Sex: F
Vaccine: HPV9
Symptoms: Quality of life decreased, Seizure
Clinical narrative: The effect on the teen's lifestyle is catastrophic; seizures; This non-valid spontaneous report as received from a consumer refers to unspecified patients of unknown gender and age (also reported as teens). No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  The reporter was curious why the side effects of this vaccine were not mentioned as it was done on most adult medication commercials. The reporter understood that statistics showed no correlation between epilepsy and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), but it was devastating for those who were heartbroken watching the patients with no family history of epilepsy, go through seizures which began on an unknown date, in close proximity to the receipt of the vaccine. The effect on the patients' lifestyle was catastrophic until and if the disease was stabilized. It was reported that pediatricians refused to acknowledge even a possibility of a relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), thus effecting the statistics.  The outcome of the events of epilepsy, seizure and quality of life decreased was unknown.  The relatedness between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.  Upon internal review, the event of seizure wasconsidered to be medically significant  This case is non-valid due to lack of the patients' identifiers.  Follow up information has been received on 02-AUG-2019. The case is considered now valid as the patient's identifier was provided.  The information was received from the patient's grandmother referring to her granddaughter (unknown age). No information was provided regarding the patient's medical history, drug reactions or allergies and concomitant therapies was provided.  The reporter stated that on an unspecified date, approximately in 2017 (reported as within the last two years), her granddaughter received a dose of vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (previously reported as quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)) (strength, dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis.  The reporter stated that the patient experienced a seizure a few days after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (unspecified date approximately in 2017), and even when the reporter explained that the patient was doing well, she had not recovered from the event seizure.  The causal relation between the event seizure and receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was updated to not related as the pediatrician stated that "there is no way it was related to the vaccine". Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between Gardasil 9 vaccine and the reported event of Seizure cannot be established. Missing important information for a meaningful assesment includes: subjects age, exact date of vaccination and number of doses administered, subject´s medical history, family history, detailed clinical course (start date of the event, including characteristics of the seizures, number of episodes, signs and symptoms associated to the event, etc.), diagnostic workup results (including cranial CT or MRI, EEG, lumbar puncture, CBC, etc.), neurologist and pediatrician official clinical concept, treatment and follow up.   Company Comment- No changes to theGardasil 9 vaccine product safety information are warranted at this time.  Merck and Co., Inc., known as MSD outside of the countries, continues to monitor the safety profile of the Gardasil 9 vaccine product.