Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Urticaria
Clinical narrative: A couple days after the rash started, she also experienced intense burning and itching in those areas/scalp, neck, arms, lower back, middle back, upper back, and hips/It was like a dermatitis type reaction; A couple days after the rash started, she also experienced intense burning and itching in those areas/scalp, neck, arms, lower back, middle back, upper back, and hips/It was like a dermatitis type reaction; she got a horrible skin rash all over her body/ She says that she got the rash on her scalp, neck, arms, lower back, middle back, upper back, and hips. The rash was patches of red; The actual rash looked like hives and became welts on the skin. Her skin looked aggravated; The actual rash looked like hives and became welts on the skin. Her skin looked aggravated; she got a horrible skin rash all over her body/ She says that she got the rash on her scalp, neck, arms, lower back, middle back, upper back, and hips. The rash was patches of red; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (A couple days after the rash started, she also experienced intense burning and itching in those areas/scalp, neck, arms, lower back, middle back, upper back, and hips/It was like a dermatitis type reaction), PRURITUS (A couple days after the rash started, she also experienced intense burning and itching in those areas/scalp, neck, arms, lower back, middle back, upper back, and hips/It was like a dermatitis type reaction), ERYTHEMA (she got a horrible skin rash all over her body/ She says that she got the rash on her scalp, neck, arms, lower back, middle back, upper back, and hips. The rash was patches of red), URTICARIA (The actual rash looked like hives and became welts on the skin. Her skin looked aggravated) and RASH (The actual rash looked like hives and became welts on the skin. Her skin looked aggravated) in a 62-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058581) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Lot 031L20A) on 08-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, Lot 003A21A) on 08-Mar-2021, Moderna COVID-19 Vaccine (Dose 3 and Lot 051F21A) on 17-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 09-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. In October 2023, the patient experienced BURNING SENSATION (A couple days after the rash started, she also experienced intense burning and itching in those areas/scalp, neck, arms, lower back, middle back, upper back, and hips/It was like a dermatitis type reaction), PRURITUS (A couple days after the rash started, she also experienced intense burning and itching in those areas/scalp, neck, arms, lower back, middle back, upper back, and hips/It was like a dermatitis type reaction), ERYTHEMA (she got a horrible skin rash all over her body/ She says that she got the rash on her scalp, neck, arms, lower back, middle back, upper back, and hips. The rash was patches of red), URTICARIA (The actual rash looked like hives and became welts on the skin. Her skin looked aggravated), RASH (The actual rash looked like hives and became welts on the skin. Her skin looked aggravated) and RASH (she got a horrible skin rash all over her body/ She says that she got the rash on her scalp, neck, arms, lower back, middle back, upper back, and hips. The rash was patches of red). The patient was treated with CLOBETASOL at an unspecified dose and frequency; CANNABIDIOL (CBD GEL) for Rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (A couple days after the rash started, she also experienced intense burning and itching in those areas/scalp, neck, arms, lower back, middle back, upper back, and hips/It was like a dermatitis type reaction), PRURITUS (A couple days after the rash started, she also experienced intense burning and itching in those areas/scalp, neck, arms, lower back, middle back, upper back, and hips/It was like a dermatitis type reaction), ERYTHEMA (she got a horrible skin rash all over her body/ She says that she got the rash on her scalp, neck, arms, lower back, middle back, upper back, and hips. The rash was patches of red), URTICARIA (The actual rash looked like hives and became welts on the skin. Her skin looked aggravated), RASH (The actual rash looked like hives and became welts on the skin. Her skin looked aggravated) and RASH (she got a horrible skin rash all over her body/ She says that she got the rash on her scalp, neck, arms, lower back, middle back, upper back, and hips. The rash was patches of red) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: allergic reaction.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. Patient received all Moderna COVID-19 vaccines previously as well. She stated that with the first three shots she did not have any reactions at all and it was perfect. She stated that she had such a bad reaction this time that she doesn't think she will go for any other Moderna COVID-19 vaccines anymore. She stated that this was an awful side effect. For her, it started on her scalp and then went to her neck. After this, it spread to different parts of her body in patches. She mentioned that the rash was really bad initially, but it seems that with all the current treatments, it's getting better. She stated that the dermatologist did biopsy her skin and the result came back as an allergic reaction. Patient also took topical steroid cream for rashes.