Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: raised red nodular lesion on the anterior chest; monomorphic punched out papules on erythematous base; generalized pruritic and painful rash started on front and back of both thighs and spread to the rest of her body; hypersensitivity reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (raised red nodular lesion on the anterior chest; monomorphic punched out papules on erythematous base), RASH PRURITIC (generalized pruritic and painful rash started on front and back of both thighs and spread to the rest of her body) and HYPERSENSITIVITY (hypersensitivity reaction) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Follicular eczema, Spongiotic dermatitis, Hives and Patch test positive (It found Gold allergy and also had multiple bouts of rashes over the neck even after the patch testing.) in 2015. Family history included Melanoma (Father had melanoma in his 50s). Concurrent medical conditions included Osteoporosis since 2010, Genital herpes simplex (Improvement following menopause) since 1986, Hypersensitivity reaction (NOS), Contrast media allergy (Severe hives and rash 7 days after CT Scan, ER prescribed a steroid, resolved fairly quickly.) since 25-Aug-2006, Drug allergy (Allergic to alendronate - Resulted in Musculoskeletal pain) since 22-Jun-2017, Drug allergy (Allergic to gold sodium thiosulfate - Resulted in Hot bumpy rash, local, not long lasting reaction.) since 2015 and Allergic contact dermatitis (2 months of numerous monomorphic punched out excoriated papules, some with central follicular core). Concomitant products included ESCITALOPRAM for Mood swings, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3), VITAMIN D NOS and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 28-Feb-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH PRURITIC (generalized pruritic and painful rash started on front and back of both thighs and spread to the rest of her body). 10-Mar-2021, the patient experienced HYPERSENSITIVITY (hypersensitivity reaction). On an unknown date, the patient experienced RASH ERYTHEMATOUS (raised red nodular lesion on the anterior chest; monomorphic punched out papules on erythematous base). The patient was treated with HYDROXYZINE (oral) from 23-Mar-2021 to 05-Apr-2021 for Itchy rash, at a dose of 25 mg at bedtime; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itchy rash, at a dose of 1 dosage form and FLUOCINONIDE (topical) for Itchy rash, at a dose of 1 dosage form twice a day. At the time of the report, RASH ERYTHEMATOUS (raised red nodular lesion on the anterior chest; monomorphic punched out papules on erythematous base) outcome was unknown and RASH PRURITIC (generalized pruritic and painful rash started on front and back of both thighs and spread to the rest of her body) and HYPERSENSITIVITY (hypersensitivity reaction) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Biopsy: abnormal (abnormal) Left lower back: Excoriation with fibrino prurulent crust, reactive epithelial changes and superficial dermal acute and chronic inflammation; viral cytopathic changes are not seen, no fungal organisms are identified; findings consistent with trauma/excoriation.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       On 03MAY2021, a CBC, CMP, TSH, Hgb A1C, and T spot were ordered. The results were not provided.  The patient's allergist recommended delaying the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up contains the completed ADR Form; Medical History, Skin biopsy results, Concomitant medications, and Treatment Information; Sender's Comments: This report refers to a case of product dose omission issue, for mRNA-1273, lot # 012A21A. Based on the current available information and temporal association between the use of the product and the start date of the event, Rash, a causal relationship cannot be excluded.