Age: 61.0
Sex: M
Vaccine: LYME
Symptoms: Neuropathy peripheral
Clinical narrative: Report A0360487A describes fibromyalgia in a 61 year old male vaccinee who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of litigation proceedings, with forwarding of medical records. Medical history included hearing loss, increased cholesterol, right knee pain, and "equilibrium problems." In November 1998, the vaccinee sustained a severe head injury along with injuries to his shoulder, elbow and knees. Since his head injury he has been on disability. On 12/3/98, the vaccinee was seen by his primary care physician secondary to receiving two deer tick bites without a rash. It was noted that he had a "cold" and was "bring up dark green mucous" for the past week. The physician "questioned Lyme tick bite" and prescribed the vaccinee Biaxin. Surgical history included cervical-lumbar disc surgery, cervical fusion, and right foot surgery. Concurrent conditions included left axilla infection. Concomitant medications included Keflex and Relenza. Concomitant vaccinations included influenza virus vaccine (Fluvirin) and flu vaccine (brand name unk). The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a Statement of Injuries, his attorney alleged that the vaccinee "suffers from joint pain, fatigue, and difficult sleeping due to his joint pain. He also suffers from osteoarthritis in his left shoulder. He also suffers from fibromyalgia syndrome." Time to onset following immunization, tretment, and outcomes of the alleged events were not reported.  After the reported onset of fibromyalgia, the vaccinee was diagnosed with chronic obstructive pulmonary disease (COPD). He also experienced dyspnea on exertion, paroxysml nocturnal dyspnea, plantar fascitis, xerosis utis bilateral, upper respiratory infections, vestibulitis, hypertension, chest pain, sinus bradycardia, minor discoid atelectastic changes at the lung bases, phenol matricectomy, enlarged left atrium, trace tricuspid regurgitation, nocturia, onychocryptosis, and bilateral knee arthroscopic surgery secondary to an injury he received in November 1998. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. The following info was obtained from medical records. On 2/11/99, the vaccinee presented to his primary care physician for re-evaluation of his blood pressure. The physician noted that the vaccinee was "recently injured in a comp case (Nov)-involving his head, shoulders, elbow et al." The vaccinee had recently had a "CT/MRI which revealed two lacunar infarcts." The physician noted the vaccinee had recently received LYMErix on 2/7/99 at another location. On 3/15/99, the vaccinee was seen by his primary care physician for a growth under his left axilla and an ingrown toenail on his right great toe. At this time he received his second injection of LYMErix. He was diagnosed with an infected left axilla and was prescribed Keflex 250mg four times daily. He also had increased blood pressure at this visit. On 3/2/00, his primary care physician saw the vaccinee. He received his third injection of LYMErix. On 6/13/00, the vaccinee returned to his primary care physician with questions about his cholesterol, hypertension, and right foot pain. He was given a referral for bilateral feet x-rays. On6/15/00, the vaccinee had bilateral feet x-rays for pain, particularly on the right which revealed the following. "There is significant narrowing of the first MP joint of the right foot. This represents a nonspecific arthropathy, most likely related to osteoarthritis. The possibility of gout cannot be excluded though the radiographic appearance is not classic for gout. No other joint space abnormality is seen. No fracture or dislocation is evident." On 6/29/00, the vaccinee returned to his primary care physician for follow up for blood pressure. His current medications were atenolol 25mg daily, Neurontin 100mg four times daily for vestibulitis, Midrin as needed, and Celdbrex 200mg daily. The pt was diagnosed with MP DJD. On 2/16/01, the vaccinee was seen by his primary care physician. The physician noted that the "pt has noticed increased joint aches (diffusely) over the last several weeks." His review of systems included fatigue and arthralgia. The physician diagnosed him with arthralgia. On 3/29/01, the vaccinee had a bone scan of his total body for "pain in multiple joints" and the summary indicated "No abnormality seen." On 8/7/01, the vaccinee presented to his primary care physician stating he "feels rotten." The physician noted that the vaccinee was diagnosed with fibromyalgia by another physician and that he "had lots of questions." The physician's review of systems included arthralgia and myalgia. On 9/20/01, the vaccinee presented to his primary care physician with questions regarding "Lyme vs fibromyalgia." The physician's review of systems included arthralgia and myalgia. His current emdications included Atacand 16,g daily, trazodone 50mg at bedtime, Viagra 50mg in the PM, Celebrex 200mg and Neurontin 100mg four times daily. On 11/5/01, the vaccinee had elecrodiagnostic consultation of the lower extremities. It was noted that the vaccinee had previously sustained a severe head injury three years ago and had been on disability since the head injury. The physician whom preformed the testing wrote, "The vaccinee presented to today's examination with complaints of pain and numbness in the right foot. Symptoms are noted predominantly into the right great toe. Symptoms have been noted now for approximately two years. He described a burning type pain with the pain being most pronounced when he is active. Symptoms are improved with rest. Symptoms are fairly well localized to the distal foot area. The vaccinee described only mild, occasional lumbar area pain which has not changed in character or severity. He also denied anymore diffuse sensory symptoms." Physical examination revealed "no tenderness over either hip. Straight leg raise test and Patrick's sign were both negative. On motor testing there was a slight relative weakness in the toe extensor muscles on the right versus the left. The vaccinee did, however, complain of pain in that area during motor testing suggesting a possible pain inhibition component. He also reported a very slight relative decrease in sensation over the medial aspect of the right foot compared to the left. He denied any other areas of focal sensory deficit in the right lower