Received Feb 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
increased neuropathy symptoms; itchy eyes; abnormal kidney function bloodwork; rash in groin area; unable to sleep at night; carpal tunnel; depression; not feeling well; This Spontaneous report was received from Consumer or other non health professional and referred to a 79 -year-old Female patient. The patient's medical history included Transthyretin-Related Amyloidosis and diarrhea. The patient's past and concomitant medications were not reported. On 21-Jan-2025, the patient started therapy with Vyndamax (Tafamidis) Capsule via Oral (Dose Text: Take 1 (61MG) capsule orally twice daily) for the treatment of Transthyretin-Related Amyloidosis (Lot # and expiration date were not reported). On an unknown date (Reported as recently), the patient was vaccinated with Zoster Vaccine Live (Reported as Shingles vaccine) (Dose, route, anatomical location, lot # and expiration date were not reported) for Prophylaxis. On an unknown date, the patient experienced increased neuropathy symptoms (Neuropathy peripheral), itchy eyes (Eye pruritus), abnormal kidney function bloodwork (Renal impairment), rash in groin area (Rash), unable to sleep at night (Insomnia), carpal tunnel (Carpal tunnel syndrome), depression, and was not feeling well (Malaise). The outcome of the events was unknown. Causality assessment was not provided. Upon internal review, the event Neuropathy peripheral and Renal impairment were determined to be Medically Significant.
Diarrhea; Transthyretin-mediated amyloidosis
sterile diluent; VYNDAMAX
Test Name: bloodwork; Result Unstructured Data: Abnormal kidney function