Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Erythema, Product dose omission issue, Pruritus, Rash
Clinical narrative: did not get second dose within vaccine schedule window; Slack hives and pimple puscle like/systemic rash and hives from his neck to buttock and around his waist and arms/red, itchy, raised, and large hives; Slack hives and pimple puscle; Red, itchy, raised, and large hives; Red, itchy, raised, and large hives; Red, itchy, raised, and large hives; 2 types of rash in his back to buttocks area/systemic rash and hives from his neck to buttock and around his waist and arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Slack hives and pimple puscle like/systemic rash and hives from his neck to buttock and around his waist and arms/red, itchy, raised, and large hives), ACNE (Slack hives and pimple puscle), URTICARIA PAPULAR (Red, itchy, raised, and large hives), PRURITUS (Red, itchy, raised, and large hives) and ERYTHEMA (Red, itchy, raised, and large hives) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever. Concurrent medical conditions included Asthma, COPD, Bee sting hypersensitivity (Itching ,  swelling  and sob), Hypersensitivity and Arthritis. Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA) and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) for COPD.    On 26-Feb-2021 at 1:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced URTICARIA (Slack hives and pimple puscle like/systemic rash and hives from his neck to buttock and around his waist and arms/red, itchy, raised, and large hives), ACNE (Slack hives and pimple puscle), URTICARIA PAPULAR (Red, itchy, raised, and large hives), PRURITUS (Red, itchy, raised, and large hives), ERYTHEMA (Red, itchy, raised, and large hives) and RASH (2 types of rash in his back to buttocks area/systemic rash and hives from his neck to buttock and around his waist and arms). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second dose within vaccine schedule window). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) on 28-Feb-2021 at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 28-Feb-2021 at a dose of 50 mg. At the time of the report, URTICARIA (Slack hives and pimple puscle like/systemic rash and hives from his neck to buttock and around his waist and arms/red, itchy, raised, and large hives), ACNE (Slack hives and pimple puscle), URTICARIA PAPULAR (Red, itchy, raised, and large hives), PRURITUS (Red, itchy, raised, and large hives), ERYTHEMA (Red, itchy, raised, and large hives) and RASH (2 types of rash in his back to buttocks area/systemic rash and hives from his neck to buttock and around his waist and arms) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not get second dose within vaccine schedule window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Annora Ellipta, Proair.  Treatment : Zyrtec, Benadryl  Patient no longer taking the treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Non significant follow up- Event Addition and source document attachment