<?xml version="1.0" encoding="UTF-8"?>
<!-- 	A minimal example containing the basic elements for a Malfunction only report, no patient.    -->
<MCCI_IN200100UV01 ITSVersion="XML_1.0" xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="urn:hl7-org:v3 C:\BAES_eVARS\Final_ICSR\4_ICH_ICSR_Schema_Files\multicacheschemas\MCCI_IN200100UV01.xsd">
	<id extension="29APR2019-sk3-4069-a2dd-08002b30309d" root="2.16.840.1.113883.3.989.2.1.3.22"/>
	<!-- Batch Number -->
	<creationTime value="20141008191617-0500"/>
	<!-- Date of Batch Transmission -->
	<responseModeCode code="D"/>
	<interactionId extension="MCCI_IN200100UV01" root="2.16.840.1.113883.1.6"/>
	<name code="1" displayName="ichicsr" codeSystem="2.16.840.1.113883.3.989.2.1.1.1"/>
	<!-- Us this string for all ICSR batches -->
	<!-- Message #1 -->
	<PORR_IN049016UV>
		<id extension="US-APHARMA-8744554B" root="2.16.840.1.113883.3.989.2.1.3.1"/>
		<!-- Message Identifier -->
		<creationTime value="20140614151617-0500"/>
		<!-- Date of Message Creation -->
		<interactionId extension="PORR_IN049016UV" root="2.16.840.1.113883.1.6"/>
		<processingCode code="P"/>
		<processingModeCode code="I"/>
		<acceptAckCode code="AL"/>
		<receiver typeCode="RCV">
			<device classCode="DEV" determinerCode="INSTANCE">
				<id extension="CBER_VAERS" root="2.16.840.1.113883.3.989.2.1.3.12"/>
				<!-- Message Receiver Identifier -->
			</device>
		</receiver>
		<sender typeCode="SND">
			<device classCode="DEV" determinerCode="INSTANCE">
				<id extension="456789012" root="2.16.840.1.113883.3.989.2.1.3.11"/>
				<!-- Message Sender Identifier -->
			</device>
		</sender>
		<controlActProcess classCode="CACT" moodCode="EVN">
			<code code="PORR_TE049016UV" codeSystem="2.16.840.1.113883.1.18"/>
			<!-- HL7 Trigger Event ID -->
			<effectiveTime value="20140614151617-0500"/>
			<!-- Date of Creation -->
			<subject typeCode="SUBJ">
				<investigationEvent classCode="INVSTG" moodCode="EVN">
					<id extension="US-APHARMA-8744554B" root="2.16.840.1.113883.3.989.2.1.3.1"/>
					<!-- Sender's (case) Safety Report Unique Identifier -->
					<id extension="US-APHARMA-8744554B" root="2.16.840.1.113883.3.989.2.1.3.2"/>
					<!-- Worldwide Unique Case Identification Number -->
					<code code="PAT_ADV_EVNT" codeSystem="2.16.840.1.113883.5.4"/>
					<text mediaType="text/plain">Product malfunction and defect report
					</text>
					<!-- Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information -->
					<statusCode code="active"/>
					<effectiveTime>
						<low value="201401111200-0500"/>
						<!-- Date Report Was First Received from Source -->
					</effectiveTime>
					<availabilityTime value="201401011815"/>
					<!-- Date of Most Recent Information for This Report -->
					<component typeCode="COMP">
						<adverseEventAssessment classCode="INVSTG" moodCode="EVN">
							<subject1 typeCode="SBJ">
								<primaryRole classCode="INVSBJ">
									<player1 classCode="PSN" determinerCode="INSTANCE">
										<name>
											<prefix>None</prefix>
											<given>None</given>
											<family>None</family>
										</name>
										<!-- Patient (name or initials) -->
										<telecom value="tel:None"/>
										<telecom value="mailto:None"/>
										<addr>
											<streetAddressLine>None</streetAddressLine>
											<city>None</city>
											<state>None</state>
											<county>None</county>
											<postalCode>None</postalCode>
											<country>None</country>
										</addr>
									</player1>
									<subjectOf2 typeCode="SBJ">
										<organizer classCode="CATEGORY" moodCode="EVN">
											<code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="relevantMedicalHistoryAndConcurrentConditions"/>
											<component typeCode="COMP">
												<observation classCode="OBS" moodCode="EVN">
													<code code="18" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="historyAndConcurrentConditionText"/>
													<value xsi:type="ED">None</value>
													<!-- Text for Relevant Medical History and Concurrent Conditions (not including reaction / event) -->
												</observation>
											</component>
										</organizer>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="reaction"/>
											<effectiveTime xsi:type="IVL_TS">
												<low nullFlavor="NASK"/>
												<!--Date of Start of Reaction / Event -->
											</effectiveTime>
											<value xsi:type="CE" code="10067482" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0">
												<!-- MedDRA Version for Reaction / Event -->
												<!-- Reaction / Event (MedDRA code) -->
											</value>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="resultsInDeath"/>
													<value xsi:type="BL" nullFlavor="NI"/>
													<!-- E.i.3.2a:  Results in Death-->
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="isLifeThreatening"/>
													<value xsi:type="BL" nullFlavor="NI"/>
													<!-- E.i.3.2b; Life Threatening -->
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="requiresInpatientHospitalization"/>
													<value xsi:type="BL" nullFlavor="NI"/>
													<!-- E.i.3.2c: Caused / Prolonged Hospitalisation -->
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="resultsInPersistentOrSignificantDisability"/>
													<value xsi:type="BL" nullFlavor="NI"/>
													<!--  E.i.3.2d:  Disabling / Incapacitating-->
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="congenitalAnomalyBirthDefect"/>
													<value xsi:type="BL" nullFlavor="NI"/>
													<!-- E.i.3.2e:  Congenital Anomaly / Birth Defect -->
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="otherMedicallyImportantCondition"/>
													<value xsi:type="BL" nullFlavor="NI"/>
													<!-- E.i.3.2f:  Other Medically Important Condition -->
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="C53513" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Emergency Room"/>
													<value xsi:type="BL" nullFlavor="NI"/>
													<!-- VAERS Required visit to the emergency room  -->
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="C16988" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Physician Office"/>
													<value xsi:type="BL" nullFlavor="NI"/>
													<!-- VAERS Required visit to the Physician Office  -->
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="outcome"/>
													<value xsi:type="CE" code="0" displayName="unknown" codeSystem="2.16.840.1.113883.3.989.2.1.1.11"/>
													<!-- E.i.7 Outcome of Reaction / Event at the Time of Last Observation -->
												</observation>
											</outboundRelationship2>
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<organizer classCode="CATEGORY" moodCode="EVN">
											<code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="drugInformation"/>
											<!-- Drug(s) Information (repeat as necessary) #1 -->
											<component typeCode="COMP">
												<substanceAdministration classCode="SBADM" moodCode="EVN">
													<id root="3c91b4d5-e039-4a7a-9c30-67671b0ef9e4"/>
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<name>Vaccine A</name>
																<!-- G.k.2.2: Medicinal Product Name as Reported by the Primary Source -->
																<ingredient classCode="ACTI">
																	<ingredientSubstance classCode="MMAT" determinerCode="KIND">
																		<name>Vaccinia virus</name>
																		<!-- G.k.2.3.r.1: Substance / Specified Substance Name  -->
																	</ingredientSubstance>
																</ingredient>
																<part>
																	<partProduct>
																		<code code="FMF" displayName="Syringe, Piston"/>
																		<!-- FDA.G.k.12.r.6 Device Product Code -->
																		<asManufacturedProduct>
																			<subjectOf typeCode="SBJ">
																				<characteristic classCode="OBS" moodCode="EVN">
																					<code code="C54026" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Device Problem"/>
																					<!--  The example uses the existing code within the NCI Thesaurus. -->
																					<value xsi:type="BL" value="true"/>
																					<!--  Local extension to indicate a malfunction. -->
																				</characteristic>
																			</subjectOf>
																			<subjectOf typeCode="SBJ">
																				<characteristic classCode="OBS" moodCode="EVN">
																					<code code="C54451" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="FDA Device Problem Code Hierarchy"/>
																					<!--  The example uses the existing code within the NCI Thesaurus. -->
																					<value xsi:type="CE" code="ABCDEFG" codeSystem="2.16.840.1.113883.3.26.1.1"/>
																					<!--  Local extension to indicate the problem type. The code will only be validated for format -->
																				</characteristic>
																			</subjectOf>
																			<subjectOf typeCode="SBJ">
																				<characteristic classCode="OBS" moodCode="EVN">
																					<code code="C54594" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type of Remedial Action ICSR Hierarchy"/>
																					<!--  The example uses the existing code within the NCI Thesaurus. -->
																					<value xsi:type="CE" code="6" codeSystem="2.16.840.1.113883.3.989.5.1.2.2.1.1.4" displayName="Inspection"/>
																					<!--  Local extension to indicate remedial action. -->
																				</characteristic>
																			</subjectOf>
																		</asManufacturedProduct>
																	</partProduct>
																</part>
															</kindOfProduct>
														</instanceOfKind>
													</consumable>
													<outboundRelationship2 typeCode="COMP">
														<substanceAdministration classCode="SBADM" moodCode="EVN">
															<effectiveTime nullFlavor="ASKU"/>
															<routeCode nullFlavor="ASKU"/>
															<performer typeCode="PRF">
																<assignedEntity classCode="ASSIGNED">
																	<code code="C16988" displayName="Physician Office" codeSystem="2.16.840.1.113883.3.26.1.1"/>
																	<!-- vaccination facility type code -->
																	<representedOrganization classCode="ORG" determinerCode="INSTANCE">
																		<name nullFlavor="NI"/>
																		<telecom nullFlavor="NI" value="tel"/>
																		<telecom nullFlavor="NI" value="fax"/>
																		<addr>
																			<streetAddressLine nullFlavor="NI"/>
																			<city nullFlavor="NI"/>
																			<state nullFlavor="NI"/>
																			<postalCode nullFlavor="NI"/>
																			<country nullFlavor="NI"/>
																		</addr>
																	</representedOrganization>
																</assignedEntity>
															</performer>
														</substanceAdministration>
													</outboundRelationship2>
													<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 xsi:type="BL" nullFlavor="NI"/>
														</observation>
													</inboundRelationship>
												</substanceAdministration>
											</component>
										</organizer>
									</subjectOf2>
								</primaryRole>
							</subject1>
							<component typeCode="COMP">
								<causalityAssessment classCode="OBS" moodCode="EVN">
									<code code="20" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="interventionCharacterization"/>
									<value xsi:type="CE" code="3" displayName="Interacting" codeSystem="2.16.840.1.113883.3.989.2.1.1.13"/>
									<!-- Characterisation of Drug Role Drug #1 -->
									<subject2 typeCode="SUBJ">
										<productUseReference classCode="SBADM" moodCode="EVN">
											<id root="3c91b4d5-e039-4a7a-9c30-67671b0ef9e4"/>
										</productUseReference>
									</subject2>
								</causalityAssessment>
							</component>
						</adverseEventAssessment>
					</component>
					<component typeCode="COMP">
						<observationEvent classCode="OBS" moodCode="EVN">
							<code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="additionalDocumentsAvailable"/>
							<value xsi:type="BL" value="false"/>
							<!--  Are Additional Documents Available? -->
						</observationEvent>
					</component>
					<component typeCode="COMP">
						<observationEvent classCode="OBS" moodCode="EVN">
							<code code="23" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="localCriteriaForExpedited"/>
							<value xsi:type="BL" value="false"/>
							<!--  Does This Case Fulfil the Local Criteria for an Expedited Report? -->
						</observationEvent>
					</component>
					<component typeCode="COMP">
						<observationEvent classCode="OBS" moodCode="EVN">
							<code code="C54588" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="localCriteriaReportType"/>
							<value xsi:type="CE" code="5" codeSystem="2.16.840.1.113883.3.989.5.1.2.2.1.1.1" displayName="Malfunction Only(No AE)"/>
							<!--  Local extension to record the type of reporting.  -->
						</observationEvent>
					</component>
					<component typeCode="COMP">
						<observationEvent classCode="OBS" moodCode="EVN">
							<code code="C156384" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Combination Product Report Indicator"/>
							<value xsi:type="BL" value="true"/>
							<!--  Local extension to indicate a combination product is included in the report. -->
						</observationEvent>
					</component>
					<outboundRelationship typeCode="SPRT">
						<relatedInvestigation classCode="INVSTG" moodCode="EVN">
							<code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" displayName="initialReport"/>
							<subjectOf2 typeCode="SUBJ">
								<controlActEvent classCode="CACT" moodCode="EVN">
									<author typeCode="AUT">
										<assignedEntity classCode="ASSIGNED">
											<code code="1" displayName="regulator" codeSystem="2.16.840.1.113883.3.989.2.1.1.3"/>
											<!--  First Sender of This Case -->
										</assignedEntity>
									</author>
								</controlActEvent>
							</subjectOf2>
						</relatedInvestigation>
					</outboundRelationship>
					<outboundRelationship typeCode="SPRT">
						<priorityNumber value="1"/>
						<!-- Primary Source for Regulatory Purposes #1 -->
						<relatedInvestigation classCode="INVSTG" moodCode="EVN">
							<code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" displayName="sourceReport"/>
							<subjectOf2 typeCode="SUBJ">
								<controlActEvent classCode="CACT" moodCode="EVN">
									<author typeCode="AUT">
										<assignedEntity classCode="ASSIGNED">
											<addr>
												<streetAddressLine>123 Main St.</streetAddressLine>
												<streetAddressLine>Apartment 4G</streetAddressLine>
												<!-- Reporter's Street #1 -->
												<city>Anytown</city>
												<!-- Reporter's City #1 -->
												<state>TX</state>
												<!-- Reporter's State or Province #1 -->
												<postalCode>87654</postalCode>
												<!-- Reporter's Postcode #1 -->
												<county>AL00</county>
											</addr>
											<telecom nullFlavor="ASKU" value="tel"/>
											<telecom nullFlavor="NASK" value="mailto"/>
											<!--  Reporter's Telephone #1 -->
											<assignedPerson classCode="PSN" determinerCode="INSTANCE">
												<name>
													<prefix>Dr.</prefix>
													<!--  Reporter's Title #1 -->
													<given>Jerome</given>
													<!--  Reporter's Given Name #1 -->
													<given>James</given>
													<!-- Reporter's Middle Name #1 -->
													<family>Jacobs</family>
													<!--  Reporter's Family Name #1 -->
												</name>
												<asQualifiedEntity classCode="QUAL">
													<code code="1" displayName="Physician" codeSystem="2.16.840.1.113883.3.989.2.1.1.6"/>
													<!-- Qualification #1 -->
												</asQualifiedEntity>
												<asLocatedEntity classCode="LOCE">
													<location classCode="COUNTRY" determinerCode="INSTANCE">
														<code code="US" codeSystem="1.0.3166.1.2.2"/>
														<!--  Reporter's Country Code #1 -->
													</location>
												</asLocatedEntity>
