Age: 65.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Bell's palsy, Hypoaesthesia, Ocular discomfort, Vaccination complication
Clinical narrative: Had an adverse reaction; Unable to close his right eye and subsequently has a patch over it.; Bell's Palsy; The right side of face is completely numb almost like paralysis but that may be too dramatic/ numb; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    The patient's past medical history included Eye patch application. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), FLUOXETINE HYDROCHLORIDE (PROZAC), LEVOTHYROXINE SODIUM (SYNTHROID), PROPRANOLOL HYDROCHLORIDE (INDERAL), GABAPENTIN, ATORVASTATIN CALCIUM (LIPITOR), LAMOTRIGINE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) and VITAMIN D NOS for an unknown indication.   On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose. On 05-Nov-2021, the patient experienced HYPOAESTHESIA (The right side of face is completely numb almost like paralysis but that may be too dramatic/ numb). On 07-Nov-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant) and OCULAR DISCOMFORT (Unable to close his right eye and subsequently has a patch over it.). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had an adverse reaction). At the time of the report, BELL'S PALSY (Bell's Palsy), HYPOAESTHESIA (The right side of face is completely numb almost like paralysis but that may be too dramatic/ numb), OCULAR DISCOMFORT (Unable to close his right eye and subsequently has a patch over it.) and VACCINATION COMPLICATION (Had an adverse reaction) outcome was unknown.            Treatment medication includes Steroid pill and OTC drops. On 05 Nov 2021 and Saturday on 06 Nov 2021, started experiencing drooping of the right side of his face.  Company Comment: This case concerns a 65-year-old, male patient with no relevant medical history reported, who experienced the unexpected event of Bell´s palsy (AESI). The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the event happened after the third dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-383378 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Added reporter's information, vaccine details, concomitant medication, new events and treatment medication.; Sender's Comments: This case concerns a 65-year-old, male patient with no relevant medical history reported, who experienced the unexpected event of Bell´s palsy (AESI). The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the event happened after the third dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report.