Sex: F
Vaccine: HPV9
Symptoms: Seizure, Suture insertion, Swelling, Vomiting
Clinical narrative: This spontaneous report was received from the patient's parents via a company employee and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, 0.5 ml, intramuscularly in right arm, lot # N013698, expiration date 19-DEC-2019 for prophylaxis. Since an unknown date, shortly after GARDASIL 9 administration, the patient started having unexplained seizure activity. On an unknown date, she had first seizure at school locker approximately 7:20 (she had period then). Computerized axial tomography(CAT) scan and blood work were performed (results were not reported). On an unknown date, she had second seizure at school locker approximately 7 :30. She hit her head and had a mild concussion. She needed medicine to stop seizure (she had period then). Electroencephalography(EEG) and magnetic resonance imaging (MRI)(result was not reported) were perfomed and electroencephalography(EEG) showed seizure activity. On an unknown date, the patient had third seizure in homeroom class around 7:30. She was taken to the hospital (it was reported that "they did nothing"). The patient needed rescue medicine to stop seizure (she was before period then).  On an unknown date, she had fourth seizure in homeroom around 7:30. She did not need rescue medicine and was recovered at school. A physician increased dosage of levetiracetam (KEPPRA) to 750 (units not reported) in the morning and evening. The patient had headache and was tired afterward (she was before or on period then).On an unknown date, she had fifth seizure- at 6:38 in bedroom before school. The seizure lasted about 3-4 minutes and she stayed home from school. She had a headache and was tired afterwards. She had weird feeling in her throat (she was after period then). On an unknown date, a physician increased dosage to 1000 mg day and night (name of a medicine was not reported). On an unknown date, the patient had sixth seizure in her bedroom- at 9:30. The seizure lasted about 3 minutes. It was reported that someone helped her. She could not move legs and arms and was very weak. On an unknown date, she had seventh and eighth seizure: one in the morning at 10:32-10:36 (in bed) and again at 4:59-5:03 (laying on couch). She vomited after both seizures. On an unknown date, she started cannabidiol (cbd) oil (she was not on period but ovulating then). She had headache and was tired afterwards. She had weird feeling in her throat and tongue. A physician said to leave medicines alone and let cannabidiol (cbd) work longer. On an unknown date, the patient had ninth possible seizure. She was thinking she had a seizure in early morning. She was given a medicine and she was laying on her covers and asked if the parent could take her to the bathroom. She had a second pillow on top of her pillow. She seemed disoriented. She slept a lot the next day. On an unknown date, she developed with big fever blister on her nose (she was in the end of her period). On an unknown date, she had tenth seizure on the bus and was recovered at home (it was the end of her period).On an unknown date, she was taken to the hospital for the second opinion appointment. She started ethusuximide and levetiracetam (KEPPRA) was increased to 1500 mg morning and night. Ethusuximide made her very tired and gave her an extremely bad headache. She became like a zombie on the medicines. On an unknown date, the medicines were reduced after she had the seizure in the shower. On an unknown date, she had eleventh seizure in the shower. The seizure lasted approximately 3 minutes. The patient vomited several times afterward. She was very disoriented for a good half of hour (She was on day 5 of period then). On an unknown date, she had a nosebleed and nose felt cold on the inside. On an unknown date, she had another seizure at locker. It lasted 3 minutes. She had headache, rested in nurse's office and went to class. (she could be ovulating then). She remembered more than usual. She has been on cannabidiol (cbd) oil half dropper. On an unknown date, she had another seizure at home on the couch from 11:16 to 11:19 . She took a while to come out of it afterward and vomited. She felt weak the night before after going out to dinner. The patient drank coke and wondered if it could possibly be linked to coke or dye in coke and vitamins. On an unknown date, she was in her bedroom doing homework. Levetiracetam (KEPPRA) was decreased to 750 (units not reported) and on this night. At 8:30 lasted about 3 1/2 minutes (it was not reported if it was another seizure). She vomited and recovered well. She stopped medical marijuana and started lamotrigine (LAMICTAL) (reported as "1 -25 mg"). On 04-FEB-2019, (1 at night for two weeks, then starting 1 in the morning too). On 05-FEB-2019, the parents by accident gave her one lamotrigine (LAMICTAL) in the morning. The medications were decreased the night to levetiracetam (KEPPRA). On 05-FEB-2019, a physician gave her another 500 mg. It was continued next with 1000 levetiracetam (KEPPRA) morning and 1000 levetiracetam (KEPPRA) at night. On 18-FEB-2019, she started 25 mg of lamotrigine (LAMICTAL) in morning. On 20-FEB-2019, around 8:30, the patient had another seizure in the shower. The seizure lasted 3-4 minutes (She was before period then). On 21-FEB-2019, at 7:00, she had another seizure in room before school. The seizure lasted 3-4 minutes. The patient did not recover quickly and had bad headache. She vomited (she was before period then). On 25-FEB-2019, she has nosebleed (she was before period then). On 09-MAR-2019, she has nosebleed again (she was after period then). On 10-MAR-2019, at 12:45 p.m.she had another seizure in shower. She broke nose and needed stitches in hospital. Her last period was on 26-FEB-2019 or 27-FEB-2019, so she could be ovulating then. Another 25mg of lamotrigine (LAMICTAL) was added in morning, so 50 was in the morning (units not reported) and remained at 50 (units not reported) at night. Another 250 more of levetiracetam (KEPPRA) was added in morning (units not reported) and night, so 1250 was in the morning and 1250 was at night (units not reported). On 31-MAR-2019, around 12:45, she had another seizure in her bedroom after fixing her hair. She walked toward mirror or bedroom door and collapsed on the floor as a result of having another seizure. The seizure lasted about 2 minutes then 30 (units not reported) for recovery. She slept for a while but did not vomit. She had a large bump on right side of her head. The outcome of the events was not reported. The relatedness between GARDASIL 9 and the events was not reported. Upon internal review, the events of seizure, limb imbollization and broken nose were considered to be medically significant.