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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no medical history, was vaccinated IM in the left arm, on 16-MAR-2007, with the second dose of Gardasil (Lot #656051/0244U). On 27-MAR-2007 the patient experienced severe myalgias that progressed over 2 weeks until the patient was unable to sit up or walk. On 04-APR-2007, the patient developed a fever and within one hour of onset, became hypotensive and developed a flushing rash: she was admitted to the pediatric intensive care unit (PICU). The patient experienced the events of abasia, diarrhea, flushing , hypokinesia, hypotension, hypotension, inflammation, myalgia, nausea, pharyngolaryngeal pain, pyrexia and rash. Treatment included pressors (unspecified) and dopamine. As of 06-APR-2007, no source had been identified (the source of infection may have been an inflammed area on the back of the patient''s earlobe at an earring hole site), and the patient was improving. The listing indicated that one or more of the events required a visit to the emergency room, resulted in hospitalization, was considered to be life threatening. No further information is available. The original reporting source was not identified. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards and was released. 04-Apr-2007 DA Streptococcus oralis culture negative, 04-Apr-2007 DA blood negative, 04-Apr-2007 DA chest X-ray normal, 04-APR-2007 DA diagnostic hematology blood test negative, 04-APR-2007 DA erythrocyte sedimentation rate 36 (units not provided), 04-Apr-2007 DA serum C-reaction protein test 8.3 (units not provided), 04-Apr-2007 DA serum antistreptolysin O antigen test negative, 04-Apr-2007 DA urine culture negative, 04-Apr-2007 DA white blood cell count elevated.
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