Age: 60.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Somnolence
Clinical narrative: knocked out; sweaty/had sweats; slept all day; did not eat much; felt like he had flu; could not take a shower; had no energy; fever; achiness; extremely tired/extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (knocked out), HYPERHIDROSIS (sweaty/had sweats), SOMNOLENCE (slept all day), EATING DISORDER (did not eat much) and INFLUENZA LIKE ILLNESS (felt like he had flu) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066D21A and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylaxis.    Concurrent medical conditions included Hypercholesterolemia. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (knocked out), HYPERHIDROSIS (sweaty/had sweats), SOMNOLENCE (slept all day), EATING DISORDER (did not eat much), INFLUENZA LIKE ILLNESS (felt like he had flu), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take a shower), ASTHENIA (had no energy), PYREXIA (fever), MYALGIA (achiness) and FATIGUE (extremely tired/extreme fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (knocked out), HYPERHIDROSIS (sweaty/had sweats), SOMNOLENCE (slept all day), EATING DISORDER (did not eat much), INFLUENZA LIKE ILLNESS (felt like he had flu), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take a shower), ASTHENIA (had no energy), PYREXIA (fever), MYALGIA (achiness) and FATIGUE (extremely tired/extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100.8-101 (High) 100.8-101° F.         Additional concomitant medications included blood pressure medication and Vitamins. Company Comment:  This case concerns a 62 year-old, male with no relevant medical history, who experienced the unexpected events of HYPERHIDROSIS, SOMNOLENCE, EATING DISORDER, INFLUENZA LIKE ILLNESS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, ASTHENIA and FEELING ABNORMAL  . The event occurred after the second dose of mRNA-1273 Moderna vaccine (onset date of events were not provided).  The patient received "flu vaccine" on the same day of 2nd dose of Moderna, this could be a potentially confounder/cosuspect for the events. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.   This case was linked to MOD-2021-320223 (Patient Link).; Sender's Comments: This case concerns a 62 year-old, male with no relevant medical history, who experienced the unexpected events of HYPERHIDROSIS, SOMNOLENCE, EATING DISORDER, INFLUENZA LIKE ILLNESS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, ASTHENIA and FEELING ABNORMAL  . The event occurred after the second dose of mRNA-1273 Moderna vaccine (onset date of events were not provided).  The patient received "flu vaccine" on the same day of 2nd dose of Moderna, this could be a potentially confounder/cosuspect for the events. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.