Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Diarrhoea, Electrocardiogram, Immediate post-injection reaction, Nausea
Clinical narrative: In under two minutes, fainted / Believed to be vasovagal syncope; Stomach hurting so bad that felt heart; Chest discomfort; had Diarrhea; Immediate post-injection reaction; Felt very nauseous; Vomited; This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (In under two minutes, fainted / Believed to be vasovagal syncope) in a 68-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.     Concurrent medical conditions included Nose congestion (For about 2 weeks.) since February 2021. Concomitant products included PAROXETINE, MELOXICAM, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ZINC, ASCORBIC ACID, QUERCETIN (QUERCITIN), LISINOPRIL, FISH OIL (OMEGA 3 [FISH OIL]), CURCUMIN and PHENYLEPHRINE HYDROCHLORIDE (SUDAFED PE) for an unknown indication.    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced SYNCOPE (In under two minutes, fainted / Believed to be vasovagal syncope) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach hurting so bad that felt heart), CHEST DISCOMFORT (Chest discomfort), DIARRHOEA (had Diarrhea), IMMEDIATE POST-INJECTION REACTION (Immediate post-injection reaction), NAUSEA (Felt very nauseous) and VOMITING (Vomited). At the time of the report, SYNCOPE (In under two minutes, fainted / Believed to be vasovagal syncope), ABDOMINAL PAIN UPPER (Stomach hurting so bad that felt heart), CHEST DISCOMFORT (Chest discomfort), DIARRHOEA (had Diarrhea), IMMEDIATE POST-INJECTION REACTION (Immediate post-injection reaction), NAUSEA (Felt very nauseous) and VOMITING (Vomited) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Abdominal X-ray: unknown Results not reported.. On 20-Feb-2021, Blood test: unknown Results not reported.. On 20-Feb-2021, Chest X-ray: unknown Result not reported.. On 20-Feb-2021, Computerised tomogram head: unknown No fall.. On 20-Feb-2021, Electrocardiogram: unknown Result not reported..     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 medications included unspecified joint supplement.  It was reported that immediately after the administration of the vaccine, the patient fainted In under two minutes. The  patient reported that there was no  prior history of fainting. After regaining consciousness the  patient reported severe nausea, an episode of diarrhea, vomiting, bad stomach pain which he felt was heart related and went to the emergency room where tests were conducted and he was there for four hours.  No treatment information was provided.; 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.