Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Tongue paralysis
Clinical narrative: tongue is paralyzed; bell's palsy really bad/eyelid will not shut at all/can't speak/can't swallow; This spontaneous case was reported by a patient and describes the occurrence of TONGUE PARALYSIS (tongue is paralyzed) and BELL'S PALSY (bell's palsy really bad/eyelid will not shut at all/can't speak/can't swallow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B22A, 017F21A, 007821A and 001A21A) for COVID-19 prophylaxis.     The patient's past medical history included Sepsis (severe sepsis when they got their ovaries removed), Ovary removal and Below knee amputation. Concurrent medical conditions included Memory impairment, Clotting disorder, AFib, Breast cancer and Hypothyroidism. Concomitant products included SOTALOL for AFib, ANASTROZOLE (ANASTRAZOLE DENK) for Breast cancer, APIXABAN (ELIQUIS) for Clotting disorder, LEVOTHYROXINE for Hypothyroidism, FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BELL'S PALSY (bell's palsy really bad/eyelid will not shut at all/can't speak/can't swallow) (seriousness criterion medically significant). On an unknown date, the patient experienced TONGUE PARALYSIS (tongue is paralyzed) (seriousness criterion medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency. In November 2022, BELL'S PALSY (bell's palsy really bad/eyelid will not shut at all/can't speak/can't swallow) had not resolved. At the time of the report, TONGUE PARALYSIS (tongue is paralyzed) had not resolved.            Caller got the second booster on 18Jul2022 and on 13Aug2022 while having dinner caller came down with bells palsy really bad. Caller has had it for 3 months this week. Caller went to the emergency room on 13Aug2022 and they asked her if she had recently had a Covid vaccine. Caller said they had some Memory problems and clotting problems previously and was not thinking on their feet. Caller was prescribed antibiotics and prednisone right away for 10 days and then they extended it for 10 more days. Caller was referred to an ENT doctor and when they had their second visit with her, the MRI showed nothing. Caller reported that their eyelid will not shut at all, can't speak, tongue was paralyzed and can't swallow. Caller said their doctors were going to discuss inserting a gold plate in their eyelid.  Company Comment: This spontaneous case concerns a 69-year-old female patient, with no medical history reported, who experienced unexpected serious (medically Significant) AESI of Bell's palsy which occurred 26 days after, receiving fourth dose of mRNA-1273 vaccine in covid-19 vaccination series. About 26 days after the second booster patient experienced bell's palsy. She went to emergency and was prescribed antibiotics and prednisone right away for 10 days and then they extended it for 10 more days. She was referred to an ENT doctor and, in the follow-up visit the MRI was normal. Patient continues to have symptoms like difficulty in closing of the eyelid, swallowing and speaking, her tongue paralyzed. patient said their doctors were going to discuss inserting a gold plate in their eyelid. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event Bell's palsy was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old female patient, with no medical history reported, who experienced unexpected serious (medically Significant) AESI of Bell's palsy which occurred 26 days after, receiving fourth dose of mRNA-1273 vaccine in covid-19 vaccination series. About 26 days after the second booster patient experienced bell's palsy. She went to emergency and was prescribed antibiotics and prednisone right away for 10 days and then they extended it for 10 more days. She was referred to an ENT doctor and, in the follow-up visit the MRI was normal. Patient continues to have symptoms like difficulty in closing of the eyelid, swallowing and speaking, her tongue paralyzed. patient said their doctors were going to discuss inserting a gold plate in their eyelid. No further information on clinical course, investigations and treatment received was available in the report. Outcome of the event Bell's palsy was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.