Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Chest discomfort, Insomnia, Lymphadenopathy, Swelling face
Clinical narrative: Swelling of the lymph nodes in neck-on the right side; Face started to swell; woke up in the middle of the night; Angioedema/lips started to swell after the injection/face started to swell; Felt pressure on the chest; This spontaneous case was reported by a patient and describes the occurrence of ANGIOEDEMA (Angioedema/lips started to swell after the injection/face started to swell) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D), PANTOPRAZOLE, BACLOFEN, MONTELUKAST SODIUM (SINGULAIR) and LORAZEPAM for an unknown indication.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced ANGIOEDEMA (Angioedema/lips started to swell after the injection/face started to swell) (seriousness criterion medically significant). 16-Jul-2021, the patient experienced CHEST DISCOMFORT (Felt pressure on the chest) and INSOMNIA (woke up in the middle of the night). On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling of the lymph nodes in neck-on the right side) and SWELLING FACE (Face started to swell). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CIMETIDINE HYDROCHLORIDE (TAGAMET [CIMETIDINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 16-Jul-2021, CHEST DISCOMFORT (Felt pressure on the chest) had resolved. On 17-Jul-2021, INSOMNIA (woke up in the middle of the night) had not resolved. At the time of the report, ANGIOEDEMA (Angioedema/lips started to swell after the injection/face started to swell), LYMPHADENOPATHY (Swelling of the lymph nodes in neck-on the right side) and SWELLING FACE (Face started to swell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient experienced angioedema her lips started to swell 30 minutes after the injection, and her face started to swell 2 days after vaccination. The patient experienced swelling of the lymph nodes in her neck  on the right side. The patient woke up in the middle of the night and felt pressure on the chest, but it lasted a couple of seconds and then went away.   The patient went to the rheumatologist and was given a Depo-Medrol shot. The patient was also taking Benadryl and Tagamet.  Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.