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Narrative

Note: links and images are rebased to the (stated) source

Source1

{
  "resourceType": "Composition",
  "id": "VaccinationExample",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "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": "2",
                "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": "1",
            "display": "Regulator"
          }
        ]
      }
    },
    {
      "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": "2021-01-05"
    },
    {
      "url": "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate",
      "valueDateTime": "2021-01-05"
    },
    {
      "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-e380bc14-2a03-7b64-c3f5-22daea2aa495"
      }
    }
  ],
  "identifier": {
    "system": "urn:oid:2.16.840.1.113883.3.989.2.1.3.1",
    "value": "US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"
  },
  "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/VaccinationPatient"
  },
  "date": "2021-01-05T14:24:44+05:00",
  "author": [
    {
      "extension": [
        {
          "url": "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-authorprimarysource",
          "valueBoolean": true
        }
      ],
      "reference": "PractitionerRole/VaccinationAuthorRole"
    }
  ],
  "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\">Developed acute facial nerve paralysis after ED administration of influenza vaccine</div>"
      },
      "entry": [
        {
          "reference": "AdverseEvent/VaccinationExampleEvent"
        }
      ]
    },
    {
      "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\">ED administration of influenza vaccine</div>"
      },
      "entry": [
        {
          "reference": "Immunization/VaccinationExampleImmunization"
        },
        {
          "reference": "MedicationAdministration/VaccinationHydrocortisoneAdministration"
        }
      ]
    },
    {
      "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\">Header: FDA CBER BEST Automated AE Reporting Prototype Case BEST Detection Phenotype Algorithm: sharepoint link BEST Certainty: Definite BEST Severity: Non-Severe BEST Causality: Probable Onset location for reaction: Preliminary investigation results: Developed acute facial nerve paralysis after ED administration of influenza vaccine; Reaction Type: vax_bells_palsy; Illness at Time of Vaccination: 1. illness, Problem, Chronic systolic (congestive) heart failure, Date 20170430; Notes: 1. notes, Progress Note - Nurse, Patient Care Documentation, Progress Note : Patient suffered face weakness from unknown cause. Patient had idiopathic facial nerve palsy and showed rapid progression. Palsy improved lot facial paralysis identified., Date 20170423;</div>"
      }
    },
    {
      "title": "Relevant Medical History",
      "code": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS",
            "code": "RelevantMedicalHistory"
          }
        ]
      },
      "text": {
        "status": "generated",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Long term (current) use of anticoagulants</div>"
      }
    }
  ]
}