Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Hypersensitivity, Joint stiffness, Laboratory test abnormal
Clinical narrative: Report A0370173A describes osteoarthritis in a 67 year old male who was vaccinated with Lyme disease vaccine recombinant. This report was received as part of the litigation proceedings, with forwarding of medical records. The subject submitted a report directly to VAERS. The subject's medical history included a gun shot wound to the chest (1945), cyst on the left side of the head (1987), "increased tiredness" (1997), dacryocystitis, allergy rhinitis, deviated nasal septum, nasal polyps, bursitis (1995), intermetatarsal neuroma (1995), joint pain (1997), hypercholesterolemia, sinus tachycardia (1996), premature strial contractions, supraventricular tachycardia (1996), labyrinthine dysfunction (1996), postional syncope (1996), bilateral spermatocela (1997), benign prostatic hypertrophy, acute cholecystitis, cholelithiasis (1990), three functioning kidneys, and glaucoma. The subject had no known drug allergies. Surgical history included apendectomy (1997), cholecystectomy (1990), nasal turbinectomy (1997), and nasla polypectomy (1998). Concurrent medications included Mycelex, and Nasonex. The subject received injections of LYMErix on 2/22/99, 3/23/99 and 2/3/00. In a Statement of injuries, the subject's attorney alleged that the subject "suffered from a fever which lasted months. He also suffers from joint pain, aches, stiffness and soreness throughout body, including legs, knees, back, neck, wrists and fingers which progressively developed after each of three vaccinations with LYMErix. He also suffers from fatigue." The following info was obtained form medical records. No adverse events were recorded in the vaccine provider's office records following the first and second injections of LYMErix. The subject presented to the vaccine provider on 2/23/00, 20 days following the third injection of LYMErix, with a complaint of "One week after LYMErix joints in knees and fingers painful." On physical examination, the physician noted the joints to have full range of motion and no swelling. The physician's impression was "arthralgia secondary to Lyme vaccine?" He prescribed Celebrex The subject remained under the care of this physician until at least 12/14/01. During that time, the subject reported "increased muscle aches and joint aches," stiffness in the joints of his knees and neck, "feverish at times," and stiffness of the wrists. During this time, the physician noted full range of motion of the hands, tenderness of the left knee medially, tenderness of the hamstrings, decreased flexion of the left knee, and "creak" in the knees. Lab analyses performed on 3/6/00, 6/19/00 and 7/26/00 were within the reference ranges. X-rays performed on 7/3/00 revealed abnormalities. The physician made a diagnosis or arthritis on 6/7/00. He referred the subject to a rheumatologist. The subject was evaluated by a rheumatologist on 9/18/00. The subject stated that he developed "musculoskeletal symptoms after receiving LYMErix injections. The pt stated receiving his first injection on 2/22/99 and receiving his second injection on 3/23/99 at which time he developed arthralgias and fevers. The pt received his third shot, this year on 3/3/00 with worsening musculoskeletal symptoms. THe pt complains of morning stiffness of his hands without associated swelling. He complains of right foot pain. He additionally complains of cervical spine limited range of motion. He complains of knee pains with ambulation. He denies any hip or low back pain. He complains of bilateral shoulder pain. There is no history of psoriasis or inflammatory bowel disease. The pt denies any lupus-like symptoms nor any myositic symptoms. The pt complains of xerostomia. The subject stated being tired on Celebrex unfortunately having gastrointestinal side effects. The pt states taking glucosamine with clinical improvement." On physical examination, the physician noted "Cervical spine tenderness in flexion, extension, rotation and lateral bending. Degenerative changes of the hands are noted. Knees crepitus, tenderness. No effusions noted." The physician's impression was "the subject appears to have had allergic reactions to the LYMErix injections. More importently, hte pt's current musculoskeletal complaints are certainly not related to after effects of the LYMErix injections. They are easily explained by generalized osteoarthritis, which is noted on x-rays performed in July. Additionally, both clinically and via serology performed by the vaccine provider, there is no evidence that the subject has an inflammatory arthropathy or connective tissue disease. The pt and I discussed various medical treatments for his osteoarthritis. The pt feels that his symptoms, at this time, are not severe enough to warrant a daily anti-inflammatory medication nor does he want selective injections either cortisone or visco therapy for his knees at this time." A variety of serologies for Lyme disease were perfomred on 10/29/01. The lab's overall interpretation was "No evidence of seroreactivity beyond that expected from the Lyme vaccine." Following the reported onset of osteoarthritis, the subject experienced bronchitis, xerostomia, kidney stone, glossitis, nasal turbinate hypertrophy, "slight" tortuous ascending aorta, increased total bilirubin concentration, sexual dysfunction, and left mid pole renal cyst. These events were not reported as adverse events due to vaccine administration but wee found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info received on 9/24/02, did not provide the outcomes of the reported events. Follow up on 02/26/04: "The most recent information received on 12/24/03 did not provide the outcome of the reported events."