Sex: F
Vaccine: LYME
Symptoms: Colitis, Diarrhoea, Disturbance in attention, Dysphagia, Electrocardiogram abnormal
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in female subject aged between 50 and 59 years old who was vaccinated with Lymerix for prophylaxis. Initially, a physician or other health care professional had not verified this report. Follow up was subsequently received via medical records. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced joint pain, flu like symptoms, headaches, fatigue, possible memory loss, tingling in extremities vision problems, gastrointestinal disorder, cognitive dysfunction, and decreased activities of daily life. In addition, she suffers from rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune medicated, or other mechanism, all reported caused by vaccination with Lymerix. At the time of reporting the outcome of the event was unspecified. This information was received via a statement of injuries. Follow up information was received on 09 January 2007 via medical records. According to medical records, the subjects history was notable for alcoholism, classical cesarean section, colectomy, depression, Morton's neuroma, Morton's neuroma excision, motor vehicle accident, and osteoporosis. Medical history also noted that in the early 1970's the subject had a large circular red rash with on symptoms and no treatment, benign positional paroxysmal vertigo from 1984-1987, 1997 bunionectomy of right toe and 2000 metatarsal tendon release. On an unspecified date in 1999, the subject received the 3rd dose of Lymerix. On an unspecified date in 2000, less than one year after receipt of the 3rd dose of Lymerix, the subject experienced insomnia, diarrhea secondary to microscopic colitis, 45 pound weight loss, neck and low back pain, headache, daytime fatigue, lack of energy, and musculoskeletal pain. On unspecified dates in 2001, the subject experienced cognitive dysfunction characterized as difficulty concentration, short term memory loss, decreased attention span, foggy brain, dysphagia and gastrointestinal bacterial and fungal infections. The subject was diagnosed with chronic fatigue syndrome, fibromyalgia and colitis. On unspecified dated in 2002, the subject was unable to work and left her job on disability. The subject was treated with Oxycontin, Klonopin, Provigil, Ultram, Gabitril, Neurontin. On unspecified dated between 2002 and 2006, the subject experienced blurred vision in the right eye. On 29 July 2005, results of Lyme disease test were notable for a positive Lyme disease ELISA 3.8 (normal lest than 1.0), and a Lyme western blot reactive for bands 23, 28 with IgG and negative for IgM. An MRI of the brain was performed in August 2005 which showed foci of high signal activity within the cerebral white matter. Following this analysis, medical records indicated that the subject was considered to have a chronic Lyme infection. On 31 August 2005, tests for Lupus Phospholipid antibody, Lupus anticoagulant were negative. On 06 October 2005 the subject tested positive for antiphospholipid antibodies with phosphatidylethanoloamine IgG 10.2 (normal 0.0-10.0 EU). On 01 November 2005, and echocardiogram showed increased thickness of non coronary cusp and right coronary cusp and possible sclerotic changes or vegetation of a small nature. On 11 November 2005, a brain SPECT scan showed small to moderate areas of diminished cortical activity consistent with Lyme disease. On 03 January 2006, Lyme disease DNA by Real Time PCR was negative, Lyme Disease ELISA was positive and Lyme disease western blot showed no bands present for IgM and IgG bands 41, 34, 31, and 20 present. On 06 February 2006, a MRI of spine showed disc protrusion at L1-2, L 2-4 and L 4-5 levels and L 4-5 demonstrated narrowed neural foraminic bilaterally and degenerative end plate disease. Medical records from a rheumatologist indicated that the subject was at an increased risk for stroke and valvular heart disease. A transesophageal echocardiogram indicated evidence of an infectious process causing damage to the aortic valve. Medical records indicated that the subject experienced a possible Lyme vaccine induced autoimmune syndrome. At the time of follow up reporting, 09 January 2007, chronic Lyme infection was considered an incidental finding unrelated to the Lymerix vaccine. Comment Microscopic colitis was assessed as medically serious by manufacturer (OMIC).