Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Tenderness, Upper respiratory tract infection
Clinical narrative: This is a spontaneous report from a 55 year old female pt who received her 1st injection with Lymerix at an unspecified dose. She immediately experienced a sore arm which resolved in 3-4 days. On 6/7/9, the pt received the 2nd dose and on 6/10/99, she had pain in all her joints of her hands and had upper arm achiness. No treatment was given. The most recent information received on 8/23/1999, reports the symptoms have lessened significantly.  Follow up information includes:  On 11 February 2002, in a Statement of Injuries, her attorney alleged that the subject "suffers from myalgias ad arthralgia secondary to vaccination with LYMErix, which manifests itself in pain and swelling in multiple joints. In particular, she experiences pain and swelling in the joints in her hands, and wrists , as well as pain and aching in her back, arms and thighs. She also experiences pain and stiffness in her neck." On 22July 1999, the subject presented for medical attention with complaints of "arm pain bilateral.  Joint pain and tenderness bilateral." Laboratory analyses were within the reference ranges; please see Laboratory Data section. The subject was referred to the vaccine provider. However, there was no record of an office visit with the vaccine provider until 04February 2000. At that itme, she was "walking/jogging" 3.5 miles three days per week. the subject as seen by another physician o 02August 1999. At that time, she reported that three to four days following receipt of her second injection of LYMErix, she begain to experience achiness of her upper arms and pain in the joints of her hands. The physician noted. "No other symptoms. PE negative." The physician's impression was "possible Lyme vaccine reaction." He referred the subject to a rheumatologist. The subject was evaluated by a rheumatologist on 12August 1999. At that time, she complains of generalized muscle and joint pain...she was generally will with no muscle or joint pain until June 8, 1999 when she had her second dose of Lyme vaccine. Four days later she developed severe pain and swelling in the hands and wrists along with an aching in the upper arms and thigh. The patient feels very stiff in the morning and describes difficulty bending her hands. She states her neck is slightly stiff. She also has osme aching int he lower back. On physical examination, the rheumatologist noted "supple neck with full range of motion....Extremities were without edema. Nailbed capillaries were normal. There was full range of motion at all joints without synovitis. There was no specific muscle tenderness." The rheumatologist wrote, "I believe this patient's myalgias and arthralgias are related to the Lyme vaccine." The rheumatoloist prescribed rofecoxib (Vioxx). On 13 October 1999, the subject told her gynecologist that she was going to be evaluated by an orthopedist because of low back pain. On 08 december 1999, the subjet telephoned her gynecologist and stated that she had "achiness (in neck and arms) since start Eviata (raloxifene) on 07 June 1999. The subject was instructed to stop taking raloxifene for two weeks to see if she felt better. If she was not better, she was instructed to telephone the gynecologist. There were no further telephone calls or office visits recorded. A variety of serologies for Lyme disease were performed on 24 October 2001. The laboratory's overall interpretation was "No evidence of seroreactivity beyond that expected from the Lyme vaccine." Following the reported onset of  arthralgia, the sbject experienced hyperparathyroidism, pharyngitis, sinusitis, upper respiratory infection, lentigines, solar elastosis, chostrochondronodilaris helices, lichen simplex chronicus with deral fibrosis and telectases on the right auricle, rosacea, osteoporosis, an acute spinal abscess of a tooth treated with root canal surgery and dyspareunia. These events were not reported as adverse events due to vaccine administration, but were found during the review of the subject's medical records. Therefore, they are not listed as adverse evetns. The most recent information, received on 29August 2003, did not provide the outcomes of the reported evetns. Information received on 10July2002 indicated taht the subject was performing weight-bearing exercises as of 30 April 2002. Information received on 23August 1999 indicated that the symptoms had lessened significantly.