Age: 48.0
Sex: F
Vaccine: LYME
Symptoms: Medication error, Tenosynovitis
Clinical narrative: This report describes arthritis in a 48 y.o. female vaccinee who received Lyme disease vax. The medical history included breast lump (97), Lyme disease treated for over 2 yrs w/antibiotics including intravenous antibiotics (92), "somewhat depressed", residual fibromyalgia secondary to Lyme disease (96), back pain (96), cervical/upper back spasms (96), recurrent paresthesias (96), shoulder pain (96), elbow pain (96), labyrinthitis (90), loss of normal cervical disc space, osteophyte formation C5-6 and C6-7, subluxation (95), cervicalgia, cervico brachial syndrom, paraspinal myofascitis, cervical sprain/strain (95), cervical myofascitis (95), myalgias (96), vaginal candidiasis, arthralgia (96), "pre-cancerous" colon polyp (97), motor vehicle accident (91), conjunctivitis, allergic rhinitis (98), insomnia (97), major depression (96), anxiety (96), panic attacks (96), headaches (87), and chronic fatigue (87). Concurrent medications included citalopram hydrobromide (Celexa), lansoprazole (Prevacid), alprazolam (Xanax), pseudoephedrine sulfate/loratadine (Claritin-D), amoxicillin/clavulanate (Augmentin), benzonatate (Tessalon perls), budesonide (Rhinocort), codeine, and fluconazole (Diflucan). The PT was allergic to codeine. Following the reported onset of arthritis, the vaccinee experienced urinary frequency, abdominal pain, diarrhea, sinusitis, dehydration, URI/pharyngitis, nausea, stomach cramps, cerumen impaction, "acid reflex", shortness of breath, and chest pain. These events were not reported as adverse events due to vax administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. The subject received injections of LYMErix on 7/19/99, 8/26/99, and 4/21/00. The 3rd injection was administered 7 mts after the first injection, rather than the recommended interval of 12 mts. In a Statement of Injuries, her attorney alleged that the vaccinee "suffers from swollen and painful joints, numbness down her arms, carpal tunnel syndrome, and pain in her spine and neck. She also experiences fatigue and memory loss. In addition, she suffers from depression." The subject was evaluated by an orthopedic surgeon on 5/1/00. Her chief complaints were neck pain and numbness in the hand and finger. She had received chiropractic treatment for these Sx's. On physical exam, the MD noted full range of motion of the cervical spine, positive Tinel's sign at the left wrist, and a negative Phalen's sign. The MD's impression was "rule out cervical disease vs. carpal tunnel." He discontinued naproxen (Naprosyn) and prescribed piroxicam (Feldene). The subject did not return to this MD for follow-up. The subject presented to the vax provider on 5/17/00. Her chief complaint was "joint pain/aches for almost one year." She c/o'd of "wrist/feel pain. Very achy. Severe Sx's started after 3rd vax in Feb. 2000." She also reported "Bilateral wrist/hand numbness." The MD's assessment was "Multi joint aches". He prescribed celecoxib (Celebrex). Quantitative Lyme IgM, IgG and Parvo B-19 were elevated. Magnetic resonance imaging (MRI) of the cervical spine revealed abnormalities. Please see Lab data section. The subject was evaluated by a rheumatologist on 7/31/00. In a letter to the vax provider, dated 11/30/00, the rheumatologist wrote "I am following your PT... for complaints of persistent pain in the joints including the feet, low back and knees. She also complains of myalgias and feels she has trouble w/short term memory. As you know, the PT had a history of Lyme disease for which she was treated w/oral and intravenous antibiotics for several mts. She continues to have Sx's and was subsequently treated with [azithromycin] Zithromax for a 2 year period... Following [the third injection of LYMErix] she developed exacerbation of joint pains and malaise. She claims she developed paresthesia of both arms, neck pains and arthralgias at that time." On exam, she showed "slightly limited extension of the cervical spine with discomfort to palpation over the upper thoracic area. She also had discomfort to palpation in the lumbar area. She had minimal synovitis of the second and 3rd MCP [metacarpophalangeal joints[ of the left hand but had no synovitis of any other joints. The remainder of the joints showed full range of motion. X-rays were reviewed w/the PT and these showed evidence of disc space narrowing in the area of the cervical spine and some bony enlargement in this area." Serology of disc space narrowing in the area of the cervical spine and some bony enlargement in this area." Serology for Epstein Barr virus was indicative of "convalescent phase". The MD's impression was "this PT has chronic Epstein Barr Virus Infection associated w/fatigue, and arthritis which may be early Rheumatoid. The possibility of arthritis following Lyme vax also needs to be considered at this point." The MD increased celecoxib dose and prescribed metaxalone (Skelaxin). On 12/19, the subject reported increased right shoulder pain. The rheumatologist noted shoulder stiffness and offered "shoulder injections" but the subject refused. "She wishes to consider chiropractic or acupuncture treatment." On 4/26/01, the rheumatologist prescribed methorexate and prednisone. The subject refused these treatments and did not return to the (just blank space). On 2/20/01, on the chiroractic health center "case history update", the vaccinee wrote that her present complaint was pinched nerve in shoulder and neck, headaches, and Lyme disease. She wrote "slept wrong?" next to "how did it happen?" On 7/31/01, the vaccinee was seen by the MD. She c/o'd of feeling cold, fatigued, "feels like she is going to pass out, all her joints hurt, frequency of urination, right abdominal pressure, left back pain x 2 weeks." The MD made an assessment of fatigue/ myalgia/ arthralgia. The plan was to continue celecoxib (Celebrex). On 8/1/01, the Epstein-Barr virus acute infection IgM antibodies were elevated; the Epstein-Barr virus early antigen antibodies IgG were positive. The MD noted "recent EBV (Epstein Barr Virus) in convalescent stage." On 11/2/01, the Lyme Elisa titer IgG was elevated, the Lyme Western Blot IgG and IgM were negative, the MarDx Western Blot IgG was negative, the Immunetics Western Blot IgG was negative and the overall interpretation was "No evidence of seroreactivity beyond that expected from the Lyme vax." As of 7/9/02, the outcomes of the adverse events were unknown. The adverse events "arthritis", "memory loss", "swollen joints", "painful joints", "numbness", and "carpal tunnel syndrome" do not meet the ICH serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.