Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Feeling abnormal, Impaired work ability, Lethargy
Clinical narrative: felt so lazy he could not even do anything; could not work, it took away 3 days from work from him; COVID-19; feeling bad; feeling not able to focus; dizzy; chest pain; sore throat; chills for a few days; fever; just by simply talking to somebody he starts tiring; sore arm; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt so lazy he could not even do anything), IMPAIRED WORK ABILITY (could not work, it took away 3 days from work from him), COVID-19 (COVID-19), FEELING ABNORMAL (feeling bad) and DISTURBANCE IN ATTENTION (feeling not able to focus) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN for Cholesterol, FENOFIBRATE for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (felt so lazy he could not even do anything), IMPAIRED WORK ABILITY (could not work, it took away 3 days from work from him), COVID-19 (COVID-19), FEELING ABNORMAL (feeling bad), DISTURBANCE IN ATTENTION (feeling not able to focus), DIZZINESS (dizzy), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills for a few days), PYREXIA (fever), FATIGUE (just by simply talking to somebody he starts tiring), MYALGIA (sore arm) and DRUG INEFFECTIVE (lack of drug effect). The patient was treated with FAMOTIDINE for Stomach ache, at an unspecified dose and frequency. At the time of the report, LETHARGY (felt so lazy he could not even do anything), IMPAIRED WORK ABILITY (could not work, it took away 3 days from work from him), COVID-19 (COVID-19), FEELING ABNORMAL (feeling bad), DISTURBANCE IN ATTENTION (feeling not able to focus), DIZZINESS (dizzy), CHEST PAIN (chest pain), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills for a few days), PYREXIA (fever), FATIGUE (just by simply talking to somebody he starts tiring), MYALGIA (sore arm) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.            The patient's concomitant d rug also includes blood pressure medications. The patient received monoclonal antibodies and is now feeling better. The treatment drug includes promethazine has not taken for the last days.; Sender's Comments: This case concerns a 63 year-old, male patient, who experienced the non serious expected/unexpected event of COVID-19, lethargy, impaired work ability, feeling abnormal, disturbance in attention, dizziness, chest pain, oropharyngeal pain, chills, pyrexia, fatigue and myalgia. Drug ineffective was considered as an additional event. The events occurred on an unknown date after the second dose of Spikevax/Moderna COVID-19 vaccine (more than 14 days according to information provided in narrative). The rechallenge was not applicable, as the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.