Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Loss of consciousness, Malaise, Pallor, Syncope
Clinical narrative: he had syncopal episode and passed out; face + skin pale; had small emesis; he did not feel well; he awoke with complaint of stomach pain and had emesis x1; This report was identified from a line listing obtained on request by the Company from the FDA under the Act.  This spontaneous report was received from a health care professional and a patient's friend, via Agency, and refers to a 12-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were provided.  On 15-MAY-2019, 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 in the left arm (exact dose was not reported) (lot # reported as R011631, which was confirmed to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and expiry date not reported but upon internal validation established as 12-DEC-2020) for prophylaxis.  On the same day, other suspect therapies were administered which included diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) (lot # MF9EA, expiry date was not reported) and meningococcal acyw conj vaccine (crm197) (MENVEO) (lot# AMVA087A, expiry date was not reported). Both vaccines were administered as first doses, intramuscularly in the left arm (exact doses were not reported) for prophylaxis.  On 15-MAY-2019 (about 15 min after the vaccines), the patient passed out. When the health care professional came to him, he was sitting on the floor and was very pale. His stomach hurt, then he had small emesis. He received a cold pack applied to his forehead, was moved to a supine position with knees elevated. The patient was feeling better and recovering from the events by about an hour.  The causality assessment between the vaccines and the events were not provided by the reporter.  The Agency considered the events to be non-serious.  Follow-up information was received from a health care professional (unspecified) on 28-FEB-2020.  The patient was reported to be 13-year-old (conflicting information, considering his date of birth). The administered vaccines were purchased with private funds. On 15-MAY-2019, after returning to class, he told the teacher that he did not feel well (malaise). Another student walked with him to the hallway, where he had a syncopal episode and passed out. The patient awoke with stomach pain (abdominal pain upper) and had emesis x1 (vomiting), face and skin pale (pallor). It was noted that ice applied to the forehead, knees up, and juice helped him to recover. The duration of the event syncope was updated to 2 min. On 15-MAY-2019, the patient recovered from the events vomiting and pallor with a duration of 15 min from the onset. The outcome of the event malaise was resolving.  The reported considered the events syncope, vomiting, and pallor to be related to the administered vaccines. The causal relationship between malaise and the vaccines was not reported.  Upon internal review, syncope was determined to be a medically significant event. In addition, vaccine administration details were updated.