Sex: M
Vaccine: HPV9
Symptoms: Adenovirus test, Ataxia, Bacterial test negative, Benzodiazepine drug level, Blood immunoglobulin M normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 655540) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient's concurrent illness included fatigue and rash consistent with tinea versicolor. The patient's medical history included behavioral problems at school, possible ADHD (Attention deficit/hyperactivity disorder), possible anxiety and possible psychiatric issues. Information on prior vaccinations was not reported. On 11-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M007764 (dose, frequency and lot expiration date were not reported) for prophylaxis. The patient's other medications included selenium sulfide (SELSUN BLUE) 1% top shampoo for tinea versicolor on 23-AUG-2016 and it was reported that no other vaccines or medications were given at that time. On 30-AUG-2016, the patient experienced headache, fever, vomiting and severe ataxia. The patient was hospitalized for 28 days and given supportive care. The patient's (CSF) cerebrospinal fluid had elevated WBC's (white blood cells) but was negative for enterovirus and (HSV) herpes simplex virus. Also bacterial cultures were negative. Enterovirus only isolated from respiratory panel, the patient's ph urine normal, viral test negative, varicella virus test negative, had urine protein quantitative, urine amphetamine was negative, streptococcus test negative, specific gravity urine was decreased, respiratory syncytial virus test negative, underwent polymerase chain reaction, patient's platelet morphology normal, opiates was  negative, underwent monocyte percentage, patient's laboratory test was normal, influenza virus test was negative, underwent influenza b virus test, patient's influenza A virus was test negative, underwent human rhinovirus test, human metapneumovirus test, eosinophil percentage, drug screen was negative, creatinine urine was normal, csf white blood cell count increased, csf red blood cell count positive, csf protein was normal, csf monocyte count decreased, csf lymphocyte count was normal csf glucose normal, csf cell count increased, bordetella test was negative, blood immunoglobulin m normal, benzodiazepine drug level , bacterial test negative and adenovirus test. The patient's lab data included; component latest ref rng 31-AUG-2016 10:08 am: adenovirus DNA, PCR not detected coronavirus 229E RNA, not detected coronavirus HKU1 RNA, not detected coronavirus NL63 RNA. The patient had returned to baseline at time of discharge from hospital, but the doctors were unsure if the patient will have complete resolution from symptoms. The outcome of all the events was reported as unknown. Causality assessment was not reported. The agency considered the events to be serious due to hospitalization/prolonged hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.