The subject's medical history included allergy to prednisone, a "long" history of low back pain, chronic sinusitis, irritable bladder dysfunction, renal squamous cell carcinoma (95), colon polyps (95), bilateral carpal tunnel syndrome, gastritis, "mild" benign prostatic hypertrophy, spinal stenosis, fractured finger (94), fractured right wrist (94), viral encephalitis (74), whiplash injury (60), chronic cough, anxiety (88), tinnitus, crying spells (88), shaking (88), a fear of going "crazy" (88), a feeling of not being himself (88), fear of losing control (88), and "secondarily convertly depressed" (88). Surgical history included bilateral carpal tunnel release (78, 82), colon polypectomy (95), and right nephrectomy (95). Concurrent medications included prochloperazine (Compazine), chlorpromazine (Thorazine), tamsulosin hydrochloride (Flomax), lactulose (Duphalac) syrup, psyllium (Metamucil), salbutamol (Proventil), melatonin, omeprazole (Prilosec), esomeprazole (Nexium), econazole topical cream (Spectzole), and amoxicillin clavulanate (Augmentin). The subject participated in a Lyme vax clinical trial. He received injections of placebo in 95 and 96. He then received injections of LYMErix in April 97, May 97, and May 98. In a Statement of Injuries, the subject's attorney alleged that the subject "first suffered from a burning rash on his hands and arms, along with joint pain in his hands. This progressed into overall flushing and burning of the skin, and tingling about the face, as well as cramping and pain in his legs. [The subject] suffers from extreme pain and cramping in his legs and buttocks, and joint pain in his knees, shoulders and hands. [He] suffers from muscle twitches, body tremors, pain and numbness in his arms, and a 'burning nerve' feeling in his legs. He suffers from forgetfulness, short-term memory loss, difficulty concentrating, exhaustion, constant ear ringing, insomnia, mood swings, depression, decreased libido and emotional outbursts." The following info was obtained from medical records. The subject presented to his primary MD on 12/5/97 with complaints of mild discomfort (rated 3-4 on a scale of 10) from the right sciatic notch down the anterior aspect of the right thigh into the foot. On physical exam, the MD noted "no tenderness over the lumbar sacral spine. Very mild discomfort in the right sciatic notch." The MD's impression was "very mild right sided sciatica." The subject remained under the care of this MD until at least 10/21/98. The following add'l signs/ symptoms were reported during this time: chronic cough; dental abscess; back, buttock and right leg pain; numbness of the right leg; persistent hiccups with abdominal bloating and upset stomach; abdominal discomfort; neck pain; and numbness of both arms. During this time period, the MD noted no tenderness to percussion over the back; no cervical lymphadenopathy; and no hepatosplenomegaly, masses or tenderness. Additionally on 6/19/98, he noted that the subject was being seen by several neurologists and that magnetic resonance imaging (MRI) of the brain, cervical spine, and lumbar spine, and electromyelography (EMG) and nerve conduction studies of both upper and lower extremities failed to show any cause for his symptoms. Please see Lab Data section. The MD made diagnosis of spinal stenosis (L4-5), carpal tunnel syndrome, and neurofibromatosis. The MD prescribed prednisone and oxaprozin (Daypro). The subject was evaluated by a neurologist on 3/30/98. At that time, the subject reported that in Nov. 97, he began to experience the sense of paresthesias and "tightness" involving the right anterior thigh and foot. On physical exam, no abnormalities were noted. The MD's impression was "Although his objective neurologic exam is unimpressive, his clinical symptoms suggest a thoracic myelopathy, etiology unclear." The subject remained under the care of his neurologist until at least 6/8/98. During this time, the subject reported extension of paresthesias to the level of the xiphoid process, and then to the chest and upper extremity. Additionally, it extended to the left leg followed by proximal extension to the abdominal region. During this time period, the MD noted that the subject's "subjective complaints far outweigh any objective abnormalities. In fact, the neurologic exam is normal." Multiple diagnostic evaluations did not reveal abnormalities. Please see Lab data section. The neurologist further stated, "I cannot find any underlying objective abnormalities, although his symptomatology sounds very organic." The subject presented to a new primary MD on 11/12/98 w/complaints of right leg pain, tightness at sciatic notch, unable to sit long periods of time and neck pain. On physical exam, the MD noted "Hyperesthesia