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					<text mediaType="text/plain">Case Narrative Including Clinical Course, Therapeutic Measures,
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							<title>Sample Autopsy Report</title>
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								<reference value="SUMMARY OF CLINICAL HISTORY.txt"/>
The patient was a 35 year old African American male with no significant past medical history
who called EMS with shortness of breath and chest pain. Upon EMS arrival, patient was
tachypneic at 40 breaths per minute with oxygen saturation of 90%. At the scene, EMS
administered breathing treatments and checked lung sounds that did not reveal any evidence of
fluid in the lung fields. EMS also reports patient was agitated upon their arrival at his residence.
Two minutes after arrival at UTMB at 1500, the patient became unresponsive, apneic, and had
oxygen saturations from 80-90%. The patient’s heart rate decreased to asystole, was intubated
with good breath sounds and air movement. Patient then had wide complex bradycardia and
ACLS protocol for pulseless electrical activity was followed for 45 minutes. The patient was
administered TPA with no improvement. Bedside echocardiogram showed no pericardial
effusion. The patient was administered D5W, Narcan, and multiple rounds of epinephrine and
atropine, calcium chloride, and sodium bicarbonate. The patient had three episodes of
ventricular trachycardia/fibrillation with cardioversion/defibrillation resulting in asystole. The
patient was pronounced dead at 1605 with fixed, dilated pupils, no heart sounds, no pulse and no
spontaneous respirations.
DESCRIPTION OF GROSS LESIONS:
EXTERNAL EXAMINATION: The body is that of a 35 year old well developed, well
nourished male. There is no peripheral edema of the extremities. There is an area of
congestion/erythema on the upper chest and anterior neck. There are multiple small areas of
hemorrhage bilaterally in the conjunctiva. A nasogastric tube and endotracheal tube are in place.
There is an intravenous line in the right hand and left femoral region. The patient has multiple
lead pads on the thorax. The patient has no other major surgical scars.
INTERNAL EXAMINATION (BODY CAVITIES): The right and left pleural cavity contains
10 ml of clear fluid with no adhesions. The pericardial sac is yellow, glistening without
adhesions or fibrosis and contains 30 ml of a straw colored fluid. There is minimal fluid in the
peritoneal cavity.
HEART: The heart is large with a normal shape and a weight of 400 grams. The pericardium is
intact. The epicardial fat is diffusely firm. As patient was greater than 48 hours post mortem, no
TTC staining was utilized. Upon opening the heart was grossly normal without evidence of
infarction. There were slightly raised white plaques in the left ventricle wall lining. The left
ventricle measures 2.2 cm, the right ventricle measures 0.2 cm, the tricuspid ring measures 11
cm, the pulmonic right measures 8 cm, the mitral ring measures 10.2 cm, and the aortic ring
measures 7 cm. The foramen ovale is closed. The circulation is left dominant. Examination of
the great vessels of the heart reveals minimal atherosclerosis with the area of greatest stenosis
(20% stenosis) at the bifurcation of the LAD.
AORTA: There is minimal atherosclerosis with no measurable plaques along the full length of
the ascending and descending aorta.
LUNGS: The right lung weighed 630 grams, the left weighed 710 grams. The lung parenchyma
is pink without evidence of congestion of hemorrhage. The bronchi are grossly normal. In the
right lung, there are two large organizing thrombo-emboli. The first is located at the first branch
of the pulmonary artery with an older, organizing area adherent to the vessel wall measuring 1.0
x 1.0 x 2.5 cm. Surrounding this organizing area is a newer area of apparent thrombosis
completely occluding the bifurcation. The other large organizing, adherent embolus is located
further in out in the vasculature measuring approximately 1.0 x 1.0 x 1.5 cm. There are multiple
other emboli located in smaller pulmonary vessels that show evidence of distending the vessels
they are located inside.
GASTROINTESTINAL SYSTEM: The esophagus and stomach are normal in appearance
without evidence of ulcers or varices. The stomach contains approximately 800 ml, without
evidence of any pills o other non food stuff material. The pancreas shows a normal lobular cut
surface with evidence of autolysis. The duodenum, ileum, jejunum and colon are all grossly
normal without evidence of abnormal vasculature or diverticuli. An appendix is present and is
unremarkable. The liver weighs 2850 grams and the cut surface reveals a normal liver with no
fibrosis present grossly. The gallbladder is in place with a probe patent bile duct through to the
ampulla of Vater.
RETICULOENDOTHELIAL SYSTEM: The spleen is large weighing 340 grams, the cut
surface reveals a normal appearing white and red pulp. No abnormally large lymph nodes were
noted.
GENITOURINARY SYSTEM: The right kidney weighs 200 grams, the left weighs 210 grams.
The left kidney contains a 1.0 x 1.0 x 1.0 simple cyst containing a clear fluid. The cut surface
reveals a normal appearing cortex and medulla with intact calyces. The prostate and seminal
vessels were cut revealing normal appearing prostate and seminal vesicle tissue without evidence
of inflammation or embolus.
ENDOCRINE SYSTEM: The adrenal glands are in the normal position and weigh 8.0 grams on
the right and 11.6 grams on the left. The cut surface of the adrenal glands reveals a normal
appearing cortex and medulla. The thyroid gland weighs 12.4 grams and is grossly normal.
EXTREMITIES: Both legs and calves were measured and found to be very similar in
circumference. Both legs were also milked and produced no clots in the venous system.
CLINICOPATHOLOGIC CORRELATION
This patient died shortly after a previous pulmonary embolus completely occluded the right
pulmonary artery vasculature.
