableConcept [0..1] « Codes describing the type of involvement of the actor in the adverse event. (Strength=Example) AdverseEvent Participant Func... ?? » AdverseEvent.subjectMedicalHistory Indicates who or what participated in the event subjectMedicalHistory actor : Reference [0..*] Condition [1..1] « Practitioner | Observation PractitionerRole | AllergyIntolerance Organization | FamilyMemberHistory CareTeam | Immunization Patient | Procedure AdverseEvent.referenceDocument referenceDocument : Reference Device [0..*] DocumentReference | RelatedPerson » 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 instance[x] : Reference DataType [1..1] « CodeableConcept | 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 » ContributingFactor method1 | method2 The item that is suspected to have increased the probability or severity of the adverse event causalityMethod item[x] : DataType [1..1] « Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference )| CodeableConcept [0..1] ; TODO Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. (Strength=Example) AdverseEvent Contributing AdverseEventCausalityMethod Fac... ?? » PreventiveAction AdverseEvent.suspectEntity.causalityAuthor The action that contributed to avoiding the adverse event causalityAuthor item[x] : DataType [1..1] « Reference [0..1] Practitioner ( Immunization | PractitionerRole Procedure | DocumentReference | MedicationAdministration | MedicationRequest )| CodeableConcept ; Codes describing the preventive actions that contributed to avoiding the adverse event. (Strength=Example) AdverseEvent Preventive Action ?? » MitigatingAction result1 | result2 The ameliorating action taken after the adverse event occured in order to reduce the extent of harm causalityResult item[x] : DataType [1..1] « Reference ( Procedure | DocumentReference | MedicationAdministration | MedicationRequest )| CodeableConcept [0..1] ; TODO Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. (Strength=Example) AdverseEventCausalityResult AdverseEvent Mitigating Action ?? » SupportingInfo Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin 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). Supporting information is not a contributing factor, preventive action, or mitigating action item[x] : DataType [1..1] « Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference )| CodeableConcept ; Codes describing the supporting information relevant to the event. (Strength=Example) AdverseEvent Supporting Infor... ?? » Indicates who or what participated in the adverse event and how they were involved participant [0..*] Information on the possible cause of the event causality [0..1] Describes the entity that is suspected to have caused the adverse event suspectEntity [0..*] The contributing factors suspected to have increased the probability or severity of the adverse event contributingFactor [0..*] Preventive actions that contributed to avoiding the adverse event preventiveAction [0..*] The ameliorating action taken after the adverse event occured in order to reduce the extent of harm mitigatingAction [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>
 <
 <</reaction>

 <identifier><!-- 0..* Identifier Business identifier for the event --></identifier>
 <status value="[code]"/><!-- 1..1 in-progress | completed | entered-in-error | unknown -->
 <actuality value="[code]"/><!-- 1..1 actual | potential -->
 <category><!-- 0..* CodeableConcept wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site --></category>
 <code><!-- 0..1 CodeableConcept Event or incident that occurred or was averted --></code>
 <subject><!-- 1..1 Reference(Group|Patient|Practitioner|RelatedPerson) Subject impacted by event --></subject>
 <encounter><!-- 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent --></encounter>
 <occurrence[x]><!-- 0..1 dateTime|Period|Timing When the event occurred --></occurrence[x]>
 <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>
 <outcome><!-- 0..1 CodeableConcept Type of outcome from the adverse event --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <participant>  <!-- 0..* Who was involved in the adverse event or the potential adverse event and what they did -->
  <function><!-- 0..1 CodeableConcept Type of involvement --></function>
  <actor><!-- 1..1 Reference(CareTeam|Device|Organization|Patient|Practitioner|
    PractitionerRole|RelatedPerson) Who was involved in the adverse event or the potential adverse event --></actor>
 </participant>

 <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..1 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>

