Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophageal spasm, Oropharyngeal discomfort, Pharyngeal swelling, Pruritus, Somnolence
Clinical narrative: angioedema symptoms; face and lips swell/swell especially the lips; face and lips swell/whole face is swell; swell especially the lips and throat/as there is swelling in the throat; extreme amount of hives that cover the whole body and rotate form different areas/hives continue as there is no improvement; itching; burning sensation like a 2nd degree burn; throat feels weird; muscle does not work; esophageal spasms; affecting her work as she is sleepy; making her life difficult/are not getting better; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema symptoms), LIP SWELLING (face and lips swell/swell especially the lips), SWELLING FACE (face and lips swell/whole face is swell) and PHARYNGEAL SWELLING (swell especially the lips and throat/as there is swelling in the throat) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 011J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced ANGIOEDEMA (angioedema symptoms) (seriousness criteria medically significant and life threatening), LIP SWELLING (face and lips swell/swell especially the lips) (seriousness criterion life threatening), SWELLING FACE (face and lips swell/whole face is swell) (seriousness criterion life threatening), PHARYNGEAL SWELLING (swell especially the lips and throat/as there is swelling in the throat) (seriousness criterion life threatening), URTICARIA (extreme amount of hives that cover the whole body and rotate form different areas/hives continue as there is no improvement), PRURITUS (itching), BURNING SENSATION (burning sensation like a 2nd degree burn), OROPHARYNGEAL DISCOMFORT (throat feels weird), MUSCLE DISCOMFORT (muscle does not work), OESOPHAGEAL SPASM (esophageal spasms), SOMNOLENCE (affecting her work as she is sleepy) and FEELING ABNORMAL (making her life difficult/are not getting better). At the time of the report, ANGIOEDEMA (angioedema symptoms), LIP SWELLING (face and lips swell/swell especially the lips), SWELLING FACE (face and lips swell/whole face is swell), PHARYNGEAL SWELLING (swell especially the lips and throat/as there is swelling in the throat), PRURITUS (itching), BURNING SENSATION (burning sensation like a 2nd degree burn), OROPHARYNGEAL DISCOMFORT (throat feels weird), MUSCLE DISCOMFORT (muscle does not work), OESOPHAGEAL SPASM (esophageal spasms), SOMNOLENCE (affecting her work as she is sleepy) and FEELING ABNORMAL (making her life difficult/are not getting better) outcome was unknown and URTICARIA (extreme amount of hives that cover the whole body and rotate form different areas/hives continue as there is no improvement) had not resolved.            No concomitant medications were reported.  Patient mentioned that 12 days after she received the booster dose, she was experiencing daily extreme amount of hives that cover the whole body and rotate form different areas. Patient stated that there was itching but along with burning sensation like a 2nd degree burn and at the same time and had angioedema symptoms where the face and lips swell, the whole face was swollen especially the lips and throat. Patient stated that her throat feels weird, muscle does not work as there was swelling in the throat and had esophageal spasms. The patient stated that the hives continue as there was no improvement and takes double the dose of antihistamine daily in order to function. This was affecting her work as she was sleepy and was making her life difficult. The patient stated that she tried to not take the antihistamines to see if symptoms were getting better but stated they were not getting better as the symptoms came back.  Patient provided consent for safety to follow up with her via email and phone. Treatment received by patient was mentioned as Antihistamine  Company comment:This is a spontaneous case concerning a 43-year-old female patient with no medical history provided, who experienced the serious unexpected events of Angioedema, Lip swelling, Swelling face, and Pharynglea swelling (seriousness criteria medically significant and life threatening). These events occurred 12 days after the patient received the third dose of mRNA-1273 (Moderna COVID-19 Vaccine).  The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-441215 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 43-year-old female patient with no medical history provided, who experienced the serious unexpected events of Angioedema, Lip swelling, Swelling face, and Pharynglea swelling (seriousness criteria medically significant and life threatening). These events occurred 12 days after the patient received the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown since there's no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.