Age: 61.0
Sex: M
Vaccine: LYME
Symptoms: Asthenia, Gastrooesophageal reflux disease, Hypertension, Hypoaesthesia, Laboratory test abnormal
Clinical narrative: Report A0359618A describes mononeuritis multiplex in a 61 year old male who received Lyme disease vaccine recombinant (LYMErix). This report was received as part of litigation proceedings, with forwarding of medical records. The subject's medical history included allergies to pcn, cephalexin, atenolol, and nifedipine. The medical history also included skull fracture with loss of consciousness (1951), closed head injury without loss of consciousness (1960), tick bites, sleep apnea, "long-standing mild episodic pedal edema," hypertension, palpitations, hypercholesterolemia, elevated uric acid concentration (1995), gastroesophageal reflux disease, hearing loss, deviated nasal septum, perennial rhinitis, "mild" benign prostatic hypertrophy, right leg fracture (1941), polyarticular arthritis of the hands, degenerative left rotator cuff syndrome, bursitis of the left shoulder, chronic anterior cruciate ligament deficient knee, osteoarthrosis of medial and lateral femoral compartment of the right knee (1988), chronic low back pain, seborrheic keratosis, multiple nevi, hemangiomas, lichen planus-like keratosis, verruca vulgaris, and an infefcted infundibular follicular cyst. Surgical history included right knee meniscal surgery, tonsillectomy, and excision of approximately 55 skin lesions. Concurrent medications included Zestoretic, Cardura, Prilosec, Famvir, prednisone, vitamin E and aspirin. In April 1999, the subject received his first injeciton of LYMErix. He received his second injection of LYMErix on an unspecified date.  The subject declined the third injection. On 2/11/02, in a statement of injuries, the subject's attorney alleged that the subject "suffers back pain, in particular under his right scapula. He also experiences numbness and weakness in both arms as well as in his right hand. In addition, he experiences cramps in his right hand. He also experiences light flashes, primarily in the right eye." The following info was obtained from medical records. On 6/28/99, the subject presented to his primary physician with a complaint of back pain. The physician noted, "The pt does not recall any specific trauma but about a week ago he began to develop pain across the upper and mid-thoracic back area. He did have to carry a computer back and forth to the computer store numerous times but that wasn't particularly heavy. He's not had pain like this before." The subject reported that he had referred himself to a physical therapist, and had one treatment session. On physical examination, "the pt moves his arms without any difficulty. No particular pain with palpation over the spinour processes and the pt can move his arms and upper torso without difficulty. There is no rash in the area of pain." The physician's assessment was "Mid-thoracic back pain due to muscle spasms." He prescribed Robaxin and physical therapy. The subject remained under the care of this physician until at least 11/15/01. During that time, he experienced "cardboard" feeling of the soles of his feet, upper thoracic and cervical backache, "dead" feeling of the palms, left arm discomfort, paresthesias of the legs, "severe" right scapular pain that was "bad enough that he's even contemplated suicide," flashes of light in his peripheral visual field, and arm numbness. The subject reported that's neurologist had made a diagnosis of "mixed type polyneuropathy. The question is whether or not this is an autoimmune repsonse to the Lyme disease vaccine." He reported that he had received two injections of LYMErix and refused the third injection. On 5/14/01, he stated that "he now feels that many of these new symptoms he's developed are the result of the vaccine." During this time period, the physician noted normal neurological examinations. Lab analyses were within the reference ranges. On 8/15/00, the physician noted "At one point, plasmapheresis was being considered for this pt's polyneuropathy. I would be concerned about taking such drastic action in a pt who is in fact stable and improving spontaneously." The physician made diagnoses of "mild" peripheral neuropathy 9/9/99 and neuropathy 3/15/00. At the subject's request, the physician referred him to a neurologist at a tertiary care center. On 12/13/99, the subject was evaluated by an orthopedist for "complaints of neck and right shoulder pain which had started approximately 20 weeks prior to his visit here. He denies trauma. Onset of symptoms began in the spring and summer, 1999. States upper back exercises helped. He has a history of long term use of sharp, shooting and disabling occurring daily. Symptoms are worse in the morning, evening and at night in bed. Aggravating factors are sleeping and looking down/up. Alleviating factors, none noted. Since the onset of the condition states symptoms are rapidly worsening." The othopedist noted that the subject was self-employed. He statd that he "must stop and limit activities due to symptoms. Has had