Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Drug screen negative, Dysarthria, Electrocardiogram normal, Electroencephalogram normal, Fatigue
Clinical narrative: This report was identified from a line listing obtained on request by the Company from FDA under the Freedom of Information Act (HA # 711691) on 22-DEC-2017. The reporter referred to a 12-year-old female patient. The patient's medical history included anxiety, constipation and congenital hip dysplasia. There was no concomitant medications and current illnesses reported. On 01-SEP-2017, the patient was vaccinated with a second dose of GARDASIL 9, in the right arm, lot # N019923, 28-APR-2019 (route of administration was not reported) for prophylaxis. On the same day, the patient did well, however went to school and started feeling weird during physical education (reported as "PE"). She stated that she was not in full control of her body and that she felt dizzy. Then the patient started feeling weak and by the time mom picked her up from school she was slurring her words and did not recognize her brother. She took her home and she rested but then one hour later she fainted and was shaking. Mom took her to the emergency room (ER) where an extensive work up including blood work, electrocardiogram (EKG), electroencephalograph (EEG), computed tomography (CT), urinalysis (UA) were all negative (also reported as "UA, Urine drug screen, complete blood count (CBC), comprehensive metabolic panel (CMP), head CT, EKG, EEG, chest X-ray (CXR), pregnancy test all normal with exception to ferritin level"). Since that time she had felt foggy, fatigued, and just not herself. She had retro amnesia and could not do tasks that she normally would. The patient stated that she had been sleeping well (reported as "ok"), going down about 22:00 in the evening and waking up normally but then feeling tired throughout the day. No more dizziness, headache (reported as "HA"), blurry vision, loss of motor function, seizure activity, or other symptoms. Eating and drinking well (reported as "ok"), normal output. No fever. No medications at that time. The patient stated also that her right arm had also been hurting since the immunization and then intravenous (IV) placement in the same arm. It hurt when she was writing for a long time or using it for a long time. She denied any numbness, tingling or loss of function. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL 9 was unknown. Follow-up has been received from a healthcare professional via FDA on 08-NOV-2017 regarding a 12-year old female patient. Patient's historical vaccine included ENGERIX-B (dose 3 in the right arm, lot # 37H34). Her concurrent conditions included anxiety, constipation and congenital hip dysplasia. On 01-SEP-2017 at 09:00, the patient was vaccinated with a second dose of GARDASIL 9. On the same day at 14:00, the patient experienced all the events. This is an amended report. Upon clarification, aware date was changed from 08-NOV-2018 to 05-NOV-2018. This is an amended report. Seriousness criteria of medically significant that had been selected in error for the events of syncope and seizure-like phenomena were removed. Follow up information has been received from the registered Nurse on 28-NOV-2018. The nurse reviewed the patient report and could not locate additional demographic information as it was blacked out. The reporter had no further information to add to the report.