Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Amnesia, Arthritis, Confusional state, Disturbance in attention
Clinical narrative: Follow up information was received from a nurse practitioner.  Medical records were received as part of litigation proceedings.  Additional information was received from a newspaper reporter. In 1977, the patient began to experience discomfort in her legs.  Atrophy of the lateral aspect of her right thigh was noted.  Although she is left handed and left side dominant, her left thigh was smaller than her right thigh.  The physician stated, "Lesion may be bilateral."  The physician recommended consideration of electromyelogram, exercise, and weight loss.  Surgical history included two full-term cesarean sections and tubal ligation.  The subject's mother had "similar ankle problems involving Achilles tension and very probably had enteropathic arthritis."  On 05/04/1999, the patient received her first 30-mcg injection of LYMErix (Lot: LY104A2).  Approximately one to two weeks later, the patient reportedly experienced joint pain in her hips, knees, and ankles; flu-like symptoms; ankle edema; swollen feet; a viral syndrome; and stiffness (NOS).  She "could scarcely walk up and down stairs."  The patient reported that she saw a rheumatologist and underwent unspecified blood tests and x-rays.  The patient stated that the rheumatologist said she had "reactive arthritis".  On 05/20/1999, the subject was seen by her primary care physician.  The medical record noted that the subject had experienced +1 ankle edema: "possible reaction to LYMErix vaccine."  The subject's medications were celecoxib (Celebrex) 100mg twice daily and nabumetone (Relafen) 750 mg twice daily.  The subject was referred to a rheumatologist.  On 05/27/1999, the infectious disease specialist wrote a letter to a nurse which stated that the patient presented now with arthralgia and myalgia.  "The subjects history is significant in that she received a Lyme vaccine on 05/04/1999 and subsequently developed polymyalgia and arthralgia predominantly of the knees and ankles...Physical examination (revealed) no other demonstrated muscle tenderness or joint swelling or redness."  The rheumatoid factor was negative.  "At the time her problems include: 1. Polyarthralgia/mylagia. 2. Recent vaccination with Lyme vaccine.  Recommendations: 1. Check pParvovirus, Ehrlichia and Eabsia titers and smear for Babesia. 2. Repeat Lyme EIA (enzyme immunoasay) and Western blot.  On an adverse event form received by the manufacturer at an unknown date, the reporting nurse stated that the patient reported on her 05/20/1999 physician visit that she had experienced joint pain, joint swelling and viral syndrome approximately two weeks after receiving LYMErix.  On 06/02/1999 the subject was seen by the physician.  She had experienced a rash which affected her entire body.  All medications were discontinued.  On 06/09/1999, the subject was seen by the rheumatologist.  The medical record noted that the subject had received an injection of LYMErix on 05/04/1999 and "subsequently developed diffuse myalgia and arthralgia...knee and ankle with dependent swelling.  On 05/31/1999, she developed a facial rash round red extended to arms, trunk resolved after five days.  05/20/1999 placed on celecoxib (Celebrex) helped pain not swelling andles and Achilles.  Three days ago developed red, nodular erythema hips."  Physical examination revealed both Achilles tendons tender and swollen, right greater than left ankle swelling, knees and hips normal.  Impression: asymetric....oligoarthritis....Doubt reaction to Lyme vaccine."  Medical records from the patient's gynecologist and gyneoendocrinologist indicated that the patient was complaining of multiple arthralgias on 05/06/1999.  Antinuclear antibody titer and rheumatoid factor measured on 05/17/1999 were negative.  The patient had elevated eosinophils 7.4% (normal 0-5%), elevated monocytes 600/cubic millimeter (normal: 0-590/cubic millimeter), and elevated globulines 3.4 gm/dL (normal: 1.3-3.4 gm/dL).  On 05/27/1999, Lyme IgG/IgM ratio was 1.34 (positive 1.10 or greater).  The symptoms were treated with an anti-inflammatory (NOS), steriods, celecoxib (Celebrex( 100mg twice daily for 1.5 weeks, and nabumetone (Relafen) 750mg every 12 hours.  On 06/02/2000, the subject was seen by the rheumatologist.  The subject never had the lab work or x-rays performed.  She did take Voltarun and Azulfidine.  The medications seemed to help her symptoms.  "Everything hurts.  Sleeps well, wakes rested.  No joint swelling.  Stiff AM all over improves with activity. " "Like I have the flu".  Better after shower.  Three weeks ago tick bite.  (Received) 10-day (course) of clarithromycin (Biaxin).  Impression: FMS (fibromyalgia syndrome), previous problems seem to have resolved.  On 06/11/1999, the rheumatologist summarized his findings in a letter to the subject's primary care provider.  "On examination, she has tenderness of both Achilles tendons and they are swollen, not at the insertion, but in their mid portion.  She has asymmetric swelling of the ankles, the right more so than the left.  Bith andles are painful to flex and extend.  The right ankle is somewhat warm.  She has nodular tender skin areas over the right head of the fibula, the right calf in it's mid portion and over the left anserine tendon.  There are no knee effusions and the hips have a normal full range of motion.  There is no pain.  There is some tenderness over the left sacroiliac dimple.  Interestingly, her mother , who is deceased from breast cancer, had Crohn's disease and had similar ankle problems involving the Achilles tendon and very probably had enterophathic arthritis.  My working diagnosis at this juncture is that the subject has reactive arthritis, or at least, an undifferentiated spondyloarthopathy.  The role that the Lyme vaccine plays in this is purely speculative....I am going to treat the subject as if she has reactive arthritis.  I am going to start her on diclofenac sodium (Voltaren) 75mg twice daily.  I am obtaining x-rays of her ankles to look at her Achilles tendons and her heels.  I will also check her sacroiliac joints to see if there is any evidence of sacroilitits radiograhically.  If sacroilitis is present radiographically, that would point to a more chronic subclinic proces that may have been activated due to some antigenic challenge.  I think overall, her prognosis is good.  Usually, reactive arthritis lasts for a period of three to six months."  The Lyme Western Blot performed on 06/16/2000 was negative.  Polymerase chain reaction testing revealed that the subject was HLA-DR4 negative.  On 06/28/2000, the subject was seen by the rheumatologist.  "PMS (fibromyalgia syndrome), stressed, reuridic house, wakes one time pernight, Voltaren helps; labs negative.  Impression: stress related symptoms.  Sensitive Voltaren, add emitriptyline hydrochloride (Elavil)."  On 06/26/2000, the subject called the rheumatologist to report that her hand stiffness had increased although she was sleeping well on Elavil 20 mg.  She was seen by the rheumatologist.  The medical record noted that "Hands feel swollen, do not look swollen; increased pain; complains of hot flashes; sleeps better.  Plan: discontinue Voltaren, change to ibuprofen (Motrin); continue Elavil."  Unspecified radiologic testing performed on 06/16/2000 revealed "Some narrowing of the right and left sacroiliac joint, more so on the right than left."  On 09/20/2000, the subject was seen by the rheumatologist.  The medical record noted that "The patient was off Elavil; sleeps OK; pain bad.  Plan: try adding cyclobenzaprine hydrochloride (flexeril) at hour of sleep."  On 09/25/2000, the subject was seen by the rheumatologist.  The medical record noted "increased pain over sides of hips, hurts to sleep on side.  Plan: discontinue Motrin; try codeine 300mg every 6 to 8 hours."  The information received on 01/31/2001 did not provide an outcome.  In a news article published 06/25/2001, a reporter stated, "The stiffness and swelling has become so severe that she is dependent on anti-inflammatory drugs to keep her mobile."  The patient stated, "I just keep moving.  It doesn't get rid of the pain, but it keeps me from stiffening."  The outcomes of the flu-like symptoms and viral syndrome were not reported.  On 02/11/2002, in a Statement of Injuries, her attorney alleged that the vaccinee "sufferes from 'severe' joint pain and stiffness." The most recent information, received on 10/31/2002, did not provide the outcomes of the reported events.  The adverse event of "reactive arthritis" does not meet ICM serious critieria, but is being submitted as an expedited report by special request per the 06/28/2000 letter. The annual follow up received on 6/19/02 states, " I have not been well since I had the LYMErix vaccine. This past winter I was finally diagnoseed with Epstein Barr and some type of autoimmune arthritis and now I have to go see doctor because I am experiencing memory loss, confusion and difficulty concentrating.