Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Pruritus, Skin exfoliation, Swelling, Urticaria
Clinical narrative: Angioedema; Hives all over body; Crazy itching; skin peeling; Difficulty swelling; Red spots around injection site; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), URTICARIA (Hives all over body), PRURITUS (Crazy itching), SKIN EXFOLIATION (skin peeling), SWELLING (Difficulty swelling) and VACCINATION SITE ERYTHEMA (Red spots around injection site). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (Angioedema), URTICARIA (Hives all over body), PRURITUS (Crazy itching), SKIN EXFOLIATION (skin peeling) and VACCINATION SITE ERYTHEMA (Red spots around injection site) had not resolved and SWELLING (Difficulty swelling) had resolved.            No pre-existing or allergy was reported  It was reported that the patient experienced similar side effects from second dose but not as severe as booster side effects.  No Concomitant medication information was reported.  Company Comment: This case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected serious (medically significant) event of Angioedema, the unexpected non-serious events of Urticaria, Pruritus, Skin exfoliation, Swelling and the expected event of Vaccination site erythema. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was treated with Prednisone and Diphenhydramine. At the time of the report the outcome of the events was not resolved except for Swelling which had resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-460640 (Patient Link).; Sender's Comments: This case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected serious (medically significant) event of Angioedema, the unexpected non-serious events of Urticaria, Pruritus, Skin exfoliation, Swelling and the expected event of Vaccination site erythema. The events occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was treated with Prednisone and Diphenhydramine. At the time of the report the outcome of the events was not resolved except for Swelling which had resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.