Age: 47.0
Sex: M
Vaccine: LYME, LYME
Symptoms: Arthralgia, Back pain, Laboratory test abnormal, Pain, Paraesthesia
Clinical narrative: Pt experienced joint pain, in hands, elbows, and knees. Severe body pain which has increased throughout the year. Back pain, tingling in arms. The annual follow-up states lyme WB +; antibiotics no response. The follow up received on 12/20/02 states possible autoimmune arthritis in a 47 year old male hwo received Lyme disease vaccine recombinant for prophylaxis. This report was received from newspaper articles with follow-up info received via the litigation process and fromt he pt's wife. Medical records were forwarded by the pt's attorney. A physician has also directly submitted a report directly to VAERS. Alcohol abuse was documented on 1/8/97. Cocaine and "speed" abuse were also documented on an unspecified date. The pt has a history of lifting heavy objects "for years" with multiple episodes of low back pain. He developed sacro-ileitis on 6/18/93, after lifting a heavy object. Lumbar spine x-rays performed on 8/31/94 revealed "a small anterior bony spur seen at the level of L5. Narrowing of L5 S1 joint space is noted. Narrowing of L4 L5 joint space is also noted. These findings are felt to be related to degenerative disease." On 4/21/99 and 5/21/99, the pt received his first and second injections of LYMErix, respectively. The litigation alleges that the pt has experienced arthritic-like symptoms in various joints of his body. The newspaper article quotes the pt as developing the "same form of arthritis that afflicts his wife after getting the vaccine." Pt has subsequently tested HLA-DR3 positive and is "positive for Lyme disease." He is being treated by a physician for these events. The ligitation states that th ept has suffered great pain, discomfort and emotional distress as well as the evnts have "severely limited his employment options and opportunities." The pt's wife stated that "her husband's pain started slowly throughout late 1999 until he hurt his back on New Year's Day (1/1/00) and has never been the same since. He used to workout and run. Now he just site around because of the pain. My husband was so bad a few weeks ago he told me he thought he was dying." The litigation alleges that pt's Lyme disease and arthritic symptoms associated with his HLA-DR4 positive status were triggered by his vaccination with LYMErix. Medical records forwarded by the pt's attorney indicated that the pt developed aching joints and numbparesthesias of his hands in 1998. A diagnosis of possible Lyme disease was made and the pt was treated with a 30-day course of doxycycline for Lyme arthritis. Nonspecific myalgias and arthralgias persisted and he was seen by an infectious disease specialist on 8/19/98. Serology for Lyme disease was negative. ELISA was "reactive minimal." Two bands were noted on the IgG Western blot. LYme disease was ruled out and the pt was treated with naproxen. The diffuse joint pain persisted and the pt was seen by the infectious disease specialist on 3/6/00. The specialist stated, "I do not have specific evidence of an infectious disease syndrome." The subject's medical history also included tick bite 1989, right nasal alar collapse, nasal polyps, deformity of the ala of his nose, rhinitis, chronic sinusitis, slight septum deviation, shoulder fracture, warts, ganglion cyst both wrists, scalp cyst, fatigue, ankle injury, conjunctivitis, intraventricular conduction delay, elevated liver function tests, presbyopia both eyes, and asthenopia. Surgical history included appendectomy, tonsillectomy, adenoidectomy, septoplasty, reconstruction of right nasal alar using plasty local flaps, bilateral intranasal antrostomiees, nasoseptal reconstruction, open transcolumellar type, and excisional biopsy left parietal scalp. However, according to the pt's wife, her husband was "very healthy prior to the vaccine." Concurrent medications included Tequin, prednisone, duratuss GP, lactulose, ranitidine, Zantac, Claritin, methadone, and Strovite. The pt was seen by a physician on 1/3/00, after hurting his back while lifting. Darvocet provided no relief. Vioxx provided some relief of joint stiffness. The pt was referred to an orthopedic surgeon. The back pain and joint pain persisted. The pt was seen by another physician on 3/16/00. At that time, the pt reported that he had pexperienced back pain "for a few years," but that it had been worsening over the past four to five months. The pt was treated with Vioxx 12.5mg daily and Percocet 5mg/325mg four times daily, as needed. He was seen by an orthopedic surgeon on 3/16/00. After "review of his x-rays taken recently" and a MRI performed in February 2000, the orthopedic surgeon made a diagnosis of "multilevel degenerative disc disease with herniations at L4-5, L5-S1 and L3-4. This could also be discogenic low back pain." The orthopedic surgeon also noted that the pt had "polyarthritis secondary to Lymerix injection for Lyme disease." The pt was treated iwth oxycodone/acetaminophen and referred to a pain clinic. At the pain clinic, he received epidural injections of triamcinolone on 4/14/00 and 5/10/00. These provided minimal relief. He was then treated with OxyContin 20mg every eight hours. The anesthesiologist at the pain clinic noted that the pt had "chronic myofascial pain secondary to Lyme vaccination, as well as chronic radiculitis." With respect to the back pain, the anesthesiologist stated that the pt "does strongly believe that his symptoms are related" to LYMErix