Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Neutrophil count increased, Nuclear magnetic resonance imaging brain normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative, White blood cell count normal
Clinical narrative: On 12/8/99 and 1/17/00 pt received first and second doses of Lymerix. As a result of the cross-reaction between OspA protein and the HLA-DR4 gene, the pt experienced treatment-resistant Lyme arthritis. Time to onset from Lymerix administration was not provided. As of 8/2001 the treatment and outcome of the Lyme arthritis were not provided. The AE "Lyme arthritis" does not meet the ICH serious criteria but is being submitted as an expedited report by special FDA request per the 6/28/00 letter.  A 15-day follow up report received 12/07/2001 adds: Report 2001020289-1 describes Lyme arthritis in a 45-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. Medical history included expressing the HLA-DR4 phenotype, "anxiety with high stress job", vertigo, allergy to tetracycline manifested by rash, allergic rhinitis, chronic Lyme disease, chronic moniliasis, malar blush, eczema (1990), hypertension, hypercholesterolemia, atypical chest pain (1995), mitral valve prolapse, bradycardia (09/13/1999), St-T wave abnormalities (09/13/1999) shortness of breath, varicose vein removal in the right leg (1993), diverticulosis, acute infectious colitis (1998), irritable bowel syndrome (1998), obesity, right temporomandibular joint dysfunction, myopia, presbyopia, benign cystic breast disease, cervix cryosurgery (1974) following an abnormal Pap smear, right-sided pelvic pain (1987), menorrhagia (1996), and endometriosis (1997). In 1979 and 1990 the pt experienced motor vehicle accidents. Following the 1990 accident, she experienced right foot "spasm and numbness" with exercise. She experienced cervical spine and right wrist pain, and right hand numbness. Her symptoms were aggravated when she played the piano. She also experienced ulnar neuropathy of the left elbow. She had radiculopathy in 1997. Following the reported onset of the Lyme arthritis, the pt was noted to have bilateral hearing loss after flying (attributed to "severe" carumen impaction by an ears-nose-throat specialist), incompetent valves in the left superior femoral vein, mitral regurgitation, palpitations, sleep apnea, hearburn and a uterine fibroid. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. Concomitant medications included echinyl estradiol/levonorgastral (Alesse-28)quinapril (Accupril), unspecified vitamins, calcium and saline. On 12/08/1999 the pt received her 1st injection of Lymerix. The vaccine was administered at her workplace. On 12/13/1999, 5 days post-immunization, she experienced pain in her legs at night, sore throat, tiredness, diffuse achiness, ear pain, gum pain, and sinus congestion. She initially self-medicated with ibuprofen (Advil). Her symptoms persisted, and she saw her primary physician on 12/27/1999. A diagnosis of viral syndrome was made and and physician prescribed loratadine 5 mg/pseudoephedrine 120 mg (Claritin-D) twice daily, mometasone furcate (Nasonex) two sprays daily, and paracetamol (Tylenol). The pt was seen in the ER on 01/01/2000. She reported that she "was coughing up diffuse green junk", had a feever of 103 degrees R, and "severe upper respiratory tract infection, bladder infection, possible kidney infection". She reported later that she was treated with "a lot of IV (intravenous) Augmentin". Medical records indicate that she was seen by her primary physician on 01/03/2000. The physician noted that the pt had been seen in the ER, where a diagnosis of urinary tract infection was made. The ER physician prescribed amoxicillin/clavulanate (Augmentin) 375 mg twice daily. The pt subsequently reported that she was "out of work for approximately 14 days in early January". The pt reported that she continued to feel "quite achy" and self-medicated with ibuprofen (Advil). The pt received her 2nd injection of Lymerix on 01/17/2000; this injection was also administered at her workplace. Her achiness persisted. On 01/28/2000, she experienced sudden, sharp pain in her right foot and knee. She was seen in the local ER. She reported that her foot, ankle and knee were "somewhat swollen". The ER physician prescribed indomethacin (Indocin). The pt was seen by her primary physician on 01/30/2000. The pt reported that Indocin upset her stomach, so she took naproxen (Naprosyn). Theh physician noted the ER physician's as possible gout. The physician also noted that the pain was "better on Naprosyn". On 01/31/2000, uric acid concentration and erythrocyte sedimentation rate were normal. Rheumatoid factor IgG and antinuclear antibody (ANA) titer were negative. The pt reported that she was out of work from 01/28/2000 "to approximately" 02/20/2000. On 02/02/2000, the pt reported to her primary physician that she had received 2 injections of Lymerix and that her pain had begun following receipt of the 2nd injection. The physician instructed her not to receive the 3rd injection of Lymerix. Lyme IgG and IgM Western blot analyses were performed on 02/07/2000; both were reported as negative. No IgM bands were present. The IgG blot demonstrated only a 30 kDa bank and a 31 (corresponding to OspA) kDa band. The pt's pain persisted, and she was referred to a rheumatologist. The pt was seen by a rheumatologist on 02/15/2000. At that time, she was taking no medication for pain. The rheumatologist wrote, "She still feels a little discomfort in the area of the forefook and knee. She still feels this might be a little bit swollen but her symptoms are nowhere near as severe as they had been." The rheumatologist also noted, "Other medical problems include a malar blush for quite some time. She has been tested in the past for lupus and this has come up negative." Upon physical examination, "Her upper extremities revealed good range of motion of all her joints without any pain, swelling or deformity, other than some minor discomfort in the right thumb. Lower extremities revealed good range of motion of all of her joints. She does have some crepitus on movement of the knee, a little bit of pain on movement of the knee, and some tenderness across the metatarsal heads and the ankle on the right, but I really could not demonstrate much in the way of swelling. Theh left side was normal. There was no evidence of any skiin rash, other than she does have a malar blush." The rheumatologist further wrote, "At this point I do not believe we can made a specific diagnosis on this lady, other than to say that she probably had some type of a reactive arthritis. Whether it is due to her Lyme vaccine or something else is unclear...I have made no particular recommendations as to treatment since overall she seems to be improving anyway." On 02/15/2000, anti-streptolysin O (ASO) titer and parvovirus B19 IgG were elevated. Sjogren's antibodies (SSA and SSB) and parvovirus B19 IgM were negative. The pt was seen by the rheumatologist on 03/01/2000. At that time, "much of her aches and pains have pretty well resolved." The rheumatologist noted, "the only thing that we have come up with in the bloodwork is an elevated ASO titer and the evidence of Parvo Virus (sic) sometime in the past. Whether or not this relates to the illness that she sustained of feeling quite sick back in Dec is unclear. The other possibility is that this could be due to the Lyme vaccine. She has no plans on taking further vaccines. I have not set up a return visit to see her and if were to place a diagnosis on her I would call it a reactive arthritis." The pt was seen by her primary physician on 06/22/2000. The pt reported that she continued to experience joint pain and had seen a "Lyme vaccine specialist". She also reported that she was unable to exercise due to joint pain. On examination, the pt had on movement of the left elbow. There was no swelling present. The physician's assessment was "Post Lymerix arthralgias". On 07/26/2000, the pt was seen by a physiatrist. The reason for the visit was recorded as "to evaluate (the vaccines), review her records and write a report commenting on objective findings and her disability status." At the time of the evaluation, she was taking clarithromycin (Biaxin) 500 mg twice daily, quinapril (Accupril) 20 mg daily and saline. The physiatrist wrote, "Her symptoms are that of chronic fatigue, difficulty walking and muscle aches and pains along with joint aches and pains. She reports that she was originally out of work for approximately 14 days in early January and then went back to work and had a second episode of disability from 1/28/00 to approximately 2/20/00. At that time she was at work in the cafeteria when she could not walk because of foot pain. Subsequently, her third disability episode occurred starting 6/13/00 to the present. At that time she felt that she was just too weak and fatigued to continue working, and her Lyme disease physician...agreed with her decision not to go back to work and to just rest and let her body recuperate. The pt states that she has total body