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Write-up: Information has been received Sanofi Pasteur MSD (SPM) (manufacturer control no E2015-03470) on 23-DEC-2015. Case received from a consumer or other non health care professional via the Health Authorities on 07-Apr-2015 under the reference number DK-DKMA-ADR 22929835 and DK-DKMA-EFO11510. Case is not medically confirmed. A 12-year-old female patient (weight: 54 kg; height: 174 cm) with no medical history reported, had received an injection of GARDASIL, (batch number, route and site of administration not reported) on 03-Sep-2014. On an unspecified date in Sep-2014, the patient developed dizziness, headache, fatigue, visual disturbance and exercise-induced dyspnea. The patient had been to the doctor, chiropractor, physiotherapist, osteopath and ENT -specialist. Nothing was found. Blood tests were taken and a MRI scan of the head was performed, without results. The patient had not been treated for the adverse reaction. At the time of reporting, the patient had not recovered. Follow up information received on 18-Aug-2015 from HA. The HA received follow up information from the patient''s physician general practitioner on 04-Aug-2015 and from the hospital physician on 12-Aug-2015 at the request of Sanofi Pasteur MSD: The patient''s physician informs of the batch number for the first vaccine and has not informed of dates of batch numbers for possible 2nd and 3rd vaccination. Furthermore, it is informed that the patient is under investigation at the pediatric department. The patient''s physician attaches blood tests results from 10-Mar-2015 and medical summaries from ear-nose-throat physician 26-Feb-2015 and from the pediatric department 22-Apr-2015, in these it is described: 26-Feb-2015: Ear-Nose-Throat physician. Here, it is described that the patient has 3-4 months previously been in treatment at chiropractor, physiotherapist and osteopath due to pain in the neck musculature and myalgia in connection to football training. Two days after visit to chiropractor the patient began feeling dizzy. The patient means that the dizziness is problematic in everyday life. Has difficulty describing the feeling, not as on a ship''s deck, but develops strange sounds in the head and feels as if she is dreaming. No observed fainting. Nausea, but no vomiting. Complains about headache intermittently. Manages school, but can develop attacks. Heart problems (long QT) in the family, however the patient is examined and established healthy. Feels discomfort at disco lights. Objectively nothing abnormal and there is found normal ontological conditions and normal audiogram. 22-Apr-2015: Pediatric and youth department. Referred with the diagnosis disorder in the equilibrium sense. Debut of dizziness in 2014, first as attacks, now a condition that has subsequently become more constant. Retrospectively, the mother and daughter links it with first HPV vaccine on 03-Sep-2014. According to attached referral, it started with periods of myalgia and progression at chiropractor, which did not have a large effect. Subsequent similar progressions at physiotherapist and osteopath. The patient symptoms have increased and the mother and patient have a list of approx. 20 different symptoms that have developed in greater or lesser extent, includes primarily dizziness that is more described as unreal sensation, sensation of being in a bubble or next to one self, but no real dizziness. Described discomfort at stroboscopic light. When the patient lies on her back, often falling sensation. Periods with sensation of increased hearing and also blurred vision. Varying headache. Visual disturbance. Discomfort at bright light. Sound sensitive. More tired than usual. Pain in the legs. Concentration problems. The last months the patient has not been able to read and in school for example she has not been able to read the material which is 400 pages per month. Describes periods with numbness, periods with shaking, nausea and periods with muscle cramps in the abdominal musculature. Above ment
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