Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Headache, Immediate post-injection reaction, Intensive care, Loss of consciousness, Neurological examination normal
Clinical narrative: fall; fainted; head injury/ head trauma; headache; immediate post-injection reaction; intensive care; pain; loss of consciousness; pallor; peripheral coldness; This report was identified from a line listing obtained on request by the Company from the FDA (HA # 739057) under the Freedom of Information Act and refers to a 16-year-old female patient. The patient's medical history included insomnia, heart palpitations and allergic rhinitis. The patient's current illnesses included syncope, anxiety, and depression. Other medications were reported as cetirizine and fluticasone. On 20-FEB-2018, at approximately 09:00, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N019923 with expiration date on 28-APR-2019 (exact dose not reported); a second dose of meningococcal acyw conj vaccine (crm197) (MENVEO) lot # M16165 (exact dose and expiration date nto reported); a first dose of meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) lot # 15C801 (exact dose and expiration date not reported). All vaccines were administered intramuscularly in the right arm for prophylaxis. On 20-FEB-2018, immediately after receiving last vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) the patient fell forward hitting her forehead on the ground from a 3 feet fall. She was "out cold" ashen color, cool extremities. Never lost pulse, vital signs within normal limits (WNL), times taken: 09:06, 09:10, 09:19. The patient did not have breakfast this morning. Rapid response was called and the patient transferred to intensive care unit (ICU). Loss of consciousness reported to be less than 30 seconds. The patient was alert and oriented but with headache. She was monitored in the PICU with every hour neurochecks. All of which were normal. She was on telemetry with showed no abnormalities. Acetaminophen (TYLENOL) was given for pain. C-collar was cleared and the patient was able to eat and drink without difficultly. She walked throughout the unit without any dizziness. The patient was released mid afternoon that same day with instructions to follow up with primary care physician (PCP) to determine need for concussion clinic. The outcome of the events was reported as unknown. The causality assessment between the events and the suspect therapies was not provided.  Follow-up information has been received from a healthcare professional via Agency on 23-MAY-2019 refers to a 16 year old female patient. The patient's concurrent conditions included allergic to cats, banana allergy and seasonal allergy. On 20-FEB-2018 at 09:02, the patient experienced fall, loss of consciousness, peripheral coldness, pallor, pain, intensive care, immediate post-injection reaction, headache and head injury.  Follow-up information has been received from the physician on 02-JUL-2019. The patient's historical conditions included closed salter-harris type I fracture of distal end of left fibula with routine healing, exercise induced bronchospasm and fracture tibia L. The patient's family historical conditions included asthma (mother), depression(mother), diabetes type II (mother and maternal grandmother), hypothyroid (father), cancer (renal, stage 2) (father), hypertension (maternal grandmother), glaucoma (maternal grandmother and aunt) and cancer (maternal grandmother and paternal grandfather). The patient's historical Vaccines included diphtheria toxoid pertussis acellular 1-component vaccine poliovirus vaccine inactivated (Vero) tetanus toxoid (DTAP) vaccine, flu vaccine, flu vaccine nasal, HIB Vaccine, hepatitis a vaccine ped adol, hepatitis b vaccine ped/ado, poliovirus vaccine inactivated (IPV), MMR Vaccine,  meningococcal vaccine, pneumococcal vaccine (7-val peds), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP) vaccine and varicella vaccine live. On 20-FEB-2018, the patient received suspect vaccines (Right Deltoid) and was admitted to hospital due to fainted, fell out of chair and hit her head. On 20-FEB-2018, the patient received physical exam and the results were as below. Blood pressure (BP) was 113/63 (unit was not reported); body temperature was 36.8 degree Celsius; pulse was 69 (unit was not reported); respirations was 15 per minute; SpO2 Pulse was 69 (unit was not reported); oxygen delivery was None (Room Air); Intensity Pain Scale 0-10 (Pain 1) was 7 (unit was not reported); glucose was 90 mg/dl.  On the same date, the patient was discharged with cetirizine (ZYRTEC) and fluticasone (FLONASE) for allergic rhinitis. The outcome of the events was recovered. Upon internal review, syncope was determined to medically significant.