This 37 year old male patient was reported to have arthritis, aching joints, aching muscles, headache, hip pain, neck pain, and pain in the back of his arm. Report 2001003260-1 describes arthritis in a male of unspecified age who participated in a Lyme vaccine clinical trial (protocol and center number not specified) and reported his symptoms unsolicitedly after the conclusion of the trial. This report was received from a lawyer and has not been verified by a physician or other health care professional. On specified dates, the vaccinee received his first , second, and third doses of Lyme vaccine respectively. The vaccine recalled that after the second and third doses, and "possibly after the first dose" he experienced immediate symptoms and pain which included headache, neck pain, hip pain, back of the left arm pain, aching muscles and joints, which reportedly he reported to the study investigator. At the time, those symptoms were some what intermittent. However, he reported that his symptoms increased in frequency and intensity as time went on. Reportedly, he was becoming disabled, and he reported that he had been diagnosed with arthritis "throughout" his body. This case is considered serious since the vaccinee was "becoming" disabled. As of 02/01/01, the outcome of the events is unknown.  F/U subsequently determined to be subject vaccine 215274, protocol LY008, Pt identification # 008,021,03205. On the study report form, the principal investigator indicated that these events were ossibly related to study vaccine administration. The additional info regarding some of the adverse events reported by the vaccinee was obtained from clinical trial records. The pt's medical history included asthma, which was treated with salbutamol. On 01/17/2001, the vaccinee's pulmonologist wrote a referral letter to an infectious disease specialist. In the lette,r the pulmonologist stated, "What is interesting about the vaccinee is that somewhere around 1995 he did participate in a Lyme vaccine study and he presents with a folder of information regarding Lyme arthritis in pts who have received the Lyme disease vaccine." The pulmonologist noted that the vaccinee underwent bone density scan by dual energy x-ray on 09/24/2000 which did rule-out osteoarthritis. The vaccinee returned to the neurologist on 03/15/2001. laboratory analyses performed on 02/15/2001 revealed erythrocyte sedimentation rate 4mm/hr, C-reactive protein 1.5 mg/L, creatine kinase 219 U/L, and negative rheumatoid factor. The neurologist's impression was lower back pain. The most recent info received on 01/24/2002 indicated that the chronic Lyme disease persisted as of 12/22/2001. At that time, the vaccinee was still able to work, however, because the vaccinee reported that he was becoming disabled, the activation of chronic Lyme disease and fibromyalgia are considered disabling. The follow-up received on 02/25/2002 states that the vaccinee was seen at a care center on 01/10/2001. The physician wrote, "He states that he was doing well until 1998 when he began developing hip, lower back pain, joint aches all over with some stiffness. He has had a workup that included a bone density scan which showed no evidence of osteoporosis. He has been taking Tylenol and intermittent Mobic for the pain which have not helped. He's still been able to work. He denies any fevers, dry eyes, dry mouth, any nodules on his skin, any rashes such as psoriasis or hair loss. He denies any pleurisy, abdominal pain or diarrhea. He has over the past six months developed worsened pain in his hips and  his fingers. Sometimes it's hard to make a fist in the morning. He has quite a bit of stiffness in the morning. His back pain is particularly problematic, when he goes to bed after several hous he wakes up because his back hurts so much. He reports feeling stiff all day. He doesn't notice any particular swelling in the joints although he has trouble moving his right PIPs and MCPs. It's difficult for him to do his work because of the hand involvement and the back involvement since he has to lift and carry heavy objects. He's wondering that type of arthritis he might have, whether htis could be related to his vaccination." On physical examination,"Examination of the joints show some decreased range of motion in the PIPs and MCPs on both hands more so on the right compared to the left. Elbows still have ful range of motion without tenderness. Bilateral shoulders have some mild reduced range of motion. Impression: I cannot determine whether vaccination with the Lyme disease vaccine may have caused his symptoms." The physician ordered back x-rays to rule out sacroilitis and prescribed Vioxx daily. The most recent info received on 02/25/2002, did not provide the outcomes of the reported events. Info received on 01/24/2002 indicated that the chronic Lyme disease persisted as of 12/22/2001. At that time, the vaccinee was still able to work. However, because the vaccinee reported that he was "becoming disabled," the activation of chronic lyme disease and fibromyalgia are considered disabling. Following the reported onset of chronic Lyme disease, the vaccinee experienced abdominal pain, nausea, vomiting, chills, fever, increased serum amylase concentration, incresed serum lipase concentration, chronic gastritis, possible duodenal ulcer, pharyngitis, bronchitis, exacerbation of asthma, and thrush. 