<?xml version="1.0" encoding="UTF-8"?>
<!-- #3:  Manufacturer submits a report that includes a vaccine that is a combination product.   There was a malfunction, but no Adverse Event.    
                             Vaccine A: Made by sender and a combo product which had a malfunction. Vaccine was administered to a patient.
 -->
<MCCI_IN200100UV01 ITSVersion="XML_1.0" xsi:schemaLocation="urn:hl7-org:v3  C:\BAES_eVARS\Final_ICSR\4_ICH_ICSR_Schema_Files\multicacheschemas/MCCI_IN200100UV01.xsd" xmlns="urn:hl7-org:v3" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
	<id extension="CombProd2020Scenario3-4069-a2dd-08002b30309d" root="2.16.840.1.113883.3.989.2.1.3.22"/>
	<!-- N.1.2 Batch Number -->
	<creationTime value="20101214151617-0500"/>
	<!-- N.1.5 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"/>
	<!--N.1.1: Type of Messages in Batch -->
	<!-- Message #1 -->
	<PORR_IN049016UV>
		<id extension="21ec1492-3aea-4069-a2ab-08002b30309d" root="2.16.840.1.113883.3.989.2.1.3.1"/>
		<!-- N.2.r.1: Message Identifier -->
		<creationTime value="20140714151617-0500"/>
		<!-- N.2.r.4: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"/>
				<!-- N.2.r.3:Message Receiver Identifier -->
			</device>
		</receiver>
		<sender typeCode="SND">
			<device classCode="DEV" determinerCode="INSTANCE">
				<id extension="4567AB89012" root="2.16.840.1.113883.3.989.2.1.3.11"/>
				<!-- N.2.r.2: 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="20140714151617-0500"/>
			<!-- C.1.2:  Date of Creation (with UTC offset)-->
			<subject typeCode="SUBJ">
				<investigationEvent classCode="INVSTG" moodCode="EVN">
					<id extension="21ec1492-3aea-4069-a2ab-08002b30309d" root="2.16.840.1.113883.3.989.2.1.3.1"/>
					<!-- C.1.1: Sender's (case) Safety Report Unique Identifier -->
					<id extension="US-APHARMA-8744554B" root="2.16.840.1.113883.3.989.2.1.3.2"/>
					<!-- C.1.8.1: Worldwide Unique Case Identification Number -->
					<code code="PAT_ADV_EVNT" codeSystem="2.16.840.1.113883.5.4"/>
					<text>Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information
					</text>
					<!-- H.1: Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information -->
					<statusCode code="active"/>
					<effectiveTime>
						<low value="201401012112-0500"/>
						<!-- C.1.4: Date Report Was First Received from Source -->
					</effectiveTime>
					<availabilityTime value="20090101"/>
					<!-- C.1.5: 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>Mr.</prefix>
											<given>John</given>
											<family>Doe</family>
										</name>
										<!-- D.1 Patient (name or initials)  and VAERS Patient Information -->
										<telecom value="tel:8974445555"/>
										<telecom value="mailto:emailAddress@site.com"/>
										<administrativeGenderCode code="1" displayName="Male" codeSystem="1.0.5218"/>
										<!-- D.5: Sex -->
										<birthTime value="20010615"/>
										<!-- D.2.1: Date of Birth -->
										<addr>
											<streetAddressLine>124 Any Street</streetAddressLine>
											<city>Center City</city>
											<state>AL</state>
											<county>AL10</county>
											<postalCode>12344123</postalCode>
											<country>US</country>
										</addr>
										<!--VAERS Patient Address-->
									</player1>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="C17049" displayName="Race" codeSystem="2.16.840.1.113883.3.26.1.1"/>
											<value xsi:type="CE" code="C41260" displayName="Asian" codeSystem="2.16.840.1.113883.3.26.1.1"/>
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="C17049" displayName="Race" codeSystem="2.16.840.1.113883.3.26.1.1"/>
											<value xsi:type="CE" code="C41219" displayName="Native Hawaiian or Other Pacific Islander" codeSystem="2.16.840.1.113883.3.26.1.1"/>
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="C16564" displayName="Ethnic Group" codeSystem="2.16.840.1.113883.3.26.1.1"/>
											<value xsi:type="CE" code="C41222" displayName="Not Hispanic or Latino" codeSystem="2.16.840.1.113883.3.26.1.1"/>
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="C102468" displayName="Illness at time of vaccination" codeSystem="2.16.840.1.113883.3.26.1.1"/>
											<value xsi:type="CE" code="87442323" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
										</observation>
									</subjectOf2>
									<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>
													<!-- 	D.7.2: Text for Relevant Medical History and Concurrent Conditions (not including reaction / event) -->
												</observation>
											</component>
										</organizer>
									</subjectOf2>
									
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<!--id root="154eb889-958b-45f2-a02f-42d4d6f4657f"/-->
