Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Encephalopathy, Enterovirus test negative, HIV test, Hallucination, Herpes simplex test negative
Clinical narrative: floridly psychotic; hallucinating; speaking of herself in 3rd person; disoriented,; agitated,; bizzare speech with a morbid theme; anti NMDA encephalitis; buccal sxs (yawning like mouth movements); morbid thinking; this would more likely represent acute medical encephalitis; An LP was traumatic; Information has been received from the Food and Drug Administration (FDA) (Agency number: 829568) on 18-AUG-2020. This spontaneous report was received from a healthcare profession and refers to a non-pregnant, female adolescent patient. She was allergic to amoxicillin. She did not have any illnesses at the time of the vaccination, chronic or long-standing health conditions and she was not taking any concomitant medications. She did not receive any other vaccine within one month prior to the vaccination.  On 05-JUL-2019, she was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9), injection, intramuscularly, in the right arm, lot 1602281 was confirmed to be valid, expiration date was not reporter but upon internal validation it was established as 21-JUL-2021 (exact dose was not provided) as prophylaxis.  On 31-JUL-2019, the patient was floridly psychotic, hallucinating, speaking of herself in 3rd person, disoriented, agitated, blizzare speech with a morbid theme. Because of some reported buccal symptoms (sxs) (yawning like mouth movements), and the morbid thinking with hallucinations, anti NMDA encephalitis was entertained. On that day, she had doctor or other healthcare professional office/clinic visit, emergency room visit and finally she was hospitalized due to the events.  Additional workup (w/u) included negative urine drug screen; head computer tomography (CT), thyroxin (T4)/ thyroid stimulating hormone (TSH), syphilis, human immunodeficiency virus (HIV), ceruloplasmin, Anti Deoxyribonuclease (DNAse) B and streptococcus polymerase chain reaction (PCR) throat, serum lactate, electroencephalography (EEG), ultrasound (US) of pelvis, magnetic resonance imaging (MRI) of abdomen and pelvis, carnitine, urine organic acid screen (however, the results were not provided). On an unspecified date in 2019, she had a lumbar puncture (LP) performed, which was traumatic but tested negative for herpes simplex virus (HSV) and enterovirus. A magnetic resonance imaging (MRI) of brain was normal but no contrast was used. She was treated empirically with intravenous immunoglobulin (IVIG) (even before MRI) and Pulse metyloprednizolon (SOLU-MEDROL) started 1gm/day x 5 days. Acyclovir (details were not provided) was started and stopped.  On an unknown date in 2019, the LP was repeated to send for autoimmune encephalitis panel as a more sensitive test. This sample was not traumatic and had 10 white blood cells (WBC). Immunoglobulin G (IGG) and immunoglobulin M (IGM) for west nile virus(WNV) were negative on this sample. 15 ml cerebrospinal fluid (CSF) was obtained with plenty of extra available for further testing if needed. The pediatrician was contacted and recommended some other testing. She felt it unlikely by symptom that this represented an infectious cause. She required doses of lorazepam (ATLVAN) early in her course.  The patient's symptoms improved dramatically by the 3rd day of metyloprednizolon (SOLU-MEDROL) and lorazepam (ATLVAN) was no longer needed. She had only subtle symptoms by 8/8 with some odd ideatlons/recollectlons of events but by that time she was eating, cooperative, socially engaging without any evidence of hallucinations or morbid thinking or speaking of herself in 3rd person.  The patient was treated according to the Protocol until the ENC 2 panel would come back negative. After pulse metyloprednizolon (SOLU-MEDROL) completed she started prednisone 60mg/day until further instructions from pediatric neurologist as outpatient. Intravenous immunoglobulin (IVIG) would be tentatively scheduled for 8/18. Rituximab was on hold and would only be given if testing was positive for anti NMDAR encephalitis.  On an unknown date in August 2019, prior to discharge, the patient had psychiatric consultation, during which psychiatric medications were considered, but it was felt that due to lack of prodromal symptoms this would more likely represent acute medical encephalitis rather than a psychiatric diagnosis. It was preferred to not start psychiatric medications yet and instead had close follow-up in psychiatric clinic in parallel with pediatric neurology clinic follow-up. On 08-AUG-2019 (reported that hospitalization lasted 9 days), the patient was discharged from the hospital. On that day, she was much improved, her behavior was appropriate, she was walking around the room oriented with pleasant affect, brushing her hair after showering. However, at the time of the report, the patient had not recovered from the events.  The relatedness between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was not provided.  As of 02-SEP-2020, all telephone attempts to obtain follow up information have been unsuccessful.  Upon internal review, the events of encephalopathy, encephalitis autoimmune and hallucination were considered to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1602281; expirationdate: 21-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent