Age: 52.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Condition aggravated, Joint stiffness, Joint swelling
Clinical narrative: This report describes exacerbation of osteoarthritis in a 52 year old female who received Lyme disease vaccine recombinant OspA. This report was received as part of the litigation proceedings, with forwarding of medical records. The subject's medical history included torn left knee meniscus, "mild baseline arthralgias" in the MCP and DIP joints, radicular pain, right carpal tunnel syndrome (1983), right ganglion cyst, arthritic changes patellofemoral joint (1994), bilateral patellofemoral syndrome (1994), osteoarthritis, left hip pain (1993), autoimmune thyroiditis (1990), obesity (1995), right rotator cuff strain (1996), Raynaud's parathesias, myalgias, "flu" followed by "tremendous" fatigue (196), hypercholesterolemia, renal stone, uterine fibroids, intersititial cystitis, bilateral parapelvic cysts (1997), hepatic cysts (1997), hypoglycemia, rosacea, tinea pedis, diverticulosis (1998), hyothyroidism (1975), menopausal sweats, alopecia, urticaria, psoriasis, cough, wheeze, pleuritic chest pain, shortness of breath, oral ulcers, erythema chronicum migrans, tick bite, headache, stiff neck, and benign breast lump. Family history was significant for arthritis, psoriasis, connective tissue disease, and colitis. There were no known allergies. Surgical history included dilation and curretage 91981), tubal ligation (1991), arthroscopy with partial left medial meniscectomy (1994), right carpal ligament release with excision of ganglion cyst (1994), and excision of a right breast fibroadenoma (1995). Concurrent medications included Synthroid and progesterone. The subject received injections of LYMErix on 2/18/99 and 3/18/99. In a Statement of Injuries, the subject's attorney alleged that the subject "suffers from knee pain, stiffness and swelling as well as shoulder pain. She also suffers from fatigue and has developed rashes." The following info was obtained from medical records. The subject presented to the vaccine provider on 3/1/99 with complaints of left knee pain and swelling that had been present for 1.5 weeks. She reported "no relief with Advil today." On physical examination, the physician noted laxity of the medial collateral ligament. He referred the subject to her orthopedic surgeon. The subject remained under the care of the vaccine provider until at least 4/18/02. During this time, the subject reported swelling of her left knee that "has started to go down leg" and left shoulder pain. She reported that she was taking glucosamine. On 4/10/00, the subject refused the third injection of LYMErix "due to increased arthritis." The physician noted good range of motion of the left "bicepital tendonitis and subluxed (replaced by chiropractor) 10/9/00." He prescribed Relafen. On 3/10/99, the subject presented to her orthopedic surgeon with a complaint of pain in both knees, but "primarily left." The subject "says that she has been having complaints of pain in her right knee for about five weeks, where she noticed some swelling in the right knee, but then it seemed to improve. Then she had pain in the left knee about three weeks ago. Over the last three weeks she has had persistent pain, which she describes as being in an anteromedial aspect of the knee." On physical examination, the orthopedist noted "a trace effusion of the left. No effusion of the right. Examination of the right knee is essentially within normal limits. Examination of the left knee shows, as I said, a trace effusion. Good range of motion. Ligamentously stable. She is tender along the medial joint line with some pain on McMurray testing. No apin with attempts at patella subluxation. Neurovascular status is intact. At this time x-rays show some mild degenerative changes of patellofemoral joint. My impression is internal derangement of the knee, possibly patellofemoral in nature." He recommended a rehabilitation program with stretching and strengthening. On 5/7/99, the subject was evaluated by a rheumatologist. On physical examination, the physician noted "a small effusion on the left knee. There was mild pain on range of motion of both knees with minimal patellar femoral crepitus. X-rays revealed bilateral osteoarthritis of the knees with medial joint space narrowing and osteophytosis, left greater than right. Impression: Osteoarthritis of the knees clearly of much longer standing than a few months with productive changes in the joints. However, a clinical exacerbation of symptoms temporarily related to the Lyme vaccine." The rheumatologist prescribed Relafen 1000mg daily for six weeks. The subject remained under the care of this rheumatologist until at least 8/1/00. During that time, the subject reported "much better on Relafen but has gained 15 pounds," increased pain. The subject also reported that she was taking glucosamine/chondroitin. The physician made diagnoses of "OA knee post traumatic 6/8/99 and HTN secondary to fluid retention secondary to Relafen 6/8/99." The physician discontinued nabumetone therapy and prescribed Dyazide, Ultam, Oxy Contin and exercise. As of 8/1/00, the subject was "stable on prn as needed Relafen. Good response to Ultram." On 4/10/00, the subject was seen by her family physician. At that time she refused the third LYMErix injection due to increased "arthritis." The physician noted, "F/U (follow-up) ortho for MRI (MRI) R/O meniscus v. DJD doubt lyme vax." The subject returned to her orthopedic surgeon on 4/17/00, with chief complaints of "extreme pain-feeling of 'slipping,' stiffness, swelling" of the left knee. The physician noted, "This has been bothering her now persistently over the past couple of years. She recalls having a Lyme injection and vaccines at that point and that seemed to have been an aggravating instance for her knee. She has also undergone arthroscopic surgery on the left knee for a torn cartilage and was known to have a little bit of arthritis in her knee at that time. On examination of her knee, she has range of motion from G to 125 degrees. She has positive medial joint line tenderness. No lateral joint line tenderness. No instability to varus or valgus stress. Negative Lachman, negative drawer. There is minimal pain around her patella. There is no effusion present. X-rays reveal severe osteoarthritis left knee mainly in the medial joint compartment." The physician prescribed Vioxx and a low-impact knee exercise program. On 9/22/00, the subject was seen by a dermatologist for evaluation of "an intemittent rash in the exact same spot on the left leg and right wrist. Physical examination revealed two deeply pigmented macules on the left leg and right wrist. No other suspicious lesions were seen on limited skin examination. The condition was most consistent with a fixed drug eruption secondary to an unknown over-the-counter medication." On 5/3/01, a bone mineral densitometry study revealed, "Normal bone mineral density of thr ap total lumbar spine, left total hip and left femoral neck." The subject was under the care of a second rheumatologist from at least 11/1/01 until at least 4/11/02. During that time, the subject reported that her left knee swelled two days following the first injection of LYMErix, "flu-like symptoms from vaccine," stiffness in both knees, right trapezius stiffness, nodules on the distal interphalangeal joints for one to two years, memory loss, and word searching problems. The physician noted moderate-to-severe crepitus in the knees, right greater than left. A varity of serologies for Lyme disease were performed by three different laboratories. Two lab reported negative results. One lab reported positive IgG and IgM Western blots. The physician made diagnoses of "underlying OA" 11/4/01, "Lyme with vaccine" 1/8/02, "Lyme-vaccine related illness, neurological and arthritis symptoms" 4/11/02. The physician prescribed doxycycline, acidophylus, and ProBioxcs. Following the reported onset of exacerbation of osteoarthritis, the subject experienced benign peroxysmal vertigo, hypertension, L4-5 "mild" radiculopathy, forgetfulness, and possible cellulitis of an insect bite. These events were not reported as adverse events due to vaccine administration, but were found during review of the subject's medical records. Therefore they are not listed as adverse events. The most recent info, received 9/24/02, did not provide outcomes of the reported events.