Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: C-reactive protein normal, Computerised tomogram head abnormal, Electroencephalogram normal, Full blood count normal, Generalised tonic-clonic seizure
Clinical narrative: C-reactive protein normal; computarised tomogram head abnormal; electroencephalogram normal; full blood count normal; generalised tonic-clonic seizure; intensive care; lumbar puncture normal; metabolic function test normal; nuclear magnetic resonance imaging brain normal; red blood cell sedimentation rate normal; unresponsive to stimuli; urine analysis normal; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, concerning a 12 year old female patient. The patient did not have any pertinent medical history or concurrent conditions and was not taking any concomitant medications.      On 02-JUN-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Lot # N001533) (dose not reported) intramuscularly in the left thigh as prophylaxis.         On 17-JUL-2017, the patient experienced c-reactive protein normal, urine analysis normal, unresponsive to stimuli, red blood cell sedimentation rate normal, nuclear magnetic resonance imaging brain normal, metabolic function test normal, lumbar puncture normal, intensive care, generalised tonic-clonic seizure, full blood count normal, electroencephalogram normal and computerised tomogram head abnormal.      It was reported that on the same day, she had an unresponsive episode followed by a tonic clonic seizure at home and another upon arrival to the Emergency Room (ER). It was stated that on the same day, she had through work up including labs as Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), C-Reactive Protein (CRP), sedimentation rate, Urinalysis (UA), spinal tap, brain Computarized Tomography (CT), Magnetic Resonance Imaging (MRI) and Electroencephalogram (EEG) which were all essentially normal.   It was informed that the patient stayed overnight in Pediatric Intensive Case Unit (PICU) and was treated with methylprednisolone sodium succinate (SOLUMEDROL) and acyclovir empirically. On an unspecified date, she was sent home on no regular medications (just Diazepam (DIASTAT)) as needed (prn) for recurrent seizures. The patient would follow up with neurology on an unknown date.  On 12-SEP-2017, the patient had another unresponsive episode, followed by a tonic clonic seizure at home, then, she was brought to the ER and was given a dose of lorazepam (ATIVAN) and started on valproic acid. It was reported that the patient was admitted overnight again and on 13-SEP-2017, an EEG was performed again and was within normal limits. The patient was discharged on levetiracetam (KEPPRA) and a follow up with neurology was arranged.   At the time of the report, the outcome of c-reactive protein normal, urine analysis normal, unresponsive to stimuli, red blood cell sedimentation rate normal, nuclear magnetic resonance imaging brain normal, metabolic function test normal, lumbar puncture normal, intensive care, generalised tonic-clonic seizure, full blood count normal, electroencephalogram normal and computerised tomogram head abnormal was reported as recovered on an unspecified date.    The causal relationship between vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and all events was unknown at the reporting time.  Follow up information was obtained on a request by the Company from the agency via a Case Line Listing on 08-AUG-2019. Information about the reporter and vaccination details was added as well as the patient started to experience all events at 15:00 and was vaccinated at 11:00.  Follow up information has been received from a clinic manager during a phone call on 27-AUG-2019. The clinic manager was unable to assist. With no actual patient identifiers, it was difficult to locate the patient. The redacted VAERS report was reviewed for additional details. The manager suggested submitting the request in writing. Maybe information could be located over time.