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Write-up: Case received from consumer via Health Authorities on 24-OCT-2014 under the reference number DK-DKMA-ADE22727173 and DK-DKMA-EFO10224 (reference # DK-1577272925-E2014-10028) on 28-OCT-2014. The primary reporter was the patients mother. This case is medically confirmed as it has also been reported by a physician. This case is linked to master case E2013-10742 as the patient was diagnosed with POTS. A 12 year old female patient (weight: 40kg; height 160cm), had received the third dose of GARDASIL (batch number not reported) via intramuscular route of administration in unspecified site of administration on 31-MAY-2012 and later on 03-JUN-2012, she developed fatigue extreme, cognitive dysfunction, autonomic dysfunction, hot flushes, itchy skin, alternating joint pain, nausea, Postural Orthostatic Tachycardia Syndrome, dizziness, dyspnea, often fever, menstrual cycle abnormal, Orthostatic intolerance, sleep disorder (problems falling asleep), abnormal headache, very severe menstrual pain (aggravation of existing pain). The first report was received from the patient''s mother. The patient was absent during the 7th grade and has been on full-time sick leave from school since October 2013 because of her symptoms. The patient is not treated for the adverse reactions. The patient had no other medications. Second report received on 21-OCT-2014 from physician (version 002). Adverse reactions reported: Postural orthostatic tachycardia syndrome, autonomic dysfunction, orthostatic intolerance, headache, dyspnea, abnormal menstrual cycle, sleep disorder, cognitive dysfunction and fatigue extreme. The days after the third GARDASIL vaccine, symptom complex with orthostatic intolerance/dizziness, nausea, severe and chronic headaches, massive fatigue, dyspnea, aggravating irregular menstruation and of menstrual pain, trouble falling asleep, cognitive problems. The patient has for a year not been unable to attend school because of the above. The patient complies by tilt table test the diagnostic criteria for postural orthostatic tachycardia syndrome (POTS) with an inappropriate increase in heart rate at orthostatic stress coincides with the familiar discomfort and indeed also orthostatic hypotension with progressive blood loss at orthostatic stress. The patient is supposedly very untrained, which could be a contributing reason of the tachycardia. The patient show signs of right pronounced autonomic dysfunction and orthostatic intolerance. The patient was investigated at child psychiatry where no evidence of psychopathology was found. Criteria for the diagnosis of POTS: 1 heart rate increases great than or equal to 30 bpm from supine to standing (10 min) in the absence of orthostatic hypotension decrease in BP greater than 20/10 mmHg) 2. Symptoms worsen with standing and improved with recumbence. 3. Symptoms last greater than or equal to 6 months. 4. Absence of other overt cause of orthostatic symptoms or tachycardia (e.g. active bleeding, acute dehydration, medications). In addition, using hospital further criterion in patients between 12-19 years: require a heart rate increase of greater than 40 bpm to make the diagnosis, and the reasons that young people have a stronger physiological heart rate response to standing up. The use of any additional criterion to avoid false positives. DHMA comment: This case has merged with the duplicate received (DK-DKMA-EF0101128/ADR 22727446) with this as the master. When duplicates were identified and merged in before sending it out, the MAH has not received version 1 of this case and they have not received the duplicate. The patients medical history includes: asthmatic bronchitis as a child (unknown if continuing). No other health problems. The patient has previously received two doses of GARDASIL (batch number not reported) via intramuscular route of administration on 16-SEP-2011 and 02-DEC-2011. The HA assessed this report as serious due to hospitalization and disability. At the lime of reporting, the patient was not recovered. The outcome for viral conditions and severe and chronic headache was not provided.
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