Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram abdomen, Computerised tomogram pelvis, Endoscopic ultrasound, Gastric perforation
Clinical narrative: Pancreatitis associated with posterior wall gastric perforation; A large intraabdominal bleed; A larger subcapsular splenic hematoma/ Spleen hematoma; Presence of subcapsular splenic parenchymal laceration/rupture/spleen may have ruptured from being nicked; Hemorrhagic shock; Pancreatic necrosis; Acute blood loss; Acute pancreatitis; Pseudocyst on pancreas; Erratic hypoglycemia/ Persistent hypoglycemia, predominantly occurring overnight; This spontaneous case was reported by a patient and describes the occurrence of INTRA-ABDOMINAL HAEMATOMA (A large intraabdominal bleed), SUBCAPSULAR SPLENIC HAEMATOMA (A larger subcapsular splenic hematoma/ Spleen hematoma), SPLENIC RUPTURE (Presence of subcapsular splenic parenchymal laceration/rupture/spleen may have ruptured from being nicked), SHOCK HAEMORRHAGIC (Hemorrhagic shock), PANCREATITIS NECROTISING (Pancreatic necrosis), GASTRIC PERFORATION (Pancreatitis associated with posterior wall gastric perforation), BLOOD LOSS ANAEMIA (Acute blood loss), PANCREATITIS ACUTE (Acute pancreatitis), HYPOGLYCAEMIA (Erratic hypoglycemia/ Persistent hypoglycemia, predominantly occurring overnight) and PSEUDOCYST (Pseudocyst on pancreas) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced HYPOGLYCAEMIA (Erratic hypoglycemia/ Persistent hypoglycemia, predominantly occurring overnight) (seriousness criterion hospitalization). In September 2021, the patient experienced SHOCK HAEMORRHAGIC (Hemorrhagic shock) (seriousness criteria hospitalization and medically significant), PANCREATITIS NECROTISING (Pancreatic necrosis) (seriousness criteria hospitalization and medically significant), BLOOD LOSS ANAEMIA (Acute blood loss) (seriousness criteria hospitalization and medically significant), PANCREATITIS ACUTE (Acute pancreatitis) (seriousness criteria hospitalization and medically significant) and PSEUDOCYST (Pseudocyst on pancreas) (seriousness criterion hospitalization). On 24-Sep-2021, the patient experienced INTRA-ABDOMINAL HAEMATOMA (A large intraabdominal bleed) (seriousness criteria hospitalization and medically significant), SUBCAPSULAR SPLENIC HAEMATOMA (A larger subcapsular splenic hematoma/ Spleen hematoma) (seriousness criteria hospitalization and medically significant) and SPLENIC RUPTURE (Presence of subcapsular splenic parenchymal laceration/rupture/spleen may have ruptured from being nicked) (seriousness criteria hospitalization and medically significant). On 25-Sep-2021, the patient experienced GASTRIC PERFORATION (Pancreatitis associated with posterior wall gastric perforation) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 03-Aug-2021 to 22-Aug-2021 due to HYPOGLYCAEMIA, then from 18-Sep-2021 to 20-Sep-2021 due to PSEUDOCYST, then from 22-Sep-2021 to 02-Nov-2021 due to BLOOD LOSS ANAEMIA, GASTRIC PERFORATION, INTRA-ABDOMINAL HAEMATOMA, PANCREATITIS ACUTE, PANCREATITIS NECROTISING, SHOCK HAEMORRHAGIC, SPLENIC RUPTURE and SUBCAPSULAR SPLENIC HAEMATOMA. The patient was treated with GLUCOSE (D10) (intravenous) for Hypoglycemia, at a dose of increased to D20 then D50; MORPHINE (intravenous) for Pain, at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) (intravenous) for Pain, at a dose of 1 dosage form; GLUCOSE (D50) (intravenous) for Hypoglycemia, at a dose of 1 dosage form; Surgery (Exploratory laparotomy) for Intra-abdominal haematoma; Surgery (Splenectomy) for Subcapsular splenic haematoma; Surgery (Pancreatic debridement) for Splenic rupture and Surgery (Repair of posterior wall gastric perforation with omental patch, Jejunostomy feeding tube placement) for Gastric perforation. At the time of the report, INTRA-ABDOMINAL HAEMATOMA (A large intraabdominal bleed), SUBCAPSULAR SPLENIC HAEMATOMA (A larger subcapsular splenic hematoma/ Spleen hematoma), SPLENIC RUPTURE (Presence of subcapsular splenic parenchymal laceration/rupture/spleen may have ruptured from being nicked), SHOCK HAEMORRHAGIC (Hemorrhagic shock), PANCREATITIS NECROTISING (Pancreatic necrosis), GASTRIC PERFORATION (Pancreatitis associated with posterior wall gastric perforation), BLOOD LOSS ANAEMIA (Acute blood loss), PANCREATITIS ACUTE (Acute pancreatitis), HYPOGLYCAEMIA (Erratic hypoglycemia/ Persistent hypoglycemia, predominantly occurring overnight) and PSEUDOCYST (Pseudocyst on pancreas) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood glucose: low Several attempts to increase blood glucose level with no improvement/ Glucose level was not increasing. On 03-Aug-2021, Blood glucose: 217 