Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Extravasation, Gastrointestinal tube insertion, Haematoma, Perforation, Pneumonia
Clinical narrative: DEATH; ASPIRATION; PERFORATION; ABDOMINAL PAIN; BILE OUTPUT ABNORMAL; COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL; COMPUTERISED TOMOGRAM NECK; COMPUTERISED TOMOGRAM THORAX ABNORMAL; GASTROINTESTINAL TUBE INSERTION; URINARY SYSTEM X-RAY; VOMITING; SARS-COV-2 TEST POSITIVE; COVID-19; DYSPNOEA; EXTRAVASATION; HAEMATOMA; ANGIOGRAM ABNORMAL; PNEUMONIA; ARTHRALGIA; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority  (VAER reference number 1541119) concerned a 94 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included hematoma right thigh, hypertension, atrial fibrillation (A-fib), gastrooesophageal reflux disease (GERD), restless leg syndrome, vitamin D deficiency, depression with anxiety, and chronic hyponatremia. The patient experienced throat swelling when treated with corticotropin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 105031, expiry: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included amiodarone, apixaban, calcium carbonate, carvedilol, colecalciferol, diclofenac diethylamine, famotidine, fluticasone, furosemide, and paracetamol.  On 10-JUL-2021, the patient presented to emergency department with hip pain (arthralgia) of two weeks in duration, and underwent computerized tomogram (CT) angiogram showed a right inguinal hematoma and active extravasation and was medically managed. The patient subsequently developed shortness of breath (dyspnoea) and pneumonia and treated with 7 days of cefepime. on 30-JUL-2021, patient tested sars-cov-2 test positive for COVID-19 (suspected clinical vaccination failure) which was the anticipated day of transfer to skilled nursing facility. On 04-AUG-2021, the patient experienced abdominal pain prompting kidney, ureter and bladder (KUB) (Urinary system X-ray) which showed small bowel obstruction (SBO) but patient deferred NG tube. Later patient had CT chest, neck and abdomen which showed worsening of pneumonia with aspiration of bowel content and SBO and possible oropharyngeal perforation. Patient did agree after detailed discussion with family about CT findings and interventional radiology (IR) able to place NG tube but shortly after she began throwing up bile (vomiting) and needing high flow oxygen. The patient was not able to maintain oxygen saturation. The hospitalization date was not reported. The patient was hospitalized for 18 days. On 06-AUG-2021 at 04:15, the patient died due to unknown cause of death. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of aspiration, pneumonia, abdominal pain, covid-19, dyspnea, extravasation, hematoma, perforation, angiogram abnormal, bile output abnormal, computerized tomogram abdomen abnormal, computerised tomogram neck, computerised tomogram thorax abnormal, gastrointestinal tube insertion, sars-cov-2 test positive, urinary system x-ray, arthralgia and vomiting was fatal, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000190819. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.  Additional information was received from a Central Complaint Vigilance department on 17-SEP-2021. The following information was updated and incorporated into the case narrative: Investigation result.; Sender's Comments: V3: Additional information received updates Product Quality complaint investigation result. This updated information does not alter prior causality assessment of reported events. : 20210843108-Covid-19 vaccine ad26.cov2.s-Death, aspiration, pneumonia,  abdominal pain,  covid-19,  dyspnoea,  extravasation,  haematoma, perforation, angiogram abnormal, bile output abnormal,  computerised tomogram abdomen abnormal, computerised tomogram neck,   computerised tomogram thorax abnormal,  gastrointestinal tube insertion, sars-cov-2 test positive, urinary system x-ray, arthralgia,  vomiting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210843108-Covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH