Age: 44.0
Sex: F
Vaccine: LYME
Symptoms: Oedema peripheral, Pain, Rheumatoid arthritis, Systemic lupus erythematosus
Clinical narrative: This report describes autoimmune hep in a 44 year-old female vaccinee who received lyme disease vaccine recombinant OspA. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections administered was not reported. In a statement of injuries, her attorney alleged that the vaccinee "has been diagnosed with Rheumatoid arthritis in her neck, hands, chest, back, elbows, knees and feet, and suffers pain from this condition every day, along with fatigue and rashes. In addition she has been diagnosed with a mild autoimmune liver hepatitis, and possible lupus. Time to onset following immunization, treatment, and outcomes of the alleged events were not reported. Autoimmune hepatitis and possible lupus are considered medically serious. The follow up states medical history included anxiety (1989), hypertension (1989), increased erythrocyte sedimentation rate, elevated aspartate aminotransferase concentration, elevated alanine aminotransferase concentration, elevated lactic dehydrogenaso concentrations, elevated alkaline phosphatase concentrations, hypocalcemia, hypokalemia, hypomagnesamia, hypo?, ?, hypocholesterolemia, decreased iron concentration, decrerased total iron binding capacity, decreased serum ferritin, decreased transferrin saturation, decreased triglyceride concentration, Lyme disease treated with a 12 week course of doxycycline, and secondary hyperparathyroidism. The most recent info received 5/6/02, did not provide the outcome of the reported events. The follow up states further medical history of toxemia (1977), hayfever, heartburn (1982), gastritis (1982), chronic duodenitis (1985), functional pylorospasm (1982), functional nardiospasm (1982), reflux esophagitis (1985), aeropohagim (1985), erosive duodenitis (1985), esophageal spasm (1990), irritable bowel syndrome (1990), rheumatoid arthritis (1991), fatigue (1991), lethargy (1991), diarrhea (1990), joint complaints (1992), night blindness (first documented in 1991), tetany (1991), Raynauds first ducumented in (1991), and livedo reticularis (first documented in 1991), fibromyalgia, positive for Epstein-Barr virus, and Jerisch-? reaction. During a history and physical on 8/20/96, the patient reported experiencing the following symptoms at that time: visual floaters, shortness of breath on exertion, palpitation, leg pain with walking, difficulty swallowing, muscle weakness, frequent headaches, back pain, osteoporosis, rashes, and depression. Surgical history included Ceasarian section (1977), total abdominal hysterectomy (1985), endoscoopy (1982), (1985), (1991), with biopsies (12/91) and flexible sigmoidoscopy (1991). On 1/21/92, the vaccinee was seen by her gastroenterologist "for a question about periods of forgetfulness." The physician noted that "the pt is thinking about going through IV treatment for Lyme disease. I reminded her that the diagnosis was made by an infectious disease person prior to our documenting the celiac disease and based on positive Lyme antibody titers. I am not stating that she absolutely does not have Lyme disease, but hse has  no symptoms of that disease while currently being treated with a gluten free diet and doxycycline for celiac disease." The vaccinee has a history of rheumatoid arthritis affecting her fingers, toes, shoulder, hips, and knees with medical records dating back to April 1991. There is also a history of rheumatoid arthritis in her mother, which is "severe and deforming" and her maternal grandmother. Additionally, medical records indicate hse has had complaints of fatigue from 1991. She also had a history of the following: joint aches, head foginess, swollen joints, overall body aches, swollen glands, and neck pain in 1994; sever fatigue, sweating, joint pain, stomach problems, and difficulty focusing eyes in 1995; and swelling and ecchymosis below left great toes in 1995. In May 1996, the patient had experienced fever adn flu-like symptoms that progressively worsened. In September 1996, the patient expereinced increased joint pains, headache, fatigue, and her rash was worse when in the sun. She was assessed as having "possible recurrent Lyme disease with possible new tick bites". In January 1997, the patient experienced severe muscle spasms and knee swelling. By March 1997, she was assessed as having chronic Lyme disease and arthritis. In April 1998, the paitent reportedly "felt miserable" and was assessed as having Lyme disease versus collagen vascular disease. Medical records also confirm the presence of "abnormal liver function tests intermittently since she was a youngster (which she said had been mistaken for chronic hepatitis in the past)." The vaccinee experienced anemia and leukopenia. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. The following info was obtained from medical records. On 2/11/99, the patient complained of severe muscle and joint pain after the Lyme vaccine. She was treated with Flexeril with some relief. She spent two days in bed. On 4/8/99, the patient complained of joint and muscle pain and feeling tired all the time. The assessment was "probable recurrent Lyme disease versus ongoing reaction to the Lyme vaccine". She was started on Suprax. On 4/23/99, a Lyme Elisa titer was negative. On 5/21/99, the patient still had marked swelling of the distal interphalangeal (DIP) and proximal interphalangeal (PIP) joints as well as some of the metatarsolphalangeal(MTP) and carpophalangeal (CP) joints and also some swelling of knees and tenderness over anterior thighs. She requested antibiotic treatment for rheumatoid arthritis. Assessemtn was "rheumatoid arthritis versus autoimmune reaction to the Lyme vaccine. Minocin sounds like a reasonable alternative." She was started on Minocin 100mg three times a week and ?. by 6/24/99, the patient was "doing extremely well on Minocin" as she was feeling much better with more energy. On 10/28/99, the patient was seen for follow-up at which time received an influenza vaccine. She had stated she "never had problems with flu shots in the past". The assessment was "chronic Lyme and/or rheumatoid arthritis. doing extremely well on the alterative therapies. She is off her prescription medications." On 6/29/00, the pt presented to her gastroenterologist for findings of abnormal liver function tests. The gastroenterolgoist referred to lab data from 5/26/00, which showed high AST and ALT values coupled with a "perfectly normal alkanine phosphatase." The physician noted that "this pt carries a diagnosis of rheumatoid arthritis which was effected her large and small joints including deformity of the knuckles and toes. She is not suffering from fever and chills, no unexplained skin rashes. She has not been taking nonsteroidal anti-inflammatory drug for many months, prior ot which she had been taking Celebrex and Vioxx at different times. She has been on antibiotics for years because of her long-standing diagnosis of Lyme disease." Physical examination showed no jaundice, rashes, or ? The physician's impression was transaminasemia and chronic rheumatoid arthritis. The pt reported that she had been testeed in the past for "hepatitis viruses as well as mono." She reportedly was told that she had "Epstein-Barr disease." On 7/13/00, the vaccinee returned to her gastroenterologist. It was ntoed that her lab data was negative for CMV, EBV, and hepatitis viruses. Her "antinuclear natibody was unremarkable as well," her white blood cell count was "low" 93,500 cells), and there was amild hormocytic anemia. The physician stated "I do not believe we are dealing with primary biliary cirrhosis or cholangitis  nor any of the viral illnesses. It is more likely that we are simply seeing an autoimmune hepatocellular reaction related to her chronic rheumatoid arthritis. From the point of view of a hematology evaluation, there is little that would be done different for this pt no matter what the bone marrow findings." On 8/21/00, the vaccinee was seen by a hematologist-oncologist. She complained of "chronic fatigue not" interfering with her job." Physical examination revealed "skin was negative for rashes." Bilateral MCP enlargement and decreased range of motion with bilateral MCP tenderness and decreased shoulder range of motion were present." The physician noted that her review of peripheral blood smear showed "no stigmata of for example chronic liver disease is obvious." He summarized the visit stating, "this forty five year old woman with rheumatoid arthritis exhibited bihematocyopenias on two occasions but these findings now seem to have resolved. I'm uncertain if this could be improvement rheumatological activity of her current meds or an unrelated cause." On 8/26/00, the gastroenterologist wrote a note in the vaccinee's chart stating "It is likely that the pt has some autoimmune process that is creating a truly minimal and clinically insignificant hepatitis that will not progress to anything of consequence." On 8/27/01, the gastroenterologist received the vaccinee's lab results and he noted that "Once again, we have the isolated hypertransamninasemias. A review of the past viral and autoimmune studies shows that hwe have no specific diagnostic answer as to why she manifests these isolated elevations of the liver cell enzymes with perfectly normal obstructive enzymes and bilirubin. Furthermore, the white blood cell count of 4,600 at this time is in the normal range compared with past episodes of leukopenia and also her platelet count of 321,000 is excellent considering that a chronic autoimmune process or chronic hepatitis is often associated with a low platelet count consider a liver biopsy simply to determine if there is a distinct inflammatory process or if there is a degree of fibrosis which may call for more aggressive action." The physician was to send a letter ot the vaccinee with the report findings and his feelings. Physician noted "we are simply curious as to whether there is any fibrosis component of what appears to be a chronic smoldering hepatocellular inflammatory process. This type of hepatitis is more than likely related to her immune disease including rheumatoid arthritis or to the medication she is taking. Of interest, the pt reprots that when she had been taking prednisone the enzyme levels were