*The subject's medical history included allergy to PCN, tick bite (98), Lyme disease (98), osteoarthritis, hip pain, chronic right knee pain, Baker's cyst of the right knee (98), right-sided neck pain (98), Vertigo (98), tinnitus (98), cluster headaches, "mild" migraine headaches (98), photophobia (98), drooping of the left angle of the mouth (98), diminished hearing (98), diminished vibratory sensation in the toes (98), sternocleidomastoid spasm w/related cervicogenic vertigo (98), possible peripheral vestibular dysfunction (98), "mild" stenosis of the left internal and right mid-common carotid arteries, coronary artery disease, myocardial infarction, dyslipidemia, hypertension, premature atrial contractions, nonspecific intraventricular conduction delay, sinus bradycardia, chest pain, micro-infarct in the left frontal lobe of the brain, and "prior" cocaine dependency. Surgical history included arthroscopic surgery for lateral meniscus tear of right knee, coronary artery bypass grafting (93), and 2 percutaneous transluminal coronary angioplasties w/stent placement (91, 97). Concurrent medications included losartan potassium (Cozaar), losartan potassium/ hydrochlorothiazide (Hyzaar), pravastatin (Pravachol), ofloxacin ophthalmic suspension (Ocuflox), and aspirin. The subject received injections of LYMErix on 4/22/99 and 6/26/99. The subject's attorney alleged that the subject received injections of LYMErix in June and July 99. "Thereafter [he] experienced fatigue, weakness and joint pain in his knees, shoulders and hands. After several courses of medication, including Doxycycline, Biaxin [clarithromycin] and Zithromax [azithromycin] the fatigue and weakness lessened, but the joint pain remained. As such, he has been left to suffer w/what has thus far been incurable and at times debilitating pain which has severely limited... his employment options and opportunities." The following info. was obtained from medical records: The subject was evaluated by a chiropractor on 12/16/99 for "injuries sustained as a result of golfing... The PT's chief complain is of severe pain in the right lower back w/radiation into the right gluteus, upper portion, and moderate to severe pain in the lower lumbar region, right side. Pain quality is sharp w/movement and otherwise is a severe ache. Pain is provoked w/standing or moving. It is decreased w/lying down. The pain is constant." The subject reported that the onset of pain was 12/8/99. The chiropractor's impressions were "Paravertebral myofascitis. Lumbar strain/sprain. Lumbar degenerative disc disease at L5-S1." The subject remained under the care of this chiropractor til at least 2/19/01. During this time he reported right sciatica, soreness btwn his shoulder blades, restricted range of motion in his neck, and right shoulder and right upper back pain. During this time, the chiropractor noted weakness in both quadriceps and the right psoas. Add'l Dx's made by the chiropractor included "Cervical sprain/strain" (2/9/00), "Thoracic sprain/strain (2/19/01), and "Shoulder sprain/strain" (2/19/01). The subject remained under the care of this chiropractor until at least 2/19/01. During this time he reported right sciatica, soreness btwn his shoulder blades, restricted range of motion in his neck, and right shoulder and right upper back pain. During this time, the chiropractor noted weakness in both quadriceps and the right psoas. Add'l Dx's made by the chiropractor included "Cervical sprain/strain" (2/9/00), "Thoracic sprain/strain" (2/19/01), and "Shoulder sprain/strain" (2/19/01). The subject presented to the vaccine provider on 1/17/00 w/complaints of continuing pain from the lower back injury sustained while playing golf several months earlier. The MD noted that the PT had degenerative joint disease, especially in the L5-S1 area of the spine. The subject remained under the care of the vaccine provider until at least 10/29/01. During this time, he did not report joint pain, weakness, or fatigue. The subject reported cool fingers, feet and tibias; back spasms; and apainful, pea-sized mass on his left write. During this time period, the subject reported to the MD that he felt "a little better" and was "even swinging a bat" (4/7/00). The MD prescribed triamcinolone (Aristocort) and hydrocodone/ paracetamol (Vicodin ES). Lab analyses performed on 10/29/01 demonstrated abnormal results. Please see Lab Data section. The MD made Dx's of "DJD [degenerative joint disease]" (10/24/00), "Spinal stenosis" (10/24/00), "? Peripheral neuropathy" (4/17/01), "? Raynaud's" (4/17/01), "Ganglion left wrist" (5/25/01), and "Lumbar stenosis" (10/29/01). The vaccine provider referred the subject to a physical therapist, neurologist, neurosurgeon, orthopedist, acupuncturist, and rheumatologist. The subject was evaluated by a neurosurgeon on 3/20/00 for "back pain and muscle spasms for about 3 weeks' duration." At that time, the subject reported that his back pain had begun after playing golf 3 mts prior. "He rested for about 3.5 wks. It got better, but then he had some muscle spasms when he turned the wrong way. Some of these were very bad. Some pain was under the shoulder blade, others were all over the lower back and the mid-back. They were more like muscle spasms, mostly in the mid-back, bilaterally. This pain did not go down the lower extremities or even to the buttocks. It did not go into the neck area either. However, he felt sometimes pain underneath the shoulder blade. W/movement of the neck or movement of the arm or the head, sometimes he would get spasms in the mid-neck area. It is not actually pain from the neck into the shoulder blade, or pain from the neck into the fingers." On physical exam, the neurosurgeon noted that the subject was "mildly overweight". Neurological exam was normal. The neurosurgeon's opinion was "The Sx's that he describes are not consistent w/lumbar stenosis or lumbar radiculopathy, either by history or by exam. So even though the MRI scan shows evidence of lumbar stenosis, it does not appear to be causing Sx's and signs at the present time... I think the complaints that he has are most likely to be muscular than related to radiculopathy. In summary, I find no evidence of cervical or lumbar radiculopathy or myelopathy for that matter." The neurosurgeon recommended physical therapy, "symptomatic treatment as needed", and advised the subject to avoid straining and weight gain. The subject was evaluated by a physical therapist on 3/27/00 for treatment of a lower back injury sustained as a result of golfing. He indicated that the injury occurred in Nov. 99. At that time, the subject reported that he had arthritis, headaches, HTN, back injury, "orthopedic prob's", and "cardiovascular prob's". The prescription for physical therapy, written by the vax provider, indicated a Dx of "somatic dysfunction - L/S [lumbosacral] areas and DJD". The physical therapist recorded the Dx as "degenerative joint disease" and listed the major clinical findings as "1) Severe spinal and LE [lower extremity] tightness. 2) 2/5 trunk strength. 3) Moderate to severe forward head posture." The subject was evaluated by a neurologist on 4/25/00. He reported "a 4-month history of recurrent transient mid back pain induced by body as well as head or arm movement. Pain is counteracted by maintaining rigid posture. Pain is characterized as sharp, stabbing and cramping lasting from seconds to mins. Sx's were previously incapacitating... Onset of his current complaint occurred 3 wks following bedrest for a low back injury experienced during the course of a gold game." On physical exam, the neurologist noted "Forward head carriage, right shoulder is elevated and both shoulders are protracted and internally rotated; right foot is externally rotated. Muscle atrophy: Bilateral rhomboids and right gluteus maximus. Muscle hypertrophy: Erector spinae at the rhoracolumbar junction. Functional: Restricted range of motion of the neck in extension, bilateral rotation and side bending, right more than left; restricted range of motion of the low back in flexion and extension and bilateral side bending; sigmental vertebral restriction T3-4 and T4-5; straight leg raising limited at 70 deg's 2ndary to hamstring tightness; bilateral pelvis instability; faulty shoulder abduction (activated upper trapezius). Muscle spasm: Bilateral upper trapezius, bilateral levator scalulae, bilateral rhomboid and bilateral pectoralis muscle." On neurologic exam, "Pertinent findings limited to diminished pin sensation below the mid tibia." The neurologist's Dx's were "1) Thoracic pain syndrome 2ndary to segmental vertebral dysfunction. 