HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot

This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

: Minimum VAERS Bundle - JSON Representation

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{
  "resourceType" : "Bundle",
  "id" : "MinimumVAERSBundle",
  "meta" : {
    "profile" : [
      "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-vaers-bundle"
    ]
  },
  "identifier" : {
    "value" : "BATCH20200210171800-05006510d41d-281d-7610-cd0d-4b07dcc8f49d"
  },
  "type" : "message",
  "timestamp" : "2020-02-10T17:18:00.000-05:00",
  "entry" : [
    {
      "fullUrl" : "Bundle/SampleVAERSMessageHeader",
      "resource" : {
        "resourceType" : "MessageHeader",
        "id" : "US-IBM-VAERS-fad94c04-29e7-5b37-e535-a8aad123cf9a",
        "meta" : {
          "profile" : [
            "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-vaers-messageheader"
          ]
        },
        "text" : {
          "status" : "extensions",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>Message Processing Category</b>: notification</p><p><b>event</b>: <span title=\"{http://terminology.hl7.org/CodeSystem/v3-ActCode PAT_ADV_EVNT}\">Patient Adverse Event</span></p><h3>Destinations</h3><table class=\"grid\"><tr><td>-</td><td><b>Endpoint</b></td></tr><tr><td>*</td><td><a href=\"http://example.org/CBERVAERS\">http://example.org/CBERVAERS</a></td></tr></table><p><b>sender</b>: <a href=\"Organization-SenderOrganization.html\">Generated Summary: active; <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.7 1}\">Pharmaceutical Company</span>; name: sender organization; Phone: +01 123 456 78, Fax: +01 123 456 89, email@city.us</a></p><h3>Sources</h3><table class=\"grid\"><tr><td>-</td><td><b>Endpoint</b></td></tr><tr><td>*</td><td><a href=\"http://example.org/SENDER-IDENTIFIER\">http://example.org/SENDER-IDENTIFIER</a></td></tr></table><p><b>reason</b>: <span title=\"Codes: {http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents received-public-health-report}\">Indicates receipt of a public health report</span></p><p><b>focus</b>: <a href=\"#Composition_SampleVAERSReport\">See above (Composition/SampleVAERSReport)</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/CBERVAERS"
          }
        ],
        "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/SampleVAERSReport"
          }
        ]
      }
    },
    {
      "fullUrl" : "Composition/SampleVAERSReport",
      "resource" : {
        "resourceType" : "Composition",
        "id" : "SampleVAERSReport",
        "meta" : {
          "profile" : [
            "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition"
          ]
        },
        "text" : {
          "status" : "extensions",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><blockquote><p><b>AdditionalDocumentInformation</b></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>ExpeditedReport</b></p><p><b>value</b>: false</p><p><b>value</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.1003 C53578}\">Non-Expedited AE</span></p></blockquote><p><b>FirstSenderType</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.3 2}\">Other</span></p><p><b>CombinationProductReport</b>: false</p><p><b>FirstReceiveDate</b>: Feb 10, 2020 10:18:00 PM</p><p><b>MostRecentDate</b>: Feb 10, 2020 10:18:00 PM</p><p><b>CaseIdentifier</b>: id: US-IBM-aed059ac-ef25-6ded-cce2-a8912d6b76ee</p><p><b>PreviousCaseIdentifier</b>: id: Other-case-identifier</p><blockquote><p><b>ReportAmendment</b></p><p><b>value</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.5 2}\">2</span></p><p><b>value</b>: Fixed some identifiers</p></blockquote><p><b>identifier</b>: id: US-IBM-94209fd1-9b0e-1adc-007a-4f5cecb8ce6a</p><p><b>status</b>: final</p><p><b>type</b>: <span title=\"Codes: {http://loinc.org 85893-6}\">Adverse event note</span></p><p><b>category</b>: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.2 1}\">Spontaneous report</span></p><p><b>date</b>: Feb 10, 2020 10:18:00 PM</p><p><b>author</b>: <a href=\"PractitionerRole-SampleAuthorRole.html\">Generated Summary: <span title=\"Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}\">Physician</span>; joe@anywhere.com</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/ibm-fda-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/ibm-fda-icsr-ext-expeditedreport"
          },
          {
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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/ibm-fda-icsr-ext-combinationproductreport",
            "valueBoolean" : false
          },
          {
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate",
            "valueDateTime" : "2020-02-10T17:18:00-05:00"
          },
          {
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate",
            "valueDateTime" : "2020-02-10T17:18:00-05:00"
          },
          {
            "url" : "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-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/ibm-fda-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/ibm-fda-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/ibm-fda-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>"
            }
          }
        ]
      }
    }
  ]
}