This report describes the occurrence of monoclonal gammopathy in an adult female of unspecified age who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of the litigation proceedings and has not been verified by a physician or other health care professional. The subject's past medical history, concurrent conditions, and concurrent medications were not reported. The subject's attorney alleged that the subject "began receiving LYMErix injections in March 1999, which continued through May 2000." Allegedly, in May 2000, the subject developed "peripheral neuropathy, depression, and monoclonal gammopathy." Time to onset from immunization, treatment, and outcomes were not reported. The adverse events "peripheral neuropathy" does not meet serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter.  A 15-day follow up report received 5/20/2003 adds: The pt's medical history included allergy to codeine, pilonidal cyst, chronic back problems with pain and spasms (1993), lumbar facet syndrome (1994), "mild" lumbar scoliosis, hip pain (1994), bilateral shoulder pain (1994), possible rotator cuff tear or tendonitis (1995), ankle and foot pain after a fall (1996), osteoporosis, fractures of left elbow (1999) and right ankle, hand tremors since age 28, memory loss (1993), gait unsteadiness, "frequent" falls (1997), "slight" right ptosis (February 2000), positive Romberg testing (February 2000), fatigue (1995), hyperlipidemia (1998), "mild" anemia, atypical chest pain (1998), irritable bowel syndrome (1993), diverticulosis (1999), heartburn (1999), reflux (1999), constipation, colon polyps, blepharitis left upper eyelid (1997), "mild" cataracts (1997), myopia (1997), presbyopia (1997), suspected glaucoma (1997), mixed urinary stress and urge continence, cystic ovaries (1994), polycystic kidneys, seborrheic keratosis (1998), insect bite (1999) and tobacco use (discontinued in 1992). On 03/07/1999, at the time the first Lymerix injection was administered, laboratory analyses revealed decreased thyroid stimulating hormone concentration increased TC concentration (as thyroxine), and increased calculated free T4 concentration. On 02/15/2000 magnetic resonance imaging (MRI) of the brain demonstrated "small punctate foci of abnormal hyperintense signal within the left frontal white matter which is non-specific." Surgical history included tubal ligation (1976), cholecystectomy (1983), pilonidal cyst resection, polypectomies, and left elbow pinning (1999). Family history was significant for depression, tremors (mother) and polycystic kidney disease (mother). Concurrent medications included calcitonin (Miacalcin) nasal spray, aspirin, ibuprofen (Motrin), alendronate tartrate (Fosamax), tolterodine (Detrol), propanolol hydrochloride (Inderal), amitriptyline (Elavil), oxybutynin hydrochloride (Ditropan), pseudoephedrine hydrochloride (Sudafed), multivitamins, calcium, and vitamin E. Concurrent vaccines included influenza virus vaccine (manufacturer unknown, 10/09/2000). ... The subject presented to the vaccine provider on 06/03/2000 with complaints of back pain, leg pain, burning feeling in the left lower back which radiated "on and off", head cold, nausea and diarrhea "on and off". She reported that she had been in bed for the preceding 4 days. The physician noted a history of chronic back problems treated with physical therapy and chiropractic. The physician's impression was "Back Strain, Viral Syndrome." The physician prescribed naproxen (Naprosyn) and instructed the subject to continue pseudoephedrine (Sudafed) therapy. The pt remained under the care of the vaccine provider until at least 11/05/2001. The following signs and symptoms were reported during this time: numbness of the hands and feet, reduced strength, pain down the spinal column, pain in the thumbs, difficulty rising to a stand, migratory joint pain (left hip, left knee and back), depression "after malignancy operation", fatigue, "feels terrible" and disturbed sleep characterized by early morning awakening. On 10/25/2000, the pt reported numbness of the hands and feet, which had been present "for a few days". The pt reported that it was "minor at first but gradual worsening." On 06/25/2001, the pt reported that "over winter" she experienced joint pains in her hands, right greater than left, and pain in both feet, the neck and the shoulder. She reported that the numbness of her hands had been getting worse over the preceding 2 months. Laboratory analyses revealed an IgG-Lambda monoclonal protein and positive Lyme ELISA screen with negative IgC and IgM Western blots. Please see Laboratory Data section. During this time period, the physician made diagnoses of "numbness hands and feet (10/25/2000), "bilateral hand paresthesias (11/27/2000), "joint pains hands, feet, neck" (06/25/2001), "numbness -hands (06/25/2001), "Fatigue" (06/25/2001), and Lyme disease (10/31/2001). The physician prescribed cyclobenzaprine hydrochloride (Flexeril), doxyxyxline, zolpidem tartrate (Ambien), venlafaxine (Effexor), lorazepam (Ativan), acidophilus, and physical therapy. The physician referred the pt to a neurologist and an orthopedist. The