Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | LA |
BRADYCARDIA; SUPRAVENTRICULAR TACHYCARDIA (SVT); HYPOVOLEMIA; Initial information received on 27-Oct-2025 and 30-Oct-2025 (all processed together) regarding a solicited valid serious case received from a physician, in the scope of company sponsored study. This case involves a 50-year-old female subject who experienced bradycardia, hypovolemia and supraventricular tachycardia (SVT), during the study participation. The subject's past vaccination(s) included covid-19 vaccine on 06-Mar-2021 and 25-Mar-2021 (variant: Wuhan) and covid-19 vaccine on 30-Sep-2021 (variant: unknown); all via intramuscular route as Immunisation. The subject's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the subject had ongoing Irritable bowel syndrome since 1995, Drug hypersensitivity since 2004, Major depression and Migraine with aura both since 01-May-2013, Sjogren's syndrome and Gilbert's syndrome both since 28-Dec-2020, Postmenopause since Nov-2023, Generalised anxiety disorder and Hyperlipidaemia both since 02-Jul-2024. Concomitant medications included venlafaxine hydrochloride (effexor) for generalised anxiety disorder; sumatriptan succinate for migraine with aura; estradiol, norethisterone acetate for postmenopause; paracetamol (tylenol extra strength) for headache; ondansetron and loperamide both for gastrointestinal disorder; potassium for hypokalaemia; and magnesium sulfate for hypomagnesaemia. On 14-Oct-2025, the screening/ visit 1 was performed. At 12:44, the subject received a dose 01 of suspect investigational NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE, Solution for injection in pre-filled syringe at an unknown dose via unknown route in the left deltoid muscle as prophylactic vaccination. On 24-Oct-2025, 9 days 11 hrs 16 min following the administration of first dose NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE, the subject was admitted to the hospital and stated that they gave her intravenous (iv) hydration and iv ondansetron. They were going to discharge (DC) her home, but her heart rate was noted to be bradycardic in the 30s-40s. The subject was diagnosed with bradycardia (intensity: severe). She was admitted with continuous telemetry. Subject stated that they corrected her potassium and magnesium levels with iv potassium (K) and magnesium (Mg). The subject also had hypovolemia (hypovolaemia; intensity: severe) due to vomiting, diarrhea, and bradycardia as per DC record. The event of hypovolemia was assessed as medically significant. On 25-Oct-2025, the subject recovered from the event bradycardia. On same day, 10 days 11 hrs 16 min following the administration of NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE, the subject was going to be discharged on saturday but was then noted to have a run of supraventricular tachycardia (SVT) (supraventricular tachycardia; intensity: moderate). Subject was given flecainide for the arrythmta. Subject stated that she had 2 echocardiograms that were normal. She did not have any further runs of SVT and has a normal heart rate (HR) at this time. All the events were assessed as a medically attended adverse event (MAAE) but not an Adverse Event of Special Interest (AESI). Healthcare encounter was required for all the events. Specialist consultation was performed for bradycardia and supraventricular tachycardia (SVT). Action taken with SARS-COV-2 (OMICRON JN.1) RECOMBINANT SPIKE PROTEIN was not applicable for all the events. On 27-Oct-2025, it was planned to discharge the subject with a holter monitor and she was going to follow-up after a week of wearing the monitor. It was reported that the subject was in for unscheduled visit after hospitalization. Subject brought DC records. Diagnosis (DX) per record was hypovolemia which was due to vomiting, diarrhea, and bradycardia. On 28-Oct-2025, the subject recovered from the event hypovolemia. At time of reporting, the outcome was Recovering / Resolving for the event supraventricular tachycardia (SVT). All the events did not cause discontinuation of the subject from the study. Bradycardia, Hypovolemia and Supraventricular Tachycardia (SVT) were considered to be not related to NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE by the reporter and not reportable by the company based on company causality assessment. Rationale for Investigator Causality Assessment (Bradycardia): Awaiting medical records, but bradycardia might have been caused by gastrointeshnal illness electrolyte imbalance Relationship between bradycardia, hypovolemia and supraventricular tachycardia (SVT) 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 06-Nov-2025: This case involves a 50-year-old female subject who was diagnosed with bradycardia, hypovolemia and supraventricular tachycardia (SVT) following the study vaccine. Considering the use of concomitant medications, ongoing medical histories and nature of the event, the Sponsor considers, all the event as not related to the study vaccine, in agreement with the Investigator. Additionally, due to lack of information regarding subject family history, concurrent illness and risk factors, the case will be re-evaluated post further update.
Drug allergy; Generalized anxiety disorder; Gilbert's syndrome; Hyperlipidemia; Irritable bowel syndrome; Major depression; Migraine with aura; Postmenopause; Sjogren's syndrome
EFFEXOR; SUMATRIPTAN SUCCINATE; ESTRADIOL / NORETHINDRONE ACETATE; TYLENOL EXTRA STRENGTH; ONDANSETRON; POTASSIUM; MAGNESIUM SULFATE; LOPERAMIDE
Test Date: 202510; Test Name: echocardiogram; Result Unstructured Data: 2 echocardiograms that were normal; Test Date: 20251024; Test Name: heart rate; Result Unstructured Data: bradycardic; Test Date: 202510; Test Name: HR; Result Unstructured Data: normal