Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: severe allergic reaction; hives; rash, undescribed rash; face swelled up/eyes swelled up; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), URTICARIA (hives), RASH (rash, undescribed rash) and ANGIOEDEMA (face swelled up/eyes swelled up) in a 23-year-old male 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.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction) (seriousness criterion medically significant), URTICARIA (hives) (seriousness criterion medically significant), RASH (rash, undescribed rash) (seriousness criterion medically significant), ANGIOEDEMA (face swelled up/eyes swelled up) (seriousness criterion medically significant), CHILLS (chills) and PYREXIA (fever). In 2021, HYPERSENSITIVITY (severe allergic reaction), URTICARIA (hives), RASH (rash, undescribed rash), ANGIOEDEMA (face swelled up/eyes swelled up), CHILLS (chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included were antihistamine to calm it down.  The ER said the rash was an undescribed rash. Patient was not history of reactions to childhood vaccines, foods, or medication and is healthy. Patient doctor told him to not get the second shot because of his severe allergic reaction. Patient saw his dermatologist and primary care physician after the ER visit (no hospital admission).  Company Comment: This spontaneous case concerns a 23 year old male with no reported medical history , who experienced Serious ( Medically significant ) , unexpected events of hypersensitivity, Angioedema, urticaria, rash which occurred on an unknown date in may 2021 after vaccination with the first of dose of mRNA-1273 vaccine ( Moderna  Covid 19 Vaccine ) . Also on an unknown date in may 2021 after vaccination with the 1st dose of mRNA-1273 vaccine , he experienced , non-serious , expected events of fever and chills.  The patient made emergency room visit ( given  antihistamine )  and follow up with dermatologist  and primary care physician . The re-challenge for this case is unknown since there are no details re the 2nd dose. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 23 year old male with no reported medical history , who experienced Serious ( Medically significant ) , unexpected events of hypersensitivity, Angioedema, urticaria, rash which occurred on an unknown date in may 2021 after vaccination with the first of dose of mRNA-1273 vaccine ( Moderna  Covid 19 Vaccine ) . Also on an unknown date in may 2021 after vaccination with the 1st dose of mRNA-1273 vaccine , he experienced , non-serious , expected events of fever and chills.  The patient made emergency room visit ( given  antihistamine )  and follow up with dermatologist  and primary care physician . The re-challenge for this case is unknown since there are no details re the 2nd dose. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.