Age: 10.0
Sex: F
Vaccine: HPV9, UNK, UNK
Symptoms: Nasal injury, Seizure like phenomena, Syncope, Tonic clonic movements
Clinical narrative: Brief seizure like activity; Vasovagal syncope; Hurt her nose; Bruise noted on the left side of forehead; This spontaneous report was received from a physician via company representative regarding a patient of an unknown demographics. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiry date were not reported) for prophylaxis. The reporter described that an unspecified patient, had seizure like activity with tonic clonic movements (tonic clonic movements, seizure like phenomena) immediately followed vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). It was reported this was the first time the patient received vaccination. No product quality complaint reported. The outcome of seizure like phenomena and tonic clonic movements was unknown. The drug relationship was not provided.   Upon internal review, the events seizure like phenomena and tonic clonic movements determined to be medically significant.  This case is non-valid case due to lack of patient identifiers.  Upon receipt of follow up information from the physician on 22-JAN-2020 this case is now considered valid as patient's identifiers were provided. The patient was confirmed to be a 10-year-old female patient.  On 10-JAN-2020, the patient was vaccinated with the first doses of meningococcal ACYW conj vaccine (carrier unspecified) (MCV4) lot number V6015AA, with expiration date 06-OCT-2019, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP), with expiration date on 01-DEC-2020 and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis, with lot number 1586752 and expiration date on 16-FEB-2021, all three vaccines were administered intramuscularly, in the left arm.  On 10-JAN-2020, after the patient received the vaccines, she was waiting in the chair, when she felt dizzy and fell forward on to the ground and hurt her nose (nose injury). The reporting physician was not in the room at the time and did not witness this happening. Immediately after the fall the blood pressure (BP) was 109/77 (units not reported) and pulse rate (PR) was 55/min. The patient was allowed to lie down.  The physician went in to evaluate patient as soon as he was informed of the incident. The patient was lying down on the examining table, she was alert and responding to the physician's prompts appropriately.  Some erythema of tip of nose at site of impact was noted. No bruising, or swelling of nose were noted. No tenderness of nasal bridge was noted. A bruise was noted on the left side of forehead at site of impact (contusion), no swelling or tenderness were noted.   Patient was allowed to rest on the examining table for another 15-20 minutes. The physician repeated BP and it was 109/77 (units not reported), PR was 74/min. Patient stated she was feeling better and said she wanted to go to school. She walked out of clinic unassisted.   The physician explained to the patient's mother that if bleeding from nose, or if nasal bridge appeared bruised or swollen, they should return to clinic for re-evaluation and the patient would need nasal bone xray to rule out a fracture. The physician explained to the mother that in rare circumstances, syncope can occur with the HPV vaccine, which is also a vaso-vagal syncope.   He further explained that she should be fine subsequently, and there was not expected to be any risk of another syncope episode on that day or later. He re-assured the mother that the patient could return to school on that day. However, if she had syncope or seizures later that day, they should communicate with the physician.  The physician assessed the events as seizure like activity and syncope, and considered them to be related to the administration of the suspect vaccines. The causality assessment between the vaccines and the events of contusion and nasal injury was not reported.  The outcome of contusion and nasal injury were not provided.  Upon internal review, syncope was determined to be a medically significant event.