Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest; was in extreme acidosis; somewhere along the line, I got sepsis; CT scan showed a hematoma in stomach; distended stomach; Still have terrible diarrhea; haven't gotten my second shot yet; following day, I started with extreme chills; Fever; was just miserable for several days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC ARREST (had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest), ACIDOSIS (was in extreme acidosis), SEPSIS (somewhere along the line, I got sepsis), HAEMATOMA (CT scan showed a hematoma in stomach), GASTRIC DILATATION (distended stomach) and DIARRHOEA (Still have terrible diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), ESTROGENS CONJUGATED (PREMARIN), VITAMIN D3, PROBIOTICS NOS and ALPRAZOLAM (XANAX) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIARRHOEA (Still have terrible diarrhea) (seriousness criterion hospitalization prolonged), FEELING ABNORMAL (was just miserable for several days), CHILLS (following day, I started with extreme chills) and PYREXIA (Fever). On 24-Mar-2021, the patient experienced CARDIAC ARREST (had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest) (seriousness criteria hospitalization prolonged, medically significant and life threatening), ACIDOSIS (was in extreme acidosis) (seriousness criteria hospitalization prolonged and life threatening), SEPSIS (somewhere along the line, I got sepsis) (seriousness criteria hospitalization prolonged and life threatening), HAEMATOMA (CT scan showed a hematoma in stomach) (seriousness criteria hospitalization prolonged and life threatening) and GASTRIC DILATATION (distended stomach) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (haven't gotten my second shot yet). The patient was hospitalized on 24-Mar-2021 due to ACIDOSIS, CARDIAC ARREST, DIARRHOEA, GASTRIC DILATATION, HAEMATOMA and SEPSIS. At the time of the report, CARDIAC ARREST (had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest), ACIDOSIS (was in extreme acidosis), SEPSIS (somewhere along the line, I got sepsis), HAEMATOMA (CT scan showed a hematoma in stomach), GASTRIC DILATATION (distended stomach), DIARRHOEA (Still have terrible diarrhea), FEELING ABNORMAL (was just miserable for several days), PRODUCT DOSE OMISSION ISSUE (haven't gotten my second shot yet), CHILLS (following day, I started with extreme chills) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Computerised tomogram: hematoma in stomach (abnormal) Four CT scans.  Showed hematoma in stomach.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24th March 21, Patient had multiple x-rays done. The result was not provided.  Treatment for the events was not provided.  CPR for 10 minutes which lead to have 4 broken ribs and one lung collapsed.; Sender's Comments: This case of 72 y/o who missed 2nd dose and experienced additional events.  Based on the information provided, the events of sepsis, broken ribs and collapse lungs are assessed as unlikely as they occurred was secondary to the other events and intervention.  Sepsis is of an infectious origin. Causality between product use and the remaining events cannot be excluded based on temporal association. Missed dose is not applicable and chills and pyrexia are consistent with product safety profile.