pain, particularly bad in her left arm and left wrist. She cannot put any weight on the ball of her right foot when she walks because of pain. The knees are also weak and painful...The pt states that her pain is made worse by damp weather. Heat and rest make the pain better. Her pain is frequently constant. Her pain is presently an 8 on a 10-point scale...She describes stiffness and pain and difficulty doing most things...Her typical day is described as sitting, resting, watching TV, reading and occasionally she may eat out". The pt reported that "She also plays piano and states that she is a concert pianist and does that on the side when she can. Lately she has not been playing the piano because her fingers hurt. The pt reported that "she becomes very fatigued and often needs to take a nap during the middle of the day." Using the Pain Disability Index, "she has a 30% disability for family and home responsibility, 50% disability for recreation, 90% disability for social activities, 90% disability for occupational activities, 90% disability for sexual activity, 50% disability for self-care, and 50% disability for life support activities." Using a pain drawing, the pt indicated that "There is achiness along the neck, low back, both arms, and into the hands which extends beyond the boundaries of the diagram. There is achiness in the knees, the thighs, and the legs. There is stabbing pain in the right foot and achiness in the left foot." On physical examination, "there are no obvious deformities except for some thickening of her right foot metatarsophalangeal (MTP) joint consistent with osteoarthritis. Both first MTP joints are tender to palpation. Neither one is actively swollen or inflamed. In the hands, there may be a hint of edema in the left hand, more in a diffuse global fashion, and more significant in the thumb, index and long finger. However, I do not feel any active effusions in any of the small joints or in the wrists. She has full passive range of motion of the small joints in the digits of the hands. There is full range of motion of the shoulders and elbows and knees and hips. There is a slight amount of crepitation of the left knee. No effusion appreciated. There is generalized tenderness on palpating along the radius of the left forearm, and, to a lesser degree, on the right. No subcutaneous nodules are appreciated...There is no evidence of muscle atrophy in the upper or lower body. Muscle strength is difficult to grade on objectively in this pt. It is difficult for me to tell whether she is giving full effort". The physiatrist's impression was "Myalgia and myositis, unspecified." He wrote, "The nature of her disability thus would have to be stated as generalized myalgia and myositis and generalized fatigue and weakness...I would try to limit her disability to 3 months maximum and try to work with her personal physicians in getting her back to work in some type of limited capacity or limited duty." The pt was seen by her dentist on 08/07/2000. The following was recorded under "Planned Treatment Schedule": Will need to change in 2001 all amalgam fillings to composite (autoimmune disease)." Bone densitometry was performed on 08/10/2000 for an unspecified reason. The radiologist's impression was "Findings fall within normal parameters." On 08/29/2000 the "Lyme vaccine specialist" wrote a letter to the pt's Disability Support Case Manager. The specialist reported that she began to care for the pt in June 2000. Lyme IgG Western blot analysis, performed 06/05/2000, was positive with 18, 23 (corresponding to OspC), 31 (corresponding to "vaccine"), 34, 39, 41 (corresponding to flagellin), 45, 54, 60 and 66 kDa bands present. Lyme IgM Western blot analysis, also performed on 06/05/2000, was positive with 23 and 41 kDa bands present. HLA-DR and HLA-DQ phenotyping, performed 06/12/2000, revealed DR4, DR13, DR52, DR53, DQ0 and DQ5 antigens. The specialist reported that the pt complained of "joint and muscle pain, severe fatigue, SOB (shortness of breath), joint swelling and stiffness, memory and concentration difficulties." The specialist stated that "Unfortunately, this status will remain a life long problem." She reported her diagnosis as "Vaccine induced autoimmune Lyme arthritis". She reported that "treatment with oral clarithromycin has to date not improved (the pt's) symptoms...Return to work is difficult after the induction of chronic disease. However, if treatment becomes available in the future, we will give (her) that option." She further stated, "I do believe that (the