Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Injection site adverse reaction; warm circular, the size of a softball injection site; red at the injection site; Itchy at the injection site; very sore circular, the size of a softball injection site; Hypersensitivity reaction; rash at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE REACTION (Injection site adverse reaction), INJECTION SITE WARMTH (warm circular, the size of a softball injection site), HYPERSENSITIVITY (Hypersensitivity reaction), INJECTION SITE ERYTHEMA (red at the injection site) and INJECTION SITE PAIN (very sore circular, the size of a softball injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021 at 9:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). 30-Mar-2021, the patient experienced INJECTION SITE RASH (rash at the injection site). On 30-Mar-2021 at 12:00 PM, the patient experienced INJECTION SITE PAIN (very sore circular, the size of a softball injection site). On 05-Apr-2021, the patient experienced INJECTION SITE REACTION (Injection site adverse reaction), INJECTION SITE WARMTH (warm circular, the size of a softball injection site), INJECTION SITE ERYTHEMA (red at the injection site) and INJECTION SITE PRURITUS (Itchy at the injection site). At the time of the report, INJECTION SITE REACTION (Injection site adverse reaction), INJECTION SITE WARMTH (warm circular, the size of a softball injection site), HYPERSENSITIVITY (Hypersensitivity reaction), INJECTION SITE ERYTHEMA (red at the injection site) and INJECTION SITE PRURITUS (Itchy at the injection site) outcome was unknown and INJECTION SITE PAIN (very sore circular, the size of a softball injection site) and INJECTION SITE RASH (rash at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INJECTION SITE REACTION (Injection site adverse reaction), INJECTION SITE WARMTH (warm circular, the size of a softball injection site), HYPERSENSITIVITY (Hypersensitivity reaction), INJECTION SITE ERYTHEMA (red at the injection site), INJECTION SITE PAIN (very sore circular, the size of a softball injection site), INJECTION SITE PRURITUS (Itchy at the injection site) and INJECTION SITE RASH (rash at the injection site) to be possibly related.    No concomitant medication was provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021 contain non-significant follow-up appended, ae contact information was updated. On 28-May-2021: Follow up received on 28-MAY-2021 and contain non significant information; patient initials and DOB updated. On 02-Jun-2021: Follow up received on 02-JUN-2021 contains: ADR form added and patient details(pregnancy, ethinicity), suspect dose route, details of facility,time of event, outcome of event injection site pain/rash was changed from unknown to recovered, Causality was updated On 01-Jul-2021: Follow up received on 01-JUL-2021 contains: updated adverse event information: Hypersensitivity reaction. On 13-Jul-2021: Follow up received on 13-JUL-2021 contains no new information (NNI)