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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # NO-1577272925-2016010439) on 20-OCT-2016. Case received from a physician via agency (authority # NO-NOMAADVRE-FHI-2016-22690) on 14-Oct-2016. A 11-year-old female child patient received GARDASIL (lot/batch number lot not rep, Dose 1) via parenteral route on 01-Oct-2010, GARDASIL (lot/batch not rep, Dose 2) on 10-Dec-2010, GARDASIL (lot/batch number lot not rep, Dose 3) on 10-Jun-2011. The patient experienced Concentration impaired, Exhaustion since 2009, worsening 2010, Headache since 2009, worsening 2010, Hyperacusis, Sleepiness since 2009, worsening 2010, Tiredness since 2009, worsening 2010, Cold feet, Twitching spontaneously and when touched, and Near syncope when getting up abruptly on an unknown date. The patient had a medical history of: Migraine in 2012; Depression in 2009; Headache in 2009; Osteomyelitis in 2009; Head injury in 2011; Anxiety in 2009. Treatment: Venlafaxin since 2014 and TELFAST as required School attendance decreased. This is a preliminary report. A full evaluation is being undertaken. Additional investigations included: Computerised Tomogram Head on 14-Sep-2016: normal; Blood test on 14-Sep-2016: normal; Nuclear magnetic resonance imaging brain on 14-Sep-2016: normal; Nuclear magnetic resonance imaging (cervical spine) on 14-Sep-2016: normal; Electroencephalogram on 14-Sep-2016: results = not epilepsy, possible drug influence. The patient''s outcome was reported as Not Recovered/Not Resolved.
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