pt) is not capable of working at this time. Sitting, bending, walking or standing for longer than several minutes are tasks that this pt cannot do on a daily basis. Stress can only compound her injury." The pt was seen by a neurologist on 09/14/2000. At that time, the pt "complains that she has generalized painful sensations of both arms and hands. Sometimes she has difficulty raising her arm at the shoulder level due to weakness. She complains that her left arm or hand feels swollen or bruised and the pain extends into all fingers with numbness and parasthesia feeling. Lately she has also developed similar symptoms on the right arm and hand with sore feeling and numbness. Off and on she complains of painful sensations of the right ankle and toes. She is also having off and on painful movements of her knees. She complains of dizzy spells and light headaches which clears up by taking a rest." On physical examination, "There is moderate tenderness of the cervical spine. Movement of neck is full, Straight leg raising is normal bilateral. She is very anxious and tense and has anxiety shakes on both hands...There is generalized weakness of both upper and lower extremities against resistance. No wasting or abnormal movement such as fasciculations notices. Pin prick light touch is impaired on the left forearm and hand. There is also patchy sensory impairment of the right hand and forearm. Cortical sensations are normal." The neurologist's diagnosis was "Neuritis and Myositic rule out Carpal Tunnel Syndrom or Neuropathy". The pt underwent electromyography (EMG) and nerve conduction studies on 09/25/2000. The studies were conducted in the distribution of C4-C8 of both upper extremities and the paracervical muscles. The results were interpreted as normal. Magnetic resonance imaging (MRI) of the brain was performed on 11/10/2000 because of "Vertigo and Lyme disease". The results were interpreted as normal. On 08/16/2001, the pt's attorney reported that, as a result of the cross-reaction between OspA protein and the HLA-DR4 gene, the pt experienced treatment-resistant Lyme arthritis. The most recent info was received on 11/21/2001. As of 08/29/2001, the "Vaccine induced autoimmune Lyme arthritis" was ongoing. The pt was unable to work due to this event. Therefore, the event was considered disabling, and this report was reclassified as serious, unexpected. A 15-day follow up report received 12/12/2001 adds: The pt relocated. On 08/17/2001, she was seen by a physician for an establishing physical examination. At that time, she reported that she was still under the care of the "Lyme vaccine specialist" and was receiving an "experimental medication regimen" for the treatment of "autoimmune arthritis". She also reported that she had developed hypothyroidism. Her medications included quinapril (Accupril) 20 mg daily, valacyclovir (Valtrox) 500 mg four times daily, clarithromycin (Biaxin) 500 mg twice daily, celecoxib (Celebrex) 200 mg twice daily, hydrochlorothiazide 25 mg once or twice daily, alprazolam (Xanax) 0.5 mg twice daily, levothroxine (Synthroid) 1.5 mg twice daily, and a multivitamin. On physical examination, the physician did "not see any erythema around her joints, but she clearly has swollen hands. She states that her ring sizes had to be increased by two measurements. Diuretics help somewhat. Celebrex does give her some relief with the pain." The physician noted that the pt was "debilitated by joint pain. Info received on 11/21/2001 indicated that the pt was unable to work due to "Vaccine induced autoimmune Lyme arthritis". Therefore, this event was considered disabling, and this report was reclassified as serious, unexpected. The most recent info was received on 12/05/2001. As of 08/17/2001 the "autoimmune arthritis" was ongoing, and the pt was "debilitated". A 15-day follow up report received 12/19/2001 adds: The pt was seen by a cardiologist on 09/11/2001. At that time, she reported chest pain, which she described as "a very sharp transient discomfort in the center of her chest, it does not radiate and is not associated with nausea, vomiting, disaphoresis or shortness of breath. It is not brought on by exertion." She also reported that "Her activity level is severely compromised due to significant arthritis of the right knee and ankle." The pt had undergone a Persantine (dipyridamole) nuclear stress test on 08/22/2001, which was "negative for ischemia". An electrocardiogram (ECG) performed on 09/11/2001 showed "normal sinus rhythm, first degree AV (atrioventricular) block, poor R wave progression. Can not rule out inferior MI (myocardial infarction), age indeterminant." The cardiologist's assessment was "1. Musculoskeletal chest pain. 2. Hypertension. 