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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD as part of a business agreement (MFR Control no. E2014-02796) on 28-MAR-2014. Case of adverse event received from patient insurance company via company representative on 20-Mar-2014 under the reference number 2014/00664. The primary reporter was a patient. A 12 year old female patient, had received the first and second dose of GARDASIL (batch number NM18120, lot number NK44350 and Exp date: 31-MAY-2012) via not reported route of administration in not reported site of administration on 18-OCT-2011 and 13-Dec-2011 respectively. On a non-specified date she received influenza vaccine (trade name not reported, MFR UNK, batch number not reported) via not reported route in not reported site of administration. Later on a non-specified date in Sep/Oct 2011, she developed pronounced tiredness and on a non-specified date vitamin D deficiency, two virus infections, was weak, recurrent headache (severe when she is very tired), asthma problems, dysregulation of autonomic nervous system, pronounced stress, general pain, chills and impaired sleep quality. On 02-Jan-2013 the patient was diagnosed with Chronic Fatigue Syndrome (also referred as Myalgic Encephalomyelitis). The physician pointed that it is very important that the patient conserves her energy. Due to this illness the patient could not go to school by herself and needed transportation between school and home for six months. Medical journal notes 13-Jan-2012: The patient sleeps every day after school, sleeps one hour, goes to bed again at 21, sleep almost right away. Very tired when woken up at 07.00, is tired after physical activity such as bicycle 5 minutes to the shop. Medical journal note 07-Feb-2012: The patient is found with vitamin D deficiency since last session, the patient takes a few vitamins daily. US (urine dipstick): PO. H: 150 cm, V: 44 kg, weight decrease. Blood pressure 90/60, pulse 70, regular. FEV1 1.12, 81%, pretty nice curve, increase with 3, 3% after inhalation with VENTOLINE (other MFR). Skin test; pollen, mites, animal hair and food including wheat/gluten: Negative. Medical journal notes 18-Apr-2012: The patient gets tired at activity and has no strength to do much. The patient received CALCIGRAN FORTE 400 mg daily. US: PO. H: 151 cm, V: 45kg, FEV1 2.42, 104%, runs 9km/h, 6% incline, max pulse 196, 4% incline. TLC 3.66, 98%. Raw 107%, NO 8.3, normal. Conclusion: negative sprinter test and normal respiratory volumes and NO. The patient is recommended vitamin 1 tablet daily. The vitamin D level is controls by the general practitioner. Medical journal notes on 27-OCT-2012: The patient is fine respiratory and circulatory. She is found without any signs of pain. Normal findings in ears or throat. Neurologic examination is normal. The patient has now normal sleep routines and goes to be between 20-21. The patient states that the pronounced tiredness could possibly be due to dysregulation of the autonomic nervous system due to pronounced stress over a long time. Before the tiredness period, the patient had a high activity level which has contributed to her current tiredness. The symptom picture with general pain, chills and impaired sleep quality could be due her dysregulation of autonomic nervous system. During the consultation blood test were taken which were normal. The patient was vaccinated with DTP-IPV-Hib vaccine (MFR unk, batch number not reported) on 16-Dec-1999, 16-Feb-2000 and 12-Sep-2000. The patient was also vaccinated with DTP-IPV vaccine (MFR unk, batch number not reported) on 17-Jan-2008. On 15-Dec-2000 and 02-Sep-2010 the patient received a dose of MMR vaccine (MFR unk, batch number not reported). Medical journal note 04-Jan-2011: The patient has several years of abdominal pain and a lot of air. Main diagnosis: Allergic rhinitis due to pollen. The patient has tried gluten- and milk- free diet without noticeable change. Normal gluten antibodies / fecal test / blood status. Hard feces 2 times daily. Abdominal pains has slowed recently. Conclusion: Adequately investigated by referred physician. She is vague in her statements of discomfort pain. The physician suspected obstipation. Following test were performed; 05-Jan-2012: S-FI4 (16.8), S-TSH (1.9), S-ALAT (34), S-Calcium (2.44), S-Vitamin B12 (269), S-Folate (33.0), Lymphocytes (2.1), Neutrophil (2.8), Monocytes (0.5), MCV (88), B-Leucocyte (5.4), S-Creatinine (44), S-iron saturation (38), MCH (30), Eosinophil (0.1), B-hemoglobin (14.2), S-iron binding capacity (66), S-Ferritin (81), B-HB without grouping: 12.8, Vitamin 03 (46), Vitamin D (46), B-thrombocytes (221). Microscopic examination (results not provided). 17-Aug-2012: S-FT4 (15.7), S-TSH (1.2), S ALAT (20), S-Calcium (2.21), S-Vitamin B12 (373), MCV (91), S-Creatinine (52), S-iron saturation (37), MCH (30), Eosinophil (0.1), B-hemoglobin (14.2), S-iron (24.8), S-iron binding capacity (64), S-Ferritin (74), B-HB without grouping: 13.6, Vitamin 03 (91), Vitamin D (491). B-HB without grouping: 13.6. Celiac test performed on 17-Aug-2012 (results not provided). Medical journal note 31-Aug-2011: gluten intolerant. Medical journal note 27-Oct-2012: The patient has undergone respiratory as well as allergy tests on different food. She has a known allergic triggered asthma. Due to abdominal pain, wheat/gluten products are avoided by the patient. She is found with normal celiac tests. The patient was very active before. She had minimum absent days from school. Previously during the year, the patient had to sleep a few hours after school. The patient''s mother has ME (myalgic encephalomyelitis) and is gluten intolerant. At the time of reporting the outcome was not recovered from Chronic Fatigue Syndrome (or ME), weak, pronounced tiredness, and impaired sleep quality. The outcome was not reported for all of her events. Relevant Test/Laboratory Data: Microscopic examination performed on 05-Jan-2012. Celiac test performed on 17-Aug-2012. B-HB without grouping: 13.6 (on 17-Aug-2012) and 12.8 (on 05-Jan-2012). 07-Feb-2012: skin test; pollen, mites, animal hair and food including wheat/gluten: Negative. 18-Apr-2012: Raw 107%, NO 8.3, normal. Conclusion: negative sprinter test and normal respiratory volumes and NO. Additional information is expected.
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