Age: 57.0
Sex: M
Vaccine: LYME
Symptoms: Polyneuropathy, Sensory disturbance, Tendon disorder
Clinical narrative: Report A0359148A describes chronic inflamatory demyelinating polneuropathy in a 57 year old male who received Lyme disease vaccination recombinant OspA (LYMErix). This report was received as part of litigation procedings with forwarding of medical records. There were no concurrent medications. The vaccinee did not report adverse events following receipt of the first two injections of LYMErix. Following the reported onset of chronic demyelinating inflamatory polyneuropathy, the vaccinee experienced basal cell carcinoma, lichenoid actinic keratosis, and eczema. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. The vaccine received his first injection of LYMErix on 5/24/99. the date of the second injection was not provided. The vaccinee received his third injection of LYMErix in June 2000 (exact date not provided). Evolution of symptoms was recorded differently in the medical records of two physicians. The vaccinee was seen by an infectious disease specialist in 08/10/2000. The vaccinee reported that the evening he received the third injection of LYMErix, "he noted drowsiness, dizziness and loss of appetite. Over the next 48 hours he continued to have the same symptoms and then four days after that he developed fever, chills, nausea and episodes of sweating. He also experienced muscle cramps in his hands and feet and on the eight or ninth day following the vaccine, a temp of 104 deg and an episode of vomiting. He went to the ER where he was told that he probably had acute Lyme diseease and he was placed on doxycycline. Gradually over the next week, the chills and sweats cleared but he developed joint pain,s continued decreased energy and headaches. He also describes a numb feeling in his legs. The pt does not recall a specific attached tick or EM (erythema migrans) rash." The vaccinee was taking doxycycline at the time of the evaluation. Physical examination was unremarkable. The physician wrote, "my first impression is that this was a reaction to the Lyme vaccine... Certainly another possibility does include Ehrlichiosis... The pt was treated appropriately with doxycycline and he is still on doxycycline with a plan to complete a six-week course. Finally, Lyme disease is also a possibility but rather less likely." The vaccine underwent electromyelography (EMG) and nerve conduction studies (NCS) on 09/21/2000. The neurologist's conclusion was "There is electrophysiologic evidence of mild demyelinating distally predominant sensorimotor polyneuropathy in lower extremities. There is bilateral demyelinating, moderate median neuropathy across the wrist, left more than right/carpal tunnel syndrome or arthritis?" The vaccinee was seen by a neurologist on 10/12/2000. "On neurologic testing, cranial nerves, mental status, gait and reflexes are intact. Motor power appears intact, but the pt has slight difficulty getting up on his toes. Sensation including vibration, joint sense as well as cerebellar and Romberg are intact. Electrical studies done today indicate a mild sensorimorot polyneuropathy" that was "likely axonal in nature." The neurologist prescribed gabapentin (Neurontin) to treat the limb pain and a trial of physical therapy. The vaccinee was seen by a rhematologist on 11/30/2000. He reported that "shortly after" receiving the 3rd injection of LYMErix, he became "very" dizzy. "One to two days later," he developed "high" fevers, chills and nausea. He presented to the local ER ten days later with persistent fever and nausea. These symptoms persisted for a number of months, but has slowly resolved. However, he subsequently developed severe cramping pain in both hands with difficulty making a fist. He also describes some general muscle aches. He then developed weakenss in the hands and feet. The pt states he has frequent periods of numbness from the elbows to the hands and also from the knees down to the feet. The numbness varies in intensity, but is always present. He also feels tha this eyesight has worsened and at times he feels that he has troubled with speech. He notes insomnia and poor energy. He is unable to exercise. At one point, he received a course of doxycycline with no improvement in the numbness or weakness, although he feels it did lower his fevers. He tried Neurontin but this caused significant dizziness. He also notes some dry mouth. The pt's physical exam was significant for some weakness in the proximal and distal upper extremities