Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Erythema, Mechanical urticaria, Pruritus
Clinical narrative: Dermatographia sometimes raised hives, red itchy skin that comes and goes; Angioedema around hands/which then turn to raised round areas on wrist.; Red itchy scalp; Red itchy scalp; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema around hands/which then turn to raised round areas on wrist.) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced PRURITUS (Red itchy scalp) and ERYTHEMA (Red itchy scalp). On 25-Dec-2021, the patient experienced ANGIOEDEMA (Angioedema around hands/which then turn to raised round areas on wrist.) (seriousness criterion medically significant). On an unknown date, the patient experienced MECHANICAL URTICARIA (Dermatographia sometimes raised hives, red itchy skin that comes and goes). At the time of the report, ANGIOEDEMA (Angioedema around hands/which then turn to raised round areas on wrist.), PRURITUS (Red itchy scalp), ERYTHEMA (Red itchy scalp) and MECHANICAL URTICARIA (Dermatographia sometimes raised hives, red itchy skin that comes and goes) outcome was unknown.            No concomitant medications were reported  The 9 days after booster her son experienced a red itchy scalp, which then turn to raised round areas on wrist. Reported angioedema around hands which was Christmas morning. Angioedema got worse went to ER a few days later and was prescribed steroids. Stated her son experiences intermittent dermatographia sometimes raised hives, red itchy skin that came and went.  Company Comment: This spontaneous  case concerns a 22 year old male with no medical history reported , who experienced Serious ( Medically significant ) , unexpected event of Angioedema 12 days post vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine). This case was accompanied by other non-serious unexpected events of pruritus, erythema  and mechanical urticaria. The  patient had worsening angioedema  and visited the ER and was given  steriods   as treatment This patient was vaccinated with mRNA-1273 vaccine  as primary series for  2 doses with no reported adverse events. The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and the outcome of the events was reported as unknown. 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 22 year old male with no medical history reported , who experienced Serious ( Medically significant ) , unexpected event of Angioedema 12 days post vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine). This case was accompanied by other non-serious unexpected events of pruritus, erythema  and mechanical urticaria. The  patient had worsening angioedema  and visited the ER and was given  steriods   as treatment This patient was vaccinated with mRNA-1273 vaccine  as primary series for  2 doses with no reported adverse events. The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and the outcome of the events was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.