Age: 49.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Pain, Polyarthritis, Raynaud's phenomenon
Clinical narrative: Pain in hands and feet. X-rays show severe arthritis in joints. Dr treating pain with Vioxx 25mg.  A follow up report received 2/3/2003 adds: (From FDA Researcher): On this date at 11:30 AM I spoke to subject patient. She provided an update regarding her condition and the adverse event she experienced following the Lyme vaccine. She stated that she is now doing worse since the time of her VAERS report and follow-up survey interview. She stated that she was still experiencing aches and pains. She is still taking medication to keep her symptoms under control. She was on a trial drug from Merck which helped, however she experienced side effects and has since stopped taking that drug. She now has severe pain in her hips as well as other previously reported joints (hands, feet, elbows). She developed Reynaud's syndrome following her Lyme vaccination, approximately 2 years ago, and asked about that being a possible side effect of the vaccine. I responded that there was no evidence at this time to indicate that. A follow up report received 9/9/2002 adds: Report A0323036A (formerly 2000007818-1) describes osteoarthritis in a 49-year-old female who was vaccinated with Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis. The initial report was received from the subject; follow-up info was received from her physician and frm her attorney with forwarding of medical records. Allergies included morphine and intravenous pyelogram (IVP) dye. Medical history included arthritis, cystitis, pain in her feet and hands (occasionally drops things), hayfever, hemorrhoids, hypothyroidism, lumpectomies (1981 and 1985) mitral valve prolapse, thyroid biopsy, palpitations, partial hysterectomy (1986), tonsillectomy (1956), irritable bowel syndrome, poor sleep and fatigue (May 1999) and gravida two, para two. At the time of the events, she was taking loratadine (Claritin), levothyroxine (Levoxyl), alendronate (Fosamax), etodalac (Lodine XL) (only when the pain gets bad) and melatonin. The pt received Lymerix in April 1999 (lot number not provided), 05/05/1999 (LY120D9) and 06/30/1999 (LY1209D). The pt received her first and second injections of Lymerix with no untoward effects. In a Statement of Injuries, the pt's attorney alleged that the pt "had suffered pain in the joints of both hands, knees and feet. The pain in her knees had been particularly acute. In addition (the pt) suffered swelling in the joints of her hands and feet." It was reported that approximately four months after the third injection of Lymerix she experienced severe joint pain in her hands and feet. Blood work was done and the pt had a "questionably elevated IgC level" for parvovirus D19, her IgM level was normal. Her Lyme test, complete blood count, chemistries, erythrocyte sedimentation rate and BHD were within normal limits. X-rays performed on 04/04/2000 were notable for osteoarthritic changes of the feet and hands. Acetaminophen (Tylenol)was given as treatment. The pt was referred to a rheumatologist. The following info was received from medical records. The pt presented to her primary care physician on 12/03/1998 with complaints of joint pain in her hips, fingers, toes and a stiff neck. She reported that she had a tick bite 4 years previous (1994). The pt reported she was performing increased lifting at the hardware store and that she walked approximately 4-5 miles each morning (1998). She also added that she was unable to wiggle her toes flexing upwards. She remained under her care until at least 02/05/2001. During this time period, the physician noted increased daily intermittent back pain for 3 years, leg and knee cramps, and a constant dull pain. On physical examination, the physician noted swollen knuckles, no changes in reflexes and hip tenderness at full extension. The physician also questioned Raynaud's. On 02/05/2001 the pt reported lower back pain which started after carrying a heavy box. The physician noted positive lower back tenderness and muscle spasms. The pt was diagnosed with a back sprain. The pt was referred to a rheumatologist. In Sept 1998, the pt was under the care of her gynecologist. A bone density test was performed on 07/29/1998 (Please see Laboratory Data Section). Laboratory tests were performed on 04/05/2000. (Please see Laboratory Data section.) On 05/04/2000 the pt was seen by a rheumatologist with complaints of hand and metatarsal pain for the previous 8 months. It was noted she had a history of metatarsl pain. She denied swelling of the hands or wrists and denied lupus-like of myositic symptoms. She was started on rofecoxib (Vioxx) 12.5 mg daily. Please see Laboratory Data section for laboratory evaluation. She was seen by the rheumatologist again on 05/29/2000 at which time her Vioxx was increased to 25 mg daily and she was started on a nutritional supplement, S-adenyl-methionine. She was assessed as having early osteoarthritis of the hands and feet. On 01/23/2001, the pt again saw the rheumatologist. On physical assessment, she was noted to have osteoarthritic changes in the hands. The pt was seen by the rheumatologist on 03/20/2001 at which time she was noted to have significant Raynaud changes in her feet. She was started on Procardia XL 30 mg daily. The pt was seen by the rheumatologist for follow-up on 04/24/2001. She was reportedly stable on Mobic 75 mg daily since 05/29/2000 with stabilization of her osteoarthritis of the hands. She also had marked clinical improvement on the Procardia. The pt's C-reactive protein and erythrocyte sedimentation rate (ESR) Westergren, were within reference ranges. The pt was seen by another rheumatologist on 05/22/2002. He noted that the pt reported significant pain and swelling in her hands about 6 after her third Lymerix injection. More recently, she had some discomfort in her wrists, elbows, hips, ankles, and across the metatarsal heads, but it had been primarily in the hands that bothered her the most. Her treatment had included Lodine, Vioxx, Kobic, Celebrex, diclofenac acid, and most recently Dextra. All of htese seemed to work for a while but then became less effective. Other complaints included Raynaud's syndrome that had been present for the past year which responded well to nifedipine, which she was not taking at the time of the visit because of the warmer weather. On physical exam, the upper extremities revealed some slight puffiness and tenderness of the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints. The DIP joints were consistent with Heberden's nodes. Her wrists had pain on movement but did not appear to be swollen. Her elbows and shoulders moved well without any pain. Examination of the lower extremities revealed good range of motion of her hips, knees, ankles and toes. There did not appear to be any swelling, but she was somewhat tender across the metatarsal heads. The physician's "concern" was that the pt may have rheumatoid arthritis. However, rheumatoid factor was within reference range. C-reactive protein and ESR, Westergren, were also within normal limits. Antinuclear antibody was negative. She was started on Voltaron 75 mg twice daily. The most recent info, received 08/23/2002 did not report on the outcome of the events. However, info received on 02/11/2002 indicated that the events were ongoing. The events of "osteoarthritis", "sore joints", "joint swelling", "hand pain", and "foot pain" are labelled per the USPI. The adverse events do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the 06/28/2000 letter.