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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR Control number DK-1577272925-2015001264) on 21-DEC-2015. Case received from a physician via health authority on 18-Dec-2015 under reference number DK-DKMA-WBS-0002100. A 11-year-old female child patient received GARDASIL (batch/lot number unknown, Dose 1) via intramuscular route on 22-Oct-2014. Other suspect products included M-M-RVAXPRO, batch number unknown) administered via intramuscular route on 22-Oct-2014. The patient experienced Headache aggravated in NOV-2014, Flu like symptoms in NOV-2014, Excessiv menstrual bleeding in DEC-2014, Muscle pain on an unknown date, Subfebrilla on an unknown date, Near syncope on an unknown date, Dizziness on an unknown date, Nausea on an unknown date, Abdominal pain on an unknown date, Aggrevated sleep disorder on an unknown date, Fatigue extreme on an unknown date, Cognitive disorder on an unknown date, Involuntary muscle movement in legs and feet on an unknown date, Limb weakness on an unknown date, Light sensitivity to eyes on an unknown date, Vascular abnormalities on an unknown date, Blurred vision on an unknown date and reduced general function on an unknown date. After first dose, the patient experience influenza like symptoms and aggravation of headache. Approximately 60 days post vaccination she experience a excessive menstrual bleeding that required hospitalization. Did not get more doses. After the rest of the symptoms. The patient did not fulfill the diagnostic criteria for POTS with tilt table test. The patient describes reduced function and has a lot of sick leave from grade 6-7. Other medicines: Unknown. The patient was admitted to hospital on an unspecified date. The patient had a medical history of: Sleep disorder. Headache. The patient had received MMRVAXPRO. Additional investigations included Tilt Table Test not pots n/a on an unknown date. The patient''s outcome was reported as Not Recovered/Not Resolved. Headache aggravated, Flu like symptoms, Muscle pain, Near syncope, Dizziness, Nausea, Abnormal pain, Fatigue extreme, Blurred vision, Excessive menstrual bleeding, subfebrille, Aggravated sleep disorder, Cognitive disorder, Involuntary muscle movement in legs and feet, Limb weakness, Light sensitivity to eyes, vascular abnormalities.
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