as well as the proximal lower extremities. There was pain with motion at the hips and shoulders. Sensation appears decreased in the hands and feet. There was no synovitis at any site. A scaling rash ws noted over the MCP and PIP joints, likely related to eczema." The rheumatologist wrote, "this pt does indeed appear to have a neuropathy related to the Lyme vaccine. There seems to be a component of myalgias and arthralgias as well which may be functional." The vaccinee was seen by another neurologist on 12/07/2000. At that time, the vaccinee reported paresthesias and weakness of the arms and legs. "He has recently noted progression in the development of dysarthria and imbalance." Significant laboratory findings included elevations of Lme total antibodies with 41 and 23 kD bands present, and erythrocyte sedimentation rate. "Neurological examination showed moderately severe distal leg weakness, vibratory and cold temp sensory loss, tandem ataxia. Rombery sign, and hyporeflexia without a disturbance in cognition, cranial nerve function, or arm weakness. The findings are consistent with chronic inflammatory demyelinating polyneuropathy." The vaccinee was hospitalized for lumbar puncture and muscle and nerve biopsy. Sural nerve biopsy "showed evidence of chronic inflammatory demyelinting polyneuropathy including a lymphocytio infiltrate around an epineural blood vessel." The neurologis trecommended intravenous immune globulin. On 01/31/2001, the vaccinee reported that "He has noted improvement in gait since initiation of  IVIg therapy. He occasionally notes numbness in the fact." The neurologist wrote, "The findings were consistent with a post-vaccination CIDP." The vaccinee was to proceed with the second month of IVIg therapy. On 04/17/2001, the vaccinee reported that the IVIg "treatments kill my strength to the point that I can just barely walk four a few mins. My joints are hurting me more and more." The vaccinee indicated that he was receiving disability benefits, and planned to do so ntil the middle of May/June when the IVIg therapy was scheduled to be completed. The vaccinee was seen by a physician specializing in physical medicine and rehabilitation on 07/19/2001. The vaccinee reported present difficulties as impaired reading comprehension and memory; constant joint pain in the legs, arms and back stiffness; easy bleeding and bruising from IVIg; leg weakness cramps in the fingers; poor endurance; shaking of his legs at night; numbness in the legs and hands; decreased balance; fatigue; impaired fine motor skills and writing; and "word-finding difficulty." The following were noted on physical examination; generalized mild weakness; hypoactive deep tendon reflexes in both triceps, biceps, knees and ankles; decreased sensation in pinprick "in a scattered fashion, worse in the bands. insensate feet in plantar aspect." Observation of gait and stance revealed "wide base of support, decreased heel/toe gait. " The physician's impression was "CIDP post Lyme vaccine with residual neurologica sequelae of weakness, sensory changes, balance difficulties, cognitive-linguistid deficits." The vaccinee was seen by a neurologist on 09/05/2001. He has noted steady improvement in neuropathic symptoms on the regimen of IVIg therapy for post Lyme vaccine CIDP. Neurological examination showed mild distal vibratory and cold temp sensory loss, Rombery sign, and hypoactive tendon reflexes, without disturbance of cognition, cranial nerves, or limb strength. The findings were consistent with improving post-vacinal CIDP.  Follow-up information received on 3/25/2003 states:On 30 November 2001, the neurologist wrote, "He continues to note mild gait and balance difficulty and neuropathic discomfort in the feet despite IVIG therapy. He no longer notes chest dicomfort." On examination, tandem ataxia and abscence of tendon reflexes were observed. On 11 February 2002, in a Statement of Damages, the vaccinee's attorney alleged that the vaccinee "suffered a diagnosed chronic inflammatory demyelinating polyneuropathy, sensorimotor and periphial, with nuerological sequelae of pain, weakness, sensory changes, balance difficulties and cognitive-linguistic deficits.  The vaccinee was evealutaed by a third neurologist at a tertiary care center on 07 March 2002. At that time, the vaccinee reported that he recievd his first and second injections of LYMErix "in February and June of 1998." The vaccinee reported that "immediately following his third vaccination...he developed fever, sweating, hot and cold chilss, skin rash, aching pains and weakness in his arms and legs, and clawing of his hands.  