Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Death, Erythema, Fall
Clinical narrative: passed away; he fell down 3 times but like in slow motion, he fell on the floor with his face down; face was more swollen; face started changing colors, it became burgundy, blue, and kind of red; his legs and arms were going numb; tested twice for COVID and the results came back as positive; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) and COVID-19 (tested twice for COVID and the results came back as positive) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic and Diabetes (Ongoing up until death) since 2021. Concomitant products included INSULIN GLARGINE (LANTUS) for Diabetes.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In February 2022, the patient experienced COVID-19 (tested twice for COVID and the results came back as positive) (seriousness criterion death) and HYPOAESTHESIA (his legs and arms were going numb). On 21-Feb-2022, the patient experienced SWELLING FACE (face was more swollen) and ERYTHEMA (face started changing colors, it became burgundy, blue, and kind of red). On 25-Feb-2022, the patient experienced FALL (he fell down 3 times but like in slow motion, he fell on the floor with his face down). The patient died on 26-Feb-2022. The cause of death was not reported. An autopsy was not performed. At the time of death, SWELLING FACE (face was more swollen), FALL (he fell down 3 times but like in slow motion, he fell on the floor with his face down), HYPOAESTHESIA (his legs and arms were going numb) and ERYTHEMA (face started changing colors, it became burgundy, blue, and kind of red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 35-36 35F-36F. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No treatment drug was provided by reporter.  It was reported that for an unknown concomitant medication description was given as Antidepressant.  Company Comment: This spontaneous case concerns a 30-year-old male patient, with relevant medical history of Allergy to antibiotic and Diabetes, who experienced the unexpected serious event of Death, the unexpected AESI of COVID-19. The events Swelling Face, Hypoesthesia, and Erythema, occurred approximately 1 day after receiving the first dose of mRNA-1273 Vaccine. The patient suddenly experienced Fall 4 days later that led to an emergency call to paramedics. However, upon evaluation of vital signs, the patient was reported to have suffered a fatal event. The cause of death was not reported. An autopsy was not performed due to the positive SARS-CoV-2 test. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 30-year-old male patient, with relevant medical history of Allergy to antibiotic and Diabetes, who experienced the unexpected serious event of Death, the unexpected AESI of COVID-19. The events Swelling Face, Hypoesthesia, and Erythema, occurred approximately 1 day after receiving the first dose of mRNA-1273 Vaccine. The patient suddenly experienced Fall 4 days later that led to an emergency call to paramedics. However, upon evaluation of vital signs, the patient was reported to have suffered a fatal event. The cause of death was not reported. An autopsy was not performed due to the positive SARS-CoV-2 test. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death