Report A0367156A describes reactive arthritis in a 45 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). Medical records were received as part of the litigation proceedings. The patient had a several year history of stiffness involving his hands which was definitely worse in winters, almost not present at all in the summers. he has noted about one hour of morning stiffness associated with some mild proximal interphalangeal (PIP) joint swelling. He had color changes of mild pallor involving his hands more so than feet for the past several years on cold exposure consistent with Raynaud's disease. Over the years has had intermitten soreness without swelling involving his knees. He has had poor sleep but no fatigue. The vaccine had no known allergies. He has had previous TNA in 1962. There was no history of psoriasis, urethritis, diarrhea or eye inflammation-conjuctivitis. Information obtained from the medical records. In may 1999 and June 1999, the vaccinee received his first and second injections of LYMErix, respectively. 1/13/02 (physician visit): chief complaint: left hip pain of three months duration, left toe, and hand pain. Three months ago the patient developed pain in his left hip and groin. This was associated with morning stiffness and mild weight bearing discomfort. There was no history of childhood disease or injury. His symptoms have really not abated. Several days ago he had one episode of pain at the base of his first metatarsophalangeal (MTP) joint associated with redness or swelling that abated in one day. He has tried over the counter ibuprofen 400mg three times daily with mild benefit. Concurrent medications Centrum vitamins, ibuprofen. The patient's joint exam was remarkable for mild puffiness of his PIP's, although there was no definite tenderness. Negative Tinel's sign both wrists. Examination of his left hip revealed pain on motion which was mildly reduced to 25 degrees of internal, external rotation, 40 degrees of abduction, full flexion with some moderate hip joint tenderness. Right hip was normal. Knees, feet were all negative. Impression: synovitis of the left hip, possible mild hand synovitis. Rule out seronegative spondylarthrophy, rheumatoid arthritis, lupus, and Lyme which were less likely. He appeared to have mild Reynaud's disease as well. He did not have extra-articulary manifestations that would be suggestive of Reiter's syndrome or psoriatic arthritis. Plan: HLA-B27 next week. Today we will obtain a sedimentation rate, CBC urine chemistry panel, rheumatoid factor and ANA. X-rays of his left hip and hands were requested. Lyme Western Blot was negative. He will discontinue the ibuprofen and start naproxen 500mg twice daily. 1/31/00 (physician visit): Peripheral joints have calmed down. No further hand or foot pain. He continued to have some left hip pain but it was intermittent and not quite as severe. He was tolerating the naproxen. His labs revealed a sedimentation rate of 2mm/hr, negative ANA, rheumatoid factor and Lyme by Western Blot. His HLA-B27 was negative. His hip x-ray was remarkable for only a small calcification adjacent to the acetabulum on the left. Hands were negative. Assessment: probably reactive arthritis, improving. Plan: switch to diolofenac 75mg twice daily in place of the Naprosyn. 2/9/02: patient called to report sleeplessness, anxiety, and depression since switched to diclofenac sodium twice daily. The patient believed that he was having an adverse reaction to Voltaren. He will stop Voltaren and restart naproxen. The patient reported that he had gotten only minimal relief from naproxen. 3/4/00 visit to orthopedic surgeon: patient stated that he had a vaccination for Lyme's disease with LYMErix vaccine, which may have caused an autoimmune reaction and has given him Lymerix arthritis. At that time, there was no clicking and no groin pain, however, it was noted that there was some discomfort in the groin area when he entered and exited from a car and when he put on his socks and shoes. Upon physical examination of the left hip, range of motion revealed flexion 90 degrees, extension 0 degrees, internal rotation 5 degrees, external rotation 10 degrees with some left groin and thigh discomfort. On the contralateral side, the patient had approximately 20 degrees more arc of motion in internal and external rotation and could be flexed to 110 degrees. There was no pain in the right side with range of motion. This hamstrings were extremely tight and at 90 degrees the patient had a popliteal angle of 60 degrees. There was full range of motion of his lumbar spine. His muscle strength was 5/5 with all lower extremity muscle groups. At that time, X-rays of the pelvis and left hip indicated mild degenerative joint disease involving the left hip and the joint space was well maintained. The surgeon's diagnosis noted: left hip mild degenerative joint disease; left hip synovitis; and possible history of LYMErix arthritis. The treatment plan included the following: patient was advised that he would benefit from an exercise program with physical therapy for back flexion and isometric exercises and lower extremity stretching exercises. Because the patient failed on two anti-inflammatories, the physician suggested that the patient try rofecoxib 25mg daily. The patient was advised that if his hip symptoms worsened, then an MRI of the left hip would be obtained to evaluate the extent of arthritis and synovitis. 7/7/00 (physician visit): The patient complained of back pain. He stated that this first occurred two to three days ago. He was not sure what may have started this. He stated that a day or two ago he was moving a jet ski. He denied previous episodes of back pain. He was quite physically active. He denied previous episodes of back pain. Examination of the back revealed no bony abnormalities although there was a paravertebral muscle spasm bilaterally. Assessment/Plan: back pain/muscle strain/muscle spasm. Patient started on cyclobenzaprine hydrochloride 10mg three times daily as needed. He was also given a prescription for nabumetone 750mg twice daily to take as needed. He was advised to rest and follow up should his symptoms not improve. 9/4/01 (physician visit): the patient was being seen for follow up to Type II diabetes, on diet control now. He was generally feeling well today and had no specific symptoms. 10/23/01: Lyme Elisa titer IgG was normal at <80, Lyme Western Blot IgG and IgM were negative, MarDX Western Blot IgG was negative, and Immunetics Western Blot IgG was negative. Overall interpretation: no evidence of seroreactivity beyond that expected from the Lyme vaccine. 1/15/02 (physician visit): the patient had a recent history of new onset Type II diabetes mellitus. He was being seen for symptoms of visual disturbance and more frequent urination. He has been taking metformin hydrochloride 500mg two tablets twice daily with his sugars being progressively elevated over the past 2 weeks. Impression: worsening Type II diabetes mellitus. Plan: he will be referred to opthalmology for retinal exam. He will also get an endocrinology referral. Will maintain Glucophage 500 mg two tablets twice daily for now, add glipizide 5 mg daily and rosiglitanzone 4 mg daily. (Please note that the adverse event diabetes mellitus was not reported as an adverse event due to vaccine administration, but was found during the course of review of the vaccinee's medical records. Therefore, it will not be listed as an adverse event.) As of 7/17/02, the outcomes of the events were unknown. The adverse event arthritis does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/02 letter.