Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Lip swelling, Pharyngeal swelling, Rash
Clinical narrative: Throat, tongue, lips, feet, face were extremely swollen; Lips, feet, face were extremely swollen; Face were extremely swollen; Difficult with breathing; Neck throat, tongue, lips, feet, face were extremely swollen; Dizziness; Hives rash on face, neck, lips, hands feet); Hives rash on face, neck, lips, hands feet); Throwing up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), URTICARIA (Hives rash on face, neck, lips, hands feet)), SWELLING (Neck throat, tongue, lips, feet, face were extremely swollen), PHARYNGEAL SWELLING (Throat, tongue, lips, feet, face were extremely swollen) and LIP SWELLING (Lips, feet, face were extremely swollen) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIZZINESS (Dizziness), URTICARIA (Hives rash on face, neck, lips, hands feet)), RASH (Hives rash on face, neck, lips, hands feet)) and VOMITING (Throwing up). On 24-Apr-2021, the patient experienced SWELLING (Neck throat, tongue, lips, feet, face were extremely swollen), SWELLING FACE (Face were extremely swollen) and DYSPNOEA (Difficult with breathing). On 30-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Throat, tongue, lips, feet, face were extremely swollen) and LIP SWELLING (Lips, feet, face were extremely swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 23-Apr-2021 at a dose of 50 milligram every eight hours; LORATADINE (CLARITIN [LORATADINE]) on 24-Apr-2021 at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) on 24-Apr-2021 at an unspecified dose and frequency; EPINEPHRINE on 25-Apr-2021 at a dose of 2 shots; ALBUTEROL [SALBUTAMOL] on 25-Apr-2021 at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 28-Apr-2021 at a dose of UNK, bid, 1tablet; PREDNISONE (oral) on 29-Apr-2021 at a dose of 20 milligram twice a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 29-Apr-2021 at a dose of 25 milligram every six hours. At the time of the report, DIZZINESS (Dizziness), URTICARIA (Hives rash on face, neck, lips, hands feet)), SWELLING (Neck throat, tongue, lips, feet, face were extremely swollen), PHARYNGEAL SWELLING (Throat, tongue, lips, feet, face were extremely swollen), LIP SWELLING (Lips, feet, face were extremely swollen), SWELLING FACE (Face were extremely swollen), DYSPNOEA (Difficult with breathing), RASH (Hives rash on face, neck, lips, hands feet)) and VOMITING (Throwing up) outcome was unknown.            Treatment medications also included steroid, antihistamine, anti-itch and IV fluid. Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-101799 (Patient Link).