Received Feb 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | 1 | — | IM / LA |
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | — | OT / LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Fever; Body aches; Loss of vision; Nausea; Abdominal cramping; Bloating; Vomiting; Vomitting; Fainting; Chills; Extreme fatigue; This serious initial Spontaneous safety report was received by Novavax on 18-Feb-2025 from a consumer or other non-health professional via agency (Web Portal) (ref. no. US-1000000481-NVAX). A 28 Year(s) old individual of an unspecified gender was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was requested but was unknown to the reporter) on 15-Feb-2025. The following secondary suspect medications were reported: INFLUENZA VACCINE (influenza vaccine). The following medical history was reported: NICKEL ALLERGY. No concomitant medications were reported. On an unspecified date after vaccination the patient experienced Loss of vision (Blindness)(Serious: Other Medically Important Condition), Fever (Pyrexia), Body aches (Pain), Nausea (Nausea), and Abdominal cramping (Abdominal pain). On 15-Feb-2025, the same day after vaccination the patient experienced Fainting (Syncope)(Serious: Other Medically Important Condition), Chills (Chills), Extreme fatigue (Fatigue), Vomiting (Vomiting) and Bloating (Abdominal distension). Relevant lab tests included: RAPID POC TEST (Result: Positive, Test Date: 01-Dec-2020) and RAPID POC TEST (Result: Positive, Test Date: 01-Sep-2023). At the time of reporting, the event outcome of Blindness, Pyrexia, Pain, Nausea, Abdominal pain, and Syncope was Recovering/Resolving. The event outcome of Chills, Fatigue, Vomiting was Recovered/Resolved on 17-Feb-2025 and Abdominal distension was Recovered/Resolved on 18-Feb-2025. A discrepancy was identified in the source document where the outcome for the events of Chills, Fatigue, Vomiting, and Abdominal distension was captured as Recovered/Resolved as cessation dates were provided. The events of Blindness and Syncope were considered as serious as these are listed on the IME list.; Sender's Comments: This 28-year-old of an unspecified sex experienced Syncope, Blindness, Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Syncope and Blindness were assessed as serious. The events Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Syncope, Blindness, Pyrexia, Pain, Chills, Fatigue, Nausea, Vomiting, Abdominal pain and Abdominal distension is considered Possible.
Nickel allergy
Test Date: 20201201; Test Name: RAPID POC TEST; Test Result: Positive ; Test Date: 20230901; Test Name: RAPID POC TEST; Test Result: Positive