 <contributingFactor>  <!-- 0..* Contributing factors suspected to have increased the probability or severity of the adverse event -->
  <item[x]><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure)|CodeableConcept Item suspected to have increased the probability or severity of the adverse event --></item[x]>
 </contributingFactor>
 <preventiveAction>  <!-- 0..* Preventive actions that contributed to avoiding the adverse event -->
  <item[x]><!-- 1..1 Reference(DocumentReference|Immunization|
    MedicationAdministration|MedicationRequest|Procedure)|CodeableConcept Action that contributed to avoiding the adverse event --></item[x]>
 </preventiveAction>
 <mitigatingAction>  <!-- 0..* Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm -->
  <item[x]><!-- 1..1 Reference(DocumentReference|MedicationAdministration|
    MedicationRequest|Procedure)|CodeableConcept Ameliorating action taken after the adverse event occured in order to reduce the extent of harm --></item[x]>
 </mitigatingAction>
 <supportingInfo>  <!-- 0..* Supporting information relevant to the event -->
  <item[x]><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure)|CodeableConcept Subject medical history or document relevant to this adverse event --></item[x]>
 </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
  "status" : "<code>", // R!  in-progress | completed | entered-in-error | unknown
  "actuality" : "<code>", // R!  actual | potential
  "category" : [{ CodeableConcept }], // wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
  "code" : { CodeableConcept }, // Event or incident that occurred or was averted
  "subject" : { Reference(Group|Patient|Practitioner|RelatedPerson) }, // R!  Subject impacted by event
  "encounter" : { Reference(Encounter) }, // The Encounter associated with the start of the AdverseEvent
  // occurrence[x]: When the event occurred. One of these 3:
  "occurrenceDateTime" : "<dateTime>",
  "occurrencePeriod" : { Period },
  "occurrenceTiming" : { Timing },
  "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
  "outcome" : { CodeableConcept }, // Type of outcome from the adverse event
  "recorder" : { Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) }, // Who recorded the adverse event
  "participant" : [{ // Who was involved in the adverse event or the potential adverse event and what they did
    "function" : { CodeableConcept }, // Type of involvement
    "actor" : { Reference(CareTeam|Device|Organization|Patient|Practitioner|
    PractitionerRole|RelatedPerson) } // R!  Who was involved in the adverse event or the potential adverse event
  }],

  "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
    }

  }],
  "|
   
  "
  "

  "contributingFactor" : [{ // Contributing factors suspected to have increased the probability or severity of the adverse event
    // item[x]: Item suspected to have increased the probability or severity of the adverse event. One of these 2:
    "itemReference" : { Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure) }
    "itemCodeableConcept" : { CodeableConcept }
  }],
  "preventiveAction" : [{ // Preventive actions that contributed to avoiding the adverse event
    // item[x]: Action that contributed to avoiding the adverse event. One of these 2:
    "itemReference" : { Reference(DocumentReference|Immunization|
    MedicationAdministration|MedicationRequest|Procedure) }
    "itemCodeableConcept" : { CodeableConcept }
  }],
  "mitigatingAction" : [{ // Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
    // item[x]: 
      Ameliorating action taken after the adverse event occured in order to reduce the extent of harm. One of these 2:
    "itemReference" : { Reference(DocumentReference|MedicationAdministration|
    MedicationRequest|Procedure) }
    "itemCodeableConcept" : { CodeableConcept }
  }],
  "supportingInfo" : [{ // Supporting information relevant to the event
    // item[x]: Subject medical history or document relevant to this adverse event. One of these 2:
    "itemReference" : { Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure) }
    "itemCodeableConcept" : { CodeableConcept }
  }],
  "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:
  fhir:

