Age: 49.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Globulins increased
Clinical narrative: Report A0360541A describe monoclonal gammopathy in an approximately 49 y.o. female who received Lyme disease vax recombinant OspA (LYMErix). This report was received with forwarding of medical records. The subject's medical history included allergies to Percodan, Percocet, iodine, Betadine, Augmentin, aspirin, latex, and tape. The medical history also included mononucleosis, "multiple" tick bites, hypertension, varicose veins, hypercholesterolemia (1996), anemia (1997), fainting spells, dizziness, palpitations, obesity, "mild" type II diabetes mellitus, elevated concentrations of liver enzymes (1992), hepatic steatosis (1993), recurrent diarrhea (1996), fractured right elbow, fractured right hand, costochondritis, abdominal pain, menometrorrhagia, two miscarriages (1978, 1985), actinic keratosis, hemangiomas, lentigo, dermal nevus (1989), seborrheic keratosis (1989), epidermal inclusion cyst (1993), and rosacea (1996). Surgical history included tonsillectomy and adenoidectomy (1956), appendectomy, excision of a vaginal cyst, bladder scraping (1969), two cesarean sections, two benign foot tumor excisions (1977), cholecystectomy (1978), two elbow surgeries (1984), and an abdominal hernia repair (1987). Family history was significant for liver cancer in the subject's father. Concurrent medications included Amaryl, Glucophage, Axid, Prevacid, Norvasc, Altace, Claritin, Nasonex, Noritate, Levaquin, Zithromax, Advil, multivitamin, calcium, and ferrous sulfate. On unspecified dates, the subject reportedly received 2 injections of LYMErix. In a Statement of Injuries, the subject's attorney alleged that the subject "suffered from joint pain in her hips, knees, hands and elbows. She also suffers from fatigue and monoclonal gammopathy (pre-cancer of the bone)." The following info was obtained from medical records: The subject was evaluated by a hematologist on 11/11/99. Medications at that time included nizatidine, levofloxacin, and mometasone furoate. The hematologist noted that the subject had "a history of abnormal liver enzymes, apparently w/etiology unclear... She was recently noted to have increasing monoclonal spike of IgA kappa." No abnormalities were noted on physical exam. Serum immunoglobulin concentrations, serum immunofixation, and bone marrow biopsy revealed abnormalities. Please see Lab Data section. On 11/10/99, the hematologist wrote, "I believe she still has benign monoclonal gammopathy w/the possibility that she could progress to smoldering myeloma or full-blown myeloma in the future." The subject was evaluated by a rheumatologist on 7/27/00. At the time, she reported that she had received two injections of LYMErix, and was due to receive the 3rd injection. The rheumatologist noted that HLA typing revealed the presence of HLA-DR4. "The PT denies any significant joint pain. Her main concern is an article showing that the Lyme vax may increase the risk of rheumatoid arthritis in such PTs. The article was more related to a lawsuit that is pending with manufacturer than any medical publication." On physical exam, that MD noted that "there may have been some synovial thickening of the wrist joints." The rheumatologist wrote, "[The subject] has no signs for rheumatoid arthritis at this time. She does have a monoclonal gammopathy but no definite signs of rheumatoid arthritis, lupus, or Lyme disease at this time. Certainly, I did indicate to the Pt that she is at increased risk for having rheumatoid arthritis w/the DR-4 that is noted, whether or not she has any Lyme vax." Lab analyses revealed an increased erythrocyte sedimentation rate, which the rheumatologist noted "is probably related to the hypergammaglobulinemia and monoclonal gammopathy." On her last recorded visit to the rheumatologist, on 9/28/00, the subject reported "some achiness in the back and hip areas on bad weather days." No active swelling of any joints was observed. The rheumatologist planned continued observation. Following the reported onset of monoclonal gammopathy, the subject experienced esophagitis, gastritis, gastroesophageal reflux disease, hiatal hernia, uterine fibroids, and a right ovarian cyst. These events were not reported as adverse events due to vax administration, but were found during the course of review of the subject's medical records. Therefore, they are not listed as adverse events. The most recent info, received on 9/3/02, did not provide the outcomes of the reported events.  On a routine follow-up visit with her oncologist on 11 December 2003, she was still carrying the diagnois of "myoclonal gammopathy of undetermined significance versus smoldering myeloma," she related ongoing complaints of arthritis, which she treated with ibuprofen. She continued to have generalized myalgias and arthralgias, which she attributed to recent initiation of bisphosphonate injections. Otherwise, she felt well and reported relatively normal energy and stamina, she continued to work on a full time basis. Continued observation was planned. The most recent information, received on 25 August 2004, did not provide the outcome of the reported events.