Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Incisional drainage, Incontinence, Iron deficiency anaemia, Laboratory test abnormal, Loss of consciousness
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 14 year old female patient was vaccinated with the first dose of GARDASIL (left arm, lot # 659054/0315Y). The vaccination date for GARDASIL was reported to be 31-AUG-2009. On an unspecified date, the patient sustained a head injury (was struck by a softball). The reported onset date for rhinoplasty was 06-AUG-2009. The reported onset date for convulsion was 08-AUG-2009 ("2 days status post rhinoplasty"). On 09-SEP-2009, the patient experienced a seizure like activity that lasted 20 minutes and she was taken home from school. On 14-SEP-2009, the patient experienced seizure like activity that lasted 40 minutes and she was taken by squad to ER and it was found that hemaglobins were 8.0 and at that moment she had severe iron deficiency anemia and was released. On 21-SEP-2009, the patient experienced chest pain an ER visit was released. On 22-SEP-2009, the patient experienced seizure like activity for 2 hours, she was squad to ER and was admitted for 4 days. On 01-OCT-2009, the patient experienced seizure like activity that lasted 2 and a half hour, she was squad to ER and was admitted for 3 days, the patient complained of blurry vision, body shaking, jaw clenching, incontinence, eyes rolled back, Loss of Consciousness, cyanosis, tongue and facial numbness. On 02-OCT-2009, the patient experienced seizure like activity that lasted 45 minutes while she was in the hospital. On 28-OCT-2009, the patient experienced seizure like activity that lasted 3 hours and she was taken home. On 27-DEC-2009, the patient experienced seizure like activity and she had trouble breathing, an ER visiting was released. On 02-JAN-2010, the patient experienced seizure like activity and she stopped breathing. A cardiopulmonary resuscitation (CPR) was performed and the patient was paralyzed for 15 minutes, she was squad to ER and released. Cardiology felt seizures not cardiac related to hematology: the patient was found to have iron deficiency anemia and started on FESO4 on 14-JAN-2010, when the patient was seen for seizure like activity. On 14-JAN-2010, the patient experienced seizure like activity and she had trouble breathing, she was tubed because her oxygen level was below 70%, she was squad to ER and was transported to another hospital, she was admitted and released after 1 day. Neurology felt all the seizures were not true seizures but pseudoseizures. It was reported that since August 2009, the patient had had 10 seizures like activity episodes, also axillary abscess, an Incision and Drainage (I&D) of abscess was done, intravenous antibiotics was given, ATIVAN and DILANTIN were administered for seizure activity and the patient was discharged on oral antibiotics (unspecified). It was also reported that the patient was on no other medication prior to vaccination, but "now after shot", was on Ferrous sulfate 65 mg 1x daily, FLORINEF - 0.1 1x daily, and vitamin C-1000 mg daily. On 22-SEP-2009, 25-SEP-2009, 01-OCT-2009, 03-OCT-2009, 29-JAN-2010, 01-FEB-2010 and on 11-FEB-2010 a magnetic resonance was performed with unknown results. On 14-SEP-2009 to 11-JAN-2010, the PCP records were reported with unknown results. On 25-NOV-2009, a neuro consult record notes was reported with unknown results. On 26-OCT-2009, the OB notes were reported with unknown results. On 14-JAN-2010, the ED records showed a final impression: pseudo-seizures/conversion disorder, left axilla abscess on 22-SEP-2009. On 29-JAN-2010, an electrocardiogram (EKG) was performed; on 01-FEB-2010, an Electroencephalogram (EEG) was performed; on 04-FEB-2010, a Video Electroencephalography (vEEG) was performed; on 11-FEB-2010, a computed Tomography scan was performed and lots of blood work were performed with unknown results for none of them. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. The original reporting source was not provided. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In a 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. The VAERS ID # is 378361. No further information is available.