Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Electroencephalogram, Generalised tonic-clonic seizure, Impaired reasoning, Migraine, Postictal state
Clinical narrative: Confused; disoriented; was not making sense; Tonic-clonic seizures; vomited; feeling dizzy, lightheaded and thought she might pass out; chills; somnolence/ she would not wake up; had a migraine; she was unresponsive, the doctors could not perform a neuro exam because she would not wake up; Information has been received from FDA (# 829612) on 18-AUG-2020.  This spontaneous report was received from a consumer, the patient's mother referring to a 11-year-old female patient. The patient had no prescriptions, over-the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination, no allergies to medications, food or other products or no other illnesses at the time of vaccination and up to one month prior. The patient was a healthy, well and athletic child. The patient was not pregnant.  On 09-AUG-2019 at 15:45, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R009615 with expiration date not reported, but upon internal validation established as 12-JUL-2020; dose and frequency were not reported) intramuscularly (IM) in the right arm, diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid(BOOSTRIX) (lot# K9DX5; dose, frequency and expiration date were not reported) intramuscularly (IM) in the left arm and meningococcal acyw conj vaccine (crm197)(MENVEO) (lot# AMVA121; dose, frequency and expiration date were not reported) intramuscularly (IM) in the right arm, all for prophylaxis.       On 10-AUG-2019 at 14:30 (reported as less than 24 hours after receiving the vaccines), the patient complained of feeling dizzy, lightheaded and thought she might pass out. About 20 minutes later, she had a tonic-clonic seizure for about 30-45 seconds. Afterward, she was very confused, disoriented and was not making sense. She also vomited several times. On the same day, the patient was taken to a hospital by ambulance. During the post-ictal period, she was unresponsive, had a migraine with vomiting, chills (no fever), somnolence and the doctors could not perform a neuro exam because she would not wake up. The patient was admitted overnight. The patient was hospitalized for 1 day. Medical tests and laboratory results included blood work and electroencephalogram (EEG) and the results were not reported. The patient would have a magnetic resonance imaging (MRI) on an unknown date in August 2019 (reported as next week).  The patient visited emergency room/department or urgent care and doctor or other healthcare professional office/clinic for the events. The outcome of all events was reported as unknown.   The causality assessments between suspect vaccines and all events were not provided.  According to the reporter and Agency, all events were determined to be life-threatening.  Follow-up information has been received from an office staff on 09-SEP-2020 via a telephone call. Due to no patient identifiers, the office was unable to fill out the forms. Additional information was not expected.