Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Lip swelling, Pruritus, Pyrexia, Urticaria
Clinical narrative: Angioedema lower lip swelled up; Experiencing full body hives around armpit and waist; Itching all over; Fever of 100 degrees fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema lower lip swelled up) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 021C21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema lower lip swelled up) (seriousness criterion medically significant), URTICARIA (Experiencing full body hives around armpit and waist), PRURITUS (Itching all over) and PYREXIA (Fever of 100 degrees fahrenheit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 50 mg; IBUPROFEN for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) for Adverse event, at a dose of 20 mg and TRIAMCINOLONE ACETONIDE for Adverse event, at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (Angioedema lower lip swelled up), URTICARIA (Experiencing full body hives around armpit and waist), PRURITUS (Itching all over) and PYREXIA (Fever of 100 degrees fahrenheit) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) Fever of 100 degrees Fahrenheit.         Concomitant product use was not provided by the reporter.  The patient experienced full body hives and itching all over body along with fever and angioedema. The symptoms were ongoing.  This is a spontaneous case concerning  a  50-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious events of decreased Angioedema, Urticaria, Pruritus, Pyrexia. The events occurred approximately on an unknown day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  50-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious events of decreased Angioedema, Urticaria, Pruritus, Pyrexia. The events occurred approximately on an unknown day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.