Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Oedema, Rash, Rheumatoid arthritis
Clinical narrative: Case A0378553A describes the occurrence of Lyme disease in a 53 year old female who received Lyme disease vaccine recombinant OspA. This report was received as part of litigation preceedings, with forwarding of medical records. Medical history included allergies to sulfa and tetracycline; chronic left shoulder, arm and spine pain (1990); shoulder bursitis; fall and subsequent knee injury; ankle fracture (19970; ankle swelling; foot swelling; fibula and tibia fractures; "severe" cervical arthritis; neck stiffness; low back pain; right leg radiculopathy (January 1994); lumbar subluxation (January 1994); sciatica; hypertension; chronic fatigue syndrome; chronic obstructive pulmonary disease; bronchitis; pneumonia; viral syndrome; sinusitis; eczema; hyperplastic polyps; and hepatomegaly. The pt was a smoker (one pack per day since age 18). Concurrent medications included Norvasc, Claritin and Combivent. Following the administration of LYMErix, the subject experienced ulcerative colitis, Clostridium difficile, and bronchitis. 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 subject received injections of LYMErix on 4/7/99, 5/10/99 and 4/20/00. In a Statement of Injuries, the attorney alleged that the subject "suffers from pain in her joints, specifically her knees, neck, back, shoulders, wrists, arms, fingers, and hips. She also experiences flu-like symptoms, fatigue and rashes. In addition, she has been diagnosed with Lyme disease." The subject called her primary care physician's office on 2/23/00 complaining of right shoulder pain. She noted both arms were very sore without any movement. She had no pain when her arms were at rest. Relevant labs performed on 2/29/00 included Lyme serology which was 0.7 and an erythrocyte sedimentation rate of 72mm/hr. On 11/10/00, the subject returned to her primary care physician at which time she expressed "Lyme disease concerns." She had been experiencing right shoulder pain and pain in her right wrist which was treated with prednisone. According to the subject's primary care physiican's office notes dated 9/13/01, she was "seeing another MD for treatment of Lyme disease." The subject was evaluated at a research center on 11/4/00. At this time, she reported that one day while at work in February 2000, she developed severe pain in her left shoulder and she "couldn't write or hold a cup of coffee." She was treated with prednisone which did help. At the time of this visit, it was noted that the "pains have not returned since." However, the pt was now complaining of low back pain and sciatica in the sacroiliac area down past her thigh. Lyme serology performed on 11/3/00 was "low" positive. The subject was treated at this research center on until at least 5/22/01. It was noted that she had reportedly received a cortizone injection in the right shoulder (by a different physician) in February 2000. The pain then moved to her left shoulder, then to her wrist, then "eased off" after two weeks. At the time of this visit, the subject reported that her left shoulder became very painful two weeks previously (approximately April 2001). At that time, she was given a cortizone injection which relieved the pain. She complained of increased arthritis in her knees, back, and neck. Her knees and back were very stiff after prolonged sitting. Her knees felt warm. It was noted she sits most of the day for her job. Impressions during this time were: "Arthritis in knees and back, degenerative joint disease versus inflammatory?," chronic obstructive pulmonary disease, hypertension, dependent edema, seronegative rheumatoid arthritis, and "?Lyme disease vaccine reaction." Relevant labs during this time revealed degenerative disc disease of the lumbar spine and minimal degenerative joint disease of the left knee. A venous duplex study was performed due to the foot ankle swelling which ruled out deep vein thrombosis. On 2/24/00, the subject was by her orthopedist due to complaints of "problems with both shoulders" and that the pain was radiating down both arms. The physician noted that the subject was "having trouble with several things. One is her lower back, her neck, and shoulder, but primarily the reason she is here today is her bursitis in her shoulder and irritation. She works as a telephone operator with reaching out occasionally." an x-ray of the neck showed severe arthritis, which the physician noted "although I don't think that's reproducing the problem with her right shoulder, which has limited internal and external rotation." The subject had a positive impingement sign and she was very sore along the bursa. She received an injection for the pain. She was also placed on an anti-inflammatory. The subject returned to the orthopedist on 3/29/00. She had reportedly injured herself "recently." The injection she received on 3/24 had helped but the pain moved from her shoulder to her wrist to her other wrist to her other shoulder. The physician noted "so I think she's got some other rheumatologic process going on more than just an acute bursitis in one area." A thyroid panel was done to make sure her thyroid was functioning and it was normal. She was placed on a rapidely-tapering course of Medrol DosePak. The subject remained under the care of the orthopedist until at least 3/8/02. During this time, she continued to have recurrent problems with her left shoulder. The subject noted that the shoulder pain that she had in the past had recurred, and although it was not severe, she did have some pain on certain motions. It was noted that the pain in her wrists and shoulders "all of a sudden" seemed to settle down but by May 2001, her left shoulder was very painful with a positive impingement. She had lost full range of motion with it. On 12/18/01, she was seen for an evaluation of her left elbow which had a lump on it (she had fallen in the Spring of 2001). The physician noted "she did have some problems with Lyme disease in the past and apparently contracted the problem from the vaccine. She had been treated with antibiotics." Physical examinations during this time revealed evidence of olecron bursitis. Examination of the elbow showed good range of motion. Examination of the shoulder revealed good abduction and good external rotation but some pain on full internal rotation in the subacromial space. Neurologically, she was "completely normal." The physician's impressions during the visit included bursitis and tendonitis of the shoulder. The physician also noted that "x-rays were taken and show that she had a little bit of arthritis, but certainly nothing major at all. The x-rays do show what appears to be some loss of calcium but this is though to say as the pt is a little bit overweight too." He later noted "As far as the back is concerned she has a bulging disc at 4-5. It is a central bulge and certainly doesn't look like there is any herniation present at all. I told her that basically she has a weak back." Physical therapy was suggested to strengthen her back. Treatment during this time included injections in the shoulder, an anti-inflammatory, methylprednisolone, Vicoprofen, and intra-articular injections of methylprednisolone acetate and Xylocaine into the shoulder. The subject also received chiropractic treatment during this time which was "not really helping." By 3/8/02, her elbow "looked better." The most recent info, received on 8/16/02, did not provide the outcomes of the reported events. Follow up on 02/26/04: "The most recent information, received on 10/15/03, did not provide the outcomes of the reported events. Information received on 02/28/03 indicated that fatigue and rash persisted as of 02/04/03."