extremity including the lateral aspect of the right foot or in the thigh or calf areas. Deep tendon reflexes were +1 to +2 at the knee while the ankle jerks were rare to trace bilaterally. Electrodiagnostic impression: The only findings of note in today's study was very mild, chronic neuropathic motor unit changes noted predominantly in an L5 and S1 distribution. This was observed bilaterally as well as the lumbosacral paraspinal muscles. The findings suggest a mild, bilateral chronic L5-S1 radiculopathy. There were no superimposed acute findings indicative of an acute nerve root irritation or injury. Motor conduction studies in the right and left paroneal and tibial nervies fell within the normal range. There was no significant right to left difference. Sensory conductions for the sural nerve were also normal bilaterally. There was no evidence seen for a distal isolated nerve entrapment syndrome nor was any evidence seen for a more generalized peripheral neuropathy. The "H" reflex response for the tibial nerve was absent bilaterally which can be seen as a result of some chronic nerve root encroachment noted at the S1 level. In conclusion, this was an essentially unremarkable study with the findings being consistent with a mild, bilateral chronic L5-S1 radiculopathy. The findings are most likely seen as a result of the vaccinee's previous lumbar surgery with some secondary, mild, chronic nerve root enroachment at those levels. The findings did not, however, reveal any evidence of a superimposed acute lumbar nerve root irritation or nerve root injury. Given the lack of acute findings in today's study the mild chronic findings observed in today's study are not felt to be responsible for the pain and burning symptoms noted by the vaccinee into the right foot." On 11/12/01, the vaccinee's rheumatologist wrote a consult letter to the vaccinee's primary care physician. He had evaluated the pt on 11/8/01. The rheumatologist wrote, "this pt reports having had a series of LYMErix injections about two years ago followed by muscle aching after the third injection and joint pain. He took Celebrex for one year with a poor response and has continued to have problems with his hands, feet, knees, shoulders, since that time. He also has been troubled with poor energy, sleeplessness and weakness. The system review is positive for fatigue and weakness. Three years ago he suffered a concussion which he says left him with "brain damage." The pt reports difficulty with descending stairs, reaching, going to sleep and staying asleep. He is currently taking Atacand for hypertension and Neurontin. Since his accident, he has been on partial disability and has had equilibrium problems. He reports stiffness in the morning that lasts sometimes up to one hour. He recently has been worked up for arm pain and had an EMG, the report of which is pending. This involved his left arm. He has had no rash, alopecia, mouth ulcers, Raynaud's or digital ulcers. He does have discomfort on range of motion of both shoulders, the left more than the right. There is no synovitis present in the small joints of the hands or wrists. Lower extremity examination reveals tenderness on range of motion of both knees. There is no evidence of any significant synovitis in the legs. There is no edema. Pulses are normal. The extremities are neurovascularly intact. Lab studies show a C-reactive protein at 1.1. Thyroid studies, hepatitis panel, CBC, sed rate, rheumatoid factor and ANA are all normal. Comprehensive metabolic panel was normal. Lyme titer showed a normal western blot but a screen that was slightly positive at 1.77. This may reflect the fact that he had the injections of Lyme vaccine. This pt presents with diffuse aching. He seems to have more of a polyarthralgia than arthritis. He has symptoms that suggest fibromyalgia syndrome." He was prescribed Vioxx 12.5mg. On 11/17/01, the vaccinee had a bone scan of his total body for "myalgia, myositis, and joint pain diffusely." The impression was "Evidence of mild degenerative change at the knees new since March 29th. Evidence or degenerative change in the hands and right foot." On 12/14/01, the vaccinee's rheumatologist wrote a consult letter to the vaccinee's primary care physician. His last evaluation of the vaccinee was 12/13/01. He wrote, "The 12.5mg Vioxx helped a little bit but he is still having a lot of diffuse and widespread aching and some joint discomfort in the knees and feet. A bone scan did show some new areas in his knees which did not show up in March. I think he has degenerative arthritis in these areas and what looks like a fibromyalgia type picture. This seems to have begun after he received the Lyme vaccine." The rheumatologist increased the vaccinee's Vioxx to 25mg daily and his Neurotin to 400mg at bedtime. On 5/17/02, the vaccinee's rheumatologist wrote a consult letter to the vaccinee's primary care physicia. He last evaluated the vaccinee on 5/14/02. The rheumatologist wrote, "He does not report very much in the way of improvement with the Vioxx. Therefore I am taking him off of it, he has a very disturbed sleep pattern and diffuse, widespread aching. There are no areas of synovitis, pain or swelling. He has normal inflammatory parameters. His symptoms are really more in keeping with fibromyalgia then an inflammatory process. Whether or not this occurred as a reaction to the Lyme vaccine is difficult to say. He is tender in few different areas but I could not palpate any synovitis warmth or limitation of motion. His labs were also normal." The rheumatologist prescribed Bextra 20mg and discontinued Vioxx. On 6/28/02, the vaccinee's rheumatologist wrote a letter to the vaccinee's primary care physician. He had last evaluated him on 6/25/02. The rheumatologist wrote, "He really did not have much of a response to the Bextra. He has had continued episodes of general aching, what he described as shooting pains in arms and legs, general stiffness and poor sleep pattern with day time fatigue. He also has been developing irritable bowel type symptoms and going to have a colonoscopy." The rheumatologist increased his Neurontin to 600mg at bedtime and restated him on Celebrax 200mg daily and 200mg as needed. The most recent info was received on 8/25/02. AS of 5/17/02, the fibromyalgia was ongoing. The adverse event "osteoarthritis" does not meet serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.