Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | 5683_MF012 | OT / RA |
I had extreme fatigue; Flu like run down mild, very mild symptoms; Got Covid in 21SEP2024; Got Covid in 21SEP2024; This serious initial Spontaneous report was received by Novavax on 16-May-2025 from a Consumer or other non-health professional via Novavax Medical Information (MI number NOV25- 00329). A 65-year-old Female was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)(Intramuscular) (LOT: 5683_MF012) on 26-Oct-2023. The following medical history was reported: COVID (on 04-Apr-2022 and 10-Feb-2023). No concomitant medications were reported. On 26-Oct-2024, the same day after vaccination the patient "Got Covid in 21SEP2024" (Vaccination failure) (Serious: Other Medically Important Condition) (COVID-19). On 21-Sep-2024, 332 days after vaccination, the patient "Got Covid in 21SEP2024" (COVID-19). On an unspecified date after vaccination the patient experienced extreme fatigue (Fatigue), and Flu like run down mild, very mild symptoms (Influenza like illness). On an unspecified date after vaccination the patient experienced I had extreme fatigue(Fatigue), and Flu like run down mild, very mild symptoms(Influenza like illness). Treatment included Paxlovid (nirmatrelvir/ritonavir). Relevant lab tests included: COVID-19 TEST (Result: Positive, Test Date: 04-Apr-2022), COVID-19 TEST (Result: Positive, Test Date: 10-Feb-2023) and COVID-19 TEST (Result: Positive, Test Date: 21-Sep-2024). At the time of reporting, the event outcome of Vaccination failure was Recovered/Resolved while the event outcome of Fatigue, Influenza like illness, and COVID-19 was Unknown.; Sender's Comments: This 65-year-old Female experienced Fatigue, Influenza like illness, Vaccination failure and COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Vaccination failure was reported as serious. The events COVID-19, Fatigue, and Influenza like illness were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Vaccination failure, COVID-19, Fatigue and Influenza like illness is considered Possible.
Medical History/Concurrent Conditions: COVID-19
Test Date: 20220404; Test Name: COVID-19 TEST; Test Result: Positive ; Test Date: 20230210; Test Name: COVID-19 TEST; Test Result: Positive ; Test Date: 20240921; Test Name: COVID-19 TEST; Test Result: Positive