Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Loss of consciousness, Myalgia, Nausea
Clinical narrative: was in neuro ICU for 2 days where she had oxygen issues; passed out while driving her car and hit a car in front of her; passed out while driving her car and hit a car in front of her; her body felt like it was vibrating on the inside, nausea, achy pains and tired; her body felt like it was vibrating on the inside, nausea, achy pains and tired; her body felt like it was vibrating on the inside, nausea, achy pains and tired; her body felt like it was vibrating on the inside, nausea, achy pains and tired; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION ABNORMAL (was in neuro ICU for 2 days where she had oxygen issues) and LOSS OF CONSCIOUSNESS (passed out while driving her car and hit a car in front of her) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Brain damage (due to coming off drugs cold turkey) and Drug abuse. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (TRIVORA) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced OXYGEN SATURATION ABNORMAL (was in neuro ICU for 2 days where she had oxygen issues) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (passed out while driving her car and hit a car in front of her) (seriousness criterion medically significant), ROAD TRAFFIC ACCIDENT (passed out while driving her car and hit a car in front of her), CHILLS (her body felt like it was vibrating on the inside, nausea, achy pains and tired), NAUSEA (her body felt like it was vibrating on the inside, nausea, achy pains and tired), MYALGIA (her body felt like it was vibrating on the inside, nausea, achy pains and tired) and FATIGUE (her body felt like it was vibrating on the inside, nausea, achy pains and tired). At the time of the report, OXYGEN SATURATION ABNORMAL (was in neuro ICU for 2 days where she had oxygen issues), LOSS OF CONSCIOUSNESS (passed out while driving her car and hit a car in front of her), ROAD TRAFFIC ACCIDENT (passed out while driving her car and hit a car in front of her), CHILLS (her body felt like it was vibrating on the inside, nausea, achy pains and tired), NAUSEA (her body felt like it was vibrating on the inside, nausea, achy pains and tired), MYALGIA (her body felt like it was vibrating on the inside, nausea, achy pains and tired) and FATIGUE (her body felt like it was vibrating on the inside, nausea, achy pains and tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. The reporter wants to know,  if the patient need to get the second dose as they were going on a cruise in August.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Myalgia, nausea , chills and fatigue are consistent with the product safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Myalgia, nausea , chills and fatigue are consistent with the product safety profile.