Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Culture urine, Echocardiogram, Electroencephalogram, Encephalopathy
Clinical narrative: vaccine encephalopathy; Non-convulsive status epilepticus; Incorrect drug administration duration; This study case was reported in a literature article and describes the occurrence of ENCEPHALOPATHY (vaccine encephalopathy) and STATUS EPILEPTICUS (Non-convulsive status epilepticus) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hyperlipidemia and Non-tobacco user. Concurrent medical conditions included Crohn's, Hereditary hemochromatosis, Hypertension and Alcohol use (3-4 drinks per week). Concomitant products included PREDNISONE for Crohn's aggravated.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENCEPHALOPATHY (vaccine encephalopathy) (seriousness criteria hospitalization and medically significant), STATUS EPILEPTICUS (Non-convulsive status epilepticus) (seriousness criteria hospitalization and medically significant) and INCORRECT PRODUCT ADMINISTRATION DURATION (Incorrect drug administration duration). The patient was treated with CEFTRIAXONE (intravenous) for Adverse event, at an unspecified dose and frequency; LEVETIRACETAM for Adverse event, at an unspecified dose and frequency and LORAZEPAM for Adverse event, at an unspecified dose and frequency. At the time of the report, ENCEPHALOPATHY (vaccine encephalopathy) and STATUS EPILEPTICUS (Non-convulsive status epilepticus) was resolving and INCORRECT PRODUCT ADMINISTRATION DURATION (Incorrect drug administration duration) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ammonia: unrevealing (normal) unrevealing. On an unknown date, Blood cortisol: unrevealing (normal) unrevealing. On an unknown date, Blood culture: positive (Positive) Positive with Staphylococcus epidermidis and Staphylococcus hominis. On an unknown date, Blood pressure measurement: 110-130 over 65-70 (normal) 110-130 over 65-70. On an unknown date, Blood thyroid stimulating hormone: unrevealing (normal) unrevealing. On an unknown date, Body temperature: afebrile (normal) afebrile. On an unknown date, C-reactive protein: normal (normal) normal. On an unknown date, CSF culture: negative (Negative) Negative. On an unknown date, CSF test: mildy elevated protein and glucose (abnormal) including meningitis, encephalitis panel were negative except mildy elevated protein and glucose. On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Computerised tomogram head: no acute findings (normal) no acute findings. On an unknown date, Culture urine: negative (Negative) Negative. On an unknown date, Echocardiogram: normal (normal) normal. On an unknown date, Electroencephalogram: non-convulsive status epilepticus (abnormal) non-convulsive status epilepticus. On an unknown date, Full blood count: unrevealing (normal) unrevealing. On an unknown date, HIV test: negative (Negative) Negative. On an unknown date, Heart rate: 90 (normal) 90. On an unknown date, Liver function test: unrevealing (normal) unrevealing. On an unknown date, Magnetic resonance imaging head: no acute findings (normal) no acute findings. On an unknown date, Nucleic acid test: negative (Negative) Negative. On an unknown date, Oxygen saturation: 96% (normal) 96%. On an unknown date, Procalcitonin: normal (normal) normal. On an unknown date, Red blood cell sedimentation rate: normal (normal) normal. On an unknown date, Respiratory rate: 18 (normal) 18. On an unknown date, Respiratory viral panel: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Toxoplasma serology: negative (Negative) Negative. On an unknown date, Vitamin B1: unrevealing (normal) unrevealing. On an unknown date, Vitamin B12: unrevealing (normal) unrevealing.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ENCEPHALOPATHY (vaccine encephalopathy) and STATUS EPILEPTICUS (Non-convulsive status epilepticus) to be possibly related. No further causality assessment was provided for INCORRECT PRODUCT ADMINISTRATION DURATION (Incorrect drug administration duration).    Reportedly patient had no history of partial seizures, no risk factors for epilepsy and no family history of seizures. Patient did not use any illicit drugs. On an unspecified date 7 days after vaccination, patient experienced staring episodes, restlessness and cognitive deficits for 10 days. Patient was hospitalized for 2 days and was discharged in improved condition following Intravenous fluid administration and stable admission course at patient's request. On an unspecified date, patient experienced hallucinations, worsening confusion and continued having periods of unresponsiveness. On an unspecified date, laboratory studies were unremarkable except for Acute kidney injury. On an unspecified date, Patient's B9 levels were unrevealing. Patient's Mental Status Examination revealed 0/5 on delayed recall after 3 minutes, with a total score of 9/30 indicating severe deficits. On an unspecified date, patient was able to recall 3 out of 3 words both immediately and after 5 minutes. On an unspecified date, patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form with no reported complications.  Company Comment: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.   This case was linked to MOD-2021-256845, MOD-2021-256855 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.