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Write-up: Information has been received from Sanofi Pasteur MSD (reference # DK-1577272925-2015000669) on 11-DEC-2015. Case received from the Health authority on 09-Dec-2015. A 13-year-old female adolescent patient received GARDASIL, (batch/lot number H003811, expiry date not reported) via intramuscular route on 25-Sep-2012. The patient received concomitant administration of PRIORIX on 25-Sep-2012. The patient experienced Tiredness / constantly tired on 26-JAN-2014, Dizziness in 2014, headache in 2014, Increased need for sleep in 2014, Loss of energy in 2014 and Common viral infections take a long time to get over in 2014. At the time of reporting, the patient was recovering. It is a little unclear when this symptom complex really started, but she had menarche (first menstruation) at the age of 12 and there have been some difficulties associated with menstruation. On 30Jan2014 there is a doctor contact due to Abdominal pain and fatigue during 4 days. Again on 03Apr2014 due to lengthy malaise about menstruation, she were home from school for a week due to headache and general symptoms. Set and assessed clinically unremarkable, blood tests revealed quite severe vitamin D deficiency with the value of the 17. Although advice given, vitamin D treatment was never really carried out and there were again contacted here on 08May2015 due. Increased absence from school and current upper respiratory infection. Since then taken 2 tablets Multi Vitamin D3 daily. New sample from 08May2015 displayed value at 21. There are planned monitoring of serum value in September. Conventional blood tests, both last spring and this year has been normal, especially normal hemoglobin. The picture is a little unclear, but parent think it all fits with possible adverse events to GARDASIL, especially as she is aware of aluminum which patient is contact allergic to. The complaints are constant fatigue, dizziness and headache, increased need for sleep and lack of energy, common viral infections that it take a long time to get over. The school has also noticed increased absence. There is no suspicion of psychological, social or vocational dissatisfaction in school or at home. The patient''s family is a classic nuclear family. Mother and father both work. No other medicines. The patient had a medical history of: Menarche; Allergy to metals; Abdominal pain; Upper respiratory tract infection on 08-MAY-2015.
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