Age: 70.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Hypoaesthesia, Muscle spasms, Myalgia, Neck pain
Clinical narrative: This report describes the occurrence of joint pain in a 70 year old male patient who received Lyme disease vaccine recombinant OsPa (LymeRix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other healthcare professional. The patient submitted a report directly to VAERS. The patient's medical history included "slightly PSA (Prostate specific antigen) (5.0), low thyroid". The patient reported that he had right knee pain at the time of immunization. Concurrent medications included "Various NSAIDS (nonsteroidal anti-inflammatory drugs), Thyroid med".  An immunization record from the vaccine provider indicated that the patient received injections of LymeRix on Dec 03, 1999 (lot LY130B9). January 3, 2000 (lot LY130A9), and June 02, 2000 (lot LY130A9). The third dose of LymeRix was administered six months sooner than recommended. On a VAERS form completed by the patient, he indicated that his adverse experience began in June 2000, at an unspecified time post-immunization. For the description of the event, he wrote, "Progressive pain and disability in the following order- knee to knee to hip- fingers to shoulders to elbows to feet- earaches. Failing eyesight. Tingling on skin surface. Finger numbness, muscle pain, head neck pain." He indicated that the events were unresolved and resulted in permanent disability. On a VAERS follow up form, the patient wrote, "got very affected (sic) after third dose". He indicated that he had not recovered. He wrote, "all bones, joints, front teeth very painful- large muscle cramp and pain. Many neuropathies. Chronic sinusitis. "Under the comment section, he wrote, "This is a crippling, painful disabling at an ever increasing pace disease." He indicated that he had been evaluated by nine doctors and was receiving treatment with gammaglobulin. On September 3, 2003, the patient's attorney alleged that the patient received injections of LymeRix "on Dec 3, 1999, Jan 3, 2000, June 2, 2000 and Aug 4, 2000 according to the client." The attorney further alleged, (The patient) suffered pain and disability of his knees, hips, fingers, shoulders, elbows, ear aches, vision problems, tingling, finger numbness, muscle pain, and head and neck pain. The onset of his symptoms began in June of 2000 according to the client and his VAERS report." A 15-day follow up report received 12/23/2003 adds: The following info was provided via medical records. The pt's medical history included arthritis affecting the hips and knees, and polyarthralgia. Concurrent medication included celecoxib (Celebrex) which the pt began receiving arround the reported date of the initial LYMErix vaccination. A letter from the VAERS reporting program indicated that the pt had received LYMErix vaccinations on 12/03/1999, 01/04/2000 (rather than 01/03/2000 as reported), and 06/02/2000. Physical examination on 01/24/2000, approximately 3 weeks after the 2nd reported LYMErix vaccination, the pt was examined for complaints of excessive coldness in his fingertips. The pt expressed concern that he might have Lyme disease, and reported that he had received a 30-day supply of doxycycline which had resulted in improvement of joint pain. General impression revealed possible axonal peripheral neuropathy. There were no signs of demyelinating polyneuropathy nor marked slowing of lower extremity nerve function. Electroneuromyographic findings revealed right carpal tunnel syndrome and possible proximal radiculopathy. Diagnostic testing revealed a low B12 value, and the physician commented that the pt's mild hypothyroidism and low B12 were possibly causing or exacerbating his symptoms. Medical records indicated a possible diagnosis of Lyme disease in April 2000, treated with intravenous Rocephin. Within the following 6 months, he developed complaints referable to the neck, hands, arms, left hip and right knee, including severe migratory polyarthralgias. Extension of the right knee was limited, and the cervical spine revealed limited mobility. He experienced diffuse nondermatomal hypesthesia of both hands and fingers, evidencing Heberdan's nodes and degenerative changes. Radiography showed cervical spondylosis, disc space narrowing with giant osteophytosis, degenerative arthritis of the right knee and left hip, joint space narrowing, marginal osteophytes and subchrondral sclerosis with cyst formation. Magnetic resonance imaging was positive for a possible medial meniscal tear of the right knee. He was diagnosed with multifocal degenerative arthritis. At that time, it was noted that he had received intravenous Lyme disease treatment on 2 previous occasions. In Oct 2000 the pt underwent arthroscopic debridement and meniscectomy of the right knee. He had improved by the following month, and was referred for a neurological evaluation for previously diagnosed polyneuropathy. Treatment medications included Daypro, Vicodin, Mobic, and Celebrex. In Feb 2001 he received a steroid injection in the right knee, and the following week reporting feeling "75 percent better". Lyme ELISA was positive, but IgG and IgM Western blot tests were negative; however, he received intravenous Rocephin after presenting to the ER the weekend prior to 06/20/2000. Examination revealed mild tenderness over the left trochanteric bursa, limited range of motion of hips, crepitus in the right knee. Assessment incuded "diffuse myalgias and arthralgias for months" and "definite osteoarthritis involving multiple joints, but particularly the right knee and the left hip". Knee pain improved in the following month, although left hip pain continued. He also complained of lower back pain and muscle spasm. He reported limited relief with Aleve, which was replaced with Anaprox and Flexeril. By Nov 2001, the pt continued to experience body pain assessed as osteoarthritis of multiple joints, most severe in the right knee and left hip, in addition to myalgias and arthralgias of unclear etiology. Treatment with Naproysn was initiated. The evaluating physician stated that "the chance that this is active Lyme disease is very slim. It is possible that he could be having a reaction to the vaccination last year." On 09/30/2003, the pt experienced ear pain and dizziness, and was diagnosed with babesiosis. He was treated with Mepron and Zithromax. Following the reported onset of joint pain, the pt experienced wheezing, possibly attributable to seasonal allergies. This event was not reported as an adverse event due to vaccine administration, but was found during the course of review of the pt's medical records. Therefore, it is not listed as an adverse event. The most recent info received on 12/8/2003, did not reveal the outcome of the reported events.