Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Hypersensitivity, Mouth swelling, Pharyngeal swelling
Clinical narrative: Facial swelling after booster; Swollen Mouth; Open sores in the mouth after booster; Swollen Throat; Very uncomfortable after booster; Swollen after booster//swollen Head after booster; Itchy after booster; Allergic reaction after booster; Fever 101F after booster; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling after booster), MOUTH SWELLING (Swollen Mouth), STOMATITIS (Open sores in the mouth after booster), PHARYNGEAL SWELLING (Swollen Throat) and DISCOMFORT (Very uncomfortable after booster) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 045B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic shock. Concurrent medical conditions included Soy allergy (She thinks that PEG 2000 in the vaccine came from Soy).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced SWELLING FACE (Facial swelling after booster), MOUTH SWELLING (Swollen Mouth), STOMATITIS (Open sores in the mouth after booster), PHARYNGEAL SWELLING (Swollen Throat), DISCOMFORT (Very uncomfortable after booster), SWELLING (Swollen after booster//swollen Head after booster), PRURITUS (Itchy after booster), HYPERSENSITIVITY (Allergic reaction after booster) and PYREXIA (Fever 101F after booster). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 15-Dec-2021, PYREXIA (Fever 101F after booster) had resolved. At the time of the report, SWELLING FACE (Facial swelling after booster), MOUTH SWELLING (Swollen Mouth), PHARYNGEAL SWELLING (Swollen Throat), SWELLING (Swollen after booster//swollen Head after booster) and PRURITUS (Itchy after booster) had not resolved and STOMATITIS (Open sores in the mouth after booster), DISCOMFORT (Very uncomfortable after booster) and HYPERSENSITIVITY (Allergic reaction after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2021, Body temperature: 101 (abnormal) Fever 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported.  Patient thinks that PEG 2000 in the vaccine came from Soy and say she did not have anything else at the time that would cause an allergic reaction. Patient also stated  many years ago patient took Tylenol FLU blue liquid and had a anaphylactic reaction to it and had to use EpiPen at the ER