Received Feb 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE WITH DEMAND ISCHEMIA; Initial information received on 25-Feb-2026 (all processed together) regarding a solicited valid serious case received from a physician, in the scope of company sponsored study. Study Title: This case involves a 59-year-old female subject who had atrial fibrillation with rapid ventricular response with demand ischemia, during the study participation. The subjects past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included dexamethasone (Decadron) for knee discomfort (not coded). On 26-Dec-2025, the subject received a dose of suspect investigational NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE VS PLACEBO Solution for injection at an unknown dose and via unknown route for COVID-19. On 06-Feb-2026, i.e., 1 month 11 days following the administration of NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE VS PLACEBO, the subject visited hospital with generalized weakness and nausea, reporting that she could barely get out of bed. She also stated that she had checked her blood glucose at home and noted it was significantly elevated (value not provided). She was admitted in the hospital for hemodynamic monitoring and further evaluation. Initial evaluation showed elevated serum creatinine 1.43mg/dl, elevated troponin (67 pg/ml), hyperglycemia 427 mg/dl (glycated hemoglobin (a1c)- 13.3%), the molecular infectious panel detected coronavirus hku1 by polymerase chain reaction (pcr) (not covid 19) (not coded). Additional laboratory testing and procedures such as arterial blood gases, electrocardiogram (ekg), echocardiogram (echo), doppler studies with contrast, and chest x-ray were performed but the results were not provided. Based on these findings, the subject was diagnosed with atrial fibrillation with rapid ventricular response with demand ischemia (Atrial fibrillation) and type 2 diabetes mellitus with no ischemic changes or evidence of acute coronary syndrome. The maximum event intensity was moderate. The event was not assessed as an Adverse Event of Special Interest (AESI). It did not represent a sign or symptom of myocarditis/pericarditis. It was not an potential immune-mediated medical condition (PIMMC). On 07-Feb-2026, the subject was discharged from the hospital. Action taken with NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE VS PLACEBO was not applicable. The subject was treated with metoprolol, diltiazem, levofloxacin (Lovenox), ondansetron (Zofran) and unknown intravenous fluids all for Atrial fibrillation. At time of reporting, the outcome was Recovering / Resolving for the event atrial fibrillation with rapid ventricular response with demand ischemia. On 24-Feb-2026, the site received medical records of the subject corresponding to the hospitalization. Atrial fibrillation with rapid ventricular response with demand ischemia was considered to be not related to NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE VS PLACEBO by the reporter and not reportable by the company based on company causality assessment. Rationale for Investigator Causality Assessment: metabolic condition. Relationship between atrial fibrillation with rapid ventricular response with demand ischemia and the study procedure was not related by the reporter and not reportable by the company based on company causality assessment.; Sender's Comments: Sanofi Company Comment dated 27-Feb-2026: This case involves a 57 59-year-old female subject who had atrial fibrillation with rapid ventricular response with demand ischemia, 1 month 11 days following the administration of NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE VS PLACEBO. Based on the nature of the event and long latency, the Sponsor considers the event as not related to the study vaccine, in agreement with the Investigator.
DECADRON [DEXAMETHASONE]
Test Date: 202602; Test Name: elevated serum creatinine; Test Result: 1.43 {DF}; Test Date: 202602; Test Name: Arterial blood gases; Result Unstructured Data: results not reported; Test Date: 202602; Test Name: Blood glucose; Result Unstructured Data: significantly elevated; Test Date: 202602; Test Name: Hyperglycemia; Test Result: 427 {DF}; Test Date: 202602; Test Name: Chest x-ray; Result Unstructured Data: results not reported; Test Date: 202602; Test Name: ECHO; Result Unstructured Data: results not reported; Test Date: 202602; Test Name: EKG; Result Unstructured Data: results not reported; Test Date: 202602; Test Name: a1c; Test Result: 13.3 %; Test Date: 202602; Test Name: Elevated troponin; Test Result: 67 {DF}; Test Date: 202602; Test Name: Doppler studies with contrast; Result Unstructured Data: results not reported