Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: angioedema/ Severe Swelling of the face.; After booster she had severe hives; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema/ Severe Swelling of the face.) in a 22-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.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (angioedema/ Severe Swelling of the face.) (seriousness criterion medically significant) and URTICARIA (After booster she had severe hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (angioedema/ Severe Swelling of the face.) and URTICARIA (After booster she had severe hives) had not resolved.            Reporter's daughter received 3 doses of mRNA-1273 vaccine on unknown dates. Minimal common side effects noted after vaccination with the first 2 doses of mRNA-1273 vaccine. Severe hives and angioedema (severe facial swelling) occurred after her booster dose with mRNA-1273 vaccine (onset date unspecified). Persistence of symptoms without difficulty of breathing prompted ER consult where Zyrtec and Pepcid were prescribed. Outcome of the events was unknown. Reporter confirmed that patient was not pregnant.  Company comment: This spontaneous case concerns a 22-year-old, female patient, with no reported medical history, who experienced an unexpected, medically significant serious event of Angioedema post-vaccination with her booster dose of mRNA-1273 vaccine. Exact onset latency of the event angioedema cannot be established without a known start date of said event and her vaccination. Reportedly, she received a 2-dose primary series with mRNA-1273 vaccine. After her booster vaccination, she had severe hives and severe facial swelling that persisted without difficulty of breathing. She then visited the emergency room for her symptoms where Zyrtec and Pepcid were prescribed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.   This case was linked to MOD-2022-546533, MOD-2022-546539.; Sender's Comments: This spontaneous case concerns a 22-year-old, female patient, with no reported medical history, who experienced an unexpected, medically significant serious event of Angioedema post-vaccination with her booster dose of mRNA-1273 vaccine. Exact onset latency of the event angioedema cannot be established without a known start date of said event and her vaccination. Reportedly, she received a 2-dose primary series with mRNA-1273 vaccine. After her booster vaccination, she had severe hives and severe facial swelling that persisted without difficulty of breathing. She then visited the emergency room for her symptoms where Zyrtec and Pepcid were prescribed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.