administration. The subject remained under the care of this anesthesiologist until at least 10/18/01. During this time, he reported that he experienced pain down both legs and in his hands, marked increase in pain, was unable to function, some symptoms of depression secondary to his chronic pain, unable to get out of bed, and marked improvement in his ability to function. It was noted by the physician that he had "diffuse musculoskeletal pain secondary to a problem with his Lyme vaccination" and "low back pain with lumbar radiculitis and myofascial pain; diffused, chronic, and severe." During this period, the physiican prescribed various dosages of Oxycontin, Norco, and a third epidural injection of triamcinolone on 4/6/01. From 4/3/98 to at least 9/14/99, the subject wsa under the care of another physician. The subject reported that he hurt his back on 8/25/99. During this time period, the physician noted the subject's low back pain was better on 9/14/99 and straight leg raising caused him pain in his lower back. The diagnosis of chronic low back pain and degentrative disc disease were made. The physician prescribed Percocet and Motrin. He also prescribed a MRI of the lumbrosacral spine and referred the subject to another physician. From 5/23/00 to at least 8/26/01, the subject was under the care of a Lyme disease specialist. At that time, the subject reported "disabling joint and muscle pain." During this time period, the physician noted on a VAERS follow-up form that the subject did not recover from the adverse events that were initially reported and that the subject "can not work. Pain." However, the subject told another physician that he was retired. She also indicated that he was HLA-DR4. The physician indicated that the subject had "unknown Lyme disease" and was treated with Biaxin. She stated "This may not reduce all his symptomatology." The physician indicated he was in "significant pain" that was not merely an "arthritic" condition that antiinflammatories relieve. The subject was evaluated by a clinical psychologist on 6/21/00 for a psychological evaluation to assit in determining appropriateness for long-term narcotic use. At that time, the subject reported severe joint pain and back pain. He also noted after he received his second LYMErix injection "his autoimmune system was turned on because of a certain gene that he has and as a result has triggered many problems including severe joint pain and overall body pain." The subject indicated he had a past medical hisotry significant for degenerative disc disease and three herniated discs. He described his "overall pain as a level 8 but it is a 12 without medication." He was taking OxyContin and "heavy dose of antibiotics." He indicated that the OxyContin completely took his pain away and allowed him to function. He denied alcohol and drug use or abuse. The subject noted he drank three to four cans of beer a month. He denied past psychological or psychiatric hisotyr. He was retired and took care of his home and his 10 year old son. The subject noted he had mild memory problems at times and described his energy and interest level as "slower than usual." On examination, the psychologist noted "The back depresion inventory and anxiety inventory both came back as normal. The MMPI-2 was valid. He may tend to control others indirectly and avoids expressing anger and negativity. He may react to stress by developing vague or nonspecific physical symptoms." The psychologist's impression was "The subjec is not depressed at this time. There is no anxiety present. There are no past or present problems with alcohol or drug use. He has no past psychological or psychiatric problems. There is no recommendation for psychological treatment at this time, and it is my opinion that he is an appropriate candidate for long-term narcotic use." The subject was evaluated by a rheumatologist on 11/21/00 for joint and muscle pains. At that time, the subject reported he had his first injection of LYMErix in May of 1999 without any problems. Then, in June of 1999, hehad his second injection of LYMErix and did not have any problems unti six months ago. He indicated that at that time, he began experiencing "pain without swelling involving his knees, feet, elbows, and hands." He developed diffuse myalgias and also developed bone aches particularly over his tibia. He also felt his hands were swollen. He described the pain as migratory in nature. It sometimes moved from his knees to his elbows and sometimes to his feet. He noted when the pain left these areas there was still residual pain and he was "never pain-free." His pain was not relieved by Celebrex, Vioxx, Motrin and Naprosyn. He had difficulty staying asleep and difficulty falling asleep and complained of nonrestorative sleep. He had complained of not looking forward to the day and admitted to some symptoms of depression. He used to run, but indicated he could no longer do it. He was not working. The pt indicated he had MRI that showed "bulging discs." On physical examination, the physician noted "Joints: no definite swelling, limitation of motion, or tendernes sinvolving the DIP's, PIP's, MCP's wrist, elbows, knees or ankles. He had bilateral and lateral epicondylitis." His nails had a slight deformity, which the rheumatologist noted as "possible early clubbing." The rheumatologist impression was "Difficult to make definitive diagnosis. Much of what he claims by history is highly suggetive of fibromyalgia. His exam also supports this diagnosis with soft tissue pain over the