right leg... Tightness on Sciatic North... Piriformis." The subject remained under the care of this MD until at least 12/20/01. The following add'l signs/ symptoms were reported during this time: pain and burning of both feet, legs aching, severe pain in buttocks and legs, losing strength, losing control of urine, insomnia, "brain fog", and decreased energy. In Jan. 01, he fell on the ice and experienced tightness in low back with low back pain. During this time, the MD noted paraspinal tenderness (cervical and left trapezius) and tenderness sacroiliac joint. The MD made diagnoses of piriformis syndrome, neuropathy right lower extremity, tarsal tunnel syndrome, chronic pain syndrome, fibromyalgia, questionable Lyme neuritis, and chronic myofascial pain syndrome. The MD noted that the subject had received hyperbaric oxygen treatment with lessening of pain. The MD prescribed celecoxib (Celebrex), dextropropoxyphene/ paracetamol (Darvocet N-100,) sustained release oxycodone (OxyContin), transdermal fentanyl (Duragesic Patch), alprazolam (Xanax), rofecoxib (Vioxx), tizanidine (Zanaflex), lorazepam, gabapentin (Neurontin), paroxetine (Paxil), sustained release morphine (MS Contin), cefuroxine (Ceftin), baclofen, Zaleplon (Sonata), zolpidem (Ambien), IM benzathine PCN G (Bicillin L-A), and massage therapy. The MD referred the subject to a "Lyme specialist", a physiatrist, an orthopedist, a spine specialist, and a neurologist. The MD noted that the subject was to seek social sec. disability benefits; however, the subject told another MD that he had retired in 94. The subject was evaluated by another neurologist on 7/9/98. At that time, the subject reported burning of his feet. In addition to the symptoms already described, this MD noted that the subject had "some formications transiently on the face." On physical exam, the MD noted dysesthesias in a myelopathic distribution. He further noted, "Most importantly, [the subject] had a similar attack like this a decade ago, and it eventually subsided completely." MRI of the cervical and thoracic spine did not reveal abnormalities. Please see Lab Data section. The subject was evaluated by a rheumatologist on 8/6/98. At that time, the subject reported burning and tingling in the legs, which progressed up the legs to involve his chest. On physical exam, the MD noted the subject to be "having hyperesthesias which may represent a peripheral neuropathy." The MD's impression was, "It seems unlikely that his symptoms are secondary to Lyme vax based on the statistical comparisons he provided me comparing central and peripheral nervous symptoms in PTs who have received vax and placebo." The MD further stated that the subject reported that he was recently found to have a pituitary tumor. However, two neurologists reportedly stated that this was unrelated to his symptoms. The subject was evaluated by an orthopedic MD at a hand center on 9/9/98. At that time, the subject reported bilateral arm numbness. He related that he had retired in 94 but has remained very active and "over the past year" was riding "two to four hours per day" on a mountain bike. He further stated that "he has not been able to do this well at this point." The MD's impression was "Bilateral recurrent median neuropathy at wrist level. Synovitis right wrist, possible TFCC injury... Ulnar neuropathy left elbow... Brachial plexitis left side greater than right... Rule out systemic disease Lyme versus possible underlying neurofibromatosis." The MD felt that the subject's low back symptoms may be related to his recent activities on the bicycle. "The posturing could have effected his low back but more / so may well effect his upper extremity issues." On 11/17/98, the subject was evaluated by an MD at a spine center. At that time, the subject reported "severe" right leg pain that was much greater than his left leg pain, and "minimal" low back pain. He reported that the symptoms had been present for the past year and related riding a bicycle extensively at the time the symptoms started. Additionally, he recalled having performed forward flexion manuevers and lifting objects when he developed pain in the right foot the following day. "The symptoms then radiated proximally through the posterior calf and into the medial thigh." The subject also described experiencing numbness in the toes. Reportedly, his symptoms improved with walking but were exacerbated with sitting. On physical exam, the MD noted no musculoskeletal deformities. "There was no tenderness to palpation, except for pain produced with pressure applied over the tarsal tunnel, the popliteal fossa and over the sciatic notch when performed on the right side." The MD's impression was that the subject "appears to be experiencing symptoms