Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Drug ineffective, Hypoaesthesia, Muscle spasms, Nerve conduction studies normal
Clinical narrative: Information has been received from a 29 yr old female with no pertinent medical history and no known allergies who received two doses of varicella virus vaccine live in 2003. It was reported that on an unspecified date in June 2003 (also previously reported as 29Jan03). She was vaccinated SC with a 0.5mL first dose of varicella virus vaccine live and a second dose of varicella virus vaccine live was administered on an unspecified date in 2003. Concomitant therapy included birth control (composition unspecified). On an unspecified date in June 2005 she had a negative antibody test and therefore no immunity to chickenpox. She was told by a physician that her vaccination from 2003 did not work because her blood test indicated that her blood level was at 53. Unspecified medical attention was sought. It was reported that the pt had not recovered as of 02Jun05. The pt was revaccinated with varicella virus vaccine live on 25Jun05. Additional information was received from the pt on 13Oct05 which reported that she had a titer check 1-2 wks ago (approx Oct 2005) and the results showed the repeat vaccination was effective. There was no product quality complaint involved. Follow up information was received on 27Feb06 from the pt who reported that she experienced a heaviness feeling in her arms and legs on the left side of her body. In addition, the pt was feeling a tingling sensation on that same side of her body near the knee and calf area. She also felt an electric shock type feeling on the left side of her body. On 08Mar06, she reported that she has had numerous MRI's and nerve conduction tests with negative results. There was no diagnosis for the symptoms the pt was experiencing. She continues to experience heaviness of the left arm and leg, spasms of the left side of her body and pain. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/12/2006. Information has been received from a 29-year-old female, with no pertinent medical history and no known allergies, who received two doses of VARIVAX (Merck) in 2003. It was reported that on an unspecified date in June 2003 (also previously) reported as 29-JAN-2003). she was vaccinated SC with a 0.5 mL first dose of VARIVAX (Merck) and a second dose of VARIVAX (Merck) was a administered on an unspecified date in 2003/ Concomitant therapy included birth control. On an unspecified date in June 2005 she had a negative antibody test and therefore no immunity to chicken pox. She was told by a physician that her vaccination fro m2003 "did not work because her blood test indicated that her blood level was at 53. "Unspecified medical attention was sought. It was repored that the patient had not recovered as of 02-JUN-2005. Additional information was received from the patient on 13-OCT-2005 which reported that she had a titer check "1-2 weeks ago" (approximately October 2005) and the results showed the repeat vaccination was effective. There was no product quality complaint involved. Follow-up information was received on 27-FEB-2006 from the patient who reported that she experienced a heaviness feeling in her arms and legs on the let side of her body. In addition, the patient was feeling a tingleing sensation on that same side of her body near the knee and calf area. She also felt an electric shock-typefeeling on the left side of her body. On 08-MAR-2006, she reported that she has had numerous MRI's and nerve conduction tests with negative results. There was no diagnosis for the symptoms the patient was experiencing. She continues to experience heaviness of the lift arm and leg, spasms of the left side of her body, and pain. Follow-up information from a certified medical assistant indicated that there was no additional information available. Follow-up information from the patient indicated that she was still experiencing constant nerve pain. Which she described as sharp shooting pain and numbing sensation. The patient started to take LYRICA, 150 mg, 2 to 3 times a day from March 2006. It was noted that it relieved her pain somewhat. It was reported that she saw seversl different neurologist who could not help her. No additional information was provided. Additional information is not expected.