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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: This spontaneous report was received a social media, TV news refers to a 16 year old female patient. The patient''s current condition included lupus and unspecified heart disease and medial history was not reported. On an unknown date in February 2014, the patient was vaccinated with second dose of GARDASIL (vial and prefilled syringe) intramuscularly (strength and frequency were not reported). Concomitant medications were not reported. On an unknown date after vaccination patient experienced fainting and worsening of pre-existing conditions (Lupus (death, life threatening and medically significant) and unspecified heart disease (death and life threatening). The outcome of worsening of pre-existing conditions (Lupus and unspecified heart disease) was reported as fatal. The outcome of fainting was unknown. The patient died on an unknown date in May 2015. The cause of death was unknown. The relatedness of the events with the quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine was not reported. Upon internal review, worsening of pre-existing conditions (Lupus) was determined to be serious as another important medical event. Additional information is not expected as the contact details were not reported.
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