Age: 63.0
Sex: F
Vaccine: LYME, LYME
Symptoms: Injection site pain, Injection site warmth, Insomnia, Malaise, Myositis
Clinical narrative: The pt's 2nd Lymerix injection was given on 9/13/00. In a Statement of Injuries, her attorney alleged that the pt "experiences joint pain in her arms, hands, shoulder, neck and back and throughout her entire body. She also experiences muscle pain throughout her body. In addition, she suffers from fatigue and insomnia. She also experiences pain when she applies any pressure to her skin. She has been dx'd with severe fibromyalgia syndrome. She also suffers from degenerative osteoarthritis. In addition, she suffers from bilateral upper quarter myofascial syndrome with prominent clinical activity of trapezius and acalane which produces a supraclavicular thoracic outlet syndrome. The pt was seen by her PCP on 10/25/00 with a chief complaint of left arm pain since receiving the 2nd Lymerix injection. The pain was described as hot, burning, sharp like a "hot poker". The pain went all the way to the neck. Neck ROM was good except turning to the left. The physician recorded a dx of left radiculopathy and myositis of the left deltoid. The physician prescribed a neck collar and X-rays. On 11/6/01, she complained of numbness of the arm and hand. On 11/7/01, she complained of tenderness in the thigh and deltoid area, as well as hand and arm numbness. On 11/20/00, the pt returned to her PCP with a chief complaint of joint pain. The physician recorded the problem list as including fluid in the left shoulder bursa, acromioclavicular arthritis, left shoulder pain and achiness since receiving Lymerix. He referred her to a rheumatologist who saw her on 12/8/00. He noted squaring, crepitus and tenderness of the 1st CMC joints of both hands. The left shoulder was "irritable with full ROM and positive signs of impingement". He noted tenderness in the upper arm muscles, the anterior pectoralis muscles, the left trapezium and the calf muscles. His impression was that the pt had generalized osteoarthritis of the hands and mid-tarsal joints, left rotator cuff tendonitis and bursitis and probable fibromyalgia. He noted, "It is unclear whether her fibromyalgia type symptoms are really related to the Lymerix vaccination or whether this is a coincidence". The pt received a steroid injection in the subacromial bursa and immediately felt analgesia. The rheumatologist prescribed Flexeril and reduced the Vioxx dosage. The pt was seen by a pain specialist on 3/21/01 and treated her with a cervical plexus nerve block, a spinal accessory nerve block, an axillary nerve block and multiple trigger point injections of lidocaine. Ultram was added to the Vioxx therapy. She gained no improvement from the 1st set of injection therapy and her pain was more severe. She was treated with extended-release Oxycontin and immediate-release Oxyir for break through pain. She saw a 2nd rheumatologist and it was noted that she was unable to tolerate Oxycontin. He noted "mild lower extremity edema which might be related to Vioxx. His impression was the pt had "moderate to severe fibromyalgia syndrome that occurred after the Lymerix injection. His recommendation was a course of Celexa. On 7/31/01, she reported that she "feels miserable...quit job". She had "poor quality sleep and poor function". The doctor prescribed Neurontin. On 8/2/01, the pt was seen by her PCP and reported severe malaise. Acute pain persists at vaccine site. She was taking Ambien at night but was still waking up 2 times a night. She was seen again on 3/25/02 with complaints of dizziness, weakness and vertigo for the previous 5 days. She also experienced a flare-up of her fibromyalgia including bad neck pain. She also reported pressure in her ears. She was treated with Antivert twice a day and Scopolamine patch. In a follow-up visit on 4/18/02, it was noted that the rheumatologist had discontinued her Vioxx and she was being treated with Bextra 10mg twice daily. She returned to her PCP on 4/24/02 regarding her increasing foot pain. At times, the pain was "so severe that she feels she is walking on a broken foot". Her foot was also swollen. X-rays showed significant arthritis of her TMT joint at the 2nd, 3rd and 4th TMT joints. There was significant arthritis of her vavicular 1st cuneiform joint. The impression was the pt had diffuse midfoot arthritis. The pt was treated with an ankle fixation orthotic. However, on 5/22/02, the pt complained that the AFO causes her to have severe back pain. The physician suggested she wear it for short periods of time. The most recent information, received on 8/1/02 did not specify the outcome of the events. A 15-day follow up report received 10/25/2002 adds: The pt's medical history included bilateral upper quarter extremity myofascial syndrome that resolved and supraclavicular thoracic outlet syndrome (both in 1995), "severe" degenerative arthritis of the right knee (June 1996), stress, migraines, recurrent Baker's cyst right knee, deviated septum, anxiety, asthma, blood transfusions (May 1999), bursitis, chronic anemia, chronic cholecystitis, hand paresthesias, hypertension, functional hypoglycemia, leg pain, neck pain, "long standing" back pain, advanced degenerative arthritis of the back and knees (1999), osteoarthritis of the hands (1996), bilateral tarsometatarsal arthritis (1998), palpitations, phlebitis, pneumonia, posterior vitreous detachment, post operative ileus, acne, rosacea, temporomandibular joint disorder after trauma, umbilical hernia, foot pain due to tarsometatarsal joint arthritis, and weight gain. Surgical history included a right oophorectomy, 3 jaw surgeries, laparoscopic cholecystectomy, hammertoe repair, appendectomy, 9 knee surgeries and left foot arthroplasty. She was hospitalized from 05/07/1999 to 05/12/1999 to undergo a bilateral total knee arthroplasty secondary to severe degenerative joint disease. In June 2000, the pt was reportedly experiencing a worsening of her midfoot arthritis with increasing pain. At this time, she was being treated with rofecoxin (Vioxx). The pt is a non-smoker. She drinks 2-4 glasses of wine per week. Concurrent medications included propoxyphene napsylate/acetaminophen (Darvocet N-100) as needed, triamcinolone acetonide (Azmacort), simvastatin (Zocor), paroxetine (Paxil), celecoxib (Celebrex), folic acid, raloxifene HCl (Evista), albuterol/ipratropium (Combivent) Mometasone furoate (Nasonex), loratadine (Claritin-D, triamterene/hydrochlorothiazide (Dyazide), terazosinn HCl (Hytrin), and verapamil HCl (Calan SR). The pt received an influenza vaccination in her right deltoid on 10/25/2000 (Medeva). Drug allergies included betadine, reperidine HCl (Demerol), erythromycin, IV contrast dye, cephalexin (Keflex), morphine, sulindac (Clinoril), acetaminophen/oxycodone (Percocet) and penicillin. The pt received her first injection of Lymerix on 06/29/2000 (lot LY146A2). She had perioral dermatitis and diaphoresis at that time. Her second injection was administered on 09/13/2000 (LY128A2).  Following the reported onset of fibromyalgia, the pt experienced depression, pulsatile mass in the right neck, lesion in the left anterior descending coronary artery, irritable bladder, urinary tract infection, left ventricular hypokinesia, shortness of breath, renal insufficiency, and fractured femur. These 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 not listed as adverse events. The most recent info, received on 08/01/2002 did not specify the outcome of the events.