<?xml version="1.0" encoding="UTF-8"?>
<!-- #1:  Manufacturer submits a vaccine report with 3 vaccines that does not include any combo products. There was an AE.
                             Vaccine A: Made by sender.
                             Vaccine B: Made by Sender 
                             Vaccine C:  Made by someone else. 
 -->
<MCCI_IN200100UV01 ITSVersion="XML_1.0" xsi:schemaLocation="urn:hl7-org:v3  ../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="30jan2021-3aea-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">
										<organizer classCode="CATEGORY" moodCode="EVN">
											<code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="drugHistory"/>
											<component typeCode="COMP">
												<substanceAdministration classCode="SBADM" moodCode="EVN">
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<code code="59762-2858" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="201411011202"/>
																<name>CureAll</name>
																<!--	D.8.r.1: Name of Drug as Reported #1 -->
															</kindOfProduct>
														</instanceOfKind>
													</consumable>
												</substanceAdministration>
											</component>
										</organizer>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<organizer classCode="CATEGORY" moodCode="EVN">
											<code code="C102467" displayName="Other Vaccinations Given within Four Weeks" codeSystem="2.16.840.1.113883.3.26.1.1"/>
											<!--VAERS Vaccines Given within 4 Weeks-->
											<component typeCode="COMP">
												<substanceAdministration classCode="SBADM" moodCode="EVN">
												<effectiveTime xsi:type="IVL_TS">
														<low value="200801011041"/>
													</effectiveTime>
												<approachSiteCode code="C105633" displayName="Left Arm" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemVersion="20141030"/>
													<routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="oral" codeSystemVersion="2014.10.30"/>
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<code code="59762-2858" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="201411011202"/>
																<name>Measles</name>
															</kindOfProduct>
														</instanceOfKind>
													</consumable>
												</substanceAdministration>
											</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 value="20141010"/>
												<!--			 Date of Start of Reaction / Event -->
											</effectiveTime>
											<value xsi:type="CE" code="10027940" 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" value="true"/>
													<!--  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" value="true"/>
													<!-- 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" value="true"/>
													<!-- 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" value="true"/>
													<!-- 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="3" displayName="not recovered/not resolved/ongoing" 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">
													<!-- Product #1 -->
													<id root="68d6f5ce-3b3b-45c7-92dd-69e06730c3a9"/>
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<code code="59762-2858" 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="BLA012345" 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>
																<ingredient classCode="ACTI">
																	<ingredientSubstance classCode="MMAT" determinerCode="KIND">
																		<name>Vaccinia virus</name>
																		<!-- G.k.2.3.r.1: Substance / Specified Substance Name  -->
																	</ingredientSubstance>
																</ingredient>
															</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"/>
																			<!-- 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>
											<component typeCode="COMP">
												<substanceAdministration classCode="SBADM" moodCode="EVN">
													<!-- Product #2 -->
													<id root="59d6f5ce-3b3b-45c7-92dd-69e06730c2b7"/>
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<code code="894444-28525-765" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="201411011202"/>
																<name>Vaccine B</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>
															</kindOfProduct>
														</instanceOfKind>
													</consumable>
												</substanceAdministration>
											</component>
											<component typeCode="COMP">
												<substanceAdministration classCode="SBADM" moodCode="EVN">
													<!-- Product #3 -->
													<id root="40d6f5ce-3b3b-45c7-92dd-69e06730c2b6"/>
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<name>Vaccine C</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">
																			<holder typeCode="HLD">
																				<role classCode="HLD">
																					<playingOrganization classCode="ORG" determinerCode="INSTANCE">
																						<name>Vaccine Manufacturer</name>
																						<!--G.k.3.3: Name of Holder / Applicant -->
																					</playingOrganization>
																				</role>
																			</holder>
																		</approval>
																	</subjectOf>
																</asManufacturedProduct>
															</kindOfProduct>
														</instanceOfKind>
													</consumable>
												</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="68d6f5ce-3b3b-45c7-92dd-69e06730c3a9"/>
											<!-- Product #1 -->
										</productUseReference>
									</subject2>
								</causalityAssessment>
							</component>
							<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 #2 -->
										</productUseReference>
									</subject2>
								</causalityAssessment>
							</component>
							<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="40d6f5ce-3b3b-45c7-92dd-69e06730c2b6"/>
											<!-- Product #3 -->
										</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"/>
										</assignedEntity>
									</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="true"/>
							<!--  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="C54588" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="localCriteriaReportType"/>
							<!--  A newly added NCI code.-->
							<value xsi:type="CE" code="C53576" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="15Day"/>
							<!--C.1.7.1 Local Criteria Report Type   -->
							<!--  Local extension to record the type of reporting. The example shows dummy OIDs for the observation code 
								and observation value code system.  It is expected that the needed values will be added to the NCI Thesuarus   -->
						</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"/>
							<!--  A newly added NCI code. -->
							<value xsi:type="BL" value="false"/>
							<!--FDA.C.1.12 Combination Product Report Indicator  -->
							<!--  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"/>
											<!--  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>Utah</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>
