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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # DK-1577272925-2015000668) on 14-DEC-2015. Case received from a physician on 09-Dec-2015 under the CA report reference number DK-DKMA-WBS-0001954. A 12-year-old female adolescent patient received GARDASIL (batch number unknown, Dose 1) via intramuscular route on 14-Apr-2011, GARDASIL (batch number unknown, Dose 2) via intramuscular route on 15-Jun-2011, GARDASIL (batch number NL35410, lot # NK10770, expiration date 31-JAN-2012, Dose 3) via intramuscular route on 19-Oct-2011. Other medication: no. Magnetic resonance imaging (MRI) nothing abnormal, appropriate blood test. The patient experienced pain in body in MAY-2011, swollen lymph node in groin after vaccination in MAY-2011, headache in 2013 and intermittent swelling in leg after removing lymph node on an unknown date. The outcome of pain in body, intermittent swelling in leg after removing lymph node on an unknown date. The main problem since autumn 2013 is the headache. The outcome of pain in body, intermittent swelling in leg after removing lymph and headache was not resolved. The outcome of swollen lymph node in groin after vaccination was unknown. The agency considered the events as disability/incapacitating. She was diagnosed with Cat scratch disease in 2012, coded by Health Authority (HA) as medical history/concurrent disease.
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