He remained in bed for several days...He then continued with weakness and pain, and in addition became forgetful and had difficulty concentrating, forcing him to stop working...He is mostly bothered by numbness and squeezing pains in his arms and legs, diffuse muscle twitching, hypersensitivity, and gait instability. He also has frequent headaches, episodes of blurred vision, difficulty concentrating, poor memory, and chronic fatigue...His hands sometimes turn dark blue or white, suggestive of vascular instability.  Recent MRI of the head revealed multiple white matter lesions consitent with central demyelination." On physical examination, the physician noted "mottling discoloration of his hands." There was no muscle atrophy noted. On motor examination, he had mild weakness of the shoulder abductors, and elbow extensors and flexors bilaterally, and of the finger flexors and extensors in the right hand.  In the lower extremities there was mild weakness of the hip flexors, and ankle dormiflexors. He had difficulty rising on his heels or toes, or getting up from a chair without using his arms, and could not hop on either foot.  On sensory examination, vabration was severely impaired are the large toes and moderately impaired at the ankles and fingers. Position was normal. Pin was impaired in the hands and feet. Deep tendon reflexes were active at the left biceps and absent at the right biceps and both knees and ankles, with bilateral plantar flexor responses.  Foot tapping was clumsy.  He could not tandem walk and Romberg was positive. Gait was moderately atoxic. Laboratory analyses performed in 06 March 2003 were within the reference ranges, with the exception of erythrocyte sedimenation rate. Please see laboratory data section. The neurologist wrote, "He has evidence for peripheral neuropathy and encephalopathy, with central and peripheral demylenation. His condition was probably induced by the LYMErix vaccine, given the temporal association."  The vaccinee returned to this neurologist ib 12 April 2002. The neurologist wrote, "MRIs of the brain were reviewed. They showed multiple white lesions including one with enhancement."  On 18 August 2002, the vaccinee told his urologist that he experienced memory loss.  The most recent information, received on 12 March 2003, did not provide the outcomes of the reported events. Information received on 02 December 2002 indicated that the chronic inflammatory demyelinating polyneuropathy and encephalopathy persisted as of 12 April 2002. A 15-day follow up report received 04/23/2003 adds: Report A0359148A describes chronic inflammatory demyelinating polyneuropathy in a 57-year-old male who received Lyme disease vaccine recombitant OspA (LYMErix). This report was received as part of litigation proceedings, with forwarding of medical records. The vaccine provider submitted this report directly to VAERS (VAERS ID 169482). Medical history included allergy to penicillin manifested by possible hallucinations, non-cardiac chest pain, foot pain, leg pain, 'chronic back disease' with back pain, spinal degeneration, lumbar radiculitis, 'slipped disc' treated with acupuncture and traction, tinnitus, dizziness, sensorineural hearing loss in the left ear, gastroesophageal reflux disorder, dyspepsia, possible thrombosed hemorrhoid, glycosuria, hypercholesterolemia, hyperuricemia, elevated prostate-specific antigen (PSA) concentration, urinary difficulty, 'mild' benign prostatic hypertrophy, prostatic intraepithelial neoplasia, and fracture of the right arm. The pt was 'overweight'. He made 'frequent trips to Africa'; during these trips, he took malarial prophylaxis. He reported 'never having had malaria'. Surgical history included tonsillectomy, adenoidectomy, otoplasty and an unspecified surgical procedure on the right arm. Concurrent medications included ranitidine hydrochloride (Zantac), lansoprazole (Prevacid), warfarin (Coumadin), tamsulosin (Flomax), alprostadil (Caverject) and ketoconazole 2% cream. The pt did not report adverse events following receipt of the first two injections of LYMErix. Following the reported onset of chronic demyelinating inflammatory polyneuropathy, the pt experienced prostate adenocarcinoma (Gleason Grade 5, major pattern 3 and minor pattern 2) treated with radical prostatectomy (10/14/2003), basal cell carcinoma, lichenoid actinic keratosis, eczema, a thyroid nodule, syncope, varicose veins, deep vein thrombosis, and joint pain. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The pt received his first injection of LYMErix on 05/24/1999. The date of the second injection was not provided. He received his third injection of LYMErix on 06/13/2000. Evolution of symptoms was recorded differently in the medical records of three physicians. The pt presented to the vaccine provider on 07/05/2000. He reported that he had experienced 'hot/cold' sensations for 3 weeks. On 06/26/2000, 13 days post-immunization, he began to experience 'slight' nasal congestion and occasional cough. He reported that he had no abdominal pain. On 06/28/2000, 15 days post-immunization, he reported that he began to experience 'frequent' diarrhea, vomiting, and loss of appetite. On 07/04/2002, he stated that he experienced dizziness, frontal headache and achy legs. The vomiting and diarrhea persisted. He presented to a local ER on 07/04/2000, where he was reportedly told that he was dehydrated. He stated that he was also told that he had blood in his urine and a low platelet count. The ER physician prescribed doxycycline. Lab records indicated that platelet count, red blood cell count, hemoglobin and hematocrit were below the reference range (please see Laboratory Data section for details of diagnostic evaluations). White blood cell count was within the reference range, with decreased polymorphonuclear neutrophils and lymphocytes, and increased banded neutrophils and atypical lymphocytes. Total bilirubin concentration was elevated. Lyme antibody screen was positive. Erythrocyte sedimentation rate was above the reference range. Antinuclear antibody titer was negative. The vaccine provider noted, 'Ehrlichia strong possibility'. On 07/06/2000, the pt telephoned the physician and reported that 'His hands are cramping up and his legs can't move. Wants to know if he should be on IV (intravenous) antibiotics for his Lyme disease'. On 07/12/2000, the physician prescribed cyclobeneprine (Flexeril) 10 mg twice daily for five days. On 07/24/2000, the physician prescribed doxycycline 100 mg twice daily for 5 days. On 07/27/2000, platelet count was within the reference range. The pt telephoned again on 08/01/2000 and stated that he 'feels awful'. The physician prescribed doxycycline 100 mg twice daily for 10 days. The follow up received on 6/30/03 states the vaccinee was seen by an infectious disease specialist on 8/10/00. The vaccinee reported that, the evening he received the third injection of LYMErix, "he noted drowsiness, dizziness and loss of appetite. Over the next 48 hrs he continued to have the same symptoms and then four days after that he developed fever, chills, nausea and episodes of sweating. He also experienced muscle cramps in his hands and feet and on the eight or ninth day following the vaccine, a temperature of 104 deg and an episode of vomiting. He went to the hospital ER where he was told that he probably had acute Lyme disease and he wasplaced on doxycycline. Gradually over the next week, the chills and sweats cleared but he developed joint pains, continued decreased energy and headaches. He also describes a numb feeling in his legs. The pt does not recall a specific attached tick or EM rash." The vaccinee was taking doxycycline at the time of the evaluation. Physical examination was unremarkable. The physician wrote, "my first impression is that this was a reaction to the Lyme vaccine. Certainly another possibility does include Ehrlichiosis especially witht he thrombocytopenia. The pkt was treated appropriately with doxycycline and he is still on doxycycline with a plan to complete a six-week course. Finally, Lyme disease is also a possibility but rather less likely." On 8/10/00, rheumatoid factor and platelet count were within the reference range. Antinuclear antibody titer was negative. Lyme antibody screen was positive. Lyme IgG Western blot was negative, demonstrating a 23 kD band. Lyme IgM Western blot was also negative, demonstrating a 23 kD band. The vaccinee underwent EMG and nerve conduction studies on 9/21/00. The neurologis's conclusion was "There is electropohysiologic evidence of mild demyelinating distally predominat sensorimotor polyneuropoathy in lower extremities. There is bilateral demyelinating, moderate median neuropathy across the wrist, left more than right/carpal tunnel syndrome or arthritis." The vaccinee telephoned the vaccine provider on 9/28/00 to report that "The night before last, he regurgitated in his sleep and almost choked to death." The physician