Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: diagnosed with bells palsy/face was all messed up on the right side/face was droopy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (diagnosed with bells palsy/face was all messed up on the right side/face was droopy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 019E21A, 028A21A and 025A21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, OXYBUTYNIN and LEVOTHYROXINE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient experienced BELL'S PALSY (diagnosed with bells palsy/face was all messed up on the right side/face was droopy) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Palsy Bells, at a dose of 40 milligram for 5 days. At the time of the report, BELL'S PALSY (diagnosed with bells palsy/face was all messed up on the right side/face was droopy) outcome was unknown.            It was reported that the next day after vaccination when she got up she noticed her face was all messed up on the right side. As the day went on her face was droopy so she went to the ER and they diagnosed her with bells palsy. She couldn't close her eyes all the way so she wore an eye patch.   Treatment medication also included unknown antiviral drugs.  Company comment: This spontaneous case reported by a consumer, concerns a 71 year old female patient, with no medical history reported, who experienced the expected, serious (medically significant) AESI of Bell's palsy 01 day after receiving the 4 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received the 2 primary doses and the third dose also with Moderna vaccines. It was reported that the next day after vaccination when she got up, she noticed her face was all messed up on the right side. As the day went on, her face was droopy, so she went to the ER and was  diagnosed with bell's palsy. She couldn't close her eyes all the way, so she wore an eye patch. The patient was treated with prednisone. Details of clinical course, risk factors, co morbidities, labs, diagnostic investigations were not provided. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 71 year old female patient, with no medical history reported, who experienced the expected, serious (medically significant) AESI of Bell's palsy, 01 day after receiving the 4 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received the 2 primary doses and the third dose also with Moderna vaccines. It was reported that the next day after vaccination when she got up, she noticed her face was all messed up on the right side. As the day went on, her face was droopy, so she went to the ER and was  diagnosed with bell's palsy. She couldn't close her eyes all the way, so she wore an eye patch. The patient was treated with prednisone. Details of clinical course, risk factors, co morbidities, labs, diagnostic investigations were not provided. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.