Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Mydriasis, Pallor, Posture abnormal, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: tonic clonic seizure/ seizure like activity; pale; diaphoretic; He was hot for a second then cold; lethargic/very slow to answer; Patients eyes were dilated; He can't remember the events that led to this issue; it was half used; Information has been received from Food And Drug Administration (Agency number: 846202) on 22-OCT-2020.  This spontaneous report was received from a regulatory authority ). Information was received from an other health professional and refers to a 14-year-old male patient. At the time of vaccination or up to one month prior the patient had a seizure and concussion. There was no information about the patient's allergies, drug reactions or medical history provided.   On 07-NOV-2019 at 16:35, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #1614898 was verified to be valid, expiration date was not provided, but upon internal validation was established as 15-NOV-2021) via intramuscular route in the left arm into left deltoid, for prophylaxis. Concomitant therapies received just before administering the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) included vaccine influenza virus split virion 4v vaccine inactivated (FLUZONE) flu shot to the right deltoid. The patient had no complications and tolerated the shot well.   After administration the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to the left deltoid, mid-injection patient began to have a tonic clonlc seizure. He was not responsive to verbal commands, and it was necessary to hold patient up In the chair so he wouldn't fall out. The patient finally came around after seizing for 30 seconds. He became pale, diaphoretic. He was hot for a second and then cold. He was lethargic and leaning on his mother. Emergency Medical Services (EMS) arrives after being called by another staff member. He was Oriented Times Three (Ox3), but very slow to answer. The patient's eyes were dilated. He could not remember the events that led to this issue. He left with EMS, and mother left to meet them at hospital. The patient recovered from all the events approximately on the same day (based on report's day).  The causality assessment between the events and suspect therapy was not provided.  Follow-up information has been received from the registered nurse on 10-DEC-2020. A few years ago, the patient fell his head and was worked up for concussion/seizure. He had history of one seizure on an unknown date in 2016. The patient received half dose (it was also reported that the vaccine was administered in accordance to the instruction leaflet, conflicting information) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine and was observed with seizure like activity. It was reported that the aforementioned event caused hospitalization since an unknown date in November 2019 (discrepant information, also reported as the patient visit Emergency Room). The nurse and mother were witnesses of this incident. At the time of the event onset, the patient was not engaged in any activities, he was sitting in exam room with his mother. The duration of treatment with the drug at event onset was reported as 0.5 to 1 second.The reporter considered the event of tonic clonlc seizure/seizure like activity to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability