Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | 6024MF025 | OT |
Debilitating chills; Fever; Head & body ache; Head & body ache; Nausea; This non serious initial spontaneous safety report was reported by a Consumer or other non-health professional and concerns an individual of an unspecified age and sex who experienced DEBILITATING CHILLS, FEVER, HEAD & BODY ACHE, HEAD & BODY ACHE and NAUSEA on an unknown date after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on unknown day. At the time of the report, the outcome of the Chills, Pyrexia, Headache, Pain, Nausea was Unknown. Based on internal review on 24-Sep-2024, it was determined that for case 2024-NVX-GB-00497, the country of incidence was captured incorrectly in the structured field. Therefore, this case 2024-NVX-US-00599 has been created with the correct country of incidence. 2024-NVX-GB-00497 will be invalidated. On 02-Sep-2025, significant information was received from a consumer via social media monitoring (Resolver No. 00367183): The following medical history was reported: pancreatic and kidney transplant, and a transplant recipient. The patient's past therapy included five doses of unspecified COVID-19 vaccines. On 11-Mar-2025, the patient received 12th dose of Novavax vaccine (Therapy #two).; Sender's Comments: This individual of an unspecified age and sex experienced Chills, Pyrexia, Headache, Pain and Nausea after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Chills, Pyrexia, Headache, Pain, Nausea was 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 Chills, Pyrexia, Headache, Pain and Nausea is considered Possible.
Immunosuppression; Transplant recipient
Medical History/Concurrent Conditions: Kidney transplant; Pancreatic transplant