Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M, Bone pain, Brain scan abnormal, C-reactive protein normal
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMErix. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMErix (unknown). At an unspecified time after vaccination with LYMErix, the subject experienced joint pain and swelling, fatigue, flu-like symptoms, muscle pain and weakness, bone pain, shooting pains, memory loss, cognitive problems, headaches, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMErix. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up was received on 26 July 2007 via medical records. Medical records dated 07 September 1998, indicated that the subject was seen at a physician's office for tiredness, weakness and pain in the elbows, toes, fingers and back. Medical history from this office visit also indicated that the subject had Lyme disease three times in the past and was treated with intravenous antibiotics on all three occasions, and secondary hepatitis from giardia. Medical history also included strabismus of the left eye at age 3 years, hypercholesterolemia, dyslipdemia, tonsillectomy, elevated prostate specific antigen, hiatal hernia, irritable bowel disease, prostatitis, liver hemangioma, prior tobacco use, no known drug allergies and atherosclerotic vascular disease. The hepatitis was described as from an unclear etiology secondary to multiple tropical travels. On 06 March 2000, the subject received a dose of LYMErix. Medical records from the office visit on 06 March 2000 noted that, on the day of LYMErix administration, prior to the injection, the subject was experiencing diarrhea, myalgia, nausea, headache, dizziness, sore throat, and low grade fever. The onset date for diarrhea, myalgia, nausea, headache, dizziness, sore throat, and low grade fever was noted as "approximately one month" prior to 06 March 2000. On 26 May 2000, tests for hepatitis B surface antibody, hepatitis B surface antigen, hepatitis C virus antibody, antinuclear antibody, rheumatoid factor, C-reactive protein, and rapid plasma reagin were all negative. On 26 May 2000, Lyme IgG western blot was negative with no bands present. On 27 November 2000, less than one year after administration of Lymerix, medical records noted that the subject reported that he had fibromyalgia "and/or reaction to Lyme vaccine." On 05 December 2002, medical records indicated that the subject had bilateral knee arthritis, but the onset date for this event was not provided and Lyme disease "which was treated four times so far." Medical records from 05 December 2002 also noted that the subject had received Cerivastatin for "about 7 or 8 years" for dyslipidemia. The Cerivastatin was discontinued due to "elevation of the liver profile." Therapy with Pravastatin sodium and ezetimibe was subsequently initiated. Review of systems on 05 December 2002 indicated that the subject "denies any neurological problem" and noted that the subject exercises three to four times per week. Medical records dated 29 January 2004 indicated that the subject experienced tiredness, right sided chest pain and tingling similar to the tingling from previous hepatitis. Medical records from a patient encounter form dated 19 October 2004 reported that in May 2000, "6 weeks after the 3rd LYMErix," the subject was diagnosed with fibromyalgia. At the time of the onset of fibromyalgia, the subject was 47 years of age. Tests performed from 15 June 2004 through 22 October 2004 were notable for positive Rheumatoid factor, elevated ESR, Lyme Western blot indeterminate for IgG (bands 60,41 and 31 present) and negative for IgM with Lyme disease serology considered non-reactive; indirect immunofluorescence for B. microti negative for IgG and IgM. Sjorgrens antibodies (SSA and SSB) negative, Anti-cardiolipin IgM negative, HLA-B Class I DNA tying at 38,63, and qualitative polymerase chain reactions for B. burgorieri, B. henselae, Mycoplasma fermentans, Babesia microti negative. On 19 October 2004, a report from a Brain SPECT scan indicated "mild global hypoperfusion consistent with focal encephalopathy of the temporal lobe that go along with the dominant hemispheric cognitive difficulties that the subject displayed, which is often seen with Lyme disease." The subject was diagnosed on 23 December 2004 with autoimmune disease. It was also noted on 23 December 2004, that on unspecified date, the subject experienced severe muscle aches, severe bone pain, constant feverish feeling and extreme fatigue. The subject was treated with "NSAIDs, neurontin without relief." On 29 April 2005 a MRI of brain with and without contrast showed a left in the left fourth periventricular area felt to represent a vascular anomaly, possibly an angioma and had evidence of old blood products. On 04 May 2005, a skin biopsy of the left calf and left thigh indicated significantly low epidermal nerve fiber density. The pathology report described the subject as "a 52 year old man with history of Lyme disease, status post LYMErix paresthesias." Medical records dated 17 September 2005 indicated that the subject was diagnosed with polyneuropathy with numbness of the lower extremities and severe cognitive decline post LYMErix vaccine. The subject was treated with intravenous immune globulin. Other medications noted on a medical record dated 01 November 2005 indicated Vicoprofen, Pantoprazol, Zolpidem tartrate, and Alprazolam. Medical records dated 18 November 2005 indicated that the subject experienced difficulties in concentration "due to CNS Lyme." On 11 October 2005 testing for antinuclear antibody was positive at 1:160 with a speckled pattern, thyroglobulin antibody was positive at 25 (normal less than 20 IU/mL). On 03 March 2006, Lyme Western blot was indeterminate for IgM (bands 18, 31, 41, 43, 58 present) and negative for IgG (only reactive for 31-opsA) with Lyme disease serology considered reactive. Expedited VAERS reports for this LYMErix case shall be referenced to BB-IND 5420, which is a change from past reports referencing the voluntarily-revoked license (STN 103757). Comment: Encephalopathy and brain lesion were assessed as medically serious by GSK.