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Life Threatening? No
Write-up: Initial and additional information has been received from a nurse practitioner concerning a 14 year old female who on 17-OCT-2006 was vaccinated with the first 0.5 ml dose of GARDASIL (lot #: 653735/0688) into the left shoulder. Concomitant therapy included ZYRTEC. In February 2007, the patient developed neck and right shoulder pain, later the patient was diagnosed with juvenile rheumatoid arthritis. The patient was seen by a rheumatologist. On 18-APR-2007, the patient''s laboratory test revealed homogeneous antinuclear antibody (ANA) pattern 1 per 80. On 24-APR-2007, the patient''s laboratory revealed rheumatoid factor 24.7 and C-reactive protein (CRP) 2.7. On 25-SEP-2007 the patient was seen by another rheumatologist. The patient also saw another physician and a homeopathic physician. On 21-APR-2008, the patient was seen by an orthopedist. On 09-APR-2009, the patient was seen by the physician in the reporter''s office. The reporter stated that while the patient was waiting to see the physician, she was seated in a cross-legged position. It was reported the patient''s mother request the patient to receive a whole body MRI. The physician was unable to examine the patient due to the patient''s pain. The whole body was not ordered by the physician. The reporter stated that she thought the patient''s mother was relating the patient''s condition to the GARDASIL. Follow-up information was received from a medical assistant in a rheumatologist''s office. The medical assistant stated that the patient was first seen the rheumatologist on 18-APR-2007. The patient''s laboratory tests revealed a positive rheumatoid factor and a positive anti-CCP (anti-cyclic citrullinated peptide) test. The patient was diagnosed with juvenile rheumatoid arthritis. The medical assistant stated that there was no mention of the patient receiving the GARDASIL vaccine in the physician''s notes. The patient was no longer a patient of the rheumatologist. Juvenile rheumatoid arthritis was considered to be disabling. Additional information has been requested. 6/19/09 Rheumatology consultant medical records received DOS 4/18/07 to 8/14/07. Assessment: Inflammatory arthritis, rheumatoid arthritis, anemia. Patient presents with neck and right shoulder pain. Numbness of R hand. ''Tightness'', pain, erythema, effusion of R knee. Loss of color left hip. Limping. Back, hip, hand and wrist aches. Sore legs and ankles. Rash on legs, knees. Tired, nauseated, headaches. Jaw pain and swelling. Wrist nodules. Soreness of gums.
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