Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: heat sensation at injection site; the left thumb became very red; Rash with intense itching on upper arm; Spot on the right back itchy and red; Redness/ right side of the back became itchy and slightly red; Exactly a week later the injection site became itchy; Injection site are became red; Exactly a week later at the injection site a rash developed; Pain went down the entire injection site arm/ Muscle pain at the injection site; muscle pain/ muscle soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Rash with intense itching on upper arm), PRURITUS (Spot on the right back itchy and red), ERYTHEMA (Redness/ right side of the back became itchy and slightly red), ERYTHEMA (the left thumb became very red) and VACCINATION SITE WARMTH (heat sensation at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included UBIDECARENONE (COQ 10), RIBOFLAVIN, CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D), FISH OIL, MULTIVITAMINS [VITAMINS NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MYALGIA (muscle pain/ muscle soreness). On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain went down the entire injection site arm/ Muscle pain at the injection site). On 10-Mar-2021, the patient experienced RASH PRURITIC (Rash with intense itching on upper arm), PRURITUS (Spot on the right back itchy and red) and ERYTHEMA (Redness/ right side of the back became itchy and slightly red). 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Exactly a week later the injection site became itchy), VACCINATION SITE ERYTHEMA (Injection site are became red) and VACCINATION SITE RASH (Exactly a week later at the injection site a rash developed). On 14-Mar-2021, the patient experienced ERYTHEMA (the left thumb became very red). On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (heat sensation at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CAPSAICIN for Myalgia, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Rash with intense itching on upper arm), PRURITUS (Spot on the right back itchy and red), ERYTHEMA (Redness/ right side of the back became itchy and slightly red), VACCINATION SITE WARMTH (heat sensation at injection site), VACCINATION SITE PAIN (Pain went down the entire injection site arm/ Muscle pain at the injection site), VACCINATION SITE PRURITUS (Exactly a week later the injection site became itchy), VACCINATION SITE ERYTHEMA (Injection site are became red), VACCINATION SITE RASH (Exactly a week later at the injection site a rash developed) and MYALGIA (muscle pain/ muscle soreness) had not resolved and ERYTHEMA (the left thumb became very red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received, added Concomitant medications, updated patient demographics and event outcome.