Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
swelling, redness and pain at injection site; swelling, redness and pain at injection site; swelling, redness and pain at injection site; nausea, headache and fatigue; nausea, headache and fatigue; nausea, headache and fatigue; Initial information received on 18-Oct-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 72 years old female patient who experienced swelling, redness and pain at injection site, mild nausea, headache and fatigue after receiving NVX-COV2373 (Original) adjuvanted vaccine [Nuvaxovid PFS]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Oct-2025, the patient received unknown dose of suspect NVX-COV2373 (Original) adjuvanted vaccine, Suspension for injection in pre-filled syringe (strength, lot number and expiry date not reported) via intramuscular route in unknown administration site for Vaccination against covid (COVID-19 immunization). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On 17-Oct-2025 the patient developed swelling, redness and pain at injection site (vaccination site swelling)(vaccination site erythema) (vaccination site pain), nausea, headache and fatigue (nausea) (fatigue) (latency: 3 days). Action taken: Not applicable. No corrective treatment was received for the events. At time of reporting, the outcome was Recovering / Resolving for all the events.