Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Feeling abnormal, Headache
Clinical narrative: Headache; Chills; Vertigo; Nausea; He threw up for about 20 minutes; He feels odd here and there; Random onset on backpain now, in the lumbar area; He almost passed out; Heart beat was 130; Fever of 100.6; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (He almost passed out), HEADACHE (Headache), CHILLS (Chills), VERTIGO (Vertigo), NAUSEA (Nausea) and VOMITING (He threw up for about 20 minutes) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (He almost passed out) (seriousness criterion medically significant), VERTIGO (Vertigo) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization), VOMITING (He threw up for about 20 minutes) (seriousness criterion hospitalization) and TACHYCARDIA (Heart beat was 130). On 20-Apr-2021 at 10:00 PM, the patient experienced HEADACHE (Headache) (seriousness criterion hospitalization) and CHILLS (Chills) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (He feels odd here and there), BACK PAIN (Random onset on backpain now, in the lumbar area) and PYREXIA (Fever of 100.6). At the time of the report, LOSS OF CONSCIOUSNESS (He almost passed out), HEADACHE (Headache), CHILLS (Chills), VERTIGO (Vertigo), VOMITING (He threw up for about 20 minutes), TACHYCARDIA (Heart beat was 130), FEELING ABNORMAL (He feels odd here and there), BACK PAIN (Random onset on backpain now, in the lumbar area) and PYREXIA (Fever of 100.6) outcome was unknown and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Body temperature: 100.6 (High) 100.6. On 20-Apr-2021, Heart rate: abnormal (abnormal) Resting heart rate was 130. Additionally irregular heartbeat reported..         Patient got to the hospital where he was given pain medication and medication for vertigo. He was in the hospital for 6.5-7 hours.When he was discharged nausea went away and it took him 48 hours after ER visit to feel normal.  Concomitant medication information not provided. Action taken with mRNA-1273 in response to the events was not applicable. 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-114588 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-114588:dose 1