of reticular nature or emanating from peripheral nerve entrapment/ compression. These symptoms could involve the right S1 nerve root which would account for his calf and not medial thigh pain, right piriformis syndrome, a mass in the popliteal fossa involving the peroneal nerve and right tarsal tunnel syndrome." The results of an MRI of the right ankle, performed on 1/27/98, were interpreted as abnormal. Please see Lab data section. The subject remained under the care of this MD until at least 3/4/99. During this time period, x-rays of the ankles demonstrated "evidence of a possible sinus tarsi syndrome." On 3/4/99, the MD's impressions were "1) Rule out discogenic low back pain now with significant symptomatic improvement, approximately 50% after L5 transforaminal infections on the right. 2) Rule out intrinsic foot process to explain right greater than left foot pain. 3) Radiographic evidence of a possible sinus tarsi syndrome and tenosynovitis of the right ankle. 4) No evidence of peripheral polyneuropathy as per recently performed electrodiagnostic studies." The subject was evaluated by a physiatrist on 5/13/99. At that time, the subject reported low back and bilateral leg pain, which he stated, "began suddenly after doing some work in his yard approximately 1 and 1.5 yrs ago." On physical exam, the MD noted "Lumbar spinal range of motion is nearly full... Deep tendon reflexes are symmetrical and intact in both lower extremities... Normal hip and knee exams." The MD's impressions were "1) Chronic pain syndrome. Clinical complaints suggest a significant neuropathic component. Small fiber neuropathies will produce electrodiagnostic evaluations. 2) Borderline lumbar spinal stenosis by MRI w/no benefit from repeated fluoroscopically guided epidural steroid injection. 3) Possible piriformis syndrome contributing to the right sided syndrome... 4) Rule out sacroiliac joint pain syndrome bilaterally." The physiatrist administered 2 left and 2 right piriformis injections for treatment of piriformis myofascial pain with probable sciatic nerve entrapment. On 7/27/99, the subject stated that the injections seemed to give him 15 to 20% improvement in pain. The subject was evaluated by a 3rd neurologist on 7/20/99. At that time, the subject reported burning in his legs and feet with pain in both ankles and in his buttocks. On physical exam, the MD noted, "Sensation intact for pain, temperature, vibration and light touch. Motor tone and strength was symmetrical. Straight leg raising was negative. There were no fasciculations." The MD's impression was "Normal EMG and nerve conduction study. We compared this to the exam that he had approximately 10 yrs ago in 88 and that is also normal. Thus, the etiology of his pain is not clear but I suspect that there is no significant structural lesion causing this." The subject was evaluated by another physiatrist on 3/30/99. At that time, the subject reported that his "symptoms first occurred on or about Nov 97 while he was running a wood splitting machine. Basically, his function was loading the logs into the machine. He developed right buttock pain, right thigh pain with radiation down the posterior lateral leg, and associated with numbness in the foot." At the time of this evaluation, he reported a six-month history of a burning, cramping sensation in the right greater than left leg, numbness in the soles of the feet, occasional hip pain, and "minimal" back pain. On physical exam, the MD noted normal sensory exam of the foot and upper body palpation negative in all points. "In the lower body, there was marked palpatory tenderness w/a trigger point in the gluteus medius, maximus and minimus, right greater than left. Iliotibial bands were tender and tight as well, right greater than left. The hamstring was adaptively shortened on the right side with the PT unable to fully extend the leg with the hip flexed in the supine position. There was marked deep palpatory tenderness with palpation of the piriformis muscles, and the gemelli which causes reproduction of paresthesias into the posterior lateral leg into the foot." The MD's impressions were, "1) Regional myofascial pain syndrome of the right hip girdle w/definite evidence of a piriformis syndrome... 2) Rule out leg length difference. 3) Subtalar asymmetry w/increased supination on the right. 4) Tarsal tunnel syndrome." The results of a bilateral lower extremity non-invasive study performed on 4/30/99 did not reveal occlusive disease. Please see Lab section. The subject remained under the care of this group of physiatrists until at least 12/22/99. During this time, he participated in physical therapy sessions 2 times weekly for 6 visits w/no significant changes in his symptoms. On 12/22/99, the subject reported to one of the MD's that he had not improved. He reported brief periods of relief w/stretching but only while he was doing the exercise. The subject was evaluated by a 4th neurologist on 10/5/99. At that time, the subject reported burning paresthesias of the legs and intermittent paresthesias of the arms. On physical exam, the MD noted that "Compression over the right gluteus muscle I would precipitate discomfort down the right leg into the foot recreating symptomatology." The MD's impression was "Probable myofascial pain syndrome". EMG and nerve conduction studies did not reveal abnormalities. Please see Lab data section. The subject remained under the care of this neurologist until at least 5/22/00. During this time period, the subject reported that he had increased pain and cramping in his lower extremities, pain of a burning type "all over", dysesthetic sensation in the arms at night, muscle weakness and stiffness, restless sleep, and a generalized sense of fatigue and irritability. During this time period, the MD noted, "I think that he really has fibromyalgia syndrome. Unfortunately there is little to do for this. I do not know other etiologies to look for besides what has been done." The MD prescribed an increased dosage of gabapentin (Neurontin) to a higher dose, baclofen, and discontinuation of cyclobenzaprine (Flexeril). He also prescribed notriptyline (Pamelor), lorazepam, and oxycodone. Left quadriceps muscle biopsy to ruled out myopathy. The subject was evaluated by another orthopedic MD on 5/5/00. At that time, the subject reported that "He has been retired, and was minding his own business, doing work around the house, when he did some heavy lifting and felt pain in the low back. This then developed into bilateral leg numbness, burning and cramping." It was in both legs approximately equally and to the point where he could barely tolerate it. On physical exam, the MD noted the subject to have "tenderness to palpation of the lumbosacral spine... He has restricted flexion/ extension of the lumbar spine. Rotation and lateral bending are close to normal limits." A myelogram and post-myelogram computed tomography (CT), performed on 5/18/00, showed minimal disc bulging of L3-4 and L4-5. Please see Lab Data section. The subject was under the care of a "Lyme specialist" from 9/25/00 until at least 1/15/02. The subject reported unexplained fever, sweats, chills, fatigue and severe cramping in his legs which reportedly started after receiving the 3rd LYMErix injection. The MD's impressions were "1) Lyme disease. 2) Possible co-infections of Ehrlichia, Babesia, but not able to show by antibody testing. 3) Exacerbation of PT's past Lyme disease by Lyme vax. 4) Severe pain syndrome and muscle spasms secondary to all of the above." During this time period, the MD prescribed cefuroxine (Ceftin), doxycycline, magnesium sulfate, guaifenesin (Duratuss G), and sustained release morphine (MS Contin). The subject noted "slight" improvement on 1/18/01 and as of 2/14/01, reported that walking helped him to sleep better. Antibiotic therapy was still providing improvement, but he continued to have severe leg pain "off and on". The MD noted that the subject had seen about 22 doctors w/out success. As of 2/22/01, the MD noted the pragnosis to be "fair to good" with an undetermined length of treatment predicted. The subject was evaluated by a psychiatrist on 5/11/01. At that time, the subject reported that, following receipt of Lyme vaccine, he "suffered shortness of breath, fatigue, and wheezing followed by a whole body flush, as if his body was burning up." The MD noted that the subject "Denies suicidality, but it sounds like a fear of leaving his wife alone is all that's stopping him. He is off antibiotics and his pain is worse now." The MD prescribed an increased dosage of zolpidem at bedtime plus a lower dose two times during the day, if needed, an increased dosage of cyclobenzaprine, co-enzyme Q10, and diazepam (Valium). He further stated that the subject "May need an antidepressant soon." Following the reported onset of fibromyalgia, the subject experienced meningoencephalitis, pain and burning of the feet, chest pain, heart palpitations, shortness of breath, confusion, "brain fog", difficulty with speech, loss of strength, neck pain, poor balance, "severe" hiccups, dental abscess, diverticulosis, bronchitis, possible urinary tract infection, eczema, prostatitis, tinea corporus, and tarsal tunnel syndrome left foot w/surgical intervention. 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.  Follow up on 02/26/04: "The most recent information received on 09/26/02, indicated that the bilateral leg burning and cramping persisted. The outcomes of the other alleged events were not provided."