Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: third degree or full thickness burn on her right upper thigh; second degree burns on her left breast and underneath her right breast; Subsequent cellulitis in right thigh and left breast; Passed out; nauseous; had a hard time sleeping at night because her entire body ached; entire body ached; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNS THIRD DEGREE (third degree or full thickness burn on her right upper thigh), BURNS SECOND DEGREE (second degree burns on her left breast and underneath her right breast), CELLULITIS (Subsequent cellulitis in right thigh and left breast) and LOSS OF CONSCIOUSNESS (Passed out) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced INSOMNIA (had a hard time sleeping at night because her entire body ached) and MYALGIA (entire body ached). On 22-Apr-2021, the patient experienced BURNS THIRD DEGREE (third degree or full thickness burn on her right upper thigh) (seriousness criteria hospitalization and medically significant), BURNS SECOND DEGREE (second degree burns on her left breast and underneath her right breast) (seriousness criterion hospitalization), CELLULITIS (Subsequent cellulitis in right thigh and left breast) (seriousness criteria hospitalization and medically significant), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and NAUSEA (nauseous). The patient was hospitalized from 22-Apr-2021 to 25-Apr-2021 due to BURNS SECOND DEGREE, BURNS THIRD DEGREE and CELLULITIS. At the time of the report, BURNS THIRD DEGREE (third degree or full thickness burn on her right upper thigh), BURNS SECOND DEGREE (second degree burns on her left breast and underneath her right breast) and CELLULITIS (Subsequent cellulitis in right thigh and left breast) had not resolved and LOSS OF CONSCIOUSNESS (Passed out), INSOMNIA (had a hard time sleeping at night because her entire body ached), MYALGIA (entire body ached) and NAUSEA (nauseous) outcome was unknown.            No concomitant medications were reported. The patient had a hard time sleeping during the night she received her second vaccine because her entire body ached. On the next morning, she was nauseous so she got out to make herself some tea.  While standing at the stove waiting for the water to boil, her nausea got worse. As she was pouring hot water from the kettle into her cup, she passed out, spilling the boiling hot water on herself and woke up as her father was picking her up from the floor. She sustained third degree or full thickness burn on her right upper thigh and second degree burns on her left breast and underneath her right breast. Subsequently, she had cellulitis in her right thigh and left breast.  As a result, she was admitted to hospital with unspecified intravenous antibiotics and was hospitalized for three and half days. At the time of this report, she was at home and had a follow up appointment with plastic surgeon for debridement of her wounds. She did not have daily medications, but had continued pain in her right thigh and under right breast that is tolerable.  Company Comment: 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.