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9.9 9.8 Resource AdverseEvent - Content

Responsible Owner: Patient Care icon Work Group Maturity Level : 0   Trial Use Normative Security Category : Patient Compartments : Group , 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 participant. The unintended effects may require additional monitoring, treatment, or hospitalization, or that results may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.

9.9.1 9.8.1 Scope and Usage

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. Choosing the appropriate form of the reporting is dependent upon workflow patterns. In particular, the implementation guides for Clinical Care adverse events icon and Clinical Research adverse events icon provide important extensions, value-sets and examples for implementing AdverseEvent.

The guides reflect that adverse event tracking in clinical care and clinical research settings can differ. In the former case, the event is tracked to meet business safety concerns and incident reporting. There is a strong interest in factors surrounding the event, if it was prevented, what happened, and if it occurred, how it was resolved or managed. In the clinical research setting, the event is additionally tracked and evaluated as part of the clinical research process for the research study, since the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment. In clinical research trials, serious adverse events are usually required to be reported to the respective health authorities (e.g., U.S. FDA). For Clinical Care or Clinical Research, the Vulcan accelerator project suggests two AdverseEvent Resource profiles.

This resource applies to events that occur during the course of medical care or medical research which may impact an individual as the recipient of care or the participant in a research study. There are also events that occur within a care setting that might or might not impact an individual but had the potential to cause an adverse event. Health care organizations monitor and report both adverse events as well as events that had the potential to cause patient harm. Data are often aggregated for reporting purposes. purposes and quality improvement initiatives.

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 cause-and-effect (although they might not be known at the time of the event), severity, and outcome.

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

A In clinical care, a potential adverse event may also be called a near miss or an error. These are also events but because but, since they were detected 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.

For examples and further guidance, it is strongly suggested that an implementer consult the Clinical Care AdverseEvent Implementation Guide icon and the Clinical Research AdverseEvent Implementation Guide icon They contain valuable extensions, value sets and, importantly, examples.

9.9.2 9.8.2 Boundaries and Relationships

The AdverseEvent resource is designed to represent events that have had 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 care, there are many actions that may impact how a subject responds to a particular treatment impacting patient safety. Therefore Therefore, the AdverseEvent resource may reference multiple other resources to represent the context or details of an adverse event including but not limited to such as Observation, Condition, MedicationAdminsitration, MedicationAdministration, 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 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 RiskAssessment 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 history, or list of potential health risks based on a patient's genetic analysis.
  • 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, an adverse event occurs, citing this relationship is important for preventing such an occurrence in the future. DetectedIssue only applies to documenting a risk associated with a specific planned or ongoing action, or the lack of an action which should be planned - not a general propensity to risk.
  • Flags highlight highly condensed view of information found in other resources, which may include AdverseEvent. The purpose of these other resources is to provide detailed clinical information. The purpose of a Flag is to alert practitioners to information that is important to influence their interaction with a Patient prior to detailed review of the record.

9.8.3 References to this Resource

9.9.3 9.8.4 Resource Content

Structure

Medical care, research study or other healthcare 0..1 product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate Type of the event itself in relation to the subject 0..1 mild | moderate | severe 0..* 0..* Assessment
Name Flags Card. Type Description & Constraints      Filter: Filters doco
. . AdverseEvent Σ TU N DomainResource An event causing physical injury that may be related to unintended effects on a patient or research participant

Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier Σ 0..* Identifier Business identifier for the event

. . . actuality status ?! Σ 1..1 code in-progress | completed | entered-in-error | unknown
Binding: Adverse Event Status ( Required )
. . . actuality ?! Σ 1..1 code actual | potential
AdverseEventActuality Binding: Adverse Event Actuality ( Required )
. . event . code Σ 0..1 CodeableConcept Event or incident that occurred or was averted
SNOMED CT Clinical Findings Binding: AdverseEvent Type ( Example )
. . . subject Σ 1..1 Reference ( Patient | Group | Practitioner | RelatedPerson ) Subject impacted by event
. . . encounter Σ 0..1 Reference ( Encounter ) The Encounter created as part associated with the start of the AdverseEvent
. . date . effect[x] Σ 0..1 When the effect of the AdverseEvent occurred
.... effectDateTime dateTime When the event occurred
. . . . effectPeriod Period
. . . detected Σ 0..1 dateTime When the event was detected
. . . recordedDate Σ 0..1 dateTime When the event was recorded
. . resultingCondition . resultingEffect Σ 0..* Reference CodeableReference ( Condition | Observation ) Effect on the subject due to this event
Binding: SNOMED CT Clinical Findings ( Example )

. . . location Σ 0..1 Reference ( Location ) Location where adverse event occurred
. . . seriousness Σ 0..1 CodeableConcept Seriousness or gravity of the event
AdverseEventSeriousness Binding: Adverse Event Seriousness ( Example )
. . severity . outcome Σ 0..* CodeableConcept Type of outcome from the adverse event
AdverseEventSeverity Binding: AdverseEvent Outcome ( Required Example )

. . outcome . recorder Σ 0..1 CodeableConcept Reference ( Patient resolved | recovering | ongoing | resolvedWithSequelae Practitioner | fatal PractitionerRole | unknown RelatedPerson ) Who recorded the adverse event
AdverseEventOutcome
. . . participant ( Required ) Σ 0..* BackboneElement Who was involved in the adverse event or the potential adverse event and what they did

. . . recorder . function Σ 0..1 CodeableConcept Reference Type of involvement
Binding: AdverseEvent Participant Function ( Patient | Practitioner | PractitionerRole | RelatedPerson Example )
Who recorded the adverse event
. . . . contributor actor Σ 1..1 Reference ( Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | Group ) Who was involved in the adverse event or the potential adverse event
. . . study Σ 0..* Reference ( ResearchStudy ) Research study that the subject is enrolled in

. . . expectedInResearchStudy 0..1 boolean Considered likely or probable or anticipated in the research study
.. . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event

. . . . instance Σ 1..1 Reference CodeableReference ( Immunization | Procedure | Substance | SubstanceDefinition | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy ) Refers to the specific entity that caused the adverse event
. . . . causality Σ 0..1 BackboneElement Information on the possible cause of the event
. . . . . assessment assessmentMethod Σ 0..1 CodeableConcept Method of if evaluating the relatedness of the suspected entity caused to the event
AdverseEventCausalityAssessment Binding: Adverse Event Causality Method ( Example )
. . . . productRelatedness . entityRelatedness Σ 0..1 string CodeableConcept Result of the assessment regarding the relatedness of the suspected entity to the event
Binding: Adverse Event Causality Assessment ( Example )
AdverseEvent.suspectEntity.causalityProductRelatedness
. . . . . author Σ 0..1 Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson ) Author of the information on the possible cause of the event
AdverseEvent.suspectEntity.causalityAuthor
. . . method . occurrence[x] Σ 0..1 When the suspect entity occurred
CodeableConcept
. . . . . occurrenceDateTime ProbabilityScale | Bayesian | Checklist AdverseEventCausalityMethod dateTime ( Example
. . . . . occurrencePeriod Period )
. . . subjectMedicalHistory contributingFactor Σ 0..* Reference CodeableReference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media Device | DocumentReference | MedicationAdministration | MedicationStatement ) Contributing factors suspected to have increased the probability or severity of the adverse event
Binding: AdverseEvent Contributing Factor ( Example )
AdverseEvent.subjectMedicalHistory
. . . referenceDocument preventiveAction Σ 0..* Reference CodeableReference ( Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) Preventive actions that contributed to avoiding the adverse event
Binding: AdverseEvent Preventive Action ( Example )
AdverseEvent.referenceDocument
. . . study mitigatingAction Σ 0..* CodeableReference ( Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm
Binding: AdverseEvent Mitigating Action ( Example )
Reference
. . . supportingInfo Σ 0..* CodeableReference ( ResearchStudy Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse ) Subject medical history or document relevant to this adverse event
Binding: AdverseEvent Supporting Information ( Example )
AdverseEvent.study
. . . note 0..* Annotation Comment on adverse event


doco Documentation for this format icon

See the Extensions for this resource

UML Diagram ( Legend )

AdverseEvent ( DomainResource ) Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server identifier : Identifier [0..1] [0..*] The current state of the adverse event or potential adverse event (this element modifies the meaning of other elements) status : code [1..1] « null (Strength=Required) AdverseEventStatus ! » Whether the event actually happened, happened or just had the potential to. was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely (this element modifies the meaning of other elements) actuality : code [1..1] « Overall nature of the adverse event, e.g. real or potential. null (Strength=Required) AdverseEventActuality ! » The overall type of event, intended for search and filtering purposes category : CodeableConcept [0..*] « Overall categorization of the event, e.g. product-related or situational. (Strength=Extensible) null (Strength=Example) AdverseEventCategory + ?? » This element defines the specific type of Specific event that occurred or that was prevented from occurring averted, such as patient fall, wrong organ removed, or wrong blood transfused event code : CodeableConcept [0..1] « Detailed type of event. null (Strength=Example) SNOMEDCTClinicalFindings AdverseEventType ?? » This subject or group impacted by the event subject : Reference [1..1] « Patient | Group | Practitioner | RelatedPerson » The Encounter during which AdverseEvent was created or to which associated with the creation start of this record is tightly associated the AdverseEvent encounter : Reference [0..1] « Encounter » The date (and perhaps time) when the adverse event effect of the AdverseEvent occurred date effect[x] : dateTime DataType [0..1] « dateTime | Period » 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 Information about the reaction condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fall resultingCondition resultingEffect : Reference CodeableReference [0..*] « Condition | Observation ; null (Strength=Example) SNOMEDCTClinicalFindings ?? » The information about where the adverse event occurred location : Reference [0..1] « Location » Assessment whether this event event, or averted event, was of real clinical importance seriousness : CodeableConcept [0..1] « Overall seriousness of this event for the patient. null (Strength=Example) AdverseEventSeriousness ?? » Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is severity : CodeableConcept [0..1] « The severity of the adverse event itself, in direct relation to the subject. (Strength=Required) AdverseEventSeverity ! » Describes the type of outcome from the adverse event event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal outcome : CodeableConcept [0..1] [0..*] « TODO (and should this be required?). (Strength=Required) null (Strength=Example) AdverseEventOutcome ! ?? » Information on who recorded the adverse event. May be the patient or a practitioner recorder : Reference [0..1] « Patient | Practitioner | PractitionerRole | RelatedPerson » Parties The research study that may the subject is enrolled in study : Reference [0..*] « ResearchStudy » Considered likely or should contribute probable or have contributed information to anticipated in the adverse event, which can consist research study. Whether the reported event matches any of one the outcomes for the patient that are considered by the study as known or more activities. Such information includes information leading likely expectedInResearchStudy : boolean [0..1] The contributing factors suspected to have increased the decision to perform probability or severity of the activity and how adverse event contributingFactor : CodeableReference [0..*] « Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DocumentReference | MedicationAdministration | MedicationStatement ; null (Strength=Example) AdverseEventContributingFactor ?? » Preventive actions that contributed to perform avoiding the activity (e.g. consultant), information that adverse event preventiveAction : CodeableReference [0..*] « Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest ; null (Strength=Example) AdverseEventPreventiveAction ?? » The ameliorating action taken after the activity itself seeks adverse event occurred in order to reveal (e.g. informant reduce the extent of clinical history), or information about what activity was performed (e.g. informant witness) harm contributor mitigatingAction : Reference CodeableReference [0..*] « Practitioner Procedure | PractitionerRole DocumentReference | MedicationAdministration | MedicationRequest ; null (Strength=Example) Device AdverseEventMitigatingAction ?? » AdverseEvent.subjectMedicalHistory Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin 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 subjectMedicalHistory supportingInfo : Reference CodeableReference [0..*] « Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media DocumentReference | DocumentReference MedicationAdministration | MedicationStatement | QuestionnaireResponse ; null (Strength=Example) AdverseEventSupportingInforat... ?? » AdverseEvent.referenceDocument Comments made about the adverse event by the performer, subject or other participants referenceDocument note : Reference Annotation [0..*] Participant Distinguishes the type of involvement of the actor in the adverse event, such as contributor or informant function : CodeableConcept [0..1] « DocumentReference null (Strength=Example) AdverseEventParticipantFuncti... ?? » AdverseEvent.study Indicates who or what participated in the event study actor : Reference [0..*] [1..1] « ResearchStudy Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | Group » SuspectEntity Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device instance : Reference CodeableReference [1..1] « Immunization | Procedure | Substance | SubstanceDefinition | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy » The date (and perhaps time) when the suspect entity occurred occurrence[x] : DataType [0..1] « dateTime | Period » Causality Assessment The method of if evaluating the relatedness of the suspected entity caused to the event assessment assessmentMethod : CodeableConcept [0..1] « Codes for the assessment of whether the entity caused the event. null (Strength=Example) AdverseEventCausalityAssessme... AdverseEventCausalityMethod ?? » AdverseEvent.suspectEntity.causalityProductRelatedness The result of the assessment regarding the relatedness of the suspected entity to the event productRelatedness entityRelatedness : string CodeableConcept [0..1] « null (Strength=Example) AdverseEventCausalityAssessme... ?? » AdverseEvent.suspectEntity.causalityAuthor The author of the information on the possible cause of the event author : Reference [0..1] « Practitioner | PractitionerRole | Patient | RelatedPerson » ProbabilityScale | Bayesian | Checklist Indicates who or what participated in the adverse event and how they were involved method : CodeableConcept participant [0..1] « TODO. (Strength=Example) AdverseEventCausalityMethod ?? » [0..*] Information on the possible cause of the event causality [0..*] [0..1] Describes the entity that is suspected to have caused the adverse event suspectEntity [0..*]

XML Template 

<

<AdverseEvent xmlns="http://hl7.org/fhir"> doco

 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>
 <
 <</category>
 <</event>
 <</subject>
 <</encounter>
 <

 <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>
 <effect[x]><!-- 0..1 dateTime|Period When the effect of the AdverseEvent occurred --></effect[x]>

 <detected value="[dateTime]"/><!-- 0..1 When the event was detected -->
 <recordedDate value="[dateTime]"/><!-- 0..1 When the event was recorded -->
 <</resultingCondition>

 <resultingEffect><!-- 0..* CodeableReference(Condition|Observation) Effect on the subject due to this event --></resultingEffect>

 <location><!-- 0..1 Reference(Location) Location where adverse event occurred --></location>
 <</seriousness>
 <</severity>
 <</outcome>

 <seriousness><!-- 0..1 CodeableConcept Seriousness or gravity of the event --></seriousness>
 <outcome><!-- 0..* CodeableConcept Type of outcome from the adverse event --></outcome>

 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <</contributor>

 <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|Group|Organization|Patient|
    Practitioner|PractitionerRole|RelatedPerson) Who was involved in the adverse event or the potential adverse event --></actor>

 </participant>
 <study><!-- 0..* Reference(ResearchStudy) Research study that the subject is enrolled in --></study>
 <expectedInResearchStudy value="[boolean]"/><!-- 0..1 Considered likely or probable or anticipated in the research study -->

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

  <instance><!-- 1..1 CodeableReference(BiologicallyDerivedProduct|Device|
    Immunization|Medication|MedicationAdministration|MedicationStatement|
    Procedure|ResearchStudy|Substance|SubstanceDefinition) Refers to the specific entity that caused the adverse event --></instance>

  <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>
  <occurrence[x]><!-- 0..1 dateTime|Period When the suspect entity occurred --></occurrence[x]>

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

 <contributingFactor><!-- 0..* CodeableReference(AllergyIntolerance|Condition|
   Device|DocumentReference|FamilyMemberHistory|Immunization|
   MedicationAdministration|MedicationStatement|Observation|Procedure) Contributing factors suspected to have increased the probability or severity of the adverse event --></contributingFactor>

 <preventiveAction><!-- 0..* CodeableReference(DocumentReference|Immunization|
   MedicationAdministration|MedicationRequest|Procedure) Preventive actions that contributed to avoiding the adverse event --></preventiveAction>

 <mitigatingAction><!-- 0..* CodeableReference(DocumentReference|
   MedicationAdministration|MedicationRequest|Procedure) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm --></mitigatingAction>

 <supportingInfo><!-- 0..* CodeableReference(AllergyIntolerance|Condition|
   DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration|
   MedicationStatement|Observation|Procedure|QuestionnaireResponse) Subject medical history or document relevant to this adverse event --></supportingInfo>

 <note><!-- 0..* Annotation Comment on adverse event --></note>

</AdverseEvent>

JSON Template 

{doco
  "resourceType" : "",

  "resourceType" : "AdverseEvent",

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

  "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
  // effect[x]: When the effect of the AdverseEvent occurred. One of these 2:

  "effectDateTime" : "<dateTime>",
  "effectPeriod" : { Period },

  "detected" : "<dateTime>", // When the event was detected
  "recordedDate" : "<dateTime>", // When the event was recorded
  "

  "resultingEffect" : [{ CodeableReference(Condition|Observation) }], // 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|Group|Organization|Patient|
    Practitioner|PractitionerRole|RelatedPerson) } // R!  Who was involved in the adverse event or the potential adverse event

  }],
  "study" : [{ Reference(ResearchStudy) }], // Research study that the subject is enrolled in
  "expectedInResearchStudy" : <boolean>, // Considered likely or probable or anticipated in the research study

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

    "instance" : { CodeableReference(BiologicallyDerivedProduct|Device|
    Immunization|Medication|MedicationAdministration|MedicationStatement|
    Procedure|ResearchStudy|Substance|SubstanceDefinition) }, // R!  Refers to the specific entity that caused the adverse event

    "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

    },
    // occurrence[x]: When the suspect entity occurred. One of these 2:

    "occurrenceDateTime" : "<dateTime>",
    "occurrencePeriod" : { Period }

  }],
  "|
   |
   
  "
  "

  "contributingFactor" : [{ CodeableReference(AllergyIntolerance|Condition|
   Device|DocumentReference|FamilyMemberHistory|Immunization|
   MedicationAdministration|MedicationStatement|Observation|Procedure) }], // Contributing factors suspected to have increased the probability or severity of the adverse event

  "preventiveAction" : [{ CodeableReference(DocumentReference|Immunization|
   MedicationAdministration|MedicationRequest|Procedure) }], // Preventive actions that contributed to avoiding the adverse event

  "mitigatingAction" : [{ CodeableReference(DocumentReference|
   MedicationAdministration|MedicationRequest|Procedure) }], // Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm

  "supportingInfo" : [{ CodeableReference(AllergyIntolerance|Condition|
   DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration|
   MedicationStatement|Observation|Procedure|QuestionnaireResponse) }], // Subject medical history or document relevant to this adverse event

  "note" : [{ Annotation }] // Comment on adverse event

}

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 
  # from 
  fhir:
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  fhir:
    fhir:|
  
    fhir:
      fhir:
      fhir:
      fhir:
      fhir:
    ], ...;
  ], ...;
  fhir:|
  
  fhir:
  fhir:

  # from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language
  # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Business identifier for the event
  fhir:status [ code ] ; # 1..1 in-progress | completed | entered-in-error | unknown
  fhir:actuality [ code ] ; # 1..1 actual | potential
  fhir:category  ( [ CodeableConcept ] ... ) ; # 0..* wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
  fhir:code [ CodeableConcept ] ; # 0..1 Event or incident that occurred or was averted
  fhir:subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ] ; # 1..1 Subject impacted by event
  fhir:encounter [ Reference(Encounter) ] ; # 0..1 The Encounter associated with the start of the AdverseEvent
  # effect[x] : 0..1 When the effect of the AdverseEvent occurred. One of these 2
    fhir:effect [  a fhir:DateTime ; dateTime ]
    fhir:effect [  a fhir:Period ; Period ]
  fhir:detected [ dateTime ] ; # 0..1 When the event was detected
  fhir:recordedDate [ dateTime ] ; # 0..1 When the event was recorded
  fhir:resultingEffect  ( [ CodeableReference(Condition|Observation) ] ... ) ; # 0..* Effect on the subject due to this event
  fhir:location [ Reference(Location) ] ; # 0..1 Location where adverse event occurred
  fhir:seriousness [ CodeableConcept ] ; # 0..1 Seriousness or gravity of the event
  fhir:outcome  ( [ CodeableConcept ] ... ) ; # 0..* Type of outcome from the adverse event
  fhir:recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 Who recorded the adverse event
  fhir:participant ( [ # 0..* Who was involved in the adverse event or the potential adverse event and what they did
    fhir:function [ CodeableConcept ] ; # 0..1 Type of involvement
    fhir:actor [ Reference(CareTeam|Device|Group|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ] ; # 1..1 Who was involved in the adverse event or the potential adverse event

  ] ... ) ;
  fhir:study  ( [ Reference(ResearchStudy) ] ... ) ; # 0..* Research study that the subject is enrolled in
  fhir:expectedInResearchStudy [ boolean ] ; # 0..1 Considered likely or probable or anticipated in the research study
  fhir:suspectEntity ( [ # 0..* The suspected agent causing the adverse event
    fhir:instance [ CodeableReference(BiologicallyDerivedProduct|Device|Immunization|Medication|
  MedicationAdministration|MedicationStatement|Procedure|ResearchStudy|Substance|
  SubstanceDefinition) ] ; # 1..1 Refers to the specific entity that caused the adverse event

    fhir:causality [ # 0..1 Information on the possible cause of the event
      fhir:assessmentMethod [ CodeableConcept ] ; # 0..1 Method of evaluating the relatedness of the suspected entity to the event
      fhir:entityRelatedness [ CodeableConcept ] ; # 0..1 Result of the assessment regarding the relatedness of the suspected entity to the event
      fhir:author [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 Author of the information on the possible cause of the event
    ] ;
    # occurrence[x] : 0..1 When the suspect entity occurred. One of these 2
      fhir:occurrence [  a fhir:DateTime ; dateTime ]
      fhir:occurrence [  a fhir:Period ; Period ]
  ] ... ) ;
  fhir:contributingFactor  ( [ CodeableReference(AllergyIntolerance|Condition|Device|DocumentReference|FamilyMemberHistory|
  Immunization|MedicationAdministration|MedicationStatement|Observation|
  Procedure) ] ... ) ; # 0..* Contributing factors suspected to have increased the probability or severity of the adverse event

  fhir:preventiveAction  ( [ CodeableReference(DocumentReference|Immunization|MedicationAdministration|MedicationRequest|
  Procedure) ] ... ) ; # 0..* Preventive actions that contributed to avoiding the adverse event

  fhir:mitigatingAction  ( [ CodeableReference(DocumentReference|MedicationAdministration|MedicationRequest|Procedure) ] ... ) ; # 0..* Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm
  fhir:supportingInfo  ( [ CodeableReference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  MedicationAdministration|MedicationStatement|Observation|Procedure|
  QuestionnaireResponse) ] ... ) ; # 0..* Subject medical history or document relevant to this adverse event

  fhir:note  ( [ Annotation ] ... ) ; # 0..* Comment on adverse event

]

Changes since R3 from both R4 and R4B

AdverseEvent.suspectEntity.instance Type Reference: Added Target Types Immunization, Procedure
AdverseEvent
AdverseEvent.identifier
  • Max Cardinality changed from 1 to *
AdverseEvent.actuality AdverseEvent.status
  • Added Mandatory Element
AdverseEvent.category
  • Max Cardinality changed from 1 to * Type changed from code to CodeableConcept Remove Binding `http://hl7.org/fhir/ValueSet/adverse-event-category` (extensible)
AdverseEvent.code
  • Change binding strength Renamed from required event to extensible code
AdverseEvent.event AdverseEvent.effect[x]
  • Added Element
AdverseEvent.subject AdverseEvent.resultingEffect
  • Min Cardinality changed Renamed from 0 resultingCondition to 1 Type Reference: Added Target Types Group, Practitioner, RelatedPerson resultingEffect
  • Type Reference: Removed Target Types ResearchSubject, Medication, Device changed from Reference(Condition) to CodeableReference
AdverseEvent.encounter AdverseEvent.outcome
  • Added Element Max Cardinality changed from 1 to *
  • Remove Binding `http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.0` (required)
AdverseEvent.detected AdverseEvent.participant
  • Added Element
AdverseEvent.recordedDate AdverseEvent.participant.function
  • Added Element
AdverseEvent.resultingCondition AdverseEvent.participant.actor
  • Added Mandatory Element
AdverseEvent.severity AdverseEvent.expectedInResearchStudy
  • Added Element
AdverseEvent.outcome AdverseEvent.suspectEntity.instance
  • Change value set Type changed from http://hl7.org/fhir/ValueSet/adverse-event-outcome Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 CodeableReference
AdverseEvent.recorder AdverseEvent.suspectEntity.causality
  • Type Reference: Added Target Type PractitionerRole Max Cardinality changed from * to 1
AdverseEvent.contributor AdverseEvent.suspectEntity.causality.assessmentMethod
  • Added Element
AdverseEvent.suspectEntity.causality AdverseEvent.suspectEntity.causality.entityRelatedness
  • Max Cardinality changed Renamed from 1 productRelatedness to * entityRelatedness
  • Type changed from code string to BackboneElement Remove Binding http://hl7.org/fhir/ValueSet/adverse-event-causality (required) CodeableConcept
AdverseEvent.suspectEntity.causality.assessment AdverseEvent.suspectEntity.causality.author
  • Type Reference: Added Element Target Types Patient, RelatedPerson
AdverseEvent.suspectEntity.causality.productRelatedness AdverseEvent.suspectEntity.occurrence[x]
  • Added Element
AdverseEvent.suspectEntity.causality.author AdverseEvent.contributingFactor
  • Added Element
AdverseEvent.suspectEntity.causality.method AdverseEvent.preventiveAction
  • Added Element
AdverseEvent.subjectMedicalHistory AdverseEvent.mitigatingAction
  • Type Reference: Added Target Types Media, DocumentReference Element
AdverseEvent.type AdverseEvent.supportingInfo
  • deleted Added Element
AdverseEvent.reaction AdverseEvent.note
  • deleted Added Element
AdverseEvent.eventParticipant AdverseEvent.date
  • deleted Deleted
AdverseEvent.description AdverseEvent.severity
  • deleted Deleted (AdverseEvent.severity is redundant with Condition.severity referenced via AdverseEvent.resultingEffect)
AdverseEvent.suspectEntity.causalityAssessment AdverseEvent.contributor
  • deleted Deleted (-> AdverseEvent.participant.actor)
AdverseEvent.suspectEntity.causalityProductRelatedness AdverseEvent.suspectEntity.causality.assessment
  • deleted Deleted (-> AdverseEvent.suspectEntity.causality.assessmentMethod)
AdverseEvent.suspectEntity.causalityMethod AdverseEvent.suspectEntity.causality.method
  • deleted Deleted (-> AdverseEvent.suspectEntity.causality.assessmentMethod)
AdverseEvent.suspectEntity.causalityAuthor AdverseEvent.subjectMedicalHistory
  • deleted Deleted (-> AdverseEvent.supportingInfo)
AdverseEvent.suspectEntity.causalityResult AdverseEvent.referenceDocument
  • deleted Deleted (-> AdverseEvent.supportingInfo)

See the Full Difference for further information

This analysis is available for R4 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). ) for R4B as XML or JSON .

Structure

Medical care, research study or other healthcare 0..1 product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate Type of the event itself in relation to the subject 0..1 mild | moderate | severe 0..* 0..* Assessment
Name Flags Card. Type Description & Constraints      Filter: Filters doco
. . AdverseEvent Σ TU N DomainResource An event causing physical injury that may be related to unintended effects on a patient or research participant

Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier Σ 0..* Identifier Business identifier for the event

. . . actuality status ?! Σ 1..1 code in-progress | completed | entered-in-error | unknown
Binding: Adverse Event Status ( Required )
. . . actuality ?! Σ 1..1 code actual | potential
AdverseEventActuality Binding: Adverse Event Actuality ( Required )
. . event . code Σ 0..1 CodeableConcept Event or incident that occurred or was averted
SNOMED CT Clinical Findings Binding: AdverseEvent Type ( Example )
. . . subject Σ 1..1 Reference ( Patient | Group | Practitioner | RelatedPerson ) Subject impacted by event
. . . encounter Σ 0..1 Reference ( Encounter ) The Encounter created as part associated with the start of the AdverseEvent
. . date . effect[x] Σ 0..1 When the effect of the AdverseEvent occurred
.... effectDateTime dateTime When the event occurred
. . . . effectPeriod Period
. . . detected Σ 0..1 dateTime When the event was detected
. . . recordedDate Σ 0..1 dateTime When the event was recorded
. . resultingCondition . resultingEffect Σ 0..* Reference CodeableReference ( Condition | Observation ) Effect on the subject due to this event
Binding: SNOMED CT Clinical Findings ( Example )