The most significant finding on autopsy was the presence of multiple old and new
thromboemboli in the pulmonary vasculature of the right lung. The autopsy revealed evidence of
multiple emboli in the right lung that were at least a few days old because the emboli that were
organizing were adherent to the vessel wall. In order to be adherent to the vessel wall, the
emboli must be in place long enough to evoke a fibroblast response, which takes at least a few
days. The fatal event was not the old emboli in the right lung, but rather the thrombosis on top of
the large saddle thrombus residing in the pulmonary artery. This created a high pressure
situation that the right ventricle could not handle resulting in cardiac dysfunction and ultimately
the patient’s demise.
Although this case is fairly straight forward in terms of what caused the terminal event, perhaps
the more interesting question is why a relatively healthy 35 year old man would develop a fatal
pulmonary embolism. Virchow’s triad suggests we should investigate endothelial injury, stasis
and a hypercoaguable state as possible etiologies. The age of the patient probably precludes
venous stasis as the sole reason for the embolus although it could have certainly contributed.
The autopsy revealed no evidence of endothelial damage in the pulmonary vasculature that
would have caused the occlusion. The next logical reason would be a hypercoagulable state.
Some possibilities include obesity, trauma, surgery, cancer, Factor V Leiden deficiency (as well
as other inherited disorders-prothrombin gene mutation, deficiencies in protein C, protein S, or
antithrombin III, and disorders of plasminogen), and Lupus anticoagulant. Of these risks factors,
obesity was the only risk factor the patient was known to have. The patient had no evidence of
trauma, surgery, cancer or the stigmata of SLE, therefore these are unlikely. Perhaps the most
fruitful search would be an examination of the genetic possibilities for a hypercoaguable state
(Factor V Leiden being the most common).
In summary, this patient died of a pulmonary embolism, the underlying cause of which is
currently undetermined. A definitive diagnosis may be ascertained with either genetic or other
laboratory tests and a more detailed history.
SUMMARY AND REFLECTION:
What I learned from this autopsy: I learned that although a cause of death may sometimes be
obvious, the underlying mechanism for the death may still be elusive. This patient was an
otherwise completely healthy 35 year old man with one known risk factor for a hypercoaguable
state.
Remaining unanswered questions: Basically the cause of the hypercoaguable state is
undetermined. Once that question is answered I believe this autopsy will have done a great
service for the patient’s family.
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							<title>Medication Information</title>
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Author (last name first), "Article Title." Name of newspaper, city, state of publication. (date): edition if available, section, page number(s).
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														<substanceAdministration classCode="SBADM" moodCode="EVN">
															<effectiveTime xsi:type="IVL_TS">
																<low value="20090101151617-0500"/>
																<!-- Start Date #1 -->
																<high value="20090101"/>
																<!--  End Date #1 -->
															</effectiveTime>
															<consumable typeCode="CSM">
																<instanceOfKind classCode="INST">
																	<kindOfProduct classCode="MMAT" determinerCode="KIND">
																		<code code="65044-5208" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="12.0"/>
																		<!-- MPID Version Date / Number  -->
																		<!--  Medicinal Product Identifier (MPID)  -->
																		<name>Molds, Rusts and Smuts, Penicillium notatum</name>
																		<!--  Name of Drug as Reported  -->
																	</kindOfProduct>
																</instanceOfKind>
															</consumable>
															<outboundRelationship2 typeCode="RSON">
																<observation classCode="OBS" moodCode="EVN">
																	<code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="indication"/>
																	<value xsi:type="CE" code="10054929" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
																	<!-- MedDRA Version for Indication -->
																	<!--  Indication (MedDRA code)  -->
																</observation>
															</outboundRelationship2>
															<outboundRelationship2 typeCode="CAUS">
																<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"/>
																	</effectiveTime>
																	<value xsi:type="CE" code="10060051" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
																	<!-- MedDRA Version for Reaction -->
																	<!-- Reactions (MedDRA code)  -->
																</observation>
															</outboundRelationship2>
														</substanceAdministration>
													</component>
													<component typeCode="COMP">
														<substanceAdministration classCode="SBADM" moodCode="EVN">
															<effectiveTime xsi:type="IVL_TS">
																<low value="200901"/>
																<!-- Start Date -->
																<high value="200903"/>
																<!-- End Date -->
															</effectiveTime>
															<consumable typeCode="CSM">
																<instanceOfKind classCode="INST">
																	<kindOfProduct classCode="MMAT" determinerCode="KIND">
																		<code code="14505-488" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="12.0"/>
																		<!-- MPID Version Date / Number  -->
																		<!--  Medicinal Product Identifier (MPID)  -->
																		<name>Guaifenesin, Dextromethorphan</name>
																		<!-- Name of Drug as Reported -->
																	</kindOfProduct>
																</instanceOfKind>
															</consumable>
															<outboundRelationship2 typeCode="RSON">
																<observation classCode="OBS" moodCode="EVN">
																	<code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="indication"/>
																	<value xsi:type="CE" code="10061372" displayName="Streptococcal infection" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
																	<!-- MedDRA Version for Indication -->
																	<!--  Indication (MedDRA code) -->
																</observation>
															</outboundRelationship2>
															<outboundRelationship2 typeCode="CAUS">
																<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"/>
																	</effectiveTime>
																	<value xsi:type="CE" code="10036960" displayName="bleeding" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
																	<!-- MedDRA Version for Reaction -->
																	<!-- Reactions (MedDRA code) -->
																</observation>
															</outboundRelationship2>
														</substanceAdministration>
													</component>
													<component typeCode="COMP">
														<substanceAdministration classCode="SBADM" moodCode="EVN">
															<effectiveTime xsi:type="IVL_TS">
																<low value="20090101"/>
																<!-- Start Date -->
																<high value="20090101"/>
																<!-- End Date -->
															</effectiveTime>
															<consumable typeCode="CSM">
																<instanceOfKind classCode="INST">
																	<kindOfProduct classCode="MMAT" determinerCode="KIND">
																		<code code="14505-488" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="12.0"/>
																		<!-- MPID Version Date / Number  -->
																		<!--  Medicinal Product Identifier (MPID)  -->
																		<name>Guaifenesin, Dextromethorphan</name>
																	</kindOfProduct>
																</instanceOfKind>
															</consumable>
															<outboundRelationship2 typeCode="CAUS">
																<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"/>
																	</effectiveTime>
																	<value xsi:type="CE" code="10036960" displayName="bleeding" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
																	<!-- MedDRA Version for Reaction -->
																	<!-- Reactions (MedDRA code) -->
																</observation>
															</outboundRelationship2>
														</substanceAdministration>
													</component>
													<component typeCode="COMP">
														<substanceAdministration classCode="SBADM" moodCode="EVN">
															<effectiveTime xsi:type="IVL_TS">
																<low value="2009"/>
																<!-- Start Date -->
																<high value="2011"/>
																<!-- End Date -->
															</effectiveTime>
															<consumable typeCode="CSM">
																<instanceOfKind classCode="INST">
																	<kindOfProduct classCode="MMAT" determinerCode="KIND">
																		<name>Guaifenesin, Dextromethorphan</name>
																		<!-- Name of Drug as Reported -->
																	</kindOfProduct>
																</instanceOfKind>
															</consumable>
															<outboundRelationship2 typeCode="RSON">
																<observation classCode="OBS" moodCode="EVN">
																	<code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="indication"/>
																	<value xsi:type="CE" code="10061372" displayName="Streptococcal infection" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
																	<!-- MedDRA Version for Indication -->
																	<!--  Indication (MedDRA code) -->
																</observation>
															</outboundRelationship2>
														</substanceAdministration>
													</component>
												</organizer>
											</subjectOf2>
										</role>
									</player1>
									<subjectOf1 typeCode="SBJ">
										<researchStudy classCode="CLNTRL" moodCode="EVN">
											<id extension="4555-3" root="2.16.840.1.113883.3.989.2.1.3.5"/>
											<!-- C Sponsor Study Number -->
											<code code="2" displayName="Individual patient use" codeSystem="2.16.840.1.113883.3.989.2.1.1.8"/>
											<!-- Study Type Where Reaction(s) / Event(s) Were Observed -->
											<title>Profound Study</title>
											<!-- Study Name -->
											<authorization typeCode="AUTH">
												<studyRegistration classCode="ACT" moodCode="EVN">
													<id extension="23489-34" root="2.16.840.1.113883.3.989.2.1.3.6"/>
													<!--  Study Registration Number -->
													<author typeCode="AUT">
														<territorialAuthority classCode="TERR">
															<governingPlace classCode="COUNTRY" determinerCode="INSTANCE">
																<code code="US" codeSystem="1.0.3166.1.2.2"/>
																<!--  Study Registration Country  -->
															</governingPlace>
														</territorialAuthority>
													</author>
												</studyRegistration>
											</authorization>
											<authorization typeCode="AUTH">
												<studyRegistration classCode="ACT" moodCode="EVN">
													<id extension="876444" root="2.16.840.1.113883.3.989.2.1.3.6"/>
													<!-- Study Registration Number -->
													<author typeCode="AUT">
														<territorialAuthority classCode="TERR">
															<governingPlace classCode="COUNTRY" determinerCode="INSTANCE">
																<code code="FR" codeSystem="1.0.3166.1.2.2"/>
																<!-- C Study Registration Country -->
															</governingPlace>
														</territorialAuthority>
													</author>
												</studyRegistration>
											</authorization>
										</researchStudy>
									</subjectOf1>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="age"/>
											<value xsi:type="PQ" value="10" unit="a"/>
											<!--  Age at Time of Onset of Reaction / Event (number) -->
											<!-- Age at Time of Onset of Reaction / Event (unit) -->
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="C103173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Age at Time of Vaccination"/>
											<value xsi:type="PQ" value="10" unit="a"/>
											<!--  Age at Time of vaccination -->
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="16" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="gestationPeriod"/>
											<value xsi:type="PQ" value="10" unit="wk"/>
											<!-- Gestation Period When Reaction / Event Was Observed in the Foetus (number) -->
											<!--  Gestation Period When Reaction / Event Was Observed in the Foetus (unit) -->
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="ageGroup"/>
											<!--value xsi:type="CE" code="4" displayName="adolescent" codeSystem="2.16.840.1.113883.3.989.2.1.1.9"/-->
											<value xsi:type="CE" nullFlavor="NI"/>
											<!-- Patient Age Group (as per reporter) -->
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="7" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="bodyWeight"/>
											<value xsi:type="PQ" value="48.2" unit="kg"/>
											<!--  Body Weight (kg) -->
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="17" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="height"/>
											<value xsi:type="PQ" value="152" unit="cm"/>
											<!--  Height (cm) -->
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="22" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="lastMenstrualPeriodDate"/>
											<value xsi:type="TS" value="20090101"/>
											<!--  Last Menstrual Period Date -->
										</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="C16352" displayName="African American" 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="C41259" displayName="American Indian or Alaska Native " 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="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="C17049" displayName="Race" codeSystem="2.16.840.1.113883.3.26.1.1"/>
											<value xsi:type="CE" code="C41261" displayName="White" 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" nullFlavor="OTH"/>
										</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="C17459" displayName="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="C114855" displayName="Patient Military Status ICSR Terminology" codeSystem="2.16.840.1.113883.3.26.1.1"/>
											<value xsi:type="CE" code="C114857" displayName="Reserve" 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">
												<!-- xxxx add an illness -->
												<observation classCode="OBS" moodCode="EVN">
													<code code="10061122" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
													<!--  MedDRA Version for Medical History #1 -->
													<!--  Medical History (disease / surgical procedure / etc.) (MedDRA code) #1 -->
													<effectiveTime xsi:type="IVL_TS">
														<low value="20090101"/>
														<!-- : Start Date #1 -->
														<high value="20090101"/>
														<!-- End Date #1 -->
													</effectiveTime>
													<outboundRelationship2 typeCode="COMP">
														<observation 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">Comment</value>
															<!--  Comments #1 -->
														</observation>
													</outboundRelationship2>
													<outboundRelationship2 typeCode="EXPL">
														<observation classCode="OBS" moodCode="EVN">
															<code code="38" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="familyHistory"/>
															<value xsi:type="BL" value="true"/>
															<!-- Family History #1 -->
														</observation>
													</outboundRelationship2>
													<inboundRelationship typeCode="REFR">
														<observation classCode="OBS" moodCode="EVN">
															<code code="13" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="continuing"/>
															<value xsi:type="BL" value="true"/>
															<!-- Continuing #1 -->
														</observation>
													</inboundRelationship>
												</observation>
											</component>
											<component typeCode="COMP">
												<observation classCode="OBS" moodCode="EVN">
													<code code="10012431" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
													<!-- MedDRA Version for Medical History -->
													<!-- Medical history (disease / surgical procedure / etc.) (MedDRA code) -->
													<effectiveTime xsi:type="IVL_TS">
														<low value="20020101"/>
														<!-- Start Date -->
														<high value="20060101"/>
														<!--  End Date -->
													</effectiveTime>
													<outboundRelationship2 typeCode="COMP">
														<observation 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">The condition was accentuated by poor diet.</value>
															<!--  Comments -->
														</observation>
													</outboundRelationship2>
													<outboundRelationship2 typeCode="EXPL">
														<observation classCode="OBS" moodCode="EVN">
															<code code="38" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="familyHistory"/>
															<value xsi:type="BL" value="true"/>
															<!--  Family History -->
														</observation>
													</outboundRelationship2>
													<inboundRelationship typeCode="REFR">
														<observation classCode="OBS" moodCode="EVN">
															<code code="13" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="continuing"/>
															<value xsi:type="BL" value="true"/>
															<!-- Continuing -->
														</observation>
													</inboundRelationship>
												</observation>
											</component>
											<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">The patient's medical history does not show anything very out of the ordinary.</value>
													<!-- Text for Relevant Medical History and Concurrent Conditions (not including reaction / event) -->
												</observation>
											</component>
											<component typeCode="COMP">
												<observation classCode="OBS" moodCode="EVN">
													<code code="11" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="concomitantTherapy"/>
													<value xsi:type="BL" value="true"/>
													<!-- Concomitant Therapies -->
												</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">
													<effectiveTime xsi:type="IVL_TS">
														<low value="20090101"/>
														<!-- Start Date #1 -->
														<high value="20090101"/>
														<!-- End Date #1 -->
													</effectiveTime>
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<code code="0071-0220" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="12.0"/>
																<!--  MPID Version Date / Number #1 -->
																<!--  Medicinal Product Identifier (NDC) -->
																<name>ACCURETIC</name>
																<!-- Name of Drug as Reported #1 -->
															</kindOfProduct>
														</instanceOfKind>
													</consumable>
													<outboundRelationship2 typeCode="RSON">
														<observation classCode="OBS" moodCode="EVN">
															<code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="indication"/>
															<value xsi:type="CE" code="10028094" displayName="Mucopolysaccharidosis IH" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
															<!-- MedDRA Version for Indication #1 -->
															<!--  Indication (MedDRA code) #1 -->
														</observation>
													</outboundRelationship2>
													<outboundRelationship2 typeCode="CAUS">
														<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"/>
															</effectiveTime>
															<value xsi:type="CE" code="10067994" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
															<!-- MedDRA Version for Reaction #1 -->
															<!-- Reaction (MedDRA code) #1 -->
														</observation>
													</outboundRelationship2>
													<outboundRelationship2 typeCode="SUBJ">
														<observation classCode="OBS" moodCode="EVN">
															<code code="C103173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Age at Time of Vaccination"/>
															<value xsi:type="PQ" value="32" unit="a"/>
															<!--  Age at Time of vaccination -->
														</observation>
													</outboundRelationship2>
												</substanceAdministration>
											</component>
											<component typeCode="COMP">
												<substanceAdministration classCode="SBADM" moodCode="EVN">
													<effectiveTime xsi:type="IVL_TS">
														<low value="20090101"/>
														<!-- Start Date -->
														<high value="20090101"/>
														<!-- End Date -->
													</effectiveTime>
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<code code="43742-0053" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="12.0"/>
																<!-- MPID Version Date / Number  -->
																<!--  Medicinal Product Identifier (MPID)  -->
																<name>Spine and Nerve Balance Core Formula</name>
																<!-- Name of Drug as Reported -->
															</kindOfProduct>
														</instanceOfKind>
													</consumable>
													<outboundRelationship2 typeCode="RSON">
														<observation classCode="OBS" moodCode="EVN">
															<code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="indication"/>
															<value xsi:type="CE" code="83459001" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
															<!--  MedDRA Version for Indication -->
															<!-- Indication (MedDRA code) -->
														</observation>
													</outboundRelationship2>
													<outboundRelationship2 typeCode="CAUS">
														<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"/>
															</effectiveTime>
															<value xsi:type="CE" code="10050987" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
