Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, COVID-19, Hypoacusis, Ocular discomfort, Off label use
Clinical narrative: Left eye problems/Eye sensitivity to light; Eye sensitivity to wind; Hearing impaired; COVID-19; Off label dosing frequency; Bell's Palsy/"looked like someone had stepped on her"; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy/"looked like someone had stepped on her") in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Zocor allergy), Drug allergy (Crestor allergy), Drug allergy (Lipitor allergy), Drug allergy (Celebrex allergy) and Drug allergy (Vancomycin allergy.). Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA), METFORMIN, INSULIN DEGLUDEC (TRESIBA), RIVAROXABAN (XARELTO), DILTIAZEM (CARDIZEM [DILTIAZEM]), PRAVASTATIN, FUROSEMIDE, LOSARTAN and FLECAINIDE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BELL'S PALSY (Bell's Palsy/"looked like someone had stepped on her") (seriousness criterion medically significant). On an unknown date, the patient experienced PHOTOPHOBIA (Left eye problems/Eye sensitivity to light), OCULAR DISCOMFORT (Eye sensitivity to wind), HYPOACUSIS (Hearing impaired), COVID-19 (COVID-19) and OFF LABEL USE (Off label dosing frequency). At the time of the report, BELL'S PALSY (Bell's Palsy/"looked like someone had stepped on her") and COVID-19 (COVID-19) was resolving, PHOTOPHOBIA (Left eye problems/Eye sensitivity to light), OCULAR DISCOMFORT (Eye sensitivity to wind) and HYPOACUSIS (Hearing impaired) outcome was unknown and OFF LABEL USE (Off label dosing frequency) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Treatment medications included steroids, antivirals and e-stim. She reported she has seen lot of specialists including a neurologist.  Company comment: This spontaneous case concerns a 76-year-old female patient with no relevant medical history who experienced serious expected event of Bell's palsy and non-serious adverse event of special interest (AESI) COVID-19. The event Bell's palsy occurred approximately within24 hours after the first dose of the Moderna COVID-19 vaccine, whereas COVID-19 occurred approximately 8 months after. Rechallenge was not applicable since the patient did not receive the second dose, as advised by her neurologist due to the event of Bell's palsy so no rechallenge was done and thus, recurrence was not applicable.  The benefit-risk relationship of product is not affected by this report; Sender's Comments: This spontaneous case concerns a 76-year-old female patient with no relevant medical history who experienced serious expected event of Bell's palsy and non-serious adverse event of special interest (AESI) COVID-19. The event Bell's palsy occurred approximately within24 hours after the first dose of the Moderna COVID-19 vaccine, whereas COVID-19 occurred approximately 8 months after. Rechallenge was not applicable since the patient did not receive the second dose, as advised by her neurologist due to the event of Bell's palsy so no rechallenge was done and thus, recurrence was not applicable.  The benefit-risk relationship of product is not affected by this report