Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Cytomegalovirus test positive, Diabetes mellitus, Dizziness, Fatigue, Feeling hot
Clinical narrative: This report described the occurrence of rheumatoid arthritis in a 55 year old female patient who received LYMERIX. This report was received as part of litigation proceedings. Medical records were subsequently provided. The patient's attorney stated that the patient received an injection of LYMERIX "on May 31, 2000, but the other dates are unclear to the client. On 03 September 2003, the patient's attorney alleged that the patient suffered joint pain and fatigue. The onset of her symptoms is not clear at this time. Treatment and outcomes of the alleged events were not reported. The following information was obtained via the patient's medical records. Medical history included fatigue and hypertension. The patient received her second LYMERIX vaccination on an unspecified date, and was due to undergo her third vaccination in July 2001. On 09 October 2000, the patient presented to her primary care physician with a five to six day history of knee swelling and pain which she treated with ibuprofen and acetaminophen without relief. She underwent drainage and cortisone injection of the left knee, followed initially by improvement. Synovial fluid culture revealed no growth, and synovial fluid aspiration revealed a white blood count of 125,500. Rheumatoid factor and antinuclear antibody testing were negative. Approximately 1 week later her symptoms were worse. On 01 November 2000 she was examined for knee pain and swelling. A large knee effusion with mild warmth was noted, without tenderness, redness, or fever. Treatment with VIOXX 25mg daily was initiated. The patient was treated by a rheumatologist between 14 November 2003 until at least 08n August 2003. On 14 November 2003 she received a rheumatologic consultation for a six week history of sub acute onset of left knee pain and swelling. The patient complained of additive polyarthritis with pain and swelling affecting her right knee, right shoulder, both jaws and the left index finger, with associated early morning stiffness and profound fatigue. Impression included a six week history of an appendicular inflammatory polyarthritis probably related to new onset of rheumatoid arthritis, bilateral knee synovitis with left knee Baker's cyst, and fatigue. Diagnostic tests were positive for Lyme disease Ab IgG and IgM IFA. Possible early Lyme arthritis was suggested. On 21 November 2000, the patient reported that CELEBREX and VIOXX were not helping her symptoms, and treatment with ULTRAM and doxycyline were initiated. However, both medications were subsequently stopped because "they interfered with blood pressure". On 19 December 2000 the patient experienced an allergic reaction to ULTRAM following treatment for presumed Lyme arthritis. However, it was noted that because the patient had Lyme vaccine, it was unlikely that she had Lyme arthiritis. Upon examination, she complained of severe pain and swelling in her hands, wrists, and left shoulder, although she noted improvement of her knee pain. Examination revealed +1 synovitis with decreased range of motion and decreased bilateral grip strength. A Baker's cyst was noted on the left knee. Stated impression was "new onset rheumatoid arthritis affecting her hands, wrists, knees and shoulders". Treatment with methotrexate 10 mg weekly was initiated. Additional treatment included CELEBREX and prednisone. On 09 January 2001, she reported improvement with far less pain, swelling, and stiffness. The patient contacted her physician by phone on 06 January 2001 to question whether she should receive her third Lyme disease vaccination in January 2001; medical records indicated that the physician found "no problems" and that the patient could receive the vaccination. On 23 January2001, the patient was doing "remarkably well" with only mild hand pain. On 12 March 2001, the patient complained of rheumatoid arthritis pain, and completed randomization to participate in a COX-2 Novartis study. In November 2001, the patient's rheumatoid arthritis was noted to be "mildly active". The patient complained of right hip pain, although an x-ray performed 15 May 2002 revealed negative findings. In June 2003 and July 2003, she continued to complain of episodic right lateral hip pain. CELEBREX was discontinued and VIOOX was resumed. In August 2002 and November 2002, the patient continued to experience hand and finger pain and swelling, and right hip pain with a moderate amount of stiffness. Medical records dated 12 February 2003 noted that the patient's arthritis has been moderately well controlled, and she continued treatment with methotrexate and VIOXX. On 08 August 2003, the patient was examined for a flare up of rheumatoid arthritis accompanied by tiredness. Her dose of methotrexate was increased at that time. Following the reported onset of rheumatoid arthritis, the patient experienced diabetes mellitus, pubovaginal sling operation, anemia (possibly related to methotrexate), endometrial polyps/fibroids, and hypercholesterolemia. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the patient's medical records. Therefore, they are not listed as adverse events. Medical records were received for this subject on 06 October 2008. Incidental finding in the course of record review included lower urinary tract symptoms for which the subject was evaluated on 19 March 2001. Evaluation of urethral function showed low leak point pressure at full capacity, a low urethral closure pressure and stress incontinenece at 50 cm bladder volume. Findings were consistent with intrinsic urethral sohincter deficiency, as expected based on initial clinical impression. Stress incontinence was diagnosed. The subject underwent a procedure for pubovaginal sling. These conditions were not captured as events at this time. Follow-up information was received on 19 November 2008 via medical records. The subject's problem list included osteoarthritis and rheumatoid arthritis. On 23 November 1999, the subject had a ganglion cyst on the left ulnar wrist. On 01 November 2000, the subject was status post drainage and injection of left knee, and was evaluated for a large knee effusion. Between and October 2002, the subject was evaluated for fatigue, headaches, dry lips, as well as her diagnosis of rheumatoid arthritis. Medications included VIOXX. Between August 2002 and 04 October 2005 she was evaluated for back pain/, chronic pain, fatigue, right hip pain, dizziness, lightheadedness, headaches, and occasional neck and leg pain.. In November 2002, the subject was experiencing "much less fatigue and lightheadedness" and resolved headaches. At the recommendation of her rheumatologist, the subject was treated by a sports medicine practice between November 2007 and January 2008 for neck pain. According to a note dated 27 August 2008, the subject's last rheumatoid arthritis flare was "two years ago", and was controlled with medication. During the course of her treatment, the subject's medications included methotrexate, DARVOCET, LIDODERM, FERCOCET, and VIOXX. Agt this time, the event of rheumatoid arthritis is assessed by GSK to be medically significant. Follow up information was received on 20 November 2008 via an interview between lawyers and the subject. The subject reported that she received the first and second doses of LYMERIX in May 2000, and in October or November 2000, administered by a federal occupational health nurse. Approximately one month after the second dose of LYMERIX, she developed knee pain and swelling. In approximately 2003 or 2004 she developed back pain. In approximately 2005 she developed fatigue, and in approximately 2006 she developed hand pain and swelling. Treatment included LIDODERM. The events were unresolved at the time of reporting.