Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea, Dysmenorrhoea, Faeces discoloured, Foreign body in gastrointestinal tract
Clinical narrative: face feels like it's tightening; painful menstrual period; Pale as a ghost; severe non-stop diarrhea since the day she got her vaccine; little stomach bug; Cannot keep eyes open at work; diarrhea has been all kinds of colors(now orange)/black when she was taking Pepto-Bismol; Fainted; Anxiety high; general health bad; Nausea; consistent low grade fever (100F to 100.4F); This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced SYNCOPE (Fainted), ANXIETY (Anxiety high), GENERAL PHYSICAL HEALTH DETERIORATION (general health bad), NAUSEA (Nausea) and PYREXIA (consistent low grade fever (100F to 100.4F)). On 18-Apr-2021, the patient experienced FAECES DISCOLOURED (diarrhea has been all kinds of colors(now orange)/black when she was taking Pepto-Bismol). On 19-Apr-2021, the patient experienced SOMNOLENCE (Cannot keep eyes open at work). On 20-Apr-2021, the patient experienced DIARRHOEA (severe non-stop diarrhea since the day she got her vaccine) and FOREIGN BODY IN GASTROINTESTINAL TRACT (little stomach bug). On 28-Apr-2021, the patient experienced SKIN TIGHTNESS (face feels like it's tightening), DYSMENORRHOEA (painful menstrual period) and PALLOR (Pale as a ghost). At the time of the report, SYNCOPE (Fainted) had resolved, SOMNOLENCE (Cannot keep eyes open at work), SKIN TIGHTNESS (face feels like it's tightening), ANXIETY (Anxiety high), GENERAL PHYSICAL HEALTH DETERIORATION (general health bad), FAECES DISCOLOURED (diarrhea has been all kinds of colors(now orange)/black when she was taking Pepto-Bismol), FOREIGN BODY IN GASTROINTESTINAL TRACT (little stomach bug), DYSMENORRHOEA (painful menstrual period), PALLOR (Pale as a ghost), NAUSEA (Nausea) and PYREXIA (consistent low grade fever (100F to 100.4F)) outcome was unknown and DIARRHOEA (severe non-stop diarrhea since the day she got her vaccine) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications include Pepto-Bismol (bismuth subsalicylate) for diarrhea for 1.5 days (unknown dose/frequency).  Patient waited out 20 minutes post-vaccination and then went to the bathroom. When she came out of bathroom she fainted, paramedics were summoned. Mother took patient to Emergency Room(ER) 20 April 2021, after taking her first to urgent care (who directed mother to take patient to the ER), ER sent her home saying it was just a little stomach bug, but no one else in the family got this "bug".  Patient's last test for Covid-19 was on Monday (26-Apr-2021) and results came back negative on 28-Apr-2021. Company comment: The event of faeces discolored is assessed as unlikely due to mRNA-1273 administration but due ingesting Pepto-Bismol. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.  Pyrexia and nausea are consistent with the product established safety profile.; Sender's Comments: The event of faeces discolored is assessed as unlikely due to mRNA-1273 administration but due ingesting Pepto-Bismol. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.  Pyrexia and nausea are consistent with the product established safety profile.