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Life Threatening? Yes
Write-up: Information has been received Sanofi Pasteur MSD (SPM) with (MFR# IE-1577272925-2016000040) on 08-JAN-2016. This case was received from the RA health authority on 05-JAN-2016. Initial report was received by the RA on 21-DEC-2015 from a member of the public which concerns a 15 year old female patient who experienced Headache, Nausea, Chest pain, Dyspnoea, Back pain, Rash, Abdominal pain upper, Arthralgia, Dizziness, Syncope, Fatigue, Lethargy, Feeling abnormal, Sleep disorder, Gluten sensitivity, Irritable bowel syndrome (IBS), Menstruation irregular, Dysmenorrhoea, Migraine and Depression following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None. The reporter indicated that the patient was perfectly healthy prior to vaccine. The patient was vaccinated with three doses of GARDASIL on 18-JAN-2011 (batch no. NN33040), 01-MAR-2011 (batch no. NN40800) and 24-MAY-2011 (NN40800). On 01-MAR-2011, the patient started to experienced headaches, nausea, chest pain, shortness of breath, back pain, rash, stomach cramps, pain in joints, dizziness, fatigue, lethargy, brain fog, irregular sleep, gluten intolerance, IBS, irregular periods and very painful, migraines and depression. Corrective treatment: Painkillers, depression tablets, steroids, magnesium, vitamin B complex, calcium and liquid silver. The patient was also given inhalers for asthma and was tried on a number of therapies for IBS. The patient was hospitalised for various tests, had a camera up and down, bloods taken, a lumbar puncture, X-rays, CT scans, MRIs. At the time of reporting the patient''s symptoms were persisting. The patient outcome was not recovered/not resolved.
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