Age: 53.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Joint stiffness, Pain
Clinical narrative: Manufacturer has received an initial report unconfimred spontaneous report from a lawyer referring to a 53 year old female who claims to have experienced rheumatoid arthritis following vaccination with Lyme vaccine. According to the reporter, the patient and her treating physician believe that rheumatoid arthritis was caused by her vaccination with LYMErix. Follow up information received from the patient's physician documents that the patient's past medical history included hypertension, cervical cancer in situ, and an episode of neurocardiac syncope (worked up two years ago with an electrocardiogram and tilt table). She has a history of allergy to prochlorperasine. It almost caused a seziure (date, dosage and route of administration were not specified). According to the physician's note of 8/29/00, the patient, in the summer of 1998 (prior to receiving the Lyme vaccine) wsa doing more gardening and noticed bumps on her distal interphalangeal joints. She reportedly attributed this to arthritis of getting older. On 4/13/99, the patient received her first LYMErix injection 0.5cc IM, site not specified. On 5/12/99, the patient received her second LYMErix injection, 0.5cc IM. In July 1999, she was once again doing more work in her garden and noticed that the bumps had worsened. She was reported to have more pain along her proximal interphalangeal joints as well. She waited until NOvember 1999 to see a physician who diagnosed osteoarthritis by X-ray. The patient was to take glucosamine and chondroitin sulfate as well as wear a copper bracelet. THe patient noticed that her hands worsened at this time. This would wake her up at night. On 4/25/00 she received her third injection of LYMErix 0.5cc IM. The patient eventually was evaluated by a rheumatologists in June 2000. She was told that she had rheumatoid arthritis. She was placed on celecoxib 200mg daily and hydroxychlorequine sulfate 200mg two times per day. As of 8/29/00 the patient had minimal morning stiffness. She did have some pain and swelling of her hands but now only on her right. Her most active joint was her third PIP. The patient had reported that overall her hand swelling and pain has slowly diminished on Plaquenil. She was seen for a Lyme study. As of 8/29/00 the patient was also taking the following medications: metoprolol succinate, conjugated estrogens, glucosamine and chondroitin sulfate double strength two per day, vitamin E, fish oil, aspirin and calcium. On physical examination the patient had normal range of mition of her cervical spine, shoulders, elbows, wrists and hands without synovitis or deformities. Hands: the left had showed some tenderness over the PIP's without synovitis, second DIP bony enlargement bilaterally, most notable is the right hand third PIP which shows 1+ synovitis. The patient had mildly diminished grip strength. According to the physician's assessment of 8/29/00, the patient was a generally healthy woman who developed signs and symptoms of osteoarthritis followed by an inflammatory arthritis of her hands, particularly of the rigth third PIP. She has been seronegative with normal inflammatory markers. She has had a low positive ANA without other symptoms of a connective tissue disorder. There was some initial question as to whether or not she ahd been exposed to Lyme disease, however, follow up labs were negative for active Lyme disease. Because of the patient's bilateral symptoms in the small joints of her hands, HEAD 4 positivity, and her response to Plaquenil, it did appear most likely that her diagnosis was seronegative rheumatoid arthritis. The physician still wonders about the positive ANA in association with other specific autoantibodies. The patient does not have sicca symptoms. She has no other suggestion of psoriatic arthritis or pseudogout. She has been screened for typical infectious or metabolic causes of the hand joint symptoms. The plan was to further characterize the ANA with specific autoantibodies, discuss the diagnosis and management of rheumatoid arthritis, eye exam (already done), continue Plaquenil therapy for the next few months and if the right third PIP continues to be swollen, consideration would be given to a corticosteroid injection and/or a change in the disease modifying antirheumatic drug therapy. The patient was to see the physician for follow up in three months. The most recent information received on 10/20/00 reports the outcome of the adverse events as not resolved. The events of rheumatoid arthritis and osteoarthritis do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter. The initial secion of this report was submitted on 9/21/00.