suggested that he sleep on his side. The vaccinee was seen by a neurologist on 10/12/00. "On neurologic testing, cranial nerves, mental status, gait and reflexes are intact. Motor power appears intact, but the pt has slight difficulty gettting up on his toes. Sensation including vibration, pins and joint sense as well as cerebellar and Romberg are intact. Electrical studies done today indicate a mild sensorimotor polyneuropathy" that was "likely axonal in nature." WBC count was normal; however, monocyte count was elevated. Erythrocyte sed rate and creatine phosphokinase concentration were elevated. On immune complex screen, "No ryoglobulin seen. Borderline positive PEG screen for circulating complexes but strongly psoitive SIA test for water precipitable circulating complexes. And tendency toward poly-oligoclonal hypergammaglobulinemia in whole serum pattern. The elevated oligoclonal gamma region is estimated as 1.7 G/6.9g/dl total serum protein. And the albumin is well below the lower limits of normal range." Serum immunofixation demonstrated an "unremarkable" immunoglobulin pattern. "No monoclonal gammopathy seen." The neurologist wrote, "Most likely the neuropathy is part of a systemic vaccine related reaction perhaps including joint and connective tissue." The neurologist prescribed Neurontin to treat the limb pain, and a trial of physical therapy. The vaccinee telephoned the vaccine provider on 11/16/00 and reported that "nothing is getting better. His arm has been numb since last night." The vaccinee requested a referral to a rheumatologist. The vaccinee was seen by a rheumatologist on 11/30/00. He reported that "shortly after" receiving the third injection of LYMErix, he became "very" dizzy. "One to two days later," he developed "high" fevers, chills, and nausea. He presented to the local ER ten days later with persistent fever and nausea. "These symptoms persisted for a number of months, but has slowly resolved. However, he subsequently developed severe cramping pain in both hands with difficulty making a fist. He also describes some general muscle aches. He then developed weakness in the hands and feet. The pt states he has frequent periods of numbness from the elbow to the hands and also from the knees down to the feet. The numbness varies in intensity, but is always present. He denies joint swelling or rashes. Some days he feels so weak that he is unable to hold a pen or a spoon. He also feels that his eyesight has worsened and at times he feels that he has trouble with speech. He notes insomnia and poor energy. He is unable to exercise. At one point, he received a course of doxycycline with no improvement in the numbness or weakness, although he feels it did lower his fevers. He tried Neurontin, but this caused significant dizziness. He also notes some dry mouth. The pt's physical exam was signficant for some weakness in the proximal and distal upper extremities as well as the proximal lower extremities. There was pain with motion at the hips and shoulders. Sensation appears decreased  in the hands and feet. There was no synovitis at any site. A scaling rash was noted over the MCP and PIP joints, likely related to eczema." The rheumatolgist wrote, "This pt does indeed appear to have a neuropathy related to the Lyme vaccine. There seems to be a component of myalgias and arthralgias as well which may be functional." The vaccinee was seen by another neurolgoist on 12/7/00. At that time, the vaccinee reported paresthesias and weakness of the arms and legs. "He has recently noted progression in the development of dysarthria and imbalance." Significant lab findings included elevations of Lyme total antibodies with 41 and 23 kD bands present, and erythrocyte sed rate. "Neurological examination showed moderately severe distal leg weakness, vibratory and cold temperature sensory loss, tandem ataxia, Romberg sing, and hyporeflexia without a disturbance in cognition, cranial nerve function, or arm weakness. The findings are consistent with chronic inflammatory demyelinating polyneuropathy." The vaccinee was hospitalized for lumbar puncture and muscle and nerve biopsy. During hospitalization, he received a five-day course of IV immune globulin and prednisone. Sural nerve biopsy "showed evidence of chronic inflammatory demyelinating poyneuropathy including a lymphocytic infiltrate around an epineural blood vessel, and excessive segmental remyelination." The vaccinee was seen by a neuro-ophthalmologist on 1/10/01. The physician noted that the vaccinee had been "diagnosed with CIDP. He was recently hospitalized and had a five day course of IVIG. The onset was apparently in the middle of June after his third shot for a Lyme vaccination. He developed fever, decreased appetite and strength problems. He describes fluctuating vision, some days good, some days bad. He gives brief episodes of not seeing well. This apparently started a month of two ago. I must noted the exact sequence/duration is somewhat vague. The past history is otherwise negative. An LP performed five days ago did nto mention pressure, though protein, glucose were normal and with no cells." After examining the vaccinee, the physician wrote, "In summary, he is suffering from transient visual blurring. From his symptoms some of this may be accommodative, as he notes he did not have to wear his glasses other than for reading, but now he wears his glasses more. Conversely, nothing abnormal is really demonstrated." In a letter dated 4/18/01, the neuro-ophthalmologist wrote, "He has episodes of not seeing well. The exact nature of this problem is unclear. It is clearly very bothersome and limits his ability to work and function." On 1/31/01, the vaccinee reported that "He has noted improvement in gait since initiation of IVIG therapy. He occassionally notes numbnes sin the face." The neurologist wrote, "The findings were consistent with a post-vaccination CIDP." The vaccinee was to proceed with the second month of IVIG therapy. On 3/2/01, the neurologist referred the vaccinee was to proceed with the second month of IVIG therapy. On 3/2/01, the neurolgoist referred the vaccinee to a cardiologist for evaluation of chest discomfort. In the referral letter, the neurologist wrote, "After two courses of IVIG therapy he noted improvement in strength, sensation, and gait. However, he has noted chest discomfort. Neurological examination showed stocking vibratory sensory loss, tandem ataxis, Romberg sing, and hypoactive reflexes. These findings are specific for CIDP without systemic involvement. There was no explanation for the chest discomfort but a primary cardiac cause should be ruled out with further testing." On 3/12/01, the neurologist noted that the vaccinee had developed a papular rash on his chest and limbs. The rash was attributed to IVIG. The neurologist recommended a tapering course of prednisone and 50% reduction of the IVIG dosage. On 3/22/01, continued chest discomfort, but improvement of rash, was noted. On 3/7/01, serology for hep B revealed a positive hep b surface antibody titer that the lab considered to be "consistent with immunity." Total hep A antibody titer was also positive; hep A IgM was negative. On 4/17/01, the vaccinee reported that the IVIG "treatments kill my strength to the point that I can just barely walk for a few minutes. My joints are hurting me more and more." The vaccinee indicated that he was receiving disability benefits, and planned to do so until "the middle of May/June" when the IVIG therapy was still evidence of mild polyneuropathy." The vaccinee was seen by the vaccine provider on 5/29/01. He reported that he had three minor car accidents while making left turns. He also reported that he "falls to right." On 6/23/01, the vaccinee reported that he was experiencing increased falling. The vaccinee was seen by a physician specializing in physical medicine and rehabilitation on 7/19/01. The vaccinee reported present difficulties as impaired reading comprehension and memory; constant joint pain in the legs, arms and back; stiffness; easy bleeding and bruising from IVIG; leg weakness; cramps in the fingers; poor eundurance; shaking of his legs at night; numbness in the legs and hands; dysesthesias in the arms, legs and feet; decreased balance; fatigue; impaired ifne motor skills and writing; and "word-finding difficulty." The following were noted on physical examination: generalized mild weakness; hypoactive deep tendon reflexes in both triceps, biceps, knees and ankles; decreased sensation to pinprick "in a scatteredfashion, worse in the hands. Insensate feet in plantar aspect." Observation of gait and stance revealed "wide base of support, decreased heel/toe giat, impaired balance on all high-level tasks. Midly decreased sit to stand balance." The physician's impression was "CIDP post Lyem vaccine with residual neurological sequelae of weakness, sensory changes, balance difficulties, cognitive-linguistic deficits." The vaccine provider compoleted a disability determination questionnaire on 8/1/01. Under current symptoms, the physician wrote, "weakness all extremities, paresthesia all extremities, finger stiffness, locking, arthralgia, cognitive problems with memory, word finding, spatial difficulties, pain in legs, arms." The physician indicated that the vaccinee was limited to lifting and carrying five pounds and could stand or walk for less than two hours per day. The vaccinee was seen by the neurologist on 9/5/01. "He has noted steady improvement in neuropathic symptoms on the regimen of IVIG therapy for post-Lyme-vaccine CIDP. Neurological examination showed mild distal vibratory and cold temperature sensory loss, Rombery sign, and hypoactive tendon reflexes, without disturbance of cognition, cranial nerves, or limb strength. The findings were consistent with improving post-vaccinal CIDP." On 11/1/01, a variety of serology and immunoblots for Lyme disease were negative. The lab's interpretation was "No evidence of seroreactivity beyond that expected from the Lyme vaccine." On 11/30/01, the neurologist wrote, "He continues to note mild gait and balance difficulty and neuropathic discomfort in the feet despite IVIG therapy. He no longer notes chest discomfort." On examination, tandem ataxia and absence of tendon reflexes were observed. On 2/11/02, in a Statement of Damages, the vaccinee's attorney alleged that the vaccinee "suffered a diagnosed chronic inflammatory demyelinating polyneuropathy, sensorimotor and peripheral, with neurological sequelae of pain, weakness, sensory changes, balance difficulties and cognitive-linguistic deficits." The vaccinee underwent MRI of the brain, with and without contrast, on 2/15/02. He also underwent EMG/NCS on 2/26/02. The MRI and electrodiagnostic studies revealed abnormalities. The vaccinee returned to his neurologist on 3/5/02. The vaccinee "has noted memory disturbance. Brain MRI showed multiple white matter lesions including one enhancing left frontal white matter lesion but was technically difficult. Neurological examination showed no new findings. The findings were consistent with post-vaccinal CIDP and MS." The neurologist referred the vaccinee to a neurologist specializing in peripheral neuropathy, for a second opinion. The vaccinee was evaluated by this third neurologist on 3/7/02. At that time, the vaccinee reported that he received his first and second injections of LYMErix "in February and June of 1998." The vaccinee reported that "immediately following his third vaccination he developed fevers, sweating, hot and chold chills, skin rrash, aching pains and weakness in his arms and legs, and clawing of his hands. He remained in bed for several days. He then continued with weakness and pain, and in addition became forgetful and had difficulty concentrating, forcing him to stop working. He is mostly bothered by numbness and squeezing pains in the arms andlegs, diffuse muscle twitching, hypersensitivity, and gait instability. He also has frequent headaches, episodes of blurred vision, difficulty concentrating, poor memory, and chronic fatigue. His hands sometimes turn dark blue or white, suggestive of vascular instability. Recent MRI of the head revealed multiple white matter lesions consistent with central demyelination." On physical examination, the physician noted "mottling discoloration of his hands. There was no muscle atrophy noted. On motor examination, he had mild weakness of the shoulder abductors, and elbow extensors and flexors bilaterally, and of the finger flexors and extensors in the right hand. In the lower extremities there was mild weakness of the hip flexors and ankle dorsiflexors. He had difficulty rising on his heels or toes, or getting up from a chair without using his arms, and could not hop on either foot. On sensory examiantion, vibration was severely imparied at hte large feet, with bilateral plantar flexor responses. Foot tapping was clumsy. He could not tandem walk and Romberg was positive. Gait was moderately ataxic." Lab analyses perfomred on 3/6/02 were within the reference ranges, with the exception of erythrocyte sed rate. The neurologist wrote, "He has evidence for peripheral neuroopathy and encephalopathy, with central and peripheral demyelination. His condition was probably induced by the LYMErix vaccine, given the temporal association." The vaccinee returned to this neurologist on 4/12/02. The neurologist wrote, "MRIs of the brain were reviewed. They showed multiple white matter lesions including one with enhancement." The most recent info, received on 6/30/03, did not provide the outcomes of the