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Life Threatening? No
Write-up: This is in follow-up to report (s) previously submitted on 4/6/2007. Information has been received from a registered nurse concerning a 16 year old female with no pertinent medical history and no previous reactions who on 26, Feb 2007, at 3:15 p.m. was vaccinated with HPV rL1 06 11 16 18 VLP vaccine (yeast) first dose. Concomitant therapy included hepatitis A vaccine (inactive) (manufacturer unknown), diphtheria toxoid and tetanus toxoid all administered on the same day (26, Feb 2007). The nurse did not know if the vaccines were administered in the same arm as HPV rL1 6 11 16 18 VLP vaccine. On 26, Feb 2007, the patient developed swelling around both eyes and her face became red and itchy. The patient did not have a fever or any other symptoms. Unspecified medical attention was sought. On 04 Mar 2007, one week later, the patient recovered from swelling around both eyes and red and itchy face. Additional information has been requested. In follow-up it was reported that the patient came into the clinic, one week after the GARDASIL was given. She complained of swelling around both eyes, face itching and red. The patient denied any trouble breathing or trouble swallowing. The swelling and itching starte the day the vaccine was given, on 26-FEB-2007. When the client came into the clinic there was no swelling and no redness on exam. The patient was advised by the physician not to get the second dose of GARDASIL. It was reported that the patient recovered 1 week later. In follow-up the nurse reported that after the patient received her first dose of GARDASIL she developed swelling around both of her eyes and her face became red and itchy. The patient did not have a fever or any other symptoms. That same day, she was vaccinated with VAQTA (inactive) (manufacturer unknown), diphteria toxiod and tetanus toxoid. The nurse did not know if the vaccines were administered in the same arm. No further information is available. Additional information is not expected.
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