Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | 1 | 6024MF020 | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8454EA | OT |
Eye swelling; Initial information received on 31-Mar-2025 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-hcp (non-healthcare professional). This case involves a 79 years old female patient who experienced eye swelling after receiving Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] and COVID-19 vaccine prot. subunit (NVX CoV 2373) [Novavax COVID-19 Vaccine]. No concomitants used/reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Dec-2024, the patient received an unknown dose (dose 1) of suspect COVID-19 vaccine prot. subunit (NVX CoV 2373), Injection not produced by Sanofi Pasteur (lot 6024MF020, strength 0.5mL; strength not reported) via intramuscular route in unknown administration site for COVID-19 immunization. On an unknown date, the patient received an unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot UT8454EA, strength 0.5mL; expiry date not reported) via intramuscular route in unknown administration site for Drug Use for Unknown Indication (Product used for unknown indication). On 13-Dec-2024, the patient developed eye swelling (latency 1 day) following the administration of COVID-19 vaccine prot. subunit (NVX CoV 2373) and (latency unknown) Influenza USP Trival A-B High Dose Subvirion Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. Sender's comment - This 79-year-old Female experienced Eye swelling after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Eye swelling was reported as non-serious.Based on the spontaneous nature of the report, the causal relationship between the vaccine and the event is considered Possible.