Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Feeling abnormal, Imaging procedure, Loss of consciousness, Nausea
Clinical narrative: became unresponsive; hemorrhagic shock; syncope; abdominal pain; wasn't feeling good; nausea; vomiting; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (became unresponsive), SHOCK HAEMORRHAGIC (hemorrhagic shock), SYNCOPE (syncope), ABDOMINAL PAIN (abdominal pain), FEELING ABNORMAL (wasn't feeling good), NAUSEA (nausea) and VOMITING (vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Splenectomy (did get embolization but progressed to further bleeding) on 24-Apr-2021.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (became unresponsive) (seriousness criterion hospitalization), SHOCK HAEMORRHAGIC (hemorrhagic shock) (seriousness criterion hospitalization), SYNCOPE (syncope) (seriousness criterion hospitalization), ABDOMINAL PAIN (abdominal pain) (seriousness criterion hospitalization), FEELING ABNORMAL (wasn't feeling good) (seriousness criterion hospitalization), NAUSEA (nausea) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). The patient was hospitalized on 21-Apr-2021 due to ABDOMINAL PAIN, FEELING ABNORMAL, LOSS OF CONSCIOUSNESS, NAUSEA, SHOCK HAEMORRHAGIC, SYNCOPE and VOMITING. At the time of the report, LOSS OF CONSCIOUSNESS (became unresponsive), SHOCK HAEMORRHAGIC (hemorrhagic shock), SYNCOPE (syncope), ABDOMINAL PAIN (abdominal pain), FEELING ABNORMAL (wasn't feeling good), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Imaging procedure: (abnormal) abd imaging showed a large splenic subcapsular hematoma of unclear etiology (no hx of trauma) with hemoperitoneum.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABDOMINAL PAIN (abdominal pain), NAUSEA (nausea) and VOMITING (vomiting) to have an unknown relationship. No further causality assessments were provided for LOSS OF CONSCIOUSNESS (became unresponsive), SHOCK HAEMORRHAGIC (hemorrhagic shock), SYNCOPE (syncope) and FEELING ABNORMAL (wasn't feeling good).    Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provide at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provide at this time. Further information has been requested.