The vaccinee received her first injection fo Lymerix (lot LY130A9) on 1/19/00. ON that date, she also received an injection of TD (lot 4998301). she subsequently reported to a rheumatologist that she experienced a "small transient local reaction" at the site fo Lymerix administration. She received her second injection of Lymerix (lot LY130A9) on 2/15/00. She subsequently reported to a rheumatologist that she experienced a "small local reaction" following this injection. The vaccinee received her third injection of Lymerix (lot LY144B9) on 5/10/00, four months following receipt of the first injection rather than the recommended interval of 12 months. She subsequently reported to a rheumatologist that she experienced a "small transient local reaction" follwing this injection. In a statement of injuries, her attorney alleged that the pt "has developed lupus. (She) suffers from joint pain and swelling and flu-like symptoms. In addition, (she) suffers from fatigue and butterfly rashes." Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. Lupus is considered "Medically Serious". The vaccinee presented to the vaccine provider on 7/19/00 with chief complaints of not feeling well. Achy hands and wrists for one month. Rash-both arms, hips, and face - slight itch for two weeks. Feels like flu symptoms. She also reported headache. On physical examination, the physician noted "slight raised bumps" on the patients face and arms. His impressions were 1. Arthralgia/myalgia/rash. Rule out Lymes (oic), rheumatoid arthritis. The physician prescribed topical erythromycin/benzoyl peroxide for treatment of the rash. Antinuclear antibody titer was 1:640 witha n homagenous pattern. Erythrocye sedimentation rate was within the reference range. Testing for rheumatoid factor and total Lyme antibodies was negative. The patient returned to the vaccine provider on 7/25/00. She still complained of tired, weak, joints painful, rash is still present. She reported that over the preceding weekend, she had noticed an increasing red rash over her face and arms. The physician observed "butterfly rash to face." His impression was  systemic lupus erythamatosus (SLE) presumptive. The physician prescribed Arthrotec and referred the patient to a rheumatologist. The patient was seen by the rheumatologist on 7/28/00. At that time, the patient "reports sudden onset of facial rash several weeks ago, as well as arthralgia...She has responded slight to Arthrotec prescribed only two days ago, but is having some abdominal discomfort and now the joint pain worsened today. The facial rash worsened with sun exposure a few days ago. This also involves the upper arms. She denies unusal alopecia or other systemic complaints. Family history is important in that her step brother has SLE at age 40. He is related through her father. On examination, there is a prominent facial eruption on the malar distribution, as well as the upper arms.  There is a mild cervical adenopathy. There is very mild synovitis of the proximal interphalangeals(PIPs) and metacarpophalangeals(MCPs). I think there is no question about the diagnosis of SLE. she was asked to avoid unusual arm exposure. Naproxan 500mg bid twice daily was given with Plaquenil 400mg once daily.  The patient returned to the rheumatologist on 8/18/00. She continues to have slight alopecia, but a more generalized eruption in the upper extremities which is not pruritic. She remains on Naproxen and Plaquenil 400mg daily. The arthralgia continues. Examination reveals a very slight synovitis of the PIPs with tightness of the fingers. She has a complaint involving the anterior chest wall which is difficult to describe. She was placed on Prednisone 5mg daily, instead of Naproxen. Aspirin 81mg daily was ordered as she has a positive anti-cardiolipin antibody. Calcium was also added at 1500mg daily. on 8/23/00, the patient telephoned the rheumatologist and reported slight pleuritic pain as well as joint pain, rash and headache. The rheumatologist increased the prednisone dosage to 10mg daily. On 8/28/00, the patient telephoned the rheumatologist and reported she felt much better overall. Rash cleared, decreased fatigue. On 10/11/00, the rheumatologist prescribed vitamin D 800 units daily. The patient was seen by the rheumatologist on 12/19/00. She remains on prednisone 10mg AM and Plaquenil 400mg daily. She continues to have arthralgia and significant fatigue. Acetaminophin is ineffective. There is absence of peripheral or central synovitis. there is no doubt she has SLE which is active, but it may be that some of these discomforts are more related to a secondary fibromyalgia type syndrome. Ultram 50 to 100mg bid (3x daily) was advised if tolerated.  