to modify social and recreational activities to control pain. Exercise-walks three to six days a week." On a visula analog pain scale, the subject recorded that "100% of the pain is located in the neck and right shoulder. At its worst pain is rated a 48, at its best a #3. Pain drawing: Reveals aching pain in the nape of the neck and right shoulder. Also spasms and cramps are noted in the right shoulder." Limited x-rays of the cervical spine were performed. The orthopedist's diagnoses were "degenerative joint disease of the cervical spine (847.0) and cervical spine strain." The physician prescribed Toradol, cervical soft collar, and physical therapy. On 12/14/99, the subject reported that ketorolac was "not helping enough with the pain." The physician prescribed Tylenol #3. On 12/15/99, the subject reported right arm weakness and numbness and decreased strength in the right thumb and third digit. He also complained of achiness in the right elbow and numbness in the right palm. He stated the onset was "last night." He requested MRI of the cervical spine. The MRI revealed abnormalities. The orthopedist stated that the subject "is not a surgical candidate." The physician prescribed Aleve. on 12/27/99, the subject complained of "mild, chronic pain in the upper back from a pinched nerve. At its best, pain is described as mild and chronic. He has some slight numbness in the palm of the right hand and wrist." He reported that physical therapy "seems to be helping," as was cervical spine traction. The physician prescribed a home cervical spine traction unit and continued physical therapy. On 1/6/00, the orthopedist spoke with the pt on the telephone. The pt stated "overall feeling better but his major concern is loss of grip strength in the right hand. He states after his initial visit here on 12/13/99 one to two days later he noticed a decrease in his grip strength by 70%. He continues to have pain under the right shoulder blade which now radiates down the arm to the elbow and palm of the right hand. This is aggravated by resting his arm on an arm rest. States wrist has altered sensation. Pt states he was awakened during sleep with right arm numbness on 1/4/00. On 1/5/00 he was awakened with bilateral numbness in both palms. States he sleeps on his back." The physician recommended bilateral wrist splints to wear at night to prevent wrist ? "Advised he may also have bilateral carpal tunnel syndrome." The physician prescribed vitamin B-6 and referred the subject to a physiatrist for EMG and nerve conduction studies to evaluate the numbness. On 2/4/00, the subject presented to the physiatrist for EMG and nerve conduction studies. The subject reported that "in approximately June of 1999 he had a sudden onset of right scapular region pain. The pain resolved over a month or so and had no residual deficit. He was not clearly weak or there were no numbness or paresthesias at that time. He denies any history of trauma or change in medical condition that he can associate with the onset of symptoms. The pt had no further symptoms until the first or second week of December 1999 when he again had sudden onset of sharp pain in the right scapular region. After a few days he noted numbness and tingling in the ulnar aspect of the right forearm and hand and then weakness of right hand grip. Again the pain resolved over a month or so and now he still has a weakness of right hand grip and numbness and tingling in the ulnar aspect of his hand and forearm. The pt had evaluation including cervical MRI scan, which revealed multilevel disc dessication from C3 through C7 with developmentally short pedicles at those levels. Multifactoral central stenosis is moderate at L3-4 and mild to moderate at C4-5, C5-6, and C6-7. There is no specific surgical lesion that seems to correspond to his symptoms. The pt notes that a year or so ago he had paresthesias in his hands and was told he had peripheral neuropathy, but there was no specific etiology for that pathology. He states that he had some treatments with what sound like antiseizure medicines or antidepressant medicines without significantly changing symptoms that were not particularly painful, just tingling." On physical examination, "His cervical spine has decreased motion in all planes, but negative Spurling's test for any radicular symptoms. Reflexes are 1/4 at bilateral biceps, tricepts, and brachioradialis. Pinprick sensation is intact throughout right upper extremity, except for diminished on the ulnar aspect of the forearm and hand, both dorsal and palmar surface including to the level of the third digit. The left upper extremity is intact. Strength is 5/5 throughout the left upper extremity, except for 4/5 left shoulder abduction. The right upper extremity has 4/5 right shoulder abduction and external rotation, but 5/5 internal rotation, elbow flexion/extension, forearm pronation/supination, wrist extension, and radial flexion. He had 4/5 right wrist ulnar flexion and five finger flexors. However, he only has 3/5 finger abductors, thumb to fifth digit opposition, thumb abduction, lumbricals, and