Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: angioedema/face swelling; Hives; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema/face swelling) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 22-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free, Solution for injection in pre-filled pen. On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2022, the patient experienced ANGIOEDEMA (angioedema/face swelling) (seriousness criterion medically significant) and URTICARIA (Hives). In 2022, ANGIOEDEMA (angioedema/face swelling) and URTICARIA (Hives) had resolved.            No concomitant medication was provided. On 21-Feb-2022, the patient experienced hives and angiodema/face swelling. In 2022, the hives and  angiodema/face swellingresolved.  Treatment medication was not provided by the reporter.  The reporter's causality for Humira for the event(s) of hives and angioedema/face swelling was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment  This is a spontaneous case reported by a consumer, concerning a 19 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Angioedema (angioedema/face swelling), about 3 days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series, along with other non serious event of Urticaria (Hives). Patient previously received the primary 2 doses with Moderna vaccine, with no adverse events reported. The patient was started on Adalimumab for Ulcerative colitis, about 6 months prior to receiving the 1 dose of Moderna vaccine. Details of co morbidities, risk factors, clinical course, labs, concomitant medications and other treatment details were not reported.  The events had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a 19 year old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Angioedema (angioedema/face swelling), about 3 days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series, along with other non serious event of Urticaria (Hives). Patient previously received the primary 2 doses with Moderna vaccine, with no adverse events reported. The patient was started on Adalimumab for Ulcerative colitis, about 6 months prior to receiving the 1 dose of Moderna vaccine. Details of co morbidities, risk factors, clinical course, labs, concomitant medications and other treatment details were not reported.  The events had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.