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Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DK-1577272925-E2015-12801) on 13-NOV-2015. Case received from the Patient Insurance Company (PIC) via Health Authorities on 05-Nov-2015 under reference number DK-DKMA-ADR 23219663. The case is not medically confirmed. The primary reporter was a lawyer. A 13 years-old female patient had received an unspecified dose of GARDASIL, (batch numbers not reported) via unspecified route of administration in unspecified site of administration on 28-Jun-2012. Later on 28-Mar-2013 she developed chronic tiredness, light sensitivity, headache, joint pain (including the jaw area), and continued depression (in treatment). The HA received the patient''s initial drug injury notification from PIC on 29-Oct-2015 reference number 15-8929: A decision from PIC concerning this case has still not been made. In the initial case it appears that patient is in treatment for depression and joint pain. Patient goes on treatment to physiotherapist and chiropractor. No information on other vaccines and medication provided. Previous dose of GARDASIL (D1, batch no. not reported) was given via not reported route and site of administration on 28-Mar-2012. No other information on medical history provided. At the time of reporting, the patient had not recovered. Follow up information received on 11-Nov-2015 from HA. The HA received follow up information on 06-Nov-2015 from the patient''s physician in the form of a new report. The patient''s physician informs that the patient was vaccinated (28-Mar-2012), 29-May-2012 and 01-Oct-2012 (with batch no. G007714)). Vaccinated with PRIORIX (batch no. A69FC807A) 28-Mar-2012. Adverse reactions: headache, dizziness, tiredness, abdominal pain, all with onset 09-Aug-2012, still experienced. Patient has received more symptoms continuously, examined at different physicians. Is put on antidepressive treatment at psychiatrist, is in treatment with methotrexate at rheumatologist. Had has large absence from school the last 2 years due to the above mentioned symptoms. The physician has reported the seriousness criterion Disability/Incapacity. No other medication. The following has been added/changed to the case based on the follow up: Relevant medical history: Commotio cerebri, depressed mood, Juvenile arthritis added. D2 of GARDASIL added (29-May-2012, route and site of administration: not specified, batch. not reported). The previously unspecified dose has been changed to D3, Date of vaccination for D3 has been changed from 28-Jun-2013 to 01-Oct-2012 (batch no: G007714). Onset aged changed from 13 to 12 years. PRIORIX (mfr other) added as concomitant vaccine (date of vaccination: 28-Mar-2012, route and site of administration: not reported, batch no: A69FC807A) Seriousness criterion disability added. The case has been upgraded to serious. The case is now medically confirmed based on the symptoms Headache, Dizziness, Chronic fatigue and Abdominal pain. Onset date for Headache and Chronic fatigue changed from 28-Mar-2013 to 09-Aug-2012. Test information: The patient had been examined by eye doctor, ear doctor, pediatrician, rheumatologist, child psychologist. There has been performed several laboratory tests, has among other things had vitamin D deficiency (not further specified).
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