. . . location Σ 0..1 Reference ( Location ) Location where adverse event occurred
. . . seriousness Σ 0..1 CodeableConcept Seriousness or gravity of the event
AdverseEventSeriousness Binding: Adverse Event Seriousness ( Example )
. . severity . outcome Σ 0..* CodeableConcept Type of outcome from the adverse event
AdverseEventSeverity Binding: AdverseEvent Outcome ( Required Example )

. . outcome . recorder Σ 0..1 CodeableConcept Reference ( Patient resolved | recovering | ongoing | resolvedWithSequelae Practitioner | fatal PractitionerRole | unknown RelatedPerson ) Who recorded the adverse event
AdverseEventOutcome
. . . participant ( Required ) Σ 0..* BackboneElement Who was involved in the adverse event or the potential adverse event and what they did

. . . recorder . function Σ 0..1 CodeableConcept Reference Type of involvement
Binding: AdverseEvent Participant Function ( Patient | Practitioner | PractitionerRole | RelatedPerson Example )
Who recorded the adverse event
. . . . contributor actor Σ 1..1 Reference ( Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | Group ) Who was involved in the adverse event or the potential adverse event
. . . study Σ 0..* Reference ( ResearchStudy ) Research study that the subject is enrolled in

. . . expectedInResearchStudy 0..1 boolean Considered likely or probable or anticipated in the research study
.. . suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event

. . . . instance Σ 1..1 Reference CodeableReference ( Immunization | Procedure | Substance | SubstanceDefinition | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy ) Refers to the specific entity that caused the adverse event
. . . . causality Σ 0..1 BackboneElement Information on the possible cause of the event
. . . . . assessment assessmentMethod Σ 0..1 CodeableConcept Method of if evaluating the relatedness of the suspected entity caused to the event
AdverseEventCausalityAssessment Binding: Adverse Event Causality Method ( Example )
. . . . productRelatedness . entityRelatedness Σ 0..1 string CodeableConcept Result of the assessment regarding the relatedness of the suspected entity to the event
Binding: Adverse Event Causality Assessment ( Example )
AdverseEvent.suspectEntity.causalityProductRelatedness
. . . . . author Σ 0..1 Reference ( Practitioner | PractitionerRole | Patient | RelatedPerson ) Author of the information on the possible cause of the event
AdverseEvent.suspectEntity.causalityAuthor
. . . method . occurrence[x] Σ 0..1 When the suspect entity occurred
CodeableConcept
. . . . . occurrenceDateTime ProbabilityScale | Bayesian | Checklist AdverseEventCausalityMethod dateTime ( Example
. . . . . occurrencePeriod Period )
. . . subjectMedicalHistory contributingFactor Σ 0..* Reference CodeableReference ( Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media Device | DocumentReference | MedicationAdministration | MedicationStatement ) Contributing factors suspected to have increased the probability or severity of the adverse event
Binding: AdverseEvent Contributing Factor ( Example )
AdverseEvent.subjectMedicalHistory
. . . referenceDocument preventiveAction Σ 0..* Reference CodeableReference ( Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) Preventive actions that contributed to avoiding the adverse event
Binding: AdverseEvent Preventive Action ( Example )
AdverseEvent.referenceDocument
. . . study mitigatingAction Σ 0..* CodeableReference ( Procedure | DocumentReference | MedicationAdministration | MedicationRequest ) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm
Binding: AdverseEvent Mitigating Action ( Example )
Reference
. . . supportingInfo Σ 0..* CodeableReference ( ResearchStudy Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse ) Subject medical history or document relevant to this adverse event
Binding: AdverseEvent Supporting Information ( Example )
AdverseEvent.study
. . . note 0..* Annotation Comment on adverse event


doco Documentation for this format icon

See the Extensions for this resource

UML Diagram ( Legend )

AdverseEvent ( DomainResource ) Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server identifier : Identifier [0..1] [0..*] The current state of the adverse event or potential adverse event (this element modifies the meaning of other elements) status : code [1..1] « null (Strength=Required) AdverseEventStatus ! » Whether the event actually happened, happened or just had the potential to. was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely (this element modifies the meaning of other elements) actuality : code [1..1] « Overall nature of the adverse event, e.g. real or potential. null (Strength=Required) AdverseEventActuality ! » The overall type of event, intended for search and filtering purposes category : CodeableConcept [0..*] « Overall categorization of the event, e.g. product-related or situational. (Strength=Extensible) null (Strength=Example) AdverseEventCategory + ?? » This element defines the specific type of Specific event that occurred or that was prevented from occurring averted, such as patient fall, wrong organ removed, or wrong blood transfused event code : CodeableConcept [0..1] « Detailed type of event. null (Strength=Example) SNOMEDCTClinicalFindings AdverseEventType ?? » This subject or group impacted by the event subject : Reference [1..1] « Patient | Group | Practitioner | RelatedPerson » The Encounter during which AdverseEvent was created or to which associated with the creation start of this record is tightly associated the AdverseEvent encounter : Reference [0..1] « Encounter » The date (and perhaps time) when the adverse event effect of the AdverseEvent occurred date effect[x] : dateTime DataType [0..1] « dateTime | Period » 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 Information about the reaction condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fall resultingCondition resultingEffect : Reference CodeableReference [0..*] « Condition | Observation ; null (Strength=Example) SNOMEDCTClinicalFindings ?? » The information about where the adverse event occurred location : Reference [0..1] « Location » Assessment whether this event event, or averted event, was of real clinical importance seriousness : CodeableConcept [0..1] « Overall seriousness of this event for the patient. null (Strength=Example) AdverseEventSeriousness ?? » Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is severity : CodeableConcept [0..1] « The severity of the adverse event itself, in direct relation to the subject. (Strength=Required) AdverseEventSeverity ! » Describes the type of outcome from the adverse event event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal outcome : CodeableConcept [0..1] [0..*] « TODO (and should this be required?). (Strength=Required) null (Strength=Example) AdverseEventOutcome ! ?? » Information on who recorded the adverse event. May be the patient or a practitioner recorder : Reference [0..1] « Patient | Practitioner | PractitionerRole | RelatedPerson » Parties The research study that may the subject is enrolled in study : Reference [0..*] « ResearchStudy » Considered likely or should contribute probable or have contributed information to anticipated in the adverse event, which can consist research study. Whether the reported event matches any of one the outcomes for the patient that are considered by the study as known or more activities. Such information includes information leading likely expectedInResearchStudy : boolean [0..1] The contributing factors suspected to have increased the decision to perform probability or severity of the activity and how adverse event contributingFactor : CodeableReference [0..*] « Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DocumentReference | MedicationAdministration | MedicationStatement ; null (Strength=Example) AdverseEventContributingFactor ?? » Preventive actions that contributed to perform avoiding the activity (e.g. consultant), information that adverse event preventiveAction : CodeableReference [0..*] « Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest ; null (Strength=Example) AdverseEventPreventiveAction ?? » The ameliorating action taken after the activity itself seeks adverse event occurred in order to reveal (e.g. informant reduce the extent of clinical history), or information about what activity was performed (e.g. informant witness) harm contributor mitigatingAction : Reference CodeableReference [0..*] « Practitioner Procedure | PractitionerRole DocumentReference | MedicationAdministration | MedicationRequest ; null (Strength=Example) Device AdverseEventMitigatingAction ?? » AdverseEvent.subjectMedicalHistory Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin 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 subjectMedicalHistory supportingInfo : Reference CodeableReference [0..*] « Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media DocumentReference | DocumentReference MedicationAdministration | MedicationStatement | QuestionnaireResponse ; null (Strength=Example) AdverseEventSupportingInforat... ?? » AdverseEvent.referenceDocument Comments made about the adverse event by the performer, subject or other participants referenceDocument note : Reference Annotation [0..*] Participant Distinguishes the type of involvement of the actor in the adverse event, such as contributor or informant function : CodeableConcept [0..1] « DocumentReference null (Strength=Example) AdverseEventParticipantFuncti... ?? » AdverseEvent.study Indicates who or what participated in the event study actor : Reference [0..*] [1..1] « ResearchStudy Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | Group » SuspectEntity Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device instance : Reference CodeableReference [1..1] « Immunization | Procedure | Substance | SubstanceDefinition | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy » The date (and perhaps time) when the suspect entity occurred occurrence[x] : DataType [0..1] « dateTime | Period » Causality Assessment The method of evaluating the relatedness of if the suspected entity caused to the event assessment assessmentMethod : CodeableConcept [0..1] « Codes for the assessment of whether the entity caused the event. null (Strength=Example) AdverseEventCausalityAssessme... AdverseEventCausalityMethod ?? » AdverseEvent.suspectEntity.causalityProductRelatedness The result of the assessment regarding the relatedness of the suspected entity to the event productRelatedness entityRelatedness : string CodeableConcept [0..1] « null (Strength=Example) AdverseEventCausalityAssessme... ?? » AdverseEvent.suspectEntity.causalityAuthor The author of the information on the possible cause of the event author : Reference [0..1] « Practitioner | PractitionerRole | Patient | RelatedPerson » ProbabilityScale | Bayesian | Checklist Indicates who or what participated in the adverse event and how they were involved method : CodeableConcept participant [0..1] « TODO. (Strength=Example) AdverseEventCausalityMethod ?? » [0..*] Information on the possible cause of the event causality [0..*] [0..1] Describes the entity that is suspected to have caused the adverse event suspectEntity [0..*]

XML Template 

<

<AdverseEvent xmlns="http://hl7.org/fhir"> doco

 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <</identifier>
 <
 <</category>
 <</event>
 <</subject>
 <</encounter>
 <

 <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>
 <effect[x]><!-- 0..1 dateTime|Period When the effect of the AdverseEvent occurred --></effect[x]>

 <detected value="[dateTime]"/><!-- 0..1 When the event was detected -->
 <recordedDate value="[dateTime]"/><!-- 0..1 When the event was recorded -->
 <</resultingCondition>

 <resultingEffect><!-- 0..* CodeableReference(Condition|Observation) Effect on the subject due to this event --></resultingEffect>

 <location><!-- 0..1 Reference(Location) Location where adverse event occurred --></location>
 <</seriousness>
 <</severity>
 <</outcome>

 <seriousness><!-- 0..1 CodeableConcept Seriousness or gravity of the event --></seriousness>
 <outcome><!-- 0..* CodeableConcept Type of outcome from the adverse event --></outcome>

 <recorder><!-- 0..1 Reference(Patient|Practitioner|PractitionerRole|
   RelatedPerson) Who recorded the adverse event --></recorder>
 <</contributor>

 <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|Group|Organization|Patient|
    Practitioner|PractitionerRole|RelatedPerson) Who was involved in the adverse event or the potential adverse event --></actor>

 </participant>
 <study><!-- 0..* Reference(ResearchStudy) Research study that the subject is enrolled in --></study>
 <expectedInResearchStudy value="[boolean]"/><!-- 0..1 Considered likely or probable or anticipated in the research study -->

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

  <instance><!-- 1..1 CodeableReference(BiologicallyDerivedProduct|Device|
    Immunization|Medication|MedicationAdministration|MedicationStatement|
    Procedure|ResearchStudy|Substance|SubstanceDefinition) Refers to the specific entity that caused the adverse event --></instance>

  <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>
  <occurrence[x]><!-- 0..1 dateTime|Period When the suspect entity occurred --></occurrence[x]>

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

 <contributingFactor><!-- 0..* CodeableReference(AllergyIntolerance|Condition|
   Device|DocumentReference|FamilyMemberHistory|Immunization|
   MedicationAdministration|MedicationStatement|Observation|Procedure) Contributing factors suspected to have increased the probability or severity of the adverse event --></contributingFactor>

 <preventiveAction><!-- 0..* CodeableReference(DocumentReference|Immunization|
   MedicationAdministration|MedicationRequest|Procedure) Preventive actions that contributed to avoiding the adverse event --></preventiveAction>

 <mitigatingAction><!-- 0..* CodeableReference(DocumentReference|
   MedicationAdministration|MedicationRequest|Procedure) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm --></mitigatingAction>

 <supportingInfo><!-- 0..* CodeableReference(AllergyIntolerance|Condition|
   DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration|
   MedicationStatement|Observation|Procedure|QuestionnaireResponse) Subject medical history or document relevant to this adverse event --></supportingInfo>

 <note><!-- 0..* Annotation Comment on adverse event --></note>

</AdverseEvent>

JSON Template 

{doco
  "resourceType" : "",

  "resourceType" : "AdverseEvent",

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

  "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
  // effect[x]: When the effect of the AdverseEvent occurred. One of these 2:

  "effectDateTime" : "<dateTime>",
  "effectPeriod" : { Period },

  "detected" : "<dateTime>", // When the event was detected
  "recordedDate" : "<dateTime>", // When the event was recorded
  "

  "resultingEffect" : [{ CodeableReference(Condition|Observation) }], // 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|Group|Organization|Patient|
    Practitioner|PractitionerRole|RelatedPerson) } // R!  Who was involved in the adverse event or the potential adverse event

  }],
  "study" : [{ Reference(ResearchStudy) }], // Research study that the subject is enrolled in
  "expectedInResearchStudy" : <boolean>, // Considered likely or probable or anticipated in the research study

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

    "instance" : { CodeableReference(BiologicallyDerivedProduct|Device|
    Immunization|Medication|MedicationAdministration|MedicationStatement|
    Procedure|ResearchStudy|Substance|SubstanceDefinition) }, // R!  Refers to the specific entity that caused the adverse event

    "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

    },
    // occurrence[x]: When the suspect entity occurred. One of these 2:

    "occurrenceDateTime" : "<dateTime>",
    "occurrencePeriod" : { Period }

  }],
  "|
   |
   
  "
  "

  "contributingFactor" : [{ CodeableReference(AllergyIntolerance|Condition|
   Device|DocumentReference|FamilyMemberHistory|Immunization|
   MedicationAdministration|MedicationStatement|Observation|Procedure) }], // Contributing factors suspected to have increased the probability or severity of the adverse event

  "preventiveAction" : [{ CodeableReference(DocumentReference|Immunization|
   MedicationAdministration|MedicationRequest|Procedure) }], // Preventive actions that contributed to avoiding the adverse event

