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 
<Bundle xmlns="http://hl7.org/fhir">
<id value="ConnectathonVAERSBundle"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-vaers-bundle"/>
</meta>
<identifier>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.22"/>
<value value="BATCH20210105142444-0500533f2636-a404-13c5-10e3-7d293893227a"/>
</identifier>
<type value="message"/>
<timestamp value="2021-01-05T14:24:44-05:00"/>
<entry>
<fullUrl value="MessageHeader/US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"/>
<resource>
<MessageHeader>
<id value="US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"/>
<meta>
<lastUpdated value="2021-01-05T14:24:44+05:00"/>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-vaers-messageheader"/>
</meta>
<text>
<status value="extensions"/>
<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_VAERSSender">See above (Organization/VAERSSender)</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/BEST-Pilot">http://example.org/BEST-Pilot</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_VAERSExample">See above (Composition/VAERSExample)</a></p></div>
</text>
<extension
url="http://hl7.org/fhir/us/medmorph/StructureDefinition/ext-messageProcessingCategory">
<valueCode value="notification"/>
</extension>
<eventCoding>
<system value="http://terminology.hl7.org/CodeSystem/v3-ActCode"/>
<code value="PAT_ADV_EVNT"/>
<display value="Patient Adverse Event"/>
</eventCoding>
<destination>
<endpoint value="http://example.org/CBERVAERS"/>
</destination>
<sender>
<reference value="Organization/VAERSSender"/>
</sender>
<source>
<endpoint value="http://example.org/BEST-Pilot"/>
</source>
<reason>
<coding>
<system
value="http://hl7.org/fhir/us/medmorph/CodeSystem/us-ph-triggerdefinition-namedevents"/>
<code value="received-public-health-report"/>
</coding>
</reason>
<focus>
<reference value="Composition/VAERSExample"/>
</focus>
</MessageHeader>
</resource>
</entry>
<entry>
<fullUrl value="Composition/VAERSExample"/>
<resource>
<Composition>
<id value="VAERSExample"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-composition"/>
</meta>
<text>
<status value="extensions"/>
<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 1}">Regulator</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: US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495</p><p><b>identifier</b>: id: US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495</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>: Jan 5, 2021 9:24:44 AM</p><p><b>author</b>: <a href="#PractitionerRole_VAERSAuthorRole">See above (PractitionerRole/VAERSAuthorRole)</a></p><p><b>title</b>: ICSR Submission</p></div>
</text>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-additionaldocumentinformation">
<extension url="availableFlag">
<valueBoolean value="false"/>
</extension>
</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"/>
</coding>
</valueCodeableConcept>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-firstsendertype">
<valueCodeableConcept>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.3"/>
<code value="1"/>
<display value="Regulator"/>
</coding>
</valueCodeableConcept>
</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="US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"/>
</valueIdentifier>
</extension>
<identifier>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.3.1"/>
<value value="US-IBM-e380bc14-2a03-7b64-c3f5-22daea2aa495"/>
</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/VAERSPatient"/>
</subject>
<date value="2021-01-05T14:24:44+05:00"/>
<author>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-authorprimarysource">
<valueBoolean value="true"/>
</extension>
<reference value="PractitionerRole/VAERSAuthorRole"/>
</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">Developed acute facial nerve paralysis after ED administration of influenza vaccine</div>
</text>
<entry>
<reference value="AdverseEvent/VAERSExampleEvent"/>
</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">ED administration of influenza vaccine</div>
</text>
<entry>
<reference value="Immunization/VAERSExampleImmunization"/>
</entry>
<entry>
<reference
value="MedicationAdministration/VAERSHydrocortisoneAdministration"/>
</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: 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>
</text>
</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">Long term (current) use of anticoagulants</div>
</text>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="Organization/VAERSSender"/>
<resource>
<Organization>
<id value="VAERSSender"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-messageorganization"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>DepartmentName</b>: sender department</p><p><b>active</b>: true</p><p><b>type</b>: <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.7 1}">Pharmaceutical Company</span></p><p><b>name</b>: sender organization</p><p><b>telecom</b>: <a href="tel:+0112345678">+01 123 456 78</a>, fax: +01 123 456 89, <a href="mailto:email@city.us">email@city.us</a></p><p><b>address</b>: street city CA postcode US </p><h3>Contacts</h3><table class="grid"><tr><td>-</td><td><b>Name</b></td></tr><tr><td>*</td><td>sender gname sender fname </td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-departmentname">
<valueString value="sender department"/>
</extension>
<active value="true"/>
<type>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.7"/>
<code value="1"/>
<display value="Pharmaceutical Company"/>
</coding>
</type>
<name value="sender organization"/>
<telecom>
<system value="phone"/>
<value value="+01 123 456 78"/>
</telecom>
<telecom>
<system value="fax"/>
<value value="+01 123 456 89"/>
</telecom>
<telecom>
<system value="email"/>
<value value="email@city.us"/>
</telecom>
<address>
<line value="street"/>
<city value="city"/>
<state value="CA"/>
<postalCode value="postcode"/>
<country value="US"/>
</address>
<contact>
<name>
<family value="sender fname"/>
<given value="sender gname"/>
<prefix value="sender title"/>
</name>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="PractitionerRole/VAERSAuthorRole"/>
<resource>
<PractitionerRole>
<id value="VAERSAuthorRole"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitionerrole"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>practitioner</b>: <a href="#Practitioner_VAERSAuthor">See above (Practitioner/VAERSAuthor)</a></p><p><b>organization</b>: <a href="#Organization_VAERSSender">See above (Organization/VAERSSender)</a></p><p><b>code</b>: <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.6 1}">Physician</span></p><p><b>telecom</b>: <a href="mailto:admin@admin.com">admin@admin.com</a>, ph: 3333333333</p></div>
</text>
<practitioner>
<reference value="Practitioner/VAERSAuthor"/>
</practitioner>
<organization>
<reference value="Organization/VAERSSender"/>
</organization>
<code>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.6"/>
<code value="1"/>
<display value="Physician"/>
</coding>
</code>
<telecom>
<system value="email"/>
<value value="admin@admin.com"/>
</telecom>
<telecom>
<system value="phone"/>
<value value="3333333333"/>
</telecom>
</PractitionerRole>
</resource>
</entry>
<entry>
<fullUrl value="Practitioner/VAERSAuthor"/>
<resource>
<Practitioner>
<id value="VAERSAuthor"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-authorpractitioner"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>identifier</b>: id: NI</p><p><b>name</b>: asdhj Admin </p><p><b>address</b>: US </p></div>
</text>
<identifier>
<system value="http://hl7.org/fhir/sid/us-npi"/>
<value value="NI"/>
</identifier>
<name>
<family value="Admin"/>
<given value="asdhj"/>
</name>
<address>
<country value="US"/>
</address>
</Practitioner>
</resource>
</entry>
<entry>
<fullUrl value="Patient/VAERSPatient"/>
<resource>
<Patient>
<id value="VAERSPatient"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-patient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>identifier</b>: id: 123456789</p><p><b>name</b>: FNAME LNAME </p><p><b>gender</b>: male</p><p><b>birthDate</b>: 1955-07-22</p></div>
</text>
<identifier>
<system value="http://hl7.org/fhir/sid/us-ssn"/>
<value value="123456789"/>
</identifier>
<name>
<family value="LNAME"/>
<given value="FNAME"/>
</name>
<gender value="male"/>
<birthDate value="1955-07-22"/>
</Patient>
</resource>
</entry>
<entry>
<fullUrl value="AdverseEvent/VAERSExampleEvent"/>
<resource>
<AdverseEvent>
