Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Neurological examination normal, Thirst
Clinical narrative: Brady-cardic; Possible syncope episode; He was thirsty; Lethargic; Diaphoretic; Hypotensive 88/40; Fell off exam table, hitting his head on floor; Not feelling well; Feeling weak; Information has been received from the agency (VAERS 828207) on 18-AUG-2020.  This spontaneous report was received from a registered nurse concerning an 14-year-old male patient. The patient did not have prescription for over the counter medications, dietary supplements or herbal remedies. He did not have known allergies, chronic or longstanding health conditions or other illnesses at the time of vaccination. The patient received an unspecified vaccine in 2017 and did not receive any vaccines within one month prior to this vaccination.  On 08-AUG-2019 at 14:35, 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), intramuscular route in the right arm, lot number R020948 with expiration date internally validated as 04-MAY-2021 for prophylaxis (dose and strength were not reported).  On 08-AUG-2019 at 14:46, 8 minutes after administering the vaccine, patient stated that was thirsty and was instructed to remain on the exam table, his father was sitting 2 feet in front of him. The patient told his father of not feelling well and turned to side and fell off the exam table, hitting his head on floor, the father was not sure if he had syncope episode. The patient was found in floor by staff and with father's assistance was moved to chair, he was lethargic, diaphoretic, brady-cardic (upon placing O2 Sat probe and then when up to 60's), hypotensive with 88/40 (unit not reported). The patient opened eyes on "ommmonia" inhalant.  Neurological checks within the normal limits. Electrocardiogram was normal, blood test for sugar level 88 (unit not reported). He was started on intravenous fluids with normal saline on titer and ice pack was applied. After 7 minutes, the patient was more alert and taking fluids and eating cookies and crackers; with no trauma, bruise or bump to head. He was moving all extremities but started feeling weak. Instructions were given to parent on discharge to watch for any mental changes, dizzines, nausea, vomiting, severe headache, high temperature and to call clinic, emergency or take the patient to the nearest emergency room (ER). Orthostatics and vital signs were done before leaving (unspecified results).  At the reporting time, the patient recovered from all reported events on an unspecified date in August 2019. The reporter did not provide causality assessment between the reported events and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  Upon internal review, the events syncope and bradycardia were determined to be medically significant.  As of 02-SEP-2020, all telephone attempts to obtain follow-up information have been unsuccessful. 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: R020948; expirationdate: 04-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