Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Altered state of consciousness, Amino acid level abnormal, Anti-thyroid antibody positive, Asthenia
Clinical narrative: ABDOMINAL PAIN UPPER; ANTI-THYROID ANTIBODY POSITIVE; AMINO ACID LEVEL INCREASED; DYSSTASIA; LETHARGY; LIMB DISCOMFORT; VERTIGO; Thyroxine free normal; Full blood count normal; Blood thyroid stimulating hormone normal; DECREASED APPETITE; DIET REFUSAL; DIZZINESS; DYSKINESIA; Gait disturbance; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES; Epstein-Barr virus test negative; Anxiety 1/10; Housebound; INFLAMMATION; OROPHARYNGEAL PAIN; PALLOR; RHINORRHOEA; Streptococcus test negative; FATIGUE; HEADACHE; ABDOMINAL PAIN; Borrelia test negative; ASTHENIA; EAR PAIN; Electroencephalogram normal; Electromyogram normal; Lumbar puncture normal; Nuclear magnetic resonance imaging brain normal; Nuclear magnetic resonance imaging spinal normal; This report was identified from a line listing obtained on request by the Company from the FDA under the Act on 21-FEB-2018.  Information has been received from the agency (agency reference# 727050) referring to a 12-year-old female patient. The patient's concurrent conditions were not reported. Concomitant therapies included albuterol, beclomethasone dipropionate (QVAR) and ibuprofen (MOTRIN). Medical history included very mild asthma, related to season, no emergency room (ER) visits for asthma.  On 13-AUG-2017, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot # and expiration date unknown) in the arm intramuscularly for prophylaxis.  One month later, on 13-SEP-2017, the patient experienced headache (HA), fatigue, stomach pain, sore throat ear pain, runny nose, no fevers. The symptoms lasted 5 days. The patient would come home from school, and then go right to bed for about an (reported as and) hour and then get up to do her schoolwork. The patient continued to have some lingering fatigue. The patient was able to go on trip, after 3rd day of the trip she was dragging quite a bit, wanted to go back to the room. On 13-OCT-2017, the patient developed another sore throat and belly pain. The patient's throat Culture (Cx) and complete blood count (CBC) were normal. Thyroid stimulating hormone (TSH) was 5 (unit not provided). Free Thyroxine (FT4) was 1.08 nml. The patient continued to have stomach and HA ear pain, lasting another couple weeks. On 05-OCT-2017, the patient went back to the doctor and tested for epsteinbarr virus (EBV), and Lyme disease showing negative. Streptococcus (Strep) was negative again. The patient was seen by ears, nose and throat (ENT) and showed no sinus disease. On 06-OCT-2017, the patient started having difficulty walking stating that the room was spinning, and the patient developed slow movements. She did not want to eat or drink. The patient continued to complain of sore throat. Pediatrician did prescribe doxycycline for a course which did not effects symptoms. The patient was treated with montelukast sodium (SINGULAIR) and diphenhydramine (BENADRYL) (reported as Benedryl) started to improve some symptoms. The patient started to need to be helped up the stairs. On 14-OCT-2017, the patient had very difficult time getting to stand which they attributed to weakness. The patient was really saying why she could not get up. The patient felt like the room was spinning (worse with eyes closed and with turning of her head) and that her legs were very heavy. No nausea or vomiting. The patient seemed lethargic and was admitted to the hospital. The patient's plasma amino acids showed acute inflammatory reaction on admission to hospital. Magnetic resonance imaging (MRI) of the brain and the spine were normal. The patient was having difficulty standing. For the first few days of admission worked with the psychologist. The patient then continued to have substantial HA, abdominal pain, anorexia, extreme fatigue, dizziness. She did have an episode when she came out the shower, she seemed pale and looked like she was going to pass out. The patient started intravenous fluid (IVF's) after that. Following this she seemed to walk a little better. On an unknown date in 2017, the patient had an electromyograph (EMG), electroencephalogram (EEG) and lumbar puncture (LP) which were all normal. Overall seemed to be slowly improving was able to walk with physical training (PT) and walk upstairs. Since the patient got home, she was eating better. Dizziness was worse in the evening. In the morning, the patient seemed to have better energy level. Now the patient had HA once every other day last 10 min or 60 minutes back of the head. The patient had belly pain waxes and wanes, about every other day. Fatigue was slowly improving but waxes and wanes. Out of school arranging for home school. Overall functionality: at its worse 2/10, currently 4/10. On 31-OCT-2017, the patient's plasma amino acids were with in normal limits (WNLs). The patient was still homebound. Antithyroid antibodies were positive. The outcome of the events was reported as not resolved.  The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Follow up information was received from a health care professional on 19-JUN-2019. The patient was allergic to penicillin. She was not pregnant, when the vaccine was administered.    It was stated that the patient had never have an adverse event following any previous vaccine.  Follow up information was received from a nurse supervisor on 29-JUL-2019. The patient's demographics were updated. The patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 14-AUG-2017 (previously reported as 13-AUG-2017). The patient did not visit that office since 30-DEC-2017 and at the time of the report, no recent information regarding the patient was available. The reporter confirmed previous information and stated that the office received consults from the various physician specialties.