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                    <text>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;</text>
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                                            <!-- PATIENT LAST NAME -->
                                            <given>FNAME</given>
                                            <family>LNAME</family>
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                                        <!-- PATIENT TELEPHONE -->
                                        <!-- PATIENT EMAIL -->
                                        <!-- PATIENT DATE OF BIRTH -->
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                                        <birthTime value="19550722"/>
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                                            <!-- PATIENT COUNTY -->
                                            <!-- PATIENT POSTAL CODE -->
                                            <!-- PATIENT COUNTRY -->
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                                                    <value xsi:type="ED">Long term (current) use of anticoagulants</value>
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                                            <!-- REACTION START DATE -->
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                                                <!-- B.2.i.3 Date of Start of Reaction / Event -->
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                                                    <!-- Results in Death-->
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                                                    <!-- Caused / Prolonged Hospitalisation -->
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                                                    <!--  Disabling / Incapacitating-->
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                                                    <!-- Congenital Anomaly / Birth Defect -->
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                                                    <!-- Other Medically Important Condition -->
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                                                    <!-- Required visit to the emergency room  -->
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                                                    <!-- VAERSNone of the above -->
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                                                    <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="outcome"/>
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                          [4]recovered/resolved with sequelae [5]fatal [6]unknown -->
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                                        <organizer>
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                                            <component typeCode="COMP">
                                                <substanceAdministration moodCode="EVN" classCode="SBADM">
                                                    <!-- Used to reference this drug administration in other places in the submission -->
                                                    <!-- VACCINATION MILITARY FLAG -->
                                                    <id root="8d36c8a1-1ad3-a6b4-6ef9-d52bd3c33749"/>
                                                    <consumable>
                                                        <instanceOfKind classCode="INST">
                                                            <kindOfProduct classCode="MMAT" determinerCode="KIND">
                                                                <!-- MEDICINAL PRODUCT NUMBER AND VERSION-->
                                                                <!-- MEDICINAL PRODUCT NAME -->
                                                                <code code="197782" codeSystem="2.16.840.1.113883.6.88"/>
                                                                <name>hydrocortisone</name>
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                                                        <substanceAdministration classCode="SBADM" moodCode="EVN">
                                                            <performer typeCode="PRF">
                                                                <assignedEntity classCode="ASSIGNED">
                                                                    <!-- VACCINATION FACILITY TYPE -->
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                                                                    <representedOrganization classCode="ORG" determinerCode="INSTANCE">
                                                                        <!-- VACCINATION FACILITY NAME -->
                                                                        <!-- VACCINATION TELEPHONE / FAX / EMAIL -->
                                                                        <!-- VACCINATION FACILITY ADDRESS -->
                                                                        <name nullFlavor="NI"/>
                                                                        <telecom nullFlavor="NI" value="tel"/>
                                                                        <telecom nullFlavor="NI" value="fax"/>
                                                                        <telecom nullFlavor="NI" value="mailto"/>
                                                                        <addr>
                                                                            <streetAddressLine nullFlavor="NI"/>
                                                                            <city nullFlavor="NI"/>
                                                                            <state nullFlavor="NI"/>
                                                                            <postalCode nullFlavor="NI"/>
                                                                            <country nullFlavor="NI"/>
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                                                    <inboundRelationship typeCode="REFR">
                                                        <observation classCode="OBS" moodCode="EVN">
                                                            <code code="C114865" displayName="Vaccination at Military Site" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                                            <value nullFlavor="NI" xsi:type="BL"/>
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                                        <organizer>
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                                            <component typeCode="COMP">
                                                <substanceAdministration moodCode="EVN" classCode="SBADM">
                                                    <!-- Used to reference this drug administration in other places in the submission -->
                                                    <!-- VACCINATION MILITARY FLAG -->
                                                    <id root="e69f88fa-1ae1-78fe-49f3-59ea57a85175"/>
                                                    <consumable>
                                                        <instanceOfKind classCode="INST">
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                                                                <!-- MEDICINAL PRODUCT NUMBER AND VERSION-->
                                                                <!-- MEDICINAL PRODUCT NAME -->
