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Write-up: Information received regarding a case in litigation from a lawyer, an Agency, a nurse, physician, patient''s (Pte) mother and news report concerning a 14 year old healthy female with occasional and well controlled migraine and acne who on 09-OCT-2008, was vaccinated with the first dose of GARDASIL, lot # not available. Concomitant Tx included hormonal contraceptives. New information received on 05-MAR-2009 from a physician who reported that in October 2008 the pte received the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine, lot # not available. In approximately October 2008 the pte had convulsions and was investigated in hospital. Nothing was found. It was reported that an autopsy was conducted and results expected by approximately 15-APR-2009. New information received on 26-MAR-2009 from the pte''s mother via a news report; on approximately 24-OCT-2008 the pte was found to be completely lost did not know her name, could not stand up, could not speak. The pte was taken to the bathroom by her mother and compress was applied. The pte''s mother at first felt that her daughter had taken drugs or had an overdose daughter was not the type to take drugs. The pte remained unresponsive and emergency services were called by mother. The pte started to respond after 25 minutes she was able to recall her name. The mother called infoHealth and was recommended to take her daughter to the hospital. The pte started to vomit upon arrival at the hospital, approximately 25 times. The pte remained under observation overnight. The following morning the pte was tested for drugs but was found clean. The pte was also examined by the neurologist and neurological exams were performed hands, to verify if there was brain damage or something else and found to be normal. The diagnosis was that the pte had a basilar migraine. The mother did not agree with the diagnosis since she also experienced migraines as well as her mother and felt it was genetic. The mother insisted that her daughter have a scan which was normal. Subsequently the pte was fine as if nothing had happened. The pte was recommended to stop taking birth control pill for her acne which was done on the day she was discharged from hospital. The pte updated her health profile at school and if the symptoms recurred she was to call emergency services. On 23-NOV-2008 the pte was vaccinated with second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine, lot # not available. The mother reported that no thought was given to the vaccine, not even at the hospital no details provided. On 09-DEC-2008, 15 days after second dose, the pte arrived from school had dinner, watched TV and at 19:00 went to take a bath. The pte did not respond to her mother. The mother broke down the door and found her daughter had drowned in the bath. The mother reported she was 10 feet from her daughter and did not hear anything not even a call for help. There was no trace of violence. The mother reported that she spoke to the coroner several times since she thought her daughter had drowned. The coroner confirmed that the pathologist had said no. The pte had not drowned since there was not enough water in her lungs. The primary autopsy showed no significant findings, the cause of death was unknown. Further analysis to be done, results might take up to six months (no details provided). The mother reported that she had seen an article in the newspaper on 11-FEB-2009 about two girls in another country that were hospitalized regarding the vaccine where the lots were recalled. The mother linked those two cases with the fact that her daughter had received the same vaccine. The mother requested her daughter''s school health record and spoke to the school nurse. The school nurse confirmed that the pte previously updated her health record. New info has been received 12-OCT-2009 by email stating that the pathologist''s conclusion was that the death was sudden and unexplained. He specifically mentioned that "we did not see any anatomopathological evidence of abnormal reaction that would suggest a link between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine and this case of sudden death. New info has been received on 14-DEC-2010 in form of a coroner''s investigation report with the following details: Date of Death: 09-DEC-2008 at 20:32. Probable Cause of Death: Drowning. Identification: The youth was identified by her mother at the hospital in the presence of personnel. External Examination: On the external examination performed at time of the autopsy, there was absence of traumatic lesions on the body. Internal Examination: On 17-DEC-2008 autopsy performed. The pathologist''s exam did not identify a precise cause of death. There were no anatomopathological or microbiological observations, nor an inflammatory reaction to explain this death. The changes observed in the brain by a neuropathological exam, or in the lungs, were probably secondary to the terminal process. Prior History: This youth was known for renal cyst, headaches, also reported as migraines and allergies to certain substances such as iodine, animals and pollen. Other Reports: A toxicological analysis of biological samples was negative. Circumstances of Death: On 09-OCT-2008 the young pte received her first Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine vaccination under an adolescent vaccination program. The pte was taking the contraceptive YASMIN for an acne problem since 2 months, as a replacement for another medication, no further details. On 25-OCT-2008 the pte was crying in her room. When her mother spoke to her, she was confused, vomited and had intense headaches, worse than what she was used to having. The pte was brought to the hospital emergency. Upon examination the pte said she was weak, dizzy upon standing, unable to walk, and nauseated. Blood sugar was 6.6. Pte was kept for observation. On 26-OCT-2008 CT scan results were within normal limits. The pte was diagnosed with basilar migraines and was discharged. It should be noted there was no mention of the pte recent vaccination. In the followup health form completed on 12-NOV-2008, the problem of basilar migraines was recorded. It was recommended to call 911 to be brought to the same hospital if the situation reoccurs. On the pre-immunization questionnaire, basilar migraines in October 2008 and flu vaccination in November 2008 were recorded. On 24-NOV-2008 the pte received second dose of Quadrivalent Human Papillomavirus Types 6,11,16,18) Recomb. Vaccine. On 09-DEC-2008, young pte returned from school around 17:10. She went into the bathroom around 19:15. Around 19:50 the mother found that too much time has passed and called her daughter who did not respond. The mother opened bathroom door and found her daughter unconscious with her head on the side and under the water. The mother released the posterior portion of her daughter''s body and ran to advise her spouse. He was outside, but came right away to help. They took the body out of the bath and called 911. Resuscitation maneuvers were undertaken. Ambulance technicians were first to arrive on the scene at 19:54. The pte did not have vital signs and upon ventilation they noticed the presence of water mixed with food. The police also arrived on the scene. The pte was transported urgently by ambulance to the hospital, where she was admitted at 20:21 by the emergency team. Asystole persisted despite advance cardiopulmonary resuscitation was stopped at 20:32. The physician pronounced the pte dead. The diagnostic impression was drowning secondary to sudden loss of consciousness. It is a little surprising to note that autopsy was not conclusive of drowning. This perhaps could be explained by the fact the autopsy was performed 7 days after the death. This was explained by the fact that the body was presented to a pathologist who refused to perform the autopsy for reasons according to him that an autopsy performed under pediatric specialty would be more appropriate. At the time of this refusal, a number of days had already passed since death. The autopsy physician indicated in report that postmortem changes of the collective organs limited her histologic exam. This exam is useful amongst other things to complement the microscopic exam. The study of the different specimens under microscope could confirm or invalidate what was seen in the autopsy, or reveal what naked eye could not perceive. The investigation concluded that it was a circumstantial drowning. There was emesis which could be compatible with drowning even if she could have had an episode of a convulsion. The ambulance technicians noted the presence of water and food at the time of respiratory ventilation. Consequently, her death resulted from a natural accidental cause in the absence of evidence of intervention by a third party, or a gesture of self destruction. It is clear that she experienced loss of consciousness or syncope when she was in the bath. It cannot be explained otherwise the fact that her head was under water. It could be that cardiac, neurological, glycemic, hydroelectrolytic, etc. events occurred without being able to detect their trace. This is what is identified as a sudden death which could occur at any age. The mother did not accept her daughter died without any known reason and this is legitimate. She points therefore to the vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine as responsible for the death of her daughter who in the first place had a reaction about 15 days after having her first dose where medicine could not give valid explanation for her daughter''s malaise. In the second place, about 15 days after her second vaccination, her daughter died and once again, medicine could not provide valid explanation. She could only associate the vaccination with the death. The pathologist indicated that there was no anatomopathological evidence of abnormal reaction to establish a link between the vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine and the pte''s death. New information on 21-DEC-2010 in form of internet news report of the coroner''s report which included that it was a death by drowning, and does not prove without a doubt that administration of the vaccine caused the death of this adolescent, however, the coroner refused to draw a link with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine to explain it. The coroner speaks in his report of a natural death which cannot be explained. New information received on 22-DEC-2010 in form of internet newspaper article on the coroner''s report which included the following: She had received the second of two doses required for the HPV vaccination on 24-NOV-2010. The coroner''s report did not make a direct link between the pte''s death and the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine vaccination she had received days earlier. The pte''s death is the first since the province set up a provincial HPV vaccination program in September 2008 for girls in Grades 4 to 9. While the coroner ruled accidental drowning was the immediate cause of the pte''s death, he went on to say in the report released yesterday that the contributing factors are far less clear. If the probable cause of death is known, the reasons for it are far from known. He noted the pte had been rushed to the hospital 26-OCT-2008, suffering headaches, confusion and vomiting. She underwent series of tests and was released with a diagnosis of migraine headaches, reported as basilar migraines in the actual coroner''s report. At that time, there was no mention of the dose of HPV she had received on 09-OCT-2008. The coroner''s report noted that a similar adverse reaction likely preceded the pte''s death because ambulance attendant reported vomit in the tub when the pte died. In addition, the coroner noted that the teenager had been taking the oral contraceptive drospirenone (plus) ethinyl estradiol to treat acne, and what link exists there, is also unknown .New information received from the Agency (# 000358593) with following events: abasia, asthenia, basilar migraine, blood glucose increased, cardiac arrest, confusional state, dizziness postural, drowning, loss of consciousness, nausea, syncope and vomiting. This was originally reported by a coroner/medical examiner. It was reported that a causal relationship was suspected between therapy with drospirenone (plus) ethinyl estradiol and the events. Agency considered the events to be serious and were considered to be other important medical events. New information received on 26-JAN-2012 from a lawyer including the following: On 25-OCT-2008 around 21:30, the pte was checked by a doctor at hospital emergency who recorded on the pte medical file. Reason for consultation: migraine plus vomiting plus confusion. History: 14 year old girl. Known as having migraine. That evening, pte was reading on her bed, was found crying, understandable, speech (unreadable), vomited in her bed and 2 times in the toilet. Confused for 30 minutes with slow improvement. Pte had no memory of the episode. Intense migraine. Not similar to the usual migraine .No fever. No drugs. No infectious contact. No loss of consciousness. No neurofacial symptoms. Otherwise good that day, no symptoms of upper respiratory tract infection. No fall/trauma. No alcohol. Not active sexually. Medications: drospirenone (plus) ethinylestradiol. Medical history: migraine. Family history: migraine. Allergy: Iode. Glasgow Coma Scale (GCS) 15/15. Heart B1/B2 normal. B3/B4 murmur. Tachycardia 120. Normal ROT and symmetric. Strength 2/5 DOR 4 members and Pte dizzy when standing up. Finger nose normal (slow but precise). Migraine or illicit drugs or hypoglycemia or intracranial process (mass, bleeding). Neurologist consultation in the morning. New information received on 31-JAN-2012 in the form of an internet newspaper article which stated that the pte was seen in consultation on 04-NOV-2008 by her family doctor (No details provided). New information received on 20-FEB-2012 stating that Information has been received from a consumer, as part of a marketing research program conducted concerning a 14 year old female who on an unspecified date was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (Lot # unknown). The consumer reported that the pte who was a friend of her daughter died suddenly 2 weeks after receiving the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine. Follow up information has been received from a blog on the internet in which the pte''s mother reported that her daughter died post Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine vaccination. The mother stated that her daughter received the vaccine at school. This is a consolidation of 2 reports for the same pte. Update (09-JUL-2012): Lot numbers were provided: NG31270 and NG09700. This is an amended case. Batch # NG31270 was entered to coincide with Lot # 658219/0817U (expiry date: 16-MAR-2010) and batch # NG09700 was entered to coincide with Lot # 658216/0735U (expiry date: 14-MAR-2010). Prophylaxis was entered into the Reported Indication field to replace acne. New information received on 01OCT2012: This spontaneous report was received from a website. In October 2008 the first injection (intramuscular) of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine for human papilloma virus was performed. After the first injection of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine in the hospital the pte felt bad (not specified). The pte was diagnosed with migraine (date not specified) and was discharged from the hospital. In November 2008 the second Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine injection was performed and the pte felt bad again. Two weeks after the pte was found dead. As it was reported the pte died on 09-DEC-2008. Update (02OCT2012): On 02OCT2012, the full translation of the article from a website was received. GARDASIL a widely Advertised papilloma vaccine has killed lots of people 25-SEP-2012. Pte, born 1993, died after a shot of GARDASIL against the human papilloma virus. Her death occurred on 09-DEC-2008, after two GARDASIL doses were administered within the framework of the program implemented by the provincial government. Pte''s mother reported that the first injection her daughter had received in the clinic in October, 2008 and immediately felt unwell. The diagnosis pronounced was migraine and the girl was released home. After the second dose of GARDASIL in November, 2008 her condition worsened, and two weeks later her parents found her dead in the bathroom. Update (06-NOV-2012) Literature report: The autopsy failed to identify a precise cause of death. In particular, there were no anatomical, microbiological nor toxicological findings that could explain this case of death which was classified as sudden and unexpected death. Nonetheless, autopsy revealed cerebral edema and cerebellar herniation indicative of a focally disrupted blood brain barrier. Although no specific antibodies to inflammatory markers were used in IHC analysis of brain sections, the autopsy reported that there was no evidence of inflammatory processes or microglial reactions in the pte''s brain. There were however acidophilic changes of the Purkinje cells in the cerebellum with vacuolation of the overlying molecular layer. According to the coroner, these changes were consistent with terminal ischemichypoxic encephalopathy. Neuropathological examination did not demonstrate an underlying structural brain disorder. In addition, the coroner''s report commented that the ischemichypoxic encephalopathy was terminal as was the cerebral edema and that either one could have been caused by the other. Based on the autopsy findings, the coroner was unable to establish a precise sequence of events and the specific etiology remained undetermined. Conclusions: Our study suggests that HPV vaccines containing HPV-16L1 antigens pose an inherent risk for triggering potentially fatal autoimmune vasculopathies. Follow-up information was received from a non-healthcare professional via a newspaper article on 24-JAN-2018. On 25-OCT-2008, the patient came out of the room disoriented, could hardly walk, could not speak and was mumbling. Causality was reported as related for all the events. It has been determined that case # CA-009507513-1801CAN009333 is a duplicate of case # CA-MERCK-0902CAN00119. Therefore, case # CA-009507513-1801CAN009333 is being deleted from our files and the cases are consolidated into case # CA-MERCK-0902CAN00119. Sender''s Comments: MERCK 0902CAN00119: Mfr number; Autopsy-determined Cause(s) of Death: Drowning.
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