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Administered by: Private Purchased by: Other
Life Threatening? No
Write-up: This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a consumer''s mother and physician concerning a 16 year old female with a MOTRIN allergy, and no medical history who on 10-FEB-2007 at 10:00 was vaccinated IM into the left arm with a first 0.5 ml dose of Gardasil (lot# 655617/1447F). There was no concomitant medication. On 12-FEB-2007, the patient experienced "heart racing, nausea, dizziness, temp of 99.7, abdomen cramps, vomiting, bad headache and diarrhea." The patient''s mother reported that the patient "had been out of school all week and was not feeling well." She also stated that "there was a follow up visit with the physician who associated the experience with the vaccine and she was given TIGAN for the nausea and cramps." No labs or testing was needed. At the time of this report, the patient had not recovered according to the consumer''s mother. The physician reported that on 17-FEB-2007 the patient recovered from diarrhea, dizziness, nausea, headache, vomiting, abdomen cramping and low grade fever. No product quality complaint was involved. Additional information is not expected.
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