3. Lyme disease." The cardiologist wrote, "(The pt's) chest pain symptoms are quite atypical for ischemia. Her stress test was also negative for ischemia. I suspect her symptoms are due to underlying arthritis...she does have first degree AV block on her electrocardiogram whicy may well be due to underlying Lyme disease." Info received on 11/21/2001 indicted that the pt was unable to work due to "Vaccine induced autoimmune Lyme arthritis". Therefore, this event was considered disabling, and this report was reclassified as serious, unexpected. The most recent info was received on 12/10/2001. As of 09/11/2001, the pt's activity level was "severely compromised" due to ongoing arthritis.  A 15-day follow up report received 12/26/2001 adds: The most recent info was received on 12/11/2001. As of 09/25/2001, the pt was disabled due to "autoimmune treatment resistant arthritis, which in all degree of reasonable certainty is permanent."  Follow up 07/30/2002: "On 01/28/2000, the vaccinee had a x-ray of her right foot and the physician's impression was "Noramal foot, Preliminary report is negative.  On 02/10/2000, in an Injury/Illness Incident Report filled out by the vaccinee's supervisor, it was noted that the vaccinee had "joint pain (right foot and leg) - can't walk - could be related to Lyme disease vaccinee given on 12/09/1999, and 01/17/2000.  On 06/19/2000, the vaccinee's supervisor completed an Injory/Illness incident report.  The description injury/illness was noted to be "continued pain and suffering and fatigue from LYMErix vaccine.  On 07/21/2000, the vaccinee telephone her Disability Support Case Manager and told him she had "autoimmune disease that is directly related to the Lyme vaccine.  She stated she was DR4 and that her condition is chronic and difficult to treat that she will have it the rest of her life.  Also stated she is being treated with heavy duty antibiotics.  The vaccinee stated "that all it woul dhave taken was a blood test to see if she had the antibody indicating she would be at risk and not a condidate for the vaccine.  The vaccinee stated if she would have received the third vaccinee it would have killed her.  On 08/17/2000, the vaccinee's disability support case manager received a telephone call from the patient's psychiatrist's office stating "that if a restriction of 4 hours a day and computer work only can be accommodated the vaccinee can return to work at the present time.  If restrictions cannot be accomodated, recommend disability to return to work would be approximately three months.  On 08/18/2000 the vaccinee left a telephone message for her Disability Support Case Manager.  She stated she "has chronic Lyme disease with severe fatigue....there is no possible way she can return to work...returning to work will put her health in treat jeopardy....is under [Lyme vaccine specialist]care and has strict instructions and just started her treatment."  Also the disability support case manager received a telephone message from the vaccinee's supervisor stating "the vaccinee's responsibility is computer use for job search, can accomodate restrictions of 4 hours a day."  On 08/18/2000, the Lyme vaccine specialist wrote a letter to the vaccinee's disability support case manager.  The specialist reported that the vaccinee, "felt sick after the first shot and her condition worsened after the second. The specialist tested her for HLA-DA phenotype and she was HLA-DR4 positive."  She also wrote, "Patients who receive an opp-a-based vaccine acquire autoimmune disease...(the vaccinee) is extremely fatigued, short of breath and has musculoskeletal problems.  She cannot work, even in a sedentary role."  On 08/25/2000, the vaccinee's disability support case manager telephoned the vaccinee and asked how she was feeling.  She replied, "she is severly fatigued, has severe pain in her muscles and joints especially her ankles.  Feels sometimes like her ankles cannot hold her."  He also asked her about her activities at home and she replied: "she does very little athome...just sits around the house reading and watching tv....goes to local food store, but husband carries packages....docs drive locally but husband (drives) the longer trips...sometimes sleeps during the day.  Has good and bad days sleeping through the night.  (She) feels she is totally disabled feels she cannot even work dedentary work, shortened hours and virtual office.  