Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, MNQ
Symptoms: Dizziness, Hyperhidrosis, Nausea, Thirst, Vomiting
Clinical narrative: mildlydiaphoretic / she did sweat; She complains of being thirsting; she felt like she was going to throw up; dizzy; This spontaneous report was received from a healthcare professional via Food and Drug Administration (FDA) referring to a 11 years old female patient on 22-OCT-2020. The patient's concomitant therapies included lithium carbonate and chlorpromazine hydrochloride (THORAZINE). The patient had no known allergies (NKA)/no known drug allergies (NKDA). The patient had no other illness at the time of vaccination or up to one month prior. The patient had no chronic or long-standing health conditions. The patient did not have an adverse event following the previous vaccine.  On 26-SEP-2019, at 13:25, the patient came over to clinic and was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1602289, not valid, expiration date and dose detail were not provided) intramuscularly in the right arm (also reported as left deltoid) for prophylaxis. The patient was also vaccinated with the first dose of meningococcal acyw conj vaccine (crm197) (MENVEO) (lot# U6543AA, expiration date, dose detail and indication were not provided) intramuscularly in the left arm (it was also reported the patient was given meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) injection in the right deltoid) in the medication room.  On 26-SEP-2019, at 13:30, the patient walked out to hallway in clinic to get a stuffed animal and she complained of (c/o) being dizzy per a doctor. The doctor assigned her to a chair in the clinic. She was mildly diaphoretic. The nurse took her vital signs (VS) and the patient then said, she felt like she was going to throw up. She closed her eyes briefly. The nurse gave her a few sternal rubs. She responded to the sternal rubs, she c/o being thirsting. Epinephrine pen was given per the doctor. The patient was able to answer question appropriately then she stated she felt better. VS results as following: pulse oximetry was 96% to room air (RA), pulse was 84 (unit not provided), temperature was 97.5 (unit not provided), blood pressure (b/p) was 97/64 (unit not provided). The staff called 911. When ambulance arrived, she was able to answer questions by emergency personnel. She was transported to emergency room (ER) per ambulance. She returned from ER around 17:00 on the same day. The therapist checked in with the patient. She was monitored through out night and legal guardian was notified. The patient recovered from above events in 2019. The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.  Follow-up information has been received from a physician and a nurse on 31-DEC-2020, referring to a currently 12 year old female patient. The physician stated that it was not clear when this happened, but stated that the patient sweated and vomiting, however, did not experienced dizziness. Additionally, was reported that the clinic was a residential facility, where children were admitted and discharged and if this was the only child anything had ever happened with, she believed the child was still at the facility (hospitalization). Additional information received from the nurse that vaccinated the patient and stated that on 26-SEP-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)  (GARDASIL 9) lot # 1602284 (previously reported as "1602289"), expiration date 26-SEP-2021, intramuscularly in the left deltoid (previously reported as "right arm"), meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) lot # U6543AA, expiration date 23-FEB-2021 (lot # previously reported for meningococcal ACYW conj vaccine (CRM197) (MENVEO)), intramuscularly, in the left deltoid (previously reported as "right deltoid") and meningococcal ACYW conj vaccine (CRM197) (MENVEO). On the same date, the patient experienced hyperhidrosis, thirst, vomiting and dizziness. The patient recovered from adverse events. These adverse events were previously reported to doctor and to manufacturer. The vaccine was used according to the instruction leaflet. There was no a previous temperature excursion. 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: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent