Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching at injection site; reports itching can be intense at times, but is not continuous / describes the itching sensation as coming and going in "flares" every few hours; Red itchy rash developed on my left arm at the exact location of the injection; vaccination site rash; Soreness at injection site 6 hours post vaccine administration, which resolved within 24 hours and; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site; reports itching can be intense at times, but is not continuous / describes the itching sensation as coming and going in "flares" every few hours), VACCINATION SITE PAIN (Soreness at injection site 6 hours post vaccine administration, which resolved within 24 hours and), VACCINATION SITE ERYTHEMA (Red itchy rash developed on my left arm at the exact location of the injection) and VACCINATION SITE RASH (vaccination site rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included Family history of cardiovascular disorder. Concurrent medical conditions included Breast cancer and Herpes NOS. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) for Bone disorder (NOS), LETROZOLE (FEMARA) for Breast cancer, VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]) for General symptom, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disease congenital, ACYCLOVIR [ACICLOVIR] for Herpes NOS.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site 6 hours post vaccine administration, which resolved within 24 hours and). On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site; reports itching can be intense at times, but is not continuous / describes the itching sensation as coming and going in "flares" every few hours), VACCINATION SITE ERYTHEMA (Red itchy rash developed on my left arm at the exact location of the injection) and VACCINATION SITE RASH (vaccination site rash). On 11-Feb-2021, VACCINATION SITE PAIN (Soreness at injection site 6 hours post vaccine administration, which resolved within 24 hours and) had resolved. On 20-Feb-2021, VACCINATION SITE PRURITUS (Itching at injection site; reports itching can be intense at times, but is not continuous / describes the itching sensation as coming and going in "flares" every few hours), VACCINATION SITE ERYTHEMA (Red itchy rash developed on my left arm at the exact location of the injection) and VACCINATION SITE RASH (vaccination site rash) had resolved.            Patient did not take any treatment for the events.  Company 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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: vaccination site rash was updated as event.concomitant medicine were updated; 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.