Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dehydration, Heart rate decreased, Loss of consciousness, Presyncope, Seizure
Clinical narrative: The patient suddenly became unresponsive and was convulsing/ 2-3 convulsions prior to regaining consciousness; Slyghtly dehydrated; Pulse slightly low but otherwise normal; Vasovagal reaction to vaccination; Information has been received from Food and Drug Administration (FDA) (VAERS number 827282) on 18-AUG-2020.  This spontaneous report has been received from a health professional, concerning a 17 year old white male patient. The patient's medical history included one incident of fainting from dehydration. Allergies to medications, food or other products were reported as unknown. Prescriptions, over the counter medications, dietary supplements, or herbal remedies taken at the time of vaccination were unknown. Other illnesses at the time of vaccination and up to one month prior were also reported as unknown.   On 01-AUG-2019 at 14:00, 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 # 1581027 which has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 03-JUN-2021) (dose not reported), intramuscular in his right arm, for prophylaxis. On the same date, he was also vaccinated with the second dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (lot # U6365AA, dose and expiration date not reported) intramuscular in his left arm. Both vaccines were administered in a public health clinic.   On 01-AUG-2019 at 14:00, when the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA), he suddenly became unresponsive (unresponsive to stimuli) and was convulsing. The patient was unresponsive for approximately 5-10 seconds and had 2-3 noticeable convulsions prior to regaining consciousness (loss of consciousness) and sitting up. The patient's mother and his younger brother were also present in the shot room. The patient was seated in the clinic bench, when the vaccine administration occurred. This Public Health Nurse (PHN) administered the meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) in the patient's left deltoid without concerns. This PHN, then administered the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in the patient's right deltoid, and within seconds the patient slumped into the chair and his body convulsed 2-3 times. This PHN braced the patient on the bench and attempted to lean him over slightly, but the patient's brother was also seated on the bench still. After 5-10 seconds, the patient regained consciousness. This PHN continued to assess the patient and reassure the mother that this was a known reaction to vaccination, and the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine. This PHN also inquired about hydration status, and expressed concerns about the patient being slightly dehydrated as well. This PHN explained that the convulsions did not appear to be seizure related, but that the patient's primary provider should be made aware of the incident. This PHN check the patient's blood pressure and it was 126/68 (units not provided), pulse 55 (units not provided), and SPO2 99%. This PHN then asked the physician to assess the patient. The physician assessed the patient and stated that his pulse was slightly low (heart rate decreased) but otherwise normal findings. The physician reassured the mother that her son was likely slightly dehydrated and additionally had a vasovagal reaction to the vaccination (presyncope). The physician, also explained that the convulsions were the body's response to the shifting of blood from the brain and decreased heart rate, and likely not seizure related due to lack of post ictal state. The family remained in the clinic for approximately 30 minutes after the appointment time for assessment and reassurance. The PHN documented the vaccination reaction in "CAIR".   Additionally, it was reported that the patient had not ever experienced an adverse event following any previous vaccine.   At the reporting time, the patient recovered from all the aforementioned adverse events.   The causal assessment between the adverse events and vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported. Except for the patient's vasovagal reaction (presyncope) assessed as related to vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA).       The agency assessed the severity for this case as non serious.  As of 20-NOV-2020, the telephone attempt trying to obtain additional 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. devicelotnumber: 1581027; expirationdate: 03-JUN-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