Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | — | OT |
Started losing weight about 4-5 months later; My kidneys declined; Had Covid again in 2023; I got a Novavax in 2022; This non-serious, initial spontaneous safety was reported by a Consumer or other non-health professional via the Novavax Medical Information (MI no. NOV25-00120) and concerns a 76-year-old Male who "received Novavax in 2021 only" on an unspecified date in 2021, and "had Covid again in 2023" on an unspecified date in 2023 after receiving Novavax COVID-19 Vaccine, Adjuvanted on an unspecified date in 2021. At the time of the report, the outcome of COVID-19 was Unknown and Incomplete course of vaccination was Recovered/Resolved. On 18-Apr-2025, significant information was received from a consumer via contact center (MI No. NOV25-00214) - This case was upgraded from non-serious to serious. Patient and primary reporter details were updated, a third reporter was added, "hernia repair" was added to the patient's medical history, added 04-Apr-2025 dose to patient's past therapy, updated therapy start and end date from --2021 to -Oct-2022, updated the event verbatim "Received Novavax in 2021 only" (Incomplete course of vaccination) to "I got a Novavax in 2022", added two new events: "My kidneys declined" (Renal impairment) (Seriousness criteria: Other medically important condition) and Started losing weight about 4-5 months later (Weight decreased), and added new lab data "I got a blood draw" done on an unknown date in 2023 with the result of "my kidneys declined". The outcome of the events renal impairment and weight decreased were unknown.; Sender's Comments: This 77-year-old Male experienced Renal impairment, Incomplete course of vaccination, COVID-19, and Weight decreased after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (1). The event Renal impairment was reported as serious. The events Incomplete course of vaccination, COVID-19, and Weight decreased were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted and Renal impairment, Incomplete course of vaccination, COVID-19, and Weight decreased is considered Possible.
Function kidney decreased (They are not in catastrophic condition, I don't take any prescription drugs, they can be hard on the kidneys); Tinnitus (Before taking Novavax. It varies in intensity, being exposed to noise or just using his own voice can intensify it.)
Medical History/Concurrent Conditions: Chronic kidney disease; COVID-19; Hernia repair
Test Date: 2020; Test Name: COVID-19 TEST; Test Result: Positive; Test Date: 2023; Test Name: COVID-19 TEST; Test Result: Positive; Test Date: 2023; Test Name: I GOT A BLOOD DRAW; Result Unstructured Data: My kidneys declined