Received Aug 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | SYR |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
unable to live my life since this reaction started; now I can barely navigate stairs; despair; can not sleep; neuropathy hands and feet; Pain; Fever; Tachycardia; progressive weakness; This serious case was reported by a consumer and described the occurrence of peripheral neuropathy in a 41-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included acute myeloid leukemia, stem cell transplant and chronic graft versus host disease. Concomitant products included belumosudil mesylate (Rezurock). On 21-MAY-2025, the patient received Shingles vaccine. On 25-MAY-2025, 4 days after receiving Shingles vaccine, the patient experienced peripheral neuropathy (Verbatim: neuropathy hands and feet) (serious criteria GSK medically significant), pain (Verbatim: Pain), fever (Verbatim: Fever), tachycardia (Verbatim: Tachycardia) and weakness (Verbatim: progressive weakness). On an unknown date, the patient experienced activities of daily living impaired (Verbatim: unable to live my life since this reaction started), mobility decreased (Verbatim: now I can barely navigate stairs), feeling of despair (Verbatim: despair) and insomnia (Verbatim: can not sleep). The outcome of the peripheral neuropathy, pain, fever, tachycardia, weakness, activities of daily living impaired and mobility decreased were not resolved and the outcome of the feeling of despair and insomnia were not reported. It was unknown if the reporter considered the peripheral neuropathy, pain, fever, tachycardia, weakness, activities of daily living impaired, mobility decreased, feeling of despair and insomnia to be related to Shingles vaccine. The company considered the peripheral neuropathy to be unrelated to Shingles vaccine. It was unknown if the company considered the pain, fever, tachycardia, weakness, activities of daily living impaired, mobility decreased, feeling of despair and insomnia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-JUL-2025 The patient received Shingles vaccine and experienced fever, tachycardia, progressive weakness, pain and neuropathy hands and feet. Each step has been harder than the last, full of challenges that the patient suffered through. The patient was so excited to finally receive vaccinations and absolutely devastated that she has been in agonizing pain and unable to live life since this reaction started. The patient was an athletic youngish 40 and at the time of reporting she can barely navigate stairs, cannot sleep because of the pain. The patient literally hobble. The patient wants her life back. The patient felt maimed by this event, and it was causing despair.; Sender's Comments: A case of Neuropathy peripheral, 4 days after receiving Shingles vaccine. in a 41-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to?onset and absence of biological plausibility and alternative risk factor (acute myeloid leukemia).
Acute myeloid leukemia; Chronic graft versus host disease; Stem cell transplant
REZUROCK