Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Peripheral swelling
Clinical narrative: Was tired; Bell's Palsy; Had a fever the next day and it seemed to get worse; Numbness in mouth; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA ORAL (Numbness in mouth). On 30-Dec-2021, the patient experienced PYREXIA (Had a fever the next day and it seemed to get worse). On 31-Dec-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Was tired). At the time of the report, BELL'S PALSY (Bell's Palsy), HYPOAESTHESIA ORAL (Numbness in mouth), FATIGUE (Was tired) and PYREXIA (Had a fever the next day and it seemed to get worse) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Reported that after the booster, patient was tired. On 29Dec2021, she started to have numbness in her mouth. She had a fever the next day and it seemed to get worse. On 31Dec2021, she thought it was a mini stroke or Bell's Palsy so she went to the ER. They diagnosed her with Bell's Palsy.  Company Comment: This spontaneous case concerns a 63-year-old, female patient with no medical history reported, who experienced the expected AESI of Bell's palsy and other associated unexpected and expected, non-serious events after administration of the booster dose of the Moderna mRNA-1273 vaccine. The report stated that after vaccination, the patient was tired. On 29Dec2021, the patient started to experience numbness in her mouth. She had a fever the next day and it seemed to get worse. On 31Dec2021, she thought it was a mini stroke or Bell's Palsy so she went to the Emergency Room. She was diagnosed with Bell's Palsy. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-456129, MOD-2022-452516, MOD-2022-451538 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63-year-old, female patient with no medical history reported, who experienced the expected AESI of Bell's palsy and other associated unexpected and expected, non-serious events after administration of the booster dose of the Moderna mRNA-1273 vaccine. The report stated that after vaccination, the patient was tired. On 29Dec2021, the patient started to experience numbness in her mouth. She had a fever the next day and it seemed to get worse. On 31Dec2021, she thought it was a mini stroke or Bell's Palsy so she went to the Emergency Room. She was diagnosed with Bell's Palsy. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.