  fhir:AdverseEvent.identifier [ Identifier ], ... ; # 0..* Business identifier for the event
  fhir:AdverseEvent.status [ code ]; # 1..1 in-progress | completed | entered-in-error | unknown
  fhir:AdverseEvent.actuality [ code ]; # 1..1 actual | potential
  fhir:AdverseEvent.category [ CodeableConcept ], ... ; # 0..* wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
  fhir:AdverseEvent.code [ CodeableConcept ]; # 0..1 Event or incident that occurred or was averted
  fhir:AdverseEvent.subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ]; # 1..1 Subject impacted by event
  fhir:AdverseEvent.encounter [ Reference(Encounter) ]; # 0..1 The Encounter associated with the start of the AdverseEvent
  # AdverseEvent.occurrence[x] : 0..1 When the event occurred. One of these 3
    fhir:AdverseEvent.occurrenceDateTime [ dateTime ]
    fhir:AdverseEvent.occurrencePeriod [ Period ]
    fhir:AdverseEvent.occurrenceTiming [ Timing ]
  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.outcome [ CodeableConcept ]; # 0..1 Type of outcome from the adverse event
  fhir:AdverseEvent.recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 0..1 Who recorded the adverse event
  fhir:AdverseEvent.participant [ # 0..* Who was involved in the adverse event or the potential adverse event and what they did
    fhir:AdverseEvent.participant.function [ CodeableConcept ]; # 0..1 Type of involvement
    fhir:AdverseEvent.participant.actor [ Reference(CareTeam|Device|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 1..1 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:
    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..1 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.contributingFactor [ # 0..* Contributing factors suspected to have increased the probability or severity of the adverse event
    # AdverseEvent.contributingFactor.item[x] : 1..1 Item suspected to have increased the probability or severity of the adverse event. One of these 2
      fhir:AdverseEvent.contributingFactor.itemReference [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Observation|Procedure) ]
      fhir:AdverseEvent.contributingFactor.itemCodeableConcept [ CodeableConcept ]
  ], ...;
  fhir:AdverseEvent.preventiveAction [ # 0..* Preventive actions that contributed to avoiding the adverse event
    # AdverseEvent.preventiveAction.item[x] : 1..1 Action that contributed to avoiding the adverse event. One of these 2
      fhir:AdverseEvent.preventiveAction.itemReference [ Reference(DocumentReference|Immunization|MedicationAdministration|MedicationRequest|
  Procedure) ]
      fhir:AdverseEvent.preventiveAction.itemCodeableConcept [ CodeableConcept ]
  ], ...;
  fhir:AdverseEvent.mitigatingAction [ # 0..* Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
    # AdverseEvent.mitigatingAction.item[x] : 1..1 Ameliorating action taken after the adverse event occured in order to reduce the extent of harm. One of these 2
      fhir:AdverseEvent.mitigatingAction.itemReference [ Reference(DocumentReference|MedicationAdministration|MedicationRequest|Procedure) ]
      fhir:AdverseEvent.mitigatingAction.itemCodeableConcept [ CodeableConcept ]
  ], ...;
  fhir:AdverseEvent.supportingInfo [ # 0..* Supporting information relevant to the event
    # AdverseEvent.supportingInfo.item[x] : 1..1 Subject medical history or document relevant to this adverse event. One of these 2
      fhir:AdverseEvent.supportingInfo.itemReference [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Observation|Procedure) ]
      fhir:AdverseEvent.supportingInfo.itemCodeableConcept [ CodeableConcept ]
  ], ...;
  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.status
  • Added Mandatory Element
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|4.4.0
AdverseEvent.category
  • Remove Binding http://hl7.org/fhir/ValueSet/adverse-event-category (extensible)
AdverseEvent.code
  • Added Element
AdverseEvent.occurrence[x]
  • Added Element
AdverseEvent.outcome
  • Remove Binding http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.0 (required)
AdverseEvent.participant
  • Added Element
AdverseEvent.participant.function
  • Added Element
AdverseEvent.participant.actor
  • Added Mandatory Element
AdverseEvent.suspectEntity.instance[x]
  • Added Mandatory Element
AdverseEvent.suspectEntity.causality
  • Max Cardinality changed from * to 1
AdverseEvent.suspectEntity.causality.assessmentMethod
  • Added Element
AdverseEvent.suspectEntity.causality.entityRelatedness
  • Added Element
AdverseEvent.suspectEntity.causality.author
  • Type Reference: Added Target Types Patient, RelatedPerson
AdverseEvent.contributingFactor
  • Added Element
AdverseEvent.contributingFactor.item[x]
  • Added Mandatory Element
AdverseEvent.preventiveAction
  • Added Element
AdverseEvent.preventiveAction.item[x]
  • Added Mandatory Element
AdverseEvent.mitigatingAction
  • Added Element
AdverseEvent.mitigatingAction.item[x]
  • Added Mandatory Element
AdverseEvent.supportingInfo
  • Added Element
AdverseEvent.supportingInfo.item[x]
  • Added Mandatory Element
AdverseEvent.event
  • deleted
AdverseEvent.date
  • deleted
AdverseEvent.severity
  • deleted
AdverseEvent.contributor
  • deleted
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 status ?! Σ 0..1 1..1 code AE in-progress | completed | entered-in-error | unknown
Adverse Event Status ( Required )
... actuality ?! Σ 1..1 code 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 )
. . . code Σ 0..1 CodeableConcept Event or incident that occurred or was averted
AdverseEvent Type ( 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 associated with the start of the AdverseEvent
... occurrence[x] Σ 0..1 When the event occurred
.... occurrenceDateTime dateTime
.... occurrencePeriod Period
.... occurrenceTiming Timing
. . . date detected Σ 0..1 dateTime When the event occurred 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 )
. . . outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Type of outcome from the adverse event
AdverseEventOutcome AdverseEvent Outcome ( Required Example )
. . . recorder Σ 0..1 Reference ( Patient | Practitioner | PractitionerRole | RelatedPerson ) Who recorded the adverse event
. . eventParticipant . participant Σ 0..1 0..* Reference ( Practitioner | Device BackboneElement ) Who was involved in the adverse event or the potential adverse event and what they did
. . . description . function Σ 0..1 string CodeableConcept Description Type of involvement
AdverseEvent Participant Function ( Example )
.... actor Σ 1..1 Reference ( Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson ) Who was involved in the adverse event or the potential adverse event
. . . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
. . . instance . instance[x] Σ 1..1 Refers to the specific entity that caused the adverse event
..... instanceCodeableConcept 1..1 CodeableConcept
..... instanceReference Reference ( Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement MedicationUsage | Device ) Refers to the specific entity that caused the adverse event
. . . . causality Σ 0..1 code BackboneElement causality1 | causality2 Information on the possible cause of the event
..... assessmentMethod Σ 0..1 CodeableConcept Method of evaluating the relatedness of the suspected entity to the event
AdverseEventCausality AdverseEventCausalityMethod ( Required Example )
. . . . . causalityAssessment entityRelatedness Σ 0..1 CodeableConcept assess1 | assess2 Result of the assessment regarding the relatedness of the suspected entity to the event
AdverseEventCausalityAssessment ( Example )
