Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Vaccination site swelling; raised rash; Hives were uncomfortable; Hives were itchy; Deltoid muscle blew up with hives; Soreness at injection site; Redness at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DISCOMFORT (Hives were uncomfortable), VACCINATION SITE PRURITUS (Hives were itchy), VACCINATION SITE URTICARIA (Deltoid muscle blew up with hives), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Celiac sprue on 02-Jan-2004 and Hashimoto's thyroiditis on 07-Jan-2003. Concurrent medical conditions included Cosmetic allergy (Juvaderm cosmotic face filler. facial redness & swelling requiring oral steroid and antibiotic.) since 10-Jan-2015, Fruit allergy (Hives, itching.) since 2010 and Cosmetic allergy (Dermatitis entire scalp requiring topical steroids) since 19-Jan-2018.   On 11-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (Hives were uncomfortable), VACCINATION SITE PRURITUS (Hives were itchy) and VACCINATION SITE URTICARIA (Deltoid muscle blew up with hives). 19-Jan-2021, the patient experienced VACCINATION SITE RASH (raised rash). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) on 18-Jan-2021 for Adverse event, at a dose of 1 dosage form; EPINEPHRINE for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. On 13-Jan-2021, VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved. On 21-Jan-2021, VACCINATION SITE DISCOMFORT (Hives were uncomfortable), VACCINATION SITE PRURITUS (Hives were itchy), VACCINATION SITE URTICARIA (Deltoid muscle blew up with hives) and VACCINATION SITE RASH (raised rash) had resolved. At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient stated Yes for the question - Was the adverse event most likely caused by mRNA-1273?   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up Appended