Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain, Pruritus, Rash, Swelling face
Clinical narrative: Pain in eyes; Lips was swollen; Itchy; Burning; all around her cheeks and near the nose was in pain; Like a rash; Mouth went to one side of her face; Left side of her face get swollen; 3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful; Big and red spot in the upper part of her face; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL ASYMMETRY (Mouth went to one side of her face) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (Takes medications for high blood pressure.). Concomitant products included INSULIN for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced FACIAL ASYMMETRY (Mouth went to one side of her face) (seriousness criterion medically significant), SWELLING FACE (Left side of her face get swollen), BLISTER (3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful), LIP SWELLING (Lips was swollen), PRURITUS (Itchy), BURNING SENSATION (Burning), PAIN (all around her cheeks and near the nose was in pain) and RASH (Like a rash). 02-Apr-2021, the patient experienced ERYTHEMA (Big and red spot in the upper part of her face). On 06-Apr-2021, the patient experienced EYE PAIN (Pain in eyes). At the time of the report, FACIAL ASYMMETRY (Mouth went to one side of her face) and ERYTHEMA (Big and red spot in the upper part of her face) was resolving and SWELLING FACE (Left side of her face get swollen), BLISTER (3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful), EYE PAIN (Pain in eyes), LIP SWELLING (Lips was swollen), PRURITUS (Itchy), BURNING SENSATION (Burning), PAIN (all around her cheeks and near the nose was in pain) and RASH (Like a rash) outcome was unknown.            Treatment: Hydrocortisone and Antihistamine Concomitant: A couple of High blood pressure medication  Additional information:Immediately after receiving the vaccine (she thinks) the L side of her face get swollen. Her lips was swollen, all around her cheeks and near the nose was in pain. And developed 3 or 4 spots on the top of her mouth, 3 or 4 fever-like blisters outside of her mouth. All outside, like a rash, it was itchy and burning. It was hurting and hard, very noise and painful. She also developed a big and red spot in the upper part of her face. Still there but is getting better (seem is going away). Her mouth went to one side of her face, to the R side. It still there but is getting better (tomorrow is going to be a week). Also, 4 days after the 2nd dose her eyes started to hurting and couldn't put drops. She never had fever, cough, chills or nausea.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.