Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
urticaria and/or angioedema; urticaria and/or angioedema; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (urticaria and/or angioedema) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ANGIOEDEMA (urticaria and/or angioedema) (seriousness criterion medically significant) and URTICARIA (urticaria and/or angioedema). In 2021, ANGIOEDEMA (urticaria and/or angioedema) and URTICARIA (urticaria and/or angioedema) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (urticaria and/or angioedema) and URTICARIA (urticaria and/or angioedema) to be related. This case was identified during a retrospective clean-up activity initiated under CAPA-036486 in response to a Inspection Observation. This case referred to patient 5 out of 29 patients reported from table 1. No concomitant medications were reported. Specific treatment medications were not reported Vaccine-related reactions were abstracted from the COVID-19 Vaccine Allergy Case Registry, a registry open for voluntary reporting of vaccine allergy cases. U/AE events attributed to COVID-19 vaccines entered by clinicians between February 13, 2021, to February 8, 2022, were reviewed. There were 481 reactions from 46 places entered by clinicians (64% Moderna, 27% Pfizer-BioNTech, and 9% other/unknown); 60 (12%) cases were U/AE events (mean age: 48?years; range: 9-85?years; SD?±?19.0 years. All U/AE events occurred after an mRNA COVID-19 vaccine (n = 29 [48%] Moderna; n = 31 [52%] Pfizer-BioNTech), and most with the first dose (n = 46, 77%). The onset time for U/AE was variable, but just 19 (32%) cases were immediate (<4 h; 15 cases [25%] =1 h) following vaccination. Onset of U/AE was more often immediate with Pfizer-BioNTech compared to Moderna (41% vs 21%), and U/AE was more often delayed with Moderna compared to Pfizer-BioNTech (69% vs 26%). Resolution times were diverse, but Moderna U/AE more commonly lasted >1 week than Pfizer-BioNTech U/AE (31% vs 6%). Out of 21 patients who had anaphylaxis after Moderna vaccine,3 were admitted in emergency department, 4 required urgent care and 5 admitted to ambulatory clinic No treatment was required in 7 patient, H1-Antihistamines in 21, H2-Antihistamines in 5, bronchodilator in 1, oral corticosteroids in 7, intravenous corticosteroids in 1 and topical corticosteroids in 5. Most U/AE events occurred following the first COVID-19 vaccine dose (77%) with events occurring comparably after Pfizer-BioNTech and Moderna vaccines (Dose 1 was 20 and Dose 2 was 9). This case was linked to US-MODERNATX, INC.-MOD-2022-476047 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow up received by safety 10-Feb-2022 contains Non Significant information. On 01-Mar-2022: Follow up received by safety on 02-Mar-2022 contains non-significant information: Literature information updated. On 05-Mar-2022: Follow up received by safety on 07-Mar-2022 contains non-significant information: Reporter information updated. On 26-Sep-2022: Follow up received by safety on 28-Sep-2022 has Email with abstract received and contains no new information. On 29-Sep-2022: Follow up received by safety on 30-Sep-2022 has email with full text article received and contains significant information: Reporter information was added, dose details were added, iNarrative supplement was updated. On 10-Oct-2023: Follow-up received by safety on 10-Oct-2023 does not contain any new information.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-476047:Master case (patient 1 out of 29)