Age: 49.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Medication error, Raynaud's phenomenon
Clinical narrative: In April, 99, the pt received her first injection of Lymerix, with no adverse effects. In June, 99, she received the second dose and experienced no ill effects. In July, 1999, the pt received the third injection of Lymerix and approximately 4 months post vax the pt experienced severe joint pain in her hands and feet.  The pt took a pain medication and plans to see her MD on 3/21/00. The information received on 3/20/00 reports the symptoms are ongoing. The subject's medical history included allergies to morphine and intravenous pyelogram dye, allergic rhinitis, poor sleep and fatigue (May 1999), arthritis, osteopenia, chronic neck pain after fallng down stairs (1995), "Raynaud's" (1998), hypercholesterolemia, hypothyroidism, bladder polyps (1997), recurrent urinary tract infections, chronic cystitis, constipation, hemorrhoids, irritable bowel syndrome, mitral valve prolapse, palpitations, uterine fibroid, fibrocystic breast disease, and tick bite (1998). In December 1998, the subject complained of joint pian in her shoulders, hands, and hips. She also reported cramps in her feet. The physician noted swelling of the knuckles, "Raynauds's," and hip tenderness at full extension. The subject reported that she had x-rays performed, but did not recall the results. She was "unsure" if she was told that she had arthritis. Dual-energy x-ray absorptiometry (DEKA) scan revealed osteopenia. The diagnosis of arthritis was later confirmed. Family history was significant for unspecified arthritis. Surgical history inclued tonsillectomy, breast lumpectomies, and partial hysterectomy. Concurrent medications included Claritin-D, Levoxyl, Fosamax, Lodine XL, Premarin, and melatonin. The subject recceived injections of LYMErix on 4/7/99 (120E9), 5/5/99 (120D9), and 6/30/99 (1209D). The third injection was administered two months after the first injection, rather than the recommended interval of 12 months. Initially, the subject reported that she received LYMErix in April 1999, June 1999, and 7/30/99. She reported that approximately four months later, she experienced "severe" joint pain in her hands and feet. On 7/7/00, the vaccinee provider stated that lab analyses revealed an elevated concentation of parovirus B19 IgG. X-rays were compatible with osteoarthritis. The vaccine provider made a diagnosis of osteoarthritis and prescribed Tylenol. The subject was referred to a rheumatologist. On 2/12/02, in a Statement of Injuries, the subject's attorney alleged that the subjet "has suffered pain in the joints of both hands, knees and feet. The pain in her knees has been particularly acute. In addition, she has suffered swelling in the joints of her hands and feet." The following info was obtained from medical records. The subject telephoned the vaccine provider on 7/9/99, nine days following receipt of the third injection of LYMErix, and reported "pain in joints and fingers and toes. Pt taking Fosamax, Lodine but not really using it. No swelling. Unable to wiggle toes flexion upward." The subject was instructed to take etodolac and go to the physician's office for evaluation. The subject did not present for evaluation until 9/8/99. At that time, she reported htat she was taking etodolac and glucosamine. The physician noted, "Arthritis better." Lyme total antibody screen was positive; all other lab analyses were within the reference ranges. The subject remained under the care of the vaccine provider until 7/2/01. On 3/29/00, the subject reported pain in the proximal interphalangeal, metacarpophalangeal, and metatarsophalangeal joints, as well as morning stiffness. She reported that these symptoms began in "October/November" 1999. Lab analyses revealed increased total Lyme antibodies and elevated parovirus B19 IgG concentration. X-rays of the hands and feet demonstrated osteoarthritis. The subject was referred to a rheumatologist. On 5/4/00, the subject was evaluated by a rheumatologist for "complaints of hand and metatarsal pain for approximately eight months time. She denies any significant morning stiffness or swelling of the hands or wrists. She gives a history of metatarsal pain. She denies any dactylitis nor does she compain of any plantar fascia or Achilles tendonitis. She denies any hip or knee pian. There is no history of psoriasis or inflammatory bowel disease. The pt denies any lupus-like symptoms nor any myositic symptoms. She gives a history of poor sleep, for one year, as well as fatigue." On physiican examination, the rheumatologist noted "Right and left second and third MCP tenderness without associated synovitis noted. Bialteral PIP, DIP tenderness noted, without associated synovitis. Bilateral metatarsal tenderness noted." lab analyses were within the reference ranges. The rheumatologist reviewed x-rays taken on 4/4/00. The rheumatologist's impression was "early osteoarthritis of the hands and feet." He prescribed Vioxx and S-adenyl-methionine. The subject remained under the care of this rheumatologist until at least 4/23/02. On 3/29/01, the rheumatologist noted "significant Raynaud changes of the pt's feet." During this time, the rheumatologist prescribed Mobic, Procardia XL, and Voltaren. As of 4/23/02, the subject continued to complain of hand and foot pain. On 7/30/01, the subject came under the care of a new primary physician. She reported that she had "arthritis from Lyme injections." She requested referral to a different rheumatologist. The subject was evaluated by a second rheumatologist on 5/22/02. He noted that the pt reported "significant" pain and swelling in her hands six months after third LYMErix injection. "More recently, she has had some discomfort in her wrists, elbows, hips, ankles, and across the metatarsal heads, but it has been primarily the hands that bother her the most." The subject reported that her first rheumatologist ahd prescribed Lodine, Vioxx, Mobic, Celebrex, diclofenac acid, and Bextra. "All of these drugs seem to work for a while but then becam less effective. Other recent complaints included Raynauds' syndrome that has been present over the last year and that has responded well to Nifedipine XR. She is now off that with the warmer weather." On physical examination, "Upper extremities revealed some slight puffiness and tenderness of the MCP, PIP and DIP joints. The DIP joints were consistent with Heberden's nodes. Her wrists had some pain on movement but did not appear to be swollen. Elbows and shoulders moved well without any pain. Lower extremities revealed good range of motion of her hips, knees, ankles, and toes. There did not appear to be any swelling, but she was somewhat tender across the metatarsal heads." Lab analyses were within the reference ranges. The rheumatologist prescribed diclofenac sodium. Following the reported onset of osteoarthritis, the subject experienced depression. This event was not reported as an adverse event due to vaccine administration, but was found during the course of review of the suject's medical records. Therefore, it is not listed as an adverse event. The most recent info, received 8/23/02, did not provide the outcomes of the reported events. Info received on 7/25/02 indicated that hand and foot pain persisted as of 4/23/02.