Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Pallor, Syncope
Clinical narrative: became very pale; patient began feeling "lightheaded"; a very short amount of syncope may have occurred; This spontaneous report was identified from a line listing obtained on request by the Company from the agency (Agency number 827201) under the Freedom of Information Act as received from a health professional referring to a 14-year -old female patient. The patient had no prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination, no other illnesses at the time of vaccination and up to one month prior or chronic or long-standing health conditions. It was unknown if the patient had any allergy.   On 02-AUG-2019 at 16:00, 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) (dose not reported), lot number R024271, expiration date was not provided, but upon validation, it was established as 08-MAY-2021, intramuscularly in the right arm; with the first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) (dose and expiration date were not provided), lot reported as 33CA7, intramuscularly in the left arm; and with the first dose of meningococcal ACYW conj vaccine (dip toxoid)(MENACTRA) (dose and expiration date were not provided), lot reported as U5869AB, intramuscularly in the right arm.  Within 5-10 minutes of receiving the vaccines, the patient began feeling "lightheaded" (Dizziness) and became very pale. She and Mom had gone to the waiting room. Taken to a clinic room with and exam table to lie down on. Blood pressure (BP) was 98/60 (units not provided), Pulse 74 (units not provided). Given some apple Juice and cold compresses were put on her neck and forehead. After about 10 -15 minutes the pink color came back Into her face. BP, 98/62 (units not provided), Pulse 72 (units not provided), blood sugar (BS) 85 (units not provided). She said that she had not eaten since earlier In the morning. Mom said she thought that she had a seizure but that was not observed, a very short amount of syncope may have occurred. She has no history of a previous seizure. Called and talked to Mom on 06-AUG-2019 and she reported calling the patient's medical doctor (MD) but had to leave a message. No reports of any other events after leaving the office.  The outcome of pallor, syncope and dizziness was reported as resolved. The Agency did not assess the relationship between the events and the suspect therapies.  As of 09-SEP-2020, telephone call was made and no further information was available. 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R024271; expirationdate: 08-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent