Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Pain in extremity, Paraesthesia, Peripheral coldness, Radiculitis, Rash
Clinical narrative: Report 2001005622-1 described "losing mental capacities" in a 43-year-old female who received LYMERIX. This report was received from the vaccinee's husband and has not been verified by a physician or other health care professional. Allergies, medical history, and concomitant medications were not specified. The patient reportedly "always get a mild dose of the flu" following receipt of influenza virus vaccine (brand name unknown). On an unspecified date, the vaccinee received her first dose of LYMERIX. Subsequently, she "noticed some pain" (site not specified). On an unspecified date, the vaccinee received the second dose of LYMERIX. Subsequently, in addition to experiencing unspecified adverse events, she experienced deteriorating eyesight (NOS) and was "losing her mental capacities." As of 23 February 2001, the outcome of the adverse events is unknown. The adverse event of 'losing mental capacities' does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Follow-up information was received on 17 February 2009 in the form of medical records. Records indicated that one dose of LYMERIX vaccine (lot number LY120A9; expiration 20 January 2000) was given in the left arm on 26 March 1999. On 29 July 1999, the subject was experiencing multiple myalgias and arthralgias particularly in the right shoulder, right knee and ankle. The subject complained of multiple arthralgias with fatigue on 26 August 1999. During a rheumatologic consultation on 08 December 2000, the subject noted that she developed pain in all of her muscles and joint following vaccination with LYMERIX. The symptoms appeared to worsen following the 2nd administration of LYMERIX. It was noted that fibromyalgia had been diagnosed. Problems with pain in the right hip, buttock and posterior right lower extremity with numbness and stabbing were reported on 15 June 2001. Evaluation of symptoms on 26 June 2001 revealed right lumbar radiculitis and large right L5-S1 lateral disc herniation. In October 2002, the subject reported left chest abnormalities, arthralgias and difficulty sleeping. Her fibromyalgia was doing well. An exam dated 05 February 2003 indicated that the subject suffered from fibromyalgia and was experiencing muscle pain. Also reported were leg cramps and a rash on the right foot which was referred to as eczematous dermatitis. Steroid cream was given as treatment. On 18 June 2003, the subject reported that overall, her muscles and joints were not doing to bad. Fibromyalgia was indicated, but overall symptoms were improved. In December of 2006, the subject presented with right clavicle pain and left sided chest pain and tightness. Additionally, she was experiencing chronic lumbar pain status post surgery (no specifics provided). Further evaluation of symptoms was necessary. An EKG was normal, but a stress test was abnormal (performed on unspecified date in December 2006). Her Sestamibi images revealed possible reversible defect in the lateral wall with a normal EF. Fibromyalgia was noted on exam as well as hypertension and hypercholesterolemia. Not indicated as events following LYMERIX at this time. Additional details regarding the event of chest pain indicated that the subject was admitted to the hospital on 21 December 2006 for observation of the event. At that time, she was experiencing left sided chest that was described as sharp and constant. She noted mild nausea and belching with the pain. Primary cause of her cardiac pain was to be identified. There was no change indicated on exam in January 2007. An esophagogastroduodenoscopy with biopsy on 26 February 2007 revealed esophagitis. No new complaints were indicated according to notes from July 2007. There was no changed on exam in December 2007, however, an incidental finding was that the subject thought she might be going through menopause with frequent missed periods. Symptoms continued unchanged in April 2008. In August of 2008, the subject presented with difficulty sleeping, muscle aches and what she described as worsening symptoms related to her nerves. Feeling was decreased in the lower extremities and hands. Sometimes she had electric shocks into the legs. One foot seemed colder than the other and she described a sensation as if bugs were crawling under her skin. No chest pain was indicated. Exams including 09 July 2004, 05 August 2004, 26 August 2004 and 02 March 2005 indicated reports by the subject of continued ankle pain dating back two years. Nothing significant was assessed.