Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Product dose omission issue, Weight, Weight decreased
Clinical narrative: He had lost 10 lbs due to the anxiety; doctor recommended he not get the second dose; bruise on his head; Hit his head on the shower stall; Lost consciousness; concussion; anxiety; hit his head on the door; felt nauseous; Lost consciousness; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of LOSS OF CONSCIOUSNESS (Lost consciousness) and the second episode of LOSS OF CONSCIOUSNESS (Lost consciousness) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced the first episode of LOSS OF CONSCIOUSNESS (Lost consciousness) (seriousness criterion medically significant), CONCUSSION (concussion), ANXIETY (anxiety), HEAD INJURY (hit his head on the door) and NAUSEA (felt nauseous). On 13-Aug-2021, the patient experienced the second episode of LOSS OF CONSCIOUSNESS (Lost consciousness) (seriousness criterion medically significant), CONTUSION (bruise on his head) and HEAD INJURY (Hit his head on the shower stall). On an unknown date, the patient experienced WEIGHT DECREASED (He had lost 10 lbs due to the anxiety) and PRODUCT DOSE OMISSION ISSUE (doctor recommended he not get the second dose). The patient was treated with CITALOPRAM HYDROCHLORIDE (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]) for Anxiety, at a dose of 10 mg once a day and ALPRAZOLAM for Anxiety, at a dose of 0.25 mg (he had only taken this twice). In March 2021, NAUSEA (felt nauseous) outcome was unknown. At the time of the report, last episode of LOSS OF CONSCIOUSNESS (Lost consciousness), CONCUSSION (concussion), ANXIETY (anxiety), HEAD INJURY (hit his head on the door), CONTUSION (bruise on his head), HEAD INJURY (Hit his head on the shower stall) and WEIGHT DECREASED (He had lost 10 lbs due to the anxiety) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (doctor recommended he not get the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Weight: lost 10 ibs (abnormal) Patient lost 10 Ibs weight due to anxiety. On an unknown date, Computerised tomogram: concussion (abnormal) The CT scan confirmed he had a concussion..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided  Patient took first vaccine on MAR-2021 and during the night after vaccination patient waked up for restroom but felt nauseous, got to the bathroom and lost the consciousness and ambulance was called where patient was took to the emergency room ang got stiches done. Patient anxiety had became severe. Patient lost consciousness again on 13-AUG-2021 and was sitting down and passed out and hit his head on the shower stall.  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. Further information has been requested. The report also refers to a case of product dose omission issue for mRNA-1273 (lot # unknown) with associated AEs reported as loss of consciousness, head injury, contusion, anxiety and weight loss.; 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. Further information has been requested. The report also refers to a case of product dose omission issue for mRNA-1273 (lot # unknown) with associated AEs reported as loss of consciousness, head injury, contusion, anxiety and weight loss.