Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, FLUN3, HPV4
Symptoms: Activities of daily living impaired, Alanine aminotransferase increased, Condition aggravated, Convulsion, Decreased activity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female with seizure disorder that came on with her periods and a history of 36 1/2 weeks gestation and difficulties at birth. The patient had a service date on 14-AUG-2009 assessment: Frontal lobe seizures, the patient presented for follow-up visit due to recent increase in seizure activity. Significant weight gain, High blood pressure. On 25-AUG-2009 the patient was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y) as well as the flu nasal spray (lot # 500673P). The patient's mother declined her the vaccination but her doctor ensured that it was safe. The patient's mother declined the same vaccination a year earlier at the downtown public health center. On 01-OCT-2009 the patient experienced convulsion, decreased activity, fall, headache, hypertension, hypoaesthesia, injury, loss of control of legs, menstruation irregular, oedema peripheral, paraesthesia, peripheral coldness, sensory loss and weight increased. The patient was getting ready for school and was standing by her closet, and all of a sudden she fell, she lost total control of her legs. She went to school and could not engage in any of the activities because of the numbness in her legs and the swelling of her foot. She also, started to get a really bad headache. Days later she woke up out of her sleep complaining of a severe headache, which usually she got if she had a seizure but she had not had a seizure this night. She continued to say that she had not feeling in her foot and tingling feeling in her leg. After the patient's mother examined her foot, she noticed that it was swollen. The next morning the doctor was called and made an appointment on 23-OCT-2009. During the month of October she had irregular periods. The patient had the following test: white blood cell count: 4.5, blood lymphocyte count: 44.3, blood monocyte count: 13.5, serum alanine aminotransferase test: 43. The patient never made it to 23-OCT-2009, which was also her birthday. She passed out on 17-OCT-2009 she was found cold, unresponsive in her room at 7 am, which the mother went to wake her up to take her morning pills. On 19-FEB-2010 Primary Care Physician records were received: Stated N/S injury 23-OCT-2009. Expired 17-OCT-2009. Neurology records received on 24-FEB-2010. Death certificate received on 23-MAR-2010. Cause of death: Sudden Unexpected Death Epilepsy (SUDEP). The listing indicated that one or more of the events resulted in death. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 663452/0671Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This was originally reported by a consumer. The VAERS ID # is 380740-1.