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Life Threatening? No
Write-up: Information has been received from a physician concerning a 24 year old female who in 2007 was vaccinated with the first dose of 0.5 ml Gardasil intramuscularly. There were no adverse events. The second Gardasil 0.5 ml dose was given intramuscularly on 29-MAY-2007. On 30-MAY-2007 the patient experienced significant rash and hives. The patient''s significant rash and hives persisted. No lab testing was performed. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow-up information has been received from a physician and a health care professional concerning a 23 year old female who in 2007 was vaccinated intramuscularly with the first 0.5 ml dose of the GARDASIL. There were no adverse events. The second GARDASIL (Lot # 657622/0388U) 0.5 ml dose was given intramuscularly on 29-MAY-2007. On 29-MAY-2007, the patient experienced injection site warmth, redness, and hives around the site. The outcome of the patient''s injection site redness, warmth and hives was unknown. Additional information is not expected.
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