217 and 48 Dropped to 48. In August 2021, Biopsy pancreas: abnormal Post-op diagnosis was non-specific slightly hyperechoic pancreatic parenchyma with no identifiable mass. In August 2021, Blood glucose: abnormal Blood glucose levels fluctuated from standard controlled level/ continued fluctuations in blood glucose. In August 2021, Blood test: results not reported Results not reported. In August 2021, Computerised tomogram: results not reported Results not reported. In August 2021, Endoscopic ultrasound: no mass identified An upper endoscopic ultrasound with fine needle aspiration was carried out and no mass was identified. In August 2021, Oesophagogastroduodenoscopy: no mass identified Esophagogastroduodenoscopy to determine if an insulinoma was "hiding" in pancreas. No mass identified. In August 2021, Ultrasound pancreas: results not reported Results not reported. In September 2021, Blood test: results not reported Ordered blood work. No results reported. In September 2021, Computerised tomogram: abnormal The CT scan results showed patient had pancreatitis and a pseudocyst on pancreas. On 22-Sep-2021, Blood glucose: elevated Elevated. On 24-Sep-2021, Blood pressure measurement: low Low with tachycardia. On 24-Sep-2021, Computerised tomogram abdomen: abnormal Intraabdominal bleed, subcapsular splenic hematoma and subcapsular splenic parenchymal laceration/ rupture. In November 2021, Blood test: high The blood work showed a high white blood count. In November 2021, Computerised tomogram abdomen: abnormal Cellulitis and somewhat loculated fluid collection in left upper quadrant which may present postoperative seroma. In November 2021, Computerised tomogram pelvis: abnormal Cellulitis and somewhat loculated fluid collection in left upper quadrant which may present postoperative seroma. On 24-Nov-2021, X-ray: normal The X-ray showed the tube was in place and to resume with the feeding tube.         Patient was admitted for further evaluation for erratic hypoglycemia and shortness of breath. Was moved to ICU for better monitoring and was placed on an IV drip which increased from D10 to D20 then D50 to help stabilize blood glucose levels. An emergency central line was placed in neck due to vein rupture then was replaced with a pic line in arm. On 22-Aug-2021, patient was discharged upon patient's blood glucose levels was stabilized. On or about 18-Sep-2021, patient did not notice much improvement, therefore admitted in hospital. Doctor indicated the pseudocyst on the pancreas was more than likely caused from any irritation like a biopsy and said removing the cyst would just irritate the pancreas even more, also indicated not eating would help the pancreas rest. On or about 22-Sep-2021, admitted for supportive management and monitoring of worsening upper abdominal pain.   On 01-Oct-2021, patient underwent a CT-guided diagnostic aspiration left pleural effusion and left diaphragmatic collection, was informed a pancreatic duct leak was suspected.  On 20-Oct-2021, patient underwent a CT-guided aspiration and a PD stent drainage tube was placed to drain the fluid leaking from pancreas. After surgery, patient was on a liquid diet for a week then placed on a soft food diet, then was placed on a low fiber diet. On 20-Nov-2021, patient noticed the area around the feeding tube was painful and removed the bandage surrounding the feeding tube. Also noticed a green puslike material with a foul odor. Patient  suffered from an infected feeding tube and loose stitching, treated with an antibiotic, the wound was cleaned and rebandaged. No concomitant medications were reported. Patient was provided rapid blood transfusions.  Company comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, serious (hospitalization) event of Hypoglycemia and Pseudocyst, the unexpected, serious (hospitalization and medically significant) adverse events of special interest of Pancreatitis acute and Pancreatitis necrotising and the unexpected, serious (hospitalization and medically significant) events of Intra-abdominal haematoma, Subcapsular splenic haematoma, Splenic rupture, Shock haemorrhagic, Gastric perforation and Blood loss anaemia. 