subject was evaluated by a neurologist on 10/30/2000 because she was "concerned about CVA (cerebrovascular accident)." At that time, the pt reported bilateral hand numbness, numbness in the feet and tingling of the toes. The physician noted "no neck symptoms, no weakness." The physician's impression was "? Neuropathy. Not TIA (transient ischemic attack)/CVA." On 12/04/2000, the neurologist noted that immunofixation and protein electrophorosis revealed "IgC-lambda monoclonal protein present; decreased IgM." On that date, the pt also reported "Increased handn symptoms: hurting now, one weekly awakening." She also reported that the symptoms awakened her at night. She reported "skin deadened: Also in feet, not as bad." The neurologist noted that she was not unsteady or weak. Physical examination was "stable." The neurologist made a diagnosis of "mild neuropathy ? secondary to monoclonal gammopathy." He referred the pt to a hematologist. It was noted that the pt was "going on vacation until May 2001." On 05/24/2001, the pt was hospitalized for evaluation of numbness in both hands and feet, particularly the left arm. She reported that the numbness in her left hand radiated up her arm. She initially reported that the numbness began one week prior to presentation. The admission diagnosis was "Anginal equivalent R/O (rule out) MI (myocardial infarction)." Later, she reported that the numbness had been present "for several months" and that she presented for care "because these symptoms have progressed." The pt was evaluated by a neurologist, who noted that "she had a probable sensory polyneuropathy with additional history of monoclonal gammopathy." Multiple diagnostic studies were performed during this hospitalization. Please see Laboratory Data section. The pt's symptoms stabilized within 24 hours and she was discharged the following day. Discharge diagnoses were "Sensory neuropathy - probable" and "Monoclonal proteinemia". The pt was seen by a hematologist on 10/22/2001 for "evaluation of monoclonal gammopathy." The physician noted, "At this time, the pt has no complaints." The pt reported that "This winter she had an arthritic type illness and she was treated with doxycycline." On review of systems, the physician noted "some small joint arthritic complaints, but there is no real swelling. She continues to complain of her neuropathy. It does not appear to have progressed." No abnormalities were noted on physical examination. Laboratory analyses revealed "an abnormal myeloma protein of 0.4 gm/dl which, on immunofixation, turned out to be an IgG lambda". The rest of the diagnostic evaluation was negative. Please see Laboratory Data section. The hematologist's assessment was "At this time the pt's diagnosis is monoclonal gammopathy of undetermined significance...The pt has a peripheral neuropathy. The cause of the peripheral neuropathy remains unclear...The evaluation of the pt from a hematologic, immunologic point of view is normal...There is no evidence of a rheumatologic condition in this pt, and there is no evidence of an immune defect...It is possible that the pt's vaccine that was given to her 2 years ago is responsible for the monoclonal gammopathy in her blood. It also appears to be the reason why she has a positive ELISA titer for Lyme with an absolutely completely negative Western blot titer. Whether or not this is also responsible for her neuropathy is unclear, but this, too, is a possibiity." No therapy was recommended. The pt was evaluated by a second neurologist on 07/20/2001. At that time, the pt reported numbness, mainly in the fingertips of both hands, right more than left, milder symptoms in the toes of both feet, and some neck pain. "She says that the symptoms began insidiously 9 months to a year ago with some numbness starting in the left hand and spreading to the right. They persisted for about 6 months and then cleared spontaneously. However, starting in April, they returned, and on one occasion seemed to be spreading into her left forearm". On 07/20/2001, she reported that the numbness "is somewhat worse than it was last fall. It does not seem to extend into the palms or up the forearms. Despite this, there is no trouble actually using her hands except for some pain in both thumbs, which causes some trouble with movements requiring some power...She has no trouble with her legs and no weakness in her legs." On physical examination, the physician noted that "Motor examination revealed normal muscle bulk, strenght and tone in both arms and both legs...Sensory examination was normal to vibration. There was reduced sensation to pinprick in the index, middle and ring fingers of both hands, shading toward normal by the middle of the digits. The right hand seemed more affected than the left. There was a mildly positive Tinel's sign bilaterally. Flexion of the neck produced only some local neck pain." The neurologist reviewed the results of computed tomography (CT) scans, which revealed abnormalities. Please see Laboratory Data section. The neurologist's impressions were "1) Symptoms of numbness in the fingers and toes. I suspect that this is most likely just a bilateral carpal tunnel syndrome. Peripheral neuropathy is to be ruled out. 2) Essential tremor. 3) Minimal cervical spondylosis producing neck pain, but no other symptoms." The subject remained under the care of this neurology group until at least 08/27/2001. During this time, the pt reported increasing symptoms of numbness in both hands and both feet, in addition to weakness and pain in her thumbs. The physician noted that electromyelography and nerve conduction studies (EMG/NCS) of median and ulnar nerves performed on 08/07/2001 showed a chronic mixed axonal and demyelinating neuropathy; asymmetry of findings suggested "a mononeuropathy multiplex." Please see Laboratory Data section. The physicians noted that "vibratory sense was greately reduced in the fingers, absent in the toes." The physicians also noted "reduced" sensation to pinprick to the mid-dorsum of both feet. The physicians made diagnoses of carpal tunnel syndrome (08/21/2001) and "peripheral neuropathy, etiology to be determined" (08/21/2001). The subject was referred to a hematologist. The pt submitted a report to VAERS on 08/28/2001. She indicated that she had no pre-existing medical conditions and was taking only alendronate at the time of immunization. Under description of adverse events, she wrote "Migrating pain: knees, spine, thumbs, shoulder/neck. Numbness: fingers and toes (nerve damage). Loss of movement and strength in thumbs. Started February 2001 (+ or -)." However, in the "Adverse event onset" box, she wrote a starting date of October 2000. She also indicated that she had not sought medical care, and had not been hospitalized. The pt was evaluated by a second hematologist on 12/03/2001 "for evaluation of an MGUS (monoclonal gammopathy of undetermined significance)". At that time, the pt reported that the peripheral neuropathy "has worsened intermittently and episodically over the past 6 months. She has gotten particularly bad over the past several months since doing some psychiatric counseling for victims (of a disaster)." The pt also reported that "She has had depression in the past and is considering going on a antidepressant now". Medications at the time of the evaluation included calcium and vitamin D. No abnormalities were noted on physical examination. The hematologist's impression was "? myeloma versus amyloid versus benign monoclonal gammopathy with associated peripheral neuropathy." He referred the pt to a neurologist at a tertiary care center. He also administered pneumococcal polysaccharide vaccine (Pneumovax, Merck). Immunoelectrophoresis was repeated. The hematologist noted, "Small IgG Lambda monoclonal protein confirmed". The remainder of the laboratory analyses were "otherwise normal." The pt remained under the care of this hematologist until at least 04/21/2003. On 12/21/2001, the hematologist recommended bone marrow aspiratino and biopsy to rule out myeloma. He also recommended rectal, muscle, skin, nerve and gingival biopsies to rule out amyloidosis. The pt declined. During this time, the pt reported that her psychiatrist had prescribed citalopram (Calexa), zertraline (Zoloft), amitriptyline and lorazepam (Ativan). On 06/11/2002, the pt reported that the third neurologist had prescribed intravenous gamma globulin every 2 to 3 weeks. "She has noticed that her symptoms have improved dramatically on the gamma globulin...If she goes much beyond the 2 week period, however, she can feel the peripheral neuropathy return." On 06/11/2002 the hematologist wrote, "All in all I think she's done quite well." On 06/25/2002, the hematologist noted that IgG lambda monoclonal protein had increased. The hematologist once again recommended bone marrow aspiration and biopsy. The pt underwent bone marrow aspiration and biopsy with chromosomal analysis on 07/30/2002. No abnormalities were detected; please see Laboratory Data section. On 04/21/2003, the pt reported that she discontinued intravenous gamma globulin therapy in December 2002 "and her symptoms returned with a vengeance in February. She's back on it, feeling somewhat better." The hematologist noted that the monoclonal protein concentration continued to increase. "On one occasion, it was seen to be monoclonal, in another lab polyclonal". Repeat serum protein electrophoresis revealed that the monoclonal gammopathy was "worse". The pt was evaluated by a third neurologist at a tertiary care center on 02/04/2002. At that time, the pt reported that "Her symptoms began approximately one year ago in the fall of 2000 with intermittent numbness and tingling in her toes and fingers, which gradually spread to the ankles and wrists. She feels as if she is walking on pebbles, and her gait in increasingly unsteady." On physical examination, the physician noted that "On motor examination, strength was normal on individual muscle testing, and she was able to rise on her heels and toes, get up from a chair without using her arms, hop on either foot and get up from a kneeling position with either leg. On sensory examination, vibration was moderately impaired at the left large toe and ankle, mildly impaired at the right toe, and normal at the right ankle. Position was normal. Light touch and pin evaluation; abnormal results were noted. Please see Laboratory Data section. The physician stated "She may be suffering from chronic inflammatory demyelinating polyneuropathy (CIDP), although amyloidosis, osteosclerotic myeloma, or other causes of neuropathy should also be considered." The physician ordered various laboratory analyses. Previously noted IgG lambda monoclonal gammopathy was "no longer present." However a laboratory report with a "Date collected" of 03/20/2002 noted "IgG-Lambda monoclonal protein present" and elevated total gamma globulin concentration. Please see Laboratory Data section. The pt remained under the care of this neurologist until at least 03/17/2003. During this time the pt reported "less pain and paresthesias in her feet, less burning pain in her soles and is less fatigued" and "electric-pains in her legs". On 03/17/2003 the pt reported that, after discontinuing intravenous immune globulin (IVIG) therapy, she "began developing more symptoms, with more numbness and pain in her hands and feet, increasing weakness, and chronic fatigue." During this time, the physician noted mild unsteadiness when the pt stood with feet together and eyes closed, and mild difficulty with tandem walking. On 12/12/2002, "strength is normal on manual muscle testing. She is able to rise on her heels and toes, get up from a chair without using her arms, and hop on either foot. She can get up from a kneeling position with her left leg, but has some difficulty with the right. Vibration is moderately impaired at the toes and ankles and mildly impaired at the fingers. Tandem walking is difficult. Romberg is negative. Gait is normal." On 03/17/2003, vibration was "severely impaired at the toes. Deep tendon reflexes were present in the biceps and knees and absent at the ankles with bilateral plantar flexor responses. She could not tandem walk and Romberg was positive. Gait was slightly wide based." Laboratory analyses revealed abnormalities; please see Laboratory Data section. The physician made a diagnosis of chronic inflammatory demyelinating polyneuropathy (04/28/2002) and prescribed IVIG and amitriptyline. He noted that the pt was doing well until she suffered a relapse, probably triggered by an upper respiratory infection, in March of 2002 resulting in more numbness in the hands and feet with "electric-like pains in her legs". On 09/09/2002, the medication regimen included intravenous immune globulin and amitriptyline. The symptoms from March 2002 were "improving". On 12/12/2002 the pt was "feeling about the same. She can function most of the time normally, although sometimes her legs feel heavy and in pain." IVIG was discontinued on 12/27/2002. On 03/17/2003 the physician noted that the pt "probably had an exacerbation of the CIDP, following discontinuation of the IVIG treatments. She may require maintenance therapy." IVIG therapy was resumed. The pt was evaluated by an orthopedist specializing in spine surgery on 02/11/2002 for "complaints of tingling and numbness in the hands and feet, as well as back pain, clicking and snapping." On physical examination, the physician noted "decreased sensation in the hands and feet. Tension signs are negative. Motor and sensory reflexes otherwise normal." X-rays demonstrated Grade I spondylolisthesis at L5-S1 and possible spondylolisthesis at L4-L5. AP (anterioposterior) X-ray reveals facet joint arthritis at L5-S1." The physician's diagnoses were "1. Lumbar strain. 2. Degenerative disc disease. 3. Spondylolistesis." CT of the lumbar spine, performed on 02/25/2002, revealed abnormalities. Please see Laboratory Data section. At the pt's request, the physician prescribed aqua therapy. He noted that the pt had been "evaluated for her previous neuropathy" and he referred her to two other neurologists. Following the reported onset of monoclonal gammopathy, the pt experienced headaches, abdominal pain, urinary urgency and pressure, hematuria, fever, chills, lack of libido, abnormal thyoid stimulating hormone concentration, difficulty losing weight, cervical spondylosis, degenerative disc disease of the cervical and lumbar spine, lumbar and lumbosacral spondylolisthesis, "severe" facet joint arthritis, bilateral parapelvic cysts with infiltrated perinephric fat and a kidney stone. These events 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 listed as adverse events. Info received on 01/15/2003 indicated that the pt had been hospitalized. Therefore this report has been reclassified as serious. The most recent info, received on 05/12/2003, did not provide the outcomes of the reported events. Info received on 04/29/2003 indicated that the monoclonal gammopathy was "worse" and the peripheral neuropathy was "somewhat better" as of 04/21/2003. A 15-day follow up report received 9/24/2003 adds: The most recent info, received on 09/03/2003, indicated that the CIDP was "significantly improved after resuming the IVIG treatments." The outcomes of the other reported events were not provided. A 15-day follow up report received 9/20/2003 adds no new info.