Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Intentional product use issue, Pruritus, Rash, Urticaria
Clinical narrative: Patient recieved the second dose of the vaccine more than 36 days from the first dose; Never took 2nd shot in fear of reactions; Rash in her neck and arm; Hives in her neck and arm/Generalized; Generalized itching; Redness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives in her neck and arm/Generalized), PRURITUS (Generalized itching), ERYTHEMA (Redness), INTENTIONAL PRODUCT USE ISSUE (Patient recieved the second dose of the vaccine more than 36 days from the first dose) and RASH (Rash in her neck and arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Osteoarthritis, Peripheral neuropathy, Hypothyroidism, Hypertension, Drug allergy (Tremors, nauseous), Drug allergy (Tremors, nauseous) and Drug allergy (Tremors, nauseous). Concomitant products included AMLODIPINE, LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, FAMOTIDINE (PEPCID [FAMOTIDINE]), MELATONIN (MELATONINA) and VITAMIN D3 for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced URTICARIA (Hives in her neck and arm/Generalized), PRURITUS (Generalized itching), ERYTHEMA (Redness) and RASH (Rash in her neck and arm). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient recieved the second dose of the vaccine more than 36 days from the first dose) and INTENTIONAL PRODUCT USE ISSUE (Never took 2nd shot in fear of reactions). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of UNK dosage form; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at a dose of UNK dosage form and PREDNISONE at a dose of 1 UNK. At the time of the report, URTICARIA (Hives in her neck and arm/Generalized), PRURITUS (Generalized itching) and RASH (Rash in her neck and arm) had not resolved, ERYTHEMA (Redness) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Patient recieved the second dose of the vaccine more than 36 days from the first dose) and INTENTIONAL PRODUCT USE ISSUE (Never took 2nd shot in fear of reactions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking medication for blood pressure and thyroid. On 3-February-2021 patient started treatment with Steroids unknown dosage and stopped use on 10-February-2021.On 16-February-2021 patient starts to use antihistamines unknown dosage daily for treatment.    This case was linked to MOD-2021-256757 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up report was received, and included information for historical medical, allergies, concomitant medication, treatment for the symptoms, onset date for the events, doctor visit. On 14-Jul-2021: Additional information include second dose details,concomitant and treatment medication added,  outcome of event updated from unknown to not recovered(urticaria, rash).