Age: 13.0
Sex: M
Vaccine: FLU3, HEP, HPV9, MNQ, TDAP
Symptoms: Unresponsive to stimuli, Visual impairment
Clinical narrative: unresponsive in his mom's arms; patient pale; opened eyes and cried asking where he was.; C/O ringing in ears; decreased vision; Diaphoretic; This spontaneous report was received from a registered nurse, and refers to a 13 year old male patient with allergy to bees (arthropod sting), allergy to opioids (drug hypersensitivity), attention deficit/hyperactivity disorder (ADHD) and mastocytosis. Concomitant medications included mupirocin 2 5 ointment and methylphenidate HCl 54 mg. Information about the patient's pertinent medical history was not provided.      On 04-APR-2019 at 14:30, 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) (Lot No. R023609 has been verified to be a valid lot number for GARDASIL 9, expiration date not reported, but upon internal validation established as 30-APR-2021), via intramuscular route of administration, in the right arm, for prophylaxis (strength, dose and frequency were not provided). On the same date at the same time, the patient also was vaccinated with the first dose of influenza virus split virion 3v vaccine inactivated (FLUARIX) (lot # EB7J7), via intramuscular route of administration, in the right arm, for prophylaxis (strength, dose, expiration date, and frequency were not provided); first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (lot # K9DXF), via intramuscular route of administration, in the right arm, for prophylaxis (strength, dose, expiration date, and frequency were not provided); fourth dose of hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B) (lot # 97LK2), via intramuscular route of administration, in the left arm, for prophylaxis (strength, dose, expiration date, and frequency were not provided) and the first dose of meningococcal acyw conj vaccine (crm197)(MENVEO) (lot # AMV052A), via intramuscular route of administration, in the left arm, for prophylaxis (strength, dose, expiration date, and frequency were not provided).      On the same date at 14:35, the physician was called to the treatment room where the patient was pale (pallor) and unresponsive in his mom's arms (loss of consciousness), and as a result, the patient was placed on treatment table in supine position where he opened his eyes and cried (crying) asking where he was. He was also complaining of (C/O) ringing in ears (tinnitus) and decreased vision (visual impairment), which returned to normal within 2 minutes on the same date. Blood pressure (BP) was also measured and the result was reported as 82/50 and the heart rate (HR) 60 (no units provided). No breathing difficulty was reported, however, the patient was reported as diaphoretic (hyperhidrosis). The patient had not eaten anything since breakfast, so a lolllpop was given to him for some sugar.  On the same date at 14:45, an additional BP measurement and HR were performed and the result was reported as 92/50 and 68 respectively. Moreover, it was also stated that at the same time, the patient's lips were pink, he was denying ringing in ears or visual disturbances and denied dizziness. He was laughing and joking with his siblings. he was assisted to sitting position on end of treatment table.     On the same date at 14:50, the patient was accompanied to the waiting area with instructions to his mom to remain seated for 15 minutes, and if symptoms returned, further invention including emergency department (ED) would be put into place. He was monitored by the staff when he was in the waiting area.   On the same date at 15:10, the patient denied further symptoms, so he was discharged to home with his family.   At the time of reporting, the outcome of loss of consciousness, decreased appetite, hyperhidrosis, crying and pallor was reported as resolved on 04-APR-2019.  Causality assessment was not provided.  Upon internal review, the event  loss of consciousness was determined to be medically significant.