. . . causalityProductRelatedness . . author Σ 0..1 Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson ) Author of the information on the possible cause of the event
... contributingFactor Σ 0..1 0..* string BackboneElement AdverseEvent.suspectEntity.causalityProductRelatedness Contributing factors suspected to have increased the probability or severity of the adverse event
. . . causalityMethod . item[x] Σ 1..1 Item suspected to have increased the probability or severity of the adverse event
AdverseEvent Contributing Factor ( Example )
..... itemReference 0..1 Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference )
. . . . . itemCodeableConcept CodeableConcept
. . . preventiveAction method1 | method2 Σ 0..* BackboneElement Preventive actions that contributed to avoiding the adverse event
AdverseEventCausalityMethod
. . . . item[x] Σ 1..1 Action that contributed to avoiding the adverse event
AdverseEvent Preventive Action ( Example )
. . . . . causalityAuthor itemReference Σ 0..1 Reference ( Practitioner Immunization | PractitionerRole Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) AdverseEvent.suspectEntity.causalityAuthor
. . . . causalityResult . itemCodeableConcept CodeableConcept
. . . mitigatingAction Σ 0..1 0..* CodeableConcept BackboneElement result1 | result2 Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
AdverseEventCausalityResult
. . . . item[x] Σ 1..1 Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
AdverseEvent Mitigating Action ( Example )
. . . . . subjectMedicalHistory itemReference Reference ( Procedure | DocumentReference | MedicationAdministration | MedicationRequest )
. . . . . itemCodeableConcept CodeableConcept
... supportingInfo Σ 0..* BackboneElement Supporting information relevant to the event
.... item[x] Σ 1..1 Subject medical history or document relevant to this adverse event
AdverseEvent Supporting Information ( Example )
..... itemReference Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference ) AdverseEvent.subjectMedicalHistory
. referenceDocument . . . Σ . itemCodeableConcept 0..* Reference ( DocumentReference CodeableConcept ) AdverseEvent.referenceDocument
. . . 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 current state of the adverse event which is important to characterize what occurred and caused harm to or potential adverse event (this element modifies the subject, meaning of other elements) status : code [1..1] « Codes identifying the lifecycle stage of an event. (Strength=Required) AdverseEventStatus ! » Whether the 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 ! » This element defines the specific 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=Example) AdverseEventCategory ?? » Specific event that occurred or that was prevented from occurring averted, such as patient fall, wrong organ removed, or wrong blood transfused type code : CodeableConcept [0..1] « Detailed type of event event. (Strength=Example) SNOMED CT Clinical Findings AdverseEvent Type ?? » 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 associated with the start of the AdverseEvent encounter : Reference [0..1] « Encounter » The date (and perhaps time) when the adverse event occurred occurrence[x] : DataType [0..1] « dateTime | Period | Timing » 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 Assessment whether this event, or severity averted event, was of the adverse event clinical importance seriousness : CodeableConcept [0..1] « Overall seriousness of this event for the patient patient. (Strength=Example) AdverseEventSeriousness ?? » Describes the type of outcome from the adverse event event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal outcome : CodeableConcept [0..1] « TODO (and should this be required?) (Strength=Required) Codes describing the type of outcome from the adverse event. (Strength=Example) AdverseEventOutcome ! AdverseEvent Outcome ?? » 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. Such information includes information leading to the decision to perform the Act and how to perform the Act (e.g. consultant), information The research study that the Act itself seeks to reveal (e.g. informant of clinical history), or information about what Act was performed (e.g. informant witness) subject is enrolled in eventParticipant study : Reference [0..1] Practitioner | Device [0..*] « ResearchStudy » Participant Describes Distinguishes the adverse event type of involvement of the actor in text the adverse event, such as contributor or informant description function : string CodeableConcept [0..1] « Codes describing the type of involvement of the actor in the adverse event. (Strength=Example) AdverseEvent Participant Func... ?? » AdverseEvent.subjectMedicalHistory Indicates who or what participated in the event subjectMedicalHistory actor : Reference [0..*] Condition [1..1] « Practitioner | Observation PractitionerRole | AllergyIntolerance Organization | FamilyMemberHistory CareTeam | Immunization Patient | Procedure AdverseEvent.referenceDocument referenceDocument : Reference Device [0..*] DocumentReference | RelatedPerson » 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 instance[x] : Reference DataType [1..1] « CodeableConcept | 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 » ContributingFactor method1 | method2 The item that is suspected to have increased the probability or severity of the adverse event causalityMethod item[x] : DataType [1..1] « Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference )| CodeableConcept [0..1] ; TODO Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. (Strength=Example) AdverseEvent Contributing AdverseEventCausalityMethod Fac... ?? » PreventiveAction AdverseEvent.suspectEntity.causalityAuthor The action that contributed to avoiding the adverse event causalityAuthor item[x] : DataType [1..1] « Reference [0..1] Practitioner ( Immunization | PractitionerRole Procedure | DocumentReference | MedicationAdministration | MedicationRequest )| CodeableConcept ; Codes describing the preventive actions that contributed to avoiding the adverse event. (Strength=Example) AdverseEvent Preventive Action ?? » MitigatingAction result1 | result2 The ameliorating action taken after the adverse event occured in order to reduce the extent of harm causalityResult item[x] : DataType [1..1] « Reference ( Procedure | DocumentReference | MedicationAdministration | MedicationRequest )| CodeableConcept [0..1] ; TODO Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. (Strength=Example) AdverseEventCausalityResult AdverseEvent Mitigating Action ?? » SupportingInfo Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin 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). Supporting information is not a contributing factor, preventive action, or mitigating action item[x] : DataType [1..1] « Reference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference )| CodeableConcept ; Codes describing the supporting information relevant to the event. (Strength=Example) AdverseEvent Supporting Infor... ?? » Indicates who or what participated in the adverse event and how they were involved participant [0..*] Information on the possible cause of the event causality [0..1] Describes the entity that is suspected to have caused the adverse event suspectEntity [0..*] The contributing factors suspected to have increased the probability or severity of the adverse event contributingFactor [0..*] Preventive actions that contributed to avoiding the adverse event preventiveAction [0..*] The ameliorating action taken after the adverse event occured in order to reduce the extent of harm mitigatingAction [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>
 <
 <</reaction>

