Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Bradycardia, Convulsion, Drug screen negative, Electrocardiogram normal, Gait disturbance
Clinical narrative: Information has been received from a nurse concerning a 19 year old female with a history of penicillin allergy who on 22-JAN-2008 was vaccinated with the first dose of GARDASIL (lot # 659653/1448U) via IM route. On 03-APR-2008 she receive the second dose (lot # 659964/1978U) and on 23-SEP-2008 received the third dose (lot #661044/0548X), both via IM route. Concomitant therapy included hormonal contraceptives (unspecified). The patient was hospitalized for possible cardiac problems after administration of 3 doses of GARDASIL. On 18-OCT-2008 the patient started to stagger and her speech became "funny" and 30 minutes later she passed out. The patient was transported to the hospital. Emergency medical technician determined patient developed bradycardia. She was admitted to hospital on 18-OCT-2008. As of the reporting time, she was still in the hospital. She was experiencing complex seizures and severe orthostatic hypertension. She was diagnosed with possible cardiac arrest and may need an implantable cardioverter defibrillator. On an unspecified date, the magnetic resonance imaging (MRI) showed normal results, electrocardiogram showed normal slow and toxicology screen was negative. The patient had not recovered. The reporter considered the events to be disabling, immediately life-threatening and to be other important medical events. A lot check has been requested. Additional information has been requested.  1/27/09 PCP records received including multiple diagnsotic studies from 10/2008 for syncope/unresponsiveness/bradycardia. In for annual exam 11/5/08. ROS note states "Drs think the problems she had were from a blood vessel in brain and reaction to meds" Not sure if Gardasil started the whole thing off. Exam WNL.   2/11/09 Tag2 received. 2/20/09 MR received for DOS 10/20-26/2008 with no definitive DX as pt was transferred to higher level of care for further w/u. Had been admitted with admission dx of syncopal episode with orthostatic hypotension and bradycardia. ER visit 12/2/08 with dx: seizure. Pt presented 10/20/08 after collapsing at work. Prior to collapse pt had been staggering, felt lightheaded and dizzy and had abnormal speech. Had been feeling unwell x several weeks with pleuritic chest pains, palpitations and night sweats. Bradycardic (32), RR 4-6/min, hypotensive and unresponsive en route to ER. Gradual return of sensorium in ER although drowsy. Had several more episodes in hospital with orthostatic sx. Pt c/o precordial chest discomfort. Cardiology consult PE (+) systolic murmur 2/6. Marked dysautonomia. Further episodes where pt passes out with eyes rolled back, preceded by numbness of the L side of body. Onset of H/As with light and sound sensitivity. Transferred to higher level of care for further diagnostic W/u. Returned 12/2/08 following a seizure. 2/27/09 MR received from transfer hospital with D/C DX:  Atypical non-epileptic spells.  UTI. Pt received from tranfer hospital for further eval of spells of unresponsiveness with R arm movement with unknown etiology. Pt had witnessed spells under EEG monitoring with no correlation to seizure activity. Tx for UTI due to bacteria present in urine.