Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: My usual trunk itching had worsened. It was a slight increase in itching. It felt like I was itching somewhere inside; There was a big lump in my arm and it was getting bigger and bigger. It started itching; itching at the injection site at a 10+; My arm was red and swollen at the site of the injection; My arm was red and swollen at the site of the injection; very minor itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (My usual trunk itching had worsened. It was a slight increase in itching. It felt like I was itching somewhere inside), VACCINATION SITE MASS (There was a big lump in my arm and it was getting bigger and bigger. It started itching), VACCINATION SITE PRURITUS (itching at the injection site at a 10+), VACCINATION SITE PRURITUS (very minor itching) and VACCINATION SITE ERYTHEMA (My arm was red and swollen at the site of the injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (very minor itching). On 09-Mar-2021, the patient experienced PRURITUS (My usual trunk itching had worsened. It was a slight increase in itching. It felt like I was itching somewhere inside), VACCINATION SITE MASS (There was a big lump in my arm and it was getting bigger and bigger. It started itching), VACCINATION SITE PRURITUS (itching at the injection site at a 10+), VACCINATION SITE ERYTHEMA (My arm was red and swollen at the site of the injection) and VACCINATION SITE SWELLING (My arm was red and swollen at the site of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and CLOBETASOL ongoing since an unknown date for Adverse event, at a dose of Clobetasol cream topically. On 02-Mar-2021, VACCINATION SITE PRURITUS (very minor itching) had resolved. On 12-Mar-2021, PRURITUS (My usual trunk itching had worsened. It was a slight increase in itching. It felt like I was itching somewhere inside), VACCINATION SITE MASS (There was a big lump in my arm and it was getting bigger and bigger. It started itching), VACCINATION SITE PRURITUS (itching at the injection site at a 10+), VACCINATION SITE ERYTHEMA (My arm was red and swollen at the site of the injection) and VACCINATION SITE SWELLING (My arm was red and swollen at the site of the injection) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Action taken with the drug was updated as "no change" (as the patient received second dose of vaccine).