HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
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HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting, published by Biomedical Research & Regulation WG. This is not an authorized publication; it is the continuous build for version 1.0.1). This version is based on the current content of https://github.com/HL7/fhir-icsr-ae-reporting/ and changes regularly. See the Directory of published versions

: Minimum Vaccination Case Report Bundle - JSON Representation

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{
  "resourceType" : "Bundle",
  "id" : "MinimumVaccinationReportBundle",
  "meta" : {
    "profile" : [
      "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bundle"
    ]
  },
  "identifier" : {
    "value" : "BATCH20200210171800-05006510d41d-281d-7610-cd0d-4b07dcc8f49d"
  },
  "type" : "message",
  "timestamp" : "2020-02-10T17:18:00.000-05:00",
  "entry" : [
    {
      "fullUrl" : "Bundle/SampleVaccinationMessageHeader",
      "resource" : {
        "resourceType" : "MessageHeader",
        "id" : "US-IBM-Vaccination-fad94c04-29e7-5b37-e535-a8aad123cf9a",
        "meta" : {
          "profile" : [
            "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageheader"
          ]
        },
        "text" : {
          "status" : "extensions",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MessageHeader</b><a name=\"US-IBM-Vaccination-fad94c04-29e7-5b37-e535-a8aad123cf9a\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource MessageHeader &quot;US-IBM-Vaccination-fad94c04-29e7-5b37-e535-a8aad123cf9a&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-messageheader.html\">ICSR MessageHeader</a></p></div><p><b>Message Processing Category</b>: notification</p><p><b>event</b>: Patient Adverse Event (Details: http://terminology.hl7.org/CodeSystem/v3-ActCode code PAT_ADV_EVNT = 'patient adverse event', stated as 'Patient Adverse Event')</p><h3>Destinations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Endpoint</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"http://example.org/CBERVaccination\">http://example.org/CBERVaccination</a></td></tr></table><p><b>sender</b>: <a href=\"Organization-SenderOrganization.html\">Organization/SenderOrganization</a> &quot;sender organization&quot;</p><h3>Sources</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Endpoint</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"http://example.org/SENDER-IDENTIFIER\">http://example.org/SENDER-IDENTIFIER</a></td></tr></table><p><b>reason</b>: Indicates receipt of a public health report <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/us/medmorph/2021Jan/CodeSystem-us-ph-triggerdefinition-namedevents.html\">US Public Health TriggerDefinition Named Events</a>#received-public-health-report)</span></p><p><b>focus</b>: <a href=\"#Composition_SampleVaccinationReport\">See above (Composition/SampleVaccinationReport)</a></p></div>"
        },
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/us/medmorph/StructureDefinition/ext-messageProcessingCategory",
            "valueCode" : "notification"
          }
        ],
        "eventCoding" : {
          "system" : "http://terminology.hl7.org/CodeSystem/v3-ActCode",
          "code" : "PAT_ADV_EVNT",
          "display" : "Patient Adverse Event"
        },
        "destination" : [
          {
            "endpoint" : "http://example.org/CBERVaccination"
          }
        ],
        "sender" : {
          "reference" : "Organization/SenderOrganization"
        },
        "source" : {
          "endpoint" : "http://example.org/SENDER-IDENTIFIER"
        },
        "reason" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents",
              "code" : "received-public-health-report"
            }
          ]
        },
        "focus" : [
          {
            "reference" : "Composition/SampleVaccinationReport"
          }
        ]
      }
    },
    {
      "fullUrl" : "Composition/SampleVaccinationReport",
      "resource" : {
        "resourceType" : "Composition",
        "id" : "SampleVaccinationReport",
        "meta" : {
          "profile" : [
            "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition"
          ]
        },
        "text" : {
          "status" : "extensions",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Composition</b><a name=\"SampleVaccinationReport\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Composition &quot;SampleVaccinationReport&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-icsr-composition.html\">ICSR Composition</a></p></div><blockquote><p><b>AdditionalDocumentInformation</b></p><blockquote><p><b>url</b></p><code>availableFlag</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>ExpeditedReport</b></p><blockquote><p><b>url</b></p><code>localCriteriaFlag</code></blockquote><p><b>value</b>: false</p><blockquote><p><b>url</b></p><code>localCriteriaReportType</code></blockquote><p><b>value</b>: Non-Expedited AE <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#C53578)</span></p></blockquote><p><b>FirstSenderType</b>: Other <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#2)</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: 2020-02-10 17:18:00-0500</p><p><b>MostRecentDate</b>: 2020-02-10 17:18:00-0500</p><p><b>CaseIdentifier</b>: id:\u00a0US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee</p><p><b>PreviousCaseIdentifier</b>: id:\u00a0Other-case-identifier</p><blockquote><p><b>ReportAmendment</b></p><blockquote><p><b>url</b></p><code>amendmentType</code></blockquote><p><b>value</b>: 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#2)</span></p><blockquote><p><b>url</b></p><code>amendmentReason</code></blockquote><p><b>value</b>: Fixed some identifiers</p></blockquote><p><b>identifier</b>: id:\u00a0US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a</p><p><b>status</b>: final</p><p><b>type</b>: Adverse event note <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://loinc.org/\">LOINC</a>#85893-6)</span></p><p><b>category</b>: Spontaneous report <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#1)</span></p><p><b>date</b>: 2020-02-10 17:18:00-0500</p><p><b>author</b>: <a href=\"PractitionerRole-SampleAuthorRole.html\">PractitionerRole/SampleAuthorRole</a></p><p><b>title</b>: ICSR Submission</p></div>"
        },
        "extension" : [
          {
            "extension" : [
              {
                "url" : "availableFlag",
                "valueBoolean" : false
              }
            ],
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation"
          },
          {
            "extension" : [
              {
                "url" : "localCriteriaFlag",
                "valueBoolean" : false
              },
              {
                "url" : "localCriteriaReportType",
                "valueCodeableConcept" : {
                  "coding" : [
                    {
                      "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.1003",
                      "code" : "C53578",
                      "display" : "Non-Expedited AE"
                    }
                  ]
                }
              }
            ],
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-expeditedreport"
          },
          {
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstsendertype",
            "valueCodeableConcept" : {
              "coding" : [
                {
                  "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.3",
                  "code" : "2",
                  "display" : "Other"
                }
              ]
            }
          },
          {
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport",
            "valueBoolean" : false
          },
          {
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate",
            "valueDateTime" : "2020-02-10T17:18:00-05:00"
          },
          {
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate",
            "valueDateTime" : "2020-02-10T17:18:00-05:00"
          },
          {
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-caseidentifier",
            "valueIdentifier" : {
              "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.2",
              "value" : "US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee"
            }
          },
          {
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-previouscaseidentifier",
            "valueIdentifier" : {
              "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.3",
              "value" : "Other-case-identifier",
              "assigner" : {
                "display" : "Case identifier source name"
              }
            }
          },
          {
            "extension" : [
              {
                "url" : "amendmentType",
                "valueCodeableConcept" : {
                  "coding" : [
                    {
                      "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.5",
                      "code" : "2"
                    }
                  ]
                }
              },
              {
                "url" : "amendmentReason",
                "valueString" : "Fixed some identifiers"
              }
            ],
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-reportamendment"
          }
        ],
        "identifier" : {
          "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.3.1",
          "value" : "US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a"
        },
        "status" : "final",
        "type" : {
          "coding" : [
            {
              "system" : "http://loinc.org",
              "code" : "85893-6",
              "display" : "Adverse event note"
            }
          ]
        },
        "category" : [
          {
            "coding" : [
              {
                "system" : "urn:oid:2.16.840.1.113883.3.989.2.1.1.2",
                "code" : "1",
                "display" : "Spontaneous report"
              }
            ]
          }
        ],
        "subject" : {
          "reference" : "Patient/SampleICSRPatient"
        },
        "date" : "2020-02-10T17:18:00-05:00",
        "author" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource",
                "valueBoolean" : true
              }
            ],
            "reference" : "PractitionerRole/SampleAuthorRole"
          }
        ],
        "title" : "ICSR Submission",
        "section" : [
          {
            "title" : "Reaction/Event",
            "code" : {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
                  "code" : "ReactionEvent"
                }
              ]
            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">No events</div>"
            }
          },
          {
            "title" : "Drug Information",
            "code" : {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
                  "code" : "DrugInformation"
                }
              ]
            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">No drugs taken</div>"
            }
          },
          {
            "title" : "Case Summary Narrative",
            "code" : {
              "coding" : [
                {
                  "system" : "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
                  "code" : "CaseSummaryNarrative"
                }
              ]
            },
            "text" : {
              "status" : "generated",
              "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div>No adverse event happened. Not sure why I'm sending this report.</div><div lang=\"fr\">il n'y a eu aucun événement indésirable</div></div>"
            }
          }
        ]
      }
    }
  ]
}