Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Chills, Computerised tomogram abnormal, Computerised tomogram head, Death, Encephalitis
Clinical narrative: Information has been received via line listing from the FDA under the Freedom of Information Act from a health care professional on 10-OCT-2007. Additional information was received from a newspaper article concerning a 18 year old female with no medical history and was unknown if the patient was ill at the time of vaccination who on 10-MAY-2007 was vaccinated with GARDASIL (lot # 657736/0389U) in the right arm. On an unspecified date concomitant therapy included meningococcal ACYW conj vaccine (name, manufacturer, and lot # U2048AA) in the left arm. The patient who was a college freshman travelled on 05-OCT-2007 to visit her family for the weekend. The patient reportedly felt "slightly ill" upon her arrival and subsequently took an aspirin and went to bed awakening at 1:30 PM the following afternoon "appearing refreshed". The patient became feverish again that night and woke at 1:00 AM the morning of 07-OCT-2007 with chills and a severe headache complaining that "my headache is about to explode". The patient was taken to a local hospital, where a brain computed axial tomography (CAT) scan was performed and the brain revealed meningococcal disease in her brain and brain stem. The patient was immediately transferred to another hospital and died the evening of 07-OCT-2007 due to complications of meningitis. The health department noted that the "lab tests have not yet confirmed the strain of meningitis" but that it was "likely the type not prevented by the vaccination". The listing indicated that pyrexia, meningitis, malaise, headache and chills required hospitalization and resulted in death. Follow-up information was received from the FDA under the Freedom of Information Act. The lot numbers and site of administration was updated. Additional information was obtained from an agency who reported that an 18 year old female patient received a meningococcal ACYW conj vaccine (name, manufacturer, and lot number not reported). On an unspecified date, the patient who was a college freshman, travelled on 05-OCT-2007, to visit her family for the weekend. She reportedly felt "slightly ill" upon her arrival and subsequently took an aspirin and went to bed, awakening at 1:30pm. The following afternoon "appearing refreshed". She became feverish again that night, and awoke at 1:00am the morning of 07-OCT-2007 with chills and a severe headache, complaining, that "my head was about to explode". She was taken to a local hospital, where a CAT scan of the brain revealed meningococcal disease in her brain and brain stem. She was immediately transferred to another hospital and died that evening of 07-OCT-2007 due to complication of meningitis. The health department noted that "lab test had not yet confirmed the strain of meningitis" but that is was "likely the type not prevented by the vaccination". Past medical history and concomitant medication were unknown. It was not known if the patient was ill at the time of vaccination. On   [Due to memory limitations, the remainder of this text could not be compared.]  18-OCT-2007, the patient name received from FDA. On 18-OCT-2007, it was received death certificate from funeral home which stated cause of death as brain death due to cerebral herniation and meningoencephalitis. On 26-OCT-2010, received vaccination record from the primary care physician which indicated that the patient received GARDASIL (lot# not reported) and MENACTRA on 10-MAY-2007. VAERS database updated with the same vaccination record indicated that the patient also received the second dose of GARDASIL (lot# 657868/0523U, left arm). On 27-NOV-2007, reviewed hospital medical records which reveal patient experienced headache, fever and neck pain for 1 day. A preliminary lot check investigation was performed. To date our investigation has found that the lot # 657868/0523U and the lot # 657736/0389U are conformed to quality release parameters and the manufacturing was typical of a lot of GARDASIL. Additional information will be provided upon finalization of this manufacturing investigation. No further information is available. The VAERS ID number is 293388.