Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells palsy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A2(Z)1A and 037K2(Z)0A) for COVID-19 prophylaxis.     Concurrent medical conditions included Specific allergy (drug) (Losartan), Diabetic and Blood pressure high.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, the patient experienced BELL'S PALSY (Bells palsy) (seriousness criterion medically significant). The patient was treated with PREDNISONE at an unspecified dose and frequency and ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells palsy) outcome was unknown.            Patient concomitant medications included diabetic and high blood pressure medications even before first dose of moderna vaccine. It was reported that in the last 2 days, the patient had developed facial paralysis, bells palsy and cant talk very well. Events Facial paralysis and dysarthria are subsume under event Bell's palsy  Patient had no positive covid test or diagnosis. Patient took prednisone and acyclovir to keep virus from replicating.  Company comment: This spontaneous case concerns a 70-year-old male patient, with no relevant medical history who experienced the expected, serious(medically significant) adverse event of special interest Bell's palsy which occurred on an unspecified date after receiving the fourth dose of mRNA1273. The patient was reported to have developed facial paralysis, bell's palsy, can't talk very well. Patient was treated with Prednisone and acyclovir to keep virus from replicating. The clinical course and treatment details were not provided. The patient's advanced age may be considered as a risk factor for Bell's palsy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-588458 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70-year-old male patient, with no relevant medical history who experienced the expected, serious(medically significant) adverse event of special interest Bell's palsy which occurred on an unspecified date after receiving the fourth dose of mRNA1273. The patient was reported to have developed facial paralysis, bell's palsy, can't talk very well. Patient was treated with Prednisone and acyclovir to keep virus from replicating. The clinical course and treatment details were not provided. The patient's advanced age may be considered as a risk factor for Bell's palsy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.