Received Feb 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | — | OT / RA |
Tingling in her fingers; Pain in the back of her legs; Lost all feelings in her hands and legs; Unable to stand, walk, hold any objects or write; Unable to stand, walk, hold any objects or write; Lose the ability to speak; Lose the ability to...swallow; Facial muscles became paralyzed; This serious initial spontaneous safety report was received by Novavax on 03-Feb-2025 from a consumer or other non health professional via Regulatory Authority (ref. no. US-1000000476-NVAX). A 73 year-old female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (Lot number was requested but was unknown to the reporter) on 22-Nov-2024. No medical history was reported. No concomitant medications were reported. On an unspecified date in Nov-2024 (reported as "within a week of the vaccine") after vaccination the patient experienced Pain in the back of her legs(Pain in extremity)(Serious: Caused/Prolonged Hospitalization) and Tingling in her fingers(Paraesthesia)(Serious: Caused/Prolonged Hospitalization). On an unspecified date in 2024 (reported as "within two weeks") after vaccination the patient experienced Lost all feelings in her hands and legs (Hypoaesthesia)(Serious: Caused/Prolonged Hospitalization), Unable to stand, walk, hold any objects or write(Loss of personal independence in daily activities)(Serious: Caused/Prolonged Hospitalization) and Unable to stand, walk, hold any objects or write(Gait inability)(Serious: Caused/Prolonged Hospitalization). On an unspecified date in 2024 after vaccination the patient experienced Facial muscles became paralyzed (Facial paralysis)(Serious: Caused/Prolonged Hospitalization, Other Medically Important Condition), Lose the ability to speak(Speech disorder)(Serious: Caused/Prolonged Hospitalization) and Lose the ability to...swallow(Dysphagia)(Serious: Caused/Prolonged Hospitalization). The patient visited a hospital on 16-Dec-2024 and Neurologist on 20-Dec-2024. Neurologist advised the patient to go immediately to another hospital. The patient visited ER and then was admitted to the medical unit and then transferred to ICU. Duration of the hospitalization was reported to be 5 weeks (35 days). Treatment included Five days of IVIG treatment. A week later when not improving, she received steroid treatment for seven days. Relevant lab tests included: Multiple MRIs (Result: Not provided, Test Date: Unknown), CAT scans (Result: Not provided, Test Date: Unknown), Spinal puncture (Result: Not provided, Test Date: Unknown), Spinal puncture (Result: Not provided, Test Date: Unknown), Nerve biopsy (Result: Not provided, Test Date: Unknown) and Blood work for all types for all types of potential viruses and bacterial infections and autoimmune disorders (Result: Not provided, Test Date: Unknown). At the time of reporting, the outcome of the events Facial paralysis, Paraesthesia, Pain in extremity, Hypoaesthesia, Loss of personal independence in daily activities, Gait inability, Speech disorder and Dysphagia was Not Recovered/Not Resolved/Ongoing.; Sender's Comments: This 73 year-old female experienced Facial paralysis, Paraesthesia, Pain in extremity, Hypoaesthesia, Loss of personal independence in daily activities, Gait inability, Speech disorder and Dysphagia after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Facial paralysis was reported as serious. The event Paraesthesia was reported as serious. The event Pain in extremity was reported as serious. The event Hypoaesthesia was reported as serious. The event Loss of personal independence in daily activities was reported as serious. The event Gait inability was reported as serious. The event Speech disorder was reported as serious. The event Dysphagia was reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Facial paralysis, Paraesthesia, Pain in extremity, Hypoaesthesia, Loss of personal independence in daily activities, Gait inability, Speech disorder and Dysphagia is considered Possible.
Test Name: MULTIPLE MRIS; Result Unstructured Data: Not provided; Test Name: CAT SCANS; Result Unstructured Data: Not provided; Test Name: SPINAL PUNCTURE; Result Unstructured Data: Not provided; Test Name: SPINAL PUNCTURE; Result Unstructured Data: Not provided; Test Name: NERVE BIOPSY; Result Unstructured Data: Not provided; Test Name: BLOOD WORK FOR ALL TYPES FOR ALL TYPES OF POTENTIAL VIRUSES AND BACTERIAL INFECTIONS AND AUTOIMMUNE DISORDERS; Result Unstructured Data: Not provided