normal or just minimally elevated. Thus, it appears that the steroids were suppressing this activity, putting it possibly into the category of autoimmune hepatitis. My primary concern is that we do not want to miss a progressive fibrotic process rather than a smoldering inflammatory process." The pt is to make arrangements for a liver biopsy. On 10/19/01, the vaccinee's gastroenterologist performed a history and physical prior to the vaccinee's liver biopsy. He stated "a percutaneous liver biopsy is ordered to determined the underlying reasons for a continually recurring leukopenia over the years and elevation of the transaminases with normal obstructive enzymes and normal bilirubin. the pt has gone through a battery of testing for the various viral antities and shows no evidence for hepatitis A, B or C nor for Epstein-Barr virus or CMV. She is not taking any medications that might account for this leukopenic hypertransaminasemia. She doesn ot have any bleeding tendencies. In the past she was treated for Celiac sprue and there have been some concern for other autoimmune diseases because she is being treated by a rheumatologist for various rheumatologic problems. Her autoimmune antibody studies including natinuclear antibody, antimitochondrial antibody, anti-smotth muscle antibody have been unrevealing. We are looking to determine if there is any inflammatory process or fibrosis within the liver that might point a diagnosis such as autoimmune hepatitis. Liver biopsy performed on 10/19/01 revealed "essentially unremarkable liver parenchyma with very focal minimal neutrophilic infiltration of hepatocytes. No increased fibrosis or iron depostiion identified." On 10/26/01, the gastroenterologist received the liver biopsy report and n oted "this is one of the most mild hepatitis that I have ever seen." On 10/29/01, the vaccinee returned to the gastroenterologist for discussion regarding her liver biopsy results. The physician noted "we simply have some mild leakage of cellular enzymes from the liver that are creating minimal inflammatory change and no fibrotic change. The only steps that I would take would be to call for six months blood testing for liver function and complete blood count, along with a liver biopsy in five years. I believe her low-grade anemia is simply due to the anemia of chronic diseases, not blood loss anemia. Her tendency toward low white blood cell counts is part of her autoimmune process and may be part of the medication she is taking recently ? I will let her rheumatologist know of my conclusions, an that htis pt may be treated a bit more aggressively iwth very little concern for any type of permanent liver, damage. One could certainly expect some elevation of the liver enzymes, but it would be of little consequence with regard to actual permanent damage of risk of fibrosis." The most recent info, received 6/11/02, did not provide the outcome of the reported events. Autoimmune hepatitis and possible lupus are considered medically serious (OMIC). The follow up states on 9/14/00, the vaccinee was seen for follow-up of her joint pain. At that time, she reportedly had alot more energy and wa snot as stiff but her feet felt worse. Physical exam revealed myofascial pain and proximal interphalangeal joint pain. Impression was rheumatoid arthritis and fibromyalgia. Ambien was discontinued. She was started on prednisone. Enbrol was later discontinued because her "white blood cells went down." The vaccinee returned to the office on 11/2/00 at which time she was noted to have a photosensitivity rash. She had also been experiencing pain in the left foot. Impression was questionable arthritis/rheumatoid arthritis and questionable systemic lupus erythematousus. Prednisones was increased. Antinuclear antiody was negative and anti-DNA wasequivocal. ESR was elevated. A MRI of the left foot showed no acute disease and an x-ray ruled out a fracture. On 2/15/00, the vacicnee was restarted on Enbrel. At this time, the pt felt "better' but continued to experience stiffness as well as joints pain in the hands and knees. On 4/10/00, the pt complained of "unable to decrease pain, feels fatigued, not sleeping because of pain." Physical assessment revealed pain in the chest wall and metacarpophalangeal and proximal interphalangeal joints as well as positive trigger point pain in the trapezius. Impression was questionable SLF, hysterectomy, and fibromyalgia. On 5/2/01, anti-DNA antibodies, antinuclear antibodies, and antiscleroderma-70 antibodies were negative. On 6/7/01, she complained of fatigue and a "flare-up" that lasted four to five days. She reportedly "had been feeling well" prior to this. Impression was fibromyalgia, anxiety, questionable SLE, and questionable rheumatoid arthritis. Erythrocyte sedimentation rate on 7/25/01 was elevated. A variety of serologies for Lyme disease were performed on 10/1/01. The overall interpretation was "no evidence of serologic reactivity indicative of infection with B burgdorferi and no reactivity to native Osp-A detected." The most recent info, received 9/3/02, indicated that as of 4/16/02, the vaccinee continued to experience fatigue and achiness of the joints.