Age: 19.0
Sex: F
Vaccine: HPV9, MNQ, UNK
Symptoms: Tremor
Clinical narrative: Seizure / Complex partial seizures; loss of consciousness; sensation of numbness noted in left arm / numbness in her extermities; She became pale; mild shaking; She felt funny; Information has been received from Food and Drug Administration (FDA) (Agency number 6230373) on 14-JUL-2020.  This spontaneous report was received from a licensed practical nurse referring to a 19 years old female patient who was not pregnant. Concomitant therapy included ethinyl estradiol (+) norethindrone (ORTHO NOVUM). Information about medical history and concurrent conditions was not provided. She had none allergies to medications, food or other products.  On 26-JUL-2019 at 13:49, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R032766, expiration date not reported but upon internal validation it was established as 31-AUG-2021, intramuscularly in the left arm; strength and dose were not reported) and the second dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (lot # U6365AA, intramuscularly in the right arm; strength, dose and expiration date were not reported) for prophylaxis.  On the same date at 13:53, she experienced seizure. The patient was laying on an exam table, fan was placed in room, and her parent was called. The symptoms lasted 30-45 seconds. The patient was observed for 15 minutes. The outcome of the event was recovered. The causality assessment was not reported.  Follow up information was received from the licensed practical nurse on 14-AUG-2020. The patient's demographics details and the concomitant medication information were updated. She had no recent alcohol intake, sleep deprivation, exposure to flashes of light, recent intake of large amounts of coffee, recent intake of energy boosting supplements or other risk factors for triggering seizures. The patient had no history of seizures, convulsions or epilepsy, brain tumor, stroke, Alzheimer disease, abuse of alcohol, head trauma or injury, central nervous system (CNS) infections, diabetes, hyperglycemia, hypoglycemia, electrolyte imbalance.The previously reported seizures where clarified as a complex partial seizures. On 26-JUL-2019, while sitting in patient exam room getting vaccine injection, the patient additionally experienced sensation of numbness in the left arm (also reported as numbness in her extremities) at the time of administration her first dose (inconsistency: previously reported as third) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). In the meantime, she was given her meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) in the right arm. She became pale with mild shaking noted as well as loss of consciousness. It was also reported that she felt funny. On the same date (reported as "very quickly"), she recovered from all of the events and her vitals remained stable. The duration of the events (complete resolution) was reported as 15 minutes (also reported as 4 minutes). The patient was discharged to care of her mother. The injection was performed by trained healthcare as a single use vaccine. There was no prescription drug treatment for the events. The adverse events were previously reported to a doctor and to health department. No digital data logger was involved. The reporter assessed the events of pallor, mild shaking and loss of consciousness as related to the suspect vaccines. The causality assessment between the events of complex partial seizures, felt funny, sensation of numbness in the left arm and extremities and suspect vaccines was not provided. Upon internal review, the events of complex partial seizures and loss of consciousness were considered to be medically significant. 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: R032766; expirationdate: 31-AUG-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent