Sex: U
Vaccine: COVID19
Symptoms: Angioedema, Dyspepsia, Dyspnoea, Pruritus, Rash
Clinical narrative: By early morning 11/11, I was worse and started to feel like I couldn't breathe; I am 8 weeks from the initial breakout and still dealing daily with breakouts and itching; I am 8 weeks from the initial breakout and still dealing daily with breakouts; Angioedema of the eyes, lips and face; broke out with hives all over my body; Indigestion; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema of the eyes, lips and face) in a  patient of an unknown age and gender 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 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced DYSPEPSIA (Indigestion). On 09-Nov-2021, the patient experienced ANGIOEDEMA (Angioedema of the eyes, lips and face) (seriousness criterion medically significant), URTICARIA (broke out with hives all over my body), PRURITUS (I am 8 weeks from the initial breakout and still dealing daily with breakouts and itching) and RASH (I am 8 weeks from the initial breakout and still dealing daily with breakouts). On 11-Nov-2021, the patient experienced DYSPNOEA (By early morning 11/11, I was worse and started to feel like I couldn't breathe). At the time of the report, ANGIOEDEMA (Angioedema of the eyes, lips and face), DYSPEPSIA (Indigestion) and DYSPNOEA (By early morning 11/11, I was worse and started to feel like I couldn't breathe) outcome was unknown and URTICARIA (broke out with hives all over my body), PRURITUS (I am 8 weeks from the initial breakout and still dealing daily with breakouts and itching) and RASH (I am 8 weeks from the initial breakout and still dealing daily with breakouts) had not resolved.            It was reported as on the night of 11/8/21, patient started feeling of indigestion. When patient got up in the morning of 11/9/2021 was broke out with hives all over body and had angioedema of eyes, lips, and face. Then patient went to urgent care and was given steroid shot also was put on oral steroids as well as antihistamines. On 11/9/2021 early morning patient was worse and started to feel like couldn't breathe. Patient went ER was given Epi shot, steroids and iv antihistamines. By the night of 11/12/2021 patient was again back in ER with same complains and was given same medications, but the steroids were increased, and other antihistamines were prescribed. Patient followed up with Primary care physician (PCP) and he sent patient to an allergist.  Patient was 8 weeks from the initial breakout and still dealing with daily breakouts and itching.   Company Comment : This case concerns a patient of unknown age and gender with no medical history, who experienced the Serious unexpected event of angioedema 11 days after receiving the booster dose of mRNA-1273 vaccine. The details of other 2 doses are not provided. 11 days after receiving the vaccine, the patient experienced hives all over the body and had angioedema of eyes, lips and face, went to urgent care and was given steroid shot and put on oral steroids as well as antihistamines. 2 days later, patient was worse and started to feel like couldn't breathe. 8 weeks from the initial breakout patient was still dealing daily with breakouts and itching.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history, who experienced the Serious unexpected event of angioedema 11 days after receiving the booster dose of mRNA-1273 vaccine. The details of other 2 doses are not provided. 11 days after receiving the vaccine, the patient experienced hives all over the body and had angioedema of eyes, lips and face, went to urgent care and was given steroid shot and put on oral steroids as well as antihistamines. 2 days later, patient was worse and started to feel like couldn't breathe. 8 weeks from the initial breakout patient was still dealing daily with breakouts and itching.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.