Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Ear pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: This report described the occurrence of joint pain and swelling in a 54 year old female pt who received Lyme disease vaccine recombinant (LYMErix) for prophylaxis. This report was received as part of litigation proceedings. Medical records were subsequently provided. The pt submitted a report directly to VAERS. On a VAERS form completed by the pt on 4/23/03, she indicated that she received an injection of LYMErix on 7/5/99. For the description of the event, she wrote, "Bullseye on stomach area. Given antibodies on 5/10/99 for five to six weeks. No further problems until fall of 2002." Under relevant diagnostic tests and lab data, the pt wrote, "Lymes test was positive, after antibodies treatment Lymes test was negative in 1999." She indicated that the outcome of hte event was "Unknown." The info in the event description and lab data areas on the VAERS form is presumed to represent medical history, since it preceded the reported date of immunization. On 9/3/03, the pt's attorney alleged that the pt "suffered knee and right shoulder pain and swelling, achiness, nausea, rash, fatigue, tingling of her hands, arms, feet and toes, headaches, numbness of her arms and legs, weakness of her legs, tinnitus, swelling of her hands and headaches. The onset of her symptoms is not clear at this time." Treatment and outcomes of the alleged events were not reported. The following info was provided via medical records. Medical history included a diagnosis of fibromyalgia. The pt received LYMErix vaccinations on 7/8/99, 8/9/99 and 9/8/99. This represents a 0, 1, and 2 months schedule rather than the recommended schedule of 0, 1 and 12 months. Approximately five months after the third LYMErix administration, on 2/1/00 the pt slipped and fell on her back and buttocks, and subsequently experienced "constant and daily pain." The following week, x-rays of the lumbar spine were taken and showed a slight compression fracture deformity of T12, which was thought to represent an old compression fracture deformity. She experienced some relief with use of Aleve and application of ice. In June 2000, she complained of aches, pains, a frontal headache, and ear pain. She was diagnosed with sinusitis at that time, and arthritis was also indicated.SHe continued to experience ear problems, and in July 2001 complained of humming in her ears. However, she was again diagnosed with sinusitis, and treatment included Augmentin, medrol, guaifenesin/ Sudafed, and Nasonex. Within the following seven months bilateral ear pain, vertigo, soreness, and headaches persisted. Medical records dated 1/16/03 indicated daily but variable arthralgias, with a possible diagnosis of Lyme disease, and she received doxycycline. On 1/21/03, Lyme IgG Western blot and plasmid-b. burgdorferi results were positive. Three months later, she was evaluated for arthritis and neck stiffness. Following imunization, the pt experienced supraclavicular fat pad enlargement with associated pain symptoms, pressure, and numbness at the base of the neck, nonproductive cough, sinusitis, allergic rhinitis, gastroesophageal reflux disease, SOB, bloody stool, costochondritis, Babesiosis treated with Mepron, and sternal pain. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The most recent  info received on 12/8/03 indicated that as recently on 9/9/03, arthralgia, myalgia, malaise, fatigue and Lyme disease were unresolved.