Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fall, Gait disturbance, Gastrointestinal disorder, Hypokinesia
Clinical narrative: attacked my GI system / felt like my digestive track was under attack/; low grade fever of 99-100.9; diarrhea; appendicitis; couldn't pass gas / felt like my stomach and intestines were locked; vertigo; crawled to bathroom because it hurt to stand up; felt like I had a decrease in blood pressure; felt like everything was falling out/hand in head stayed in the bathroom on the floor for 3 hours; couldn't use the bathroom; altered and couldn't focus; crawled back in bed and couldn't sleep; passed out; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and APPENDICITIS (appendicitis) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 077C21B, 007M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (removal and repair in 2013) in 2013. Concurrent medical conditions included Penicillin allergy, Drug allergy, Stevens-Johnson syndrome and Irritable bowel syndrome. Concomitant products included VITAMINS NOS, FISH OIL, POLYCARBOPHIL CALCIUM (FIBER), CALCIUM, DOCUSATE SODIUM (STOOL SOFTENER) and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (couldn't pass gas / felt like my stomach and intestines were locked), VERTIGO (vertigo), GAIT DISTURBANCE (crawled to bathroom because it hurt to stand up), BLOOD PRESSURE DECREASED (felt like I had a decrease in blood pressure), FALL (felt like everything was falling out/hand in head stayed in the bathroom on the floor for 3 hours), HYPOKINESIA (couldn't use the bathroom), DISTURBANCE IN ATTENTION (altered and couldn't focus) and INSOMNIA (crawled back in bed and couldn't sleep). On 12-Jun-2022, the patient experienced APPENDICITIS (appendicitis) (seriousness criterion medically significant) and DIARRHOEA (diarrhea). On 13-Jun-2022, the patient experienced GASTROINTESTINAL DISORDER (attacked my GI system / felt like my digestive track was under attack/) and PYREXIA (low grade fever of 99-100.9). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vertigo, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out), APPENDICITIS (appendicitis), ABDOMINAL DISCOMFORT (couldn't pass gas / felt like my stomach and intestines were locked), VERTIGO (vertigo), GAIT DISTURBANCE (crawled to bathroom because it hurt to stand up), BLOOD PRESSURE DECREASED (felt like I had a decrease in blood pressure), FALL (felt like everything was falling out/hand in head stayed in the bathroom on the floor for 3 hours), HYPOKINESIA (couldn't use the bathroom), DISTURBANCE IN ATTENTION (altered and couldn't focus), INSOMNIA (crawled back in bed and couldn't sleep), GASTROINTESTINAL DISORDER (attacked my GI system / felt like my digestive track was under attack/), DIARRHOEA (diarrhea) and PYREXIA (low grade fever of 99-100.9) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-100.9 99-100.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse reported side effects after Moderna vaccine stating that side effects got worse with every vaccine.  Patient reported that she started to walk a bit where she could not eat anything but had Jell-O. On 13 Jun 2022, she started to walk a bit more, ate crackers, banana and potato but used the bathroom  after consuming even water.  Company Comment: This spontaneous case concerns a 58-year-old female patient with a relevant medical history of irritable bowel syndrome, who experienced the unexpected serious (medically significant) AESI of Appendicitis, unexpected serious (medically significant) event of Loss of consciousness and several non-serious events of Vertigo, Fall, Gastrointestinal disorder and Diarrhoea after Fourth dose of mRNA-1273 vaccine in covid-19 vaccination series. After receiving the vaccine patient woke up in the night with severe abdominal cramps, felt like indigestion and almost passed out. She was unable to stand up as she felt like there is decrease in blood pressure and everything falling out. She had abdominal discomfort could not sleep, with reduced appetite, anorexia. The next day she had diarrhea followed by severe stabbing abdominal pain, fever, vomiting and GI disorder. She took Tylenol for the same. She had vertigo since a week and is on Benadryl. She went to emergency suspecting appendicitis, triaged by a nurse but did not stay. Patients relevant medical history of irritable bowel syndrome could be confounder for the events Gastrointestinal disorder and abdominal discomfort. Concomitant product Docusate Sodium (stool softener) could be confounding for the event Diarrhoea. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-589013, MOD-2022-589031, MOD-2022-589045, MOD-2022-589106 (Patient Link).; Sender's Comments: This spontaneous case concerns a 58-year-old female patient with a relevant medical history of irritable bowel syndrome, who experienced the unexpected serious (medically significant) AESI of Appendicitis, unexpected serious (medically significant) event of Loss of consciousness and several non-serious events of Vertigo, Fall, Gastrointestinal disorder and Diarrhoea after Fourth dose of mRNA-1273 vaccine in covid-19 vaccination series. After receiving the vaccine patient woke up in the night with severe abdominal cramps, felt like indigestion and almost passed out. She was unable to stand up as she felt like there is decrease in blood pressure and everything falling out. She had abdominal discomfort could not sleep, with reduced appetite, anorexia. The next day she had diarrhea followed by severe stabbing abdominal pain, fever, vomiting and GI disorder. She took Tylenol for the same. She had vertigo since a week and is on Benadryl. She went to emergency suspecting appendicitis, triaged by a nurse but did not stay. Patients relevant medical history of irritable bowel syndrome could be confounder for the events Gastrointestinal disorder and abdominal discomfort. Concomitant product Docusate Sodium (stool softener) could be confounding for the event Diarrhoea. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.