Release 5 Ballot
Clinical SummaryThis page is part of the FHIR Specification (v5.0.0-ballot: R5 Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B R4 R3
| Patient Care Work Group | Maturity Level: 0 | Trial Use | Security Category: Patient | Compartments: Patient, Practitioner, RelatedPerson |
An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research subject. The unintended effects may require additional monitoring, treatment, hospitalization, or 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. Given the differences between these two arenas, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.
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 and Clinical Research adverse events 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. 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 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 (although they might not be known at the time of the event), severity, and outcome.
The context of an adverse event is also important. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause-and-effect relationship for an adverse event.
In clinical care, a potential adverse event may also be called a near miss or an error. These are also events but, since 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.
For examples and further guidance, it is strongly suggested that an implementer consult the Clinical Care AdverseEvent Implementation Guide and the Clinical Research AdverseEvent Implementation Guide
They contain valuable extensions, value sets and, importantly, examples.
The AdverseEvent resource is designed to represent events that 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, 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 such as Observation, Condition, 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, an 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.
No references for this Resource.
Structure
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  AdverseEvent | 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..* | Identifier | Business identifier for the event |
 status | ?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Adverse Event Status (Required) |
| actuality | ?!Σ | 1..1 | code | actual | potential AdverseEventActuality (Required) |
| category | Σ | 0..* | CodeableConcept | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site AdverseEventCategory (Example) |
| code | Σ | 0..1 | CodeableConcept | Event or incident that occurred or was averted AdverseEvent Type (Example) |
 subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Subject 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 | |||
| detected | Σ | 0..1 | dateTime | When the event was detected |
| recordedDate | Σ | 0..1 | dateTime | When the event was recorded |
| resultingCondition | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event |
| location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred |
| seriousness | Σ | 0..1 | CodeableConcept | Seriousness or gravity of the event AdverseEventSeriousness (Example) |
| outcome | Σ | 0..* | CodeableConcept | Type of outcome from the adverse event AdverseEvent Outcome (Example) |
| recorder | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Who recorded the adverse event |
 participant | Σ | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did |
| function | Σ | 0..1 | CodeableConcept | Type of involvement AdverseEvent Participant Function (Example) |
| actor | Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | 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[x] | Σ | 1..1 | Refers to the specific entity that caused the adverse event | |
| instanceCodeableConcept | CodeableConcept | |||
| instanceReference | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationUsage | Device | BiologicallyDerivedProduct | ResearchStudy) | |||
 causality | Σ | 0..1 | BackboneElement | 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 AdverseEventCausalityMethod (Example) |
| entityRelatedness | Σ | 0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event AdverseEventCausalityAssessment (Example) |
| author | Σ | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event |
| contributingFactor | Σ | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse event |
| item[x] | Σ | 1..1 | Item suspected to have increased the probability or severity of the adverse event AdverseEvent Contributing Factor (Example) | |
| itemReference | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DocumentReference | MedicationAdministration | MedicationUsage) | |||
| itemCodeableConcept | CodeableConcept | |||
| preventiveAction | Σ | 0..* | BackboneElement | Preventive actions that contributed to avoiding the adverse event |
| item[x] | Σ | 1..1 | Action that contributed to avoiding the adverse event AdverseEvent Preventive Action (Example) | |
| itemReference | Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||
| itemCodeableConcept | CodeableConcept | |||
| mitigatingAction | Σ | 0..* | BackboneElement | Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm |
| 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) | |