extensor indicis propius." EMG and nerve conduction studies were abnormal. The physician's impressions were "Symptoms are consistent with brachial plexitis, unclear etiology. Mild symmetric sensory and motor peripheral neuropathy. He has symptoms in his feet that are also consistent with brachial plexitis in June 1999 that resolved. Though he is weak in his suprascapular nerve distribution, there is no EMG findings in the infraspinatus. But there were findings in the latissimus dorsi that brought up the possibility that he could have had involvement of the thoracodorsal nerve back in June 1999 with subsequent reinnervation findings. With two different episodes of potential brachial neruitis brings the possibility of a chronic process such as neuritis multiplex or early CIDP picture. Lyme disease would be less likely and cancer would be possibility with secondary effects." The subject remained under the care of this physiatrist until at least 8/2/00. During this time, the subject reported intermittent spasms in  his calves, which the physician considered to be "consistent with nocturnal claudication." He also reported recurrence of visual flashes. On 8/2/00, "in trying to reconstruct the etiology of his symptoms," he told this physician that the first occurrence of flashes were after the first injection of LYMErix, and the pain and weakness occurred after the second injection. The physician made additional diagnoses of "general symmetric polyneuropathy consistent iwth demyelinating pathology with paresthesias in hands and feet," "I am concerned whether he ahs CIDP," and "widespread sensory and motor polyneuropoathy most consistent with a mononeuritis type pattern and CIDP is a possibility or an autoimmune process related to the Lyme vaccine is certainly a possibility." The physiatrist referred the subject to a neurologist. As of 8/2/00, "The pt has not had any further flare of symptoms. He feels his strength is slowly improving. It is not normal. He still has occasional areas of paresthesias, more in the radial aspect of his hand on the right side." On 4/20/00, the vaccinee was evaluated the neurologist for "pain in right sided upper back under scapula. Loss of strength and sensation in right forearm, hand and fingers." The subject reported that "back in May of 1999, he started experiencing visual symptoms described as "showers of light sparks." These typically would occur at night and might last for weeks at a time. At that time he was worried about a detached retina and went to see an ophthalmologist who did  not find any ocular pathology. Since then he has had occasional recurrences of these symptoms of "showers of light sparks." These showers were not associated with any significant headaches. Back in June 1999, he started experiencing very significant mild upper back pain. He was treated conservatively with physical therapy and analgesic medications. By 9/9/99, he was experiencing numbness in both feet. At that time, he was checked for diabetes and vitamin B12 deficiency. He had a recurrence of pain under his right shoulder blade in 12/99. The subject started experiencing numbness in the palms of both hands back in 1/2000. He also started to re-experience the "light flashes" back in the later part of February." The neurologist noted no abnormalities on physical examination. He reviewed previous lab analyses, including the February 2000 EMG and nerve conduction studies. His impressions were "I rather doubt the possibility of chronic inflammatory demyelinating polyradicular neuropathy or, indeed, significant polyneuropathy of any type. The subject has wonderfully intact ankle reflexes bilaterally and does not have any loss of vibration or vibratory sensation or proprioception. He does not have any trouble with a tandem walk. Possible mild brachial plexopathy. Question of possible Lyme disease versus reaction to the Lyme disease vaccine. Hypertention. Gastroesophageal reflex disease." MRI of the brain with and without contrast, performed 5/1/00, revealed minimal changes. EMG and nerve conduction studies, performed on 5/22/00, were consistent with "mononeuropathy multiplex of undetermined origin." Other diagnostic studies did not reveal abnormalities. The neurologist referred the subject to an infectious disease specialist. The subject returned to the neurologist on 8/21/00. At that time, "The subject has not had any significant progression in his symptom." The neurologist's assessments were "Monomeuropathy multiplex of undetermined origin. Hypertension. Gastroesophageal reflux disease. History of reaction to Lyme disease vaccine." On 9/28/00, the subject told his dentist that he had "developed autoimmune disease from Lyme disease vaccine." Following the reported onset of mononeuritis multiplex, the subject experienced atypical nevi, solar elastosis, odynophagia, "mild" glossitis, and "mild" strain/tendonitis of the left elbow. These events were not reported as adverse events due to vaccine 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 6/6/02, did not provide the outcomes of the reported events.