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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number IE-1577272925-2016000982) on 10-FEB-2016. This case was received from a health authority on 05-FEB-2016. Initial report was received from the RA on 23-JAN-2016 from a member of the public which concerns a 13 (also reported as 12) year old female who experienced Dyskinesia, Paralysis, Amnesia, Disturbance in attention, Disorientation, Neck pain, Body temperature fluctuation, Intentional self-injury, Dysarthria, Drooling, Paraesthesia, Insomnia, Heart rate increased, Tachycardia, Spinal pain following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None. The patient was vaccinated with 3 doses of GARDASIL at a dose of 0.5ml via intramuscular route on 16-SEP-2011 and also 17-APR-2012 (dose 3). A third date was not provided and only one batch number was provided and it is not specified which dose it relates to - GO1450 (digit missing). The reporter indicated that all the complaints started after the patient''s third dose, reported as 02-SEP-2012. She had severe neck and spinal pain, then involuntary head shakes which eventually spread to her whole body. The patient has been seen by numerous doctors and neurologists and has undergone multiple tests including MRIs and EEGs. The reporter indicated that the tests have not explained anything. The patient''s EEG has shown a right focal sharp slow wave. The patient is tired and drained most of the time. She has Tourette''s like symptoms both vocal and physical. She has uncontrollable body movements, extreme body temperature changes, punches walls and hurts herself, has memory loss, no concentration, slurred speech, drooling, disorientation, tingling sensations, difficulty getting to sleep as her head could be shaking so badly, and rapid onset of paralysis which can affect some or all of her body at any time, hence the patient has had to resort to a wheelchair. She also has a high pulse rate and has been tachycardic. Corrective treatment: None. At the time of reporting the patient''s symptoms were reported as not recovered/not resolved.
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