Acetaminophen can be continued. The patient returned to the rheumatologist on 1/9/02. At taht time, the calcium carbonate dosage was 1800mg daily. Joint aches were mostly better but the patient was very fatigued. The physician noted, sleep non-restorative. The rheumatologist's assessment was 1. SLE-quiescent. Start taper (of prednisone dosage). check labs 2. PM (fibromyalgia). will consider Ambien. the patient, however, declined to take Ambien, *although pharmarcy records indicated that it was dispensed on 4/23/01.* In April 2001, the patient began to take Celebrex. On 4/10/01, she telephoned the physician to report that she feels like heart is beating fast. She reported that her heart rate was 104 beats/minute. The rheumatologist suggested that she stop takin Celebrex. On 4/11/01, she telephoned again and reported that she had go to the local emergency room on 4/10/01, where a diagnosis of pericarditis was made. She reported that she had taken prednisone 20mg and felt better. On 4/13/01, the rheumatologist instructed the patient to conitnue taking prednisone 20mg daily. Celebrex therapy was reinstated. The patient returned to the rheumatologist on 6/7/01. she was tired. Working full time. The prednisone dosage at the time was 7.5mg daily. The rheumatologist noted trace edema of the extremities. the rheumatologist's assessment was SLE-active. He prescribed hydrochlorothiazide 25mg daily and recommended that the patient begin therapy with Arava. The medical records indicated that the patient began taking Wellbutrin SR 150mg twice daily in June 2001. By 7/5/01, the patient had not taken Arava. She was feeling good. The rheumatologist considered the SLE to be "quiescent". The patient was seen by the rheumatologist on 8/16/01. She was feeling awful. Very tired and achy, very tight by end of week. Discomfort is generalized, wrist and hands worse. Rash on arm. Skin blotchy. She also reported occasional pleuritic pain. On examination the rheumatologist noted mild pharyngaela erythema, no exudate. Rash upper arms. Synovitis wrists/MCPs. The rheumatologist again discussed MARD (disease modifying antirheumatic drug) with the patient. ON an unspecified date, the patient began taking Arava. On 8/3/01, she reported that she started having fluttering and so stopped Arava. She took cholestryramine and the fluttering resolved.  On 9/13/01, the rheumatologist discussed Imuran (arathioprine) will hold for now. Try selenium/primrose oil. On 10/25/01 the patient was feeling good and energy level is good. Rash resolved to significant extent. Joints sore-hands/knees. Medications at that time included plaquenil, aspirin, calcium carbonate, vitamin D, celebrex, prednisone 10mg daily, and selenium. The patient was seen by the rheumatologist on 11/29/01. She reported that she had begun to experience pain and swellin in her right leg on 11/21/01. These resolved, but then she experienced pain and swelling in her left leg. She also noted a rash on her chest and face. Medications at that time included plaquenil, aspirin, calcium carbonate, vitamin D, celebrex, prednisone 30mg daily. The physician noted trace edema of the extremities. His assessment was "SLE-active." He reduced the prednisone dosage to 25mg daily for one week, then 20mg daily. He prescribed methotrexate 15mg weekly, **ampicillin lidocaine (Lidocorm patch) and folie acid.** By 12/13/01, the patient was tired, achy, feels better overall. The rheumatologist assessment was "SLE-stable." On 12/13/01, the patient saw another rheumatologist for evaluation of her rheumatic disease. She describes the gradual onset of severe flu-like symptoms in July 2000. Initially, she had severe fatigue with diffuse arthralgias and myalgia. She also noticed some swelling of her hands, wrists, knees, andkles, and foot, along with aching in her shoulders and elbows. She had a malar rash and photosensitivity. She also complains of dryness of her eyes, but not her mouth. She was initially noted to have an ANA(antinuclear antibody) of 1:640. A diagnosis of SLE was made. She was initially treated with prednisone, at doses up to 30mg a day. She has continued to take steroids at various levels between 7.5 and 30mg. She also started treament with planquenil 200mg bid. She has had recurrent episodes of pleuritis and pericarditis by history, with persistent elevation of anti-ds-DNA and persistently low complement levels. She was