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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number DK-1577292925-2016006287) on 16-JUN-2016. Case received from a HCP (physician) via HA with the reference nrs. DK-DKMA-WBS-0003732 / DK-DKMA-ADR 23518733 on 14-JUN-2016. A 14-year-old female adolescent patient received GARDASIL, (batch/lot number J010357, Dose 1, expiry date: 02-DEC-2015) via intramuscular route on 28-JAN-2015. SIDE EFFECTS: The patient experienced influenza like symptoms, fever, headache, general malaise and 1 year duration of complaints, which contributed to 25% of school absenteeism on an unknown date. HISTORY AROUND side effect: Onset of symptoms after the first vaccination. 1 year duration of complaints, which contributed to 25% of school absenteeism. The patient had a concurrent depression in JUL-2015. About 6 months after vaccination, she had been diagnosed with depression with complicating eating problems. The patient''s sister also had depression. Other vaccine: No. Other medicine: No. The patient''s outcome was reported as recovering/resolving.
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