Report A0368860A describes Lyme disease in a 56 year old female who received Lyme disease vaccine recombinant (LYMErix). The medical history included a seven day hospitalization in 1981 for acute depression with suicidal tendency, tinnitus (1985), earaches (1985), hearing loss bilaterally (1985), fall on ice striking back of head (1985), sprain right wrist (1985), buttocks contusion 91985), rectal bleeding possibly from an ulcerated area in the low sigmoid colon (1990), focal lobal breast hyperplasia; intraductal papillomatosis fibrocystic breast disease 91992), fall at work injuring the wrist and low back (1994), thigh numbness, decreased sensation, and pain (1994), meralgia paresthetica 91996), hemorrhoids, total abdominal hysterectomy/bilateral salpingo-oophorectomy, minimal degenerative joint disease (1994), hiatal hernia (1997), epigastric pain with vomiting (1997), pain after eating (1997), mild gastritis (1997), abnormal esophageal pH study consistent with reflux disease (1997), acute pancreatitis (1997), esophageal spasm (1997), low esophageal sphincter pressure 10 (1997), liver cyst (1997), left ventricular hypertrophy by electrocardiogram (1997), seronegative Lyme disease (1998), osteoarthritic changes at the distal interphalangeal joints of the fingers, the index and fifth fingers on both sides. There were also osteoarthritic changes at the first carpal/metacarpal joint space of both hands, left greater than right (1998), hand pain (1998), and polyarthralgias of unclear etiology (1998). The pt was allergic to pcn, ampicillin, sulfa, coconut, pineapple, meperidine, hydrochloride, and tetracycline. Concurrent medications included conjugated estrogens, Premarin, Zoloft, Toprol, trazodone, and Metamucil. In a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "suffers from symptoms akin to treatment-resistent chronic Lyme disease, including significant joint pain affecting her knees and shoulders along with arthralgias, fatigue, lassitude, sleep disturbance, hand swelling, and an impairment in the visual field of her left eye." On 3/29/99 the vaccinee received her first injection of LYMErix. Subsequently, she was "slightly sick." On 4/29/99, the pt received her second injecction of LYMErix. Subsequently, she had local swelling and an erythema migrans rash. On 10/17/99, the pt was seen by the physician. Her hands swelled intermittently. Impression: Lyme disease was diagnosed one year ago. In November 2000, a PICC line infused azithromycin for seven days per week for eight weeks. Her symptoms improved for the first four weeks and were worse the second days per week for eight weeks. On 12/30/00 the pt experienced severe back spasms. The pt was bedridden. MRI showed lumbosacral and hips "signs of Lyme disease." The pt has not "been well" since December 2000. On 8/9/01, the pt tested negative for the HLA-DR4 allele. On 8/9/01, Lyme disease by PCR blood was negative, Lyme disease by PCR urine was negative and Babesia by PCR was negative At the initial examination at the Lyme Disease Treatment Center, the pt was referred due to chronic hip and back pain, lateral knee pain, migraines, and twitching on "side of face." Her symptoms were arthralgias, new hypertension, palpitations withexertion, dizziness, worsened mood swings, flushes, and flu-like symptoms. On a questionnaire, she indicated that she had the following symptoms: chills, fever, sore throat, flu-like symptoms, headache, diarrhea, nausea/vomiting, irregular heart beats/palpitations, chest pain, SOB, jaw pain, neck and/or back pain, "severe" knee pain, muscle aches, stiff neck, right face twitching, left medial ankle swelling, fatigue, photophobia, floaters, hearing problem, ringing in ears, right sided facial weakness/palsy, right knee/thigh numbness/tingling sensation, forgetfulness, lack of concentration, change in ability to think, change in ability to work with numbers, change in ability to remember words, recurring rashes, and nightmares. The medical record indicated that the pt had been treated for Lyme disease for the past three years. On 8/29/01, MRI of the brain without contrast was performed. Clinical indication: Follow-up Lyme disease and evaluate pulsatile right neck mass. Impression: Normal magnetic resonance angiogram of the brain. On 8/29/01, MRI of the orbit, face, and neck with and without contrast was performed. Clinical indication: Follow-up Lyme disease and evalute pulsatile right neck mass. Comments: Transverse and coronal images were obtained prior to and following the IV infusion of Gadolinium. There are several bilateral lymph nodes along the carotid jugular chain ranging in size up to 1cm. These are ovoid in shape and have a benign appearance. There is a very small, 9mm left anterior triangle node. Bilateral small submandibular nodes are noted. The parotid and submandibular glands are normal. In the lower back, the trachea is to the right of midline and the brrachiocephalic artery crosses from its midline origin anterior to the trachea. Impression: Bilateral small jugular chain lymph nodes. Tortuous right brachiocephalic artery. On 8/29/01, MRI of the brain with and without contrast was performed. Clinical indication: Follow-up Lyme disease and evaluate pulsatile right neck mass. Impression: Stable nonspecific white matter hyperintensities. No gross change in the appearance of the brain. On 8/29/01, magnetic resonance angiography of the carotid with and without contrast was performed. Clinical indication: Follow-up Lyme disease and evaluate pulsatile right neck mass. Impression: There is a slightly tortuous right brachicephalic artery. This is regarded as a normal anatomic variant. On 8/30/01, Lyme disease by PCR blood was negative; LYme disease PCR urine was negative. Anti-nuclear antibodies were <1:40. On 9/5/01, Lyme disaese by PCR blood was negative; Lyme disease by PCR urine was positive. At the Lyme Disease Treatment Center, the medical record indicated that the pt was experiencing better sleeping with the consistent use of Ultram two at hour of sleep. She was having "better" days with minimal breakthrough pain using Darvocet daily. Her blood pressure was 150/96. Today she had increased floaters. She felt as if her blood pressure had increased. her right proximal interphalangeal joint was swollen without synovitis. Impression: hypertension untreated, arthralgias, myalgias, neurological chronic pain. On 9/27/01, a tissue culture showed scant growth of staphylococcus aureus and scant growth of staphylococcus epidermis. The physician's note in the medical record indicated that these results were "consistent with colonization." At the Lyme Disease Treatment Center, the medical record indicated that the pt had pemphigus-like eruptions. Diagnosis: Lyme disease. On 10/1/01, at the Lyme Disease Treatment Center, after three days of IV therapy for Lyme disease, the pt's hair was falling out in clumps. She complained of chest pain, midline/low sternum which felt "like someone sitting on me when I lie down." She had slightly pruritic "bumps" on inner thighs, nausea and emesis. Impression: The physician stated that the pruritus and the nausea was secondary to Rocephin. The pt had hypertension, Lyme disease, chronic pain, and chronic fatigue. Acidophilus was increased to four times daily, the diluent was changed to 5% dextrose and water. Zyrtec was prescribed. On 10/9/01 a peripherally inserted central catheter was placed. On 10/18/01, the erythrocyte sedimentation rate was 7mm/hr, the white blood cell count was 11.8 thous/MCL and the absolute neutrophils were 8850 cells/MCL. A reflex urinalysis showed trace leukocyte esterase negative, 20-40/HPF squamous epithelial cells, moderate calcium oxalate crystals/HPF, and 1-3 hyaline casts/LPF. On 10/29/01, at the Lyme Disease Treatment Center, the pt's medications were Rocephin 2gm, Zithromax 250mg daily, Zoloft 100mg every morning, Ultram 50mg two three to four times daily, Diflucan 150mg one tablet three times daily was prescribed. On 11/1/01, at the Lyme Disease Treatment Center, an office note indicated that the pt has had "a lot of good days" and that the yeast vaginitis cleared with fiflucan. On 11/8/01, the reflux urinalysis showed trace protein (negative), 6-10 squamous epithelial cells/HPF, few bacteria/HPF, and "many" amorphous sediment/HPF. At the Lyme Disease Treatment Center, the pt's cognitive symptoms flared: she was forgetful and nervous. She had right knee effusion, and increased third distal DIP swelling. She was without right peri-oral droop now. Diagnoses: Lyme