Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: at the injection site, I have a big red mark; slightly painful to the touch; slightly swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (at the injection site, I have a big red mark), VACCINATION SITE PAIN (slightly painful to the touch) and VACCINATION SITE SWELLING (slightly swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (at the injection site, I have a big red mark), VACCINATION SITE PAIN (slightly painful to the touch) and VACCINATION SITE SWELLING (slightly swollen). At the time of the report, VACCINATION SITE ERYTHEMA (at the injection site, I have a big red mark), VACCINATION SITE PAIN (slightly painful to the touch) and VACCINATION SITE SWELLING (slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Jan-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (at the injection site, I have a big red mark), VACCINATION SITE PAIN (slightly painful to the touch) and VACCINATION SITE SWELLING (slightly swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (at the injection site, I have a big red mark), VACCINATION SITE PAIN (slightly painful to the touch) and VACCINATION SITE SWELLING (slightly swollen). At the time of the report, VACCINATION SITE ERYTHEMA (at the injection site, I have a big red mark), VACCINATION SITE PAIN (slightly painful to the touch) and VACCINATION SITE SWELLING (slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; 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 of vaccination site swelling, erythema and pain, a causal relationship cannot be excluded.