Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, TDAP, HEPA, HPV9, TDAP
Symptoms: Tension, Tremor
Clinical narrative: Possible seizure; crying; This spontaneous report as received from a health care professional via VAERS form from Agency refers to a 11-year-old white male patient. The patient's medical history, concomitant medication and current condition was reported as none. On 25-FEB-2019 at 9:30, the patient was vaccinated with second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly in the right arm (exact dose, lot number and expiration date were not reported) for prophylaxis. On 25-FEB-2019, the patient was also vaccinated with first dose hepatitis a vaccine, inactivated(VAQTA) intramuscularly in the left arm, lot number R018935 and expiration date 5-SEP-2019 (exact dose was not reported) for prophylaxis. On 25-FEB-2019, the patient was also vaccinated with second dose diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL) intramuscularly in the left arm, lot number c5519ba and expiration date 19-SEP-2020 (exact dose was not reported) for prophylaxis. On the same day, 10 minutes after vaccination the patient was shaking for about 30 seconds and appeared to lose consciousness for about 30 seconds. All vitals where in normal range, including blood sugar, before patient was discharged on the same day. The outcome of events was reported as recovered. Reporter described events as non-serious. The causality between the event and the suspect therapies was not provided.  Follow-up information has been received on a 20-NOV-2019 from a registered nurse, who was also vaccine provider in this case.  On 25-FEB-2019, at 9:30, the patient was vaccinated with the second (also reported as the third and final) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1586749, expiration date 13-FEB-2021 given in right deltoid. Previously the patient had not experienced any adverse event to this vaccine.. Anatomical location of other suspect vaccines was reported as left deltoid. The nurse reported that on 25-FEB-2019, 2 to 5 minutes after vaccination (also reported at 9:40), the patient was crying, then tensed up and displayed seizure-like activity. The nurse called to the emergency but the patient's parent refused transport so Emergency Medical System (EMS) was cancelled. The patient was examined by Medical Doctor (MD), Nurse Practitioner (NP) and Registered Nurse (RN). The symptoms resolved in 2-3 minutes. The patient's mother stated that she would take child to Emergency Room (ER) following appointment. The patient was monitored and followed-up on 25-FEB-2019, 26-FEB-2019 and 28-FEB-2019. Additional information was obtained from the patient's mother that on the day of event patient had a headache but had been doing fine since. Both events: seizure and crying was assessed by reporter as Important Medical Event (IME) and causality between events and suspect therapies was provided as possibly related. The causality between the event of headache and suspect therapies was not provided. Upon internal review the event of loss of consciousness was considered to be medically significant.