Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Loss of personal independence in daily activities, Myalgia, Pyrexia, Somnolence
Clinical narrative: knocked out; sweaty/had sweats; could not take a shower; had no energy; felt like he had flu; slept all day; did not eat much; a fever that went highest 100.8 F/fever never went more than 101 F; achiness; extremely tired/extreme fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (knocked out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII on 03-Sep-2021. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (knocked out) (seriousness criterion medically significant), HYPERHIDROSIS (sweaty/had sweats), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take a shower), ASTHENIA (had no energy), INFLUENZA LIKE ILLNESS (felt like he had flu), SOMNOLENCE (slept all day), EATING DISORDER (did not eat much), PYREXIA (a fever that went highest 100.8 F/fever never went more than 101 F), MYALGIA (achiness) and FATIGUE (extremely tired/extreme fatigue). At the time of the report, LOSS OF CONSCIOUSNESS (knocked out), HYPERHIDROSIS (sweaty/had sweats), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take a shower), ASTHENIA (had no energy), INFLUENZA LIKE ILLNESS (felt like he had flu), SOMNOLENCE (slept all day), EATING DISORDER (did not eat much), PYREXIA (a fever that went highest 100.8 F/fever never went more than 101 F), MYALGIA (achiness) and FATIGUE (extremely tired/extreme fatigue) outcome was unknown.            No concomitant medication information was provided No treatment product information was provided. other concomitant medication includes vitamins and Blood pressure medication.  Company comment: Atorvastatin) who experienced the unexpected serious event of loss of consciousness and non-serious event of hyperhidrosis, somnolence, eating disorder, Influenzalike illness, loss of personal independence, and asthenia and expected events of pyrexia, myalgia and fatigue . The events occurred following an unspecified period after the second dose of mRNA-1273 (onset date provided). The rechallenge was unknown. Causality for the events was not provided by the reporter. The events of pyrexia, myalgia and fatigue are consistent with the current understanding of the mechanism of action of mRNA-1273.The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-320106 (Patient Link).; Sender's Comments: Atorvastatin) who experienced the unexpected serious event of loss of consciousness and non-serious event of hyperhidrosis, somnolence, eating disorder, Influenzalike illness, loss of personal independence, and asthenia and expected events of pyrexia, myalgia and fatigue . The events occurred following an unspecified period after the second dose of mRNA-1273 (onset date provided). The rechallenge was unknown. Causality for the events was not provided by the reporter. The events of pyrexia, myalgia and fatigue are consistent with the current understanding of the mechanism of action of mRNA-1273.The benefit-risk relationship of mRNA-1273 is not affected by this report.