Age: 16.0
Sex: F
Vaccine: FLU4, HEP, HPV9, IPV, MENB, MNQ
Symptoms: Dizziness, Dyspnoea, Heart rate decreased, Hypotension, Loss of consciousness
Clinical narrative: shortly after passed out and appeared to seize for approximately 30 seconds; shortly after passed out and appeared to seize for approximately 30 seconds; shortness of breath; BP 81/46; HR 46; Syncopal epidose//dizziness; This spontaneous report was received from a registered nurse via Food and Drug Administration (FDA) referring to a 16 years old female patient. There was no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination, no allergies to medications, food or other products, no other illness at the time of vaccination and up to one month prior, no chronic or longstanding health conditions. The patient did not have an adverse event following any previous vaccine. She was not pregnant at the time of the report.  On 28-OCT-2019, at 11:00, 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 # R027576 has been verified to be valid, expiration date was not reported, but upon internal validation established as 23-JUN-2021; dose was not reported) intramuscularly in the right arm for prophylaxis. At the same time, the patient was also vaccinated with the first dose of meningococcal b rfhbp rnada rnhba omv vaccine (e. coli) (BEXSERO) (lot# ABX794AZ; dose, indication and expiration date were not reported, intramuscularly in the right arm), the third dose of hepatitis b virus vaccine rhbsag (yeast) (ENGERIX-B) (lot# 9794C; dose, indication and expiration date were not reported, intramuscularly in the right arm), the first dose of influenza virus split virion 4v vaccine inactivated (FLUARIX QUADRIVALENT) (lot# 7AR35; dose, indication and expiration date were not reported, intramuscularly in the left arm), the third dose of poliovirus vaccine inactivated (vero) (IPOL) (lot# P1F491M; dose, indication and expiration date were not reported, subcutaneously in the left arm) and the second dose of meningococcal ACTYW conj vaccine (dip toxoid) (MENACTRA) (lot# U6565AB; dose, indication and expiration date were not reported, intramuscularly in the left arm).  On the same date, at the same time, after the patient received vaccines, she complained of dizziness and shortly after passed out and appeared to seize for approximately 30 seconds. When the patient became conscious and alert again, she complained of shortness of breath. The patient was helped into recovery position and vitals were taken (blood pressure (BP): 81/46 (units not provided), heart rate (HR): 46 (units not provided)). Called 911 due to shortness of breath and symptoms. Took vitals again after 3 minutes, BP was 97/64 (units not provided), HR was 56 (units not provided). Ambulance arrived within 3 minutes and assessed patient. Per Medics, the patient was within normal limits however they advised the patient to be assessed at the hospital and the patient's parent agreed. Parent came by later to collect paperwork and stated that the patient was doing fine and was released from the hospital with no issues. The patient was sent to emergency room/department or urgent care. The outcome of all events was recovered in 2019. The causality between all suspect vaccines and all events was not provided.  Follow up information was received from the nurse manager on 15-JAN-2021.   The patient's demographics were updated. It was confirmed that the patient did not have any previous history of seizures, convulsions, or epilepsy. It was unknown of she had any other pertinent medical history, or if she had any anti epileptic medication, or bloods levels of anti-epileptic were monitored. The following information was added: after the patient received the vaccines, she complained of dizziness, it was given water, and said she felt better, but then she had a syncopal episode (syncope), and appeared to size she was kept safe from falling and regained consciousness, after approximately 30 seconds at 11:41 her blood pressure was 81/46 (units not provided) and her heart rate was 46 (units not provided), at 11:43 her blood pressure was 97/64 (units not provided) and her heart rate was 64 (units not provided). Medics were called, they stated that the client was within normal limits, but her father took her to the hospital, then he returned on the same day to the clinic and stated that his daughter was fine. The outcome of the aforementioned events was reported as recovered at the same date, after 30 seconds. The causality assessment between all the suspect vaccines with the aforementioned event was not provided.  Upon internal review, syncope, seizure and loss of consciousness were determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027576; expirationdate: 23-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent