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This is VAERS ID 634896

Case Details

VAERS ID: 634896 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
   Days after vaccination:0
Submitted: 2016-04-22
   Days after onset:839
Entered: 2016-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Anal incontinence, Blood test, CSF test, Computerised tomogram head normal, Condition aggravated, Confusional state, Delirium, Electroencephalogram abnormal, Facial paralysis, Fatigue, Fear, Gait disturbance, General physical health deterioration, Headache, Hypoaesthesia, Infection, Intensive care, Mechanical ventilation, Mental disorder, Monoplegia, Multiple sclerosis, Neurological examination normal, Noninfective encephalitis, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Optic neuritis, Oxygen saturation decreased, Plasmapheresis, Speech disorder, Suicidal ideation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Optic nerve disorders (narrow), Cardiomyopathy (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Human papillomavirus immunisation
Preexisting Conditions: Demyelination, Disease in which the insulation around nerve fibers in the CNS was destroyed (demyelinating disorder); Acute disseminated encephalomyelitis, OBS ADEM (Acute disseminated encephalomyelitis); Multiple sclerosis, OBS sclerosis; Posture abnormal, Stoop; Muscular weakness, Weak back muscles; Overweight; Myalgia, Tendency to muscle pain in the upper back
Diagnostic Lab Data:
CDC Split Type: WAES1604DNK014358

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

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