Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Hypoaesthesia oral, International normalised ratio, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: Bell's Palsy; felt like he was having a stroke; paralysis of the left side of his face/whole left side of his face was drooping; mouth went numb; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (felt like he was having a stroke) and FACIAL PARALYSIS (paralysis of the left side of his face/whole left side of his face was drooping) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS, AMLODIPINE and ESCITALOPRAM for an unknown indication, ROSUVASTATIN CALCIUM (CRESTOR).   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (felt like he was having a stroke) (seriousness criterion medically significant), FACIAL PARALYSIS (paralysis of the left side of his face/whole left side of his face was drooping) (seriousness criterion medically significant) and HYPOAESTHESIA ORAL (mouth went numb). The patient was hospitalized for 1 day until 09-May-2021 due to BELL'S PALSY. The patient was treated with PREDNISONE at a dose of 60 mg for one week. At the time of the report, BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (felt like he was having a stroke), FACIAL PARALYSIS (paralysis of the left side of his face/whole left side of his face was drooping) and HYPOAESTHESIA ORAL (mouth went numb) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Blood glucose: negative (Negative) negative. On 08-May-2021, Chest X-ray: negative (Negative) negative. On 08-May-2021, Computerised tomogram head: negative (Negative) negative. On 08-May-2021, Computerised tomogram neck: negative (Negative) negative. On 08-May-2021, Electrocardiogram: negative (Negative) negative. On 08-May-2021, Full blood count: negative (Negative) negative. On 08-May-2021, International normalised ratio: negative (Negative) negative. On 08-May-2021, Metabolic function test: negative (Negative) negative. On 08-May-2021, Prothrombin time: negative (Negative) negative. On 08-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2021, Blood magnesium: negative (Negative) Negative. On 09-May-2021, Full blood count: negative (Negative) negative. On 09-May-2021, Glycosylated haemoglobin: negative (Negative) negative. On 14-May-2021, Magnetic resonance imaging head: negative (Negative) MRI of the brain with and without contrast and a transthoracic echocardiogram.         Lab data Pronin-1, Type and Screen, ABO and Rh, Lipid panel, Hepatic Function panel, CT angio head, gray Top Tube, Gold Top Tube provided with Negative results.  On 08May2021 around noon, the caller stated that he felt like he was having a stroke.  He reported that his mouth went numb, and then two hours later the whole left side of his face was drooping.  The caller stated that he had paralysis of the left side of his face only. The right side of his face was not involved. He went to the emergency room on 08May2021 around 4:00 PM to rule out if he was having a stroke.  On 08May2021, the patient reported having the following tests performed while in the emergency room: POC Glucose, ECG 12-lead, CBC with differential, PT/INR, Pronin-1, Type and Screen, Comprehensive Metabolic Panel, X-Ray chest, Gray Top Tube, Gold Top Tube, CT Brain without IV contrast,  CT Angio head and neck,  and COVID-19 WVUH molecular lab test.  All test results negative for stroke. The caller stated he was diagnosed with Bell's Palsy on 08May2021.  He was given an antibiotic (unknown name) for one week and Prednisone 60 mg daily for one week as treatment.  The patient was hospitalized for one night.  While in the hospital on 09May2021, the patient reported having the following tests performed: HGA1C hemoglobin test, CBC with differential, Lipid Panel, Hepatic Function Panel, Magnesium, Basic Metabolic Panel, and ABO and RH.  All test results negative for stroke.  The caller stated that he was discharged from the hospital on 09May2021.  On 14May2021, patient had an MRI of the brain with and without contrast and a transthoracic echocardiogram.  The caller stated that every test he had performed was negative.  Stroke was ruled out.     The caller mentioned that the Bell's Palsy has only improved 5% since 08May2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.