# US Quality Core AdverseEvent - US Quality Core Implementation Guide v0.1.0

* [**Table of Contents**](toc.md)
* [**Artifacts Summary**](artifacts.md)
* **US Quality Core AdverseEvent**

## Resource Profile: US Quality Core AdverseEvent 

| | |
| :--- | :--- |
| *Official URL*:http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-adverseevent | *Version*:0.1.0 |
| Active as of 2026-03-31 | *Computable Name*:USQualityCoreAdverseEvent |

 
An adverse event (AE) is an untoward occurrence during treatment that should be reported, for example, to a clinical study sponsor or safety oversight organization. AEs include reportable serious medical errors such as those defined by National Quality Forum (see http://www.qualityforum.org/Topics/ SREs/List_of_SREs.aspx), and Patient Safety Healthcare Events as defined by AHRQ. Some AEs can involve conditions such as "recurring headaches" but others do not, such as accidental falls, surgical errors, sexual abuse of patient, and sudden death. An adverse event can also be an unsafe condition that increases the probability of a patient safety event, and near-misses. An adverse event can be caused by exposure to some agent (e.g., a medication, immunization, food, or environmental agent). An adverse reaction can range from a mild reaction, such as a harmless rash to a severe and life-threatening condition. They can occur immediately or develop over time. For example, a patient may develop a rash after taking a particular medication. 

**Usage**
  See the [patterns](patterns.md) page for implementation and usage patterns.  

### Examples

 

| |
| :--- |
| [Mild Rash Example](AdverseEvent-example.md) |

 

**USCDI+ Quality Elements:**

* category: (USCDI+ Quality) product-problem \| product-quality \| product-use-error \| wrong-dose \| incorrect-prescribing-information \| wrong-technique \| wrong-route-of-administration \| wrong-rate \| wrong-duration \| wrong-time \| expired-drug \| medical-device-use-error \| problem-different-manufacturer \| unsafe-physical-environment
* event: (USCDI+ Quality) Type of the event itself in relation to the subject
* date: (USCDI+ Quality)
* detected: (USCDI+ Quality) When the event was detected
* recordedDate: (USCDI+ Quality) When the event was recorded
* suspectEntity.instance: (USCDI+ Quality) Refers to the specific entity that caused the adverse event

**Usages:**

* Examples for this Profile: [AdverseEvent/example](AdverseEvent-example.md)
* CapabilityStatements using this Profile: [US Quality Core Client CapabilityStatement](CapabilityStatement-us-quality-core-client.md) and [US Quality Core Server CapabilityStatement](CapabilityStatement-us-quality-core-server.md)

You can also check for [usages in the FHIR IG Statistics](https://packages2.fhir.org/xig/fhir.astp.us-quality-core|current/StructureDefinition/us-quality-core-adverseevent)

### Formal Views of Profile Content

 [Description of Profiles, Differentials, Snapshots and how the different presentations work](http://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#structure-definitions). 

 

Other representations of profile: [CSV](StructureDefinition-us-quality-core-adverseevent.csv), [Excel](StructureDefinition-us-quality-core-adverseevent.xlsx), [Schematron](StructureDefinition-us-quality-core-adverseevent.sch) 



## Resource Content

```json
{
  "resourceType" : "StructureDefinition",
  "id" : "us-quality-core-adverseevent",
  "url" : "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-adverseevent",
  "version" : "0.1.0",
  "name" : "USQualityCoreAdverseEvent",
  "title" : "US Quality Core AdverseEvent",
  "status" : "active",
  "experimental" : false,
  "date" : "2026-03-31",
  "publisher" : "ASTP",
  "contact" : [{
    "telecom" : [{
      "system" : "url",
      "value" : "https://www.healthit.gov/"
    }]
  }],
  "description" : "An adverse event (AE) is an untoward occurrence during treatment that should be reported, for example, to a clinical study sponsor or safety oversight organization.  AEs include reportable serious medical errors such as those defined by National Quality Forum (see http://www.qualityforum.org/Topics/ SREs/List_of_SREs.aspx), and Patient Safety Healthcare Events as defined by AHRQ.  Some AEs can involve conditions such as \"recurring headaches\" but others do not, such as accidental falls, surgical errors, sexual abuse of patient, and sudden death. An adverse event can also be an unsafe condition that increases the probability of a patient safety event, and near-misses. An adverse event can be caused by exposure to some agent (e.g., a medication, immunization, food, or environmental agent). An adverse reaction can range from a mild reaction, such as a harmless rash to a severe and life-threatening condition. They can occur immediately or develop over time. For example, a patient may develop a rash after taking a particular medication.",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "urn:iso:std:iso:3166",
      "code" : "US",
      "display" : "United States of America"
    }],
    "text" : "USA"
  }],
  "fhirVersion" : "4.0.1",
  "mapping" : [{
    "identity" : "w5",
    "uri" : "http://hl7.org/fhir/fivews",
    "name" : "FiveWs Pattern Mapping"
  },
  {
    "identity" : "rim",
    "uri" : "http://hl7.org/v3",
    "name" : "RIM Mapping"
  }],
  "kind" : "resource",
  "abstract" : false,
  "type" : "AdverseEvent",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/AdverseEvent",
  "derivation" : "constraint",
  "differential" : {
    "element" : [{
      "id" : "AdverseEvent",
      "path" : "AdverseEvent"
    },
    {
      "id" : "AdverseEvent.actuality",
      "path" : "AdverseEvent.actuality",
      "short" : "actual | potential"
    },
    {
      "id" : "AdverseEvent.category",
      "extension" : [{
        "url" : "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/uscdiplusquality",
        "valueBoolean" : true
      }],
      "path" : "AdverseEvent.category",
      "short" : "(USCDI+ Quality) product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment"
    },
    {
      "id" : "AdverseEvent.event",
      "extension" : [{
        "url" : "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/uscdiplusquality",
        "valueBoolean" : true
      }],
      "path" : "AdverseEvent.event",
      "short" : "(USCDI+ Quality) Type of the event itself in relation to the subject",
      "min" : 1,
      "max" : "1",
      "binding" : {
        "strength" : "preferred",
        "description" : "Detailed type of event.",
        "valueSet" : "http://hl7.org/fhir/ValueSet/adverse-event-type"
      }
    },
    {
      "id" : "AdverseEvent.subject",
      "path" : "AdverseEvent.subject",
      "short" : "Subject impacted by event",
      "min" : 1,
      "max" : "1",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-patient",
        "http://hl7.org/fhir/StructureDefinition/Group",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-practitioner",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-relatedperson"]
      }]
    },
    {
      "id" : "AdverseEvent.encounter",
      "path" : "AdverseEvent.encounter",
      "short" : "Encounter created as part of",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-encounter"]
      }]
    },
    {
      "id" : "AdverseEvent.date",
      "extension" : [{
        "url" : "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/uscdiplusquality",
        "valueBoolean" : true
      }],
      "path" : "AdverseEvent.date",
      "short" : "(USCDI+ Quality)",
      "mustSupport" : false
    },
    {
      "id" : "AdverseEvent.detected",
      "extension" : [{
        "url" : "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/uscdiplusquality",
        "valueBoolean" : true
      }],
      "path" : "AdverseEvent.detected",
      "short" : "(USCDI+ Quality) When the event was detected"
    },
    {
      "id" : "AdverseEvent.recordedDate",
      "extension" : [{
        "url" : "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/uscdiplusquality",
        "valueBoolean" : true
      }],
      "path" : "AdverseEvent.recordedDate",
      "short" : "(USCDI+ Quality) When the event was recorded"
    },
    {
      "id" : "AdverseEvent.resultingCondition",
      "path" : "AdverseEvent.resultingCondition",
      "short" : "Effect on the subject due to this event",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-condition-problems-health-concerns",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-condition-encounter-diagnosis"]
      }]
    },
    {
      "id" : "AdverseEvent.location",
      "path" : "AdverseEvent.location",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-location"]
      }],
      "mustSupport" : false
    },
    {
      "id" : "AdverseEvent.seriousness",
      "path" : "AdverseEvent.seriousness",
      "short" : "Seriousness of the event"
    },
    {
      "id" : "AdverseEvent.recorder",
      "path" : "AdverseEvent.recorder",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-patient",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-relatedperson",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-practitioner",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-practitionerrole"]
      }],
      "mustSupport" : false
    },
    {
      "id" : "AdverseEvent.contributor",
      "path" : "AdverseEvent.contributor",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-practitioner",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-practitionerrole",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-device",
        "http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device"]
      }],
      "mustSupport" : false
    },
    {
      "id" : "AdverseEvent.suspectEntity",
      "path" : "AdverseEvent.suspectEntity",
      "mustSupport" : false
    },
    {
      "id" : "AdverseEvent.suspectEntity.instance",
      "extension" : [{
        "url" : "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/uscdiplusquality",
        "valueBoolean" : true
      }],
      "path" : "AdverseEvent.suspectEntity.instance",
      "short" : "(USCDI+ Quality) Refers to the specific entity that caused the adverse event",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-immunization",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-procedure",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-substance",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-medication",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-medicationadministration",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-medicationstatement",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-device",
        "http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device"]
      }]
    },
    {
      "id" : "AdverseEvent.suspectEntity.causality",
      "path" : "AdverseEvent.suspectEntity.causality",
      "min" : 0,
      "max" : "1",
      "mustSupport" : false
    },
    {
      "id" : "AdverseEvent.subjectMedicalHistory",
      "path" : "AdverseEvent.subjectMedicalHistory",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-simple-observation",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-allergyintolerance",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-familymemberhistory",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-immunization",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-procedure",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-condition-problems-health-concerns",
        "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-condition-encounter-diagnosis"]
      }],
      "mustSupport" : false
    }]
  }
}

```