3 days after receiving the second dose of mRNA-1273 vaccine, the patient blood glucose dropped to 48. The patient was admitted to a hospital for further evaluation for hypoglycemia and shortness of breath. The patient was treated with IV drip of concentrated glucose. The patient developed abdominal pain and underwent esophagogastroduodenoscopy where no mass was identified. The patient still has fluctuations in blood glucose and underwent pancreatic biopsy with findings of non-specific slightly hyperechoic pancreatic parenchyma with no identifiable mass. The patient blood glucose was stabilizing and was discharged on the 20th hospital day. 27 days after being discharged, the patient was admitted again due to nausea, vomiting, chills and acute abdominal pain. Computerized tomogram showed pancreatitis and a pseudocyst in the pancreas. The patient was advised bowel rest and discharged after 2 days. 2 days after being discharged the patient was admitted again for worsening of upper abdominal pain, left sided flank pain radiating to her shoulder, vomiting, nausea and pancreatitis. The computerized tomogram showed a large intraabdominal bleed, a larger subcapsular splenic hematoma and presence of subcapsular splenic parenchymal laceration/rupture. The patient blood pressure was low with tachycardia and underwent exploratory laparotomy, splenectomy, pancreatic debridement, repair of posterior wall gastric perforation with omental patch and jejunostomy feeding tube placement and blood transfusions. The patient was diagnosed with hemorrhagic shock, pancreatic necrosis, pancreatitis associated with posterior wall gastric perforation, spleen hematoma, acute blood loss and acute pancreatitis. The patient subsequently underwent a CT-guided aspiration and a PD stent drainage tube was placed to drain the fluid leaking from the pancreas. The patient was discharged on 41th day of hospital with a feeding tube. 8 days after being discharged the feeding tube was infected associated with cellulitis and was treated with antibiotics. The feeding tube was eventually removed. The patient reported to suffer from anxiety and depression and complained of persistent pain on left side of her abdomen. It should be noted that the two doses of mRNA-1273 vaccine were given on a 42-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the unexpected, serious (hospitalization) event of Hypoglycemia and Pseudocyst, the unexpected, serious (hospitalization and medically significant) adverse events of special interest of Pancreatitis acute and Pancreatitis necrotising and the unexpected, serious (hospitalization and medically significant) events of Intra-abdominal haematoma, Subcapsular splenic haematoma, Splenic rupture, Shock haemorrhagic, Gastric perforation and Blood loss anaemia. 3 days after receiving the second dose of mRNA-1273 vaccine, the patient blood glucose dropped to 48. The patient was admitted to a hospital for further evaluation for hypoglycemia and shortness of breath. The patient was treated with IV drip of concentrated glucose. The patient developed abdominal pain and underwent esophagogastroduodenoscopy where no mass was identified. The patient still has fluctuations in blood glucose and underwent pancreatic biopsy with findings of non-specific slightly hyperechoic pancreatic parenchyma with no identifiable mass. The patient blood glucose was stabilizing and was discharged on the 20th hospital day. 27 days after being discharged, the patient was admitted again due to nausea, vomiting, chills and acute abdominal pain. Computerized tomogram showed pancreatitis and a pseudocyst in the pancreas. The patient was advised bowel rest and discharged after 2 days. 2 days after being discharged the patient was admitted again for worsening of upper abdominal pain, left sided flank pain radiating to her shoulder, vomiting, nausea and pancreatitis. The computerized tomogram showed a large intraabdominal bleed, a larger subcapsular splenic hematoma and presence of subcapsular splenic parenchymal laceration/rupture. The patient blood pressure was low with tachycardia and underwent exploratory laparotomy, splenectomy, pancreatic debridement, repair of posterior wall gastric perforation with omental patch and jejunostomy feeding tube placement and blood transfusions. The patient was diagnosed with hemorrhagic shock, pancreatic necrosis, pancreatitis associated with posterior wall gastric perforation, spleen hematoma, acute blood loss and acute pancreatitis. The patient subsequently underwent a CT-guided aspiration and a PD stent drainage tube was placed to drain the fluid leaking from the pancreas. The patient was discharged on 41th day of hospital with a feeding tube. 8 days after being discharged the feeding tube was infected associated with cellulitis and was treated with antibiotics. The feeding tube was eventually removed. The patient reported to suffer from anxiety and depression and complained of persistent pain on left side of her abdomen. It should be noted that the two doses of mRNA-1273 vaccine were given on a 42-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.