Sex: M
Vaccine: COVID19
Symptoms: Electroencephalogram, Epilepsy, Herpes simplex test, Laboratory test, Magnetic resonance imaging head
Clinical narrative: new-onset refractory status epilepticus; new-onset refractory status epilepticus; This is a literature report.  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPILEPSY (hospitalization, medically significant), STATUS EPILEPTICUS (hospitalization, medically significant), all with latency 2 weeks after the suspect product(s) administration, outcome "recovered", and all described as "new-onset refractory status epilepticus". The patient underwent the following laboratory tests and procedures: Bacterial test: negative; Body temperature: fever; Borrelia test: negative; CSF glucose: 76; CSF lymphocyte count: mild lymphocytic pleocytosis; CSF oligoclonal band: negative; CSF pressure: 47; CSF protein: 24; CSF test: mild lymphocytic pleocytosis with WBC 16 cells/mm3, notes: protein 24, glucose 76, and an opening pressure of 47; CSF white blood cell count: 16 cells/uL; Electroencephalogram: showed temporally predominant seizures occurring, notes: independently bilaterally (right greater than left). Clinical seizures were characterized by head turn to the left and right hand movements. He then developed sustained right frontotemporal spike and slow wave activity consistent with non-convulsive status epilepticus; Herpes simplex test: negative; encephalopathy panel: negative; negative; negative; Magnetic resonance imaging head: Initial MRI brain was unremarkable; 1 week after symptom onset he developed bilateral, notes: hippocampal edema; Psychiatric evaluation: had improved; Treponema test: negative; Viral test: negative; West Nile virus test: negative. Therapeutic measures were taken as a result of epilepsy, status epilepticus. Clinical Course: A 56 year old healthy man presented with three days of fever, fatigue, and aphasia beginning 2 weeks after he received his first dose of the Pfizer-BioNTech COVID- 19 vaccine. Video EEG showed temporally predominant seizures occurring independently bilaterally (right greater than left). Clinical seizures were characterized by head turn to the left and right hand movements. He then developed sustained right frontotemporal spike and slow wave activity consistent with non-convulsive status epilepticus. CSF demonstrated mild lymphocytic pleocytosis with WBC 16 cells/mm3, protein 24, glucose 76, and an opening pressure of 47. CSF bacterial and viral encephalitis panels, HSV, Lyme, West Nile virus, and VDRL were all negative. Oligoclonal bands, paraneoplastic panel, and encephalopathy panel were negative. Systemic malignancy workup was negative. Initial MRI brain was unremarkable, but 1 week after symptom onset he developed bilateral hippocampal edema. The patient was empirically treated with broad spectrum antibiotics and antivirals which were later discontinued. Due to presumed diagnosis of autoimmune encephalitis, he was treated with high dose steroids, plasmapheresis, IVIG, and rituximab. He was treated with progressively escalating anti-seizure medications including midazolam, propofol, and ketamine continuous infusions and eventually stabilized on levetiracetam, lacosamide, phenobarbital, clobazam, zonisamide, oxcarbazepine, and perampanel. At the time of discharge, mental status had improved, and aphasia resolved. To our knowledge, this is the first case of NORSE reported after Pfizer COVID-19 vaccination. While no test exists to definitively establish causality, these findings warrant further investigation of the possible association between COVID-19 vaccination and autoimmune encephalitis.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of. Status Epilepticus, Epilepsy. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate