Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site is tender; injection site had redness/ a little redder; injection site had a bump/ feel a bump in the skin; injection site was hard/ area of about 2 or 2,5 inches round; injection site was itchy; injection site was a little red; had swelling at the injection site; injection site was hard; injection site was very tender and hurt/ had pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection site had a bump/ feel a bump in the skin), VACCINATION SITE INDURATION (injection site was hard/ area of about 2 or 2,5 inches round), VACCINATION SITE INDURATION (injection site was hard), VACCINATION SITE PAIN (injection site is tender) and VACCINATION SITE ERYTHEMA (injection site had redness/ a little redder) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Allergy to antibiotic (allergic to several antibiotics). Concomitant products included ESTRADIOL (DIVIGEL) for Hysterectomy, VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) and OMEPRAZOLE for an unknown indication.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced VACCINATION SITE INDURATION (injection site was hard), VACCINATION SITE PAIN (injection site was very tender and hurt/ had pain at the injection site), VACCINATION SITE ERYTHEMA (injection site was a little red) and VACCINATION SITE SWELLING (had swelling at the injection site). On 22-Oct-2021, the patient experienced VACCINATION SITE MASS (injection site had a bump/ feel a bump in the skin), VACCINATION SITE INDURATION (injection site was hard/ area of about 2 or 2,5 inches round), VACCINATION SITE ERYTHEMA (injection site had redness/ a little redder) and VACCINATION SITE PRURITUS (injection site was itchy). On 23-Oct-2021, the patient experienced VACCINATION SITE PAIN (injection site is tender). The patient was treated with CALAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (IVAREST [CALAMINE;DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site pruritus, at an unspecified dose and frequency. On 18-Oct-2021, VACCINATION SITE INDURATION (injection site was hard), VACCINATION SITE PAIN (injection site was very tender and hurt/ had pain at the injection site), VACCINATION SITE ERYTHEMA (injection site was a little red) and VACCINATION SITE SWELLING (had swelling at the injection site) had resolved. At the time of the report, VACCINATION SITE MASS (injection site had a bump/ feel a bump in the skin), VACCINATION SITE INDURATION (injection site was hard/ area of about 2 or 2,5 inches round), VACCINATION SITE PAIN (injection site is tender) and VACCINATION SITE ERYTHEMA (injection site had redness/ a little redder) had not resolved and VACCINATION SITE PRURITUS (injection site was itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other Concomitant medications included Allergy pill (occasionally 22Oct2021).