                                                                <code code="70461-019-03" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="20210105142444"/>
                                                                <name>influenza virus vaccine, inactivated</name>
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                                                    <outboundRelationship2 typeCode="COMP">
                                                        <substanceAdministration classCode="SBADM" moodCode="EVN">
                                                            <performer typeCode="PRF">
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                                                                    <!-- VACCINATION FACILITY TYPE -->
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                                                                    <representedOrganization classCode="ORG" determinerCode="INSTANCE">
                                                                        <!-- VACCINATION FACILITY NAME -->
                                                                        <!-- VACCINATION TELEPHONE / FAX / EMAIL -->
                                                                        <!-- VACCINATION FACILITY ADDRESS -->
                                                                        <name nullFlavor="NI"/>
                                                                        <telecom nullFlavor="NI" value="tel"/>
                                                                        <telecom nullFlavor="NI" value="fax"/>
                                                                        <telecom nullFlavor="NI" value="mailto"/>
                                                                        <addr>
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                                                                            <postalCode nullFlavor="NI"/>
                                                                            <country nullFlavor="NI"/>
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                                                        <observation classCode="OBS" moodCode="EVN">
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                                <assignedEntity classCode="ASSIGNED">
                                    <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.7"/>
                                    <!-- A.3.1: Sender Type [1] Pharmaceutical Company [2]Regulatory Authority [3]Health Professional [4] Regional Pharmacovigilance Center
                 [5] WHO collaborating center for international drug monitoring [6] Other [7] Patient / Consumer -->
                                    <!-- A.3.4f: Sender's Telephone -->
                                    <!-- A.3.4i: Sender's Fax -->
                                    <!-- A.3.4l : Sender's E-mail Address -->
                                    <!-- A.3.4.f,i,l Sender's address, fax, telephone and E-mail address -->
                                    <addr>
                                        <streetAddressLine>street</streetAddressLine>
                                        <!-- A.3.4a: Sender's Street Address -->
                                        <!-- A.3.4b: Sender's City -->
                                        <!-- A.3.4c: Sender's State or Province -->
                                        <!-- A.3.4d: Sender's Postcode -->
                                        <city>city</city>
                                        <state>CA</state>
                                        <postalCode>postcode</postalCode>
                                    </addr>
                                    <telecom value="tel:+01 123 456 78"/>
                                    <telecom value="fax:+01 123 456 89"/>
                                    <telecom value="mailto:email@city.us"/>
                                    <assignedPerson classCode="PSN" determinerCode="INSTANCE">
                                        <name>
                                            <prefix>sender title</prefix>
                                            <!-- A.3.3b: Sender's Title -->
                                            <!-- A.3.3c: Sender's Given Name -->
                                            <!-- A.3.3e: Sender's Family Name -->
                                            <given>sender gname</given>
                                            <family>sender fname</family>
                                        </name>
                                        <asLocatedEntity classCode="LOCE">
                                            <location classCode="COUNTRY" determinerCode="INSTANCE">
                                                <code code="US" codeSystem="1.0.3166.1.2.2"/>
                                                <!-- A.3.4e: Sender's Country Code -->
                                            </location>
                                        </asLocatedEntity>
                                    </assignedPerson>
                                    <representedOrganization classCode="ORG" determinerCode="INSTANCE">
                                        <name>sender department</name>
                                        <!-- A.3.3a: Sender's Department -->
                                        <assignedEntity classCode="ASSIGNED">
                                            <representedOrganization classCode="ORG" determinerCode="INSTANCE">
                                                <name>sender organisation</name>
                                                <!-- A.3.2: Sender's Organization -->
                                            </representedOrganization>
                                        </assignedEntity>
                                    </representedOrganization>
                                </assignedEntity>
                            </author>
                        </controlActEvent>
                    </subjectOf1>
                    <subjectOf2 typeCode="SUBJ">
                        <investigationCharacteristic classCode="OBS" moodCode="EVN">
                            <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" displayName="ICH ReportType"/>
                            <!-- [1] Spontaneous report [2] Report from study [3] Other [4] Not available to sender (unknown) -->
                            <value xsi:type="CE" code="1" displayName="Spontaneous report" codeSystem="2.16.840.1.113883.3.989.2.1.1.2"/>
                        </investigationCharacteristic>
                    </subjectOf2>
                    <subjectOf2 typeCode="SUBJ">
                        <investigationCharacteristic classCode="OBS" moodCode="EVN">
                            <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" displayName="otherCaseIds"/>
                            <value xsi:type="BL" nullFlavor="NI"/>
                        </investigationCharacteristic>
                    </subjectOf2>
                </investigationEvent>
            </subject>
        </controlActProcess>
    </PORR_IN049016UV>
    <receiver typeCode="RCV">
        <device classCode="DEV" determinerCode="INSTANCE">
            <!-- BATCH RECEIVER IDENTIFIER -->
            <id extension="CBERVAERS" root="2.16.840.1.113883.3.989.2.1.3.14"/>
        </device>
    </receiver>
    <sender typeCode="SND">
        <device classCode="DEV" determinerCode="INSTANCE">
            <!-- BATCH SENDER IDENTIFIER -->
            <id extension="SENDER-IDENTIFIER" root="2.16.840.1.113883.3.989.2.1.3.13"/>
        </device>
    </sender>
</MCCI_IN200100UV01>