Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Respiratory tract congestion, Syncope, Tremor, Upper respiratory tract congestion, X-ray
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.  On 31-MAR-2008 a 16 year old female was vaccinated with the second dose of GARDASIL (lot no. 659657/1487U) IM in the left arm.  Concomitant therapy included ROCEPHIN and ZITHROMAX on the same day.  On 03-APR-2008, she experienced cardiac arrest, convulsion, cough, dyspnoea, fall, headache, hypotonia, loss of consciousness, respiratory tract congestion, syncope, tremor, upper respiratory tract congestion and death.  The listing indicated that one or more of the events resulted in death.  The report was as follows: "My daughter went to our nurse practitioner on 31-MAR-2008 for a sore throat.  She complained of her throat for about two days prior.  She would get pharyngitis and strep about twice a year since she was 13.  She received a shot of ROCEPHIN in the office on 31-MAR-2008 as well she was given a prescription for ZITHROMAX (Z-PAK) at the same time.  I'm not sure exactly what time her appointment was it was around 11:00 am that day.  She dropped off her prescription at the pharmacy and I picked up on my way home.  She took her first dose of ZITHROMAX on 31-MAR-2008.  She stayed home from school the next two days.  She slept late both days which is not abnormal for her.  In the evenings we played rummy, she was congested and coughing a little.  She complained of a headache the next night and I gave her some ibuprofen.  On Wednesday 3-APR-2008 she went to school (school gets out at 3:05 p.m.).  After school she went to track practice.  Her track practice was a short one.  I know she ran but I'm not sure how much.  She stopped at a convenience store on the way home from school and got a Red Bull.  She went home and changed clothes for work.  She called me between 4:30 and 5:00 p.m. on her way to work to tell me about the road being blocked due to rain where we live.  She parked her car and was walking the short distance into where she works she collapsed and started seizing.  A lady in the drive through told the owner that she had fallen and he went out immediately.  He said she was shaking, the employees inside called 911 and then me.  The owner told me she stopped shaking and took a few strained breaths and then went limp.  The police officer arrived within three minutes, he was a first responder.  He did not check for a pulse or attempt CPR (I am in the process of getting a police report as well).  Just as I got there an off duty paramedic arrived and started CPR.  It took quite a while before the ambulance arrived; she had been down too long.  I later learned that they did not get her heart started until..."  No further information is available.  This was originally reported by a consumer.  The VAERS ID# is 321696.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question 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 and was released.