Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersomnia, Lethargy, Pyrexia, Syncope
Clinical narrative: 3 days of intense diarrhea, lost about 10 pounds; Weak, no appetite, lethargic, sleeping a lot; Weak, no appetite, lethargic, sleeping a lot; Weak, no appetite, lethargic, sleeping a lot; Weak, no appetite, lethargic, sleeping a lot; Still just don't have the energy to this day; Chills all the time, fever of 102 for 5 days - went up every time after eating; Friday, got worse, by afternoon, was in bed. Got up to use restroom, next thing I remember was that I was on the floor and could not get up; Thursday, started not feeling great; 3 days of intense diarrhea, lost about 10 pounds; Chills all the time, fever of 102 for 5 days - went up every time after eating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Friday, got worse, by afternoon, was in bed. Got up to use restroom, next thing I remember was that I was on the floor and could not get up) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LEVOTHYROXINE SODIUM (SYNTHROID) and FINASTERIDE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Thursday, started not feeling great). On 19-Mar-2021, the patient experienced SYNCOPE (Friday, got worse, by afternoon, was in bed. Got up to use restroom, next thing I remember was that I was on the floor and could not get up) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (3 days of intense diarrhea, lost about 10 pounds), WEIGHT DECREASED (3 days of intense diarrhea, lost about 10 pounds), ASTHENIA (Weak, no appetite, lethargic, sleeping a lot), DECREASED APPETITE (Weak, no appetite, lethargic, sleeping a lot), LETHARGY (Weak, no appetite, lethargic, sleeping a lot), HYPERSOMNIA (Weak, no appetite, lethargic, sleeping a lot), ASTHENIA (Still just don't have the energy to this day), CHILLS (Chills all the time, fever of 102 for 5 days - went up every time after eating) and PYREXIA (Chills all the time, fever of 102 for 5 days - went up every time after eating). The patient was treated with Bed rest for Feeling abnormal. At the time of the report, SYNCOPE (Friday, got worse, by afternoon, was in bed. Got up to use restroom, next thing I remember was that I was on the floor and could not get up) and DIARRHOEA (3 days of intense diarrhea, lost about 10 pounds) had resolved and FEELING ABNORMAL (Thursday, started not feeling great), WEIGHT DECREASED (3 days of intense diarrhea, lost about 10 pounds), ASTHENIA (Weak, no appetite, lethargic, sleeping a lot), DECREASED APPETITE (Weak, no appetite, lethargic, sleeping a lot), LETHARGY (Weak, no appetite, lethargic, sleeping a lot), HYPERSOMNIA (Weak, no appetite, lethargic, sleeping a lot), ASTHENIA (Still just don't have the energy to this day), CHILLS (Chills all the time, fever of 102 for 5 days - went up every time after eating) and PYREXIA (Chills all the time, fever of 102 for 5 days - went up every time after eating) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Diagnostic procedure: all normal (normal) All normal.         The patient has taken acetaminophen (TYLENOL), loperamide (IMMODIUM), and an unspecified prescription nausea medication to alleviate his discomfort. The patient saw a doctor who ran unspecified tests and they were all normal.   This case was linked to MOD21-065196 (Patient Link).; 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.