Sex: F
Vaccine: HPV9
Symptoms: Complement factor normal, Computerised tomogram thorax normal, Culture, Differential white blood cell count, Dysarthria
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 # 618771). This spontaneous report refers to a 12 year old female patient. The patient's historical conditions, concurrent conditions and concomitant therapies were not reported. On 20-JUL-2015 the patient was vaccinated with 2nd dose of GARDASIL 9 (lot # I006s47) intramuscularly in the left arm for prophylaxis. 6-7 weeks after her 2nd vaccination, on 01-SEP-2015, the patient experienced optic neuritis bilaterally. She then developed weakness (asthenia), behavioral change, dysarthria, facial tics, sensory losses, difficulty in managing seizures with multifocal encephalitis, cerebrospinal fluid (csf) pleiocytosis. On the same day, the patient had negative herpes simplex serology test, white matter lesion, white blood cell (WBC) count normal, west nile virus test, varicella virus test, treponema test, polymerase chain reaction (PCR), decreased platelet count, plasmapheresis, abnormal nuclear magnetic resonance imaging brain, mycoplasma test, mycobacterium test, decreased lymphocyte percentage, immunophenotyping, Herpes simplex virus (HSV) serology test, normal haemoglobin (Hgb), HIV (Human immunodeficiency virus) antigen (AG) test, HIV antibody (AB) test, full blood count (WBC:7.5, Hgb: 12.6, platelets: 149, 70% polys, 7% bands, 13% lymphs, 1% metas), flow cytometry, Epstein-barr virus (EBV) test negative, Epstein-barr virus antibody, negative enterovirus test , differential white blood cell count, culture, normal computerised tomogram thorax, complement factor c4 test, complement factor normal, complement factor c3 increased, central nervous system lesion, csf oligoclonal band, csf myelin basic protein, band neutrophil percentage, antinuclear antibody and anti-aquaporin-4 antibody test. The results were pending for Aquaporin antibody, Enterovirus PCR, West nile AB, Varicella PCR, myelin basic protein, leukemia/lymphoma phenotyping, oligoclonal banding, VORL CSF, T Whipple, flow cytometry, Blood HIVAG/AB, VZV(Varicella Zoster virus), EBV PCR, ANA, HSV type 1/2 combined antibody, Herpes PCR blood, Mycoplasma IgM and Enterovirus rectal culture tests. VRP was negative and ALC was 1. Broad workup of autoimmune, infectious, oncologic etiologies over the past month unrevealing so far. Slight improvement on intravenous steroids, and no improvement in 5 cycles plasmapheresis. She continued to worsen clinically and remained inpatient. The outcome of abnormal behaviour, white matter lesion, white blood cell count normal, west nile virus test, varicella virus test, treponema test, tics, sensory loss, seizure, polymerase chain reaction, pleocytosis, platelet count decreased, plasmapheresis, optic neuritis, nuclear magnetic resonance imaging brain abnormal, mycoplasma test, mycobacterium test, lymphocyte percentage decreased, immunophenotyping, herpes simplex test negative, herpes simplex test, haemoglobin normal, hiv antigen, hiv antibody, full blood count, flow cytometry, epstein-barr virus test negative, epstein-barr virus antibody, enterovirus test negative, encephalitis, dysarthria, differential white blood cell count, culture, computerised tomogram thorax normal, complement factor normal, complement factor c4, complement factor c3 increased, central nervous system lesion, csf oligoclonal band, csf myelin basic protein, band neutrophil percentage, asthenia, antinuclear antibody and anti-aquaporin-4 antibody were reported as unknown. Causality assessment was not provided. The agency considered the case to be serious as all these events lead lo prolonged hospitalization.   Additional information is not expected from the Agency as follow up information cannot be obtained.