Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Electrocardiogram normal, Hypotension, Presyncope
Clinical narrative: syncopal episode; blood pressure: 42/27; glucose of 93; This report was obtained on request by the Company from the Food and Drug Administration (FDA) under the Freedom of Information Act (VAERS # 818541) on 12-MAY-2020.  This spontaneous report was received from health care professional and refers to a 16-year-old, non-pregnant female patient of other race (not Hispanic or Latino). It was reported that the patient had almost passed out on an unspecified date (reported as once before), during cheerleading practice. The patient did not have prescriptions, over the counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination, other illness at the time of vaccination and up to one month prior or chronic or long standing health conditions. She had no known allergies. She had never had any adverse reaction following any previous vaccination.   On 12-JUN-2019, the patient went to sleep at 3 am and had no breakfast or food this morning. On that day at 09:00, she was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R020949 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 04-MAY-2021) intramuscularly in the right arm (strength and exact dose were not provided) for prophylaxis; and with the second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) lot # U6204AA, intramuscularly in the right arm (expiration date, strength and exact dose were not provided).  On the same day at 09:19, the patient had a near syncopal episode in the waiting room following her vaccinations; her initial random blood glucose (BG) was 93 (units not provided) (blood glucose abnormal) and blood pressure (BP) was 42/27 (units not provided). She was given a juice, put in wheelchair and brought back to room for observation. It was reported that BP improved while lying down, however continued to drop to below systolic blood pressure (SBP) of 80s (units not provided); she had recurrent symptoms when trying to stand up. On the same day, she recovered from the events.  The causality assessment between the suspect vaccines and the events was not provided.  Follow-up information was received from a physician on 28-OCT-2020.  It was reported that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered in the right deltoid. The vaccine was a single use device which was used according to the instruction leaflet and it was threw away appropriately in the sharp container after its use.  It was reported that the blood pressure at the office visit was 101/68 (units not provided). However after the near syncopal episode, her blood glucose was 93 and she experienced hypotension. Her blood pressure was taken about 2 hours to improve to baseline. She received food, oral hydration and rest. An electrocardiogram (EKG) was performed and came out with a normal result. On the same date, the patient recovered from hypotension and presyncope. The outcome of blood glucose abnormal was not provided.  The causal relationship between the suspect vaccines and hypotension was not provided.  The reporting physician considered pre-syncopal episode and hypotension to be important medically events. 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: R020949; expirationdate: 04-MAY-2021; deviceage and unit: 0 ; operatorofdevice: Physician; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: No; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent