Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Illness, Loss of personal independence in daily activities, Pyrexia, Syncope
Clinical narrative: cannot drive to work; super sick for a week; Bell's paralysis, left side (paralysis of the 7th nerve); Fallen to the floor; Banged her head; Felt Dizzy; Fever  99.6F; Passed out/ Unconscious/loss of consciousness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's paralysis, left side (paralysis of the 7th nerve)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 034C21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021 at 9:30 PM, the patient experienced CHILLS (Chills). On 20-Nov-2021, the patient experienced SYNCOPE (Passed out/ Unconscious/loss of consciousness). On 20-Nov-2021 at 6:30 AM, the patient experienced FALL (Fallen to the floor), HEAD INJURY (Banged her head), DIZZINESS (Felt Dizzy) and PYREXIA (Fever  99.6F). On 18-Dec-2021, the patient experienced BELL'S PALSY (Bell's paralysis, left side (paralysis of the 7th nerve)) (seriousness criterion medically significant). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot drive to work) and ILLNESS (super sick for a week). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 20-Nov-2021 for Fever, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's paralysis, left side (paralysis of the 7th nerve)), FALL (Fallen to the floor), HEAD INJURY (Banged her head), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot drive to work), DIZZINESS (Felt Dizzy), PYREXIA (Fever  99.6F), SYNCOPE (Passed out/ Unconscious/loss of consciousness) and CHILLS (Chills) outcome was unknown and ILLNESS (super sick for a week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 99.6f (High) 99.6F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 01-Dec-2021, she had dental works included dental cleaning and on 09-Dec-2021, had dental filling done on the right side. On 18-Dec-2021, she went to the emergency room (ER) because she could hardly talk and eat. She ended up developing Bell's paralysis, left side (paralysis of the 7th nerve) which she thinks is a reaction to the vaccine. She was given anti viral to be taken for a week. She cannot take corticosteroids because she has a bad reaction to it. She now cannot drive to work. She consulted with a neurologist who informed her that nothing can be done at the moment.   Company comment: This is a spontaneous case concerning a 59-year-old female patient with no reported medical history, who experienced the non-serious event Syncope and the serious (medically significant) expected event bell´s palsy. Patient passed out, loss her consciousness and have a head injury the next day after receiving the third dose of mRNA-1273 and recovered without medical intervention. 30 days after vaccination she experienced speech and feeding disorders and was diagnosed with Bell´s palsy on the left side.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-396447, MOD-2021-395855 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow Up appended. Patient's name updated. On 25-Jan-2022: Follow up report received included new events (Speech disorder, Feeding disorder, Bell's palsy, Loss of personal independence in daily activities, Illness) was added and narrative was updated.; Sender's Comments: Company comment: This is a spontaneous case concerning a 59-year-old female patient with no reported medical history, who experienced the non-serious event Syncope and the serious (medically significant) expected event bell´s palsy. Patient passed out, loss her consciousness and have a head injury the next day after receiving the third dose of mRNA-1273 and recovered without medical intervention. 30 days after vaccination she experienced speech and feeding disorders and was diagnosed with Bell´s palsy on the left side.  The benefit-risk relationship of mRNA-1273 is not affected by this report.