Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram head
Clinical narrative: Left eyes feel like it about to pop (bell's palsy); This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Left eyes feel like it about to pop (bell's palsy)) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Patient was on diabetic medication). Concomitant products included GLIMEPIRIDE, SAXAGLIPTIN (ONGLYZA [SAXAGLIPTIN]) and INSULIN DEGLUDEC (TRESIBA FLEXTOUCH) for Diabetes, HYDROCHLOROTHIAZIDE (HYDRODIURIL), ATORVASTATIN CALCIUM (LIPITOR), DOXAZOSIN and CARVEDILOL (VEDILOL) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Left eyes feel like it about to pop (bell's palsy)) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Left eyes feel like it about to pop (bell's palsy)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram head: results were ok.         Patient received 3rd COVID 19 vaccine and he felt like he was having stroke, his mouth was twisted, and he can't put on his dentures, left eyes felt like it was about to pop (Bell's palsy) and the left side numbness from mouth to eyes. Patient didn't have any vaccine info with him and when he went to emergency room head scan was done for which results were ok. Patient was on diabetic medication.   Patient had no known allergies. Patient didn't have COVID and COVID-test. Patient didn't receive any other vaccine 1 month prior to Moderna vaccine No treatment information was reported.  Company Comment: This spontaneous case concerns a 75 year old male with a relevant history of diabetes, who experienced the serious (medically significant) expected adverse event Bell's palsy, which occurred unknown days after the third dose of mRNA-1273 Bivalent .222 (Original/Omicron BA.4/5) vaccine administration. The outcome was reported as unknown. It was reported that after the receiving the third dose, patient felt like having a stroke, his mouth was twisted, can't put on his dentures, left eye felt like it was about to pop and left side numbness from mouth to eyes. Patient went to the emergency room for a consult and CT scan was done which showed normal results. Treatment medications were not provided. Underlying history of diabetes could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75 year old male with a relevant history of diabetes, who experienced the serious (medically significant) expected adverse event Bell's palsy, which occurred unknown days after the third dose of mRNA-1273 Bivalent .222 (Original/Omicron BA.4/5) vaccine administration. The outcome was reported as unknown. It was reported that after the receiving the third dose, patient felt like having a stroke, his mouth was twisted, can't put on his dentures, left eye felt like it was about to pop and left side numbness from mouth to eyes. Patient went to the emergency room for a consult and CT scan was done which showed normal results. Treatment medications were not provided. Underlying history of diabetes could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.