Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lethargy, Lymphadenopathy, Myalgia
Clinical narrative: Fainted 3 times/can't stay more than 30 to 45 seconds; Need to lay on the floor/not stay for more than 30-45 seconds; Need to lay on the floor; Injection site pain; Chills; Fever; Body aches/muscle aches; Swollen lymph nodes; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted 3 times/can't stay more than 30 to 45 seconds), LETHARGY (Need to lay on the floor/not stay for more than 30-45 seconds), FATIGUE (Need to lay on the floor), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body aches/muscle aches), LYMPHADENOPATHY (Swollen lymph nodes) and PAIN IN EXTREMITY (sore arm) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced SYNCOPE (Fainted 3 times/can't stay more than 30 to 45 seconds) (seriousness criteria disability and medically significant), FATIGUE (Need to lay on the floor) (seriousness criterion disability), VACCINATION SITE PAIN (Injection site pain) (seriousness criterion disability), CHILLS (Chills) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability), MYALGIA (Body aches/muscle aches) (seriousness criterion disability), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion disability) and PAIN IN EXTREMITY (sore arm) (seriousness criterion disability). 28-May-2021, the patient experienced LETHARGY (Need to lay on the floor/not stay for more than 30-45 seconds) (seriousness criterion disability). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Fever, at a dose of 0.5 dosage form. At the time of the report, SYNCOPE (Fainted 3 times/can't stay more than 30 to 45 seconds), LETHARGY (Need to lay on the floor/not stay for more than 30-45 seconds), FATIGUE (Need to lay on the floor), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body aches/muscle aches), LYMPHADENOPATHY (Swollen lymph nodes) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  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.   This case was linked to MOD-2021-186579 (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.