Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Fatigue, Hypersensitivity, Mechanical urticaria
Clinical narrative: Hives and intense itching all over body, accompanied by dermatographia and angiodema; Hives and intense itching all over body, accompanied by dermatographia and angiodema; Hypersensitivity reaction; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Hives and intense itching all over body, accompanied by dermatographia and angiodema) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070h21a, 0321321a and 025b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022 at 8:00 AM, the patient experienced ANGIOEDEMA (Hives and intense itching all over body, accompanied by dermatographia and angiodema) (seriousness criterion medically significant), MECHANICAL URTICARIA (Hives and intense itching all over body, accompanied by dermatographia and angiodema), HYPERSENSITIVITY (Hypersensitivity reaction) and FATIGUE (Extremely tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing from 25-Jan-2022 for Adverse event, at a dose of 1-4x prescribed dosage; LORATADINE (CLARITIN [LORATADINE]) ongoing from 25-Jan-2022 for Adverse event, at a dose of 1-4x prescribed dosage; FEXOFENADINE HYDROCHLORIDE (ALLEGRA 12 HOUR) ongoing from 25-Jan-2022 for Adverse event, at a dose of 1-4x prescribed dosage; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing from 25-Jan-2022 for Adverse event, at a dose of 1-4x prescribed dosage and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) ongoing from 25-Jan-2022 for Adverse event, at a dose of 1-4x prescribed dosage. At the time of the report, ANGIOEDEMA (Hives and intense itching all over body, accompanied by dermatographia and angiodema), MECHANICAL URTICARIA (Hives and intense itching all over body, accompanied by dermatographia and angiodema), HYPERSENSITIVITY (Hypersensitivity reaction) and FATIGUE (Extremely tired) had not resolved.            No concomitant medication were reported. It was reported that  Approximately 10 days after receiving booster, patient tarted itching all over, developed hives, dermatographia, and angiodema. It has been 8 weeks and condition has not improved at all. Patient received anti-histamine. Patient experienced symptoms of generalized itching/pruritus, Hives/urticaria generalized, Redness/erythema generalized, Rash Generalized. Patient was visit to the doctor's office /urgent care visit for medical care. Patient use anti-histamines: Benadryl- that did not help symptoms, Claritin - little improvement in symptoms, Zyrtec - very good improvement in itching and hives, very little improvement on dermatagraphia. Makes extremely tired, Xyzal- very good improvement in itching and hives, some improvement on dermatagraphia.  Company comment: This spontaneous case concerns a 35-year-old female patient with no medical history reported, who experienced the serious (medically significant) unexpected event of Angioedema, associated with the expected event of Hypersensitivity, 10 to 12 days after receiving the booster dose of mRNA- 1273 vaccine. Multiple treatments with antihistamines were prescribed, but the condition was ongoing after 8 weeks, at the time of the report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 35-year-old female patient with no medical history reported, who experienced the serious (medically significant) unexpected event of Angioedema, associated with the expected event of Hypersensitivity, 10 to 12 days after receiving the booster dose of mRNA- 1273 vaccine. Multiple treatments with antihistamines were prescribed, but the condition was ongoing after 8 weeks, at the time of the report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.