Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Acute kidney injury, Atrial fibrillation
Clinical narrative: Arm rash/Rash came out over the stomach; Chest pain; Elevated blood protein; elevated lipase; Elevated transaminase level; Lactic acidosis; Abdominal pain; Sepsis; Chronic atrial fibrillation; Acute kidney injury/kidney problems; Nausea; Vomiting; Chills; Liver problems; Stomach feels irritated/stomach feels like scalded; Kind of sick/so sick she could not go to the bathroom/when she started eating she started to get real sick again; Her stomach is really swollen; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Sepsis), ATRIAL FIBRILLATION (Chronic atrial fibrillation), ACUTE KIDNEY INJURY (Acute kidney injury/kidney problems), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), LIVER DISORDER (Liver problems), RASH (Arm rash/Rash came out over the stomach), CHEST PAIN (Chest pain), HYPERPROTEINAEMIA (Elevated blood protein), HYPERLIPASAEMIA (elevated lipase), HYPERTRANSAMINASAEMIA (Elevated transaminase level), LACTIC ACIDOSIS (Lactic acidosis) and ABDOMINAL PAIN (Abdominal pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Yeast infection, Fibrillation atrial, Heart enlarged, Macular degeneration and Dermatitis. Concomitant products included METRONIDAZOLE SODIUM (METRONIDAZOLE [METRONIDAZOLE SODIUM]) for Dermatitis, METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD) for Heart disorder, CARMELLOSE SODIUM (REFRESH [CARMELLOSE SODIUM]) for Macular degeneration, NYSTATIN (NYSTOP) for Yeast infection, FAMOTIDINE (FAMOTIDINE ACID REDUCER), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40), DIAZEPAM, CORTISONE and VITAMINS NOS for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury/kidney problems) (seriousness criteria hospitalization and medically significant), NAUSEA (Nausea) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization) and LIVER DISORDER (Liver problems) (seriousness criterion hospitalization). On 13-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach feels irritated/stomach feels like scalded), ILLNESS (Kind of sick/so sick she could not go to the bathroom/when she started eating she started to get real sick again) and ABDOMINAL DISTENSION (Her stomach is really swollen). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), ATRIAL FIBRILLATION (Chronic atrial fibrillation) (seriousness criteria hospitalization and medically significant), RASH (Arm rash/Rash came out over the stomach) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), HYPERPROTEINAEMIA (Elevated blood protein) (seriousness criterion hospitalization), HYPERLIPASAEMIA (elevated lipase) (seriousness criterion hospitalization), HYPERTRANSAMINASAEMIA (Elevated transaminase level) (seriousness criterion hospitalization), LACTIC ACIDOSIS (Lactic acidosis) (seriousness criteria hospitalization and medically significant) and ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization). The patient was hospitalized from 24-Aug-2021 to 27-Aug-2021 due to ABDOMINAL PAIN, ACUTE KIDNEY INJURY, ATRIAL FIBRILLATION, CHEST PAIN, CHILLS, HYPERLIPASAEMIA, HYPERPROTEINAEMIA, HYPERTRANSAMINASAEMIA, LACTIC ACIDOSIS, LIVER DISORDER, NAUSEA, RASH, SEPSIS and VOMITING. At the time of the report, SEPSIS (Sepsis), ATRIAL FIBRILLATION (Chronic atrial fibrillation), ACUTE KIDNEY INJURY (Acute kidney injury/kidney problems), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), LIVER DISORDER (Liver problems), RASH (Arm rash/Rash came out over the stomach), CHEST PAIN (Chest pain), HYPERPROTEINAEMIA (Elevated blood protein), HYPERLIPASAEMIA (elevated lipase), HYPERTRANSAMINASAEMIA (Elevated transaminase level), LACTIC ACIDOSIS (Lactic acidosis), ABDOMINAL PAIN (Abdominal pain), ABDOMINAL DISCOMFORT (Stomach feels irritated/stomach feels like scalded), ILLNESS (Kind of sick/so sick she could not go to the bathroom/when she started eating she started to get real sick again) and ABDOMINAL DISTENSION (Her stomach is really swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrophoresis protein: elevated (High) Elevated. On an unknown date, Heart rate: 150 (High) 150 beats per minute. On an unknown date, Lipase: elevated (High) Elevated. On an unknown date, Transaminases: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She had heart monitor.  About 3 weeks after the vaccine, when the patient quit the sulfa drug, she started with symptoms: she had nausea, vomiting, chills, her heart was beating 150 beats a minute, she had kidney problems, liver problems and for all that she was admitted in hospital for 4 days since 26Aug2021. The doctor had to pick her up and put her in a chair at hospital. She is still having some problems. Her discharge papers from hospital say: abdominal pain, acute kidney injury, chest pain, chronic atrial fibrillation, elevated blood protein, elevated lipase, elevated transaminase level, lactic acidosis, nausea and vomiting, rapid atrial fibrillation, rash, sepsis (they did not know the cause).  She was on sulfa drugs at time of Moderna vaccination and rash appeared after stopping of sulfa drugs.  She is also taking Blood thinners and using topical cream 100,000 units along with other concomitant drugs. No treatment information was reported by reporter.  Patient is on liquid diet due to swollen stomach. She is scheduled for second dose of vaccine on 16-SEP-2021  Compnay comment This case concerns a  66-year-old, female patient with relevant medical history of heart enlarged, atrial fibrillation and cardiac pacemaker, who experienced the unexpected events of sepsis, atrial fibrillation, acute kidney injury, nausea, vomiting, chills, liver disorder, abdominal pain, chest pain, rash, hyperproteinaemia, hyperlipasemia, hypertransaminasemia and lactic acidosis. The events of nausea, vomiting, chills, kidney problems/acute kidney injury and liver problems occurred approximately 20 days after the first dose of Spikeva. The patient was hospitalised and per discharge notes the patient had additional events mentioned previously.The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report. Patient's medical history and concomitant unspecified sulfa drug use remains a confounder.; Sender's Comments: This case concerns a  66-year-old, female patient with relevant medical history of heart enlarged, atrial fibrillation and cardiac pacemaker, who experienced the unexpected events of sepsis, atrial fibrillation, acute kidney injury, nausea, vomiting, chills, liver disorder, abdominal pain, chest pain, rash, hyperproteinaemia, hyperlipasemia, hypertransaminasemia and lactic acidosis. The events of nausea, vomiting, chills, kidney problems/acute kidney injury and liver problems occurred approximately 20 days after the first dose of Spikeva. The patient was hospitalised and per discharge notes the patient had additional events mentioned previously.The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report. Patient's medical history and concomitant unspecified sulfa drug use remains a confounder.