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 physician referred the vaccinee to a locl rheumatologist for continued care. The vaccinee saw the local rheumatologist on 01/17/2001 "for evaluation of a rather acute pain in his left hip, morning stiffness, awakening with pain in his low back, and hand pain. He feels he has had some recent blurry vision. No iritis. Recently he has had some weakness in his legs and has had to drag his left leg. He has noticed a decrease in his grip strengt and has had some difficulty lifting sacks at work. He describes occasional "lightening bolts" of pain in his arms and legs on and off for the last year." On examination, "He had a limp. The examintion of his skin was significant only for an area of folliculitis behind his left ear. No sicca. His grip strength was reduced in his left hand more than the right. He ha dpain with more than 60% motion of his shoulders, was unable to squat to rise from the floor. The shober index is normal. He doesn't give a sleep history consistent with fibromyalgia, although the picture he drew of his skeleton was certainly consistent with that." The rheumatologist prescribed ibuprofen 600 mg three times daily. The restrcted duty form listed the "employee's medical problem" as pain, progressive arthralgia. Restrictions included walking to and from the bathroom only; sitting in a straight back chair; no lifting, pushing, or pulling, no cold, damp areas; no reaching or working above the shoulder; and no driving. The pulmonologist indicates that the vaccinee needed to use a cane. He also indicated that the vaccinee could work more than eight hours per day. However, as of 01/30/2001, the vaccinee was "now out of work because his employment was unable to find light duty for him." On 02/15, C-reactive protein concentration and erythrocyte sedimentation rate were within the reference ranges. Rheumatoid factor was negative. Creatine phosphokinase concentration was elevated. The vaccineew was seen by the local rheumatologist on 02/22/2001. At that time, he was "still not working. The neurologist treated him with mobic which caused tremendous heartburn. Started Celebrex 400 mg yesterday. NOne of the NSAIDs have helped at all, but he has never been able to take them longer than a few days to a week. His bone scan did not light up anything in the spine, hips or legs. I think the activity in his shoulders and chest is compatible with his job and age. He sleeps poorly and snores. Unclear whether he has sleep apnea. Today I don't see any inflammation in his hands or wrists. He is not tender over the right trochanter where there is a cyst and some "bone marrow edema." This is looking more and moe like fibromyalgia. I put him on amitriptyline 10 mg before bed each night. HIs CPK is essentially normal now." The vaccinee obtained a second orthopedic opinion on 04/03/2001 "for evaluation of multiple joint complaints of long-standing duration particularly involving the low back and both hips. He indicates that he has been having aching pain in his hips, back, knees, and upper extremities for several years. On clinical examination today, he gets onto and off the examining table slowly. He stands with his pelvis level and has a negative trendelenburg. He has full range of motion of both knees with no effusion. He has full range of motion of both ankles with no swelling. He is able to abduct and forward flex both shoulders to 135 degrees but there is no evidence of apprehension to abduction external rotation. He has full range of motion of both elbows and wrists. Grasp is full into both hands. There is no small joint swelling into his fingers. He has full lateral neck flexibility. He can forward flex his dorsolumbar spine to approx. 