Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: rash itching severely; rash was now 2 & 1/2 inch in large oval shape that was inch wide/rash grew that covered the entire arm about 7-3 inches which was bright red; Some swelling; itching at the injection site; little red/bright red at the injection site; delayed hypersensitivityreaction (Moderna Arm); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivityreaction (Moderna Arm)), RASH PRURITIC (rash itching severely), RASH ERYTHEMATOUS (rash was now 2 & 1/2 inch in large oval shape that was inch wide/rash grew that covered the entire arm about 7-3 inches which was bright red), PERIPHERAL SWELLING (Some swelling) and VACCINATION SITE PRURITUS (itching at the injection site) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy and Kidney stone. Concomitant products included MAGNESIUM CITRATE, MAGNESIUM OXIDE, POTASSIUM CITRATE, PYRIDOXINE HYDROCHLORIDE (THERALITH) for Kidney stone prevention.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivityreaction (Moderna Arm)), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (little red/bright red at the injection site). On 30-Jan-2021, the patient experienced RASH PRURITIC (rash itching severely), RASH ERYTHEMATOUS (rash was now 2 & 1/2 inch in large oval shape that was inch wide/rash grew that covered the entire arm about 7-3 inches which was bright red) and PERIPHERAL SWELLING (Some swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; HYDROCORTISONE for Adverse event, at an unspecified dose and frequency; ALVERINE CITRATE (ALVERATE) for Adverse event, at an unspecified dose and frequency and HAMAMELIS VIRGINIANA EXTRACT (WITCH HAZEL [HAMAMELIS VIRGINIANA EXTRACT]) for Adverse event, at an unspecified dose and frequency. On 03-Feb-2021, TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivityreaction (Moderna Arm)) had resolved. On 05-Feb-2021, RASH PRURITIC (rash itching severely), RASH ERYTHEMATOUS (rash was now 2 & 1/2 inch in large oval shape that was inch wide/rash grew that covered the entire arm about 7-3 inches which was bright red), PERIPHERAL SWELLING (Some swelling) and VACCINATION SITE ERYTHEMA (little red/bright red at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had a telehealth visit with primary care physician and was misdiagnosed with cellulitis. The patient never ended up taking the heavy dose of antibiotic medicine as prescribed by physician. From 30-Jan-201, rash grew that covered the entire arm about 7-3 inches. On 02-Feb-2021, the rash faded out and itching was mild to intermittent. After 3 days, rash and itching disappeared. At the time of adverse events, the patient started using ice (bigger relief for 10 mins and itching would come back).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Patient demographics, medical history, concomitant medication and event information updated