In May, 1999, the pt received her first injection of Lymerix and immediately experienced severe flu symptoms. After receiving her second injection, her elbows began to ache. The pain spread down her arms and throughout her body until by November 1999, she could barely clasp a carton of milk. She was reportedly diagnosed with chronic fatigue, depression and fibromyalgia. Eventually, sometime since November 1999, she was diagnosed with autoimmune arthritis.   Follow-up received 8/1/00 states following the 2nd injection, by 11/99 she reportedly was so stiff and was suffering so much pain in her chest and arms that she could barely mover fore hours in the morning nor could she barely clasp a carton of milk. According to the legal summons and complaint, the pt has been treated with anti-inflammatory and other medication as well as a pain management specialist with no relief of her symptoms. In a new report posted on the internet on 02/28/2002, the vaccinee stated, "within 48 hrs of the second one (LYMErix) I was in extreme pain." The reporter stated, "she never got the third dose recommended one year later. She remains sickly today. She suffers from arthritic pain in her hands, knees, elbows, hips and shoulders." On 07/22/1994, the pt was seen by the vaccine provider with a chief complaint of "pain of right foot, around metatarsophalangeal joint area." The pain had been present for approx. one month. The pt returned to the vaccine provider on 11/28/1994 with pain around wrist with pain radiation to fingers. The physician prescribed Medrol Dosepak and florioet. On 12/03/1997, tiny subcutaneous nodules less than .5cm diameter were observed around both arms. Fatigue was also documented in 1997 and 1998. On 05/25/1999, the pt telephoned the vaccine provider to request a refill of Stadol NS; no mention of flu-like symptoms, elbow pain or muscle pain was made. The pt was seen by the vaccine provider on 06/04/1999 with chief complaints of crusty and red eyelid for one day, complained of back pain. The physician's assessment was cellulitis, face, left eyelid. He prescribed Vancenase for nasal congestion and allergy. The pt returned to the vaccine provider on 06/30/1999 with chief complaints of bodyache all over the body abot one week with back pain, low-grade fever about 100 deg. F. The pt also requested second Lyme vaccine. The vaccine was administered. Office records of another physician indicated that the pt was seen on 10/19/1999. The pt returned to the vaccine provider on 01/21/2000. Pt believes Lyme vaccination caused auto-immune arthritis pain all over the body. Pain in both elbows, knees. Interscapular area. Difficulty moving neck. The pt reported that she had been seen by a second rheumatologist, who had made diagnosis of fibromyalgia. She reported that her pain was worse on cold days. The physician's assessment was myalgia, unknown/joint pain. The pt was seen by an infectious disease specialist on 03/06/2000. The pt returned to the vaccine provider on 09/07/2000. The pt was seen by a rheumatologist on 01/25/2001. The pt reported the following after receiving LYMErix: burning pain in joints and muscles, occasional swelling, four episodes of paralysis, infrequent migraines, bad memory, chronic shoulder problem, disequilibrium, muscle twitching in the arms, hands, thighs, and calves, and constipation. On 03/06/2001, the pt began therapy with levothyroxine daily. On 04/04/2001, pt was seen by the vaccine provider with chest pain for a few weeks on and off. The pt reported that she only took one-half of the Synthroid tablet daily. Pt believed her chest pain is related to side effect of Synthroid. The pt reported that she wsa feeling better without Synthroid. She requested prednisone for relief of joint pain. On examination, the physician noted decrease range of motion of the left shoulder. The physician prescribed fioricet for headache and prednisone for joint pain. The p returned to the vacicne provider on 10/25/2001. She was crying and depressed. She also reorted headache, muscle pain, joint pain in her knees, elbows and hands. She requested Paxil for treatment of depression. The physician noted that rheumatoid factor measured on 10/08/2001 was believes her increase RF is caused by Lyme vaccine's side effect. Redommended to see rheumatologist for positive RF. The most recent info received on 04/05/2002 indicated that the joint pain, muscle pain, headhache, and depression persisted as of 10/25/2001. The follow-up states that the vccinee began seeing a counselor on 11/12/1998 for an unspecified reason. In a letter to the pt's employer dated 12/03/1998, the counselor