											<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"/>
											<!-- E.i.2.1a:  MedDRA Version for Reaction / Event -->
											<!-- E.i.2.1b:  Reaction / Event (MedDRA code) -->
											<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"/>
											<!-- G.k Drug(s) Information (repeat as necessary) -->
											<component typeCode="COMP">
												<substanceAdministration classCode="SBADM" moodCode="EVN">
													<id root="59d6f5ce-3b3b-45c7-92dd-69e06730c2b7"/>
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
														<productInstanceInstance classCode="MMAT" determinerCode="INSTANCE">
															<part>
																<partProductInstance>
																	<lotNumberText>123444-AB</lotNumberText>
																	<!--G.K.12.r.9  Device Lot number -->
																</partProductInstance>
															</part>
														</productInstanceInstance>
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<code code="894444-28525-765" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="201411011202"/>
																<name>Vaccine A</name>
																<!-- G.k.2.2: Medicinal Product Name as Reported by the Primary Source -->
																<asManufacturedProduct classCode="MANU">
																	<subjectOf typeCode="SBJ">
																		<approval classCode="CNTRCT" moodCode="EVN">
																			<id extension="BLA012567" root="2.16.840.1.113883.3.989.2.1.3.4"/>
																			<!-- G.k.3.1: Authorisation / Application Number -->
																			<holder typeCode="HLD">
																				<role classCode="HLD">
																					<playingOrganization classCode="ORG" determinerCode="INSTANCE">
																						<name>Big Biopharma Vaccines</name>
																						<!--G.k.3.3: Name of Holder / Applicant -->
																					</playingOrganization>
																				</role>
																			</holder>
																			<author typeCode="AUT">
																				<territorialAuthority classCode="TERR">
																					<territory classCode="NAT" determinerCode="INSTANCE">
																						<code code="US" codeSystem="1.0.3166.1.2.2"/>
																						<!-- G.k.3.2: Country of Authorisation / Application -->
																					</territory>
																				</territorialAuthority>
																			</author>
																		</approval>
																	</subjectOf>
																</asManufacturedProduct>
																<part classCode="PART">
																	<partProduct classCode="DEV" determinerCode="KIND">
																		<code code="FMF" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Syringe, Piston"/>
																		<!-- FDA.G.k.12.r.6 Device Product Code -->
																		<!-- FDA Device Component Hierarchy  -->
																		<name>Brand Name</name>
																		<!--FDA.G.k.12.r.4 Device Brand Name  -->
																		<name>Common Device Name</name>
																		<!--FDA.G.k.12.r.5 Common device name as displayname. -->
																		<asManufacturedProduct classCode="MANU">
																			<manufacturerOrganization classCode="ORG" determinerCode="INSTANCE">
																				<name>Manufacturer Name</name>
																				<addr>
																					<city>Manufacturer City</city>
																					<state>Manufacturer State</state>
																					<country>US</country>
																				</addr>
																			</manufacturerOrganization>
																			<!-- Manufacture information -->
																			<subjectOf typeCode="SBJ">
																				<characteristic classCode="OBS" moodCode="EVN">
																					<code code="C54026" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Malfunction"/>
																					<!--The example uses the existing code within the NCI Thesaurus. -->
																					<value xsi:type="BL" value="true"/>
																					<!--  FDA.G.k.12.r.1 Malfunction -->
																					<!--  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"/>
																					<!--  FDA.G.k.12.r.3 Device Problem Code The example uses the existing code within the NCI Thesaurus. -->
																				</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="DEVICE2" codeSystem="2.16.840.1.113883.3.26.1.1"/>
																					<!--  FDA.G.k.12.r.3 Device Problem Code The example uses the existing code within the NCI Thesaurus. -->
																					<!--  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="C54595" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="Device Usage"/>
																				     <value xsi:type="CE" code="2" codeSystem="2.16.840.1.113883.3.989.5.1.2.2.1.1.4" displayName="Reuse"/>
