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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from SP MSD (manufacturer control number E2014-04063) on 14-MAY-2014. Case was received from a health care professional via the Health Authorities on 09-May-2014 under the references DK-DKMA-ADR 22521429 and DK-DKMA-EFO8853. Case is medically confirmed. Primary source was a physician. A 12-year-old female patient (weight 54 kg, height 173 cm) with no medical history reported received a dose of GARDASIL (batch no. reported as 004954) via intramuscular route into not reported site of administration on 10-Feb-2012. On 28-Feb-2012, the patient developed tiredness, visual disturbance, photophobia, fainting and severe headache. MRI of cerebellum, eye examination, CSF test, pressure measurement, EEG, ECG, Holter monitoring, echocardiography was performed. No results were provided. No other medication was given. At the time of reporting, the patient was recovering. A previous dose of GARDASIL was given on 07-Oct-2011 (batch no. reported as 004954) via intramuscular route on 07-Oct-2011. Toleration was not reported.
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