Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Local itching/pruritus; Hypersensitivity reaction; Hot to touch; Hardness at the injection site,hard area over deltoid; Injection site redness, red area at vaccine site; red rash on injection site,rash area at vaccine site; a little bit sore; This spontaneous case was reported by a health care professional and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE INDURATION (Hardness at the injection site,hard area over deltoid), VACCINATION SITE PRURITUS (Local itching/pruritus) and VACCINATION SITE PAIN (a little bit sore) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypersensitivity reaction and Hay fever. Concurrent medical conditions included Seasonal allergy (Runny nose,Sinus Issues). Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (a little bit sore). On 11-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE INDURATION (Hardness at the injection site,hard area over deltoid), VACCINATION SITE ERYTHEMA (Injection site redness, red area at vaccine site) and VACCINATION SITE RASH (red rash on injection site,rash area at vaccine site). On 12-Jan-2021 at 8:00 AM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Local itching/pruritus). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 07-Jan-2021, VACCINATION SITE PAIN (a little bit sore) had resolved. On 16-Jan-2021, HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE INDURATION (Hardness at the injection site,hard area over deltoid), VACCINATION SITE PRURITUS (Local itching/pruritus), VACCINATION SITE ERYTHEMA (Injection site redness, red area at vaccine site) and VACCINATION SITE RASH (red rash on injection site,rash area at vaccine site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE INDURATION (Hardness at the injection site,hard area over deltoid), VACCINATION SITE PRURITUS (Local itching/pruritus), VACCINATION SITE PAIN (a little bit sore), VACCINATION SITE ERYTHEMA (Injection site redness, red area at vaccine site) and VACCINATION SITE RASH (red rash on injection site,rash area at vaccine site) to be possibly related.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up information received on 09 JUN 2021 contains Reporter details,Patient Demographics and medical history were updated . Event Hypersensitivity was added. Outcome of the events updated.; 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