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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (DK-1577272925-E2015-10018) on 12-JAN-2016. Case received from healthcare professional via Health Authorities on 27-Jul-2015 under the reference number DK-DKMA-ADR 23070016. The case is medically confirmed. The primary reporter was a physician. A 12-year-old female patient with a medical history of headache during child years suspected relation to swimming and suspected cervicogenic headache, had received the first dose of GARDASIL (batch/lot number H014677 expiration date 28-FEB-2015) via i.m route of administration in unspecified site of administration 28-Jan-2013 and later the same day, she developed headache, concentration impaired, muscle weakness, dizziness, tiredness, light sensitivity and nausea. The patient had received concomitant injection of PRIORIX (other mfr, batch number not reported) via unspecified route of administration in unspecified site of administration on 28-Jan-2013. D2 and D3 of GARDASIL were given via i.m route of administration in unspecified site of administration on 08-Apr-2013 (D2. batch number: H019462) and 16-Aug-2013 (D3, batch number: J001983, expiration date 31-AUG-2015).No information on other vaccines and/or medications provided. No information on tests and procedures provided. At the time of reporting, the patient had not recovered. Follow up information received on 5Jan2015 (also reported 05-JAN-2016) from the HA. The HA identified duplicate (DK-DKMA-WBS-0002118 / DK-DKMA-ADR 23278876) from the Hospital. Not previously sent to agency, now merged with this master case. From duplicate: adverse events reported Headache, Knee pain, Near syncope, Dizziness, Palpitation, Nausea, Obstipation, Abdominal pain, Voiding difficulty, Skin disorder, Shortness of breath, Menstrual disorder, Hyperventilation, Fatigue, Cognitive disorder, involuntary muscle movement, Limb weakness, Light sensitivity to eye. The patient reports that her onset of symptoms came after dose 1. It started with blackening before her eyes. She was elite swimmer, but her physique could suddenly not keep up. Subsequently, the other reported symptoms developed. A tilt table test at the department showed normal examination. Patient describes that she has had many absences in primary schools. Other vaccines/medicines: unknown. Added/changed by the HA: test added, patient initials. Case is upgraded to serious due to seriousness criterion Hospitalisation and Disability. Tiredness is changed to fatigue. Reactions Obstipation, Vascular anomaly, involuntary muscle movement, Shortness of breath, Abdominal pain, Cognitive disorder, Menstrual disorder, Palpitation, Voiding difficulty, Hyperventilation, Skin disorder, Near syncope, Muscular weakness and Knee pain is added. Case initially reported as non-serious and upgraded to serious due to seriousness criterion Hospitalization and Disability.
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