elbows, paravertebral muscles of the L5 and cervical spine. However, his migratory joint symptoms do not fit the typical fibromyalgia story. One could certainly make an argument that this would be most compatible with a viral type illness although the length of time is too long to implicate a viral arthropathy. Sometimes atypical rheumatoid arthritis would be migratory in naturre. This would certainly be atypical but certainly not unheard-of. I don't see any evidence by exam or history to support other intermittent or migratory arthritic syndrome such as Behcet's syndrome or inflamamtory bowel disease or even rheuamtic fever." The rheumatologist prescribed Plaquenil and encouraged physical activity. Laboratory analyses performed on 11/21/00 demonstrated some abnormal findings. From 11/15/01 to at least 9/19/02, the subject was under the care of another physician. The subject reported muscle aches and joint pains, which developed six months after he received LYMErix in May and June of 1999. His "muscle aches were initially in the thighs and the calves and symmetrical. Later he developed muscle aches in the biceps and forearms. He also has joint pains in the feet and ankles as well as other joints. About a year ago, he developed numbness in his right lateral thigh with pins and needles and tingling sensation. This particularly occurs when lying flat and is not a problem when walking. This symptom, for the last year, is not progressing, but also not improving. His left is okay in regard to numbness and pins and needles feelings. He also had Raynaud's symptoms for the last eight months. He's had back pain but no radicular pain preceding all these recent complaitns and this has been going on for over ten years. He denies stabbing pains and denies burning pains, though, a couple of months ago, he did have burning pains in both of his feet. This has resolved. Currently, the muscle and joint pains he would describe as a four to five on a scale of zero to ten. He is currently taking OxyContin 80mg four times a day and Roxicodone 10mg five times a day and a multivitamin. He also complains of forgetfulness, particularly in the last six months. He goes into rooms and can't remember why he does this. He still does his finances but is more cautious with osme of his investments because of a concern of forgetfulness. He has tried Celebrex and other non-steroidal medications with no benefit. In 1995, he had a bite. He is not sure whether it was a tick bite or not. A year after the bite, he had a Lyme Western blot that was negative and the decision was not to treat." On physical examination, the physician noted "He has no rash. On mental status, he is alert and oriented. He can recall three objects at five minutes. His language is normal.  He can name objects, shapes and colors and his repetition and comprehension is normal. He descrbies the cookie jar picture appropriately. OKN testing reveals normal saccades and prusuits. His facial strength and sensation is nomal. His tongue is midline without atrophy or fasciculations. On motor testing, he has no pronator drift. He has normal rapid alternating movements of the hands and feet. He has 5/5 strength in the neck flexors, extensors, deltoids, biceps, triceps, wrist flexors and extensors, interoseal, hip flexors, quadriceps, tibialis anterior, gastrocs. His sensory exam reveals decreased cold and light touch sensation in the hands and normal in the feet. His reflexes were preserved and nomal at the biceps, triceps, brachioradialis, knees and ankles. HIs toes are downgoing. His gait is nomal. He can walk on his toes and heels and tandem without difficulty. The Romberg test was normal. His finger-to-nose testing was normal." The physician's impression was "The subject described muscle aches and joint pains that began occurring six months after receiving the LYMErix vaccine. He also has complaints of numbness in his right lateral thigh. His neurological exam does reveal numbness in the lateral femoral cutaneous distribution and also has numbness distally in the hands. Other features of his neurological exam are normal. He did have EMG and nerve conductions performed with a separate report prepared. This did not show any signs of neuropathy or focal neuropathies or evidenceo r radiculopathies. There was an absent lateral femoral cutaneous nerve on the right, though this is often a technical difficult nerve to obtain in normal subjects and it was also absent on the asymptomatic left side. My impression is that he may have neuralgia paresthetica and he also complains of cognitive problems occurring in the last year." The physician recommended a MRI of the brain with gadolinium, neuropsychological tests to determine areas of cognitive dysfunction, glucose tolerance test with a suspicion of diabetes, serum protein electrophoresis and immunofixation electrophoresis, quantitative immunoglobulins, anti-gliadin and ant-endomysial antibodies for celiac disease, B12, and compolete blood count. Followoing the reported onset of pain, the subject experienced transient gastritis, Raynaud's syndrome, lump on his brreast, rare crmaps, urinary frequency, thirstiness, possible diabetes, sexual dysfunction, nausea after eating, blurred vision, "toes right foot turning dark," possible fibromyalgia, and a possible viral tyype illness. 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. As of 4/9/02, the subject's back pain was unresolved.  The most recent info, received on 1/23/03 did not provide the outcomes for the other reported events.