Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site is really warm; Large red spot; Almost like an allergic reaction; A little bit of dizziness; Injection site is itching really bad; Injection site is a little bit swollen; Injection site was really red; A knot at the injection site that was kind of hard; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A knot at the injection site that was kind of hard), VACCINATION SITE WARMTH (Injection site is really warm), ERYTHEMA (Large red spot), HYPERSENSITIVITY (Almost like an allergic reaction) and DIZZINESS (A little bit of dizziness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy and Gastritis. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, BIOTIN for Vitamin supplementation, AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE MASS (A knot at the injection site that was kind of hard) and MYALGIA (Soreness). On 03-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is really warm), ERYTHEMA (Large red spot), HYPERSENSITIVITY (Almost like an allergic reaction), DIZZINESS (A little bit of dizziness), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE SWELLING (Injection site is a little bit swollen) and VACCINATION SITE ERYTHEMA (Injection site was really red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Itching, at an unspecified dose and frequency. On 27-May-2021, VACCINATION SITE MASS (A knot at the injection site that was kind of hard) and MYALGIA (Soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site is really warm), ERYTHEMA (Large red spot), HYPERSENSITIVITY (Almost like an allergic reaction), DIZZINESS (A little bit of dizziness), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE SWELLING (Injection site is a little bit swollen) and VACCINATION SITE ERYTHEMA (Injection site was really red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products also included centrum silver.  Patient said that after using Benadryl cream, it kind of went away but she currently has an ice pack on it with some gauze.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-Jun-2021, included fax number was updated and no new information was recorded