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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 # E2015-13009) on 17-NOV-2015, as a part of business agreement. This serious case was reported from the RA on 13/Nov/2015. GB-MHRA-ADR 23218631. This case is medically confirmed as it was reported from a HCP. A 12 year-old female patient, with no medical history reported, received an injection of GARDASIL, lot K006975, via IM route, dose 1, site not reported, on 24/Sep/2015. Patient was concomitantly receiving ibuprofen, paracetamol and salbutamol (doses and indications not reported). Approximately 1 hour following first vaccination, on 24/Sep/2015, patient developed muscle aching in her back legs which is ongoing. Patient is suffering from severe fatigue and lethargy which is also ongoing. The pain in her back has been so severe at times that she has had to be collected from school and taken home and she is unable to do physical activities such as physical education. Patient''s mother reports that her GP has taken blood samples. The blood tests are being repeated next week to rule out a viral infection and if they are still raised she is being referred to a pediatrician. No onset date was reported for pain back. At the time of reporting the outcome for the AEs was reported as not recovered. The RA considers this case serious, due to patient disability.
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