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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2015-12787) as part of business agreement on 13-NOV-2015. Case received from Health Care Professional via Health Authorities on 11-Nov-2015 under the reference number DK-DKMA-ADR 23221751 and DK-DKMA-WBS-0001596. The case is medically confirmed. The primary reporter was a physician. A 12-year-old female patient (weight: 47 kg; height: 164 cm) had received the third dose of GARDASIL, batch number J010618 via intramuscular route of administration in unspecified site of administration on 25-Aug-2014 and later on 13-JAN-2015, she developed reduced gait function, muscle pain, memory impairment, fainting and tiredness. Insidious debut of abovementioned symptoms. The parents suspect adverse reactions to HPV vaccinations. The case is serious due to seriousness criterion disability. No other vaccines or medications. The patient has undergone blood tests (not further specified). The patient''s medical history included psychological impact after bullying and the parents'' divorce. Early eating difficulties. Noteworthy: The HA had not coded the abovementioned in medical history, the company chose to code psychological trauma and eating disorder, unspecified. Previous doses of GARDASIL (D1-D2, batch no. D1 and D2: J012135) were given via IM route of administration in unspecified site of administration on 12-Feb-2014 and 23-Apr-2014. At the time of reporting, the patient had not recovered.
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