Report 2001010092-1 described rheumatoid arthritis and deep vein thrombosis in the leg in a 57 year old female who received Lyme disease vaccine recombinant OspA (Lymerix) for the prevention of Lyme disease. This report was received from the vaccinee's spouse and has been verified by the PCP and medical records from a rheumatologist. The vaccinee had no known allergies. Her medical history included colitis and stomach problems (NOS) every four to five months. She received estrogens conjugated / medroxyprogesterone acetate (Prempro). ON May 25, 1999 and on June 22, 1999, the vaccinee received her 1st and 2nd doses of Lymerix, respectively. Approximately six to eight weeks after receiving the 2nd dose of Lymerix (in August or Sept 1999), the vaccinee experienced a swollen left wrist. MRI, x-ray (NOS), and labs including erythrocyte sedimentation rate and C-reactive protein were performed. The vaccinee was told that her diagnosis was "inflammation". Her left wrist remained swollen for several months. In the spring 2000, the vaccinee's left knee swelled. The joint swelling then shifted to the right knee and then back to the left knee. Joint fluid was obtained three times. It "showed nothing" The vaccinee was seen by several physician's and, subsequently, more lab tests were performed. Rheumatoid factor was found to be positive. At no time did any of the vaccinee's physician's suggest a link between her symptoms and Lymerix. In August 2000, the vaccinee developed a blood clot in the leg which was treated with warfarin sodium (Coumadin). As of 04/20/01, the joint swelling and inflammation were resolved. The outcome of the blood clot was not specified. The adverse events of "joint swelling' and "joint inflammation" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Per F/U, rheumatologist medical record of 3/21/00 states that in 9/99, while working on some stained glass, the pt noticed a "pop" and swelling in the left wrist. She has had significant pain since that time but that it has gradually progressed and she was left more with stiffness. On 5/10/01, the pt's PCP reported that the pt's rheumatoid arthritis began on 9/1/99, when she developed swelling and redness to the left wrist. In 11/99, the pt noticed muscle loss in the forearms. X-rays showed bone loss and MRI showed inflammation. The left hand only, pronated and supinated approx. 80 degrees. She had 20 degrees of left wrist extension and 30 degrees of flexion. The wrist was warm, swollen and tender on palpation. There was swelling over the dorsum of the left, less prominant over the volar aspect. There was significant and advanced atrophy of the left forearm musculature. Assessment: monoarthritis affecting the left wrist. The pt developed bilateral knee pain and swelling with resolution of the right knee inflammation when a physician aspirated and injected the knee with steroid (NOS). She had the left knee aspirated but not injected and it did not improve until it was aspirated again and injected with steroid (NOS). She had fallen off her bike and injuured the left wrist. The pt's ESR was running in the 30's to 50's. Assessment: We are probably looking at the early onset of rhematoid arthritis. Celebres 200mg 1 twice daily orally was prescribed. At some later date, the physician prescribed hydroxychloroquine (Plaquenil). The pt telephones the physician on an unspecified date and stated that she had been having a rash where she sweated and her ankle and wrist were swollen. The physician held Plaquenil. On 8/24/00, the pt developed a deep vein thrombosis in the leg which was treated with warfarin sodium (Coumadin). This resolved in 6 months. The pt reported severe abdominal bloating and had to stop the Plaquenil. Her exam showed active synovitis in the left wrist and right knee with swelling and pain. On 2/01, Plaquenil 200mg 1 po twice daily was re-prescribed. On 4/6/01, the pt developed borderline hypertension. The PCP stated the rheumatoid arthritis was possibly related to Lymerix and also that the adverse events could be associated with PremPro therapy.