Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dyskinesia, Eye swelling, Feeling abnormal, Headache
Clinical narrative: Drooping of the left side of my face; numbness on the left side of  my face; severe weakness of both of my legs and left arm; brain fog; severe lethargy; heaviness in my left eye; swelling in my left eye; I was in bed Wednesday and Thursday.; flu like symptoms; could not lift my head up; headache; started having a lot of mucus; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Drooping of the left side of my face) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Sever e Asthmatic.).    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SECRETION DISCHARGE (started having a lot of mucus). On 08-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSKINESIA (could not lift my head up) and HEADACHE (headache). On 09-Sep-2021, the patient experienced OCULAR DISCOMFORT (heaviness in my left eye), EYE SWELLING (swelling in my left eye) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was in bed Wednesday and Thursday.). On 10-Sep-2021, the patient experienced BELL'S PALSY (Drooping of the left side of my face) (seriousness criterion medically significant), HYPOAESTHESIA (numbness on the left side of  my face), MUSCULAR WEAKNESS (severe weakness of both of my legs and left arm), FEELING ABNORMAL (brain fog) and LETHARGY (severe lethargy). At the time of the report, BELL'S PALSY (Drooping of the left side of my face), SECRETION DISCHARGE (started having a lot of mucus), INFLUENZA LIKE ILLNESS (flu like symptoms), DYSKINESIA (could not lift my head up), OCULAR DISCOMFORT (heaviness in my left eye), EYE SWELLING (swelling in my left eye), HYPOAESTHESIA (numbness on the left side of  my face), MUSCULAR WEAKNESS (severe weakness of both of my legs and left arm), FEELING ABNORMAL (brain fog), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I was in bed Wednesday and Thursday.), LETHARGY (severe lethargy) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive. On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 04-Jun-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported.  This case concerns a 57-year-old male patient with relevant medical history of severe Asthma who experienced the unexpected event of Bell's palsy. The event occurred 3 days after first dose of mRNA-1273. The rechallenge was not applicable as the patient had the first dose and not eligible for second dose at the time of the report base on dosing schedule. Causality assessment for the event was not provided by the reporter. The event is consistent with the current understanding of the mechanism of action of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and event is a medical important event.; Sender's Comments: This case concerns a 57-year-old male patient with relevant medical history of severe Asthma who experienced the unexpected event of Bell's palsy. The event occurred 3 days after first dose of mRNA-1273. The rechallenge was not applicable as the patient had the first dose and not eligible for second dose at the time of the report base on dosing schedule. Causality assessment for the event was not provided by the reporter. The event is consistent with the current understanding of the mechanism of action of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and event is a medical important event.