															<!--  MedDRA Version for Reaction -->
															<!--  Reaction (MedDRA code) -->
														</observation>
													</outboundRelationship2>
													<outboundRelationship2 typeCode="SUBJ">
														<observation classCode="OBS" moodCode="EVN">
															<code code="C103173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Age at Time of Vaccination"/>
															<value xsi:type="PQ" value="32" unit="a"/>
															<!--  Age at Time of vaccination -->
														</observation>
													</outboundRelationship2>
												</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"/>
											<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">
															<productInstanceInstance classCode="MMAT" determinerCode="INSTANCE">
																<lotNumberText>123444-AB</lotNumberText>
															</productInstanceInstance>
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<code code="49281-650" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="201401011041"/>
																<name>Ultimate Vaccine</name>
																<asManufacturedProduct classCode="MANU">
																	<subjectOf typeCode="SBJ">
																		<approval classCode="CNTRCT" moodCode="EVN">
																			<holder typeCode="HLD">
																				<role classCode="HLD">
																					<playingOrganization classCode="ORG" determinerCode="INSTANCE">
																						<name>ACME Production Corp.</name>
																						<!-- Manufacturer Name  -->
																					</playingOrganization>
																				</role>
																			</holder>
																		</approval>
																	</subjectOf>
																</asManufacturedProduct>
															</kindOfProduct>
														</instanceOfKind>
													</consumable>
													<outboundRelationship2 typeCode="FLFS">
														<sequenceNumber value="2"/>
														<substanceAdministration classCode="SBADM" moodCode="INT"/>
													</outboundRelationship2>
												</substanceAdministration>
											</component>
											<component typeCode="COMP">
												<substanceAdministration moodCode="EVN" classCode="SBADM">
													<effectiveTime xsi:type="IVL_TS">
														<low value="20090101"/>
													</effectiveTime>
													<approachSiteCode code="C105633" displayName="Left Arm" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemVersion="20141030"/>
													<!--4weeks site-->
													<routeCode code="C28161" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Intramuscular Route of Administration" codeSystemVersion="12.0"/>
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
															<productInstanceInstance classCode="MMAT" determinerCode="INSTANCE">
																<lotNumberText>123444-AB</lotNumberText>
															</productInstanceInstance>
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<code code="0052-0603" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="201401011041"/>
																<name>BCG vaccine</name>
																<asManufacturedProduct classCode="MANU">
																	<subjectOf typeCode="SBJ">
																		<approval classCode="CNTRCT" moodCode="EVN">
																			<holder typeCode="HLD">
																				<role classCode="HLD">
																					<playingOrganization classCode="ORG" determinerCode="INSTANCE">
																						<name>BEST Maker Ltd.</name>
																						<!-- Manufacturer Name  -->
																					</playingOrganization>
																				</role>
																			</holder>
																		</approval>
																	</subjectOf>
																</asManufacturedProduct>
															</kindOfProduct>
														</instanceOfKind>
													</consumable>
													<outboundRelationship2 typeCode="FLFS">
														<sequenceNumber value="2"/>
														<substanceAdministration classCode="SBADM" moodCode="INT"/>
													</outboundRelationship2>
												</substanceAdministration>
											</component>
										</organizer>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="32" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="reportedCauseOfDeath"/>
											<value xsi:type="CE" code="10036807" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0">
												<!-- MedDRA Version for Reported Cause(s) of Death #1 -->
												<!-- Reported Cause(s) of Death (MedDRA code) #1 -->
												<originalText>Progressive multifocal leukoencephalopathy</originalText>
												<!-- : Reported Cause(s) of Death (free text) #1 -->
											</value>
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="32" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="reportedCauseOfDeath"/>
											<value xsi:type="CE" code="10036805" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0">
												<!-- : MedDRA Version for Reported Cause(s) of Death -->
												<!--  Reported Cause(s) of Death (MedDRA code) -->
												<originalText>Excessive Fibrosis</originalText>
												<!-- Reported Cause(s) of Death (free text) -->
											</value>
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<code code="5" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="autopsy"/>
											<value xsi:type="BL" value="true"/>
											<!-- Was Autopsy Done?  -->
											<outboundRelationship2 typeCode="DRIV">
												<observation classCode="OBS" moodCode="EVN">
													<code code="8" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="causeOfDeath"/>
													<value xsi:type="CE" code="10067063" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0">
														<!-- MedDRA Version for Autopsy-determined Cause(s) of Death #1 -->
														<!--  Autopsy-determined Cause(s) of Death (MedDRA code) #1 -->
														<originalText>What we learned during the autopsy</originalText>
														<!-- Autopsy-determined Cause(s) of Death (free text) #1 -->
													</value>
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="DRIV">
												<observation classCode="OBS" moodCode="EVN">
													<code code="8" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="causeOfDeath"/>
													<value xsi:type="CE" code="10061227" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0">
														<!-- MedDRA Version for Autopsy-determined Cause(s) of Death -->
														<!--  Autopsy-determined Cause(s) of Death (MedDRA code) -->
														<originalText>Metabolic Abnormality</originalText>
														<!-- Autopsy-determined Cause(s) of Death (free text) -->
													</value>
												</observation>
											</outboundRelationship2>
										</observation>
									</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="20090101"/>
												<!-- Date of Start of Reaction / Event -->
												<high value="20090102"/>
												<!-- Date of End of Reaction / Event -->
											</effectiveTime>
											<!-- It is also possible for the reaction to show a start date/time and a duration.  -->
											<value xsi:type="CE" code="10027940" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0">
												<!-- MedDRA Version for Reaction / Event -->
												<!-- Reaction / Event (MedDRA code) -->
												<originalText language="por">consciência alterada</originalText>
												<!-- Reaction / Event as Reported by the Primary Source in Native Language -->
												<!-- Reaction / Event as Reported by the Primary Source Language -->
											</value>
											<location typeCode="LOC">
												<locatedEntity classCode="LOCE">
													<locatedPlace classCode="COUNTRY" determinerCode="INSTANCE">
														<code code="EU" codeSystem="1.0.3166.1.2.2"/>
														<!-- Identification of the Country Where the Reaction / Event Occurred -->
													</locatedPlace>
												</locatedEntity>
											</location>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="30" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="reactionForTranslation"/>
													<value xsi:type="ED">Altered Consciousness</value>
													<!-- Reaction / Event as Reported by the Primary Source for Translation-->
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="37" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="termHighlightedbyReporter"/>
													<value xsi:type="CE" code="2" displayName="No, not highlighted by the reporter, NOT serious" codeSystem="2.16.840.1.113883.3.989.2.1.1.10"/>
													<!-- Term Highlighted by the Reporter -->
												</observation>
											</outboundRelationship2>
											<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" value="true"/>
													<!-- 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"/>
													<!-- 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" value="true"/>
													<!-- 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"/>
													<!--  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"/>
													<!-- 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"/>
													<!-- 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"/>
													<!-- 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"/>
													<!-- Required visit to the Physician Office  -->
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="C50414" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Hospitalization Required"/>
													<value xsi:type="BL" value="true"/>
													<!-- Required visit to the hospital  -->
													<outboundRelationship2 typeCode="PERT">
														<observation classCode="OBS" moodCode="EVN">
															<code code="C102443" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Number of hospitalization days"/>
															<value xsi:type="INT" value="5"/>
															<!-- number of hospitalization days  -->
															<performer typeCode="PRF">
																<assignedEntity classCode="ASSIGNED">
																	<representedOrganization classCode="ORG" determinerCode="INSTANCE">
																		<name>Memorial Hospital</name>
																		<addr>
																			<city>Metropolis</city>
																			<state>Pennsylvania</state>
																		</addr>
																	</representedOrganization>
																</assignedEntity>
															</performer>
														</observation>
													</outboundRelationship2>
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="24" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="medicalConfirmationByHealthProfessional"/>
													<value xsi:type="BL" value="true"/>
													<!-- medical confirmation -->
												</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"/>
												</observation>
											</outboundRelationship2>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="C17649" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Other"/>
													<value xsi:type="BL" nullFlavor="NI"/>
													<!-- VAERSNone of the above -->
												</observation>
											</outboundRelationship2>
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<observation classCode="OBS" moodCode="EVN">
											<id root="2baa28d6-c9e8-4e6c-93e9-5b860b314220"/>
											<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"/>
											</effectiveTime>
											<value xsi:type="CE" code="10024381" 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>
											<outboundRelationship2 typeCode="PERT">
												<observation classCode="OBS" moodCode="EVN">
													<code code="C17649" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Other"/>
													<value xsi:type="BL" nullFlavor="NI"/>
													<!-- VAERSNone of the above -->
												</observation>
											</outboundRelationship2>
										</observation>
									</subjectOf2>
									<subjectOf2 typeCode="SBJ">
										<organizer classCode="CATEGORY" moodCode="EVN">
											<code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="testsAndProceduresRelevantToTheInvestigation"/>
											<component typeCode="COMP">
												<observation classCode="OBS" moodCode="EVN">
													<code code="10050520" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0">
														<!-- MedDRA Version for Test Name #1 -->
														<!--  Test Name (MedDRA code) #1 -->
														<originalText>Calcium Level</originalText>
														<!--  Test Name (free text) #1 -->
													</code>
													<effectiveTime value="20090101"/>
													<!-- : Test Date -->
													<value xsi:type="IVL_PQ">
														<center value="10" unit="mg/dl"/>
														<!-- Test Result (value / qualifier) #1 -->
														<!--  Test Result (unit) #1 -->
													</value>
													<interpretationCode code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.12"/>
													<!-- Test Result (code) #1 -->
													<referenceRange typeCode="REFV">
														<observationRange classCode="OBS" moodCode="EVN.CRT">
															<value xsi:type="PQ" value="40" unit="mg/dl"/>
															<!-- Normal Low Value #1 -->
															<interpretationCode code="L" codeSystem="2.16.840.1.113883.5.83"/>
														</observationRange>
													</referenceRange>
													<referenceRange typeCode="REFV">
														<observationRange classCode="OBS" moodCode="EVN.CRT">
															<value xsi:type="PQ" value="110" unit="mg/dl"/>
															<!-- Normal High Value #1-->
															<interpretationCode code="H" codeSystem="2.16.840.1.113883.5.83"/>
														</observationRange>
													</referenceRange>
													<outboundRelationship2 typeCode="PERT">
														<observation 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">These results may be skewed</value>
															<!--  Comments (free text) #1 -->
														</observation>
													</outboundRelationship2>
													<outboundRelationship2 typeCode="REFR">
														<observation classCode="OBS" moodCode="EVN">
															<code code="25" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="moreInformationAvailable"/>
															<value xsi:type="BL" value="true"/>
															<!-- More Information Available #1 -->
														</observation>
													</outboundRelationship2>
												</observation>
											</component>
											<component typeCode="COMP">
												<observation classCode="OBS" moodCode="EVN">
													<code code="10059578" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0">
														<!--  MedDRA Version for Test Name -->
														<!-- Test Name (MedDRA code) -->
													</code>
													<effectiveTime value="2009"/>
													<!-- Test Date -->
													<value xsi:type="IVL_PQ">
														<low nullFlavor="NINF"/>
														<high value="10" unit="mg/dl" inclusive="false"/>
													</value>
													<!--  Test Result (value / qualifier) -->
													<!-- Test Result (unit) -->
													<!-- LT 10 mg/dl -->
													<interpretationCode code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.12"/>
												</observation>
											</component>
											<component typeCode="COMP">
												<observation classCode="OBS" moodCode="EVN">
													<code code="10059478" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0">
														<originalText>Blood work</originalText>
														<!--  Test Name (free text) #3 -->
													</code>
													<effectiveTime value="20090101"/>
													<!-- Test Date #3 -->
													<value xsi:type="IVL_PQ">
														<low nullFlavor="NINF"/>
														<high value="10" unit="mg/dl" inclusive="true"/>
													</value>
													<!--  Test Result (value / qualifier) #3 -->
													<!--  Test Result (unit) #3 -->
													<!-- LE 10 mg/dl  #3-->
												</observation>
											</component>
											<component typeCode="COMP">
												<observation classCode="OBS" moodCode="EVN">
													<code>
														<originalText>A special test</originalText>
													</code>
													<effectiveTime value="20090101"/>
													<!-- Test Date #4 -->
													<value xsi:type="IVL_PQ">
														<low value="10" unit="mg/dl" inclusive="false"/>
														<high nullFlavor="PINF"/>
													</value>
													<!-- Test Result (value / qualifier) #4 -->
													<!-- Test Result (unit) #4 -->
													<!-- GT 10 mg/dl  #4 -->
													<interpretationCode code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.12"/>
												</observation>
											</component>
											<component typeCode="COMP">
												<observation classCode="OBS" moodCode="EVN">
													<code code="10005362" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
													<effectiveTime value="20090101"/>
													<!--  Test Date #5 -->
													<value xsi:type="IVL_PQ">
														<low value="10" unit="mg/dl" inclusive="true"/>
														<high nullFlavor="PINF"/>
													</value>
													<!-- : Test Result (value / qualifier) #5 -->
													<!--  Test Result (unit) #5 -->
													<!-- GE 10 mg/dl #5 -->
													<interpretationCode code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.12"/>
												</observation>
											</component>
											<component typeCode="COMP">
												<observation classCode="OBS" moodCode="EVN">
													<code code="10005362" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
													<effectiveTime value="20090101"/>
													<!--  Test Date #5 -->
													<value xsi:type="ED"> 10 mg per imaginary unit all the way up to positive infinity

													</value>
												</observation>
											</component>
											<component typeCode="COMP">
												<observation classCode="OBS" moodCode="EVN">
													<code code="10062994" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
													<effectiveTime value="20090101"/>
													<value xsi:type="ED">The over all outcome was quite spectacular.</value>
													<!--  Result Unstructured Data (free text) #6 -->
													<interpretationCode code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.12"/>
												</observation>
											</component>
										</organizer>
									</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 displayName="syringe"/>
																		<!-- device common name  -->
																	</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>
											<!-- Drug(s) Information (repeat as necessary) -->
											<component typeCode="COMP">
												<substanceAdministration classCode="SBADM" moodCode="EVN">
													<id root="68d6f5ce-3b3b-45c7-92dd-69e06730c3a9"/>
													<consumable typeCode="CSM">
														<instanceOfKind classCode="INST">
															<kindOfProduct classCode="MMAT" determinerCode="KIND">
																<code code="37808-0031" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="201401011041"/>
																<name>Aspirin</name>
																<!-- Substance administration and product details have been removed from the second interation of the substance administration.  -->
																<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>
												</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>
							<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"/>
									<!-- Characterisation of Drug Role Drug -->
									<subject2 typeCode="SUBJ">
										<productUseReference classCode="SBADM" moodCode="EVN">
											<id root="68d6f5ce-3b3b-45c7-92dd-69e06730c3a9"/>
										</productUseReference>
									</subject2>
								</causalityAssessment>
							</component>
							<component typeCode="COMP">
								<causalityAssessment classCode="OBS" moodCode="EVN">
									<code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="causality"/>
									<value xsi:type="ST">Highly related</value>
									<!-- : Result of Assessment Drug #1, Reaction #1, Assessment #1 -->
									<methodCode>
										<originalText>Introspection</originalText>
										<!-- Method of Assessment Drug #1, Reaction #1, Assessment #1 -->
									</methodCode>
									<author typeCode="AUT">
										<assignedEntity classCode="ASSIGNED">
											<code>
												<originalText>Reporter</originalText>
												<!--  Source of Assessment Drug #1, Reaction #1, Assessment #1 -->
											</code>
										</assignedEntity>
									</author>
									<subject1 typeCode="SUBJ">
										<adverseEffectReference classCode="OBS" moodCode="EVN">
											<id root="154eb889-958b-45f2-a02f-42d4d6f4657f"/>
										</adverseEffectReference>
									</subject1>
									<subject2 typeCode="SUBJ">
										<productUseReference classCode="SBADM" moodCode="EVN">
											<id root="3c91b4d5-e039-4a7a-9c30-67671b0ef9e4"/>
										</productUseReference>
									</subject2>
								</causalityAssessment>
							</component>
							<component typeCode="COMP">
								<causalityAssessment classCode="OBS" moodCode="EVN">
									<code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="causality"/>
									<value xsi:type="ST">80%</value>
									<!--Result of Assessment Drug #1, Reaction #2, Assessment #1 -->
									<methodCode>
										<originalText>algorithm</originalText>
										<!--: Method of Assessment Drug #1, Reaction #2, Assessment #1 -->
									</methodCode>
									<author typeCode="AUT">
										<assignedEntity classCode="ASSIGNED">
											<code>
												<originalText>Company</originalText>
												<!-- Source of Assessment Drug #1, Reaction #2, Assessment #1 -->
											</code>
										</assignedEntity>
									</author>
									<subject1 typeCode="SUBJ">
										<adverseEffectReference classCode="OBS" moodCode="EVN">
