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Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number DK-1577272925-2016004308) on 21-APR-2016. Case received on 19-APR-2016 from a lawyer via HA (HA # DK-DKMA-ADR 23442750). The HA received the case from Patient Compensation (PIC) 18-APR-2016. PIC is hereby responding to the patient''s claim in connection with her vaccinations with GARDASIL in the period from January 3 to July 3, 2014. DECISION: The patient is not entitled to compensation. FACTS: Reviewer sought damages on behalf of the patient because the reviewer believes that the patient can bear side effects to vaccination with GARDASIL. Patient Compensation is based on the notification, file material and the other information subject to this sequence of events as the basis for the decision: Reviewer has stated that the patient shortly after vaccination with HPV were symptoms of strange changes. She was very mentally unstable, and there was contact to the family house. She had mental unrest, fear of going out, was afraid of the dark and lay with closed curtains and turned on the light. When she was at home was she just would not go out. She also talked about suicide. Reviewer has also informed that the patient has had headaches since vaccinations and that she has fainted and been confused. According to the vaccination card that the patient received vaccinations with GARDASIL, respectively, on January 3, March 7 and 3 July 2014. According to medical records the patient received the second HPV vaccination 6 March 2014. At the consultation, it is noted, she tended to muscle pain in the upper back, and that she was very computer. It has been reported that she was obese and had a stooping position and a weak back muscles. There was normal movement, and there was no tenderness of the bones. She got advice back exercise. On 14 December 2015 the patient was examined at Hospital after referral from her doctor because she was the day before had woken up with a numbness from the chest down. She had no pain, and there was no motor disorders. She had no problems with feces or water landing. There were no headache, nausea or vomiting. She could walk and there were no problems with balance. Apart from the fact that she pointed towards the mouth, instead of the navel, there were completely normal by the neurological examination. It was considered that it was a benign condition that would go off by itself. The family was advised to return if her symptoms became worse. She was examined again December 16, 2015, because she had had involuntary defecation. She did not know that the condition had deteriorated. She was most bothered by the fact that she was very tired. She had difficulty walking, and her mother had to support her. The family thought that the condition had worsened. The neurological exam was normal and she was able to walk normally when she was derived. On 17 December 2015 the patient was admitted because she had begun to talk wildly and had paralysis of the right side of the face and right arm. There was made an acute MRI scan of the brain which showed changes in the brain that can be suspected due to an infection. They took a sample of the fluid around the spinal cord (CSF) and blood tests. You put her in treatment with medication (acyclovir) against inflammation of the brain. Later she was also put on treatment with antibiotics against possible infection with Borrelia. The patient got worse during the evening, and that was made CT scan of the brain that do not immediately showed signs of high blood pressure. She was moved to the intensive care unit. On December 18, 2015 was made study of the brain''s electrical impulses (EEG) and the displayed influences that could be due to inflammation of the brain. There were also signs of an inflammation of the optic nerve in the right eye (opticus neuritis). There was made new EEG December 21, and showed fewer abnormal changes. A new MRI showed more changes in the brain and around the spinal cord in the neck. On 23 December, it noted that there was a suspicion that there was a connection between the patient''s condition and vaccination against HPV in the period January to July 2014. She drew even the weather, but there was scant contact with her and she was soothing medicine. It was considered that it could be inflammation of the walls of the blood vessels (vasculitis) in the brain without an external cause (autoimmune). The patient had replaced the plasma in the blood (plasma) and she started treatment with drugs to inhibit the body''s immune system (cyclophosphamide). On December 28, 2015 was given to a specialist at the hospital to evaluate the MRI scans, and this estimated that the patient could have multiple sclerosis or a disease in the insulation of nerve fibers in the brain and spinal cord (ADEM). By convention with another expert at the Hospital was assessed that it most likely was ADEM. The patient returned to the children''s ward 7 January 2016. There was improvement of the condition, but still sparse contact with her. There was a new EEG made January 21, 2016, and it described a significant deterioration. Her clinical condition was worsening. On January 22, 2016 began again with plasmapheresis. On 24 January the patient''s oxygen saturation fell, and she was on a respirator. She was moved to the intensive care unit again. At the information meeting 27 January 2016 doctors explained again that the patient''s condition was not caused by HVP vaccination in 2014. It was sure that she had a disease in which the insulation around nerve fibers in the central nervous system were destroyed (demyelinating disorder), but not the specific disease, it was about. There was no difference in the incidence of the type disorders between vaccinated and unvaccinated. It is primarily suspected to be due to an aggressive form of multiple sclerosis. One sends scanning images for a review at Hospital and a consultant. At the request of the parents sent also a case for the assessment of a neurosurgeon. On February 5, 2016 the patient was again treated with cyclophosphamide, because there was still no peace in the disease. One suspect continued that it was ADEM. New MRI showed a small improvement in conditions in the brain, while there was little increase in changes in the spinal cord in the thoracic spine. The patient was disconnected from the ventilator on February 9. She came to Neuro Center, but came back to another Hospital on March 24 with changes in the lungs. On April 3, 3016 eliminated a tube in the throat and the patient could take breath freely and with normal oxygenation, but at night she would again be connected to the ventilator. JUSTIFICATION: Patient Compensation has assessed that the patient''s progress and current state of health is not a result of treatment with GARDASIL, and they have therefore assessed that she has not suffered a physical injury in the legal sense. It is concluded in the assessment that there is no temporal relationship between vaccination and the patient''s symptoms, because she got vaccinations with GARDASIL in the period from 3 January 2014 to 3 July 2014 and had symptoms as a numbness from the chest down in mid-December 2015. It is also concluded that another Hospital has assessed that there is no connection between vaccinations and the patient''s serious condition. Patient Compensation is aware that it is described that there were weird (psychological) changes and mental turmoil patient shortly after the last vaccination with GARDASIL. Psychiatric problems are not covered by the rules on drug damage. A 12-year-old female adolescent patient received GARDASIL (batch number lot not rep, Dose 1) on 03-Jan-2014, GARDASIL (batch number lot not rep, Dose 2) in Mar-2014, GARDASIL (batch number lot not rep, Dose 3) on 03-Jul-2014. The patient experienced Headache since vaccinations on 03-JAN-2014, Talked about suicide on an unknown date, Mentally unstable / mental turmoil / weird (psychological) changes on an unknown date, Fear of going out, was afraid of the dark on an unknown date, Fainting on an unknown date, was confused on an unknown date, Numbness from the chest down on 13-DEC-2015, Involuntary stools on 16-DEC-2015, difficulty walking in DEC-2015, very tired in DEC-2015, Speaking delirious on 17-DEC-2015, Paralysis of the right arm on 17-DEC-2015, Paralysis on the right side of the face on 17-DEC-2015, Change in the Brain on an unknown date, Inflammation of the brain on an unknown date, Inflammation of the optic nerve in the right eye (opticus neuritis) on an unknown date, Changes around the spinal cord in the neck / slightly increased changes in the spinal cord in the thoracic spine on an unknown date, Sparse contact to her on an unknown date, Attention inflammation of the walls of the blood vessels (vasculitis) in the brain on an unknown date, Was coupled to a respirator on 24-JAN-2016 and Changes to the lungs in 2016. The patient was admitted to hospital on an unspecified date. The patient had a medical history of: -Myalgia -Overweight -Muscular weakness -Posture abnormal -Multiple sclerosis -Acute disseminated encephalomyelitis -Demyelination. The patient''s outcome was reported as Not Recovered/Not Resolved.
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