Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy/she woke up one morning and her face was hanging down on the right side; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (bell's palsy/she woke up one morning and her face was hanging down on the right side) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005m21a) for COVID-19 prophylaxis.     Patient had no allergies and no COVID-19 diagnosis.  The patient's past medical history included Hypothyroidism.   On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BELL'S PALSY (bell's palsy/she woke up one morning and her face was hanging down on the right side) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (bell's palsy/she woke up one morning and her face was hanging down on the right side) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BELL'S PALSY (bell's palsy/she woke up one morning and her face was hanging down on the right side) to be related.    No relevant concomitant medications were reported. No treatment medication reported.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Approximately 6 weeks after she received the shot, she developed Bell's Palsy. She was calling to report this as a possible side effect of the vaccine. Lab data of MRI was reported on an unknown date with unspecified result. On an unknown date, the patient received dose of MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)   (unknown route) 1 dosage form (additional booster) batch number 005m21a.   Company comment: This Spontaneous case concerns a 76-year-old female patient with no medical history reported, who experienced the expected serious (medically significant) AESI event of Bell's palsy which occurred approximately six weeks after the dose of mRNA-1273 vaccine was administered.  Vaccination dose and vaccination schedule was not disclosed. At the time of the report, event outcome had not resolved. It was reported that approximately 6 weeks after she received the shot, she developed Bell's Palsy. Lab data of MRI was reported on an unknown date with unspecified result. On unknown date patient received additional booster. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Dec-2022: Live follow up report included additional booster information updated in I narrative.; Sender's Comments: This Spontaneous case concerns a 76-year-old female patient with no medical history reported, who experienced the expected serious (medically significant) AESI event of Bell's palsy which occurred approximately six weeks after the dose of mRNA-1273 vaccine was administered.  Vaccination dose and vaccination schedule was not disclosed. At the time of the report, event outcome had not resolved. It was reported that approximately 6 weeks after she received the shot, she developed Bell's Palsy. Lab data of MRI was reported on an unknown date with unspecified result. On unknown date patient received additional booster. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.