Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy on the right side of face; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bells Palsy on the right side of face) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy (Bells Palsy on the left side of her face before the first dose.) on 08-Mar-2021. Concurrent medical conditions included Allergy to antibiotic, Alpha-1 antitrypsin deficiency (no change) since 2015 and Diabetes (Started 2 years ago,no change).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BELL'S PALSY (Bells Palsy on the right side of face) (seriousness criterion medically significant). The patient was treated with ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy on the right side of face) had resolved.            No concomitant medications were reported. Patient reported that she had 6 doctors tell her that they'd never seen it on both sides. She had tests done, and none of them were strokes. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient had not experienced similar event in the past. Patient was prescribed steroids as treatment.  Company comment- This is a spontaneous case concerning a 66-year-old female patient with medical condition of diabetes and medical history of Bell´s Palsy on left side before vaccination with first dose of mRNA-1273 (outcome was recovered), who experienced the unexpected and serious (medically significant) AESI Bell´s Palsy the following day a second dose of mRNA-1273 vaccine was administered. Patient got Bell's Palsy on the right side of her face; It lasted three months. She had 6 doctors tell her that they'd never seen it on both sides. She had tests done, and none of them showed that she had strokes. Acyclovir and steroids were prescribed. The second time, it resolved again. Medical condition of diabetes remains as a contributory risk factor while medical history of Bell´s Palsy before vaccination with first dose remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-597755, MOD-2022-597763, MOD-2022-597755, MOD-2022-597763 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 66-year-old female patient with medical condition of diabetes and medical history of Bell´s Palsy on left side before vaccination with first dose of mRNA-1273 (outcome was recovered), who experienced the unexpected and serious (medically significant) AESI Bell´s Palsy the following day a second dose of mRNA-1273 vaccine was administered. Patient got Bell's Palsy on the right side of her face; It lasted three months. She had 6 doctors tell her that they'd never seen it on both sides. She had tests done, and none of them showed that she had strokes. Acyclovir and steroids were prescribed. The second time, it resolved again. Medical condition of diabetes remains as a contributory risk factor while medical history of Bell´s Palsy before vaccination with first dose remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.