											</assignedPerson>
											<representedOrganization classCode="ORG" determinerCode="INSTANCE">
												<name>Reporting</name>
												<!--  Reporter's Department #1 -->
												<assignedEntity classCode="ASSIGNED">
													<representedOrganization classCode="ORG" determinerCode="INSTANCE">
														<name>Pharma Company</name>
														<!--  Reporter's Organisation #1 -->
													</representedOrganization>
												</assignedEntity>
											</representedOrganization>
										</assignedEntity>
									</author>
								</controlActEvent>
							</subjectOf2>
						</relatedInvestigation>
					</outboundRelationship>
					<outboundRelationship typeCode="SPRT">
						<relatedInvestigation classCode="INVSTG" moodCode="EVN">
							<code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" displayName="sourceReport"/>
							<subjectOf2 typeCode="SUBJ">
								<controlActEvent classCode="CACT" moodCode="EVN">
									<author typeCode="AUT">
										<assignedEntity classCode="ASSIGNED">
											<addr>
												<streetAddressLine>89 Central Ave</streetAddressLine>
												<streetAddressLine>Cubby No 3</streetAddressLine>
												<!--  Reporter's Street -->
												<city>Anytown</city>
												<!--  Reporter's City -->
												<state>MD</state>
												<!--  Reporter's State or Province -->
												<postalCode>01340</postalCode>
												<!--Reporter's Postcode -->
												<county>AL00</county>
											</addr>
											<telecom nullFlavor="ASKU" value="tel"/>
											<telecom nullFlavor="NASK" value="mailto"/>
											<!-- : Reporter's Telephone -->
											<assignedPerson classCode="PSN" determinerCode="INSTANCE">
												<name>
													<prefix>Professor</prefix>
													<!-- Reporter's Title -->
													<given>Ronald</given>
													<!-- : Reporter's Given Name -->
													<given>Robert</given>
													<!--  Reporter's Middle Name -->
													<family>Rhodes</family>
													<!--  Reporter's Family Name -->
												</name>
												<asQualifiedEntity classCode="QUAL">
													<code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.6"/>
													<!-- Qualification -->
												</asQualifiedEntity>
												<asLocatedEntity classCode="LOCE">
													<location classCode="COUNTRY" determinerCode="INSTANCE">
														<code code="US" codeSystem="1.0.3166.1.2.2"/>
														<!--  Reporter's Country Code -->
													</location>
												</asLocatedEntity>
											</assignedPerson>
											<representedOrganization classCode="ORG" determinerCode="INSTANCE">
												<name>Reporting</name>
												<!-- Reporter's Department -->
												<assignedEntity classCode="ASSIGNED">
													<representedOrganization classCode="ORG" determinerCode="INSTANCE">
														<name>Medium Size Pharma</name>
														<!-- Reporter's Organisation -->
													</representedOrganization>
												</assignedEntity>
											</representedOrganization>
										</assignedEntity>
									</author>
								</controlActEvent>
							</subjectOf2>
						</relatedInvestigation>
					</outboundRelationship>
					<subjectOf1 typeCode="SUBJ">
						<controlActEvent classCode="CACT" moodCode="EVN">
							<author typeCode="AUT">
								<assignedEntity classCode="ASSIGNED">
									<code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.7"/>
									<!--  Sender Type -->
									<addr>
										<streetAddressLine>49 Main St.</streetAddressLine>
										<streetAddressLine>Building 2030A</streetAddressLine>
										<!-- ]Sender's Street Address -->
										<city>Anytown</city>
										<!-- Sender's City -->
										<state>CT</state>
										<!-- Sender's State or Province -->
										<postalCode>23456</postalCode>
										<!--  Sender's Postcode -->
									</addr>
									<telecom value="tel:8884562344"/>
									<!-- Sender's Telephone -->
									<telecom value="fax:6109991122"/>
									<!--  Sender's Fax -->
									<telecom value="mailto:emailAddress@company.com"/>
									<!-- Sender's E-mail Address -->
									<assignedPerson classCode="PSN" determinerCode="INSTANCE">
										<name>
											<prefix>Mr</prefix>
											<!-- Sender's Title -->
											<given>Charles</given>
											<!--  Sender's Given Name -->
											<given>Castile</given>
											<!-- Sender's Middle Name -->
											<family>Conner</family>
											<!-- : Sender's Family Name -->
										</name>
										<asLocatedEntity classCode="LOCE">
											<location classCode="COUNTRY" determinerCode="INSTANCE">
												<code code="US" codeSystem="1.0.3166.1.2.2"/>
												<!-- Sender's Country Code -->
											</location>
										</asLocatedEntity>
									</assignedPerson>
									<representedOrganization classCode="ORG" determinerCode="INSTANCE">
										<name>Management</name>
										<!--  Sender's Department -->
										<assignedEntity classCode="ASSIGNED">
											<representedOrganization classCode="ORG" determinerCode="INSTANCE">
												<name>Big Pharma</name>
												<!-- Sender's Organisation -->
											</representedOrganization>
										</assignedEntity>
									</representedOrganization>
								</assignedEntity>
							</author>
						</controlActEvent>
					</subjectOf1>
					<subjectOf1 typeCode="SUBJ">
						<controlActEvent classCode="CACT" moodCode="EVN">
							<id assigningAuthorityName="Reporting Ltd Corporation" extension="FR-RPTLTD-15998" root="2.16.840.1.113883.3.989.2.1.3.3"/>
							<!--  Source(s) of the Case Identifier (repeat as necessary) #1 -->
							<!--  Case Identifier(s) #1 -->
						</controlActEvent>
					</subjectOf1>
					<subjectOf1 typeCode="SUBJ">
						<controlActEvent classCode="CACT" moodCode="EVN">
							<id assigningAuthorityName="European Medicines Agency" extension="EU-EMA-999999" root="2.16.840.1.113883.3.989.2.1.3.3"/>
							<!--  Source(s) of the Case Identifier (repeat as necessary) -->
							<!--  Case Identifier(s) -->
						</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"/>
							<value xsi:type="CE" code="1" displayName="Spontaneous report" codeSystem="2.16.840.1.113883.3.989.2.1.1.2"/>
							<!-- Type of Report -->
						</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" value="true"/>
							<!-- Other Case Identifiers in Previous Transmissions -->
						</investigationCharacteristic>
					</subjectOf2>
					<subjectOf2 typeCode="SUBJ">
						<investigationCharacteristic classCode="OBS" moodCode="EVN">
							<code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" displayName="Nullification/Amendment Code"/>
							<value xsi:type="CE" code="1" displayName="Nullification" codeSystem="2.16.840.1.113883.3.989.2.1.1.5"/>
							<!--  Report Nullification / Amendment -->
						</investigationCharacteristic>
					</subjectOf2>
					<subjectOf2 typeCode="SUBJ">
						<investigationCharacteristic classCode="OBS" moodCode="EVN">
							<code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" displayName="Nullification/Amendment Reason"/>
							<value xsi:type="CE">
								<originalText>A text reason for ammending the document</originalText>
								<!--  Reason for Nullification / Amendment -->
							</value>
						</investigationCharacteristic>
					</subjectOf2>
				</investigationEvent>
			</subject>
		</controlActProcess>
	</PORR_IN049016UV>
	<!-- Message #1 -->
	<!-- Message -->
	<!-- PORR_IN049016UV 
	Only a stub is provided for the second message.
   /PORR_IN049016UV -->
	<!-- Message -->
	<receiver typeCode="RCV">
		<device classCode="DEV" determinerCode="INSTANCE">
			<id extension="CBER_VAERS" root="2.16.840.1.113883.3.989.2.1.3.14"/>
			<!-- Batch Receiver Identifier -->
		</device>
	</receiver>
	<sender typeCode="SND">
		<device classCode="DEV" determinerCode="INSTANCE">
			<id extension="123456789" root="2.16.840.1.113883.3.989.2.1.3.13"/>
			<!-- Batch Sender Identifier -->
		</device>
	</sender>
</MCCI_IN200100UV01>
