Age: 54.0
Sex: U
Vaccine: LYME
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain, Paraesthesia, Pharyngolaryngeal pain
Clinical narrative: This report describes the occurrence of chronic relapsing late Lyme disease in a 54 year old male who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix). This report was received as part of litigation proceedings, with forwarding of medical records. The subject's medical history included multiple food allergies, symptoms of Lyme disease since 1970, late-stage Lyme disease with neuropathy of the arms and legs, squamous and basal cell carcinomas, Bowen's disease, solar keratosis, actinic keratoses, measles and chicken pox as a child, chronic tonsillitis, chronic yeast overgrowth, hypertension, chest discomfort, hypercholesterolemia, mild mitral regurgitation, left dorsal wrist ganglion cyst, and broken fingers. Family history was significant for unspecified arthritis in the subject's father. Surgical history included multiple excisions of basal cell carcinoma, adenoidectomy, tonsillectomy, vasectomy and ganglion cyst removal. Concurrent medications included co-enzyme Q10, vitamin B complex, vitamin E, vitamin C, and a multivitamin. The subject reportedly received injections of LYMErix on two unspecified dates, the latter in June 2000. In a statement of injuries, the subject's attorney alleged that the subject suffers from joint pain in his hands, elbows, shoulders, knees and ankles. He also experiences muscular pain. he also experiences back and neck pain. The following information was obtained from medical records. The subject was evaluated by an infectious disease specialist on 8/6/01. At that time, the subject reported that he had sustained two tick bites, one on the right heel and one on the right leg, three weeks earlier. He reported receiving two injections of LYMErix, with the last one administered in June 2000. He complained of headaches, no feeling like himself, and paresthesias in the hands. The physician prescribed azithromycin. Lyme serology was negative. Please see lab data section. ON 8/27/01, the subject reported only mild headaches, no joint aches, and feels otherwise fine. The physician noted, no further treatment. The subject presented to an alternative medicine specialist on 10/29/01, stating that he had received two courses of azithromycin following the July 2001 tick bites, but seemed to have a relapse after each course of antibiotics and is now requesting IV vitamin C, which helped him three years ago. His symptoms included general fatigue and feeling lousy, stiff neck, and back pain. At times his heels also hurt. No abnormalities were noted on physical examination. The physician's assessment was Lyme disease with arthralgias. The physician administered three vitamin C infusions. The subject returned to the infectious disease specialist on 12/27/01 with recurrence of syndrome consisting of multiple arthralgias, myalgias, headache, fatigue, neck discomfort, stiffness, throat pain. Physical examination negative. The physician's impression was chronic relapsing late Lyme disease. He prescribed azithromycin. Lyme serology was negative. Please see lab data section. The subject returned to the infectious disease specialist on 1/11/02. he reported that he had discontinued azithromycin therapy after two days. He reported that an alternative medicine physician had made a tentative diagnosis of systemic yeast and prescribed anti-yeast vitamins and fluconazole. Following the administration of LYMErix, the subject experienced possible systemic yeast, unstable angina, telangiectasis and skin hyperpigmentation. 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 information received on 10/4/02, did not provide the outcomes of the reported events.