Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Headache, Influenza like illness, Lymphadenopathy, Muscle twitching
Clinical narrative: Report A0362649A describes rheumatoid arthritis in a 50 year old male who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, with forwarding of medical records. Medical history included Lyme disease (with tiredness, arthritis, and neuritis 1986), joint pain (hand), high blood pressure, chest pain, myocardial infarction (1999) managed with Beta blocker (metoprolol tartrate) and aspirin, trace mitral insufficiency, concentric left ventricular hypertrophy, sinus arrhythmia, sinus bradycardia, palpitations, coronary artery disease, left posterior fascicular block, non specific ST abnormality, hyperlipidemia, fatty liver, chronic pancreatitis, sigmoid polyp, abdominal pain, diverticulitis, back pain, fall, plantar spur, cellulitis, allergic rhinitis, multiple nevi, and occasional marijuana usage. Surgical history included colonoscopy with biopsies and heart catheterization. The subject smoked two packs of cigarettes per day. The subject had no known drug allergies. There was a family history of osteoarthritis and Alzheimer's. Concurrent medications included metoprolol tartrate (Lopressor), aspirin, amoxicillin/clavulanate potassium, simvastatin, cortic ear drops, amoxicillin, loratadine, cluticasone propionate, and ammonium lactate. The subject received injection of LYMErix 3/2/00 (lot LY130N4) and 5/30/00 (lot LY144B9). on 2/12/02, in a statement of injuries, the subject's attorney alleged that the subject suffers from joint pain, especially, his knees and hands swell and ache. He experiences pain in his back, hips, groin, and feet. He also experiences muscle aches and twitching. In addition he has eye problems and buzzing in his ears. He experiences flu-like symptoms and fatigue and his glands have swollen. He also suffers from fatigue, a stiff neck and he has decreased sex drive. The following information was obtained from medical records. The subject presented to his vaccine provider on 8/15/00 with complaints of knee pain. The physician's impression was illegible. Lab analysys performed on 8/15/00 demonstrated normal results. Please see lab data section. The subject remained under the care of this physician until at least 12/4/01. During this time, the subject reported foot swelling. The physician made a diagnosis of Lyme disease with rheumatoid arthritis. The physician prescribed meloxicam. Per pharmacy records, the physician also prescribed amoxicillin/clavulanate potassium, amoxicillin, and nabumetone. The subject as evaluated by another physician on 9/28/00. The subject reported that following the second injection of LYMErix, he developed knee, ankle and hand swelling; neck pain; muscle pain as if exercising; hip pains; left ear aches; eye twitching; muscle twitching and cramping; profound fatigue; paresthesias of the fingers and feet; and intermittent nausea. The physician noted he had no fevers, sweats or cognitive changes. The subject had a family history of osteoarthritis and Alzheimer's. On physical examination, the physician noted bilateral knee effusions and Heberden's nodes. Lyme serology was equivocal. Pleas see lab data section. The physician prescribed weekly IM injections of benzathine penicillin G, magnesium, and vitamin B12; discontinuation of cigarettes; physical therapy; diet; and meloxicam. The subject remained under the care of this physician until at least 1/7/02. During this time, the physician noted noticeable improvement on shots on 11/16/00; increased symptoms day 10-14 and in exactly 21 days after that flare, multiple joint pain and  new neuropathic pain right leg. She noted he also had increased gas and bloating on 12/21/00; progressive improvement of all symptoms with 24 day cyclical fares; left knee with slight prepatellar bursitis; definite improvement with last flare lasting only 2 days and less intense and knee better on 3/25/01. He had increased headache, constant back pain, and increased knee pain. His MRI showed arthrtiis/Baker's cyst. He had a left knee effusion on 4/30/01; ongoing fatigue, headaches, neck pain, bilateral knee pain. Taking Celebrex as needed. Lyme in remission. Post-vaccine arthritis on 6/28/01; rheumatoid arthritis: was improving on Arava but stopped few days ago - rash....fatigue. No response to Celebrex on 8/9/01; knees without fluid on 10/11/01. On 12/10/01, the subject reported that an ophthalmologist told him that he had evidence of neurologic Lyme in eye with bilateral eye pain and right eye twitching on and off. 3 headaches bi-frontal. On 1/7/02, the subject reported right temporomandibular pain - acute onset lasting three to six hours radiating to face, ear, and neck, citirizine hydrochloride for headaches as needed, leflunomide, ibuprofen, doxycycline, hydroxychloroquin phosphate, and gabapentin. Pharmacy records indacted the physician also prescribed meloxicam, methylprednisolone, and ciprofloxacin hydrochloride. Lab analysis performed on numerous dates demonstrated some abnormal results. Please see lab data section. The subject was evaluated by an orthopedic surgeon on 4/4/01 for multiple and diffuse arthralgias. At that time, the subject reported that he had been treated with antibiotics for the past four months for Lyme disease. He expressed some concern about having had the Lyme vaccine in the past. The physician advised him that he had no specific knowledge about reactions to Lyme vaccine. The subject complained of left knee pain that he had for the past several months. The subject denied any history of effusions, locking or giving way. On physical examination, the physician noted exquisite tenderness over the anteromedial joint line. Range of motion is from 0 to 130 degrees. The knee is stable to varus/valgus and anterior/posterior stress. The left lower extremity is neurovascularly intact. Standing AP and lateral views of the left knee show no abnormalities. The physician's impression was I feel the subject may have a medial meniscal tear because of his significant disability related to this. The physician urged the subject to continue meloxicam therapy. MRI performed on 4/6/01 showed some abnormalities but no discernible meniscal tear. Please see lab data section. The subject was evaluated by an orthopedist on 7/24/01 for pain and swelling in his left knee. At that time, the subject indicated he had a Lyme disease vaccine a year ago and since then he has developed aches and pains with swelling in his leg and knee and in his hip. He has been on a number of different anti-inflammatory medications but has not had any significant improvement. He is currently being treated by a Lyme disease specialist and....Avava for his pain. On physical examination, the physician noted he was neurovascularly intact, had full range of motion of his knee, mild tenderness medially, no pain laterally, no effusions present, and had full range of mition of his hip with mild tenderness radiating to the groin. X-rays of the knee were normal. The physician's impression was synovitis left knee, possibly related to Lyme disease versus the Lyme vaccine. The physician referred him back to his rheumatologist. The subject was evaluated by an ophthalmologist on 12/7/01 for eye pain. At that time, the subject reported that his eyes were sore for two months and his eyes were swollen and painful. On physical examination, the physician noted no ophthalmologic abnormalities or refractive error. He indicated that the subject had a normal eye exam. The physician made the diagnosis of eye pain - probable neuralgia. He indicated that no treatment was needed. Following the reported onset of rheumatoid arthritis, the subject experienced eczema, allergic reaction to leflunomide, varicose veins left leg, otitis externa, vocal cord polyps, yeast on tongue, athlete's foot and dyshydrotic eczema. These events were not as adverse events due to vaccine administration but were found during the course of review of the subject's medical records. Therefore, hey are not listed as adverse events. The most recent information, received on 7/29/02, did not provide the outcomes of the reported events. Information received on 2/8/02, indicated that as of 6/28/01 his Lyme was in remission and as of 8/9/01 his rheumatoid arthritis was improving.