<id value="VAERSExampleEvent"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-vaers-adverseevent"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>actuality</b>: actual</p><p><b>event</b>: <span title="Codes: {http://meddra.org 10004223}">Bell's Palsy</span></p><p><b>subject</b>: <a href="#Patient_VAERSPatient">See above (Patient/VAERSPatient)</a></p><p><b>date</b>: 2017-04-23</p><p><b>seriousness</b>: <span title="Codes: {urn:oid:2.16.840.1.113883.3.989.2.1.1.19 26}">26</span></p><p><b>outcome</b>: <span title="Codes: {http://terminology.hl7.org/CodeSystem/adverse-event-outcome recovering}">Recovering</span></p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="#Immunization_VAERSExampleImmunization">See above (Immunization/VAERSExampleImmunization)</a></p><h3>Causalities</h3><table class="grid"><tr><td>-</td><td><b>ProductRelatedness</b></td></tr><tr><td>*</td><td>Suspect</td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="#MedicationAdministration_VAERSHydrocortisoneAdministration">See above (MedicationAdministration/VAERSHydrocortisoneAdministration)</a></p><h3>Causalities</h3><table class="grid"><tr><td>-</td><td><b>ProductRelatedness</b></td></tr><tr><td>*</td><td>Concomitant</td></tr></table></blockquote></div>
</text>
<actuality value="actual"/>
<event>
<coding>
<system value="http://meddra.org"/>
<code value="10004223"/>
<display value="Bell's Palsy"/>
</coding>
</event>
<subject>
<reference value="Patient/VAERSPatient"/>
</subject>
<date value="2017-04-23"/>
<seriousness>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.19"/>
<code value="26"/>
</coding>
</seriousness>
<outcome>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/adverse-event-outcome"/>
<code value="recovering"/>
</coding>
</outcome>
<suspectEntity>
<instance>
<reference value="Immunization/VAERSExampleImmunization"/>
</instance>
<causality>
<productRelatedness value="Suspect"/>
</causality>
</suspectEntity>
<suspectEntity>
<instance>
<reference
value="MedicationAdministration/VAERSHydrocortisoneAdministration"/>
</instance>
<causality>
<productRelatedness value="Concomitant"/>
</causality>
</suspectEntity>
</AdverseEvent>
</resource>
</entry>
<entry>
<fullUrl value="Immunization/VAERSExampleImmunization"/>
<resource>
<Immunization>
<id value="VAERSExampleImmunization"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-immunization"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>AgeAtVaccination</b>: 12 years</p><p><b>status</b>: completed</p><p><b>vaccineCode</b>: <span title="Codes: {http://hl7.org/fhir/sid/ndc 7046101903}">7046101903</span></p><p><b>patient</b>: <a href="#Patient_VAERSPatient">See above (Patient/VAERSPatient)</a></p><p><b>occurrence</b>: 2017-04-23</p><p><b>primarySource</b>: false</p></div>
</text>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-ext-ageatvaccination">
<valueAge>
<value value="12"/>
<unit value="years"/>
<system value="http://unitsofmeasure.org"/>
<code value="y"/>
</valueAge>
</extension>
<status value="completed"/>
<vaccineCode>
<coding>
<system value="http://hl7.org/fhir/sid/ndc"/>
<code value="7046101903"/>
</coding>
</vaccineCode>
<patient>
<reference value="Patient/VAERSPatient"/>
</patient>
<occurrenceDateTime value="2017-04-23"/>
<primarySource value="false"/>
</Immunization>
</resource>
</entry>
<entry>
<fullUrl value="MedicationAdministration/VAERSHydrocortisoneAdministration"/>
<resource>
<MedicationAdministration>
<id value="VAERSHydrocortisoneAdministration"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-medicationadministration"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>status</b>: completed</p><p><b>medication</b>: <span title="Codes: {http://www.nlm.nih.gov/research/umls/rxnorm 197782}">hydrocortisone 10 MG Oral Tablet</span></p><p><b>subject</b>: <a href="#Patient_VAERSPatient">See above (Patient/VAERSPatient)</a></p><p><b>effective</b>: 2017-04-23</p></div>
</text>
<status value="completed"/>
<medicationCodeableConcept>
<coding>
<system value="http://www.nlm.nih.gov/research/umls/rxnorm"/>
<code value="197782"/>
</coding>
</medicationCodeableConcept>
<subject>
<reference value="Patient/VAERSPatient"/>
</subject>
<effectiveDateTime value="2017-04-23"/>
</MedicationAdministration>
</resource>
</entry>
</Bundle>
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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