Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: bell's palsy in his upper lip corner; We suppose we got the delta variant; pain in the stomach; he was more ill; Patient developed Suspected COVID 19 after both the doses of vaccine; had a worst case than I did; probably more fatigued; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (bell's palsy in his upper lip corner) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No other medical history was reported.  Concomitant products included TIMOLOL MALEATE for Eye discomfort, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), AMLODIPINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (bell's palsy in his upper lip corner) (seriousness criterion medically significant), COVID-19 (We suppose we got the delta variant), ABDOMINAL PAIN UPPER (pain in the stomach), ILLNESS (he was more ill), DRUG INEFFECTIVE (Patient developed Suspected COVID 19 after both the doses of vaccine), CONDITION AGGRAVATED (had a worst case than I did) and FATIGUE (probably more fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (bell's palsy in his upper lip corner), COVID-19 (We suppose we got the delta variant), ABDOMINAL PAIN UPPER (pain in the stomach), ILLNESS (he was more ill), DRUG INEFFECTIVE (Patient developed Suspected COVID 19 after both the doses of vaccine), CONDITION AGGRAVATED (had a worst case than I did) and FATIGUE (probably more fatigued) had resolved.            It was reported that patient went to the hospital twice but was never admitted. Patient wife was checking his stats and the temperature. His legs weren't never painful, he was probably more fatigued than overall.  Patient treatment medication was reported as monoclonal antibodies, after receiving the antibodies he was as bad or worse, and that is why he returned to the hospital.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not applicable. Company Comment : This is a case of vaccination failure. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID 19 infection and mRNA-1273 is assessed as not applicable.Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This is a case of vaccination failure. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID 19 infection and mRNA-1273 is assessed as not applicable.Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.