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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (DK-1577272925-E2015-10024) on 12-JAN-2016. Case received from non-healthcare professional via Health Authorities on 27-Jul-2015 under the reference numbers DK-DKMA-ADR 23071942 and DK-DKMA-WBS-0000443. The case is not medically confirmed. The primary reporter was a patient. A 13-year-old female patient (weight: 58 kg; height: 165 cm) had received the first dose of GARDASIL (batch number not reported) via I.M route of administration in unspecified site of administration on unspecified date in 2009. On unspecified date in 2011, she developed tiredness. On unspecified date in 2012, she developed headache and fluctuating hair loss. On unspecified date in 2013, she developed abdominal pain. On unspecified date in 2014, she experienced rapid heart pounding, slow heart pounding, increased hunger, vomiting, shaking hands while rapid heart pounding, sleeplessness, often swollen tonsils, constipation and changed bowel movement. On unspecified date in 2015, she developed concentration impaired, depressive and dizziness. The patient has not been treated for the adverse reactions. The patient has not been hospitalized due to the adverse reactions. No information on other vaccines and/or medications provided. No tests or procedures have been performed. The patient has otherwise no health issues. At the time of reporting, the patient was recovering from shaking hands while rapid heart pounding and dizziness. The patient had not recovered from the remaining reactions. Follow up information received on 5-Jan-2015 from the HA. The HA identified duplicate (DK-DKMA-ADR 23278860) from the Syncope center (physician), Hospital on 16Dec2015. Not previously sent to MAH, now merged with this master case. Adverse events reported: Headache, Fatigue, Near syncope, Dizziness, Orthostatic intolerance, Palpitation, Nausea, Abdominal pain, Dyspnea, Cognitive function abnormal, Pain knee, Hair loss, Light sensitivity to eye, Obstipation. After dose 3 of GARDASIL, headache and fatigue and other symptoms developed. In 2013, headaches and fatigue worsened considerably. The patient went to cheerleading and dance in Championship, but has stepped down over time. Going to high school, but has some absences due headache especially. The patient has performed tilt table test at the Syncope center which showed orthostatic intolerance, but the patient does not fulfill the diagnostic criterion for POTS. Other vaccines/medicines: unknown. Added/changed by the HA: case has been upgraded to serious due to seriousness criterion disability. Case is now medically confirmed. New adverse events added (please see above). Onset date for Headache and tiredness is changed to 2010. Outcome for Dizziness is changed to Not recovered. Vaccination dates added; dose 1 of GARDASIL 28Oct2009 and dose 2 22Dec2009. Patient initials are changed.
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