Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: fell into her arms/stiffened, eyes rolled back/wake up and said "i had a bad dream"/ brief loss of consciouness/ patient fainted/ vasovagal reaction to needle; had a seizure like sx after HPV shot; This report was identified from a line listing obtained on request by the Company from the Food and Drugs Administration (FDA) under the Act (VAERS # 801632) and refers to a 14-year-old male patient. The patient was allergic to prednisolone (ORAPRED), lemonade and orange crush. His concurrent condition included mild sleep apnoea. The patient had no adverse events following any previous vaccine and had no other vaccine received within one month prior. The patient had no concomitant medications.  On 13-FEB-2019 at 11:15, 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 into right arm (lot# R008164 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 12-NOV-2020) for prophylaxis. On the same day at 11:20, immediately after receiving the vaccination, the patient got up, walked to his mom and fell into her arms, around her arms and neck, stiffened, with his eyes rolled back for 5 seconds. Then he woke up and said to have had a bad dream. The patient lied down for 15 - 20 minutes. The patient was monitored for half an hour. The patient was also anxious about needles after the administration. The events resulted in doctor or other healthcare professional office/clinic visit.  The outcome of syncope was reported as recovered on 13-FEB-2019. The outcome of fear of injection was unknown. The relatedness between the events and the suspect vaccine was not provided.  Upon internal review, the event of syncope was determined to be medically significant.  Follow up information was received via medical records from the physician on 05-NOV-2019.  The patient had a medical history of being born by c-section delivery and was triplet. The patient's allergies were specified as rash on rectum caused by prednisolone (ORAPRED) and hives due to lemonade and orange crush. Furthermore, the patient had a similar syncope episode followed procaine hydrochloride (NOVOCAIN) injections for a dental procedure in July 2017. The patient had no concomitant therapies, and was not ill at time of vaccination.  It was specified that, on the above-mentioned date, the patient was very anxious about the vaccination previous of the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient was vaccinated only with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (which was not exposed to a temperature excursion) 0.5 milliliter, in the right deltoid. The physician confirmed the syncope episode, and stated that immediately after getting vaccine, the patient stood up and then walked toward mom, had brief loss of consciousness and fell into her arms (lastet about 5 seconds), and experienced a seizure like syndrome. Subsequently, the physician walked in the room and called patient's name and he woke up and tried to stand up. Within 30 seconds, the patient was speaking and answering questions coherently.  Consecutively, a physical exam was performed with the following results: the patient was afebrile, heart rate (HR) was 110 (units were not provided), respiratory rate (RR) 12 (units were not provided), blood pressure (BP) was 110/58 mmHg; extraocular movements intact (EOMI); pupils equal, round, reactive to light (PERRL); regular rate and rhythm (RRR) no murmur, lungs clear; abdomen soft, Non Tender Non Distended (NTND), presence of bowel sounds normal (+BS); 5/5 strength in arms and legs. The patient had lie down for 10 to 15 minutes. Next he sat up and drank water and was monitored in room for 30 minutes. He said he felt fine prior to went home with mom. No prescription drug treatment was required for the events. The physician stated it was attributable to a vasovagal reaction to the needle, and told mom to let providers know that he could react in this form so that he could be lying down for medical procedures and vaccines in the future. It was determined to be ok the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and it was scheduled in 6 months. The physician's assessment was reported as "encounter for immunization".  The causality between the event syncope and seizure and the suspect therapy was related. The outcome of the events was resolved.  Upon internal review, the event seizure was considered to be medically significant.  All available medical records will be provided upon request.