Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Erythema, Hypersensitivity, Hypoaesthesia, Pruritus
Clinical narrative: light pink rash on nose and cheeks; rash around neck, swelling; Angioedema; Hypersensitivity reaction; Numbness; Itching-Local; Blotchy red rash on left arm; Erythema redness left arm; Tenderness left arm; chest to belly itching rash, hives; face red all over and getting plumped and swollen; face red all over and getting plumped and swollen; This spontaneous case was reported by a nurse and describes the occurrence of ANGIOEDEMA (Angioedema) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfa) since 1980, Penicillin allergy (Rash) since 1980 and Drug allergy (Compazine for vomiting- Dystonia of jaw after two doses of Compazine) since 1990. Concomitant products included FAMOTIDINE (PEPCID AC) for GERD, adult multivitamin, COLECALCIFEROL (D3) and CALCIUM CITRATE for Supplementation therapy.    On 19-Feb-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), HYPERSENSITIVITY (Hypersensitivity reaction), HYPOAESTHESIA (Numbness), PRURITUS (Itching-Local), RASH MACULAR (Blotchy red rash on left arm), ERYTHEMA (Erythema redness left arm), TENDERNESS (Tenderness left arm), URTICARIA (chest to belly itching rash, hives), ERYTHEMA (face red all over and getting plumped and swollen), SWELLING FACE (face red all over and getting plumped and swollen) and RASH (rash around neck, swelling). On 03-Mar-2021, the patient experienced RASH (light pink rash on nose and cheeks). The patient was treated with PREDNISONE (oral) from 01-Mar-2021 to 15-Mar-2021 for Swelling, at a dose of 40 milligram; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 01-Mar-2021 to 07-Mar-2021 at a dose of 25 mg every four hours and LORATADINE (CLARITIN [LORATADINE]) (oral) from 01-Mar-2021 to 09-Mar-2021 at a dose of 10 mg twice a day. On 02-Mar-2021, TENDERNESS (Tenderness left arm) had resolved. On 21-Mar-2021, ANGIOEDEMA (Angioedema), HYPERSENSITIVITY (Hypersensitivity reaction), HYPOAESTHESIA (Numbness), PRURITUS (Itching-Local), RASH MACULAR (Blotchy red rash on left arm), ERYTHEMA (Erythema redness left arm), URTICARIA (chest to belly itching rash, hives), ERYTHEMA (face red all over and getting plumped and swollen), SWELLING FACE (face red all over and getting plumped and swollen), RASH (light pink rash on nose and cheeks) and RASH (rash around neck, swelling) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Hypersensitivity reaction , Angioedema, Numbness and Itching were added. On 20-Jun-2021: Added patient demographics, height, allergy, concomitant medications and events stop date.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.