 <identifier><!-- 0..* Identifier Business identifier for the event --></identifier>
 <status value="[code]"/><!-- 1..1 in-progress | completed | entered-in-error | unknown -->
 <actuality value="[code]"/><!-- 1..1 actual | potential -->
 <category><!-- 0..* CodeableConcept wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site --></category>
 <code><!-- 0..1 CodeableConcept Event or incident that occurred or was averted --></code>
 <subject><!-- 1..1 Reference(Group|Patient|Practitioner|RelatedPerson) Subject impacted by event --></subject>
 <encounter><!-- 0..1 Reference(Encounter) The Encounter associated with the start of the AdverseEvent --></encounter>
 <occurrence[x]><!-- 0..1 dateTime|Period|Timing When the event occurred --></occurrence[x]>
 <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>
 <outcome><!-- 0..1 CodeableConcept Type of outcome from the adverse event --></outcome>
 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <participant>  <!-- 0..* Who was involved in the adverse event or the potential adverse event and what they did -->
  <function><!-- 0..1 CodeableConcept Type of involvement --></function>
  <actor><!-- 1..1 Reference(CareTeam|Device|Organization|Patient|Practitioner|
    PractitionerRole|RelatedPerson) Who was involved in the adverse event or the potential adverse event --></actor>
 </participant>

