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Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number DK-1577272925-2016005165) on 12-MAY-2016. Case received from a physician via health authority on 10-MAY-2016 under reference number DK-DKMA-WBS-0003362. A 15-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route on 29-OCT-2008, GARDASIL (batch number unknown, Dose 2) via intramuscular route on 07-JAN-2009, GARDASIL (batch number unknown, Dose 3) via intramuscular route on 06-MAY-2009. The patient experienced Abdominal pain in JUL-2009, Headache on an unknown date, Dizziness on an unknown date, Voiding difficulty in JUL-2009, Asthma on an unknown date, Sleep disorder on an unknown date, Fatigue in JUL-2009, Cognitive disorder on an unknown date, Involuntary muscle movement on an unknown date, Weakness of limbs on an unknown date, Strawberry allergy on an unknown date, Joint pain on an unknown date, Orthostatic intolerance on an unknown date, Dry mouth on an unknown date, Obstipation on an unknown date, Diarrhea on an unknown date, cat allergy on an unknown date, hay fever on an unknown date, frequent infections on an unknown date, a lot absence in high school, 20% all ready on an unknown date and alternation between diarrhoea and constipation in JUL-2009. Description of the reactions: Patient informs that symptom debut approximately 2 months after 3rd dose. Started with abdominal pain, alternation between diarrhoea and constipation and tiredness. After 3rd dose she also developed asthma, hay and cat allergy. The other symptoms have come thereafter. The patient performed exercise 4-7 times per week (gymnastic, soccer, running, horse riding) until 2 months before the first vaccine, when she had an injury. The patient informs that this has of course had consequences for her, to have all these symptoms. She have frequent infection and therefor a lot of absence from high school. 20% already. Other vaccines: No. Other medicines: No. The patient''s outcome was reported as Not Recovered/Not Resolved. MA Comment: There is a related case (ADR 23012447 / DK-DKMA-EFO12234, E2015-06526), in which the suspected drugs are both GARDASIL and Sertralin "Hexal" and the reported reactions are: Dizziness, High pulse rate, Blood pressure low, Concentration impaired, Muscle weakness, Decreased immune responsiveness, Headache, Sore throat, Urticaria, Rash, Anxiety, Sleeplessness, Chronic fever, Infection NOS, Chest pain, Gastric acid increased, Cystitis, Drug hypersensitivity, Memory impaired, Chillness, Cold hands and feet, Muscle tension, Stress, Nose congestion, Heart rate high, Confusion, Sickness, Touch sensitivity increased, Heart pounding, Chronic fatigue, Disorganised speech, Learning disorder, Light sensitivity to eye, Vitamin D deficiency.
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