given Arava several months ago , but discontinued that after a few doses becasue of gastrointestinal intolerance. She started methotrexate 15mg a week, about two weeks ago. She continues to complain of photosensitivity with intermittent molar rash, dry eyes, persistent diffuse sweling of her hands and feet, and severe fatigue. She has diffuse arthralgias and myalgias, but without definite joint inflammation. Her monring stiffness is severe and lasts for about one-half hour. The pains occassionally wake her up at night. She sleeps poorly and wakes feeling unrested. Her past medical history is remarkable for having had a Lyme vaccine series in January, February, and May of 2000. She had only small transient local reactions to these injections. She has no history of Lyme disease. She has a sibling with systemic lups erythematosus. There is no other immediatte family history of systemic rheumatic disease.  At this time, she complains of chronic fatigue, weakness, and sleep problems. She has gained 15 pounds. She bruises easily. She has an intermittent malar rash and photosensitivity, with erythematous papules in sun-exposed areas. She has been unalbe to ride her horse, becasue of diffusely decreased strength and energy. She has dryness of her eyes but not her mouth. She denies Raynaud's symptoms. She has occasional chest pain and pressure. Her last episode of pleuritic pain was about a month ago. She has not had changes in appetite or bowel habits. She denies irritable bowel or bladder symptoms. She has intermittent tingling of her hands, feet, and legs. she has only occasional headaches. Menses are normal. She has never been pregnant. She has no history of bleeding or coltting abnormalities. On physical examination, there in on malar rash. There is no adenopathy or palpably enlarged thyroid. She has diffuse tenderness over most of her muscles, bones, and joints. She has specific tender points bilaterally in the ? suboccipital areas, sternomastoids, trapanil, suporapinatous (sio) insertions, buttocks, greater trochanters, medial fat pads, costochondral joints, and lateral epicondylas. She has slight diffuse puffiness of her hands and feet, but without definite joint swelling, pain on motion or synovial change. The patient has SLE by history, manifested by malar rash, arthritis, fatigue, photosensitivity, positive ANA, and high titer anti-ds-DNA with low complement levels. She has had intermittent episodes of pleuritis and/or pericarditis by history. At the presetnt time, there in no active rash or synovitis. Her clincial findings appear to be well controlled with the steroids and Plaquenil. She also has secondary fibromyalgia with diffuse tender points, sleep abnormality, and fatigue. This seems to be the major basis for her ongoing symptoms at this time. She apparently had been in excellent health prior to January 2000, when she received her first Lyme vaccine. She continued to receive the series of three injections, without (sic) local reactions. However, her symptoms of lupus began two months after the third injection. The temporal relationship between the Lyme vaccine and onset of clinical signs and symptoms of SLE rasies the possiblity of a casual relationship, in addtion to the temporal relationship. Her present symptoms of fibromyalgia appear to have developed secondarily to the SLE. The patient was referred back to the first rheumatologist for continued care. The most recent information received 9/13/02, did not provide the outcome of the reported events. Info received 4/23/02, indicated that the SLE and fibromyalgia persisted as of 12/13/01. SLE is considered medically serious by the manufacturer. The follow up states medical history also included genital warts. The vaccinee smoked one-half pack of cigarettes per day; her ethapol use was. The most recent information received 01Oct04, indicated that the systemic lupus erythematous and fibromyalgia persisted as of 10Jan04. On 08Jan04, the pt was hospitalized for three days with chest pain, dyspnea on exertion, and dysphagia. She was dianosed with pleuropericarditis secondary to systemic lupus erythematous. She improved following treatment with intravenous solumedrol and Procrit. She was discharged home on Prednisone and Vioxx. Following the reported onset of systemic lupus erythematous, the pt experienced anemia and hiatal hernia. These events were not reported as adverse events due to vaccine administration, but were found during the couse of review of the pt's medical records. Therefore, they are not listed as adverse events.