Reporte zur Charge 05004M20A

Symptomtext

Injection site hardness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Injection site hardness) and INJECTION SITE SWELLING (Injection site swelling) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05004M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INJECTION SITE INDURATION (Injection site hardness) and INJECTION SITE SWELLING (Injection site swelling). At the time of the report, INJECTION SITE INDURATION (Injection site hardness) and INJECTION SITE SWELLING (Injection site swelling) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.