Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site pruritus, Injection site rash, Rash, Rash pruritic
Clinical narrative: Large red area appeared on the injection site; itches; rash on both arms and across shoulder all hands; left side of her face was very red and very itchy; Allergic Reaction; rash size of silver dollar/rash over shoulder and chest, arm, face; Red area around the injection site; soreness area around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE RASH (rash size of silver dollar/rash over shoulder and chest, arm, face), VACCINATION SITE ERYTHEMA (Red area around the injection site), VACCINATION SITE PAIN (soreness area around the injection site), VACCINATION SITE ERYTHEMA (Large red area appeared on the injection site) and INJECTION SITE PRURITUS (itches) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FASENRA (Patient had Fasenra Injection four times in the past prior to vaccine administration.) on 13-Jan-2020. Concurrent medical conditions included Asthma. Concomitant products included BENRALIZUMAB and BUDESONIDE;FORMOTEROL FUMARATE for Asthma.  On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red area around the injection site) and VACCINATION SITE PAIN (soreness area around the injection site).   On 07-Jan-2021, the patient experienced INJECTION SITE RASH (rash size of silver dollar/rash over shoulder and chest, arm, face).   On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Large red area appeared on the injection site), INJECTION SITE PRURITUS (itches), RASH (rash on both arms and across shoulder all hands), RASH PRURITIC (left side of her face was very red and very itchy) and HYPERSENSITIVITY (Allergic Reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency.   On 09-Jan-2021, INJECTION SITE RASH (rash size of silver dollar/rash over shoulder and chest, arm, face), VACCINATION SITE ERYTHEMA (Red area around the injection site) and VACCINATION SITE PAIN (soreness area around the injection site) had resolved.   At the time of the report, VACCINATION SITE ERYTHEMA (Large red area appeared on the injection site) and RASH (rash on both arms and across shoulder all hands) had resolved and INJECTION SITE PRURITUS (itches), RASH PRURITIC (left side of her face was very red and very itchy) and HYPERSENSITIVITY (Allergic Reaction) 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.   For treatment, patient was given IV Steroids in ER and Oral Steroids have been prescribed for 3 days.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.