Reporte zur Charge 011J20A/011T20A

Symptomtext

Arm warm to the touch; Feels like the muscle has hardened; A hard, red lump that is 10 cm in diameter out from the injection site; Itchy arm; Swollen arm; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Swollen arm) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A/011T20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm). At the time of the report, VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included an ice pack. Based on the current available information and temporal association between the use of the product and the start dates 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 dates of the events a causal relationship cannot be excluded.