Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Presyncope, Swelling face, Throat tightness
Clinical narrative: Face is red as a tomato; Face is swollen; Throat is closed and cannot breathe; Chest pain; Body aches; Her throat keeps closing up on her/ throat began to close up and off; Almost passing out; Almost passing out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Her throat keeps closing up on her/ throat began to close up and off), NEAR DEATH EXPERIENCE (Almost passing out), ERYTHEMA (Face is red as a tomato), SWELLING FACE (Face is swollen), DYSPNOEA (Throat is closed and cannot breathe), CHEST PAIN (Chest pain), PRESYNCOPE (Almost passing out) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRESYNCOPE (Almost passing out) (seriousness criterion hospitalization). On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROAT TIGHTNESS (Her throat keeps closing up on her/ throat began to close up and off) (seriousness criteria hospitalization and life threatening) and NEAR DEATH EXPERIENCE (Almost passing out) (seriousness criteria hospitalization and medically significant). On 18-May-2021, the patient experienced ERYTHEMA (Face is red as a tomato) (seriousness criterion hospitalization), SWELLING FACE (Face is swollen) (seriousness criterion hospitalization), DYSPNOEA (Throat is closed and cannot breathe) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and MYALGIA (Body aches) (seriousness criterion hospitalization). The patient was hospitalized until 18-May-2021 due to CHEST PAIN, DYSPNOEA, ERYTHEMA, MYALGIA, NEAR DEATH EXPERIENCE, PRESYNCOPE, SWELLING FACE and THROAT TIGHTNESS. At the time of the report, THROAT TIGHTNESS (Her throat keeps closing up on her/ throat began to close up and off) had not resolved and NEAR DEATH EXPERIENCE (Almost passing out), ERYTHEMA (Face is red as a tomato), SWELLING FACE (Face is swollen), DYSPNOEA (Throat is closed and cannot breathe), CHEST PAIN (Chest pain), PRESYNCOPE (Almost passing out) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Chest X-ray: (Inconclusive) Lungs look good.         No concomitant medications were reported.   Treatment included epinephrine (EpiPen), morphine,  2 breathing treatments (unknown) and diphenhydramine (Benadryl).  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.      Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18 May 2021. The product details updated. Event details updated.; 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.