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Administered by: Other Purchased by: Unknown
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (MFR control number # GB-1577272925-2016012448) on 05-DEC-2016. This report was received from the regulatory authority on 01-DEC-2016 under reference number GB-MHRA-ADR 23310013. Case received from a consumer/other non health professional concerning a 15-year-old female adolescent patient (weight: 53.52kg) who received (Gardasil, batch number unknown) via parenteral route in October 2013, (Gardasil, batch number unknown) via parenteral route on an unknown date and (Gardasil, batch number unknown) via parenteral route in March 2014. The patient just had flu injection in the right arm and so was given human papilloma virus vaccine in the same arm. The patient was told that she should never had the two together. Current conditions included asthma. The patient received concomitant administration of Clenil Modulite, Fluoxetin and Ventolin on an unknown date. The patient experienced chronic headaches, dizziness, chronic fatigue syndrome, muscle spasms, blood thyroid stimulating hormone abnormal, nausea, blood growth hormone abnormal, digestion impaired, multi-vitamin deficiency, mineral deficiency in March 2014, anxiety, low blood pressure in September 2014, dairy intolerance in February 2015, non-epileptic seizure in September 2015 and menstrual disorder on an unknown date. The mother wants to investigation for postural tachycardia syndrome and myalgic encephalopathy as her daughter shows side effects of both. The patient visited general practitioner several times who referred her to paediatrician who diagnosed lactose then dairy intolerance, then referred to child mental health services and currently children and young person service who prescribed medication and counselling. She now can''t eat lactose or dairy at all. Additional investigations included blood pressure measurement (low), blood growth hormone (abnormal) and blood thyroid stimulating hormone (abnormal) on an unknown date. The event chronic headaches, dizziness, chronic fatigue syndrome, muscle spasms, non-epileptic seizure, dairy intolerance, low blood pressure, digestion impaired, multi-vitamin deficiency, mineral deficiency were not recovered/not resolved, blood thyroid stimulating hormone abnormal, blood growth hormone abnormal, nausea were recovering/resolving, anxiety recovered with sequelae and the outcome of menstrual disorder was unknown. The patient''s overall outcome was reported as not recovered/not resolved.
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