Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Gastroenteritis, Gastrointestinal disorder, HLA marker study positive, Immunology test
Clinical narrative: Report A0362612A describes Epstein-Barr virus infection in a 45 year old female who received LYMERIX. This report was received as part of litigation proceedings, with forwarding of medical records. The subject submitted a report directly to VAERS (VAERS ID 171062). The subject's medical history included mood swings (1994), depression (1995), fatigue (1995), possible Lyme disease (1990), Eustachian tube dysfunction, serous otitis media, sinusitis, otitis externa, bronchitis, urinary tract infection, influenza (17 February 1999), kyphoscoliosis, back spasms, right shoulder bursitis (1992), arthralgias, dysmenorrhea, endocervical polyps, cervical carcinoma in-situ (1983), cervical parakeratosis, cervical hyperkeratosis, acute and chronic endocervicitis (1994), seborrheic keratosis, lymph-hemangioma on the left knee, and a motor vehicle accident. Surgical history included fractional dilation and curettage and cold knife conization of the cervix (1983) and loop electrosurgical excision procedure (1996). Concurrent medications included TYLENOL #3, FLONASE, and AMBIEN. The subject received injections of LYMERIX on 20 April 1999 (lot LY120A9), 15 May 1999 (lot LY120F9), and 12 April 2000 (Lot LY136B9). In a statement of injuries, the subject's attorney alleged that the subject "experiences joint pain, fatigue, pain in her ribs, muscle pain and nausea. She has also been diagnosed with Epstein-Barr". The following information was obtained from medical records. The subject telephoned the vaccine provider on 16 June 1999, one month following receipt of the second injection of LYMERIX, and reported flu-like symptoms. The physician wrote, "? secondary to vaccine versus viral syndrome." The subject returned to the vaccine provider on 15 April 2000, three days following receipt of the third injection of LYMERIX "with the primary complaint of mild throat discomfort." In addition, she wanted to review previous diagnostic evaluations conducted because of thoracolumbar back pain. On physical examination, the physician noted "moderate to severe kyphoscoliosis with mild bilateral paraspinal spasm." His assessments were "URI; Kyphoscoliosis; Musculoskeletal pain." For treatment of the musculoskeletal pain, the physician prescribed naproxen, therapeutic massage, and physical therapy. The subject returned to the vaccine provider on 25 May 2000 "still not feeling well, some GI distress and a lot of diffuse achiness and fatigue, often with some difficulty sleeping." No abnormalities were noted on physical examination. The physician's assessments were "Abdominal distress. Diffuse achiness. Question fibromyalgia picture." The physician prescribed CELEXA. The subject remained under the care of the vaccine provider until at least 22 October 2001. During that time, she reported nausea and vomiting on two separate dates. On 29 June 2001, she told the vaccine provider that she was under the care of an "emerging diseases" specialist, who "thinks that she has active Epstein Barr and started her on VALTREX 500mg bid (twice daily) on 6/1901.". On 07 August 2001, she reported that the "emerging diseases" specialist had prescribed CEFTIN and BIAXIN. On 22 October 2001, she reported that she had been evaluated by an infectious disease specialist, who had prescribed VIOXX. Serologies for Epstein Barr virus and Lyme disease were positive. Please see laboratory data section. During this time, the physician made additional diagnoses of "Fibromyalgia" (20 July 2000), "Viral syndrome with otitis media and externa" (05 September 200), "fatigue; nasal stuffiness" (27 November 2000), "gastroenteritis" (01 June 2001), and "fatigue-etiology uncertain, question Lyme" (07 August 2001). He prescribed fluoxetine and intramuscular hydroxyzine to treat nausea. The subject presented to an "emerging diseases" specialist on 18 June 2001. She stated the reason for the evaluation as "adverse reaction to Lymes [sic] vaccine." She reported joint pain, fatigue, pain in ribs, and nausea. She reported that she "felt sick" following receipt of the first injection of LYMERIX. "By August 1999, I was experiencing joint pain, fatigue, pain in my ribs, muscle pain and nausea. The most severe being pain in my ribs, fatigue and nausea." The specialist noted that the rib pain was worse on the left side and that all symptoms "come and go in waves". Pain did not go away." The subject stated, "(the vaccine provider) began treating these symptoms as if they were associated with the chronic fatigue syndrome. On May 25, 2000, test results showed that I have active Epstein Barr virus. Since then (the vaccine provider) has been treating my symptoms as if they were associated with Epstein Barr virus. Treatment has been PROZAC 20mg daily and DARVON 65mg as needed for pain. My symptoms persist with no change. On 19 July 2001, the subject reported "pain in rib - stabbing pain in arms, muscle". The subject also reported fatigue and "not sleeping". The specialist prescribed clarithromycin, cefuroxime, and DIFLUCAN. The subject came under the care of a new physician on 20 September 2001. She reported "two years of not feeling well. Lyme vaccine times 3. ? felt bad post first shot, especially second. ? Chronic Fatigue Syndrome. Treated PROZAC/DARVON but not better. EBV positive." She also reported that she slept poorly and had muscle pain and rib pain "not joint". The subject remained under the care of this physician until at least 04 February 2002. During this time, she reported dreaming when taking AMBIEN, "pain/fatigue intensity less", "less panic", and waking up once per night. She also reported "VIOXX helps". Following the reported onset of Epson-Barre virus infection, the subject experienced hemangiomas, nevi, subconjunctival hemorrhage, urinary tract infection, nasal stuffiness, upper respiratory tract infections, otitis externa, otitis media, and "questionable sinusitis". These events were not reported as adverse events due to vaccine administration, 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 information, received on 06 May 2002, did not provide the outcomes of the reported events. Medical records information received on 16 June 2005 revealed that on 31 November 2003, the patient was referred to a neurologist because of pain in arms with numbness and tingling which started one month ago. She also experienced burning sensation on arms that later felt at the bottom of her foot. She has been treated with BEXTRA without improvement. According to the patient, she is HLA DR4 positive and has an autoimmune arthritis. The physical examination was unremarkable except for prominence of the right scapula and tenderness of the supraclavicular area upon deep palpation more prominent in right; positive Tinel's sign (bilateral) at wrist percussion. The patient was diagnosed with cervical myofacial pain syndrome and bilateral brachial plaxitis. Her neurologist suggested treatment with prednisone taper followed by nonsteroidal inflammatory agent, massage with muscle relaxant, physical therapy and use of Tens unit. On 21 January 2004, a Magnetic Resonance Imaging (MRI) cervical scan revealed a moderately advanced degenerative bone and disc changes throughout the cervical spine and levoacoliotic curve. The combination produced mild stenosis of the central canal from C2 to C6. Medical records received on 14 July 2005 indicated that the patient was seen by a physician on 10 March 2005 and the events were ongoing. A statement of injuries received on 08 November 2005 stated the following: " (the patient) sufferes/suffered fromfatigue, stiffness, achiness, pain in her joints including her hips, elbows, and wrists, pain in her neck and back, pain in her hands and arms and legs, pain in her ribs, difficulty sleeping, numbness/burnig in her arms, numbness in leg, burning sensation in the botton of her feet, difficulty with word finding, illegible penmanchip, nausea." The events of "difficulty with word finding" and illegible penmanship" were assessed as medically serious by GSK. Follow-up information was received on 14 March 2006 via medical records. According to the patient during a routine eye examination, she had developed rheumatoid arthritis and extreme fatigue following LYMERIX vaccination. Medical records provided did not confirm a diagnosis of rheumatoid arthritis. As recently as 09 June 2005, the patient was examined for continued aches and pains, fatigue, myalgia, and paresthesias. At that time working diagnoses included fibromyalgia, paresthesia, anxiety state, and vaginitis/vulvovaginitis. Future expedited VAERS reports for this LYMERIX case shall be referred to BB-IND 5420, which is a change from a past reports refering the voluntarily-revoked license (STN 103757).