Age: 44.0
Sex: F
Vaccine: LYME
Symptoms: Upper respiratory tract infection
Clinical narrative: This report describes cramping and pain of the arms and hands of a 44 year old female who received LYMErix. This report was received as part of litigation proceedings with forwarding of medical records. The medical history included allergies to iodine, trees, grass, ragweed, house dust, dog, molds, and dust mites, for which she received allergy shots. The medical history also included allergy to iodine, seasonal and perennial allergic rhinitis, sinusitis, acne rosacea, gastroesophageal reflux disorder and low back pain treated with chiropractic. Concurrent medications included Mylanta as needed, MetroGel twice daily, Claritin daily, Flonase, nasal spray, Cefzil and Advil. The vaccinee received her third injection of LYMErix on 04/26/2002. In a Statement of Injuries, her attorney alleged that the vaccinee "suffers from pain and cramping in her hands and lower forearms, such that she cannot perform simple tasks such as holding a brush." Time to onset following immunization, treatment, and outcome of the alleged events were not reported. Medical records from the vaccine provider indicated that the vaccinee presented to the physician on 09/14/2000, four months post immunization, seeking a referral to a chiropractor for the treatment of hand and pain. the physician noted, " complains of arthralgia, unable to use thumbs well secondary to pain." On examination, the physician noted "malar rash, tenderness hands equally, increased erythema fingertips." His assessment was "Rule out connective tissue disorder." He prescribed Vioxx, but the vaccinee "refuses meds," she "would like chiropractic referral." Antinuclear antibody titer, anti-double stranded DNA antibody titer, anti-smooth muscle antibody titer, anti-ribonucleoprotein antibody titer and rheumatoid factor were negative. Erythrocyte sedimentation rate, serum complement 3 concentration, and serum complement 4 concentration were within the reference reanges. HLA typing was positive for HLA-B27. The most recent info received on 02/19/2002, did not specify the outcome of the reported events. Follow up States: Report A0360498A describes the ocurrence of a carpal tunnel syndrome in a 44 year old female who was vaccinated with LYME disease vaccine recombinant OsPA(LYMErix). The subject was evaluated by a rheumatologist on 20 Sept 2000 with a chief complaint of "hand pain for 14 months. Pain in MCP with difficult to use hands, weakness, sweating, stiffness variable (difficult to brush dog), paresthesia." Under systems review, the physician noted "Raynauds". The ohysician's impression was "pain in hands and phalen. Carpal tunnel syndrome left/right. "He prescribed a carpal tunnel brace. in addition, he ordered an x-ray of both hands and multiple laboratory tests results were not provided. Following the reported onset of carpal tunnel syndrome, the subject experienced intermittent low back pain with jogging and walking. tick bite with associated bulls eye rash, follicle based epidermal cyst, upper respiratory infection, sinusitis and bronchitis. 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. therfore, they are not listed as adverse events. The most recent information received on 28 Aug 2002, did not provide the outcome of the reported events.