60 degrees with tenderness in the paralumbar region. There is no active paralumbar muscle spasming. Straight leg raising is to 90 degrees bilateraly in the seated position and to 40 bilaterally in the supine position. HIs hips are non-irritable with nonspecific inflammatory arthritis." The orthopedist recommended nonsteroidal anti-inflammatory medication and activity "as comfort dictates." The vaccinee returned to the local rheumatologist on 04/17/2001. He feels no better after two months of 10 mg amitriptyline. No side effects. Complains of total body stiffness, pain in his hip, right elbow, pain in his hands. Continues using a cane. Has returned to light duty work. Looks very depressed. Moving slow, using cane but his gait implies it is not necessary. Head hung low. Tender right lateral epicondyle. No other trigger points or tender spots. Exam of hands, wrists, elbows entriely normal. He has no limited motion of eiher hip or knee. Negative straight leg raising to 90 degrees. Since he feels Celebrex is not helping and he is now complaining of some "dyslexia," I stopped the Celebrex. Increase amitriptyline to 25 mg two hours before bed nightly. I refused to give him anote for light dutu work. At his reuest, I wrote a note for work stating that he has fibromyalgia, and the outcome depends on his sleep study and amitriphyline. If his sleep study doesn't show anything that can be improved with C-pap or other means to improve his sleeping, I think a consult with a psychiatrist would be helpful for his depression." A sleep study performed on 04/09/2001 revealed "no obstructive apneas. There were 13 obstructive hypopneas." The pulmonologist wrote," There does not appear to be any significant evidence for obstructive sleep apnea syndrome; nor a hyper-resistance airway syndrome. There are numerous spontaneous arousals that may be related to the pt's complaints of muscular pain and skeletal pain. There does not appear to be any significant evidence for a nocturnal myoclenus or restless leg syndrome." The vaccinee was seen by a third rheumatologist on 07/17/2001. At the time of evaluation,t he vaccinee was receiving clarithromycin and hydroxychloroquine therapy. "The vaccinee reports that since beginning on this treatment, he has had an increase in joint pain which has become more severe, but he claims that from what he reviewed on the internet and in the medical literature that his is typical of people being treated for Lyme disease. He reports that his social activity has declined dramatically." The rheumatologist noted that the vaccinee's father had arthritis and gout. On examination, "musculoskeletal exam fails to reveal any synvitis in his hands. He has good ROM at the wrists, elbows, and shoulders. Some stiffness with rotation at the hips and discomfort with passive ROM at the shoulders, hips and kness. However, he does not have any restricted ROM of any joints. There is no synovitis or joint effusions. He also has some tender points at the elbows, the shoulders, the paracervical and trapezios muscles, the lumbar region and hips. His multiple somatic complaints, and tender points on exam suggests the diagnosis of fibromyalgia as indicated by the local rheumatologist." The vaccinee was evaluated by an orthopedist on 09/20/2001. The examination "focuses on his lower back and leg complaints today. These are his primary complaints. He states increasing low back pain. he is three weeks into physical therapy without significant changes. In fact, he states worsening with radiation on a constant basis to the right foot with numbness and tingling is a similar distribution. He continued to complain of later hip pain as well. The pt's lower back is with marked pain with full flexion and extension. Straight leg raises test appears positive on the right, negative on the left, in a seated and supine position. Neurologic exam is intact with perhaps slight decrease pinwheel sensation to the lateral aspect of the right foot. Hip exam is with marked pain with full flexion and internal rotation as well as moderate discomfort with FABER testing. There is moderate to marked tenderness over the trochanteric bursa. Trendelenburg is with discomfort as well. There is right sciatic notch tenderndess. Mechanical low back pain with right leg radiculitis worsening. Trochanteric bursitis and trochanterio cyst." He recommended continuation of physical therapy. The vaccinee was seen by a second neurologist on 10/01/2001. "He has joint pain in the hips, knees. He has difficulty with numbness in the lateral aspect of the right lower extremity, extending from the hip down to the level of the ankle. He denies any bowel or bladder difficulty. He is unsure whether he developed any weakness in the leg." On physical examination, there was "some minor weakness of the extensor ballucis longus on the right otherwise the motor strength was graded as 5/5 throughout. Bulk and tone were normal. Sensory examination revealed an S1 deficit to pinprick in the right lower extremity with some patchy deficits over the L4-5 distribution as well on the right. Straight leg raising was markedly limited bilaterally. Gait examination revealed mild antalgia favoring the right lower extremity." The neurologist's impressions were "it appears that the vaccinee has low back pain and right lower extremity pain which may be radicular in origin. It appears he has an L5-S1 radiculitis without any evidence of active denervation in the limb or the paraspinals at this time. I suspect this is in part contributory to his symptoms, however, it also appears that there may be an arthritic component form the Lyme or other etiology. There is no evidence to suggest a peripheral neuropathy at this time." Various types of Lyme IgG western blot analysis were performed on 10/24/2001. The laboratory's overall interpretation was "one commercial WB yielded a positive result by DCD criteria. Prior studies suggest that this reflects a false positive and can be caused by vaccine alone." In an open letter dated 01/03/2002, the vaccinee's pulmonology nurse practitioner wrote, "His diagnosis is vaccine aggravated Lyme disease as per the second infectious disease specialist. He is going to continue on a therapeutic trial combining Clarithromycin 500 mg and Hydroxychloroquine 200 mg over the next few months. He will be cycled with Tetracycline His condition is not controlled. He is continuing to have joint worsening dysfunction. Currently his right shoulder reveals increased crepitus on rotation and has noticeable marked weakness and right shoulder drop. At this time partial or full recovery or remission is not expected. His activities are limited to extremely light duty with no lifting, with minimal standing, with sititng with occasional ambulation at least every hour and we expect that those restrictions will remain in place and may in fact need to be more restricted as time goes on to protect his joints." The most recent info received on 03/27/2002, indicated thatt he chronic Lyme disease persisted as of 01/03/2002. The vaccinee was seen by his primary on 07/11/01 for follow up Lyme disease. At that time, the pt stated that he was not feeling well and had complaints of diarrhea, nausea, and vomiting. Medications included Ventolin, Flovent, Biaxin, and Plaquenil. The physician's assessment was, "Drug Side Effect-Gastroenteritis." Biaxin and Plaquenil were discontinued. Trimethobenzamide hydrochloride was prescribed for relief of nausea and vomiting. Lab analysis revealed elevated concentrations of total bilirubin and lactic dehydrogenase. Lyme antibody screen was positive, but IgM and IgG Western blots were negative. Babesia IgG and IgM by immunofluorescent assay (IFA) were negative. Human granulocytic ehrlichiosis antibody screen HME IgG were negative. Plaquenil was restarted after three days. The most recent info received 05/28/02,did not specify the outcomes of the reported events. X-ray of the right hand revealed a "Probable old injury of the radial styloid." technetium bone scan performed on 01/25/01 revealed degenerative changes in sternoclavicular and acromioclavicular joints bilaterally and possible arthritis in both hands. Clinical correlation was recommended.  On the referral form completed by the vaccines, he indicated that he had experienced back, hip and knee pain for five years. He indicated that the given diagnosis for the pain was "stenosis". Some stiffness with rotation at the hips, and discomfort with passive ROM at the shoulders, hips and knees. However, he does not have any restricted ROM of any joints. He aslo has some tedner poitns at the elbows, the shoulders, the paracervical and trapezius muscles, the lumbar region and hips. The vaccinee was seen by the third rheumotologist on 25 February 2002 for follow-up of chronic arthralgias. "He continues to be quite limited in his activities of daily living. He suffers from chronic fatigue, chronic joint complaints and occasional joint swelling. At times he feels that there is is swelling in his knees as well as hands. He finds that he is quite limited in his functional activities being able to lift or carry no more than 5 pounds. He has difficulty and limitations to bending, squating or climbing stairs. He is unable to be on his feet for more than an hour at a time before he must sit and rest. He is currently seeing a physician in Boston, who has put him on Tetracycline 500 mg tid (three times a day) which he has been on for the past month. However, to my opinion all of these antibiotics have not helped to relieve his symptoms very much. He has been taking some anti-inflammatories without much benefit. He has been working light duty at the post office, mostly as a sedentary and desk position. He continues to suffer with low back pain and hip pain. Previous MRI and x-rays have shown early degerative arthritis in the hip and central stenosis at L4-5 due to a bulging disc and x-rays and degenerative changes." On physical examination, " He continues to have very limited ROM (range of motion) of the lumbar spin. His hands fail to reveal any synovitis. He has tender points at the