Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Eye pruritus, Eye swelling, Nasal congestion, Nasal oedema
Clinical narrative: puffy bags under my eyes; itching on my cheeks; throat sore because I'm breathing through my mouth; face was totally swollen/face swollen up like a balloon; started with my right eye itching/both eyes started itching; right eye was shut/both my eyes were completely shut/eyes are shut down for two and half days now; nose is all swollen; nose is so swollen that I can't breath with that; had a slight temperature; started with adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was totally swollen/face swollen up like a balloon), EYE SWELLING (right eye was shut/both my eyes were completely shut/eyes are shut down for two and half days now), PERIORBITAL SWELLING (puffy bags under my eyes) and PRURITUS (itching on my cheeks) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not provided.).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced ADVERSE REACTION (started with adverse reaction). On 10-Apr-2021, the patient experienced SWELLING FACE (face was totally swollen/face swollen up like a balloon) (seriousness criterion medically significant), EYE PRURITUS (started with my right eye itching/both eyes started itching), EYE SWELLING (right eye was shut/both my eyes were completely shut/eyes are shut down for two and half days now) (seriousness criterion intervention required), PRURITUS (itching on my cheeks) (seriousness criterion intervention required), OROPHARYNGEAL PAIN (throat sore because I'm breathing through my mouth), NASAL OEDEMA (nose is all swollen), NASAL CONGESTION (nose is so swollen that I can't breath with that) and PYREXIA (had a slight temperature). On 11-Apr-2021, the patient experienced PERIORBITAL SWELLING (puffy bags under my eyes) (seriousness criterion intervention required). At the time of the report, SWELLING FACE (face was totally swollen/face swollen up like a balloon), EYE PRURITUS (started with my right eye itching/both eyes started itching), EYE SWELLING (right eye was shut/both my eyes were completely shut/eyes are shut down for two and half days now), PERIORBITAL SWELLING (puffy bags under my eyes), PRURITUS (itching on my cheeks), OROPHARYNGEAL PAIN (throat sore because I'm breathing through my mouth), ADVERSE REACTION (started with adverse reaction), NASAL OEDEMA (nose is all swollen), NASAL CONGESTION (nose is so swollen that I can't breath with that) and PYREXIA (had a slight temperature) outcome was unknown. Not Provided          Patient reports taking diphenhydramine with no improvement and prednisone with slight improvment. PCP (primary care physician) advised the patient to go to the ER (emergency room); however, no information was provided suggesting the patient adhered to the HCP's recommendation.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.