Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
drug induced polyneuropathy/Tingling in toes and fingers; This serious case was reported by a consumer via call center representative and described the occurrence of polyneuropathy in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included non-hodgkin's lymphoma (in 2020). Concomitant products included RSV VACCINE, Flu unspecified (Influenza vaccine), COVID-19 VACCINE and rituximab (Rituxan). On 17-JAN-2025, the patient received the 1st dose of Shingrix. In JAN-2025, less than a month after receiving Shingrix, the patient experienced polyneuropathy (Verbatim: drug induced polyneuropathy/Tingling in toes and fingers) (serious criteria GSK medically significant). The outcome of the polyneuropathy was unknown. It was unknown if the reporter considered the polyneuropathy to be related to Shingrix. The company considered the polyneuropathy to be unrelated to Shingrix. Linked case(s) involving the same patient: US2025AMR132241 Additional Information: GSK Receipt Date: 13-OCT-2025 The patient reported that on 31st October 2024, she got her COVID-10 and flu shot (unknown manufacturer) and on 9th November 2024, she got an RSV shot (unknown manufacturer). She received her first dose of Shingrix and she developed tingling in her fingers and toes in January 2025. At her doctor's appointment in February, she was told that she had drug induced polyneuropathy. The batch number was not provided and a request for this information has been made. This case is linked with US2025AMR132241, reported by same reporter.; Sender's Comments: A case of Polyneuropathy, less than a month after receiving Shingrix in a elderly female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (h/o non-hodgkin's lymphoma and concomitant RSV vaccine, Influenza vaccine, COVID-19 vaccine and rituximab). US-GSK-US2025AMR132241:same patient
Medical History/Concurrent Conditions: Non-Hodgkin's lymphoma (in 2020)
RSV VACCINE; Influenza vaccine; COVID-19 VACCINE; RITUXAN