Age: 36.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Headache, Hypoaesthesia, Lymphadenopathy, Malaise
Clinical narrative: This report described the occurrence of vision loss in a 35-year-old female patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis.  This report was received as part of litigation proceedings, and has not been verified by a physician or other healthcare professional.  The patient's medical history included "swollen glands and ? frequent URI's (upper respiratory infections)".  Concurrent medications included fluticasone propionate inhaler (Flovent) and an albuterol inhaler.  On 09/03/2003, the patient's attorney alleged that the patient received injections of LYMErix "on 05/13/1999, 10/18/1999, 06/14/2000 according to the client and medical records."  Only documentation of the first dose of LYMErix was provided, no lot number was provided.  If the patient received LYMErix as alleged, she received it on a 0,5, and 13 month schedule, rather than the recommended schedule of 0,1, and 12 months.  The attorney further alleged, "(The patient) suffered vision loss, depth perception problems, headaches, leg numbness, fever and shills (sic) after her first vaccination according to the client."  Vision loss is considered to be medically serious (OMIC) by manufacturer. A 15-day follow up report received 12/12/2003 adds: In Sept 2000, the pt developed a severe migraine that lasted for 5 days associated with photophobia. The events were preceded by a 3 week history of headaches. She also experienced onset of pain with eye movement and "peculiarity" in her side vision. She received low dose prednisone for 3 days for pain control. The following day, she developed scotoma of the right eye. She was diagnosed with optic neuritis, and treament included intravenous steroids. Diagnostic testing revealed positive antiphosphatidyl ethanolamine (38 with a normal of less than 2), positive antiphosphatidyl serine (38 with a normal of less than 6), slightly elevated protein C, and antiphospholipid antibodies. Magnetic resonance imaging revealed changes consistent with multiple sclerosis, although optic nerves were noted to be normal. The pt also complained of fatigue, malaise, depression, tinnitus, imbalance, and word-searching. Estrogens were discontinued. It was noted that the pt's multiple sclerosis was possibly the form associated with antiphospholipid antibodies, thus somewhat different than "classic" multiple sclerosis. She received anticoagulant agents and aspirin. A rheumatologis indicated that Lyme vaccine and estrogens were suspected as 2 "major risk factors" for potentially triggering an immunologic process demyelination. Diagnostic examination revealed positive antiphospholipid antibodies of multiple isotopes. She was examined on 09/05/2000 for follow-up of optic neuritis. At that time her headaches had resolved and her pupils were almost symmetrical. On 10/18/2000, she was examined for optic neuritis, at which time complaints included abnormal depth perception. The pt also reported that her legs fell asleep during car trips. Neurologic review of symptoms included loss of train of thought, stress, mood liability, feeling unrefreshed upon wakening, dizziness with quick changes in position, occasional choking, slight imbalance, visual disturbances, and hip pain. Extraocular movements were intact with a few beats of endgaze nystagmus. She experienced no intranuclear opthalmoplegia, although afferant pupil defect on the right with mild optic atrophy was noted. She was assessed with optic neuritis and MRI suggestive of a central nervous system inflammatory demyelinating process, and intravenous methylprednisolone was recommended for vision improvement. She was diagnosed with probable multiple sclerosis. The evaluating physician did not believe that clinically the pt had antiphospholipid antibody syndrome. Optic neuritis recovered spontaneously; however, on 08/06/2001 she was again evaluated for symptoms of blurred vision thought to be related to optic neuritis, although significantly better than upon initial presentation. On 09/21/2001, she underwent a lumbar puncture. On 09/25/2001, the pt complained of post-spinal headache which was unrelieved by codeine. On 12/04/2001, the pt was examined following a recent tick bite. The examining physician expressed suspicion that the pt's Lyme vaccination may have been responsible for her multiple sclerosis-like disease/neurologic demyelinating process. At the time of examination her neurologic symptoms were stable, and she had recently been started on Avonex. Doxycycline therapy was begun until a determination could be made whether she had received a Lyme tick bite. Medical records dated 01/22/2002 noted that the pt had a "history of Lyme disease recently created". At that time, she was functioning without complaint. On 06/11/2002 the pt was generally doing well and was tolerating Avonex. She complained of some slight paresthesias in her hands, but no other signs of exacerbation of illness. On 09/30/2002, the pt experienced no symptoms of worsening illness, although she continued to experience fatigue. Suspected multiple sclerosis was "quite stable" at that time. On 12/17/2002 the pt was "generally neurologically doing well". She experienced no visual problems, hearing problems, paresthesias, focal motor weakness, gait disorder, bowel and bladder dysfunction, or difficulties with fatigue. Multiple sclerosis was suspected; however, the physician stated that the pt "appears to have collagen vascular syndrome". Avonex was stopped at that time, and aspirin and Plaquenil for suspected collagen vascular disease were prescribed. Medical records dated 04/17/2003 indicated that the pt experienced no typical features of multiple sclerosis at that time. She did not experience fatigue, weakness, malaise nor persistent tingling or numbness in her fingers, toes, hands, or feet. Memory loss was "significant". Antiphospholipid antibodies were normalized. She was "working full time." The rheumatologist reported his impression of "MS (multiple sclerosis) versus APS" (antiphospholipid syndrome)." The pt remained unchanged at her next evaluation on 07/08/2003. Vision loss and multiple sclerosis are considered to be medically serious by manufacturer. Following the reported onset of vision loss, the pt experienced a tick bite (late Nov 2001 or early Dec 2001), finger laceration and irregular heartbeat at times. 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 11/26/2003 revealed that the outcome of multiple sclerosis was improved, but the outcome of the collagen vascular disease was not provided. On 15Sept 2004, the attorney alleged that the pt, now 40 years old experienced severe heasdaches, numbness, optic neuritis followed by optic atrophy, gait disturbance, joint pain, congnitive losses with abnormal brain MRI with demyelination treated with Avonex. Time to onset and outcome were not reported. This report described the occurrence of vision lose in a 35-year-old female patient who received LYMERIX. This report was received as part of litigation proceedings, and has not been verified by a physician or other healthcare professional. The patient's medical history included "swollen glands and 7 frequent URI's . Concurrent medications included FLOVENT and an albuterol inhaler. On 03 September 2003, the patient's attornery alleged that the patient received injections of LYMERIX "on May 13, 1999, October 18, 1999 and June 14, 2000 according to the client and medical records." Only documentation of the first dose of LYMERIX was provided, no lot number was provided. If the patient received LYMERIX as alleged, she received it on 0, 5, and 13 month schedule, rather than the recommended schedule of 0, 1, and 12 months. The attorney further alleged, "(The patient) suffered vision loss, depth perception problems, headaches, leg numbness, fever and chills (sic) after her first vaccination according to the client." Vision loss is considered to be medically serious by GlaxoSmithKline.