Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 1 | — | OT |
heart failure; reduced refraction; enlarged aorta; inflammation; Initial information received on 21-Oct-2025 regarding an unsolicited valid serious case received from a Patient. This case involves an unknown age and unknown gender patient who experienced heart failure, reduced refraction, enlarged aorta and inflammation after receiving NVX-COV2705 (OMICRON JN.1) adjuvanted vaccine [Novavax Covid-19 Vaccine, Adjuvanted (2024-2025 Formula)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose 4 (unknown dose) of suspect NVX-COV2705 (OMICRON JN.1) adjuvanted vaccine, Injection (strength, lot number and expiry date not reported) via unknown route in unknown administration site and 3 other doses were administered on unknown dates for same vaccine for prophylactic vaccination. On an unknown date the patient developed heart failure (cardiac failure), reduced refraction (refraction disorder), enlarged aorta (aortic dilatation) and inflammation (unknown latency). Patient had 4 novavax vaccines and a single mrna in the beginning, wanted to understand the percentage of people with this side affect as compared to the mrna vaccine. trying to decide if he should get the latest shot Action taken: Not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events. Seriousness criteria: Medically significant for cardiac failure.; Sender's Comments: Sanofi Company Comment dated 28-OCT-2025: This case involves an unknown age and unknown gender patient who experienced heart failure, reduced refraction, enlarged aorta and inflammation after receiving NVX-COV2705 (OMICRON JN.1) adjuvanted vaccine [Novavax Covid-19 Vaccine, Adjuvanted (2024-2025 Formula)]. Further information regarding medical history, concomitant medications and tolerance, clinical course, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.