Sex: F
Vaccine: LYME
Symptoms: Hepatitis C antibody negative, Hypoaesthesia, Injection site atrophy, Joint stiffness, Liver function test normal
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a female subject of unspecified age who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose Lymerix (unknown). At an unknown time after vaccination with Lymerix, the subject experienced joint pain, joint stiffness, pain, swelling, blurred vision, activities of daily living impaired, fatigue, tingling, hair loss, weight gain, twitch, imbalance, cognitive difficulty, numbness, burning sensation, nerve injury, possible autoimmune disease and decreased ability to perform daily activities. At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries. Follow up information was received via medical records on 17 January 2007. The subject's medical history included cholelithiasis, chronic cholecystitis, hypertension, hypothyroidism, knee ligament tear, knee surgery, laparoscopic cholecystectomy, non smoker, no known drug allergies, and non drinker. Concurrent medication included Synthroid and Hyzaar. On an unspecified date in 1999, the subject received 2nd dose of Lymerix in the right arm. At the time of the administration of the 2nd dose of Lymerix, the subject aged between 50 and 59 years old. In 1999, less than one year after vaccination with Lymerix, the subject experienced burning pains in her hands and feet, aching muscle and joint pain, numbness in her arms, mild weakness in the right leg and chronic fatigue. The subject was seen by a physician. The joint pain was treated with oxaprotin. On 09 July 2002, a Lyme disease screen was positive at 4.71, but Lyme disease western blot results for IgM and IgG were negative or nonreactive for all bands. On 28 July 2003, A Lyme disease DNA by qualitative PCR was negative. On an unspecified date in 2004, the subject experienced skin atrophy at the injection site of the 2nd dose of Lymerix. The subject was seen by a dermatologist. On 09 February 2004, a biopsy of the atrophic patch at the site of Lymerix immunisation from 1999 (right upper arm) revealed morphea with no evidence of Spirochetes on staining. The dermatologist reported that, I do no know of any association of morphea and a Lyme vaccine, but in the past, there has been I believe morphea and Lyme were somehow connected. On 20 November 2004 the subject was seen by a neurologist. An electrodiagnostic study revealed evidence of a moderately severe right median neuropathy at the wrist (carpal tunnel syndrome). On 15 February 2005, biopsies of skin from proximal right thigh and distal leg showed significantly reduced epidermal nerve fiber density, consistent with small fiber neuropathy. Test performed from 10 November 2004 through 17 April 2006 were normal or negative for Chem7, liver and renal function, ESR, hemoglobin ALC, thyroid function, antinuclear antibody, rheumatoid factor, sjogren syndrome antibody (A and B), total hemolytic component, antineutrophil cytoplasmic antibody, ganglioside GDIB IgG and IgA, C reactive protein, gliadin IgA and IgG, myeloperoxidase antibody, proteinase 3 antibody, DS DNA antibody, and hepatitis C virus antibody. At the time of follow up reporting, 17 January 2007, the outcome of the events was not reported. This case was assessed as medically serious by manufacturer.