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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This spontaneous report was received from a physician assistant, via a company representative, concerning a female patient of unknown age. Medical history and concurrent conditions were not reported. In approximately 2013 (reported as about a year ago) the patient was vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The physician assistant reported to the representative, "about a year ago, approximately in 2013, 1 week after receiving GARDASIL the anonymous patient (demographics unknown) developed Guillain-Barre and was hospitalized". The outcome of "Guillain-Barre" was reported as recovered on an unknown date. Patient sought medical attention. The physician assistant considered the event as serious due the disability. Upon internal review the event "Guillain-Barre" was considered as Medically significant. Additional information has been requested.
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