Sex: M
Vaccine: HPV9
Symptoms: Headache, Immediate post-injection reaction, Loss of personal independence in daily activities, Magnetic resonance imaging normal, Malaise
Clinical narrative: seizure like episode with twitching; complalned about a headache and "not feeling right"; complalned about a headache and "not feeling right" / he still did not feel well; Looklng off and sluggish; hls head slumped forward in the car on the way home. This was his first seizure; transient neurological symptoms; muscle twitching; he can gesture but not speak; positive for emotional stress; patient in arm, fell asleep, headaches; migraine or migraine wariant/migraine like episode; patient in arm, fell asleep, headaches; Information has been received from Food and Drug Administration (FDA) (845589-1) on 22-OCT-2020.  This spontaneous report was identified on request by the Company from the FDA under the Freedom of Information Act and was received from a consumer referring to his/her son - a 13-year-old male patient. No information regarding his pertinent medical history, allergies and concomitant therapies was provided. He had never had an adverse event following any previous vaccine.  On 11-OCT-2017 at 08:30, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On 11-OCT-2017 at 08:40 (also reported as immediately after receiving the shot), the patient complained about a headache and "not feeling right." He went back to school, but as he came home the same afternoon he still did not feel well. The parent and the patient decided to go to hockey practice that evening and "sweat it out." The patient was looking off and sluggish the entire practice, his head slumped forward in the car on the way home. This was his first seizure. It was then around 7:20 p.m. the same day he received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient sought for medical attention visiting a doctor's office/clinic and then emergency room. Finally, on an unreported date, he was hospitalized for 6 days due to the events. He had magnetic resonance imaging (MRI) and electroencephalograms (EEGs) performed and according to neurologists, they were "squeaky clean". The patient had been still suffering from the seizures till the reporting day which was on 11-MAY-2019. The outcome of the events was reported as not recovered.  The causality assessment between the events and the suspect therapy was not provided.  Follow up information was received on 28-OCT-2020. On 28-0CT-2020, a return telephone call was received. hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number was N014470, expiration date 17-JUN-2019, administration site was unknown. On 12-OCT-2017, for complaint of pain in arm, fell asleep, headaches, "zone out and look forward" referred to neurologist and they reviewed his case and completed EEGs, MRI, and various blood test which has not yielded an answer. One potential diagnosis was migraine or migraine variant, non-epileptic events but the patient did not have electrical pattern on EEG. Both events could have been triggered the events in life such as anxiety and depression. Per neurology, they felt it was more migraine like episode. The patient's father reported 43 episodes occurred while at school. School determined the patient should have been homeschooled. On 16-OCT-2017, blood work and MRI were normal, history of concussion 2 times. On 18-OCT-2017 at 2:47 pm, video EEG was normal. On 11-NOV-2017, the patient was seen in the ER for further evaluation of seizure like episode with twitching. The father reported 38 episodes have occurred and daily. Episodes only occurred during school hours and between 9-11. The father picked him up and he could gesture but not speak, the right eye and right upper extremity always twitched and sometimes the left upper and right lower extremity twitch lasted between 15-25 minutes and was followed by headache. The father reported the patient had hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on the day these episodes started. Hospital EEG was normal, and video EEG was normal. No trauma, fever, substance abuse, or vomiting were noted. He was positive for emotional stress. The patient was admitted for observation due to staring episode. EEG was normal and the patient was discharged home. On 17-NOV-2017, neurologist reviewed the records and determined the patient was having transient neurological symptoms and might have resumed to normal activities and return to school. Last contact with this family was 30-NOV-2017. Additional information was not expected.