Age: 63.0
Sex: F
Vaccine: LYME
Symptoms: Tenderness, Weight increased
Clinical narrative: Patient claims to have experienced aches and pains in her hands, wrists and knees and was subsequently diagnosed with arthritis following the first injection site of Lymerix. The patient's medical history and concomitant medications were not specified. The patient reportedly did not have aches and pains prior to vax. On 4/13/1999, the patient received her first injection of Lymerix. Within one year, patient allegedly began experiencing chronic aches and pains in her hands, wrist and knees. The physician  diagnosed her pains as being associated with arthritis. The patient is being treated for the event with pain relievers (nos) on a daily basis. She did not receive further injection with Lymerix. On 04/19/1999, the pt experienced painful breathing. She had normal expansion of the chest but was very tender over the coracoclavicular (CC) junctions. On 05/11/1999, the pt received her second dose of LYMErix. on 06/03/1999, the pt experienced pain and swelling of the right ankle for three weeks. She had a previous fracture there. There was no history of recent trauma. On 07/26/1999 the pt experienced recurrent pains in the first metacarpophalangeal joint and the right ankle. Review of systems was normal except for tenderness over the first MCP joint. The pt was given samples of Celebrex. On 08/20/1999 the pt experienced increased pain, expecially at the first left MCP. She was injected with lidocaine and methylprednimolone acetate (Depo-Medrol).  Celebrex dosage was increased. On 10/12/1999, the pt reported that she was doing better on Celebrex but had occasional gastrointestinal upset. The physician prescribed rofeccxib (Vioxx). The pt received 0.5cc trivalent flu vaccine. On 12/10/1999 the pt reported "little relief with Vioxx." The physician discontinued Vioxx. The pt was bothered with fluid retention and archralgias. She was fatigued, had low back discomfort, and occasional pruritus without rash. She had rhinorrhea for two days. She had "many personal problems." Pharyngeal injection was noted. She had "1+" edema in her extremities. there was no synovitis and there was normal range of motion of all joints. On 01/10/2000 the pt's weight was 128 lbs. She was prescribed orlistat (Xenical). On 01/14/2000 the pt experienced pain in the left heal for two weeks. She had changed shoes without improvement. She was "very stressed" because of "personal problems." On 03/16/2000 the pt experienced increased diffuss musculoskeletal discomfort, especially in the knees, ankles, and back. The physician prescribed "diclofenae/guaifenssin cream." On 04/10/2000 the pt was fatigued and had experienced weight gain. she experienced right upper body pains and was retaining fluid. She had increased problems with her memory. the review of systems was otherwise negative. Multiple tender muscular areas were found in the upper right back. these areas were injected with lidocaine. On 04/24/2000 the pt was fatigued and reported increased arthralgias. She reported increased stress at home. On 07/03/2000 the pt was again seen for fatigue. Lasix for her edema was continued. On 07/18/2000 the pt had a sore throat and rhinorrhea for two days. She had frontal headaches that morning and was fatigued. She had intermittent pain in the left knee. There was no swelling, history of trauma, or redness. the pt had slightly tender flex tendon of left knee. The pt was advised to exercise and change shoes. Arelastine hydrochloride (Astelin) was prescribed. On 08/25/2000 the pt had acute pharyngitis. On 09/28/2000 the pt was "very stressed," and had increased musculoskeletal discomfort, aching, and fatigue. Muscles were tense. She received 0.5cc trivalent flu vaccine. On 11/03/2000 the pt experienced a sore throat for three days. On 11/30/2000 the pt experienced acute pharyngitis and was treated with phenylephrine/chlorpheniramine/pyrilamine. On 02/06/2001 the pt had an upper respiratory infection for one week. She presented with chills, sore throat, was dizzy and had a fever of 99.3 deg F. There was tenderness over the left maxillary sinus. Her pharynx was injected. The physician prescribed Zithromax and Duratuss. On 05/31/2001 the pt had a dry cough and rhinorrhea. Her pharynx was beggy and pale. Her lungs were clear. Allegra-D was prescribed. On 07/01/2001 the pt had fatigue and a dry cough for two hours; she could not sleep. She experienced diffuse arthralgiasThe most recent information received on 4/6/00 reports the outcome as ongoing. Follow up states that the patient's age was 63 years old. Medical records were forwarded by the pt's attorney. The pt had unspecified allergies. Her medical history included Raynaud's "asthma," upper respiratory infections bilateral otitis media, acute sinusitis, abdominal pains, complex ovarian cyst, insomnia, fatigue, lethargy, urinary frequency, hematuria, low back discomfort, suprapubic pressure, memory impairment, positional vertigo trated with meclizine, paresthesias of the hand, rash, unspecified skin cancer, rhinorrhea, allergic rhinitis, temporal headaches, lump in the axilla, leg edema treated with furosemide, colitis, and weight gain treated with phentermine hydrochloride and fenfluramine. She was noted to be "depressed" or "very depressed" beginning in 1996. The pt had a long history of musculoskeletal complaints prior to immunization. She fractured her right ankle on an unspecified date. As early as 02/27/1992. a trigger area was noted on the pt's left upper back. On 05/03/1994, her physician wrote,"findings and signs and symptoms suggestive of fibromyalgia with tender points." She went on to experience increasing lethargy and increasing "MS discomfort." Multiple tender points were noted on 08/04/1994. The pt reported increasing arthralgias; back and foot pains; stiffness, especially in the morning; tenderness over metacarpophalangeal joints, wrists, right elbow, and left knee; painful metatarsophalangeal joint; swollen metacarpophalangeal joints; acute synovitis of the right shoulder and right wrist with shoulder pain and decreased shoulder range of motion; and acute cervical strain. On 02/02/1998, her erythrocyte sedimentation rate was 27 m/hr. Her musculoskeletal symptoms were treated with Ansaid, Ambien, naproxen, Relafen, Darvocet, Elavil, Duract, Trilisate, Daypro, Arthrotec, Vicodin ES, Percocet, and an injeciton lidocaine and methylprednisolone acetate. There was a family history of osteoporosis. At the time of immunization with LYMErix, the pt was taking phentermine hydrochloride. The following info was obtained from the office records of the pt's primary physician. 04/19/1999 the pt experienced painful breathing. She had normal expansion of the chest but was very tender over the coracoclavicular junctions. 05/11/1999, the pt received her second dose of LYMErix. On 06/08/1999, the pt experienced pain and swelling of the right ankle for three weeks. She had a previous fracture there. There was no history of recent trauma. On 07/26/1999, the pt experienced recurrent pains in the first metacarpophalangeal joint and the right ankle. Review of systems was normal except for tenderness over the first MCP joint. The pt was given samples of Celebrex. On 08/20/1999, the pt experienced increased pain, especialy at the first left MCP. She was injected with lidocaine and methylprednisolone acetate. Celebres dosage was increased. On 10/12/1999 the pt reported that she was doing better on Celebrex, but had occasional gastrointestinal upset. The physician pescribed rofecoxib. The pt received .5cc trivalent flu vaccine. On 12/10/1999, the pt reported "little relief with Vioxx." The physician discontinued Vioxx. The pt was bothered with fluid retention and arthralgias. She was fatigued, ahd low back discomfort, and occasional pruritus without rash. She had rhinorrhea for two days. She had "many personal problems." Pharyngeal injection was noted. She had "1+" edema in her extremities. There was not synovitis and therre was normal range of motion of all joints. On 01/10/2000, the pt's weight was 128 pounds. She was prescirbed orlistant. On 01/14/2000, the pt experienced pain in the left heel for two weeks. She had changed shoes without improvement. She was "very stressed" because of personal problems. 03/16/2000, the pt experienced increased diffuse musculoskeletal discomfort, especially in the knees, ankles, and back. The physician prescribed "diclofenac/guaifenesin cream." On 04/18/2000, the pt was fatigued and had experineced weight gain. She experienced right upper body pains and was retaining fluid. She had increased problems with her memory. The review of systems was otherwise negative. Multiple tender muscular areas were found in the upper right back. These areas werre injected with lidocaine. On 04/24/2000, the pt was fatigued and reported increawed arthralgias. She reported increaed stress at home. On 07/03/2000, the pt was again seen for fatigue. Lasix for her edema was continued. On 07/06/2000, the pt had a sore throat and rhinorrhea for two days. Seh had frontal headaches that morning and was fatigued. She had intermittent pain in the left knee. There was no swelling, history of trauma, or redness. The pt had slightly tender flex tendon of left knee. The pt was advised to exercise and change shoes.  Azelastine hydrochloride was prescribed. On 08/25/2000, the pt had acute pharyngitis. On 09/29/2000, the pt was "very stressed" and had increased musculoskeletal discomfort, aching, and fatigue. Muscles were tense, with a "spasm" in teh lumbosacral spine. She received .5cc trivalent flu vaccine. On 11/03/2000, the pt experienced a sore throat for three days. On 11/30/2000, the pt experienced acute pharyngitis and was treated with Rynatan. On 02/06/2001, the pt had an upper respiratory infection for one week. She presented with chills, sore throat, was dizzy, and had a fever of 99.2 deg. f. There was tenderness over the left maxillary sinus. Her pharynx was injected. The physician prescribed Zithromax and Duratuss. On 05/31/2001, the pt had a dry cough and rhinorrhea. Her pharynx was boggy and pale. Her lungs were clear. Allegra-D was prescribed. On 07/03/2001, the pt had fatigue and a dry cough for two hours; she could not sleep. she experienced diffuse arthralgias associated with joint tenderness. No redness or swelling was noted. The pt experienced spontaneous bruising. she found that her short-term memory loss has increased. At this time, she was taking no medication. She was taking vitamins; none were taken in excess doses. her musculoskeletal examination was normal except for diffuse joint tenderness. Several ecchymotic areas were ntoed on her hands and left thigh. The physician prescribed Tussionex. On 08/16/2001, does not provide the outcome of the alleged arthritis. The adverse event of 'arthritis' does not meet serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.