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Life Threatening? No
Write-up: Information has been received from a nurse practitioner concerning a 23 year old female who on 29 Nov 2006 was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil vaccine (yeast) (lot#654389/0961F). Concomitant therapy included fluconazole which was started on 29 Nov 2006 for a pre-existing infection. On 29 Nov 2006 the patient experienced chest pains described as subclavian and numbing at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered from the subclavian chest pains and numbing at the injection site on 30 Nov 2006. Additional information has been requested. 04/06/2007 This is in follow-up to report(s) previously submitted on 12/14/2006. Initial and follow-up information has been received from a nurse practitioner concerning a 24 year old female with no past medical history, who on 29-NOV-2006 at 9:00 AM was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (lot #654389/0961F). Illness at time of vaccination included vaginal candidiasis. Concomitant therapy included fluconazole which was started on 29-NOV-2006. On 30-NOV-2006, at 12:00 AM, the patient experienced right sided arm numbness along with right sided burning sensation in her chest (described as subclavian). The patient had 5-6 episodes during the night. The patient stated the sensations were resolved by the time she reported it to her physician in the AM of 30-NOV-2006. No further information is expected.
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