Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, UNK
Symptoms: Seizure like phenomena
Clinical narrative: started convulsing and making jerky movements (looked as If he was having a seizure)./Shortly after receiving the Gardasil 9, the patient collapsed, became unconscious and started to exhibit convulsing like behavior for approximately five minutes.; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act on 04-SEP-2020. This initial spontaneous report has been received from a healthcare professional concerning a 11 years old male patient. The patient had no prescriptions, over-the-counter medications. No allergies, to medications or food. No other illnesses. No chronic or long-standing. On 30-AUG-2019 at 8:20 am, 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 # 1602284, expiration date not reported but upon internal validation was established as 26-SEP-2021 intramuscularly  in the right arm for prophylaxis; the patient was also vaccinated with the first doses of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL) lot # reported as U6321AA and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) lot # reported as U6521AA, both vaccines administered intramuscularly in the left arm for prophylaxis.  On the same date (30-AUG-2019 at 8:20 am), the patient fell to the floor as soon as the shot was given and started convulsing and making jerky movements (looked as If he was having a seizure). Lasted 30 seconds. It was confirmed that the first shot that was given was hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), then diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL) and then meningococcal acyw conj vaccine (dip toxoid)(MENACTRA). The reporter stated that the patient never had an adverse event following any previous vaccine. The outcome of seizure was unknown. The casuality assessment between all the vaccines and the seizure was not reported.  Follow up information has been received from the nurse practitioner on 23-OCT-2020, the reporting nurse stated that the patient was also not taking any concomitant medications at the time.  It was confirmed that on 30-AUG-2019, the patient received diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) both in the left deltoid (previously reported as "left arm"), followed by hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in the right deltoid (previously reported as "right arm"). Shortly after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient collapsed, became unconscious and started to exhibit convulsing like behavior for approximately five minutes. The patient regained consciousness and recovered while still in the office. Emergency Medical Services were not activated. The patient did not have a past medical history of seizures, or any other neurological deficits, as well as no other medical history. This was the first time the patient had received any of the aforementioned vaccinations. A neurology referral was made, however the patient did not follow-up. Upon internal review, the convulsion was considered as a medically significant event. 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; 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