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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Initial report received on 26 January 2007, from another manufacturer, under the reference number B0454855A, concerning a patient. A 12 year old female patient, was enrolled in the other manufacturers study and received on 04 January 2007 a dose of Menactra (lot number U2091AA) intramuscular intro the left upper deltoid and the first dose of study vaccine of Gardasil (lot number DHPVA017A). Since 16 January 2007, since 12 days post administration, the patient had been experiencing pneumonia and developed erythema multiforme and was hospitalized. The patient had been to th e(study) office two days prior to admission with fever, swollen lips and vaginal itch. Exam failed to reveal significant findings other than rales over left posterior lung fields (urine analysis and chest X ray were normal). A clinical diagnosis of rash fitting description of erythema multiform was made. The patient was discharged with symptomatic treatment. She was seen in emergency room the next day and admitted on 18 January 2007 for intravenous treatment (rochepin). The event was unresolved at the time of reporting. The other manufacturer''s investigator considered that there was a reasonable possibility that th erythema multiforme may have been caused by Gardasil and Menactra and was due to pneumonia.
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