Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Lot of swelling and inflammation; COVID arm; Red rash; hot to touch; itching; Swelling; tender to touch; Injection site itching so badly; Tender; Bad rash in that area; Lot of swelling and inflammation; Hives; Redness is going underneath the arm to the armpit/Some redness; Arm a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a little sore), URTICARIA (Hives), ERYTHEMA (Redness is going underneath the arm to the armpit/Some redness), VACCINATION SITE INFLAMMATION (Lot of swelling and inflammation) and VACCINATION COMPLICATION (COVID arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: shingrix (produced inflammation and redness of the arm and). Past adverse reactions to the above products included Inflammation with shingrix. Concurrent medical conditions included Drug allergy (Naproxen) and Osteoporosis NOS. Concomitant products included CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3) for Calcium supplementation, RALOXIFENE HYDROCHLORIDE and FISH OIL for Nutritional supplement, VITAMIN B12 NOS for Vitamin B12 supplementation, BIOTIN for Vitamin supplementation, TADALAFIL (EDYSTA) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm a little sore) and ERYTHEMA (Redness is going underneath the arm to the armpit/Some redness). On 09-Mar-2021, the patient experienced URTICARIA (Hives), VACCINATION COMPLICATION (COVID arm), RASH ERYTHEMATOUS (Red rash), FEELING HOT (hot to touch), PRURITUS (itching), SWELLING (Swelling), TENDERNESS (tender to touch), VACCINATION SITE PAIN (Tender), VACCINATION SITE RASH (Bad rash in that area) and VACCINATION SITE SWELLING (Lot of swelling and inflammation). 09-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (Lot of swelling and inflammation) and VACCINATION SITE PRURITUS (Injection site itching so badly). The patient was treated with HYDROCORTISONE for Itching and Rash, at an unspecified dose and frequency and IBUPROFEN for Swelling, at an unspecified dose and frequency. On 21-Mar-2021, VACCINATION COMPLICATION (COVID arm), RASH ERYTHEMATOUS (Red rash), FEELING HOT (hot to touch), PRURITUS (itching), SWELLING (Swelling) and TENDERNESS (tender to touch) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm a little sore), URTICARIA (Hives), VACCINATION SITE INFLAMMATION (Lot of swelling and inflammation), VACCINATION SITE PAIN (Tender) and VACCINATION SITE SWELLING (Lot of swelling and inflammation) outcome was unknown, ERYTHEMA (Redness is going underneath the arm to the armpit/Some redness) had not resolved and VACCINATION SITE PRURITUS (Injection site itching so badly) and VACCINATION SITE RASH (Bad rash in that area) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient treated herself with over the counter with cream.   This case was linked to MOD-2021-109657 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: added patient demographics, concomitant medications added, treatment updated, events updated, dose 2 cross-linked. On 30-Jul-2021: Follow up received contains no new information.