											<id root="2baa28d6-c9e8-4e6c-93e9-5b860b314220"/>
										</adverseEffectReference>
									</subject1>
									<subject2 typeCode="SUBJ">
										<productUseReference classCode="SBADM" moodCode="EVN">
											<id root="3c91b4d5-e039-4a7a-9c30-67671b0ef9e4"/>
										</productUseReference>
									</subject2>
								</causalityAssessment>
							</component>
							<component typeCode="COMP">
								<causalityAssessment classCode="OBS" moodCode="EVN">
									<code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="causality"/>
									<value xsi:type="ST">Likely</value>
									<!-- Result of Assessment Drug #2, Reaction #2, Assessment #1 -->
									<methodCode>
										<originalText>Bayesean</originalText>
										<!-- Method of Assessment Drug #2, Reaction #2, Assessment #1 -->
									</methodCode>
									<author typeCode="AUT">
										<assignedEntity classCode="ASSIGNED">
											<code>
												<originalText>Company</originalText>
												<!-- Source of Assessment Drug #2, Reaction #2, Assessment #1 -->
											</code>
										</assignedEntity>
									</author>
									<subject1 typeCode="SUBJ">
										<adverseEffectReference classCode="OBS" moodCode="EVN">
											<id root="2baa28d6-c9e8-4e6c-93e9-5b860b314220"/>
										</adverseEffectReference>
									</subject1>
									<subject2 typeCode="SUBJ">
										<productUseReference classCode="SBADM" moodCode="EVN">
											<id root="68d6f5ce-3b3b-45c7-92dd-69e06730c3a9"/>
										</productUseReference>
									</subject2>
								</causalityAssessment>
							</component>
							<component typeCode="COMP">
								<causalityAssessment classCode="OBS" moodCode="EVN">
									<code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="causality"/>
									<value xsi:type="ST">The reason</value>
									<!-- Result of Assessment Drug #2, Reaction #2, Assessment -->
									<methodCode>
										<originalText>Introspection</originalText>
										<!-- Method of Assessment Drug #2, Reaction #2, Assessment -->
									</methodCode>
									<author typeCode="AUT">
										<assignedEntity classCode="ASSIGNED">
											<code>
												<originalText>Reporter</originalText>
												<!-- Source of Assessment Drug #2, Reaction #2, Assessment -->
											</code>
										</assignedEntity>
									</author>
									<subject1 typeCode="SUBJ">
										<adverseEffectReference classCode="OBS" moodCode="EVN">
											<id root="2baa28d6-c9e8-4e6c-93e9-5b860b314220"/>
										</adverseEffectReference>
									</subject1>
									<subject2 typeCode="SUBJ">
										<productUseReference classCode="SBADM" moodCode="EVN">
											<id root="68d6f5ce-3b3b-45c7-92dd-69e06730c3a9"/>
										</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">It appears very likely that the primary drug is responsible for all the reactions.</value>
									<!-- 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="15" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="diagnosis"/>
									<value xsi:type="CE" code="10047319" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
									<!-- MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event #1 -->
									<!--  Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event  (MedDRA code) #1 -->
									<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>
							<component1 typeCode="COMP">
								<observationEvent classCode="OBS" moodCode="EVN">
									<code code="15" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="diagnosis"/>
									<value xsi:type="CE" code="10047334" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
									<!-- MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event -->
									<!-- Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event  (MedDRA code) -->
									<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>
							<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">The condition came on suddenly, and was a complete surprise to the responsible clinicians.</value>
									<!--  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="true"/>
							<!--  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"/>
							<!--  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"/>
							<!--  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"/>
							<!--  A newly added NCI code. -->
							<value xsi:type="BL" value="true"/>
							<!--  Local extension to indicate a combination product is included in the report. -->
						</observationEvent>
					</component>
					<component typeCode="COMP">
						<observationEvent classCode="OBS" moodCode="EVN">
							<code code="36" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="summaryAndComment"/>
							<value xsi:type="ED" language="eng">H.5.r.1a 1</value>
							<!--  Case Summary and Reporter's Comments Text  #1 -->
							<!-- Case Summary and Reporter's Comments Language #1 -->
							<author typeCode="AUT">
								<assignedEntity classCode="ASSIGNED">
									<code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.21" displayName="reporter"/>
								</assignedEntity>
							</author>
						</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">
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							<code nullFlavor="NA"/>
							<subjectOf2 typeCode="SUBJ">
								<controlActEvent classCode="CACT" moodCode="EVN">
									<id extension="FR-PHARMA-3448976655" root="2.16.840.1.113883.3.989.2.1.3.2"/>
									<!--  Identification Number of the Report Which Is Linked to This Report (repeat as necessary)  #1 -->
								</controlActEvent>
							</subjectOf2>
						</relatedInvestigation>
					</outboundRelationship>
					<outboundRelationship typeCode="SPRT">
						<relatedInvestigation classCode="INVSTG" moodCode="EVN">
							<code nullFlavor="NA"/>
							<subjectOf2 typeCode="SUBJ">
								<controlActEvent classCode="CACT" moodCode="EVN">
									<id extension="FR-QPHARMA-12345678" root="2.16.840.1.113883.3.989.2.1.3.2"/>
									<!-- Identification Number of the Report Which Is Linked to this Report (repeat as necessary)  -->
								</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>State of Residence</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 -->
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												<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>
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						</relatedInvestigation>
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					<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>Idaho</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 -->
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												<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) -->
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					</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 -->
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					<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 -->
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					<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>
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	<!-- 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>
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