disease, dermatophytosis, hypertension with fluid retention which was diuretic responsive, yeast vaginitis, recurrent depression controlled/improved, resolving sleep fragmentation. Medications: Toprol 50mg one daily, Zithromax 250mg daily, trazodone 100mg at hour of sleep, Celebrex (helps headache/pressure). Plan: Nizoral 2%, Diflucan, furosemide 20mg Wednesday and Sunday. On 11/15/01, the erythrocyte sedimentation rate was 7mm/hr, the white blood cell count was 3.0 thous/MCL and the absolute neutrophils were 870 cell/MCL. At the Lyme Disease Treatment Center, the pt complained of diarrhea, chills, sweats, tinnitus, swollen and painful hand joints, and migraine headache. She had "prominent" right eye ptosis. Diagnoses: Lyme disease, arthralgias, right knee effusion, hemorrhoidal bleed. The physician prescribed Celebrex and Metamucil and suggested increasing the pt's oral water intake. On 12/6/01, at the Lyme Disease Treatment Center, the pt complained of severe right temporal vise-like headaches, right knee pain and swelling, and drenching sweats. She had right eye ptosis. Diagnoses: Lyme disease with reactive symptoms, accelerated hypertension, sinus tenderness vs. cranial nerve VII neuropathy. Plan: nifedipine 100mg orally, discontinue azithromycin, continue doxycycline 100mg twice daily, increase Toprol to 100mg twice daily, increase oral water, increase furosemide to 40mg in the morning. On 12/13/01, at the Lyme Disease Tretment Center, the pt complained of chills and sweats, right medial knee pain, photophobia, scalp paresthsias. She had normal facies, decreased redness, decreased puffing, decreased skin eruptions. No ptosis. Diagnoses: Lyme disease, hypertension, edema, neuralgias. Fuosemde was incrreased to 80mg every morning. On 12/20/01, at the Lyme Disease Treatment Center, the pt's short-term memory was "severely impaired" and she was having intermittent chest pain. She had recurrent skin lesions on her face, neck, legs, and trunk. Neurontin helped itching and scalp/skin tingling. Diagnosis: Lyme disease on treatment, controlled hypertension, and depression. On 12/27/01, at the Lyme Disease Treatment Center, the pt complained of knee pain (left greater than right), "severe" stiff neck, diarrhea for two days (none today), sleep fragmentation, right eye ptosis. The plan was to continue Neurontin, furosemide, Zoloft, Celebrex, and Prilosec. Doxycycline, Zyrtec, and Zithromax were discontinued. The PICC line was discontinued. On 12/10/01, the erythrocyte sedimentation rate was 4mm/hr. On 12/11/01, Babesia by PCR was negative. On 1/3/01, the vaccinee was seen by the physician because of a chief complaint of headaches behind her eyes as well as the observation of floaters. She also stated that she had some photophobia at night. On physical examination, visual acuity was 20/20 bilaterally. Slit lamp was unremarkable, except for decreased tear film. Dilated fundoscopic examination showed no evidence of vasculitis or inflammation of her optic nerve. The physician's clinical impression was that she had headaches secondary to Lyme disease. He thought that her photophobia at night might have been due to dry eye syndrome. There were no objective signs of inflammation in the anterior or posterior pole of her eye. The physician recommended the use of artificial tears four times a day, as well as getting an anti-reflective coating on her glasses. He reviewed with the vaccinee the possible ocular symptoms of Lyme disease. As of 5/14/02, the outcomes of the events were unknown. The adverse events 'joint pain,' 'defective visual field,' 'migraine,' dizziness,' 'facial palsy,' 'numbness,' 'tingling,' 'forgetfulness,' 'lack of concentration,' 'inability to think clearly,' 'decreased memory,' and 'neuralgia' do not meet serious criteria, but are begin submitted as an expedited report by special FDA request per the June 28, 2000 letter. Follow up on 02/26/04: "The most recent information received on 06/23/03, indicated that Lyme disease persisted as of 02/12/03." On 15September 2004, a legal complaint was received in which the attorney alleged  that the patient, now 59 years old experienced "joint pain, fatigue, vision loss , headaches with demyelination on brain MRI. Time to onset, treatment, and outcome were not reported.