 <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..1 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>

 <contributingFactor>  <!-- 0..* Contributing factors suspected to have increased the probability or severity of the adverse event -->
  <item[x]><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure)|CodeableConcept Item suspected to have increased the probability or severity of the adverse event --></item[x]>
 </contributingFactor>
 <preventiveAction>  <!-- 0..* Preventive actions that contributed to avoiding the adverse event -->
  <item[x]><!-- 1..1 Reference(DocumentReference|Immunization|
    MedicationAdministration|MedicationRequest|Procedure)|CodeableConcept Action that contributed to avoiding the adverse event --></item[x]>
 </preventiveAction>
 <mitigatingAction>  <!-- 0..* Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm -->
  <item[x]><!-- 1..1 Reference(DocumentReference|MedicationAdministration|
    MedicationRequest|Procedure)|CodeableConcept Ameliorating action taken after the adverse event occured in order to reduce the extent of harm --></item[x]>
 </mitigatingAction>
 <supportingInfo>  <!-- 0..* Supporting information relevant to the event -->
  <item[x]><!-- 1..1 Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure)|CodeableConcept Subject medical history or document relevant to this adverse event --></item[x]>
 </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
  "status" : "<code>", // R!  in-progress | completed | entered-in-error | unknown
  "actuality" : "<code>", // R!  actual | potential
  "category" : [{ CodeableConcept }], // wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
  "code" : { CodeableConcept }, // Event or incident that occurred or was averted
  "subject" : { Reference(Group|Patient|Practitioner|RelatedPerson) }, // R!  Subject impacted by event
  "encounter" : { Reference(Encounter) }, // The Encounter associated with the start of the AdverseEvent
  // occurrence[x]: When the event occurred. One of these 3:
  "occurrenceDateTime" : "<dateTime>",
  "occurrencePeriod" : { Period },
  "occurrenceTiming" : { Timing },
  "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
  "outcome" : { CodeableConcept }, // Type of outcome from the adverse event
  "recorder" : { Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) }, // Who recorded the adverse event
  "participant" : [{ // Who was involved in the adverse event or the potential adverse event and what they did
    "function" : { CodeableConcept }, // Type of involvement
    "actor" : { Reference(CareTeam|Device|Organization|Patient|Practitioner|
    PractitionerRole|RelatedPerson) } // R!  Who was involved in the adverse event or the potential adverse event
  }],

  "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
    }

  }],
  "|
   
  "
  "

