Report A0359658A describes restless leg syndrome in a 49 year old female who received Lyme disease vaccine recombinant OspA LYMErix. This report was received as part of litigation proceedings, with forwarding of medical records. The medical history included Lyme disease, restless leg syndrome, migratory arthralgias, back pain, heart surgery NOS, tearfulness, moodiness, anxiety, degenerative disc changes lumbosacral spine, hysterectomy, chronic pain, memory problems, "nerve twitching," and difficulty sleeping. From 1996 to 3/2/99, the pt was treated by a chiropractor for the following:constant low backache (lumbar pain/tenderness) with intermittent posterior right leg pain, lumbar/lumbosacal area subluxation-radicular syndrome of the lower limb, lumbar strain, lumbalgia, lumbar related paresthesia, low back tight and achy, lower back pain into left/right buttock region and intermittent left/right proximal posterior leg ache with cramping, low back muscle spasms, muscle spasms, muscle ache and tenderness across the low back and lumbar spine, increased pain with movement at the waist, pain in lumbar spine over the left S1 joint, pain and ache over right S1 joint, pain radiates across the belt line, pain with quick movement, pain that radiates down to the lumbosacral, muscle spasms, aches and mild cramping in the left/right legs, muscle ache and ache that radiates into proximal left/right posterior legs, pain across the left upper "trapes" and shoulder, subluxations at cervical/thoracic area, cervical/thoracic area with muscle tenderness, cervicalgia, cervical strain, cervical stiffness, cervical pain cervical/thoracic spine pain, "felt pop in her neck," pain and "felt a pop in her mid thoracic spine," increased pain with [[name]] movement in cervical area, [[name]]ache, migraine type [[name]]ache, increased stress, sinus [[name]]ache, stiffness in the upper spine, stiff neck, lumbar related paresthesia, pain in cervical area, activities of daily living and movement were decreased, increased stress, left shoulder pain, migraine type of [[name]]ache, [[name]] right leg, severe coughing spells, and "unable to function normally." The vaccinee was "possibly" allergic to pcn and had hayfever. Concurrent medications included conjugated Premarin, ibuprofen, Actifed, Celebrex, Zoloft, Diflucan, Prilosec, Actifed, thyroid, baby aspirin, and nutritional supplements. Following the reported onset of restless leg syndrome, the vaccinee experienced persisting soft tissue enlargement/macrodactyly left toe with resulting pain at same and adducto varus deformity with distal soft tissue distortion fourth toe left causing underlapping, impingement and irritation on the left third toe, nausea, sciatica, nasopharyngitis, yeast infection, vomiting, heartburn, clammy sweaty skin, dizziness, sore throat, increased appetite, fevers, chills, tinnitus, red eyes, chest pain, epigastric pain, constipation, heat intolerance, depression, anxiety, back pain, abnormal urinary frequency, chronic fatigue, moodiness, tearfulness, pain, nasopharyngitis, emotional instability, twitch, neck pain, somatoform disorder, paresthesias, rashes, [[name]]ness of breath, palpitations, reflux, and vasomotor flushing. 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. Therefore, they are not listed as adverse events. The vaccinee received injections of LYMErix on 5/4/99, 6/4/99 and in August 2000. In a Statement of Injuries, her attorney alleged that the vaccinee "suffers from severe pain and swelling in her joints as well as weakness in her limbs. She also suffers from restless leg syndrome. She also experiences flu-like symptoms. In addition, she suffers from memory loss, loss of concentration and cognitive deficits. She also suffers from migraines and insomnia." The following info was obtained from medical records. On 6/15/99 the pt was referred to a neurologist for further assessment of possible restless leg syndrome. According to the pt, she developed "problems" with her legs in the late 1980's at about the same time that she developed symptoms tha tultimately because diagnosed as Lyme disease in 1990. She stated that she would have times where while trying to relax, her legs would start to jump or her body would jump or startle. This was continued to the present time. She denied any extremity numbness or paresthesias or weakness on any persistent level. She stated that in-between these episodes, her balance and equilibrium and movements were fine and there were no coordination difficulties. The pt stated that her sleep was poor overall. She stated that she just felt exhausted much of the time despite trying to sleep six hours at night and two hours in the daytime. The pt has received chlorzoxazone, which might have helped 'a [[name]] bit." She was on