HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.0 - STU 1
HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.0 - STU 1
This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions 
<Bundle xmlns="http://hl7.org/fhir">
<id value="ConnectathonFAERSBundle"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bundle"/>
</meta>
<type value="message"/>
<entry>
<fullUrl value="MessageHeader/beafb541-3eab-eb9e-1bf1-5fa477d56e77"/>
<resource>
<MessageHeader>
<id value="beafb541-3eab-eb9e-1bf1-5fa477d56e77"/>
<meta>
<lastUpdated value="2021-01-05T14:14:39+06:00"/>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageheader"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "beafb541-3eab-eb9e-1bf1-5fa477d56e77" Updated "2021-01-05T08:14:39Z" </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>-</td><td><b>Endpoint</b></td><td><b>Receiver</b></td></tr><tr><td>*</td><td><a href="http://example.org/ZZFDA">http://example.org/ZZFDA</a></td><td><a href="#Organization_FDA">See above (Organization/FDA)</a></td></tr></table><p><b>sender</b>: <a href="#Organization_BESTPrototype">See above (Organization/BESTPrototype)</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>: 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_FAERSExample">See above (Composition/FAERSExample)</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/ZZFDA"/>
<receiver>
<reference value="Organization/FDA"/>
</receiver>
</destination>
<sender>
<reference value="Organization/BESTPrototype"/>
</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/FAERSExample"/>
</focus>
</MessageHeader>
</resource>
</entry>
<entry>
<fullUrl value="Composition/FAERSExample"/>
<resource>
<Composition>
<id value="FAERSExample"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-composition"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "FAERSExample" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-composition.html">ICSR Composition</a></p></div><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>: Non-Expedited AE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#2)</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>: 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>: 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>: 2021-01-05</p><p><b>author</b>: <a href="#PractitionerRole_BESTAuthorRole">See above (PractitionerRole/BESTAuthorRole)</a></p><p><b>title</b>: ICSR Submission</p></div>
</text>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-additionaldocumentinformation">
<extension url="availableFlag">
<valueBoolean value="false"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/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/icsr-ext-firstsendertype">
<valueCodeableConcept>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.3"/>
<code value="2"/>
<display value="Other"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-combinationproductreport">
<valueBoolean value="false"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-firstreceivedate">
<valueDateTime value="2021-01-05"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-mostrecentdate">
<valueDateTime value="2021-01-05"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/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>
</extension>
<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/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>
</resource>
</entry>
<entry>
<fullUrl value="Organization/FDA"/>
<resource>
<Organization>
<id value="FDA"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageorganization"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "FDA" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-messageorganization.html">MessageHeader Organization</a></p></div><p><b>DepartmentName</b>: Office of Surveillance and Epidemiology</p><p><b>active</b>: true</p><p><b>type</b>: Regulatory Authority <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#2)</span></p><p><b>name</b>: FDA</p><p><b>telecom</b>: <a href="mailto:faersesub@fda.hhs.gov">faersesub@fda.hhs.gov</a></p><p><b>address</b>: 10903 New Hampshire Avenue Silver Spring MD 20993 US </p><h3>Contacts</h3><table class="grid"><tr><td>-</td><td><b>Name</b></td></tr><tr><td>*</td><td>FAERS </td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-departmentname">
<valueString value="Office of Surveillance and Epidemiology"/>
</extension>
<active value="true"/>
<type>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.7"/>
<code value="2"/>
<display value="Regulatory Authority"/>
</coding>
</type>
<name value="FDA"/>
<telecom>
<system value="email"/>
<value value="faersesub@fda.hhs.gov"/>
</telecom>
<address>
<line value="10903 New Hampshire Avenue"/>
<city value="Silver Spring"/>
<state value="MD"/>
<postalCode value="20993"/>
<country value="US"/>
</address>
<contact>
<name>
<given value="FAERS"/>
</name>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="Organization/BESTPrototype"/>
<resource>
<Organization>
<id value="BESTPrototype"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-messageorganization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "BESTPrototype" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-messageorganization.html">MessageHeader Organization</a></p></div><p><b>active</b>: true</p><p><b>name</b>: BEST-Prototype</p></div>
</text>
<active value="true"/>
<name value="BEST-Prototype"/>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="PractitionerRole/BESTAuthorRole"/>
<resource>
<PractitionerRole>
<id value="BESTAuthorRole"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitionerrole"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "BESTAuthorRole" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-authorpractitionerrole.html">PractitionerRole Author</a></p></div><p><b>practitioner</b>: <a href="#Practitioner_BESTAuthor">See above (Practitioner/BESTAuthor)</a></p><p><b>organization</b>: <a href="#Organization_BESTPrototype">See above (Organization/BESTPrototype)</a></p><p><b>code</b>: Physician <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#1)</span></p><p><b>telecom</b>: <a href="mailto:admin@admin.com">admin@admin.com</a></p></div>
</text>
<practitioner>
<reference value="Practitioner/BESTAuthor"/>
</practitioner>
<organization>
<reference value="Organization/BESTPrototype"/>
</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>
</PractitionerRole>
</resource>
</entry>
<entry>
<fullUrl value="Practitioner/BESTAuthor"/>
<resource>
<Practitioner>
<id value="BESTAuthor"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitioner"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "BESTAuthor" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-authorpractitioner.html">Practitioner Author</a></p></div><p><b>identifier</b>: id: NI</p><p><b>name</b>: NI </p></div>
</text>
<identifier>
<system value="http://hl7.org/fhir/sid/us-npi"/>
<value value="NI"/>
</identifier>
<name>
<family value="NI"/>
</name>
</Practitioner>
</resource>
</entry>
<entry>
<fullUrl value="Patient/BESTPatient"/>
<resource>
<Patient>
<id value="BESTPatient"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "BESTPatient" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-patient.html">ICSR Patient</a></p></div><p><b>identifier</b>: id: 123456789</p><p><b>name</b>: CM </p><p><b>gender</b>: female</p><p><b>birthDate</b>: 1999-06-24</p></div>
</text>
<identifier>
<system value="http://hl7.org/fhir/sid/us-ssn"/>
<value value="123456789"/>
</identifier>
<name>
<family value="CM"/>
</name>
<gender value="female"/>
<birthDate value="1999-06-24"/>
</Patient>
</resource>
</entry>
<entry>
<fullUrl value="Observation/BESTPatientAgeGroup"/>
<resource>
<Observation>
<id value="BESTPatientAgeGroup"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patientagegroup"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "BESTPatientAgeGroup" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-patientagegroup.html">Descriptive Age Group for the Patient</a></p></div><p><b>status</b>: final</p><p><b>code</b>: Age group <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://loinc.org/">LOINC</a>#46251-5)</span></p><p><b>subject</b>: <a href="#Patient_BESTPatient">See above (Patient/BESTPatient)</a></p><p><b>value</b>: Adult <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#5)</span></p></div>
</text>
<status value="final"/>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="46251-5"/>
<display value="Age group"/>
</coding>
</code>
<subject>
<reference value="Patient/BESTPatient"/>
</subject>
<valueCodeableConcept>
<coding>
<system value="urn:oid:2.16.840.1.113883.3.989.2.1.1.9"/>
<code value="5"/>
<display value="Adult"/>
</coding>
</valueCodeableConcept>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="AdverseEvent/FAERSExampleEvent"/>
<resource>
<AdverseEvent>
<id value="FAERSExampleEvent"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/faers-adverseevent"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "FAERSExampleEvent" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-faers-adverseevent.html">FAERS Adverse Event</a></p></div><p><b>AgeAtTimeOfOnset</b>: 1 a<span style="background: LightGoldenRodYellow"> (Details: UCUM code a = 'a')</span></p><p><b>actuality</b>: actual</p><p><b>event</b>: Allergic transfusion reaction <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (meddra.org#10066173)</span></p><p><b>subject</b>: <a href="#Patient_BESTPatient">See above (Patient/BESTPatient)</a></p><p><b>date</b>: 2000-01-01</p><p><b>seriousness</b>: Serious <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/3.0.0/CodeSystem-adverse-event-seriousness.html">AdverseEventSeriousness</a>#serious)</span></p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="#Procedure_FAERSExampleTransfusion">See above (Procedure/FAERSExampleTransfusion)</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_FAERSEpinephrine">See above (MedicationAdministration/FAERSEpinephrine)</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><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="#MedicationAdministration_FAERSDiphenhydramine">See above (MedicationAdministration/FAERSDiphenhydramine)</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>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset">
<valueAge>
<value value="1"/>
<system value="http://unitsofmeasure.org"/>
<code value="a"/>
</valueAge>
</extension>
<actuality value="actual"/>
<event>
<coding>
<system value="http://meddra.org"/>
<code value="10066173"/>
<display value="Allergic transfusion reaction"/>
</coding>
</event>
<subject>
<reference value="Patient/BESTPatient"/>
</subject>
<date value="2000-01-01">
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate">
<valueDateTime value="2019-01-20"/>
</extension>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration">
<valueDuration>
<value value="19.05"/>
<system value="http://unitsofmeasure.org"/>
<code value="a"/>
</valueDuration>
</extension>
</date>
<seriousness>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
<code value="serious"/>
</coding>
</seriousness>
<suspectEntity>
<instance>
<reference value="Procedure/FAERSExampleTransfusion"/>
</instance>
<causality>
<productRelatedness value="Suspect"/>
</causality>
</suspectEntity>
<suspectEntity>
<instance>
<reference value="MedicationAdministration/FAERSEpinephrine"/>
</instance>
<causality>
<productRelatedness value="Concomitant"/>
</causality>
</suspectEntity>
<suspectEntity>
<instance>
<reference value="MedicationAdministration/FAERSDiphenhydramine"/>
</instance>
<causality>
<productRelatedness value="Concomitant"/>
</causality>
</suspectEntity>
</AdverseEvent>
</resource>
</entry>
<entry>
<fullUrl value="Procedure/FAERSExampleTransfusion"/>
<resource>
<Procedure>
<id value="FAERSExampleTransfusion"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-transfusion"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "FAERSExampleTransfusion" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-transfusion.html">ICSR Transfusion</a></p></div><p><b>UsedProductAmount</b>: 1 unit<span style="background: LightGoldenRodYellow"> (Details: UCUM code {unit} = '{unit}')</span></p><p><b>status</b>: completed</p><p><b>code</b>: 36430 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/3.0.0/CodeSystem-CPT.html">Current Procedural Terminology (CPT®)</a>#36430)</span></p><p><b>subject</b>: <a href="#Patient_BESTPatient">See above (Patient/BESTPatient)</a></p><p><b>performed</b>: 2002-01-09</p><p><b>usedReference</b>: <span>: Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container</span></p></div>
</text>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-usedproductamount">
<valueQuantity>
<value value="1"/>
<unit value="unit"/>
<system value="http://unitsofmeasure.org"/>
<code value="{unit}"/>
</valueQuantity>
</extension>
<status value="completed"/>
<code>
<coding>
<system value="http://www.ama-assn.org/go/cpt"/>
<code value="36430"/>
</coding>
</code>
<subject>
<reference value="Patient/BESTPatient"/>
</subject>
<performedDateTime value="2002-01-09"/>
<usedReference>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-usedproduct">
<valueReference>
<reference value="BiologicallyDerivedProduct/FAERSBloodProduct"/>
</valueReference>
</extension>
<display
value="Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container"/>
</usedReference>
</Procedure>
</resource>
</entry>
<entry>
<fullUrl value="BiologicallyDerivedProduct/FAERSBloodProduct"/>
<resource>
<BiologicallyDerivedProduct>
<id value="FAERSBloodProduct"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-bloodproduct"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "FAERSBloodProduct" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-bloodproduct.html">ICSR Blood Product</a></p></div><p><b>productCategory</b>: cells</p><p><b>productCode</b>: Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterminology#E7003)</span></p><h3>Collections</h3><table class="grid"><tr><td>-</td><td><b>Extension</b></td></tr><tr><td>*</td><td></td></tr></table></div>
</text>
<productCategory value="cells"/>
<productCode>
<coding>
<system value="https://iccbba.org/standardterminology"/>
<code value="E7003"/>
<display
value="Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container"/>
</coding>
</productCode>
<collection>
<extension
url="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-donationIdentificationNumber">
<valueIdentifier>
<system value="http://example.org/bloodDonationNumber"/>
<value value="G101610840386"/>
</valueIdentifier>
</extension>
</collection>
</BiologicallyDerivedProduct>
</resource>
</entry>
<entry>
<fullUrl value="MedicationAdministration/FAERSEpinephrine"/>
<resource>
<MedicationAdministration>
<id value="FAERSEpinephrine"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "FAERSEpinephrine" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-medicationadministration.html">ICSR MedicationAdministration</a></p></div><p><b>status</b>: completed</p><p><b>medication</b>: Epinephrine <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/3.0.0/CodeSystem-v3-rxNorm.html">RxNorm</a>#3992)</span></p><p><b>subject</b>: <a href="#Patient_BESTPatient">See above (Patient/BESTPatient)</a></p><p><b>effective</b>: 2002-01-09</p></div>
</text>
<status value="completed"/>
<medicationCodeableConcept>
<coding>
<system value="http://www.nlm.nih.gov/research/umls/rxnorm"/>
<code value="3992"/>
<display value="Epinephrine"/>
</coding>
</medicationCodeableConcept>
<subject>
<reference value="Patient/BESTPatient"/>
</subject>
<effectiveDateTime value="2002-01-09"/>
</MedicationAdministration>
</resource>
</entry>
<entry>
<fullUrl value="MedicationAdministration/FAERSDiphenhydramine"/>
<resource>
<MedicationAdministration>
<id value="FAERSDiphenhydramine"/>
<meta>
<profile
value="http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></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 "FAERSDiphenhydramine" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-icsr-medicationadministration.html">ICSR MedicationAdministration</a></p></div><p><b>status</b>: completed</p><p><b>medication</b>: Diphenhydramine <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/3.0.0/CodeSystem-v3-rxNorm.html">RxNorm</a>#3498)</span></p><p><b>subject</b>: <a href="#Patient_BESTPatient">See above (Patient/BESTPatient)</a></p><p><b>effective</b>: 2002-01-09</p></div>
</text>
<status value="completed"/>
<medicationCodeableConcept>
<coding>
<system value="http://www.nlm.nih.gov/research/umls/rxnorm"/>
<code value="3498"/>
<display value="Diphenhydramine"/>
</coding>
</medicationCodeableConcept>
<subject>
<reference value="Patient/BESTPatient"/>
</subject>
<effectiveDateTime value="2002-01-09"/>
</MedicationAdministration>
</resource>
</entry>
</Bundle>
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#1.0.0 based on FHIR 4.0.1. Generated 2022-01-19
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