Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, SARS-CoV-2 test, Somnolence
Clinical narrative: Lack of effect; He tested positive for COVID; Flehm; General/muscle fatigue; 36 hours sleeping (for two days was bent out); Headache; Headache after second dose/massive headache; Fatigue after second dose/general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Flehm), MUSCLE FATIGUE (General/muscle fatigue), SOMNOLENCE (36 hours sleeping (for two days was bent out)), DRUG INEFFECTIVE (Lack of effect) and COVID-19 (He tested positive for COVID) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A23A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (Headache after second dose/massive headache) and FATIGUE (Fatigue after second dose/general fatigue). On 14-Nov-2021, the patient experienced DRUG INEFFECTIVE (Lack of effect) and COVID-19 (He tested positive for COVID). In November 2021, the patient experienced PRODUCTIVE COUGH (Flehm), MUSCLE FATIGUE (General/muscle fatigue), SOMNOLENCE (36 hours sleeping (for two days was bent out)) and HEADACHE (Headache). At the time of the report, PRODUCTIVE COUGH (Flehm), MUSCLE FATIGUE (General/muscle fatigue), SOMNOLENCE (36 hours sleeping (for two days was bent out)), DRUG INEFFECTIVE (Lack of effect), COVID-19 (He tested positive for COVID), HEADACHE (Headache after second dose/massive headache), FATIGUE (Fatigue after second dose/general fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medication were reported. No Treatment medication were reported.  Company comment: This is a spontaneous case concerning a 50-year-old male patient, with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19. The event occurred more than 6 months after the second  dose of mRNA-1273.  Patient reports productive cough, headache, muscle fatigue and somnolence and tested positive for COVID-19. Lack of effect was also captured a an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-386972 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 50-year-old male patient, with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19. The event occurred more than 6 months after the second  dose of mRNA-1273.  Patient reports productive cough, headache, muscle fatigue and somnolence and tested positive for COVID-19. Lack of effect was also captured a an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.