Age: 45.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Joint swelling, Laboratory test abnormal, Pelvic pain, Synovitis
Clinical narrative: Report A0367156A describes reactive arthritis in a 45 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of litigation proceedings, with forwarding of medical records. A report has been submitted directly to VAERS. The medical history included a "several year history" of hand stiffness that was "definitely worse in winters, almost not present at all in the summers," one hour of morning stiffness associated with some mild proximal interphalangeal joint swelling, intermittent knee pain "over the years," and Raynaud's disease. He had no known allergies. There was no history of psoriasis, arthritis, diarrhea, eye inflammation, or conjunctivitis. Surgical history included tonsillectomy and adenoidectomy in 1962. Concurrent medications included Glucophage, Glucotrol XL, Avandia, Relafen, Flexeril, and Centrum. On 9/25/02, in a Statement of Injuries, the subject's attorney alleged that the subject "suffers from debilitating left hip pain and has developed arthritis. He also suffers from hand pain." The following info was obtained from medical records. In May1999 and June 1999, the vaccinee received his first and second injections of LYMErix, respectively. Exact dates and lot numbers of vaccines were not provided. On 1/13/00, the subject was evaluated by a rheumatolgoist for chief complaints of left hip pain of three months duration, left toe pain, and hand pain. The rheumatologist wrote, "about three months ago developed pain in his left hip and groin. This was associated with morning stiffness and mild weight-bearing discomfort. His symptoms have really not abated. Several days ago he had one episode of pain at the base of his first MTP joint not associated with redness or swelling that abated in one day. He has tried OTC Advil 400mg three times/day with mild benefit." Review of systems was "Positive for poor sleep but no fatigue." On physical examination, the rheumatologist noted "mild puffiness of his PIP's although there is no definite tenderness. Negative Tinel's sign both wrists. Examination of his left hip reveals pain on motion which is mildly reduced to 25 degrees of internal, external rotation, 400 degrees of abduction, full flexion with some moderate hip joint tenderness. Right hip is normal. Knees, foot are all negative." The rheumatologist's impression was "Synovitis of the left hip, ? mild hand synovitis. Rule out seronegative spondylarthropathy, RA, lupus, Lyme are less likely." The rheumatologist discontinued ibuprofen therapy and prescribed naproxen sodium. The subject returned to the rheumatologist on 1/31/00. His "Peripheral joints have calmed down. No further hand or foot pain. He continues to have some left hp pain but it is intermittent and not quite as severe." X-ray of the hip "was remarkable only for a small calcification adjacent to the acetabulum on the evaluations. The rheumatologist's assessment was "Probable reactive arthritis, improving." The rheumatologist discontinued naproxen therapy and prescribed Voltaren. The subject did not tolerate Voltaren, so therapy was changed to naproxen on 2/9/00. The subject was evaluated by an orthopedist on 3/4/00 for chief complaints of left groin and thigh pain. The subject "states that he had a vaccination for Lyme's (sic) disease with LYMErix vaccine, which may have caused an autoimmune reaction and has given him LYMErix arthritis. He states that he has pain in his left groin. There is no clicking and no groin pain. However, he has some discomfort in the groin area when he gets in and out of a car and when he puts on his socks and shoes." On physical examination of the left hip, "range of motion, 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 pt has, approximately, 20 degrees more arc of motion in internal and external rotation and can be flexed to 110 degrees. There is no pain in the right side of range of motion. Hamstrings are extremely tight and at 90 degrees the pt has a popliteal angle of 60 degrees." X-rays of the pelvis and left hip revealed "mild degenerative joint disease involving the left hip. The joint space is well maintained." The orthopedist's diagnoses were "1. Left hip mild degenerative joint disease. 2. Left hip synovitis. 3. Possible history of LYMErix arthritis." Naproxen therapy was discontinued. The orthopedist prescribed Vioxx and physical therapy. A variety of serologies for Lyme disease were performed on 10/23/01. The laboratory's overall evaluation was "No evidence of seroreactivity beyond that expected from the Lyme vaccine." Following the reported onset of reactive arthritis, the subject experienced type II diabetes mellitus, "back pain/muscle strain/muscle spasm" after moving a jet ski, increased cholesterol concentration, and increased total bilirubin concentration. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info, received on 9/25/02, did not provide the outcomes of the reported events.