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Administered by: Private Purchased by: Unknown
Life Threatening? No
Write-up: Received Tdap and HPV vaccine on 10/16/2006 noticed some blisters at the corner of mouth and swelling of lower lip on the evening of 10/18/2006 and facial swelling around eyes on 10/19/06. No fever, headache, dizziness or any GI symptoms. Information has been received from nurse manager in a physician''s office concerning a 15 year old female who on 16-OCT-2006 at 1600 was vaccinated in the right deltoid with the first dose of GARDASIL (lot # 653937/0637P). Concomitant therapy that day included DTP. Subsequently, the patient experienced an allergic reaction, her face and body began to swell. The physician recommended the patient take an unspecified dose of BENADRYL. After raking BENADRYL the patient''s face and body swelling "went down". On 20-OCT-2006 it was reported that "the swelling became worse again". At the time of this report the patient had not recovered from the event. Follow up information was received from the patient''s physician which stated that on 18-OCT-2006 the patient developed blisters in the corners of her mouth and swelling of her lip and face and she was seen in the office. She was treated with acyclovir for possible herpes simplex. Laboratory results from 19-OCT-2006 included HSV type 1 and/or 2 was 11% and Herpes simplex virus culture was negative. On approximately 23-OCT-2006 the patient was considered to have recovered from these events. On 02-NOV-2006 the patient reported swelling on her face and lower lip again. Laboratory results that same day included serum herpes simplex type 1 IgG Ab 5.6 and a eosinophil count of 11%. The physician reported that the patient recovered from these events on an unspecified date. This report was identified from a line listing obtained on request by the Company. A 15 year old female with no pre-existing conditions was vaccinated in 16-OCT-2006, intramuscularly into the right arm with GARDASIL (lot#653937/0637F). Concomitant therapy that day included DTAP (Lot # C2572AA), vaccinated into the left arm (route unknown). The patient noticed on the evening of 18-OCT-2006, some blisters at the corner of her mouth and swelling of lower lip and facial swelling around her eyes ib 19-OCT-2006. There was no reported fever, headche, dizziness or any gastrointestinal symptoms. Additional information has been requested.
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