clonazepam, but that gradually just made her more sedated even on one-quarter tablet. The pt was diagnosed with Lyme disease when she developed 'significant" migratory arthralgias. She was initially treated with oral antibiotics, but the symptoms seemed to recur, so she was given a three-week course of IV antibiotics. She has "done well" overall since that time and pain has really not been an issue since then. The pt stated that she was told that she had degenerative disc changes in her lumbosacral spine andwill occasionally get some [[name]] pain in the back area, but it was always very localized without radiation into her legs and without any increase in coughing or Valsalva maneuvers. The pt stated that she had 'a lot" of urinary frequency. The impression was, the physician stated, given the pt's clinical history one would certainly consider that she had restless leg syndrome, but of course these movements also can translate into a period of relaxation during the course of a day when someone is sitting undisturbed. No other abnormalities were found on examination to postulate another origin for these symptoms. Past work-up excluded seizure. The physician prescribed Mirapex 0.25mg one at bedtime to eventually increase to one twice daily. On 7/12/99 the pt was seen by the physician. She had many complaints. Some were of recent onset. Some have been occurring for as many as two years. Her complaints were: fatigue, weakness, nausea, vomiting, heartburn, clammy sweaty skin, dizziness, [[name]]ache, sore throat for one week, increased sleep, decreased energy, increased appetite, fevers, chills, tinnitus, red eyes, two-pillow orthopnea, which she believed was related more to her heartburn than to SOB, chest pain, epigastric pain, constipation, urinary frequency, heat intolerance, occasional depression, occasional anxiety, and back pain. The objective findings were well-nourished female in no distress. The extremities had no edema. Neurologially she was alert and oriented. Musculosrkeletal 5/5 strenght. The pt had many complaints consistent with depression. The physician prescribed Prilosec 20mg one daily orally. From 8/9/00 to 5/17/02, the vaccinee was under the care of a chiropractor. The following additional sings/symptoms were reported during this time: a decrease in cervical range of motion, loss of range of motion with stiffness and ache noted, intermittent 'restless syndrome," unable to function normally, muscle tenderness, secondary complaint was stiffness across the low back, [[name]]ache, [[name]] pain at the right S1 joint, pain that also interfered with sleep, low back pain, low back muscle spasms and pain, pain aggravated with upper body movement, intermittent dull nagging ache, increased pain with movement, discomfort with movement, cervical/thoracic pain, cervical ache and stiffness, stiffness, cold weather bothers her, low back ache, spinal stiffness with muscle tenderness, spinal pain especially in the upper spine and right shoulder, palpatory tenderness and spasms at cervical/thoracic/lumbar areas, pain was constant, deep ache, [[name]] at times and well localized to the lower back and into the left/right buttock region and stiffness of the lower back, mild cervical stiffness, left/right legs and muscle discomfort and tenderness and stiffness across the low back, spine stiff with muscle tenderness stiffness, restless leg syndrome, thoracic/lumbar spine muscle tenderness and ache, stiff neck, ? followed by neck pain, decrease in cervical/thoracic range of motion and pain with [[name]] movement, cervical and upper thoracic pain, pain that radiates down the posterior proximal right leg with an accompanying stiffness across the low back, leg discomfort, right proximal posterior leg had mild ache, ache in the left/right distal legs, difficult to get out of bed or a chair, difficult to sit for a [[name]] periods, activities of daily living, tight neck, decreased movement, difficulty turning her [[name]], ringing in ears, depression, panic attacks, elevated blood pressure, pain and pressure behind eyes, and neck injury that affected her hearing. Chiropractor diagnosed her with lumbar/cervical/thoracic subluxation, cervicalgia, lumbar strain, lumbalgia, thoracic pain, [[name]]ache, lumbar muscle spasm, radicultiis and right shoulder pain. On 8/9/99, the vaccinee stated that she "cannot notice any appreciable improvement with the Lyme shot." On 2/7/00 the vaccinee felt a gradual onset of spinal pain which she "thinks [[name]]be due in part to the Lyme's disease and also due increased stress as a result of classroom studies. At that time, the vaccinee reported that she still experiences "restless leg syndrome which the physician is caring." Chiropractor noted at that time, the vaccinee still experienced "restless leg syndrome" and was seeing a specialist. On 7/25/00, the vaccinee "still believes her spinal ache is attributed to the Lymes." On 8/1/01, the vaccinee reported "insidious onset over the past several months, but has had similar pain on and off since [[name]] 1999. The pt stated she felt low back pain as a result of normal household chores of lifting, carrying, cleaning etc. Pt further states she believes she is unable to function at her pre Lymes shot status. There is thoracic/lumbar muscle tenderness. It is difficult to get up out of a chair. The pain is a cosntant, deep ache, [[name]] at times and well localized to the lower back and into the left/right buttock region. Pain does radiate into the left/right legs, distal. On a pain scale of one to 100 the pain is rated a 30. The pt further states there is a loss of normal range of motion and is unable to function normally. There is increased pain with movement. "Restless leg syndrome" present. Secondary complaint is a stiff neck. No further details as to the cause could be given." At that time, the vaccinee was "not talking any antibodies for Lymes disease." On 1/8/01, the vaccinee noted that she had activities of daily living/working that are painful, difficult or limited because of this injury or illness and described "reaction from Lyme disease. Shots is causing recurring symptoms of Lyme disease including [[name]]aches, pain in hips, back, neck, restless legs, insomnia, brain fog or confusion, etc. She reported that her symptoms developed in [[name]] of 1999 from Lyme vaccine. She also reported that sometimes the pain interferred with her sleep, sleeps with three pillows, heat helped her pain, being on her feet a lot made her condition worse in mid-back, low back, shoulder, arm, hand, hip, leg and foot. On 1/8/01, the vaccinee reported that she "is unable to function at her pre-Lymes shot status" and she was "not taking any antibodies for the Lymes disease." At this time, the vaccinee when questioned on her pt health record form if she had activities of daily living/working that are painful, difficult or limited because of this inuury or illness, noted "reaction from Lyme disease shots is causing recurring symptoms of lyme disease including [[name]]aches, pain in hips, back and neck, restless legs, insomnia, brain fog or confusion, etc." which began in [[name]] 1999. Neuropathic pain was also noted. The vaccinee was questioned what makes the condition worse in mid back, low back, shoulder, arms, hand, hip, leg and foot and she noted "being on my feet a lot." She further noted that the pain "sometimes" interferred with her sleep. When quesitoned frequency of [[name]]aches, she noted "some migraines." On this form she was questioned if she suffered from any condition other than that for which you are now consulting us and she noted "restless leg syndrome and deteriorating disks in back." On 1/22/01, it was noted "that she had to cut back on Zoloft because it was making my neurological damage worse. It was causing a [[name]]ache." At that time she also noted that she suffered from "optical rectumosis." On 5/17/02, the vaccinee noted on the history of present form when questioned if she suffered from any condition other than that for which you are now being treated "don't know for sure, but I suspect Lyme infection." On this form it was also noted that she had "some neuropathy." During this time the vaccinee was reported taking Wellbutrin and Zoloft. On 8/10/00, the pt was evaluated by the physical therapist. The pt reported the onset of restless leg syndrome in 1990, [[name]]ly after she was diagnosed with Lyme disease. The pt reported she "struggled" with Lyme disease until approximately 1996 and has had a mild increase in the severity of her restless leg syndrome of late. She related that quinine does not control her restless leg syndrome at night; she had a work-up by a neurologist approximately 18 months to 2 years ago and was palced on Mirapex which offered greater relief. The pt related that she was usually able to fall asleep at night but then is awakened consistently by her restless legs. These tremors and spasms seemed worse when her legs were fatigued. The pt also reported significant anxiety trying to control and prevent these motions especially when out in public. The pt denied pain throughout, complained of generally being tired and having difficulty sleeping sleeping because of the restless legs. The pt was not currently employed, she was taking computer classes at a local technical school. The pt presented to the dept in no apparent distress. The pt demonstrated the degree of spasms she experienced with these restless legs tremors by lying supine with hips and knees extended and relaxed. Also noted were one or two episodes of what appeared