Age: 10.0
Sex: M
Vaccine: FLU4, HPV9, TDAP, FLU4, HPV9, TDAP
Symptoms: Blood glucose normal, Computerised tomogram head normal, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging brain normal, Seizure
Clinical narrative: Blood glucose normal; Computerised tomogram head normal; Generalised tonic-clonic seizure; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 10-year-old male patient. The patient's medical history included mild intermittent asthma, no recent exacerbations. The patient had no current illnesses or other medications.  On 04-JAN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly, in the right arm (lot# R023006, expiration date not reported, but upon internal validation established as 06-MAY-2021) (exact dose was not reported) for prophylaxis. Other suspect therapies administered on the same day included diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX), lot # 5N2YG, intramuscularly in the left arm (dose and was not reported) and influenza virus split virion 4v vaccine inactivated (FLULAVAL) lot # HY5Y7, intramuscularly in the left arm (dose was not reported). On 04-JAN-2019 (reported as during the night after receiving his immunizations), the patient experienced a tonic-clonic seizure. It self resolved on an unknown date. He had no history of seizure. He went via emergency medical service (EMS) to the emergency room (ER) where he had a normal work up. On 05-JAN-2019, the patient had head computerized tomogram (CT) and blood glucose test with normal results. The outcome of blood glucose normal, generalised tonic-clonic seizure and computerized tomogram head normal was reported as recovered/resolved.   The causality assessment was not provided.  Follow-up information was received on 03-JUL-2019. The report was received from a physician. The White patient had no adverse events following any previous vaccinations. He was vaccinated on 04-JAN-2019 at 08:30, and experienced tonic-clonic seizure on the same day at 22:00.  Follow-up information was received from a physician on 18-JUL-2019. The reporter stated the patient did not have a history of seizures, convulsions nor epilepsy and did not use any concomitant medications within one month prior to the event. It was reported he did not change dose of any concomitant medication, did not intake alcohol, large amounts of coffee nor energy boosting supplements, did not have sleep deprivation, exposure to flashes of light nor strident sounds. The patient had no other risk factors nor history of brain tumor, stroke, Alzheimer disease, abuse of alcohol or "llllclt" drugs, head trauma or injury, central nervous system (CNS) infections, diabetes/hyperglycemia/hypoglycemia or electrolyte imbalance, the child was fully normal. It was reported the patient went to sleep normally, had no activities and was in home in bed when generalised tonic-clonic movement developed. The reporter stated seizures lasted less than 5 minutes. After the event, the patient was on an observation in the hospital and brain magnetic resonance imaging (MRI) was performed on 20-FEB-2019 with a normal result.  Upon internal review, the event generalised tonic-clonic seizure was considered to be medically significant.