wrote, "I recommand that she decreases the number of hours she works for the next few weeks to see how she does regarding stress, headaches." The pt was evaluated by a pain specialist on 06/15/2000 "with chief complaints of diffuse musculoskeleta pain. She describes the pain in the cervical area between her soapular blades in both upper extremities, low back as well as in both lower extremities. The pt states she had develped this painful syndrome one year back, which she states this is a result of Lyme vaccination secondary to which she has developed an autoimmune disorder." Although the pt reported that "she currently works as a RN," she also stated that "currently, the pain is totally disablign her." Medications included "Amgian, Floriose apparently for headaches, Oxycodone prn 4mg for pain. She also takes vitamin supplements and vitamins." Physical examination "revealedmusculoskeletal tenderness at he trigger prints almost in all the muscle groups. NO other neurological deficit noted. NO musculotrophy noted." The physician's assessment was "diffuse musculoskeletal pain secondary to Lyme vaccination as a result of autoimmune disorder as per "emerging disease" specialist's evaluation." The physician prescribed Osycontin 20 mg every 12 hrs and Zanaflex 4mg every 12 hours. The vaccinee was seen by a rheumatologist on 11/21/2000. The pt "claims tha she developed arthritis aftera Lyme vaccine. On 03/27/2000 she claims that she was paralyzed for 40 mins. She describes this event as the inability to walk. She describes this event as not being able to make a connection between her brain and her legs. She subsequently, several months later had an event of paralysis involving her back down to her feet lasting about 20 minutes. On further questioning she is not sure if this was actually paralysis or any bladder or bowel incontinence. She now claims to be stiff in the morning particularly involving her hands, elbows and knees lasting about 30 to 45 minutes. She claims to have difficulty gettting her rings on and off. The pain has not been relieved with the use of Celebrex, Naprosyn, Motrin and VioxxThe pt works as a hospice nurse and has interrupted sleep often." Medications at the time of evaluation included Oxycontin and Fioricet. On examination of the joints, there was "no definite swelling, limitation of ankkes r MTP joints. Diffuse tenderness without swelling over the DIPs but excellent bandgrip. Some tenderness voer the paravertebral muscles of the L5 lumbosacral spine and some minimal discomfor tover the trapazius muscles but no true trigger points were noted." The rheumatologist's impression was "normal exam, multiple areas of discomfort along witha  sleep disturbance poitns more towards fibromyalgia than inflammatory arthropathy. I could not detect any joint swelling or limitation of motion on exam. I could detect no joint deformities or erythema. It is not clear to me whether or not her episodes of paralysis were truly neuologic in nautre or secondary to pain. I cannot detect any overt evidence of depression although the pt does have a fear of sleeping and I still have to wonder whether or not there is some element of depression in the background although I could not elicit that history today." The rheumatologist had a "long discussion about limited therapeutic options given her excellent exam. Discussed possibility of Prozac. Pt reluctant. I'm reluctant to give any other anti-inflammatory since previous attempts were not successful. I certainly do no want to give her any type of remittive agents as I am not convinced we are dealing with an inflammatory arthropathy. My only suggestion at this poin would be to undergo physical therapy and this may help some of her pain. We discussed the possible role of sleep enhancing her overall pain." In a handwritten addendum, the rheumatologist noted hepatitis C antibody, Sjogren's SEA antibody, Sjogren's ESN antibody, and antinuclear antibody titers were negative. Thyroid stimulating hormone concentration, C-reactive protein concentration, and rheumatoid factor were elevated. He prescribed "trial of Plauencil 200 mg BID." On 07/09/2001, the pain specialist wrote, "The pt is currently doing very well on OxyContin 40mg TID." He prescribed OxyContin 40mg three times daily and immediate-release oxycondone. The pt was seen by a neurologis tat a tertiary care center on 04/09/2002. At that time, the pt reported that "she also develoepd numbness, first in her left arm down to the middle finger. Just in the last two weeks, she had swelling in her right wrist and had numbness in all five fingers with tingling, pins and needles sensation and numbness. She also has numbness and tingling in both feet. This symptom is intermittent and moves about. Sometimes, she has numbness in the top of the foot and sometimes on the lateral side of the foot. Both feet are involved but the right foot is worse. She had nocturia two times a night, denies urinary urgncy She had urinary frequency, often very hour-and-a-half. She has neck pain just in the last two weeks but not prior to this. Also, in the last six months. She has had difficulty concentrating on reading complains of fatigue. She used to be extensive reader recently, she has been having episodes where she awakes paralyzed, sometimes from the waist down and sometimes from the neck down. This has also occurred when she has been lying down watching TV. This first started four motnhs after she received the LYMErix vaccine. It often happens when the pain is very severe. The last time was two months ago where the episode lasted two minutes. It has hppened a total of six times, usually for about five minutes at a time. Though, one time was twenty minute. Medications at that time included OxyContin 80mg three times daily, immediate release oxycodone 30mg four times daily, vitamin C 1000mg twice daily and thyroid daily. She recently had her thyroid medication changed because she believed it was too high from synthorid to what she believes in "thyroid, three weeks ago." On physical examination, "she is alert and attentive with fluent and prosodic speech. On sensory exam, she had diminished light though, pin and cold sensation to the mid-pale region and up to below the knee in the legs. Her vibration was also impaired, more in the toes than in the fingers." The neurologist's impession was "The pt complains of joint pains and muscle aches. On her neurological exam, she has distal and symetrical sensory loss that suggest a mild polyneuropathy. She does appear to have normal strength and no atrophy and normal reflexes. The etiology of this is unclear. She does have hypothyroidism and it is not clear that she is now on adequate thyroid replacement. She also has had elevated rheumatoid factors on at least tow occasions. She also has complaints of episodes of paralysis. She does attribute this to frequently being associated with pain though they have some features that suggest an antity periodic paralysis. She does not have a family history of this and usually people who develop periodic paralysis over the age of 40 do have hyperthyroidism." The neurologist recommended electromyelography, nerve conduction studies, magnetic resonance imaging of the brain with contrast serum and anti-endomysial antibodies, quantitative immunoglobuline, thyroid stimulating hormone concentration, and cyanocobalamin concentration. Results of these studies were not provided by the pt's attorney. In medical records from another physician, dated 10/23/1998, arthritis is noted to be part of the past medical history. The most recent info received on 05/28/02, did not provide the outcome of the reported events. The follow-up states that on 06/29/00, the pt was seen by the pain specialist who noted, "She reported moderate relief, at least 50% reduction of pain. She states she is more functioning, able to do a lot more things." On 07/27/00, the pt was seen by the pain specialist who noted the pt reported "having a certian amount of breakthrough pain after 8 hours of taking Oxycontin." On 08/22/00, the pt was seen by the pain specialist who noted the pt "has shown significant improvement of her pain." She reportedly wished to limit to 12 hour shifts, because longer shits exacerbated her "chronic pain situation." On 10/16/00, the pt was seen by the pain specialist who noted "the pt is currently doing well." On 11/09/00, the pt was seen by her pain specialist who noted the pt "states her pain is essentially the same but is being manageable with the help of Oxycontin." The pain specialist referenced an unspecified consult in which he notes "no further recommendations were made except continuing pain management." On 12/04/00, the pt was seen by the pain specialist. "She is rating her ain with 75%." On 01/04/01 the pt was seen by the pain specialist who noted, "The pt is currently doing very well." On 02/01/01, the pt was seen by the pain specialist. She was "currently doing very well." she has noticed no side effects from the medications. She was currently using OxyContin 40mg in the afternoon and 20 mg every 12 hours. She was also having some shoulder discomfort. She was recommended surgery by an orthopedic specialist. The physician referred her for a second opinion and treatment, if possible. On 02/26/01, the pt was seen by the pain specialist. She was currently having depression symptoms. Zoloft 50mg daily was prescribed. On 03/26/01, the pt was seen by the pain specialist. She currently was complaining of diffused body pain. Her symptoms had not changed. She was taking OxyContin 40mg every 12 hours but that was not enough. Physical examination revealed "diffused" trigger points. Assessment: "myofascial pain, diffused, chronic in nature. Status post Lyme vaccination." Her medication was changed to MS Contin 30mg by mouth every 8 hours. On 04/25/01, the pt was seen by the pain specialist who noted "She is having some shoulder discomfort. She was recommended surgery by an orthopedic specialist." The pain specialist referred the pt for a second opinion. She was prescribed Oxycontin 40mg by mouth twice daily. On 05/17/01, the pt was seen by the pain specialist who noted that the pt again "complained of diffuse musculoskeletal pain. She was also having shoulder pain for which she is scheduled for surgery." On 06/11/01, the pt was seen by the pain specialist who noted the pt's pain was "getting worse." Bone scan reportedly ordered by another physician. Her Oxycontin was increased to 40mg mouth every 8 hours. On 08/02 and 09/24/01, the pt was seen by her pain specialist who noted no significant change in her status. The office note of 11/30/00 from the Rheumatology physician reported that the vaccinee's blood shows positive rheumatoid test for which she was tob e started on plaqueril 200mg twice daily. Additionally, it was noted that her "thyroid may be a little low and htis could increase her symptoms." The office note dof 12/01/00 from the Rheumatology physician reported the vaccinee was very hesitant to take Plaqneril if it was a "young medication." The  vaccinee refused "to take any new medications since the LYMErix vaccine." Vaccinee furthe reported she has an "abnormal thyroid which was always borderline. On 05/10/01, the pt was seen by the physician. She stated tha two months ago, with no particular injury, she felt belt-like sawing pain across her low back. She would complain of periodic periods of paralysis either involving both of her legs or quadriplegia from her neck and her upper extremities down through her legs. This would last for approximately twenty minutes. She also would get left low back pain radiating to the lateral groin on the left side and then down her anterior thigh. This hip complaint was actually greater than her back complaints. Standing, sitting, going from sitting to standing and walking all produce back pain. She said that she did not do much bending, so she cannot address it. There was no change in her symptoms as the day progressed and her sympoms increased with activity. She had morning stiffness in her low back for less than one hour. She had negative cauda equina compxession signs and symptoms and negativve Valsalva maneuver. "Treatment has been nothing to this point in time." The physician state dthat "this is a women who received a LYMErix vaccination and has developed what appears to be an autoimmune arthritic condition." On physical examination "she would not squat because of knee pain." "On palpation, she has lumbosacral paraspinal tenderness radiating out into both SI joints." "On extension, she feels back pain." "Straight leg raising is to 40 degree with hamstring tightness." "Hip exam shows minimal pain on the left on internal rotation with no loss of internal rotation." Review of her x-rays show a true scoliosis, minimally so, with a rotatory component to the curve. She is convexed to the right. The lateral is not a true lateral and there is a suggestion, "but I can only say suggestion," of decreased disc height at L5-S1 and L4-5. The physician's impression was "she has a pre-existing structural scoliosis and an autoimmune arthritis due to the LYMErix vaccination." The physician offered the pt physical therapy. She would rather do home exercises and the physician released her with the home exercises. The most recent info was received on 06/12/02. This case is considered medically serious as the pt is considered incapacitated. The follow-up states that the pt was seen by an "emerging disease" specialist on 04/06/00. This physician indicated that the pt "became ill after injection of LYme vaccine. Increasingly disabled. Unable to get out of bed and walk due to pain." The pt reported that she received LYMErix in May 1999 and June 31 1999. In July or August could not go down slide with son. August started hands weak and pain. Elbows weak. On ansymptoms checklist, the pt indicated that she expeirenced joint pain