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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information has been received on request by the company from the agency via public case details form concerning a 16 year old female patient who on 11-MAY-2007 was vaccinated with the first dose of GARDASIL (Lot number 655742/0138U and Batch number J0799) intramuscular, on 12-JUN-2007 with the second dose of GARDASIL and on 29-OCT-2007 with the third dose of GARDASIL (Lot number not reported). On 26-NOV-2007 the patient experienced rheumatoid arthritis and still''s disease adult onset. The first episode of illness resulted in general malaise and flu like symptoms and progressed to cyclical pattern of fevers/chills/sweats several times, during 24 hours period. This first episode of illness resolved around 09-DEC-2007 and patient recovered. The patient was taken to a medical centre during this illness. The second episode of illness was very severe and began on 22-DEC-2007 and again started with malaise and flu like symptoms progressing to a continuous cycle if fevers/chills/sweats with no break between the cycles. The patient had severe abdominal and joint pain, sore throat, headache, vomiting and was incapacitated and continually bedridden and unable to attend to ADL''s such as showering and eating for two weeks. The patient also suffered from hallucinations and lost 6 kg. The patient again attended a medical centre for treatment. In January 2007, the patient was admitted to the hospital for 5 days under specialist care. The patient was then referred to another specialist (Rheumatologist) and registered and had been under their care since February 2008. A firm diagnosis had not been reached to date, however the specialist had started that it appeared to resemble adult onset still''s disease. It was unsure if the following information was relevant, but the patient the patient suffered a mild fever after the first dose of GARDASIL in May 2007. The patient also suffered an illness in mid July 2007. The symptoms of the illness involved high fever, severe headache, neck stiffness, extreme aversion to light, vomiting and petechie, and GP was given for treatment. This illness was resolved satisfactorily after one week. The patient received ongoing treatment by rheumatologist for chronic inflammatory disorder. Currently, the patient was taking medications: Prednisolone, methotrexate, NAPROSYN, folic acid, STEMETIL and calcium supplement. The patient had to resign from her part time job in January 2008 as her illness was so debilitating. The patient managed to complete grade 12. The last year despite repeated absences from school and was currently studied at university. She continually battles extreme fatigue and joint pain and suffered intermittent relapses that resulted in the return of symptoms such as fevers, chills, sweats, headache, sore throat and rashes. At the time of reporting on 04-JUL-2009, the patient had not yet recovered. The agency considered that all the symptoms were possibly related to therapy with GARDASIL. The original reporting source was not provided. Rheumatoid arthritis and still''s disease adult onset were considered to be disabling. No further information is available.
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