Age: 40.0
Sex: F
Vaccine: LYME
Symptoms: Mood swings, Nausea, Oedema peripheral, Pain, Photophobia
Clinical narrative: This report describes cognitive problem in a female 39 year old who received Lyme disease vaccine recombinant IsoA (Lymerix). This report was received as part of the litigation proceedings and medical records were provided. The subject's past medical history included telanangiectases posterior neck which itched (1998), and elevated liver function tests with liver hemagiomas (found during pregnancy). The subject had no known allergies. Concurrent medications included unspecified multi-vitamins, possibly a birth control pill (it was not clarified if this was  past or current medical history and beclomethasone dipropionate (Vancenase AQ). Family history noted: her father had a history of saroma and diverticular disease; her mother had a  history of arthritis osteoporosis and a goiter; and her husband had a history of depression the primary care physician on 11/16/98 had reported that the patient had pulled multiple ticks off of herself in the past and at that time her son had Lyme, however, Lymes testing was negative". The subject received Lymerix on 03/24/99 (lot number LY129B9), 05/12/99 (lot number LY120A(), and 04/12/00 (LY136B9). In a Statement of Injuries, the subject's attorney alleged that the subject "suffers from pain, and fatigue. She experience swelling in her fingers as well as a rash on her neck. In addition, she suffers from Bell's Palsy as well as depression and some cognitive problems. (She used to experienced pain and swelling in her eyes and face, but all that is controlled due to antibiotics. Used to suffer nausea, diarrhea, dizziness, sensitivity to sound and light, mood swings, and difficulty sleeping. She takes medication which controls these symptoms. her cognitive problems have improved.") The following information was obtained from medical records.  The subject presented to the vaccine provider/her primary physician on 06/14/00 with complains of neck pain for the past week and fatigue since 06/11/00.the physician noted that after the Lymerix vaccination, the  subject had one day of flu symptoms. The physicians noted malaise in reference to the office visit. The subject had Lyme two years ago that started with her neck pain and then with fatigue. The physician noted that she had an erythema migrans (EM) rash prior to the other symptoms two years ago, and he had not seen a rash this time. On physical examination, the physician noted it hurt for her to extend the neck, hurt to laterally flex to either physician had prescribed doxycycline HCL. On 06/14/00, Lyme IgG and IgM Western Blot, and HLA-DR4 results were negative. Please see Laboratory Data Section. The subject remained under the care of her primary physician from 06/23/00 until 01/14/02. The following additional signs and symptoms were recorded during this this time; severe fatigue, neck pain, depression. pain, liver function tests mildly elevated and sleeping OK except before her period. Physician progress note indicated "other problems" on 10/19/00 as primary complaint "PC Lymerix". The subject denied suicidal ideation. the subject's depression was discussed in length which seemed controlled. During this time period, the PCP noted "complete blood count and Lyme were negative" and she did not improve on doxycycline. The physician prescribed buproprion HC1 (Wellbutrin SR) to treat her depression and advised ongoing counseling. Wellbutrin has "done nothing for the oatient's pain/fatigue". Relevent medical history included: probable anxiety in 1997, dizziness in 1997, palpitations in 1997, eye-swelling (eye lid dermatitis) in 1998, fatigue,headache and malaise in 1998, neck pain in 1999, history of rash in 1998 and moderate fibrocystic changed bilaterally to the breasts (1997). In 1997, the subject had a positive hepatitis B surface antibody. At the end of December, 2001, patient had an unspecified emergency room visit. the subject was referred to a rheumatologist whom she had previously seen. The subject was evaluated by a gastroenterologist on 06/16/99 for left lower quadrant pain and discomfort which lasted for one week. She had experienced intermittent soreness in the left lower quadrant (area tender to touch) and felt a bulging sensation in this region. She had also experienced episodes of nausea. At the time, the subject reported that she was referred to her gynecologist and an ultrasound (data unknown) was preferred with negative results. This physician felt that she had a ventral hernia and suggested follow-up with a surgeon. Upon another referral, she saw a physicist who suggested that diverticulitis may be the problem and that she should follow-up with a gastroenterologist. on the personal history sheet, she noted upon "Lyme' as a serious illness which she had had not requiring hospitalization. On this  evaluation, she reported that "symptoms had subsided since initial onset, although the last few days had a little soreness to area" On this form, she indicated that her left lower quadrant pain had started in April of that year. her father has a history of diverticular disease. On 06/16/99, the gastroenterologist noted that a review of her systems in her chart "was non-contributory for current gastrointestinal problems".  It was recommended that the subject "undergo minimal sigmoidoscopy examination to assure no colonic etiology for her pain and discomfort". Colitis formation and diverticular disease is possible, however. the gastroenterologist reported that "it is not a classic story for diverticular disease in the fact that it is not related to stool function and no change associated with having bowels movements or eating." The results of a sigmoidoscopy performed on 04/17/99 was interpreted as abnormal. A rectal biopsy was performed on 08/17/99 and the result were abnormal. A colonoscopy conducted on 10/29/99 was interpreted as abnormal (Please see Laboratory Data section). From 01/12/01 to at least 04/25/02, the subject was under the care of another primary physician (progress notes were provided which were not legible). The subject reported that one week after Christmas, she had experienced numbness in the left side of her face. She also experienced increased vertigo described as on and off, a virus, "got really sick", and fatigue. She also reported that "I wasn't good for anything and this week no so good". During this time, the physician noted positive IgG Western Blot for Lyme disease. The  physician had noted under Impressions/diagnosis the following: Lyme disease, Babesiosis, HGE, HME panels and depression. (Please Laboratory Data section). The physician prescribed Wellbutrin and she had some improvement. Cefuroxine (Ceptin) Doxycycline, HCL, atovaquone (Mepron), ceftibutin (Cadex) and amoxicillin trihydrate/potassium clavulante (Augmentin), ibuprofen (Motrin), Nystatin, fluconazole (Diflucan), cefdinir (Omicef) and were also prescribed.  The physician instructed the patient to increase milk thistle. A Lyme Disease Report form was sent to the health agency on 06/28/01 which noted sign and symptoms of erythema migrans at least 5 cm in diameter, arthritis characterized by brief attacks of swelling in one or a few joints. The physician noted other clinical conditions as fatigue, pelvic pain, headaches and double vision.  The onset of the first symptoms was 05/10/01 and date of diagnosis as 06/27/01. Patient was not hospitalized. Augmentin was used to treat the episode in 30 days. The patient had most likely been exposed in her backyard. In 2001, a laboratory analyses performed revealed titer of IgG Western blot as positive. Revised Lyme disease case report form also indicated serologic test results for Lyme were positive which included IgM/IgG and recombinant antigen. (Please see Laboratory Date Section). The subject was evaluated by a cardiologist on 04/17/01 for palpitations, a diagnosis of mitral valve prolapse and a history of Lyme's disease. It was noted palpitations has cleared up with vitamin and mineral supplements. The physician's impression was "I think the presence of mitral valve prolapse is borderline, but there is enough presumptive evidence that she should probably use antibiotic prophyalxis prior to dental procedure. Concerning her palpitations, her overall left ventricular function appears to be quite benign and I would suspect that she has an equally benign cardiac prognosis." The physician recommended follow-up in two or three years unless she developed suggestive symptoms. The summary results of echocardiogram performed on 04/17/01, included normal left ventricular function with evidence of mild mitral regurgitation and borderline criteria for mitral valve prolapse. There is also mild physiologic tricupsid regurgitation with normal pulmonary pressure.". From 01/05/00 to 09/19/00, the subject was under the care of a rheumatologist. The subject reported that she experienced severe neck pain, headache, bad fatigue, chills, nausea,being very irritable and no energy. The patient reported that she had the same sequence two years ago when her blood test was positive for Lyme. The physician's statement to patient's insurance company reported nature of sickness or injury as "Lyme". The physician noted on statement "undetermined" as to how long will patient will be unable to work in his/her occupation. The patient's prognosis was noted as guarded. The date patient was first treated with condition was reported as 06/20/00. The physician noted on statement, "No, Not yet" if he felt his patient was a candidate for vocational rehabilitation. A monthly progress report was completed along with physician' s statement and forwarded to her insurance company on 09/20/00. The subject noted on this form "I am unable to perform my job as an ER nurse" on an unspecified date, the patient had reported "went back to work" and reported that she had "good and bad days". She experienced being "a little tired", neck pain and joint pain is transient more each day. Laboratory analyses performed 06/20/00 for HLA-DR4 was negative and the Lyme Disease test result was positive. On 08/01/00 and 09/06/00, the Lyme disease test was negative. (Please see laboratory Data section). The subject's mother had osteoarthritis. (*Please note the left lowest quadrant pain with intermittent soreness, discomfort, bulging sensation in left lower quandrant region, trapezil tender, knee pain, liver function tests mildly elevated, numbness in the left side of face, increased vertigo, virus,"got really sick", arthritis, pelvis pain, headache, double vision, rectal polyp, internal hemorrhoids, rectum tubular adenoma, active bowels sounds, malaise, neck pain, palpitations, mitral valve prolapse, chills, very irritable, no energy, and "mild physiologic tricuspid regurgitation with normal pulmonary were not reported as adverse events due to vaccine administeration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as an adverse events). The most recent information, received on 07/17/02, did not provide the outcome of the following reported events; cognitive disorder NBC, pain NOS, fatigue, peripheral swelling, rash NOS, facial palsy, depression, nausea, diarrhea NOS, dizziness, hypercusis, photophobia,mood swings, insomnia, eye pain, eye swelling, and facial pain. Information received on 03/13/02 indicated that influenza like illness had resolved in a day.