in her hands, shoulder, wrist, hips, knees, ankles, feet, and elbows; swelling of hand joints; "confusion.disorientation"; change in sleep pattern; fatugue; chills; sweats; hadache; "tingling, numbness, burning or stabbing sensation"; "depression/behavioral change"; and decreased short term memory. On 04/11/00, HLA typing using polymerase chain reaction and sequence specific oligonucleotide probes revealed the presence of HAL-DR4 and HLA-DR6 alleles. On an unspecified date, the "emerging disease" specialist submitted a report directly to VAERS. On the VAERS form, the physician indicated othe rmedications as "None," illness at time of immunization as "None," and pre-existing medical conditions and allergies as "None." She indicated that the first injection of LYMErix was administered in May 1999and the second injection was administered on 06/31/99. She noted adverse event onset on 07/07/1999. As a description of the event, she wrote, "After seond shot LYMErix, within one week, developed severe muscle and joint pain that progressed by August to a point that prevented pt from walking very much, or playing with her son. She is still bedridden much of the time and in severe pain." In a letter to the vaccine provider dated 05/23/00, this physician stated that she had seen both the pt and her husband (please see report 2000015518-1 for details regarding the husband) "in consult concerning Lyme disease and vaccination with LYMErix. Both suffer from disabling joint and muscle pain. The pt has developed autoimmune Lyme disease secondary to the vaccine. She is HLA-DR4 positiive and does not, as far as we know, had Lyme disease in the past. This means that we cannot reat her with antibiotics to alleviate the pain." She indicated that the pt was ,"right now, in significant pain. this is not merely an "arthritic" condition that anti-inflammatories relieve." On 11/06/2000, Lyme IgG and IgM western blots were negative. The IgG western blot demonstrated a 31kd band. The most recent info, received 06/26/02, did not provide the outcome of the reported events. Info received on 05/14/02 indicated that fatigue, numbness, tingling, episodes of paralysis, joint pain, and muscle pain persisted as of April 2002. Information received on 04/05/2002 indicated that headache, and depression persisted as of 10/25/01. This case is considered medically serious as the pt is considered incapacitated. The follow up states that on 04/04/01, the pt sought a second opinion for her left and right shoulder problem from an orthopedic surgeon which she had seen for right shoulder pain/bursitis prior to receiving LYMErix. The orthopedist noted that the pt had been intermittently treated for years for pain in both shoulders and had responded to cortisone injections. The physician noted his impression as bilateral impingement syndrome and autoimmune arthritis secondary to Lyme vaccine. On 05/30/01, the pt was seen for follow-up by her orthopedic surgeon (the one seen for second opinion). The physician noted that the pt's MRI from 05/24/01, revealed mild tendinopathy in the right rotator cuff without evidence of rotator cuff tear. He noted that the pt complained tha the shoulder was "still more painful" and that she chose to decline having arthroscopic surgery. On 06/08/01, the pt was again seen by the orthopedic surgeon. The pt complained of a two month history of left posterior hip pain. The physician noted that examination of the pt was unremarkable and she had ful pain-free range of motion and tha tx-rays of the left hip which included the left hemi-pelvis revealed no evidence of obvious fracture, dislocations or bone destruction. The physician recommended a bone scan given the pt's family history of paternal bone cancer. On 12/19/01, the pt was seen by the orthopedic surgeon. The pt complained of lef thsoulder pain, one week in duration and right shoulder pain, one day in duration. The physician noted that the pt couldn't lift either shoulder more than 20 or 30 degrees before experiencing severe pain. She received cortisone injections and was prescribed ten tablets of Flaxeril. In a newspaper article, the pt stated that her physician beliees LYMErix caused her experiences. The most recent info, received 12/2/02, did not provide the outcome of the reported events. Information received on 5/14/02 indicated that fatigue, numbness, tingling, episodes of paralysis, joint pain, and muscle pain persisited as of April 2002. Information received on 4/5/02 indicated that the headaches, and depression persisted as of 10/25/01. This case is cosnidered medically serious (OMIC) as the pt is considered incapacitated.