Age: 65.0
Sex: F
Vaccine: LYME
Symptoms: Oedema peripheral, Pain, Paraesthesia
Clinical narrative: This report describes arthralgias in a 64 y.o. female who received Lyme disease vax recombinant (LYMErix). This report was received with forwarding of medical records. The subject's medical history included anxiety, motor vehicle accident ('93) chronic fatigue since '94, left hand dysesthesias, possible ulnar radiculopathy, "mild" degenerative joint disease, obesity, diabetes mellitus, HTN, hypercholesterolemia, coronary artery disease ('94), angina pectoris, atrial septal defect, myocardial infarction, congestive heart failure (Sept '94), right bundle branch block, URI, gastroesophageal reflux, hemorrhoids, and muscle pain attributed to simvastatin. Surgical history included triple-vessel coronary artery bypass grafting ('94), atrial septal defect repair ('94), tonsillectomy / adenoidectomy, and hemorrhoidectomy. Concurrent medications included amlodipine / benazepril (Lotrel), simvastatin (Zocor), furosemida (Lasix), carvedilol (Coreg), famotidine (Pepcid), pantoprazole (Protonix), nabumetone (Relafen), aspirain / butalbital / caffeine (Fiorinal), chlordiazepoxide, aspirin, vitamin E, and vitamin C. The subject reportedly received injections of LYMErix on 6/13/00 and approx 7/11/00. In a Statement of Injuries, the subject's attorney alleged that the subject "suffers from swelling and a burning sensation in her feet, along w/cramping in her lower legs and 'shooting, lightening-type' pain and numbness in her ankles and knees, and joint pain in her wrists, fingers, toes, elbows and hips as well. She also experiences fatigue and sweats." The following info was obtained from medical records. The subject presented to her primary MD on 8/14/00 with c/o dizziness, fatigue, and joint aches. The subject remained under the care of this MD until at least 10/16/02. During this time, she reported weakness, blurred vision, "generalized arthralgias since Lyme vax", leg muscle spasms, lightheadedness, and backache. During this time, the MD made Dx of "Arthralgias - Lyme reaction?" (4/18/01), "Osteoarthritis" (4/18/01), "Fatigue/dizziness" (9/19/01), "Joint pain" (4/8/02 and 4/10/02), and "Fatigue" (6/4/02, 9/2/02, and 10/16/02). He prescribed celecoxib (Celebrex), refecoxib (Vioxx), carvedilol (Coreg), meloxicam (Mobic), tetracycline, meclizine, gabapentin (Neurontin), and cyclobenzaprine. The joint pain and fatigue persisted as of 10/16/02. On 1/4/01, the subject was evaluated by an infectious disease specialist "because of Sx's which developed subsequent to receiving the Lyme vax. The PT states states that in June '00, she received her first dose of Lyme vax and, subsequently, felt fatigued. Approx 7/11/00, she states she received her 2nd injection and felt even more fatigues. In addition, following the 2nd vax, she developed generalized achiness along with arthralgias involving the knees, ankles, shoulders, elbows, wrists and hands. She describes these pains as occasionally "shooting in nature". There is no myalgia per se, however, she feels that while walking, her legs, at times, feel like 'lead  pipes' and she is 'wobbly'. Furthermore, she states that, over the last 6 mts, she has noticed sweating from the waist up that can occur either day or night. There are no night sweats, fevers, dyspnea, or chest discomfort. She states that she takes up to 3 diet pills daily as prescribed... in order to maintain a wakeful state." Medications at that time included amlodipine / benazepril, aspirin / meprobamate (Equagesic) and simvastatin. On physical exam, "Extremities show no edema, cyznosis or clubbing. There is no joint swelling or erythema. There is no significant pain w/range of motion of the joints of the extremities. No focal motor weakness is detected." The MD's impression was "Generalized arthralgia and fatigue, possibly secondary to cross reacting antibodies elicited by Lyme vax. The PT's Sx's do seem to temporally correlate with receiving her Lyme vax... I told the PT that, although her Sx's are temporally related, I cannot be completely certain that the Lyme vax was the cause of her Sx's." The MD prescribed celecoxib (Celebrex). Lab analyses were w/in the ref ranges. Please see Lab Data section. On 3/9/01, the subject was evaluated by a rheumatologist. At that time, she reported that she received an injection of LYMErix "on 6/13/00 and after that, she felt tired. She received a 2nd one on 7/17/00 and after that, she said she felt achy." She reported that celecoxib therapy "helped her somewhat but the pain came back when she stopped it. She says that all of her joints ached, specifically wrists, ankles, toes, fingers, elbows, knees and hips. Her feet feel burning and swollen in her shoes. She gets cramps in her lower legs. She gets lightening-type pains and numb feelings in her ankles and knees and she gets very tired. She says she barely makes it to work and then she comes home and falls asleep. She also gets sweats from her waist up which go away in a few seconds. She does not have any swelling of any joints. She is still in the morning for 1-2 mins. She has been fatigued since June 00." She also reported that she had difficulty sleeping because of the pain in her legs. Medications at that time included amlodipine / benazepril, famotidine (Pepcid), simvastatin, aspirin, and celecoxib. On physical exam, "Vibratory sensation is intact. She walks favoring the left knee. Heel and toe walking are okay. Toe touch is ok. Straight leg raising is neg. Cervical spine motion is decreased generally. She has full range of motion of shoulders w/no pain. She does have some Heberden's but otherwise the joints in her upper extremities were neg. The left knee appeared to possibly have a small effusion. I aspirated it and was able to see just a drop of fluid in the tip of the syringe which was clear. There is no heat or redness, tenderness or limitation of motion. She does have a positive patellar inhibition test in both knees. Hips, ankles, and feet were negative. She is tender over the trochanteric bursa and is tender in approximately half of the fibromyalgia tender points." The MD stated, "I do not believe that any of her Sx's are related to the Lyme vax... I believe she has a fibromyalgia-type picture." The MD recommended a calcium supplement w/Vitamin D, aerobic exercises, and increased water intake. On 5/21/01, the subject was evaluated by a 2nd infectious disease specialist w/the chief complaint of "fatigue and joint pains developed after received Lyme vax." The MD wrote, "After receiving the first dose [of LYMErix], she tells me that she gradually became tired and achy; after the 2nd dose, these Sx's because much worse and were associated w/shooting pains in her knees and elbows, burning and swelling of her feet and intermittent night sweats. These Sx's have continued." On physical exam, "She has no gross joint abnormalities, no increased warmth, erythema, or swelling, and no skink lesions or edema. Her motor and sensory exams are grossly normal, and her reflexes are 2+." Lab analyses revealed a decreased concentration off thyroid stimulating hormone. Please see Lab Data section. The MD wrote, "I do not see any evidence of active Lyme disease in this PT. She has no gross signs of arthritis. The etiology of her fatigue and arthralgias are unclear at this time. I would specifically rule out hyperthyroidism." The subject returned to her cardiologist on 3/6/02. At that time, "she still has intermittent numbness of the left finger. She has less fatigue. She believes the fatigue and joint Sx's have increased after the Lyme vax." Following the report onset of arthralgias, the subject experienced weakness, blurred vision, lightheadedness, and backache. These events were not reported as adverse events due to vax admin, 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 1/15/03, did not provide the outcomes of the reported events. Info received on 12/20/02 indicated that joint pain and fatigue persisted as of 10/16/02.  Follow up on 02/26/04: "The most recent information, received on 01/29/04, indicated that the fatigue and achiness persisted as of 08/29/02.  The outcomes of the other reported events were not provided."