Age: 37.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Difficulty in walking, Fatigue, Joint stiffness
Clinical narrative: Report A0368605A describes the occurrence of polyarthritis in a 37 year old male who received Lyme disease vaccine recombinant OspA. This report was received as part of litigation proceedings, with forwarding of medical records. The subject's past medical history included congenital stridor with possible tracheomalacis, head injury with bleeding from the right oxternal ear canal (1964), another head injury with a scalp laceration (1966), migraines (with associated nausea, phonophobia and photopsia), neck spasms and knee injury requiring brace after motor vehicle accident (1996), knee dislocations, degenerative joint disease and degenerative disc disease with narrowing at C6-7, "diffuse joint symptoms," deer tick bite (1994), three episodes of groin rash (one of which was diagnosed as folliculitis) all of which, resolved when treated wtih Bactroban, male pattern baldness, obesity, hypertension, hypercholesterolemia, hypertriglyceridemia, stress, and anxiety. He has no known drug allergies. Surgical history included an appendectomy (1974). Concurrent medications included Fiorinal, BuSpar, and Amerge. Following the reported onset of polyarthritis, the subject experienced abdominal pain after taking Celebrex 200mg doses, poison ivy, infection NOS treated with Bactroban, and bilateral trochanteric bursitis treated with physical therapy. 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. On 3/25/99, the subject received his first injection of LYMErix in the left deltoid. He received his second injection on 4/23/99 in the right deltoid. He remained under the care of the vaccine provider until 6/8/99. No adverse experiences were reported following the administration of LYMErix. In a Statement of Injuries, the subject's attorney alleged that the subject "suffers from joint pain and stiffness throughout his body, including, but not limited to, his hands, wrists, ankles and feet." He also fatigues easily and suffers from memory impairments. He developed treatment-resistant Lyme arthritis." The following info was obtained from medical records. On 10/24/00, the subject was evaluated by a rheumatologist at a tertiary care center "because of a nearly two-year history of joint stiffness and pain, mainly in the small joints in the hands and in the wrists and in the feet, but nearly all joints in his body have been painful and stiff. He has particularly stiffness in the hands, wrists and ankles in the morning that lasts for about an hour. It is relieved by activity and also the joint pain and stiffness is relieved by hot tub baths. He says that the joints of his ankles and fingers have been swollen and that his knees have been warm, but he has not had fluid in any of his joints that he knows of. Treatment with ibuprofen was not helpful. Celebrex at 200mg per day did help a great deal, but it upset his stomach. Vioxx did not help. He has had stiffness in his back and hips, as well." The subject denied any rashes. The subject reported that he had received LYMErix in January 1999 and that "It was soon after that that his toubles began. He has now had all three injections. However, the Lyme antibody was negative in July of 2000." The vaccinee was noted to be HLA-DR4 positive. On physical examination, the rheumatologist noted that "the joints are brought through full range of motion, but the shoulders and the hips and the knees are quite stiff. There is also crepitus at both knees. In addition, there is tenderness with full flexion at both wrists and there is tenderness with pressure at the PIP joints two through four, right and left, and the MTP joints two through four, left and right. I believe that there is a tiny subcutaneous nodule that is movable under the examining thumb at the extensor surface of the right forearm about two inches from the elbow." The rheumatologist stated, "The history is certainly compatible with rheumatoid arthritis, but certainly Lyme vaccine induced arthritis in a DR4 positive person is a real consideration." The rheumatologist stated, "He is rheumatoid factor negative." X-rays of the wrists, hands, and feet revealed no significant abnormalities. The rheumatologist suggested that the subject take celecoxib 100mg twice daily. The subject remained under the care of this rheumatologist until at least 1/15/02. On 2/20/01, the subject reported that his "major problem" was "shoulder pain after dinner." On 7/10/01, he reported "pain in all of his joints. The ankles have pain and especially when he walks the staris as do his knees and he feels as though his knees are 'being torn apart.' He also says that walking helps a bit, but he feels like his 'hips give out.' He says he cannot go to the gym anymore to exercise because his elbows and hands hurt too much." He also reported easy fatigue, lack of refreshing sleep, and muscle aches, especially in the morning. On 1/15/02, the subject reported that he had been evaluated by an infectious disease specialist, who reportedly "believes his problems are related to Lyme or Lyme vaccine." The subject reported that he self-medicated with acetaminophe, which "does not help," and ibuprofen, which "only helped a little bit." The subject reported that the infectious disease specialist prescribed Neurontin, Ultram, Plaquenil, and an unspecified antibiotic for a three-month period, "none of which were helpful." The subject reported that the infectious disease specialist had recommended a trial of tetracycline. Physical examinations performed during this time revealed no evidence of swelling or redness of the joints, and no synovitis. There was "fairly exquisite tenderness to pressure over the trochanteric bursea on the right and to a lesser extent on the left." Tenderness to pressure at the MTP joints of the right foot resolved. The rheumatologist made an additional diagnosis of trochanterio bursitis, for which he prescribed physical therapy and "perhaps" corticosteroid by phonophorosis. During this time, he also wrote that the subject had "what looks to be Lyme vaccine induced arthritis in a DR4 positive person." The rheumatologist also noted, "I do not think that he will develop rheumatoid arthritis." On 1/15/02, the rheumatologist noted that the subject "continues to be out of work because of aches and pains, easy fatigue, and inability to get good refreshing sleep." The rheumatolgost began the process to certify the subject for disability. During this time period, the rheumatologist prescribed celecoxib up to 400mg daily, difluenisal, neproxen and amitriptyline. The subject was referred to a physical therapist. The most recent info received on 9/24/00, did not specify the outcome of the events. As of 1/15/02, the polyarthritis was ongoing and considered disabling by the rheumatologist. This report of a serious expect event is being submitted as an expedited report by special FDA request per the 6/28/00.