Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Tired; Rash around the site of injection; Redness around the site of injection; Mild swelling around the site of injection; Redness, swelling and itching; Red scar, teeny bit of swelling around red site for 48 hours; Hypersensitivity reaction; Itching for first 18 hours; Itching around the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness, swelling and itching), SWELLING (Red scar, teeny bit of swelling around red site for 48 hours), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itching for first 18 hours) and VACCINATION SITE PRURITUS (Itching around the site of injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN from 01-Nov-2018 to an unknown date for Blood pressure high, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM D3) for Bone disorder, MULTIVITAMINS WITH IRON [ASCORBIC ACID;CYANOCOBALAMIN;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHEROL] and FISH OIL for Vitamin supplementation, VITAMIN D3 for an unknown indication.   On 28-Jan-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 2:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021 at 4:00 AM, the patient experienced ERYTHEMA (Redness, swelling and itching), SWELLING (Red scar, teeny bit of swelling around red site for 48 hours), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itching for first 18 hours), VACCINATION SITE PRURITUS (Itching around the site of injection), VACCINATION SITE RASH (Rash around the site of injection), VACCINATION SITE ERYTHEMA (Redness around the site of injection) and VACCINATION SITE SWELLING (Mild swelling around the site of injection). On an unknown date, the patient experienced FATIGUE (Tired). The patient was treated with HYDROCORTISONE (topical) ongoing since an unknown date for Itching, Redness and Rash, at an unspecified dose and frequency. On 08-Feb-2021 at 10:00 AM, ERYTHEMA (Redness, swelling and itching), SWELLING (Red scar, teeny bit of swelling around red site for 48 hours), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itching for first 18 hours), VACCINATION SITE PRURITUS (Itching around the site of injection), VACCINATION SITE RASH (Rash around the site of injection), VACCINATION SITE ERYTHEMA (Redness around the site of injection) and VACCINATION SITE SWELLING (Mild swelling around the site of injection) had resolved. At the time of the report, FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       patient started experiencing the events 'eight days after getting the first dose of the Moderna vaccine" and that the event fatigue was experienced on the second dose only.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up updated on 26-Jun-2021:Patients demographic details, lab data, concomitant product details , event  start date and end date, event outcome updated.