Age: 42.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Disturbance in attention, Hypercholesterolaemia, Memory impairment, Myalgia
Clinical narrative: Report A0340224A (formerly 2000036741-1) describes arthralgia in a 42 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of litigation proceedings, in the form of medical records forwarded by an attorney. The medical history included depression, for which the vaccinee was on disability. He had no known allergies. he was a tennis pro for 20 years. He recalled having at least one tick on him. Concurrent medications also included venlafaxine hydrochloride (Effexor XR), levofloxacin (Levaquin), and atorvastatin (Lipitor). Follow the reported onset of arthralgia, the vaccinee experienced pneumonia and hypercholesterolemia. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. Subsequent to receiving the second dose of Lymerix, the pt began to experience arthralgia and myalgia involving the heel, knee and lower back. He sought medical treatment. The physician prescribed Celebrex and physical therapy. The pt was switched from Celebrex to Vioxx. The pt was again seen by the physician at which time he continued to have arthralgia and myalgia affecting the thoracic vertebrae, lower back, both shoulders and the left knee. No joint redness or swelling was noted. The pt admits that the symptoms are getting better with physical therapy. The outcome of the arthralgia and myalgia was not known. The follow up states the vaccinee returne dot the vaccine provider on 8/14/01, and reported that he was under the care of a "Lyme specialist," who had amde a diagnosis of Lyme disease and prescribed Biaxin and Ceftin. He was seen by the vaccine provider on 1/2/01. At that time, he stated that the "Lyme specialist" had made a diagnosis of "reaction to Lyme vaccine." The vacicnee complained of malaise, joint pain, and memory deficits. The vaccine provider's assessment was "Lyme." The vaccinee was evaluated by another physician on unspecified dates. The vaccinee reported "severe" joint pain in the neck and elbow that began within one week of receiving the second injection of LYMErix. The joint pain was reported to worsen the second week post-immunization. The vacicnee reported that he then expeirneced "severe" joint pain in his neck, elbow, right shoulder, left knee, and lower back. He also reported "sugar craving" and pain in both Achilles tendons. He stated that he was under the care of a "Lyme specialist," who had mad a diagnosis of Lyme disease and prescribed Biaxin and Ceftin. The "Lyme specialist" also prescribed Valtrex for the treatment of fatigue. The physician noted that "some of trigger points hurt." The physician reviewed the results of Lyme IgG and IgM western blots performed by the "Lyme specialist" on 6/19/00. The physician's assessments included "Lyme" and "Lyme vaccine." The physician prescirbed Zithromax and Bexra. On 12/17/01, polymerase chain reaction (PCR) analysis for Lyme disease was negative as were IgG and IgM western blots. He returned to this physician on 3/18/02 and reported that he was "feeling good joint wise" but was experiencing night sweats. Serum protein electrophoresis revealed a normal pattern on 4/17/02. On 2/11/02,in a Statement of Injuries, the vaccinee's attorney alleged that the vaccinee "suffers from joint pain and arthralgia in his elbows, shoulders and knees, along with back and muscular pian. He also experience fatigue, memory loss and difficulty concentrating." THe most recent info was received on 6/13/02. As of 3/18/02, the vaccinee was "feeling good joint wise." The outcomes of the other reported events were not provided. The adverse events arthralgia, memory loss, and concentration difficulty do not meet serious criteria but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.