  "contributingFactor" : [{ // Contributing factors suspected to have increased the probability or severity of the adverse event
    // item[x]: Item suspected to have increased the probability or severity of the adverse event. One of these 2:
    "itemReference" : { Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure) }
    "itemCodeableConcept" : { CodeableConcept }
  }],
  "preventiveAction" : [{ // Preventive actions that contributed to avoiding the adverse event
    // item[x]: Action that contributed to avoiding the adverse event. One of these 2:
    "itemReference" : { Reference(DocumentReference|Immunization|
    MedicationAdministration|MedicationRequest|Procedure) }
    "itemCodeableConcept" : { CodeableConcept }
  }],
  "mitigatingAction" : [{ // Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
    // item[x]: 
      Ameliorating action taken after the adverse event occured in order to reduce the extent of harm. One of these 2:
    "itemReference" : { Reference(DocumentReference|MedicationAdministration|
    MedicationRequest|Procedure) }
    "itemCodeableConcept" : { CodeableConcept }
  }],
  "supportingInfo" : [{ // Supporting information relevant to the event
    // item[x]: Subject medical history or document relevant to this adverse event. One of these 2:
    "itemReference" : { Reference(AllergyIntolerance|Condition|DocumentReference|
    FamilyMemberHistory|Immunization|Observation|Procedure) }
    "itemCodeableConcept" : { CodeableConcept }
  }],
  "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:
  fhir:

