Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Arthralgia, Back pain, Blister, Burning sensation
Clinical narrative: face has blisters; cheeks were swollen; could not move her hands; did not feel good; peeling all over her body; terrible pain/in a lot of pain; her whole face is burnt red/cheeks burn and are red.; back hurt; Face was burning; red down the neck/her whole throat on both sides and under her chin is burnt red; headache; Her knees-she can't walk like she used to/her knees do not work anymore/could not move her hands; hives about the size of a quarter; very bad face and eyelid swelling; Sensitive to sunburn and cannot put any sunscreen or cream on because it burns the skin; Right eye is blood shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (hives about the size of a quarter) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D30120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Knees and back surgery). Previously administered products included for an unreported indication: CORTICOSTEROID NOS (Corticosteroid injections therapy 2 years ago). Concurrent medical conditions included Diabetes.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced OCULAR HYPERAEMIA (Right eye is blood shot). On 23-Jan-2021, the patient experienced ANGIOEDEMA (hives about the size of a quarter) (seriousness criterion medically significant), SWELLING OF EYELID (very bad face and eyelid swelling), BACK PAIN (back hurt), BURNING SENSATION (Face was burning), SKIN BURNING SENSATION (Sensitive to sunburn and cannot put any sunscreen or cream on because it burns the skin), ERYTHEMA (red down the neck/her whole throat on both sides and under her chin is burnt red), HEADACHE (headache) and ARTHRALGIA (Her knees-she can't walk like she used to/her knees do not work anymore/could not move her hands). On 07-Apr-2021, the patient experienced ERYTHEMA (her whole face is burnt red/cheeks burn and are red.). On an unknown date, the patient experienced BLISTER (face has blisters), SWELLING (cheeks were swollen), HYPOKINESIA (could not move her hands), FEELING ABNORMAL (did not feel good), SKIN EXFOLIATION (peeling all over her body) and PAIN (terrible pain/in a lot of pain). On 23-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, ANGIOEDEMA (hives about the size of a quarter), SWELLING OF EYELID (very bad face and eyelid swelling), BLISTER (face has blisters), SWELLING (cheeks were swollen), ERYTHEMA (her whole face is burnt red/cheeks burn and are red.), BACK PAIN (back hurt), BURNING SENSATION (Face was burning), HYPOKINESIA (could not move her hands), FEELING ABNORMAL (did not feel good), SKIN EXFOLIATION (peeling all over her body), OCULAR HYPERAEMIA (Right eye is blood shot), SKIN BURNING SENSATION (Sensitive to sunburn and cannot put any sunscreen or cream on because it burns the skin), PAIN (terrible pain/in a lot of pain), ERYTHEMA (red down the neck/her whole throat on both sides and under her chin is burnt red) and ARTHRALGIA (Her knees-she can't walk like she used to/her knees do not work anymore/could not move her hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After 3 days, she decided to go to the ER by ambulance because the events did not improve. Received a Benadryl injection in the ER and was better until the next day when the problem started all over again. This day her cheeks burn and are red and sensitive to sunburn and cannot put any sunscreen or cream on because it burns the skin. Around the eyes she has large dark circles. Relevant concomitant medications were not reported.  Treatment information were included diphenhydramine (for oral) and diphenhydramine injection.  Based on the current available information and the temporal relationship between the product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up included reporter's contact details, patient's age, medical history, prior drug therapy, suspect drug batch number, route of administration, events, events onset date and treatments.; Sender's Comments: Based on the current available information and the temporal relationship between the product use and the start date of the events a causal relationship cannot be excluded.