On 12/08/2000, the vaccinee's psychiatrist wrote a letter to the vaccinee's disability support case manager.  He wrote, "I am writing to say that on the basis of my recent psychiatric/neurophsychiatric independent medical examination (IME) of her, it is my professional opinion that the vaccinee at the present time is permanently and totally disabled from her prior position (....[her] position has been discontinued as a consequence of organizational downsizing, as I understand), and is not disabled in that way from her present work (to locate another position at her company), using facilities and services available through her workplace.  From a practical clinical perspective, the main psychiatric/neuropsychiatric factor, in my opinion, which limits the vaccinee's ability to carry out complex cognitive tasks on a sustained basis is her distractibility (from her chronic fatigue syndrome and her chronic pain syndrome), and not any inherent or underlying organicity or encephalopathy, in my opinion.  Testing and medical consultations have been done over the months to attempt to elucidate and explain the vaccinee's clinical picture, which to my knowledge, have not suggested underlying organicity or encephalopathy.  therefore, at this time, I do not feel or recommend that neuropsychological testing/evaluation be undertaken for the vaccinee."  The psychiatrist's recommendations included considering "a trial of amitriptyline (Elavil) on an empirical basis to reduce (the vaccinee's) neuropathic pain....engaging in educational programming activities...to avoid stagation and boredom while she is not involed in fulltime work....(she) should be monitored and followed with a psychiatric/neuropsychiatric follow up IME scheduled within 3-4 months....[and] Infectious Disease IME/Consultation....concerning (the vaccinee's) Lyme Disease, her immunologic response to the Lyme disease and chronic pain and chronic fatigue syndrome.  On 02/27/2001, the vaccinee had her second IME by a internal medicine and infectious disease physician and on 03/13/2001 the physician wrote a letter to the vaccinee's disability support case manager.  The physician's physical examination "revealed a mallar facial rash in a somewhat butterfly pattern over the nose and cheeks...Examination of the extremities revealed no joint fullness, swelling, rednes....There were Reynaud's changes of the toes.  There was some violacious discoloration over both first MP (metacarpal phalangeal) joints right being greater than left, however, there was no tenderness to palpation.  Patient complained of weakness in the lower extremities....In my opinion the following statements can be made.  1) This patient presents with multiple somatic complaints, however no objective physical findings were present, to support the concept of physical disability in this patient. 2) Although theoretical consideration has been given to the possble risk of severe arthritis symptoms due to the lyme vaccine in patient's who are DR 4 positive, there is no documented surveillance program CDc.  Although instances of arthritis have been reported, they have to date been reported as short lived and not permanent nor deforming.  Therefore the symptom complex is not consistent with the reported reactions seen with tis vaccine to date.  3) The credentials of this "emerging disease specialist" who is making this diagnosis of vaccine related arthritis in this patient are not clear to me, because I am not aware of what qualifications would in-fact designate such a specialty.  4) The Infectious Disease society of America guidelines for the treatment of Lyme disease been published, and they do not support a diagnosis of chronic lyme disease.  Therefore based on those recommendation, and in my opinion, further antibiotic treatment would not be indicated for this patient.  On 05/15/2001, in an addendum letter to the vaccinee's case manager,the "lyme vaccinee specialist" wrote "i have been seeing (the vaccinee) monthly since the referenced letter.  her serum Western blot for Lyme disease was positive and despite her HLA-DR4 positive status.  I hoped for some improvement by treating her with antibiotics.  Even after several months of Biaxin, treatment failed.  the vaccinee has clearly converted to chronic autoimmune disease that is not treatable.  Her condition remains the same except unstable hypertension.  i am seeing her with a dariologist for this problem.  Effot and stress still fatigue her and she continues to experience many multiple musculoskeletal problems.  