Received Jan 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
received the vaccines that were placed on the market by the defendants or by entities acting as their statutory representatives; claims that damage, bodily injury, or other adverse consequences have resulted therefrom.; pulmonary embolism; extreme anxiety reactions; damages, interventions, or consequences; Initial information received regarding an unsolicited valid serious legal case received from a Consumer/Non-HCP (Non-Healthcare Professional) at our licensee partner (LP) NOVAVAX-USA GSP-PCP on 22-Jan-2026 and transmitted to Sanofi on 22-Jan-2026 This case involves an unknown age and unknown gender patient who received the vaccines that were placed on the market by the defendants or by entities acting as their statutory representatives; claims that damage, bodily injury, or other adverse consequences have resulted therefrom., pulmonary embolism, extreme anxiety reactions and damages, interventions, or consequences after receiving NVX-Cov2373 (Original) Adjuvanted Vaccine [Nuvaxovid]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect NVX-COV2373 (Original) Adjuvanted Vaccine, Injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for Covid-19 vaccination [Covid-19 immunisation]. On an unknown date, the patient received the vaccines that were placed on the market by the defendants or by entities acting as their statutory representatives; claims that damage, bodily injury, or other adverse consequences have resulted therefrom (immunisation reaction); pulmonary embolism; extreme anxiety reactions (anxiety) and damages, interventions, or consequences (vaccination site reaction) (unknown latency). Final diagnosis was (life-threatening) immunisation reaction. Action taken was 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 Criteira: This event (immunisation reaction) was assessed as life-threatening and event (pulmonary embolism) was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 29-Jan-2026, This case involves an unknown age and unknown gender patient who received the vaccines that were placed on the market by the defendants or by entities acting as their statutory representatives; claims that damage, bodily injury, or other adverse consequences have resulted therefrom., pulmonary embolism, extreme anxiety reactions and damages, interventions, or consequences after receiving NVX-Cov2373 (Original) Adjuvanted Vaccine [Nuvaxovid]. Further information regarding tolerance, allergic history, medical history, concomitant medication and tolerance, 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.