Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a 23 year old female with a history of being seen in the emergency room with "IUD pregnancy terminated" on 27-AUG 2007. On 04-SEP-2007, the patient was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5ml (# of doses not reported). Concomitant therapy was unspecified. On 04-SEP-2007, the patient was given a prescription to fill for medroxyprogesterone acetate (PROVERA) and ibuprofen (MOTRIN) at the same visit that the HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered. It was unknown if the prescriptions were taken by the patient. On 07-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed until she was examined in the emergency room. On 07-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event), immediately life-threatening, required hospitalization and was disabling. Additional information has been requested.  12/18/07-records received for DOS 9/10-9/28/07- DC DX:  Guillain-Barre syndrome, quadriparesis, improving at time of discharge. Decreased mobility in self care. pregnancy has resolved. Urinary tract infection. See in ED wit 2 day history of weakness started in fingers/hands and leg pains. Difficulty walking, can not get up wlk or move legs and arms. Short of breath when she tries to talk.  PE: reflexes absent in both lower and upper extremities.  This is in follow-up to report(s) previously submitted on 10/12/2007 1/7/2008.  Initial and follow-up information has been received from two physicians concerning a 23 year old female with a history of bein seen in the emergency room with "IUD-pregnancy terminated" on 27-AUG-2007.  On 04-SEP-2007, the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #0530U) # of doses not reported.  On 14/SEP/2007, the patient was given  a prescription to PROVERA and MOTRIN at the same time that GARDASIL was administered.  It was unknown if the prescriptions wore taken by the patient.  On approximately, 11-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed.  She presented to the emergency room, with Guillain Barre syndrome where she was examined.  On approximately, 11-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome.  The patient had a magnetic resonance imaging performed that was being evaluated.  At the time of reporting, the patient had not recovered and was in the intensive care unit.  The reporting physician felt that the event was serious (Other Important Medical  Event) immediately life-threatening, required hospitalization, and was disabling.  A review of the release testing data revealed that 0530U conformed to all required testing at the time of product release.  Additional information is not expected.