																					<!--  Devive Usage G.K.12.r.8 -->
																				</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>
																			<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="5" codeSystem="2.16.840.1.113883.3.989.5.1.2.2.1.1.4" displayName="Notification"/>
																					<!--  Local extension to indicate remedial action. -->
																				</characteristic>
																			</subjectOf>
																			<subjectOf typeCode="SBJ">
																				<characteristic classCode="OBS" moodCode="EVN">
																					<code code="C54592" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type of Follow Up Report"/>
																					<!--  The example uses the existing code within the NCI Thesaurus. -->
																					<value xsi:type="CE" code="2" codeSystem="2.16.840.1.113883.3.989.5.1.2.2.1.1.5" displayName="Additional Information"/>
																					<!--  Local extension to indicate type of followup. -->
																				</characteristic>
																			</subjectOf>
																			<subjectOf typeCode="SBJ">
																				<characteristic classCode="OBS" moodCode="EVN">
																					<code code="C54592" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type of Follow Up Report"/>
																					<!--  The example uses the existing code within the NCI Thesaurus. -->
																					<value xsi:type="CE" code="4" codeSystem="2.16.840.1.113883.3.989.5.1.2.2.1.1.5" displayName="Device evaluation"/>
																					<!--  Local extension to indicate type of followup. -->
																				</characteristic>
																			</subjectOf>
																		</asManufacturedProduct>
																	</partProduct>
																</part>
															</kindOfProduct>
														</instanceOfKind>
													</consumable>
													<performer typeCode="PRF">
														<assignedEntity classCode="ASSIGNED">
															<code codeSystem="2.16.840.1.113883.3.989.5.1.2.2.1.1.6" code="1" displayName="Health Professional"/>
															<!-- Device Operator -->
														</assignedEntity>
													</performer>
													<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"/>
																			<!-- G.k.2.4: Identification of the Country Where the Drug was obstained -->
																		</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="1" displayName="suspect" codeSystem="2.16.840.1.113883.3.989.2.1.1.13"/>
									<!-- G.k.1:Characterisation of Drug Role Drug -->
									<subject2 typeCode="SUBJ">
										<productUseReference classCode="SBADM" moodCode="EVN">
											<id root="59d6f5ce-3b3b-45c7-92dd-69e06730c2b7"/>
											<!-- Product #1 -->
										</productUseReference>
									</subject2>
								</causalityAssessment>
							</component>
							<component1 typeCode="COMP">
								<observationEvent classCode="OBS" moodCode="EVN">
									<code code="10" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="comment"/>
									<value xsi:type="ED">H.2</value>
									<!-- H.2: Reporter's Comments -->
									<author typeCode="AUT">
										<assignedEntity classCode="ASSIGNED">
											<code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.21" displayName="sourceReporter"/>
										</assignedEntity>
									</author>
								</observationEvent>
							</component1>
							<component1 typeCode="COMP">
								<observationEvent classCode="OBS" moodCode="EVN">
									<code code="10" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="comment"/>
									<value xsi:type="ED">H.4</value>
									<!-- H.4: Sender's Comments -->
									<author typeCode="AUT">
										<assignedEntity classCode="ASSIGNED">
											<code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.21" displayName="sender"/>
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									</author>
								</observationEvent>
							</component1>
						</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"/>
							<!--  C.1.6.1:  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"/>
							<!--  C.1.7:  Does This Case Fulfil the Local Criteria for an Expedited Report? -->
						</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"/>
							<!--FDA.C.1.12 Combination Product Report Indicator  -->
							<!--  Local extension to indicate a combination product is included in the 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)"/>
							<!--C.1.7.1 Local Criteria Report Type   -->
						</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"/>
											<!--  C.1.8.2: First Sender of This Case -->
										</assignedEntity>
									</author>
								</controlActEvent>
							</subjectOf2>
						</relatedInvestigation>
					</outboundRelationship>
					<outboundRelationship typeCode="SPRT">
						<priorityNumber value="1"/>
						<!-- C.2.r.5: 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>13 Elm St.</streetAddressLine>
												<!-- C.2.r.2.3: Reporter's Street #1 -->
												<city>Metropolis</city>
												<!-- C.2.r.2.4: Reporter's City #1 -->
												<state>UT</state>
												<!-- C.2.r.2.5: Reporter's State or Province #1 -->
												<postalCode>65498</postalCode>
												<!-- C.2.r.2.6:  Reporter's Postcode #1 -->
												<county>Center</county>
											</addr>
											<telecom value="tel:6102227777"/>
											<!--  C.2.r.2.7:  Reporter's Telephone #1 -->
											<telecom value="mailto:alladdresses@site.com"/>
											<!-- Reporter's email - FDA Regional element -->
											<assignedPerson classCode="PSN" determinerCode="INSTANCE">
												<name>
													<prefix>Doctor</prefix>
													<!--  C.2.r.1.1: Reporter's Title #1 -->
													<given>Roger</given>
													<!--  C.2.r.1.2:  Reporter's Given Name #1 -->
													<!-- C.2.r.1.3: Reporter's Middle Name #1 -->
													<family>Robertson</family>
													<!--  C.2.r.1.4: 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"/>
													<!-- C.2.r.4 Qualification #1 -->
												</asQualifiedEntity>
												<asLocatedEntity classCode="LOCE">
													<location classCode="COUNTRY" determinerCode="INSTANCE">
														<code code="US" codeSystem="1.0.3166.1.2.2"/>
														<!--  C.2.r.3: Reporter's Country Code #1 -->
													</location>
												</asLocatedEntity>
											</assignedPerson>
										</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"/>
									<!--  C.3.1:  Sender Type -->
									<addr>
										<streetAddressLine>49 Main St. Building 2030A</streetAddressLine>
										<!-- C.3.4.1:Sender's Street Address -->
										<city>Anytown</city>
										<!-- Sender's City -->
										<state>CT</state>
										<!-- C.3.4.2  Sender's State or Province -->
										<postalCode>23456</postalCode>
										<!--  C.3.4.3: Sender's Postcode -->
									</addr>
									<telecom value="tel:6108887766"/>
									<!-- C.3.4.6:  Sender's Telephone -->
									<telecom value="fax:6109991122"/>
									<!--  C.3.4.7: Sender's Fax -->
									<telecom value="mailto:emailAddress@company.com"/>
									<!-- C.3.4.8:  Sender's E-mail Address -->
									<assignedPerson classCode="PSN" determinerCode="INSTANCE">
										<name>
											<prefix>Mr</prefix>
											<!-- C.3.3.2:  Sender's Title -->
											<given>Charles Castile</given>
											<!--  C.3.3.3:  Sender's Given Name -->
											<family>Conner</family>
											<!-- C.3.3.5: Sender's Family Name -->
										</name>
										<asLocatedEntity classCode="LOCE">
											<location classCode="COUNTRY" determinerCode="INSTANCE">
												<code code="US" codeSystem="1.0.3166.1.2.2"/>
												<!-- C.3.4.5:  Sender's Country Code -->
											</location>
										</asLocatedEntity>
									</assignedPerson>
									<representedOrganization classCode="ORG" determinerCode="INSTANCE">
										<name>Management</name>
										<!--  C.3.3.1: Sender's Department -->
										<assignedEntity classCode="ASSIGNED">
											<representedOrganization classCode="ORG" determinerCode="INSTANCE">
												<name>Big BipPharma Vaccines</name>
												<!-- C.3.2: Sender's Organisation -->
											</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"/>
							<value xsi:type="CE" code="1" displayName="Spontaneous report" codeSystem="2.16.840.1.113883.3.989.2.1.1.2"/>
							<!--  C.1.3:  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" nullFlavor="NI"/>
							<!-- C.1.9: Other Case Identifiers in Previous Transmissions -->
						</investigationCharacteristic>
					</subjectOf2>
				</investigationEvent>
			</subject>
		</controlActProcess>
	</PORR_IN049016UV>
	<!-- Message #1 -->
	<!-- Message #2-->
	<!-- PORR_IN049016UV 
	Only a stub is provided for Message #2.
   /PORR_IN049016UV -->
	<!-- Message #2-->
	<receiver typeCode="RCV">
		<device classCode="DEV" determinerCode="INSTANCE">
			<id extension="CBER_VAERS" root="2.16.840.1.113883.3.989.2.1.3.14"/>
			<!-- N.1.4:Batch Receiver Identifier -->
		</device>
	</receiver>
	<sender typeCode="SND">
		<device classCode="DEV" determinerCode="INSTANCE">
			<id extension="4567AB89012" root="2.16.840.1.113883.3.989.2.1.3.13"/>
			<!-- N.1.3: Batch Sender Identifier -->
		</device>
	</sender>
</MCCI_IN200100UV01>
