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Write-up: Information has been received from a medical assistant concerning a 16 year old female with hypothyroidism, eczema and acne who on 06-JUN-2008 was vaccinated with the first dose of GARDASIL (0.5ml, IM). The patient received the second dose of GARDASIL (0.5ml, IM) on unspecified date. On 13-FEB-2009 the patient received the third dose of GARDASIL (0.5ml, IM). The patient was diagnosed with viral or early rheumatoid arthritis by a rheumatologist. Her symptoms began 1 month after the third vaccination. The rheumatologist evaluated the patient in May 2009 where he said it was either viral arthritis or early rheumatoid arthritis. The rheumatologist said the patient was not in acute distress but joints were sensitive. The rheumatologist said he was leaning to early rheumatoid arthritis because of the duration of symptoms. At the reporting time the patient had not recovered. Follow-up information has been received from a clinical manager: The patient had previous drug reaction (vomiting) to codeine and CEFTIN. The patient was vaccinated with GARDASIL series as following: the first dose on 06-JUN-2008, lot# 658558/1061U; the second dose on 28-JUL-2008, lot# 658558/1061U; the third dose on 13-FEB-2009, lot# 661764/0650X; no other vaccines given on these dates. Concomitant therapy included SYNTHROID. The consult report from a rheumatologist from May 2009 showed "early rheumatoid arthritis". The report from the rheumatologist from 25-AUG-2009 showed that the patient was started on ENBREL, 50 mg weekly and methotrexate, 12.5 mg weekly for rheumatoid arthritis (RA). Follow-up information was received from the medical assistant via medical records indicating that the patient was a student and was vaccinated with three doses of GARDASIL IM in the left arm. The patient''s symptoms occurred on 03-MAR-2009. On 02-MAY-2009 parvovirus B-19 antibody (IGM) was negative (<0.9), rheumatoid factor was 21 IU/ml, C-reactive protein was 0.26 mg/dl, thyroid-stimulating hormone (TSH) was 3.36 mIU/L and sed rate was 11 mm/h. She was diagnosed with rheumatoid arthritis at the end of May 2009. On 09-JUN-2009 rheumatoid factor was 38 IU/ml, C-reactive protein was 1.06 mg/dl, cyclic citrullinated peptide IgG antibody was 20 unites, sed rate was 17 mm/h and antinuclear antibodies was negative. On 18-AUG-2009 rheumatoid factor was 347 IU/ml and sed rate was 41 mm/h. At the time of reporting, the patient had not recovered from rheumatoid arthritis. The reporter considered rheumatoid arthritis to be disabling. Additional information is not expected. All available medical records will be provided upon request. 10/19/09 Primary Care Records and Rheumatology consult received for dates of service 2/14/00-9/18/09 Dx: Rheumatoid Arthritis Assessment: Per rheumatologist: Pt. c/o pain in feet and hands and wrists since 8/08. Her fingers have started to swell and she has significant morning stiffness. For several weeks she has been stiff when she wakes up and it is difficult to get out of bed, with the stiffness lasting several hours. There is no family history of arthritis. On exam she has multiple tender small joints in her hands. Her MCP and PIP joints are swollen. There is tenderness in the wrists. She is tender over the metatarsal area of the feet and the area has trace swelling. There is a possibility of another autoimmune disease such as lupus or other inflammatory arthritis. Medrol Dosepak prescribed with plan to switch to Naprosyn BID. Also started on Methotrexate weekly, sulfasalazine and folic acid. Later switched to Enbrel weekly.
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