2) Musculoskeletal dysfunction bilateral shoulder girdles and mid back area. 3) Peripheral neuropathy lower extremities." He recommended acupuncture and trigger point and nerve block. The subject remained under the care of this neurologist until at least 9/30/02. During this time, he reported "band-like pain extending to the lateral rib cage on the right side" that began "following moderate trauma to the right subscapular rib cage"; tingling, numbness, and burning paresthesias of both feet; tingling paresthesia of his hand; proximal muscle fatigue of his lower extremities; "some improvement" in symtomatology subsequent to discontinuation of pravastatin (Pravachol) therapy; easily fatigued; difficulty when climbing stairs or uphill walking or prolonged walking on level ground; and frequent muscle aches of the gastrocnemius area bilaterally. The subject reported that he had received LYMErix in Aug. and Sept. 99. He reported recurrence of mid back and scapular pain "only in association w/vigorous physical activity" (4/12/01). On 9/30/02, he reported "no subjective response" to 4 intravenous immunoglobulin treatments. During this time, the neurologist noted focal tenderness of the right inferior scapular border and adjacent rib cage, trophic changes of the distal lower extremity demonstrating decrease in distal hair growth, diminished cutaneous temperature of the distal extremities, diminished vibratory sensation below the knees bilaterally, diminished proprioception over the toes, diminished pin sensation below the wrist bilaterally, 4/5 exertional strength of the proximal and distal muscle groups of the legs, mild balance instability manifested by increase in body away, decreased ankle deep tendon reflexes, and "difficulty during tendem posture". On 9/30/02, the neurologist noted, "In spite of [the subject's] subjective report of no change in his neurologic status, findings on today's neurologic exam indicate significant improvement in muscle strength and sensory exam." Electromyelography (EMG) and nerve conduction studies and other lab analyses revealed abnormalities. Please see Lab Data section. Add'l Dx's made by the neurologist included "Chronic musculoskeletal dysfunction of the mid back (3/9/01), "New onset peripheral neuropathy, etiology undetermined" (3/9/01), "Gradual progression of peripheral neuropathy, etiology remains undetermined. Primary consideration is post vax injury to the peripheral nervous system" (11/6/01), and "Progressive polyneuropathy subsequent to administration of Lyme vax" (3/4/02). During this time period, the neurologist prescribed gabapentin (Neurontin), nortriptyline, procaine intradermal injection, rofecoxib (Vioxx), hot moist packs, electrical muscle stimulation, combination ultrasound/ interferential therapy, spinal manipulative therapy, and intravenous immunoglobin. The neurologist referred the subject to a rheumatologist. The subject's attorney forwarded the subject's medical records to a rheumatologist. In a letter dated 5/3/02, the rheumatologist discussed "the PT's Sx's complex" including "stabbing" back pain that was "at times incapacitating"; back spasms; "band like restriction around the lateral rib cage"; numbness, tingling, and burning paresthesias of the feet; diminished cutaneous temperature over the distal lower extremities; decreased pin sensation below the midtibial level; diminished proprioception of the toes; diminished pin sensation below the wrist bilaterally; easy fatiguability; and difficulty w/ambulation. The rheumatologist wrote, "I believe that w/in a reasonable degree of medical certainly that the progressive peripheral neuropathy that [the subject] currently suffers from is a result of the admin of the LYMErix vax... Unfortunately, the prognosis for this PT is poor, since his neuropathy has progressed despite extensive physical therapy and a variety of medications. Following the reported onset of peripheral neuropathy, the subject experienced degenerative disc changes, DJD, diffuse theoracic spondylosis, spinal stenosis, shoulder sprain/strain, left atrial enlargement, left ventricular hypertrophy, "mild" mitral and tricuspid regurgitation, hypertriglyceridemia, diverticulosis, possible carpal tunnel syndrome, corneal abrasion, and ganglion cyst on the left wrist. "These events were not reported as adverse events due to vax administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info, received on 12/9/02, indicated that the peripheral neuropathy had improved as of 9/30/02. The outcome of the joint pain was not reported.*