elbows, shoulders, throughout the spin especially the lumbar region, hips and knees. He has marked stiffness with flexion and rotation at the hips which is restricted by 50%. He as reduction of 50% ROM of the lumbar spine. There is som ecrepitus with flexion of the knees." The rheumatologist's impression was "Degenerative arthritis along with probable fibromyalgia remains symtomatic. He is prescribed valdecoxib. (Bextra) 10 mg daily in hopes of relieving some of his joint pain. Follow-up will be in 4-6 months. In my medical opinion he remains functionally limited due to his chronic pain, osteoarthritis and fibromyalgia. He shoud be restricted long-term/chronically to light duty at work lifting no more than 5 pounds, avoid stooping, squatting, kneeling, crawling or climbing of stairs. He should not be on his feet for more than one hour at a time. The most recent information received 25 July 2002 indicated that the fibromyalgia persisted as of 25 February 2002. The vaccinee was seen by a third rheumatologist on 17 July 2001. On the referral form completed by the vaccinee he indicated that he had experienced back, hip and knee pain for five years. He indicated that the given diagnosis for the pain was "stenosis". At the time of evaluation, the vaccinee was receiving clarithromycin and hydroxychloroquine therapy. "(The vaccinee) reports that since beginning on this treatment, he has had an increase in joint pain which has become more severe, but he claims that from what he reviewed on the Internet and in the medical literature that his is typical of people being treated for Lyme diseas... He reports that his social activity has declined dramatically." The rheumatologist noted that the vaccinee's father had arthritis and gout. On examination, "Musculoskeletal exam fails to reveal any synovitis in hi hands... He has good ROM (range of motion) at the wrists, elbows, and shoulders. Some stiffness with rotation at the bips, and discomfort with passive ROM at the shoulders, hips and knees. However he does not have any restricted ROM of any joints. There is no synovitis or joint effusions. He also has some tender points at the elbows, the shoulders, the paracervical and trapezius muscles, the lumbar region and hips.  He occasionally experiences blurring of vision, nausea, lightheadedness, and hand tremors. Ongoing symptoms include fatigue, arthralgias, with an increased amount in the hips and back, myalgias, painful bumps in his scalp, tinnitus, headaches, muscle spasms, numbness of his hands and feet, a crawling sensation of his skin, short memory loss, and mood swings. The vaccinee returned to the second neurologist on 28 January 2002. At that time, the vaccinee described continuing multifocal problems including back pain radiating down to the right lower extremity. He remained on treatment for Lyme disease. On physical examination, the physician noted "good strength in both lower extremities. Sensory examination reveals an L5-S1 deficit to pinprick on the right. Reflexes symmetrical at 2/4 throughout except for the ankle jerks which were graded as trace positive bilaterally. Toes showed bilateral flexor plantar responses. Straight leg raising is limited bilaterally." The physician's impression was: "He continues to demonstrate neuropathic changes in the right lower extremity in an L5-S1 distribution. There does not appear to be any evidence of active denervation at this time. Nerve conduction parameters are within normal limits." The vaccinee was seen by the third rheumatologist on 25 February 2002 for follow-up of chronic arthralgias. " He continues to be quite limited in his activities of daily living. He suffers from chronic fatigue, chronic joint complaints and occasional joint swelling. At times he feels that there is swelling in his knees as well as hands. he finds that he is quite limited in his funcitonal activities being able to life or carry no more than 5 pounds. He has difficulty and limitations to bending, squatting or climbing stairs. He is unable to be on his feet for more than an hour at a time before he must sit and rest. He has tender points at the elbows, shoulders, throughout the spins especially the lumbar region, hips and knees. He has marked stiffness with flexion and rotation at the hips which is restricted by 50%. The most recent information, received 23 August 2002, indicated that the vaccinee continued to be treated for Lyme disease and continued to experience back pain and right leg symptoms as of 28 January 2002. Informaiton received 25 July 2002 indicated that the fibromyalgia persisted as of 25 February 2002. As of 03 January 2002, the vaccinee was still able to work. However, because the vaccinee reported that he was "becoming disabled", the activation of chronic Lyme disease and fibromyalgia are considered disabling.