Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Contusion, Headache, Loss of consciousness, Nausea, Neurological examination normal
Clinical narrative: passed out on ground; contusion noted back of head and left elbow; concussion symptoms multiple times; was hungry; felt sick on stomach; head hurt; emesis; Information has been received on 18-AUG-2020. This spontaneous report as received from a healthcare professional refers to an 18-year-old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On 31-JUL-2019 at 15:00, the patient was intramuscularly vaccinated in his right arm with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose was not reported, lot # R017251, expiration date was not reported but upon internal validation, it was established as 04-MAY-2021) and with a second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA), intramuscularly in his left arm, lot# U6365AA (exact dose and expiration date were not reported), both for prophylaxis. On the same day at 15:05, after getting shots, the patient walked outside and passed out on a ground. His girlfriend found him lying in parking space unconscious, easily aroused and got health department staff. A nurse went out and assessed the patient. His blood pressure (BP) was 142/88 (units not provided), pulse (P) was 88 (units not provided), neuro checks were completed and all were within normal limits, the patient was alert and oriented to person, place and time. The nurse noted contusion of the patient's back of head and left elbow. The patient was assisted to sit in truck in air conditioning and he received water and candy. He reported felt sick on stomach and head hurt but just thought he was hungry due to not eating since early morning (am). The registered nurse advised the patient to go to emergency room (ER) for further evaluation due to hitting his head and concussion symptoms multiple times, however the patient refused. His girlfriend called back later to advice the patient letting her take him to the ER/department or urgent care for evaluation due to extreme headache and emesis. On an unknown date in 2019, the patient recovered from the events. The relatedness between the events and the suspect vaccines was not reported. The agency considered the report to be non-serious.  Follow-up information was received from the healthcare professional on 04-SEP-2020.  The reporter was not able to locate any additional information because they sought "a lot of eighteen-year-old males". No additional patient demographics were available to assist with follow-up. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename:; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R017251; expirationdate: 04-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent