Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site nodule, Vaccination site pain, Vaccination site pruritus
Clinical narrative: small nodule to injection site; Itching worsened; Itching in the arm  of injection; Redness in the arm of injection; Sore in the arm of injection; swelling in the arm of injection; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection) and VACCINATION SITE PAIN (Sore in the arm of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 307K20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 29-Dec-2020 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021 at 12:24 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection), VACCINATION SITE PAIN (Sore in the arm of injection) and VACCINATION SITE SWELLING (swelling in the arm of injection). The patient was treated with IBUPROFEN (oral) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at a dose of 1 dosage form. On 12-Jan-2021, VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection), VACCINATION SITE PAIN (Sore in the arm of injection) and VACCINATION SITE SWELLING (swelling in the arm of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE NODULE (small nodule to injection site), CONDITION AGGRAVATED (Itching worsened), VACCINATION SITE PRURITUS (Itching in the arm  of injection), VACCINATION SITE ERYTHEMA (Redness in the arm of injection), VACCINATION SITE PAIN (Sore in the arm of injection) and VACCINATION SITE SWELLING (swelling in the arm of injection) to be possibly related.    It was noted per follow-up report that the patient had a delayed topical reaction to the TB skin test.   This case was linked to MOD-2021-031261, MOD-2021-027551, MOD-2021-025815, MOD-2021-028822, MOD-2021-028858 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow-up ADR form received and contained first and second dose details, concomitant/treatment medications, event onset and resolution dates, medical history and causality.