Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | 407271 | — |
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | No batch number | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | No batch number | — |
Weakness bilateral in lower extremities; This spontaneous case, initially received on 09-Sep-2025, was reported by a health professional and concerns an elderly male patient. Past medical history included lumbar puncture. At the time of the event the patient had Hypertension, Hyperlipidemia, Vitamin D Deficiency, Benign Neoplasm Of Left Renal Pelvis, aortic aneurysm, Chronic Kidney Disease Stage 3A, Elevated PSA(Prostatic specific antigen). Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 28-Aug-2025, the patient received Fluad (TIV) for Active immunization against influenza disease, Dose regimen: 0.5 ml, Route of administration: Not reported, Anatomical site: Not reported, Lot number: 407271. Expiration date: 01-May-2026. Non-company suspect drugs: On 28-Aug-2025, patient received Arexvy (RSV vaccine prot. subunit PreF3), Indication: Not reported, Dose regimen: not reported, Route of administration: Not reported, Anatomical site: Not reported. On 28-Aug-2025, patient Boostrix (Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid), Indication: Not reported, Dose regimen: not reported, Route of administration: Not reported, Anatomical site: Not reported.. Adverse reactions/events and outcomes: On 05-Sep-2025, the patient experienced Weakness bilateral in lower extremities (Hospitalized, outcome: Not recovered / Not resolved). The patient got his vaccine on 28-Aug-2025, and the day previous this report was sent and admitted to the hospital. Office manager adds: The patient was experiencing weakness bilateral in lower extremities. They saw him in the office, and sent him to a neurologist, that sent him to the hospital, where he was admitted on 08-Sep-2025. Start date of event: 05-Sep-2025 Stop date of event: patient was in the hospital at the time of reporting, so reporter assumed the issue was still ongoing Patient received RSV vaccine Arexvy and Boostrix at the same time as Fluad Fluad (TIV) action taken: Not Applicable Treatment measures associated with event: lumbar puncture Reporter's assessment: The reporter provide seriousness as unknown and did not provide the causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Related considering plausible temporality (7 days after fluad vaccine administration). Underlying conditions of At the time of the event the patient had Hypertension, Hyperlipidemia, Vitamin D Deficiency, Benign Neoplasm Of Left Renal Pelvis, aortic aneurysm, Chronic Kidney Disease Stage 3A provide plausible etiology for the event reported.
Aortic aneurysm; Benign neoplasm of renal pelvis; Chronic kidney disease stage 3; Hyperlipidemia; Hypertension; Prostate specific antigen increased; Vitamin D deficiency
Medical History/Concurrent Conditions: Lumbar puncture
Metoprolol; Rosuvastatin; Vitamin D2