Age: 77.0
Sex: M
Vaccine: LYME
Symptoms: Back pain, Injection site erythema, Joint swelling, Mental impairment, Pain
Clinical narrative: This report describes the occurrence of back pain in a 77 year old male who received Lyme disease vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings, with forwarding of medical records. The subject's medical history included arthritis, anxiety, vertigo (1994), metastatic prostate cancer (poorly differentiated adenocarcinoma, Gleason score IVV; 1993), weight loss, tobacco use until 1992, "severe" steroid-dependent chronic obstructive pulmonary disease, asthma, hypertension, hyperlipidemia, "severe" coronary disease, unstable angina, "mild" claudication, "mild" mitral regurgitation, "mild to moderate" tricuspid regurgitation, "1+" ankle edema, right renal cyst (1998), constipation, diverticulosis, and colon polyps. Surgical history included right hip replacement (1983) and removal of rectal polyps (8/21/98). There were no known allergies. A total bone scan performed on 7/13/93 revealed areas of increased uptake involving dorsal and lumbar vertebrae that "suggest metastatic tumor" from the prostate. Concurrent medications included Atenolol, Imdur, Theo-Dur, Cardura, Brethine, Trental, BusPar, Accolate, Lupron Depot, aspirin, sublingual nitroglycerin, colchicine, medrol, Lipitor, Antivert, Dulcolax, Fleets, Kristalose, and unspecified inhalers. He also received influenza virus vaccine on 9/28/00 and 11/1/01. The subject received his first injection of LYMErix on an unspecified date. He received his second and third injections on 5/13/99 and 8/30/00, respectively. In a Statement of Injuries, the subject's attorney alleged that the subject 'suffers from back pain, redness at injection site and mental health problems. Symptoms come and go." The following info was obtained from medical records. The subject presented to the vaccine provider on 3/8/01 with complaints of back pain since "walking around casino 3/3/01. Naprosyn helping." The physician's assessments were "low back  pain DJD suspected, R/O met disease, prostatic ca, progressive constipation/history of polyps." The physician ordered an x-ray of the lumbosacral spine, which was performed on 3/22/01 and revealed demineralization of the bony structures. The physician also ordered a bone scan, which was performed on 3/22/01 and indicated that a bone metastasis in the lumbar spine area could not be completely excluded. The subject remained under the care of this physician until at least 6/20/02. During this time, the subject reported decreased back pain and increased left hip pain. During this time period, the physician noted, "+1 ankle edema both ankles" and "decreased range of motion of hte left hip with pain." On 3/28/02, the subject reported "back ok." Following the reported onset of back pain, the subject experienced an upper respiratory infection with cough, acute bronchitis, edema both ankles and left hip pain. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info was received 9/24/02. As of 3/28/02, the subject's back was "OK." Outcomes of the other reported events were not provided.