On 06/21/2001, the vaccinee's case manager received medical documentation from the company's medical physician stating that the "employee's current disability condition/complaints are not related to the Lyme vaccine she received at (her employers) medical facility.  Case denied."  Follow up on 08/13/2002: "On 10/19/2000, the vaccinee was seen by her "Lyme vaccine specialist".  The physician noted that the vaccinee was fatigued and her hands and feet were swollen.  The vaccinee stated her right knee "feels like it's going to give out."  Her current medications were alpzazolan 0.5 mg and clarithromycin 500mg.  She was prescribed celecoxib 200mg and clarithromycin was discontinued.  The physician wrote, "Probably due to HLA-DR4 + vaccine.  Patient will be permanently disabled."  In a typed diary, the vaccinee listed her current medications as of 11/27/2000.  Her medications included colacoxib 200mg twice daily, quinapril hydrochloride 20mg daily or twice daily as needed.  Valacyclovix 500mg four times daily, alprozolam 0.5mg two equal to 1.0 mg three times daily, and clarithromycin 500mg twice daily (recently discontinued).  She also wrote that she took the following "vitamins for menopause, Lyme, etc.", black cohash 200mg twice daily, chaste tree berry one in the AM, 'calcium 1200' 1500mg with vitamin E 400mg daily, magnesium 600mg daily, vitamin C 1500mg daily, vitamin E 500mg daily, echinacea 750mg daily and goldenseal 600mg daily, and primadophilis 200 mg daily.  On 01/14/2001 the vaccinee completed Social Security disability forms.  She wrote in the remarks section that she was "Extremely fatigued from Autoimmune Disease.  Pain/arthritis/swollen joints/muscles is throughout entire body.  I cannot sit for longer than 30 minutes - stiffness.  Cannot squat, reach, climb, or stoop.  My arms, legs, wrists, fingers, toes are very weak and hurt continuously.  I cannot stand for very long.  I will collapse.  Knees feel like they will give out.  Condition is the worse when the weather is damp.  I have great difficulty even walking a few feet when the barometric pressure drops.  The LYMErix vaccine has also done permanent damage to my immune system.  Therefore I catch colds/flu like symptoms easily.  Need to stay away from crowds or people who have colds because my resistance is down.  Have also been tested by (Lyme vaccine specialist) and I am experiencing memory concentration problem.  I have been diagnosed by my doctore with a chronic disabling condition."  Follow up on 09/18/2002: "Medical records from the emergency room dated 01/02/2000 indicated that the chief complaints were "flu type illness times one month.  Low-grade temp-right lower quadrant pain occupied with urinary incontinence."  Temperature was 100.8F.  The emergency room physician made the diagnoses of urinary tract infection and bronchitis.  Laboratory analysis performed on 01/02/2000 demonstrated some abnormal results.  The subject was treated with intravenous normal saline, paracetamol, and amoxicillin.  The "Lyme vaccine specialist" completed a Long Term Disability form, on 03/08/2001, indicated diagnoses of autoimmune Lyme arthritis and hypertension.  Blood pressure was 160/100 mm Mg.  Medications included clarithromycin, valacyclovir, quinapril hydrochloride, and celecoxib.  The subject was "Ambulatory with certain limitations."  Physical impairments or limitations were graded "Class 4 - Marked limitation.  (60-7070)".  Functional capacity was graded "Class 4 - Complete limitation."  Mental or nervous impairment was graded "Class 4 - Patient is unable to engage in stress situations or engage in interpersonal relations.  (marked limitations)."  The physician indicated that the subject was "totally disabled" from all work and would "never" be able to perform other duties.  Follow up on 10/02/2002: "On 06/12/2000, the vaccinee completed a VAERS form.  She noted that her first injection of LYMErix Lot # LY130A9 was on 12/08/1999 at 15:00.  On 12/13/1999, she reported that she experienced flu-like symptoms, was "very achy", and went to the emergency room.  She reported she had a fever of 103 degrees F, and "infection throughout body".  She reported that she received her second injection of LYMErix Lot # LY130A9 on 01/01/2000.  Sometime later she experienced fatigue, she "collapsed could not walk", and had "acute arthritis".  She noted she was rushed by ambluance to the hospital.  She reported that as of 06/12/2000, she "still have acute pain in joints."  She indicated that the events resulted