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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 mentioned symptoms have resulted in varying degree of absence from school, where the patient goes to 6th grade. However, the last weeks/months the absence from school is described as 3 hours per week. The absence decreased after the parents had agreed with the school that the patient should show up as much as possible, but could go home if she felt worse. The patient manages school well. She describes that a math tests went really well. No described school problems. The patient plays in her spare time, football approx. 3-4 times per week. The patient and the mother believe that the symptoms might be caused by HPV vaccine, this suspicion has increased after TV coverage regarding girls with suspected adverse reaction to the vaccines. Objectively: appears completely without remarks psychologically, cognitively and in regards to the presented medical history. Appears neurologically intact. Assessment: Complex symptom picture with several unspecific symptoms. Plan: first to be evaluated with MRI scan of cerebrum. There is also indication for EEG. In the follow up received on 12-Aug-2015 from the hospital physician: it is informed that above mentioned examination has been performed, but that the MRI scan has not been performed as the patient has not undergone other relevant tests as the pediatric and youth department. The following has been added to the case based on the follow up: Batch number for the 1st vaccination (J010618). The following tests information: 10-Mar-2015: blood test shows increased potassium, 4, 8 and low vitamin D, 45. Thrombocyte, erythrocyte mean (MCV), haemoglobin, vitamin B12, Ery Vol Varia, leukocytes, alkaline phosphatase, alanine aminotransferase, thyrotropin, sodium, calcium (albumin corrected), large unstained cells, basophils, calcium, eosinophils, albumin, monocytes, lymphocytes, neutrophil, ferritin, creatine and glucose all within reference range (not further specified). The following reactions have been added : noises in the head (onset:2014, outcome: not recovered), nausea (onset: 2014, outcome: not recovered), photophobia (onset: 2014, outcome: not recovered), feeling unreal (onset: 2014, outcome: not recovered), sound sensitivity increased (onset: not reported, outcome: unknown), blurry vision (onset: not reported, outcome: unknown), light sensitivity to eye (onset: not reported, outcome: unknown), concentration impaired (onset: not reported, outcome: unknown), leg pain (onset: not reported, outcome: unknown), numbness (onset: not reported, outcome: unknown), shaking (onset: not reported, outcome: unknown) and muscle cramps (onset: not reported, outcome: unknown). The HA coded: neck pain and myalgia in medical history (both with start date: 2014, continuing: unknown), the company chose to just mention them in the narrative. Follow up information receive on17-Dec-15: the HA received follow up from the Syncope Center at the hospital. Report (DK-DKMA-WBS-0002044 / DK-DKMA-ADR 23275666) has been found to be a duplicate to this case, not previously sent to MAH, but is now merged with this case. Adverse reactions: dizziness, muscle pain, headache, pain in legs, near syncope, numbness left-sided, palpitation, nausea, orthostatic intolerance, abdominal pain generalized, dyspnoea, sleep disorder, tics, cognitive disturbance. The start of symptoms came a few days after dose 1 of GARDASIL with dizziness, muscle soreness and headache afterwards the other reported symptoms occurred. Only received dose 1. Significant decreased functioning level. A tilt table test at the department showed orthostatic intolerance, but she do not meet the diagnostic criteria for POTS. Added/changed by the HA based on the follow up information: The case has been upgraded to serious with seriousness criteria disability by then HA and is now medically confirmed, patient initials added, tilt table test showed orthostatic intolerance, reactions muscle pain, near syncope, palpitation, orthostatic intolerance, abdominal pain generalized, dyspnoea, sleep disorder, tics and cognitive disturbance added. Light sensitivity to eye has been put under Photophobia. Outcome is reported as unknown for the event photophobia and as not recovered for the other events.
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