Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient was feeling faint, fainted in chair; Despondent, cold to touch, weak and pale; Cold to touch; Weak; Pale; Difficulty in muscle control; This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (Patient was feeling faint, fainted in chair), FEELING OF DESPAIR (Despondent, cold to touch, weak and pale), FEELING COLD (Cold to touch), ASTHENIA (Weak) and PALLOR (Pale) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced SYNCOPE (Patient was feeling faint, fainted in chair), FEELING OF DESPAIR (Despondent, cold to touch, weak and pale), FEELING COLD (Cold to touch), ASTHENIA (Weak), PALLOR (Pale) and MOTOR DYSFUNCTION (Difficulty in muscle control). At the time of the report, SYNCOPE (Patient was feeling faint, fainted in chair), FEELING OF DESPAIR (Despondent, cold to touch, weak and pale), FEELING COLD (Cold to touch), ASTHENIA (Weak), PALLOR (Pale) and MOTOR DYSFUNCTION (Difficulty in muscle control) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company comment: This concerns a case of a 22 year old Male with no relevant medical history who experienced unexpected events of syncope, feeling of despair, feeling cold,  asthenia, pallor, and motor dysfunction. The events happened 1 day after receiving the first dose of the vaccine. The event syncope was upgraded to serious , however it is downgraded to non serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-315343, US-MODERNATX, INC.-MOD-2021-141984, US-MODERNATX, INC.-MOD-2021-141984, US-MODERNATX, INC.-MOD-2021-141758, US-MODERNATX, INC.-MOD-2021-142081, US-MODERNATX, INC.-MOD-2021-142219 (E2B Linked Report).; Sender's Comments: This concerns a case of a 22 year old Male with no relevant medical history who experienced unexpected events of syncope, feeling of despair, feeling cold,  asthenia, pallor, and motor dysfunction. The events happened 1 day after receiving the first dose of the vaccine. The event syncope was upgraded to serious , however it is downgraded to non serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2021-315343:Same report US-MODERNATX, INC.-MOD-2021-141984: US-MODERNATX, INC.-MOD-2021-141984: US-MODERNATX, INC.-MOD-2021-141758: US-MODERNATX, INC.-MOD-2021-142081: US-MODERNATX, INC.-MOD-2021-142219: