Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Erythema, Pruritus, Pyrexia, Rash
Clinical narrative: small dots were mildly itchy; rash of small undefined 2 to 5 inches in diameter (didn't have distinct edges) red patches, all over patient's body, predominantly in torso, but also in arms, hands and legs,a small rash right above stomach on chest; fever, symptoms associated with the fever; Bell's palsy on left side of face, a mild to moderate bell's palsy; Partial Paralysis; rash of small undefined 2 to 5 inches in diameter (didn't have distinct edges) red patches, all over patient's body, predominantly in torso, but also in arms, hands and legs,small dots were not raised; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy on left side of face, a mild to moderate bell's palsy) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included EZETIMIBE for an unknown indication.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced BELL'S PALSY (Bell's palsy on left side of face, a mild to moderate bell's palsy) (seriousness criterion medically significant) and PARALYSIS (Partial Paralysis). On an unknown date, the patient experienced ERYTHEMA (rash of small undefined 2 to 5 inches in diameter (didn't have distinct edges) red patches, all over patient's body, predominantly in torso, but also in arms, hands and legs,small dots were not raised), PRURITUS (small dots were mildly itchy), RASH (rash of small undefined 2 to 5 inches in diameter (didn't have distinct edges) red patches, all over patient's body, predominantly in torso, but also in arms, hands and legs,a small rash right above stomach on chest) and PYREXIA (fever, symptoms associated with the fever). At the time of the report, BELL'S PALSY (Bell's palsy on left side of face, a mild to moderate bell's palsy), PARALYSIS (Partial Paralysis), ERYTHEMA (rash of small undefined 2 to 5 inches in diameter (didn't have distinct edges) red patches, all over patient's body, predominantly in torso, but also in arms, hands and legs,small dots were not raised), PRURITUS (small dots were mildly itchy), RASH (rash of small undefined 2 to 5 inches in diameter (didn't have distinct edges) red patches, all over patient's body, predominantly in torso, but also in arms, hands and legs,a small rash right above stomach on chest) and PYREXIA (fever, symptoms associated with the fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jun-2021, SARS-CoV-2 test: negative (Negative) negative for COVID 19.         The patient stated that the bumps did not respond to allergy medication or antihistamines.  Company comment: 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: 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.