Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: sores in mouth; itching; torso rash; face and tough stared swelling; red blisters all over face; angioedema; hives on neck and face and lips; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL TARTRATE (LOPRESSOR), PRASUGREL HYDROCHLORIDE (EFFIENT), HYDROCHLOROTHIAZIDE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VIT D [VITAMIN D NOS], CALCIUM, ATORVASTATIN CALCIUM (LIPITOR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (itching). On 06-Mar-2021, the patient experienced STOMATITIS (sores in mouth). In March 2021, the patient experienced ANGIOEDEMA (angioedema) (seriousness criterion medically significant), URTICARIA (hives on neck and face and lips), SWELLING FACE (face and tough stared swelling), BLISTER (red blisters all over face) and RASH (torso rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 30-Mar-2021, ANGIOEDEMA (angioedema), URTICARIA (hives on neck and face and lips), STOMATITIS (sores in mouth), SWELLING FACE (face and tough stared swelling), BLISTER (red blisters all over face), PRURITUS (itching) and RASH (torso rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       The patient symptoms started that 5th day (04Mar2021) after vaccination started with itching then got torso rash then two days later 06Mar2021, got sores in mouth. Then face and tough stared swelling and red blisters all over face on Mar2021. Caller mentioned angioedema on Mar2021. Then had hives on neck and face and lips on Mar2021. The patient was treated with IM and PO steroids, Zyrtec, Pepcid, Benadryl, Claritin, and Prednisone around the clock went to urgent care, primary care position and ER for symptoms. Symptoms lasted about 10 days and did not quickly respond steroids. Had sores after swelling went down and took pictures of it. 3 to 4 weeks after she felt better (30Mar2021). The only medication that has changed since vaccination was the blood pressure medication. Primary Care Physician did not want her to get the second vaccination due to the side effects.  Company Comment: This case refers to a 64-year-old female patient with no relevant medical history who experienced the unexpected event of Angioedema approximately 5 days after the first dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a 64-year-old female patient with no relevant medical history who experienced the unexpected event of Angioedema approximately 5 days after the first dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.