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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a nurse, via a company representative, concerning a 34 year old female patient, who on 09-SEP-2006 was vaccinated with the first dose, 0.5ml, of Gardasil (Lot #653937/0637F). Concomitant therapy included Loestrin and Detrol LA. The nurse reported that after the vaccine was administered (date unspecified), the patient "experienced tingling and numbness in most areas of her body." On an unspecified date, the patient received her second dose, 0.5 ml, IM, of Gardasil (Lot #653938/0954F), and had a recurrence of the numbness and tingling in her body. On 20-MAR-2007, the patient received her third dose, 0.5ml, IM, of Gardasil (Lot #655849/0263U), and once again had a recurrence of the numbness and tingling in her body (date unspecified). A magnetic resonance imaging test was performed (date unspecified), and was negative. At the time of this report, the nurse confirmed that the patient had not recovered. Additional information has been requested. 6/27/07-records received for DOS 3/27/07-6/15/07-On 3/27/07-presented with bilateral leg pain, numbness and tingling. No strength issues. Seeing neurologist. Note on 4/26/07-suspect restless leg syndrome for her migratory sensory discomfort in all 4 limbs and torso. Neuro exam did not show peripheral neuropathy. Note on 6/20/07-Sensory 85% better.
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