| 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 | MedicationAdministration | MedicationUsage) | |||
| itemCodeableConcept | CodeableConcept | |||
| note | Σ | 0..* | Annotation | Comment on adverse event |
| Documentation for this format | ||||
See the Extensions for this resource
UML Diagram (Legend)
XML Template
<AdverseEvent xmlns="http://hl7.org/fhir"><!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <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| ResearchSubject) 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><!-- 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|ResearchSubject) 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|ResearchSubject) 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[x]><!-- 1..1 CodeableConcept|Reference(BiologicallyDerivedProduct| Device|Immunization|Medication|MedicationAdministration|MedicationUsage| Procedure|ResearchStudy|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|ResearchSubject) Author of the information on the possible cause of the event --></author> </causality> </suspectEntity> <contributingFactor> <!-- 0..* Contributing factors suspected to have increased the probability or severity of the adverse event --> <item[x]><!-- 1..1 Reference(AllergyIntolerance|Condition|Device| DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration| MedicationUsage|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|MedicationAdministration|MedicationUsage| Observation|Procedure)|CodeableConcept Subject medical history or document relevant to this adverse event --></item[x]> </supportingInfo> <note><!-- 0..* Annotation Comment on adverse event --></note> </AdverseEvent>
JSON Template
{
"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|
ResearchSubject) }, // 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|ResearchSubject) }, // 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|ResearchSubject) } // 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[x]: Refers to the specific entity that caused the adverse event. One of these 2:
"instanceCodeableConcept" : { CodeableConcept },
"instanceReference" : { Reference(BiologicallyDerivedProduct|Device|Immunization|
Medication|MedicationAdministration|MedicationUsage|Procedure|ResearchStudy|
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|ResearchSubject) } // 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|Device|
DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration|
MedicationUsage|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|MedicationAdministration|MedicationUsage|
Observation|Procedure) },
"itemCodeableConcept" : { CodeableConcept }
}],
"note" : [{ Annotation }] // Comment on adverse event
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes since R4
| AdverseEvent | |
| AdverseEvent.identifier |
|
| AdverseEvent.status |
|
| AdverseEvent.category |
|
| AdverseEvent.code |
|
| AdverseEvent.subject |
|
| AdverseEvent.occurrence[x] |
|
| AdverseEvent.outcome |
|
| AdverseEvent.recorder |
|
| AdverseEvent.participant |
|
| AdverseEvent.participant.function |
|
| AdverseEvent.participant.actor |
|
| AdverseEvent.expectedInResearchStudy |
|
| AdverseEvent.suspectEntity.instance[x] |
|
| AdverseEvent.suspectEntity.causality |
|
| AdverseEvent.suspectEntity.causality.assessmentMethod |
|
| AdverseEvent.suspectEntity.causality.entityRelatedness |
|
| AdverseEvent.suspectEntity.causality.author |
|
| AdverseEvent.contributingFactor |
|
| AdverseEvent.contributingFactor.item[x] |
|
| AdverseEvent.preventiveAction |
|
| AdverseEvent.preventiveAction.item[x] |
|
| AdverseEvent.mitigatingAction |
|
| AdverseEvent.mitigatingAction.item[x] |
|
| AdverseEvent.supportingInfo |
|
| AdverseEvent.supportingInfo.item[x] |
|
| AdverseEvent.note |
|
| AdverseEvent.event |
|
| AdverseEvent.date |
|
| AdverseEvent.severity |
|
| AdverseEvent.contributor |
|
| AdverseEvent.suspectEntity.instance |
|
| AdverseEvent.suspectEntity.causality.assessment |
|
| AdverseEvent.suspectEntity.causality.productRelatedness |
|
| AdverseEvent.suspectEntity.causality.method |
|
| AdverseEvent.subjectMedicalHistory |
|
| AdverseEvent.referenceDocument |
|
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 |
|---|---|---|---|---|
| AdverseEvent | 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..* | Identifier | Business identifier for the event |
| status | ?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Adverse Event Status (Required) |
| actuality | ?!Σ | 1..1 | code | actual | potential AdverseEventActuality (Required) |
| category | Σ | 0..* | CodeableConcept | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site AdverseEventCategory (Example) |
| code | Σ | 0..1 | CodeableConcept | Event or incident that occurred or was averted AdverseEvent Type (Example) |
| subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Subject 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 | |||
| detected | Σ | 0..1 | dateTime | When the event was detected |
| recordedDate | Σ | 0..1 | dateTime | When the event was recorded |
| resultingCondition | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event |
| location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred |
| seriousness | Σ | 0..1 | CodeableConcept | Seriousness or gravity of the event AdverseEventSeriousness (Example) |
| outcome | Σ | 0..* | CodeableConcept | Type of outcome from the adverse event AdverseEvent Outcome (Example) |
| recorder | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Who recorded the adverse event |
| participant | Σ | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did |
| function | Σ | 0..1 | CodeableConcept | Type of involvement AdverseEvent Participant Function (Example) |
| actor | Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | 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[x] | Σ | 1..1 | Refers to the specific entity that caused the adverse event | |
| instanceCodeableConcept | CodeableConcept | |||
| instanceReference | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationUsage | Device | BiologicallyDerivedProduct | ResearchStudy) | |||
| causality | Σ | 0..1 | BackboneElement | 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 AdverseEventCausalityMethod (Example) |
| entityRelatedness | Σ | 0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event AdverseEventCausalityAssessment (Example) |
| author | Σ | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event |
| contributingFactor | Σ | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse event |
| item[x] | Σ | 1..1 | Item suspected to have increased the probability or severity of the adverse event AdverseEvent Contributing Factor (Example) | |
| itemReference | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DocumentReference | MedicationAdministration | MedicationUsage) | |||
| itemCodeableConcept | CodeableConcept | |||
| preventiveAction | Σ | 0..* | BackboneElement | Preventive actions that contributed to avoiding the adverse event |
| item[x] | Σ | 1..1 | Action that contributed to avoiding the adverse event AdverseEvent Preventive Action (Example) | |
| itemReference | Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||
| itemCodeableConcept | CodeableConcept | |||
| mitigatingAction | Σ | 0..* | BackboneElement | Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm |
| 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) | |
| 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 | MedicationAdministration | MedicationUsage) | |||
| itemCodeableConcept | CodeableConcept | |||
| note | Σ | 0..* | Annotation | Comment on adverse event |
| Documentation for this format | ||||
See the Extensions for this resource
XML Template
<AdverseEvent xmlns="http://hl7.org/fhir">
JSON Template
{
"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|
ResearchSubject) }, // 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|ResearchSubject) }, // 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|ResearchSubject) } // 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[x]: Refers to the specific entity that caused the adverse event. One of these 2:
"instanceCodeableConcept" : { CodeableConcept },
"instanceReference" : { Reference(BiologicallyDerivedProduct|Device|Immunization|
Medication|MedicationAdministration|MedicationUsage|Procedure|ResearchStudy|
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|ResearchSubject) } // 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|Device|
DocumentReference|FamilyMemberHistory|Immunization|MedicationAdministration|
MedicationUsage|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|MedicationAdministration|MedicationUsage|
Observation|Procedure) },
"itemCodeableConcept" : { CodeableConcept }
}],
"note" : [{ Annotation }] // Comment on adverse event
}
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> .
Changes since Release 4
| AdverseEvent | |
| AdverseEvent.identifier |
|
| AdverseEvent.status |
|
| AdverseEvent.category |
|
| AdverseEvent.code |
|
| AdverseEvent.subject |
|
| AdverseEvent.occurrence[x] |
|
| AdverseEvent.outcome |
|
| AdverseEvent.recorder |
|
| AdverseEvent.participant |
|
| AdverseEvent.participant.function |
|
| AdverseEvent.participant.actor |
|
| AdverseEvent.expectedInResearchStudy |
|
| AdverseEvent.suspectEntity.instance[x] |
|
| AdverseEvent.suspectEntity.causality |
|
| AdverseEvent.suspectEntity.causality.assessmentMethod |
|
| AdverseEvent.suspectEntity.causality.entityRelatedness |
|
| AdverseEvent.suspectEntity.causality.author |
|
| AdverseEvent.contributingFactor |
|
| AdverseEvent.contributingFactor.item[x] |
|
| AdverseEvent.preventiveAction |
|
| AdverseEvent.preventiveAction.item[x] |
|
| AdverseEvent.mitigatingAction |
|
| AdverseEvent.mitigatingAction.item[x] |
|
| AdverseEvent.supportingInfo |
|
| AdverseEvent.supportingInfo.item[x] |
|
| AdverseEvent.note |
|
| AdverseEvent.event |
|
| AdverseEvent.date |
|
| AdverseEvent.severity |
|
| AdverseEvent.contributor |
|
| AdverseEvent.suspectEntity.instance |
|
| AdverseEvent.suspectEntity.causality.assessment |
|
| AdverseEvent.suspectEntity.causality.productRelatedness |
|
| AdverseEvent.suspectEntity.causality.method |
|
| AdverseEvent.subjectMedicalHistory |
|
| AdverseEvent.referenceDocument |
|
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).)
Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis
| Path | Definition | Type | Reference |
|---|---|---|---|
| AdverseEvent.status | Codes identifying the lifecycle stage of an adverse event. | Required | AdverseEventStatus |
| AdverseEvent.actuality | Overall nature of the adverse event, e.g. real or potential. | Required | AdverseEventActuality |
| AdverseEvent.category | Overall categorization of the event, e.g. product-related or situational. | Example | AdverseEventCategory |
| AdverseEvent.code | This value set includes codes that describe the adverse event or incident that occurred or was averted. | Example | AdverseEvent Type |
| AdverseEvent.seriousness | Overall seriousness of this event for the patient. | Example | AdverseEventSeriousness |
| AdverseEvent.outcome | This value set includes codes that describe the type of outcome from the adverse event. | Example | AdverseEvent Outcome |
| AdverseEvent.participant.function | This value set includes codes that describe the type of involvement of the actor in the adverse event. | Example | AdverseEvent Participant Function |
| AdverseEvent.suspectEntity.causality.assessmentMethod | TODO. | Example | AdverseEventCausalityMethod |
| AdverseEvent.suspectEntity.causality.entityRelatedness | Codes for the assessment of whether the entity caused the event. | Example | AdverseEventCausalityAssessment |
| AdverseEvent.contributingFactor.item[x] | This value set includes codes that describe the contributing factors suspected to have increased the probability or severity of the adverse event. | Example | AdverseEvent Contributing Factor |
| AdverseEvent.preventiveAction.item[x] | This value set includes codes that describe the preventive actions that contributed to avoiding the adverse event. | Example | AdverseEvent Preventive Action |
| AdverseEvent.mitigatingAction.item[x] | This value set includes codes that describe 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] | This value set includes codes that describe 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.
| Name | Type | Description | Expression | In Common |
| actuality N | token | actual | potential | AdverseEvent.actuality | |
| category | token | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site | AdverseEvent.category | |
| code | token | Event or incident that occurred or was averted | AdverseEvent.code | |
| date | date | When the event occurred | AdverseEvent.occurrence | |
| identifier | token | Business identifier for the event | AdverseEvent.identifier | |
| location | reference | Location where adverse event occurred | AdverseEvent.location (Location) | |
| patient | reference | Subject impacted by event | AdverseEvent.subject (Practitioner, Group, Patient, ResearchSubject, RelatedPerson) | |
| recorder | reference | Who recorded the adverse event | AdverseEvent.recorder (Practitioner, Patient, PractitionerRole, ResearchSubject, RelatedPerson) | |
| resultingcondition | reference | Effect on the subject due to this event | AdverseEvent.resultingCondition (Condition) | |
| seriousness | token | Seriousness or gravity of the event | AdverseEvent.seriousness | |
| status N | token | in-progress | completed | entered-in-error | unknown | AdverseEvent.status | |
| study | reference | Research study that the subject is enrolled in | AdverseEvent.study (ResearchStudy) | |
| subject | reference | Subject impacted by event | AdverseEvent.subject (Practitioner, Group, Patient, ResearchSubject, RelatedPerson) | |
| substance | reference | Refers to the specific entity that caused the adverse event | (AdverseEvent.suspectEntity.instance as Reference) (Immunization, BiologicallyDerivedProduct, Device, Medication, Procedure, Substance, MedicationAdministration, MedicationUsage, ResearchStudy) |
FHIR ®© HL7.org 2011+. FHIR R5 Ballot hl7.fhir.core#5.0.0-ballot generated on Sat, Sep 10, 2022 05:01+1000.
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