Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Swelling hardness; Rash at shot site had hard center; Red and itch; Rash, about 6 inches long, 2 1/2-3 inches wide appeared at 8 days post inoculation at shot site; Red and itch; Prior to 8 days, upper arm just ached a lot for about 24 hours after the first injection; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (Swelling hardness), VACCINATION SITE INDURATION (Rash at shot site had hard center), VACCINATION SITE PRURITUS (Red and itch), VACCINATION SITE RASH (Rash, about 6 inches long, 2 1/2-3 inches wide appeared at 8 days post inoculation at shot site) and VACCINATION SITE ERYTHEMA (Red and itch) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Mitral valve prolapse and Premature atrial contraction. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 17-Jan-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Prior to 8 days, upper arm just ached a lot for about 24 hours after the first injection). On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWELLING (Swelling hardness), VACCINATION SITE INDURATION (Rash at shot site had hard center), VACCINATION SITE PRURITUS (Red and itch), VACCINATION SITE RASH (Rash, about 6 inches long, 2 1/2-3 inches wide appeared at 8 days post inoculation at shot site) and VACCINATION SITE ERYTHEMA (Red and itch). On 18-Jan-2021, VACCINATION SITE PAIN (Prior to 8 days, upper arm just ached a lot for about 24 hours after the first injection) had resolved. On 26-Jan-2021, VACCINATION SITE INDURATION (Rash at shot site had hard center) and VACCINATION SITE RASH (Rash, about 6 inches long, 2 1/2-3 inches wide appeared at 8 days post inoculation at shot site) had resolved. At the time of the report, SWELLING (Swelling hardness) outcome was unknown and VACCINATION SITE PRURITUS (Red and itch) and VACCINATION SITE ERYTHEMA (Red and itch) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE INDURATION (Rash at shot site had hard center), VACCINATION SITE PRURITUS (Red and itch), VACCINATION SITE RASH (Rash, about 6 inches long, 2 1/2-3 inches wide appeared at 8 days post inoculation at shot site), VACCINATION SITE ERYTHEMA (Red and itch) and VACCINATION SITE PAIN (Prior to 8 days, upper arm just ached a lot for about 24 hours after the first injection) to be related. No further causality assessment was provided for SWELLING (Swelling hardness).    Treatment medication was not reported.   This case was linked to MOD-2021-105203 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Reporter/patient demography updated. Current conditions added. Adverse events added and/or updated. Dose 2 details received. On 18-Jun-2021: Follow up- 2 received on 18-JUN-2021, it does not contain no new information/NNI