Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Face injury, Fall, Loss of consciousness, Neck pain, Syncope
Clinical narrative: hit face on exam table and then fell to floor; neck pain; syncopal episode/ faint; Information has been received from (VAERS number: 828475) on 19-AUG-2020. This spontaneous report was received from a healthcare professional and a consumer, refers to a 15-year-old, male patient. The patient had no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination. He had no allergies to medications, food, or other products. No illnesses at the time of vaccination and up to one month prior were reported. The patient had no chronic or long-standing health conditions.  On 13-AUG-2019 at 9:00 (also reported as 9:15), 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 # 1602283 was confirmed to be valid, expiration date was not reported but upon internal validation was established as 18-AUG-2021, intramuscularly(also reported as unknown) in the right arm (exact dose was not provided), for prophylaxis.  On the same day, several minutes after the patient received shot (also reported as at 9:10 or 9:26), while standing up in the exam room, the patient had a syncopal episode (also reported as faint at the doctor's office). He hit face (face injury) on exam table and then fell to the floor. The patient was awake in less than 1 minute. His vitals were stable. He had a neck pain after the event, so he was sent via an ambulance to a hospital emergency room (ER) to evaluate spine. He rested there for 2 hours and a doctor checked "OK" for discharge. It was also provided, that regardless ER visit, he had doctor or other healthcare professional office/clinic visit due to the events. The outcome of the event of syncope episode was reported as recovered approximately on the same date. The outcome of the events of face injury and neck pain was reported as unknown.  The relatedness between the aforementioned events and the suspect vaccine was not provided. The case was assessed as non-serious.  Follow-up information has been received on 16-DEC-2020 from a medical assistant who was also the administer of vaccine referring to the patient. The patient did not have adverse event following a prior vaccination. The patient did not have any vaccine within 4 weeks prior to the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On 13-AUG-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (expiration date was reported as 16-AUG-2021, but upon internal validation was established as 18-AUG-2021) intramuscularly in the right deltoid (previously reported as the third dose, inconsistent information). No illness was reported at time of vaccination. It was reported that the patient had recovered from aforementioned events of fainting after getting vaccination, face injury and fell on floor and neck pain. The patient was awake within 1 minute. The date of recovery for face injury and neck pain was not provided.  No prescription drug treatment was given for the events. The vaccine was not available for return/evaluation because it had already been administered. There was no product quality complaint. No temperature excursion occurred as a result of reading from a digital data logger. The medical assistant did not report the adverse events previously.  The reporter considered all the events as important medical events (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: 1602283; expirationdate: 18-AUG-2021; deviceage and unit: 0; operatorofdevice: Medical Assistant; 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 meet the criteria for Reportability