  "mitigatingAction" : [{ CodeableReference(DocumentReference|
   MedicationAdministration|MedicationRequest|Procedure) }], // Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm

  "supportingInfo" : [{ CodeableReference(AllergyIntolerance|Condition|
   DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration|
   MedicationStatement|Observation|Procedure|QuestionnaireResponse) }], // Subject medical history or document relevant to this adverse event

  "note" : [{ Annotation }] // Comment on adverse event

}

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 
  # from 
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:|
  
    fhir:
      fhir:
      fhir:
      fhir:
      fhir:
    ], ...;
  ], ...;
  fhir:|
  
  fhir:
  fhir:

  # from Resource: fhir:id, fhir:meta, fhir:implicitRules, and fhir:language
  # from DomainResource: fhir:text, fhir:contained, fhir:extension, and fhir:modifierExtension
  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Business identifier for the event
  fhir:status [ code ] ; # 1..1 in-progress | completed | entered-in-error | unknown
  fhir:actuality [ code ] ; # 1..1 actual | potential
  fhir:category  ( [ CodeableConcept ] ... ) ; # 0..* wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
  fhir:code [ CodeableConcept ] ; # 0..1 Event or incident that occurred or was averted
  fhir:subject [ Reference(Group|Patient|Practitioner|RelatedPerson) ] ; # 1..1 Subject impacted by event
  fhir:encounter [ Reference(Encounter) ] ; # 0..1 The Encounter associated with the start of the AdverseEvent
  # effect[x] : 0..1 When the effect of the AdverseEvent occurred. One of these 2
    fhir:effect [  a fhir:DateTime ; dateTime ]
    fhir:effect [  a fhir:Period ; Period ]
  fhir:detected [ dateTime ] ; # 0..1 When the event was detected
  fhir:recordedDate [ dateTime ] ; # 0..1 When the event was recorded
  fhir:resultingEffect  ( [ CodeableReference(Condition|Observation) ] ... ) ; # 0..* Effect on the subject due to this event
  fhir:location [ Reference(Location) ] ; # 0..1 Location where adverse event occurred
  fhir:seriousness [ CodeableConcept ] ; # 0..1 Seriousness or gravity of the event
  fhir:outcome  ( [ CodeableConcept ] ... ) ; # 0..* Type of outcome from the adverse event
  fhir:recorder [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 Who recorded the adverse event
  fhir:participant ( [ # 0..* Who was involved in the adverse event or the potential adverse event and what they did
    fhir:function [ CodeableConcept ] ; # 0..1 Type of involvement
    fhir:actor [ Reference(CareTeam|Device|Group|Organization|Patient|Practitioner|PractitionerRole|
  RelatedPerson) ] ; # 1..1 Who was involved in the adverse event or the potential adverse event

  ] ... ) ;
  fhir:study  ( [ Reference(ResearchStudy) ] ... ) ; # 0..* Research study that the subject is enrolled in
  fhir:expectedInResearchStudy [ boolean ] ; # 0..1 Considered likely or probable or anticipated in the research study
  fhir:suspectEntity ( [ # 0..* The suspected agent causing the adverse event
    fhir:instance [ CodeableReference(BiologicallyDerivedProduct|Device|Immunization|Medication|
  MedicationAdministration|MedicationStatement|Procedure|ResearchStudy|Substance|
  SubstanceDefinition) ] ; # 1..1 Refers to the specific entity that caused the adverse event

    fhir:causality [ # 0..1 Information on the possible cause of the event
      fhir:assessmentMethod [ CodeableConcept ] ; # 0..1 Method of evaluating the relatedness of the suspected entity to the event
      fhir:entityRelatedness [ CodeableConcept ] ; # 0..1 Result of the assessment regarding the relatedness of the suspected entity to the event
      fhir:author [ Reference(Patient|Practitioner|PractitionerRole|RelatedPerson) ] ; # 0..1 Author of the information on the possible cause of the event
    ] ;
    # occurrence[x] : 0..1 When the suspect entity occurred. One of these 2
      fhir:occurrence [  a fhir:DateTime ; dateTime ]
      fhir:occurrence [  a fhir:Period ; Period ]
  ] ... ) ;
  fhir:contributingFactor  ( [ CodeableReference(AllergyIntolerance|Condition|Device|DocumentReference|FamilyMemberHistory|
  Immunization|MedicationAdministration|MedicationStatement|Observation|
  Procedure) ] ... ) ; # 0..* Contributing factors suspected to have increased the probability or severity of the adverse event

  fhir:preventiveAction  ( [ CodeableReference(DocumentReference|Immunization|MedicationAdministration|MedicationRequest|
  Procedure) ] ... ) ; # 0..* Preventive actions that contributed to avoiding the adverse event

  fhir:mitigatingAction  ( [ CodeableReference(DocumentReference|MedicationAdministration|MedicationRequest|Procedure) ] ... ) ; # 0..* Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm
  fhir:supportingInfo  ( [ CodeableReference(AllergyIntolerance|Condition|DocumentReference|FamilyMemberHistory|Immunization|
  MedicationAdministration|MedicationStatement|Observation|Procedure|
  QuestionnaireResponse) ] ... ) ; # 0..* Subject medical history or document relevant to this adverse event

  fhir:note  ( [ Annotation ] ... ) ; # 0..* Comment on adverse event

]

Changes since Release 3 from both R4 and R4B

AdverseEvent.suspectEntity.instance Type Reference: Added Target Types Immunization, Procedure
AdverseEvent
AdverseEvent.identifier
  • Max Cardinality changed from 1 to *
AdverseEvent.actuality AdverseEvent.status
  • Added Mandatory Element
AdverseEvent.category
  • Max Cardinality changed from 1 to * Type changed from code to CodeableConcept Remove Binding `http://hl7.org/fhir/ValueSet/adverse-event-category` (extensible)
AdverseEvent.code
  • Change binding strength Renamed from required event to extensible code
AdverseEvent.event AdverseEvent.effect[x]
  • Added Element
AdverseEvent.subject AdverseEvent.resultingEffect
  • Min Cardinality changed Renamed from 0 resultingCondition to 1 Type Reference: Added Target Types Group, Practitioner, RelatedPerson resultingEffect
  • Type Reference: Removed Target Types ResearchSubject, Medication, Device changed from Reference(Condition) to CodeableReference
AdverseEvent.encounter AdverseEvent.outcome
  • Added Element Max Cardinality changed from 1 to *
  • Remove Binding `http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.0` (required)
AdverseEvent.detected AdverseEvent.participant
  • Added Element
AdverseEvent.recordedDate AdverseEvent.participant.function
  • Added Element
AdverseEvent.resultingCondition AdverseEvent.participant.actor
  • Added Mandatory Element
AdverseEvent.severity AdverseEvent.expectedInResearchStudy
  • Added Element
AdverseEvent.outcome AdverseEvent.suspectEntity.instance
  • Change value set Type changed from http://hl7.org/fhir/ValueSet/adverse-event-outcome Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 CodeableReference
AdverseEvent.recorder AdverseEvent.suspectEntity.causality
  • Type Reference: Added Target Type PractitionerRole Max Cardinality changed from * to 1
AdverseEvent.contributor AdverseEvent.suspectEntity.causality.assessmentMethod
  • Added Element
AdverseEvent.suspectEntity.causality AdverseEvent.suspectEntity.causality.entityRelatedness
  • Max Cardinality changed Renamed from 1 productRelatedness to * entityRelatedness
  • Type changed from code string to BackboneElement Remove Binding http://hl7.org/fhir/ValueSet/adverse-event-causality (required) CodeableConcept
AdverseEvent.suspectEntity.causality.assessment AdverseEvent.suspectEntity.causality.author
  • Type Reference: Added Element Target Types Patient, RelatedPerson
AdverseEvent.suspectEntity.causality.productRelatedness AdverseEvent.suspectEntity.occurrence[x]
  • Added Element
AdverseEvent.suspectEntity.causality.author AdverseEvent.contributingFactor
  • Added Element
AdverseEvent.suspectEntity.causality.method AdverseEvent.preventiveAction
  • Added Element
AdverseEvent.subjectMedicalHistory AdverseEvent.mitigatingAction
  • Type Reference: Added Target Types Media, DocumentReference Element
AdverseEvent.type AdverseEvent.supportingInfo
  • deleted Added Element
AdverseEvent.reaction AdverseEvent.note
  • deleted Added Element
AdverseEvent.eventParticipant AdverseEvent.date
  • deleted Deleted
AdverseEvent.description AdverseEvent.severity
  • deleted Deleted (AdverseEvent.severity is redundant with Condition.severity referenced via AdverseEvent.resultingEffect)
AdverseEvent.suspectEntity.causalityAssessment AdverseEvent.contributor
  • deleted Deleted (-> AdverseEvent.participant.actor)
AdverseEvent.suspectEntity.causalityProductRelatedness AdverseEvent.suspectEntity.causality.assessment
  • deleted Deleted (-> AdverseEvent.suspectEntity.causality.assessmentMethod)
AdverseEvent.suspectEntity.causalityMethod AdverseEvent.suspectEntity.causality.method
  • deleted Deleted (-> AdverseEvent.suspectEntity.causality.assessmentMethod)
AdverseEvent.suspectEntity.causalityAuthor AdverseEvent.subjectMedicalHistory
  • deleted Deleted (-> AdverseEvent.supportingInfo)
AdverseEvent.suspectEntity.causalityResult AdverseEvent.referenceDocument
  • deleted Deleted (-> AdverseEvent.supportingInfo)

See the Full Difference for further information

This analysis is available for R4 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). ) for R4B as XML or JSON .

 

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

9.9.3.1 9.8.4.1 Terminology Bindings

AdverseEvent.actuality AdverseEvent.severity AdverseEvent.outcome AdverseEvent.suspectEntity.causality.assessment AdverseEvent.suspectEntity.causality.method
Path Definition ValueSet Type Reference Documentation
AdverseEvent.status Overall nature of the adverse event, e.g. real or potential. AdverseEventStatus Required

Codes identifying the lifecycle stage of an adverse event.

AdverseEvent.actuality AdverseEventActuality Required

Overall nature of the adverse event, e.g. real or potential.

AdverseEvent.category AdverseEventCategory Example

Overall categorization of the event, e.g. product-related or situational.

AdverseEvent.code AdverseEventType Extensible Example AdverseEventCategory

This value set includes codes that describe the adverse event or incident that occurred or was averted.

AdverseEvent.event AdverseEvent.resultingEffect Detailed type of event. SNOMEDCTClinicalFindings Example SNOMEDCTClinicalFindings

This value set includes all the "Clinical finding" SNOMED CT icon codes - concepts where concept is-a 404684003 (Clinical finding (finding)).

AdverseEvent.seriousness AdverseEventSeriousness Example

Overall seriousness of this event for the patient.

AdverseEvent.outcome AdverseEventOutcome Example AdverseEventSeriousness

This value set includes codes that describe the type of outcome from the adverse event.

AdverseEvent.participant.function The severity of the adverse event itself, in direct relation to the subject. AdverseEventParticipantFunction Required Example AdverseEventSeverity

This value set includes codes that describe the type of involvement of the actor in the adverse event.

AdverseEvent.suspectEntity.causality.assessmentMethod TODO (and should this be required?). AdverseEventCausalityMethod Required Example AdverseEventOutcome

Codes for the method of evaluating the relatedness of the suspected entity to the adverse event

AdverseEvent.suspectEntity.causality.entityRelatedness AdverseEventCausalityAssessment Example

Codes for the assessment of whether the entity caused the event.

AdverseEvent.contributingFactor AdverseEventContributingFactor Example AdverseEventCausalityAssessment

This value set includes codes that describe the contributing factors suspected to have increased the probability or severity of the adverse event.

AdverseEvent.preventiveAction AdverseEventPreventiveAction Example TODO.

This value set includes codes that describe the preventive actions that contributed to avoiding the adverse event.

AdverseEvent.mitigatingAction AdverseEventMitigatingAction Example

This value set includes codes that describe the ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.

AdverseEvent.supportingInfo AdverseEventCausalityMethod AdverseEventSupportingInforation Example

This value set includes codes that describe the supporting information relevant to the event.



9.9.4 9.8.5 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource , and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
actuality token actual | potential AdverseEvent.actuality
category token product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate wrong-patient | wrong-duration procedure-mishap | wrong-time medication-mishap | expired-drug device | medical-device-use-error unsafe-physical-environment | problem-different-manufacturer hospital-aquired-infection | unsafe-physical-environment wrong-body-site AdverseEvent.category
code token date Event or incident that occurred or was averted AdverseEvent.code 19 Resources
effect date When the effect of the event occurred AdverseEvent.date AdverseEvent.effect.ofType(dateTime) | AdverseEvent.effect.ofType(Period)
event identifier token Type of Business identifier for the event itself in relation to the subject AdverseEvent.event AdverseEvent.identifier 58 Resources
location reference Location where adverse event occurred AdverseEvent.location
( Location )
occurrence date When the suspect entity occurred AdverseEvent.suspectEntity.occurrence.ofType(dateTime) | AdverseEvent.suspectEntity.occurrence.ofType(Period)
patient reference Subject impacted by event AdverseEvent.subject.where(resolve() is Patient)
( Patient ) 		60 Resources
recorder reference Who recorded the adverse event AdverseEvent.recorder
( Practitioner , Patient , PractitionerRole , RelatedPerson )
resultingeffect-code token resultingcondition Effect on the subject due to this event AdverseEvent.resultingEffect.concept
resultingeffect-reference reference Effect on the subject due to this event AdverseEvent.resultingCondition ( Condition ) AdverseEvent.resultingEffect.reference
seriousness token Seriousness or gravity of the event AdverseEvent.seriousness
status severity token mild in-progress | moderate completed | severe entered-in-error | unknown AdverseEvent.severity AdverseEvent.status
study reference AdverseEvent.study Research study that the subject is enrolled in AdverseEvent.study
( ResearchStudy )
subject reference Subject impacted by event AdverseEvent.subject
( Practitioner , Group , Patient , RelatedPerson )
substance reference Refers to the specific entity that caused the adverse event AdverseEvent.suspectEntity.instance ( Immunization , Device , Medication , Procedure , Substance , MedicationAdministration , MedicationStatement ) AdverseEvent.suspectEntity.instance.reference