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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information has been received on 06-OCT-2009 by Health Authority (HA ref. DK-DKMA-20092549) concerning a 15 year old female who in ultimo December 2008, was vaccinated with the first dose of GARDASIL intramuscularly (lot#, batch# and site of administration not reported). There was no concomitant medication. It was reported that on 01-JAN-2009 the patient experienced muscular pain, convulsions, joint pain, dizziness and weakness. The patient was diagnosed with influenza by the doctor from the emergency service and received treatment with PANODIL (manufactured by GlaxoSmithKline, dose not reported, no dates reported). According to the patient''s parents, the symptoms were not consistent with influenza, thus the patient''s GP was contacted a few days later. The patient was referred for a neurological examination that revealed no abnormalities except paralysis of extremities. It was not specified which examinations that were performed or the date of neurological examination. One week later, the patient''s condition had not improved. The patient was seen by a reflexologist who stated that the patient was "cold" (not further specified). The patient was treated with warmth, reflexology and diet advice (not further specified). It was reported that patient''s condition improved slowly and the patient recovered on an unspecified date. It was reported that the symptoms returned in February 2009 (not further specified), and that the patient also experienced anxiety due to the uncertainty regarding causality. The neurological examination was repeated with the same conclusion (no abnormalities except paralysis of extremities). After a week, the symptoms had declined and the patient recovered. In primo March 2009, the patient was vaccinated with the second dose of GARDASIL intramuscularly (lot#, batch# and site of administration not reported). No adverse reactions were reported. In primo May 2009, the patient was vaccinated with the third dose of GARDASIL intramuscularly (lot#, batch# and site of administration not reported). It was reported that on 18-MAY-2009 the patient experienced convulsions, joint pain, dizziness and weakness. The patient recovered on an unspecified date. In ultimo June 2009, the patient experienced dizziness and pain in hands after low intense physical activity. Immediately rest improved the patient''s condition rapidly (not further specified). Psychiatric examination excluded functional disorder. It was reported that the patient had not recovered. Convulsion, muscular pain, anxiety, joint pain, weakness, dizziness and transient paralysis of limb were considered to be disabling by the reporter. Other business partner number included: E200909365. Additional information has been requested.
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