Received Jan 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
cigarette Smoke Smell, phantosmia without smoking, within 15 minutes of vaccine intense smell; partial seizures; Initial information received on 05-Jan-2026 (Live follow-up processed together) regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 59 years old female patient who had partial seizure and cigarette smoke smell, phantosmia without smoking, within 15 minutes of receiving Nvx-Cov2373 (Original) Adjuvanted Vaccine [Nuvaxovid PFS]. The patient's past vaccination(s) included Nuvaxovid PFS on an unknown date in Nov-2024 for Covid-19 immunisation and had cigarette smoke smell, Phantosmia and Moderna Covid-19 Vaccine on an unknown date without Phantosmia. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Haemangioma. On 12-Nov-2025, the patient received 0.5mL dose of suspect NVX-COV2373 (Original) Adjuvanted Vaccine, Injection, (unknown strength and expiry date) lot number not reported via subcutaneous route in unknown administration site for protection against covid 19 virus [Covid-19 immunisation]. Information regarding batch number corresponding to the one at time of event occurrence is requested. On an unknown date in 2025, the patient developed partial seizures (unknown latency). On 12-Nov-2025, the patient developed cigarette smoke smell, phantosmia without smoking, within 15 minutes of vaccine intense smell (phantosmia) (Latency Same day). It was reported that, "Patient met with a neurologist for get a follow up MRI for an existing cavernous malfunction in my brain. After bring the cigarette smell to her attention she is concerned, Patient have parial seizures possibly set off by the vaccines by Novavax." Action taken was not applicable. No corrective treatment was received for both the events. At time of reporting, the outcome was Not Recovered / Not Resolved for both the events. Seriousness Criteria: This event (partial seizure) was assessed as medically significant and both events were leading to disability.; Sender's Comments: Sanofi Company Comment dated 09-Jan-2026, This case involves a 59 years old female patient who had partial seizure and cigarette smoke smell, phantosmia without smoking, within 15 minutes of receiving Nvx-Cov2373 (Original) Adjuvanted Vaccine [Nuvaxovid PFS]. 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.
Cavernoma