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 1 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-2022-656623, US-MODERNATX, INC.-MOD-2022-656624, US-MODERNATX, INC.-MOD-2022-656625, US-MODERNATX, INC.-MOD-2022-791671, US-MODERNATX, INC.-MOD-2022-791672, US-MODERNATX, INC.-MOD-2022-791673, US-MODERNATX, INC.-MOD-2022-791674, US-MODERNATX, INC.-MOD-2022-791675, US-MODERNATX, INC.-MOD-2022-791676, US-MODERNATX, INC.-MOD-2022-791677, US-MODERNATX, INC.-MOD-2022-791678, US-MODERNATX, INC.-MOD-2022-791679, US-MODERNATX, INC.-MOD-2022-791680, US-MODERNATX, INC.-MOD-2022-791681, US-MODERNATX, INC.-MOD-2022-791682, US-MODERNATX, INC.-MOD-2022-791683, US-MODERNATX, INC.-MOD-2022-791684, US-MODERNATX, INC.-MOD-2022-791685, US-MODERNATX, INC.-MOD-2022-791686, US-MODERNATX, INC.-MOD-2022-791687, US-MODERNATX, INC.-MOD-2022-791688, US-MODERNATX, INC.-MOD-2022-791689, US-MODERNATX, INC.-MOD-2022-791690, US-MODERNATX, INC.-MOD-2022-791691, US-MODERNATX, INC.-MOD-2022-791692, US-MODERNATX, INC.-MOD-2022-791693, US-MODERNATX, INC.-MOD-2022-791694, US-MODERNATX, INC.-MOD-2022-791695 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2022: Case was unlocked on 08-Nov-2025 as a part of Inspection to perform significant correction to update report type as Literature Non-study, case validity from invalid to valid, literature information, event start date and narrative updated. This case was identified during a retrospective review conducted following the inspection (CAPA-036486) as requiring correction of validity assessment. Upon internal review on 21-Nov-2025, it was identified that the case MOD-2022-501093 is a duplicate of the case MOD-2022-476047. Hence, all the information from the case MOD-2022-501093 has been added and merged into the retained case MOD-2022-476047. The duplicate case MOD-2022-501093 will be deleted from the safety database. On 10-Oct-2023: Follow-up received by safety on 10-Oct-2023 does not contain any new information.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-656623:patient 27 out of 29 This case refers to Figure D with no patient identifier US-MODERNATX, INC.-MOD-2022-656624:patient 28 out of 29 This case refers to Figure E with no patient identifier US-MODERNATX, INC.-MOD-2022-656625:patient 29 out of 29 This case refers to Figure F with no patient identifier US-MODERNATX, INC.-MOD-2022-791671:patient 2 out of 29 US-MODERNATX, INC.-MOD-2022-791672:patient 3 out of 29 US-MODERNATX, INC.-MOD-2022-791673:patient 4 out of 29 US-MODERNATX, INC.-MOD-2022-791674:patient 5 out of 29 US-MODERNATX, INC.-MOD-2022-791675:patient 6 out of 29 US-MODERNATX, INC.-MOD-2022-791676:patient 7 out of 29 US-MODERNATX, INC.-MOD-2022-791677:patient 8 out of 29 US-MODERNATX, INC.-MOD-2022-791678:patient 9 out of 29 US-MODERNATX, INC.-MOD-2022-791679:patient 10 out of 29 US-MODERNATX, INC.-MOD-2022-791680:patient 11 out of 29 US-MODERNATX, INC.-MOD-2022-791681:patient 12 out of 29 US-MODERNATX, INC.-MOD-2022-791682:patient 13 out of 29 US-MODERNATX, INC.-MOD-2022-791683:patient 14 out of 29 US-MODERNATX, INC.-MOD-2022-791684:patient 15 out of 29 US-MODERNATX, INC.-MOD-2022-791685:patient 16 out of 29 US-MODERNATX, INC.-MOD-2022-791686:patient 17 out of 29 US-MODERNATX, INC.-MOD-2022-791687:patient 18 out of 29 US-MODERNATX, INC.-MOD-2022-791688:patient 19 out of 29 US-MODERNATX, INC.-MOD-2022-791689:patient 20 out of 29 US-MODERNATX, INC.-MOD-2022-791690:patient 21 out of 29 US-MODERNATX, INC.-MOD-2022-791691:patient 22 out of 29 US-MODERNATX, INC.-MOD-2022-791692:patient 23 out of 29 US-MODERNATX, INC.-MOD-2022-791693:patient 24 out of 29 US-MODERNATX, INC.-MOD-2022-791694:patient 25 out of 29 US-MODERNATX, INC.-MOD-2022-791695:patient 26 out of 29