Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperventilation, Nausea, Oxygen saturation decreased
Clinical narrative: Dizziness, nausea, low oxygen from hyperventilating for 20 minutes solumedrol 125 mg administered im to right vastus lateralis patient was sent to er for observation; Dizziness, nausea, low oxygen from hyperventilating for 20 minutes solumedrol 125 mg administered im to right vastus lateralis patient was sent to er for observation; Dizziness, nausea, low oxygen from hyperventilating for 20 minutes solumedrol 125 mg administered im to right vastus lateralis patient was sent to er for observation; This spontaneous report was received from a healthcare professional, referring to a non-pregnant 11-year-old female patient. The patient's concurrent conditions included allergy to ibuprofen (MOTRIN CHILDREN), tension-type headache, constipation, anxiety disorder, attention deficit/hyperactivity disorder (combined type), pain in left finger, abdominal pain, decreased concentration, dizziness, headache, obstructive sleep apnoea syndrome and sleeplessness. Concomitant therapies included diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA). At the time of vaccination, the patient was taking ranitidine 15mg/1ml syrup 5ml po (orally); qd (a day), cetirizine hydrochloride 10mg; 1 tablet po; at bedtime (qhs), methylphenidate hydrochloride 30mg capsule; 1 cap po; qam and sertraline hydrochloride (ZOLOFT) 25 mg tablet at bedtime.    On 09-NOV-2018 at 09:20, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose was not reported) lot # R016127 (expiration date not reported, but upon internal validation established as 22-MAR-2021) intramuscularly (IM), in the right arm for prophylaxis.         On 09-NOV-2018 at 09:20, the patient experienced dizziness, nausea, low oxygen from hyperventilating for 20 minutes, due to which methylprednisolone sodium succinate (SOLUMEDROL) 125 mg was administered IM to right vastus lateralis. The patient was sent to ER (emergency room) for observation. It was reported that, the patient recovered form the events on an unknown date.   The causality assessment between the events and the suspect therapy was not reported.  Follow-up information was received from a healthcare professional on 15-NOV-2019.  The patient's concomitant medications included ranitidine, cetirizine hydrochloride, methylphenidate hydrochloride and sertraline hydrochloride (ZOLOFT) (previously reported as other therapies taken at the time of vaccination). The patient's other suspect therapies included first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) in the left arm via intramuscular route (lot# XJ5L1 and expiry date: 19-OCT-2020) and first dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) in the left arm via intramuscular route (lot# U6015AA and expiry date: 06-OCT-2019) (strengths, schedules and doses was not reported) (previously reported as concomitant medications) for prophylaxis. The vaccine was not available for return/evaluation as it was a single dose vaccine and the patient was vaccinated according to the instruction leaflet. There was no associated product quality complaint. There was no temperature excursion. The reporter stated that, the events were related to anxiety disorder. On 09-NOV-2018, the patient recovered from the reported events.  The reporter considered the events of dizziness, nausea, low oxygen from hyperventilating for 20 minutes to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).