HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot
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 
<Composition xmlns="http://hl7.org/fhir">
<id value="FAERSExample"/>
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<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 2}">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>: 2021-01-05</p><p><b>MostRecentDate</b>: 2021-01-05</p><p><b>CaseIdentifier</b>: id: BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77</p><p><b>identifier</b>: id: BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77</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>: 2021-01-05</p><p><b>author</b>: <a href="PractitionerRole-BESTAuthorRole.html">Generated Summary: <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}">Physician</span>; admin@admin.com</a></p><p><b>title</b>: ICSR Submission</p></div>
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<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-additionaldocumentinformation">
<extension url="availableFlag">
<valueBoolean value="false"/>
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</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-expeditedreport">
<extension url="localCriteriaFlag">
<valueBoolean value="false"/>
</extension>
<extension url="localCriteriaReportType">
<valueCodeableConcept>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.1003"/>
<code value="2"/>
<display value="Non-Expedited AE"/>
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<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype">
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<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.3"/>
<code value="2"/>
<display value="Other"/>
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</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-combinationproductreport">
<valueBoolean value="false"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstreceivedate">
<valueDateTime value="2021-01-05"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-mostrecentdate">
<valueDateTime value="2021-01-05"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-caseidentifier">
<valueIdentifier>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.2"/>
<value value="BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77"/>
</valueIdentifier>
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<identifier>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.1"/>
<value value="BEST_beafb541-3eab-eb9e-1bf1-5fa477d56e77"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="http://loinc.org"/>
<code value="85893-6"/>
<display value="Adverse event note"/>
</coding>
</type>
<category>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.2"/>
<code value="1"/>
<display value="Spontaneous report"/>
</coding>
</category>
<subject>
<reference value="Patient/BESTPatient"/>
</subject>
<date value="2021-01-05"/>
<author>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource">
<valueBoolean value="true"/>
</extension>
<reference value="PractitionerRole/BESTAuthorRole"/>
</author>
<title value="ICSR Submission"/>
<section>
<title value="Reaction/Event"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
<code value="ReactionEvent"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">Allergic transfusion reaction</div>
</text>
<entry>
<reference value="AdverseEvent/FAERSExampleEvent"/>
</entry>
</section>
<section>
<title value="Drug Information"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
<code value="DrugInformation"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">Description code for blood products: E7003, Blood group and type: N/A Blood processing type: Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:&lt;5E6|2nd container</div>
</text>
<entry>
<reference value="Procedure/FAERSExampleTransfusion"/>
</entry>
<entry>
<reference value="MedicationAdministration/FAERSEpinephrine"/>
</entry>
<entry>
<reference value="MedicationAdministration/FAERSDiphenhydramine"/>
</entry>
</section>
<section>
<title value="Case Summary Narrative"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
<code value="CaseSummaryNarrative"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">Header: FDA CBER BEST Automated AE Reporting Prototype Case BEST Detection Phenotype Algorithm: Phenotype link: rules-cd BEST Certainty: Definite BEST Severity: Non-Severe BEST Imputability: Probable Form Type: 3500 Contact Method: Email Adverse Event: 1 Center to which the case is being routed to: CBER Whether the case is being sent to DQRS: false Whether the report is related to drugs or food/cosmetics: 1 Whether the blood report is of type Transfusion or Collection: 2 Patient Race Code: 2f, Blood group of patient: N/A, Onset location for reaction: MedStar Location Description code for blood products: N/A, Blood group and type: N/A Blood processing type: N/A Product available for evaluation: 2 Volume of transfusion: NI NHSN Workup: NI Preliminary investigation results: Developed rash &#38; stridor following transfusion prbc for anemia. Tx with benadryl &#38; epinephrine &#38; sx improved., Adverse Event Type Imputability: Blood Transfusion - Certainty: Definite; Notes: 1. notes, Eval+Plan Note, For admission to Hosp with Dx Anemia. Transfuse PRBC now., Date 20020109; 2. notes, Eval+Plan Note, Patient has developed a new maculopapular rash following transfusion. Will give Benadryl 25 mg., Date 20020109; 3. notes, Eval+Plan Note, New onset Stridor following transfusion. Will give Epinephrine .5mg, and do transfusion Rxn workup, Date 20020109; 4. notes, Eval+Plan Note, RN note - Administered Benadryl 25mg IV for skin sx. After 30 min pt. reports some improvement in skin symptoms, Date 20020109 Labs, Vitals, and Tests: 1. labs, Diastolic Blood Pressure, 75.918 mm[Hg], Date 20020109; 2. labs, Systolic Blood Pressure, 123.08 mm[Hg], Date 20020109; 3. labs, Physical findings of Skin, generalized rash, Date 20020109; 4. labs, Respiratory status finding, Stridor, Date 20020109; Illness at Time of Vaccination: 1. illness, Problem, Anemia, Date 20020109;</div>
</text>
</section>
<section>
<title value="Patient Information"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
<code value="PatientInformation"/>
</coding>
</code>
<entry>
<reference value="Observation/BESTPatientAgeGroup"/>
</entry>
</section>
<section>
<title value="Relevant Medical History"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/icsr-ae-reporting/CodeSystem/ICSRSectionCodeCS"/>
<code value="RelevantMedicalHistory"/>
</coding>
</code>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">NI</div>
</text>
</section>
</Composition>
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#0.1.0 based on FHIR 4.0.1. Generated 2021-08-05
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