Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Lethargy, Loss of consciousness
Clinical narrative: Redness presently cover entire body; one of my eyelids is swollen; itching; I also woke up during the night & I passed out.; lethargic; had the shivers; headache; soreness in my left arm; My body was covered in hives again / hives all over my body now, including the soles of my feet / chronic hives for the last few months which started a few days after getting the first dose of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (I also woke up during the night & I passed out.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced URTICARIA (My body was covered in hives again / hives all over my body now, including the soles of my feet / chronic hives for the last few months which started a few days after getting the first dose of the vaccine). On 27-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (I also woke up during the night & I passed out.) (seriousness criterion medically significant), LETHARGY (lethargic), CHILLS (had the shivers), HEADACHE (headache) and MYALGIA (soreness in my left arm). On 03-Jul-2021, the patient experienced PRURITUS (itching). On 12-Jul-2021, the patient experienced SWELLING OF EYELID (one of my eyelids is swollen). On an unknown date, the patient experienced ERYTHEMA (Redness presently cover entire body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC HIVES RELIEF) for Adverse event, at an unspecified dose and frequency and PREDNISOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (I also woke up during the night & I passed out.), LETHARGY (lethargic), URTICARIA (My body was covered in hives again / hives all over my body now, including the soles of my feet / chronic hives for the last few months which started a few days after getting the first dose of the vaccine), PRURITUS (itching), SWELLING OF EYELID (one of my eyelids is swollen), ERYTHEMA (Redness presently cover entire body), CHILLS (had the shivers), HEADACHE (headache) and MYALGIA (soreness in my left arm) outcome was unknown.            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-2021-254121 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non significant follow up appended; 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.