  fhir:AdverseEvent.identifier [ Identifier ], ... ; # 0..* Business identifier for the event
  fhir:AdverseEvent.status [ code ]; # 1..1 in-progress | completed | entered-in-error | unknown
  fhir:AdverseEvent.actuality [ code ]; # 1..1 actual | potential
  fhir:AdverseEvent.category [ CodeableConcept ], ... ; # 0..* wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
  fhir:AdverseEvent.code [ CodeableConcept ]; # 0..1 Event or incident that occurred or was averted
  fhir:AdverseEvent.subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ]; # 1..1 Subject impacted by event
  fhir:AdverseEvent.encounter [ Reference(Encounter) ]; # 0..1 The Encounter associated with the start of the AdverseEvent
  # AdverseEvent.occurrence[x] : 0..1 When the event occurred. One of these 3
    fhir:AdverseEvent.occurrenceDateTime [ dateTime ]
    fhir:AdverseEvent.occurrencePeriod [ Period ]
    fhir:AdverseEvent.occurrenceTiming [ Timing ]
  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.outcome [ CodeableConcept ]; # 0..1 Type of outcome from the adverse event
  fhir:AdverseEvent.recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 0..1 Who recorded the adverse event
  fhir:AdverseEvent.participant [ # 0..* Who was involved in the adverse event or the potential adverse event and what they did
    fhir:AdverseEvent.participant.function [ CodeableConcept ]; # 0..1 Type of involvement
    fhir:AdverseEvent.participant.actor [ Reference(CareTeam|Device|Organization|Patient|Practitioner|PractitionerRole|RelatedPerson) ]; # 1..1 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:
    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..1 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.contributingFactor [ # 0..* Contributing factors suspected to have increased the probability or severity of the adverse event
    # AdverseEvent.contributingFactor.item[x] : 1..1 Item suspected to have increased the probability or severity of the adverse event. One of these 2
      fhir:AdverseEvent.contributingFactor.itemReference [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Observation|Procedure) ]
      fhir:AdverseEvent.contributingFactor.itemCodeableConcept [ CodeableConcept ]
  ], ...;
  fhir:AdverseEvent.preventiveAction [ # 0..* Preventive actions that contributed to avoiding the adverse event
    # AdverseEvent.preventiveAction.item[x] : 1..1 Action that contributed to avoiding the adverse event. One of these 2
      fhir:AdverseEvent.preventiveAction.itemReference [ Reference(DocumentReference|Immunization|MedicationAdministration|MedicationRequest|
  Procedure) ]
      fhir:AdverseEvent.preventiveAction.itemCodeableConcept [ CodeableConcept ]
  ], ...;
  fhir:AdverseEvent.mitigatingAction [ # 0..* Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
    # AdverseEvent.mitigatingAction.item[x] : 1..1 Ameliorating action taken after the adverse event occured in order to reduce the extent of harm. One of these 2
      fhir:AdverseEvent.mitigatingAction.itemReference [ Reference(DocumentReference|MedicationAdministration|MedicationRequest|Procedure) ]
      fhir:AdverseEvent.mitigatingAction.itemCodeableConcept [ CodeableConcept ]
  ], ...;
  fhir:AdverseEvent.supportingInfo [ # 0..* Supporting information relevant to the event
    # AdverseEvent.supportingInfo.item[x] : 1..1 Subject medical history or document relevant to this adverse event. One of these 2
      fhir:AdverseEvent.supportingInfo.itemReference [ Reference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  Observation|Procedure) ]
      fhir:AdverseEvent.supportingInfo.itemCodeableConcept [ CodeableConcept ]
  ], ...;
  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.status
  • Added Mandatory Element
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|4.4.0
AdverseEvent.category
  • Remove Binding http://hl7.org/fhir/ValueSet/adverse-event-category (extensible)
AdverseEvent.code
  • Added Element
AdverseEvent.occurrence[x]
  • Added Element
AdverseEvent.outcome
  • Remove Binding http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.0 (required)
AdverseEvent.participant
  • Added Element
AdverseEvent.participant.function
  • Added Element
AdverseEvent.participant.actor
  • Added Mandatory Element
AdverseEvent.suspectEntity.instance[x]
  • Added Mandatory Element
AdverseEvent.suspectEntity.causality
  • Max Cardinality changed from * to 1
AdverseEvent.suspectEntity.causality.assessmentMethod
  • Added Element
AdverseEvent.suspectEntity.causality.entityRelatedness
  • Added Element
AdverseEvent.suspectEntity.causality.author
  • Type Reference: Added Target Types Patient, RelatedPerson
AdverseEvent.contributingFactor
  • Added Element
AdverseEvent.contributingFactor.item[x]
  • Added Mandatory Element
AdverseEvent.preventiveAction
  • Added Element
AdverseEvent.preventiveAction.item[x]
  • Added Mandatory Element
AdverseEvent.mitigatingAction
  • Added Element
AdverseEvent.mitigatingAction.item[x]
  • Added Mandatory Element
AdverseEvent.supportingInfo
  • Added Element
AdverseEvent.supportingInfo.item[x]
  • Added Mandatory Element
AdverseEvent.event
  • deleted
AdverseEvent.date
  • deleted
AdverseEvent.severity
  • deleted
AdverseEvent.contributor
  • deleted
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.type AdverseEvent.suspectEntity.causality AdverseEvent.suspectEntity.causalityMethod AdverseEvent.suspectEntity.causalityResult
Path Definition Type Reference
AdverseEvent.status Codes identifying the lifecycle stage of an event. Required AdverseEventStatus
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. Example AdverseEventCategory
AdverseEvent.code Detailed type of event event. Example SNOMED CT Clinical Findings AdverseEvent Type
AdverseEvent.seriousness Overall seriousness of this event for the patient patient. Example AdverseEventSeriousness
AdverseEvent.outcome TODO (and should this be required?) Codes describing the type of outcome from the adverse event. Required Example AdverseEventOutcome AdverseEvent Outcome
AdverseEvent.participant.function TODO Codes describing the type of involvement of the actor in the adverse event. Required Example AdverseEventCausality AdverseEvent Participant Function
AdverseEvent.suspectEntity.causality.assessmentMethod TODO. Example AdverseEventCausalityMethod
AdverseEvent.suspectEntity.causalityAssessment AdverseEvent.suspectEntity.causality.entityRelatedness TODO Codes for the assessment of whether the entity caused the event. Example AdverseEventCausalityAssessment
AdverseEvent.contributingFactor.item[x] TODO Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. Example AdverseEventCausalityMethod AdverseEvent Contributing Factor
AdverseEvent.preventiveAction.item[x] TODO Codes describing the preventive actions that contributed to avoiding the adverse event. Example AdverseEventCausalityResult AdverseEvent Preventive Action
AdverseEvent.mitigatingAction.item[x] Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. Example AdverseEvent Mitigating Action
AdverseEvent.supportingInfo.item[x] Codes describing the supporting information relevant to the event. Example AdverseEvent Supporting Inforation

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 N token actual | potential AdverseEvent.actuality
category token AE wrong-patient | procedure-mishap | medication-mishap | 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 | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site AdverseEvent.category
code token Event or environmental substance, a potential adverse event is something incident that occurred and that could have caused harm to a patient but did not or was averted AdverseEvent.category AdverseEvent.code
date date When the event occurred AdverseEvent.date AdverseEvent.occurrence
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
status N token in-progress | Moderate completed | Severe entered-in-error | unknown AdverseEvent.seriousness AdverseEvent.status
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 )