Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: it got warm again 2 weeks later; It was hard under the surface for 3-4 weeks after that; normal reaction of arm was swollen; arm was red; arm was warm for longer than it should have been; Arm was affected for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was warm for longer than it should have been), VACCINATION SITE REACTION (Arm was affected for 2 weeks), VACCINATION SITE WARMTH (it got warm again 2 weeks later), VACCINATION SITE INDURATION (It was hard under the surface for 3-4 weeks after that), VACCINATION SITE SWELLING (normal reaction of arm was swollen) and VACCINATION SITE ERYTHEMA (arm was red) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm was warm for longer than it should have been) (seriousness criterion medically significant), VACCINATION SITE REACTION (Arm was affected for 2 weeks) (seriousness criterion medically significant), VACCINATION SITE INDURATION (It was hard under the surface for 3-4 weeks after that) (seriousness criterion medically significant), VACCINATION SITE SWELLING (normal reaction of arm was swollen) (seriousness criterion medically significant) and VACCINATION SITE ERYTHEMA (arm was red) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE WARMTH (it got warm again 2 weeks later) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE WARMTH (arm was warm for longer than it should have been), VACCINATION SITE REACTION (Arm was affected for 2 weeks), VACCINATION SITE WARMTH (it got warm again 2 weeks later), VACCINATION SITE INDURATION (It was hard under the surface for 3-4 weeks after that), VACCINATION SITE SWELLING (normal reaction of arm was swollen) and VACCINATION SITE ERYTHEMA (arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company comment This case concerns a 54 year-old female patient with no medical history provided, who experienced the unexpected events of Vaccination site reaction, Vaccination site warmth, and Vaccination site erythema, with the expected events of Vaccination site warmth, Vaccination site induration, and Vaccination site swelling (seriousness criterion medically significant). These events occurred on the same day the patient received the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-363206, MOD-2021-363213 (Patient Link).; Sender's Comments: This case concerns a 54 year-old female patient with no medical history provided, who experienced the unexpected events of Vaccination site reaction, Vaccination site warmth, and Vaccination site erythema, with the expected events of Vaccination site warmth, Vaccination site induration, and Vaccination site swelling (seriousness criterion medically significant). These events occurred on the same day the patient received the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.