to be involuntary cervical motions primarily left during the course of evaluation. The pt sat with generally forward shoulders and decreased lumbar lordosis but did not have pain or difficulty assuming an erect retracted posture. At present, the pt is most limited by inability to sleep undisturbed throughout the night secondary to restless leg syndrome. She does have mild muscular restrictions in her lower extremities. The pt was instructed in a home exercise program for generalized lumbopelvic and lower extremity flexibility. On 8/24/00, the Lyme antibody was "negative." On 8/31/00, the vaccinee was seen by the physician. She reported increased stress because she was taking a number of college courses now. She has cut down on her Mirapex which has helped with resolution of some of her fatigue. She is getting a positive response and less anxiety with her lorazepam twice daily. She has noticed a marked reduction in her neck twitching and movements when she is on Mirapex. On 9/14/00, the vaccinee was seen by the physician. The vaccinee stated that she was diagnosed with Lyme disaese on 8/9/89 after three years of suffering with problems of Lyme disease. At that time, she was having nerve twitching and memory problems. She received treatment and seemed to improve. She received three injections of LYMErix, and since then she has been worsening. "It seems that the Lyme vaccine has caused her problems." She stated that she was needing more Mirapex to control her restless legs. She noted left arm shaking and [[name]] shaking. She was having more upper body involvement. She stated that she has had problems with sciatica, constant [[name]]aches, and restless leg syndrome. Her neck has been sore, problems with her shoulder joints, sore throat, emotional instability, constipation, tiredness, fogginess in her brain and a pulling on the side of her face, and ringing in her ears. She was treated with antibiotics and she felt improved. However, she received her third injection of LYMErix and she got worse again. At this time she is requesting antibiotics for Lyme disease. The physician's assessment was that the pt had an obsession about Lyme disease and thinking that the Lyme vaccine was causing her Lyme disease to worsen. The pt wanted antibiotic treatment today. The physician prescribed doxycycline 100mg orally twice daily for four weeks. On 1/15/01, the pt was seen by the physician. She stated that she had multiple symptoms, including pain, [[name]]ache, migraine, cold, sores on her tongue, exhaustion and fatigue, inability to concentrate, [[name]] pain in her legs, knees, hips and ankles, and restless legs. She stated that all of this started after she received LYMErix. The physician noted that the pt did have Lyme disease 6-7 years ago. The pt stated that she did have neurologic Lyme's. She saw a neurologist and took multiple antibiotics. She had a spinal tap. They did not identify this in the spinal fluids, but yet she was treated with, she stated IV Rocephin for this. The physician noted that in his chart "there is no real documentation of this." THe pt stated that when the physician gave her antibiotics one month ago, she was 100% convinced that she had Lyme disease and the doxycycline seemed to help for a month and then things just got worse again, although at that time she did do a Lyme disease test which was negative, the physician stated that "I reminded her that she had these same symptoms when I first saw her in 1998 and this was prior to her receiving the Lyme's vacicne, but she stated she had no arthritis sympotms at that time I did agree with her in my notes I did not note any arthritis symptoms. However, she had all of the other symptoms." The physician's assessment was that the pt had multiple complaints including arthritis, fatigue, concentration difficulties with a history of Lyme vaccination and Lyme disease, though not well documented in my charts. "Concern that the Lyme's vaccine [[name]] have brought on her arthritis and problems. At this time, it is possible this could be some kind of auto-immune reaction or some reaction to the Lyme's disease vaccine, but I am unclear on this. The Lyme Western Blot IgG antibodies were negative (bands 41 and 31 kDa were present). The Lyme Western Blot IgM antibodies were negative. On 1/23/01 anterior-posterior and lateral x-rays of the left knee were obtained. The indication was "no injury, pain 2-3 months." The impression was "normal appearance of the left knee." On 2/7/01 the pt was seen by the neurologist. The pt stated that her restless leg symptoms were noticeable when she tried to relax during the day and she will start to get "that restless feeling." At night, it was variable, but still could bother her. She still felt that the Mirapex helped her and currently took 0.5mg. She stated that this problems seems to have worsened in the wake of the Lyme vaccine which might have been completed in the fall of last year. She wondered if there was a relationship to that. She felt that she had a "terrible" reaction to the Lyme vaccine, and lists many symptoms that she's noted to have become worse, including the restless syndrome, problems with back pain, especially chronic fatigue, much more moodiness and tearfulness. A Western Blot was negative, although the pt stated that she had been treated with doxycycline prior to that test. She also underwent testing for the change of any other collagen vascular disorder and essentially her lab studies were unremarkable. She stated that her chiropractic x-rays have shown much more arthritic changes in her lower back than she had. She stated that her chiropractic x-rays shown much more arthritic changes in her lower back than she had perhaps six years ago. She stated that "all of a sudden everything flared up with her back" and once again she was concerned about the Lyme vaccine. The pt felt that the Mirapex not only helped her restless leg problem, but also helped her lower back tightness and spasms. The physician prescribed lorazepam 0.5mg, which she [[name]] take several times weekly or less. The physical exam was without abnormality. Impression: the pt did have restless leg syndrome and certainly it can fluctuate apart from any other influences and so the physician really did not feel that that would tie into her having received the Lymes vaccine. She can increase her nighttime dose to a full tablet of 0.5mg tablets and leave the half dose in the daytime for now and try that for a week. Certainly, there was no evidence of Parkinson's disease on exam, and her exam really looked very [[name]], with no tremors or the like. As to her lower back, she did bring the chiropractic x-rays. The anterior-posterior view showed what appeared to be severe disc space narrowing at L4-5 and some osteophytic changes as well. There also was some offset from the alignment. Neurologically though, she was doing well, with no focal findings of concern on exam and yet of course with this underlying process, pain can fluctuate, and the physician did not feel that that was necessarily at all a reflection of having undergone the Lyme vaccine. As for the moodiness and sleep, she really has had all of those problems previously, although she jus thought that everything seemed worse after her vaccine. The physician stated that "I really don't feel that vaccine issues have played a major role here at all in terms of the lingering symptoms that she is describing and which she did have previously." In 8/23/01, the pt was seen by the rheumatologist. The pt stated that in the mid-1980's she had Lyme disese characterised by a variety of symptoms of fatigue, pain, myalgias, arthralgias, change incognition and [[name]]haces. She apparently was quiet and avid outdoors woman hunting and trapping. She then completed a course of three Lyme disease vaccinations. She now felt that the administration of the vaccines has caused worsening of her constitutional complaints. On 10/22/01, the Lyme [[name]] titer IgG was <80, the Lyme western blot IgG was negative, the Lyme western blot IgM was negative, the MarDx western blot IgG was negative, the Immunetics western blot IgG was negative (1 signifiant band present: 41kDa). Overall interpretation: no evidence of serioreactivity beyond that expected from the Lyme vaccine. on 11/23/01, the pt was seen by the physician. She was doing better with her bladder, has been practicing holding it, and was having a lot less problems with frequency. She was still having a lot problems with the restless leg syndrome and also with other muscle aches, pains, and jumps. She has been seeing neurology regarding this was taking Mirapex and was doing "okay" with this. Her past medical history was significant for depression, [[name]] history of multiple aches and pains, as well as chronic fatigue syndrome, history of chest pain with negative stress test done 8/21/01 which was a Sestamibi stress, past history of Lyme disease, per pt's report, history of rheumatic fever as a child, history of restless leg syndrome. She had no known allergies. Her medications include Zoloft, Premarin, Mirapex, and lorazepam. Assessment. Depression, improved on the Zoloft, although she was having some decreased libido from this, as well as some changes in her sleep. White[[name]]s and black[[name]]s improved on the Retin-A. Yeast infection. Diflucan 150mg one orally now given. Urinary frequency. Pt improving with bladder training. Chronic fatigue syndrome, multiple aches and pain. The most recent info, received on 8/23/02, did not provide the outcomes of the reported events.