Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Recombinant adjuvant zoster vaccine-associated acute mucocutaneous toxicity/; progressivelyworsening polyarthralgia; pancytopenia; This serious case was reported in a literature article and described the occurrence of mucocutaneous toxicity in a 37-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Literature Reference:. The patient's past medical history included heart disease congenital and aortic valve replacement. Concurrent medical conditions included psoriatic arthritis and immunocompromised. Concomitant products included warfarin, methotrexate and adalimumab. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced mucocutaneous toxicity (Verbatim: Recombinant adjuvant zoster vaccine-associated acute mucocutaneous toxicity/) (serious criteria hospitalization and GSK medically significant), polyarthralgia (Verbatim: progressivelyworsening polyarthralgia) (serious criteria hospitalization) and pancytopenia (Verbatim: pancytopenia) (serious criteria hospitalization and GSK medically significant). The patient was treated with methylprednisolone, Corticosteroids and prednisone. The outcome of the mucocutaneous toxicity, polyarthralgia and pancytopenia were resolved. The reporter considered the mucocutaneous toxicity, polyarthralgia and pancytopenia to be related to Shingrix. The company considered the mucocutaneous toxicity, polyarthralgia and pancytopenia to be unrelated to Shingrix. GSK receipt date: 14-NOV-2025 A patient with a past medical history of con-genital heart disease status following prosthetic aortic valve replacement on chronic warfarin therapy, and psoriatic arthritis managed with methotrexate and adalimumab, presented with a 10 day history of progressively worsening polyarthralgia, melaena, and painful, erythematous skin lesions. Patient also reported new-onset oral and perineal mucosal ulcerations. Notably, these symptoms developed 4 days after receiving his first dose of the recombinant zoster vaccine (RZV) (Shingrix).On admission, physical examination revealed numerous tender, erythematous papules and vesicles with central necrosis distributed across the trunk and bilateral lower extremities, along with oral mucosal ulcers and perineal mucositis. Laboratory testing demonstrated new-onset pancytopenia with a White blood cell count of 3300/µL, leucocyte differential of 81 percent neutrophils, 13.9 percent lymphocytes, 1.4 percent monocytes,3.2 percent eosinophils, and 0.5 percent basophils, haemoglobin of11.7 g/dL, and platelet count of 92 000/µL. Patient inter-national normalized ratio was supratherapeutic, and the erythrocyte sedimentation rate was elevated at 38 mm/h. Upper endoscopic evaluation revealed diffuse erosive gastritis, probably the cause of melaena. Given the timing of symptom onset following RZV administration, lack of evidence for active infection, and the patient's previously stable course on long-standing immunosuppressive therapy, a hypersensitivity reaction to RZV was suspected. Methotrexate was held, and intra-venous methylprednisolone was initiated. A dermatology consultation was obtained, and a skin biopsy was performed. Histopathological examination showed erosive folliculitis with neutrophilic inflammation, squamous hyperplasia, increased mitotic activity, and perifollicular abscess formation, findings consistent with a vaccine-induced inflammatory reaction. Further immunological evaluation was unremarkable, and serum methotrexate levels remained within normal limits, making drug toxicity unlikely. A broad infectious work-up, including testing for herpesvirus reactivation, was negative. The patient demonstrated marked clinical improvement within days of corticosteroid therapy. The mucocutaneous lesions began to resolve, and patient was discharged after 1 week on a tapering regimen of oral prednisone. The patient experienced gradual resolution of skin lesions over the next few weeks, pancytopenia resolved, and patient was successfully reinitiated on methotrexate and adalimumab. This case underscores a rare but clinically significant mucocutaneous hypersensitivity reaction to RZV in an immunocompromised host, highlighting important considerations for vaccination in patients with autoimmune disease on chronic immunosuppressive therapy.; Sender's Comments: A case of Mucocutaneous toxicity, Arthralgia and Pancytopenia, 4 days after receiving Shingrix in a 37-year-old male patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (h/o heart disease congenital, concurrent psoriatic arthritis and immunocompromised).
Immunocompromised; Psoriatic arthritis
Medical History/Concurrent Conditions: Aortic valve replacement; Heart disease congenital
WARFARIN; METHOTREXATE; ADALIMUMAB
Test Name: basophils; Test Result: 0.5 %; Test Name: serum methotrexate level; Result Unstructured Data: (Test Result:remained within normal limits,Unit:unknown,Normal Low:,Normal High:); Test Name: Upper endoscopic evaluation; Result Unstructured Data: (Test Result:diffuse erosive gastritis,Unit:unknown,Normal Low:,Normal High:); Test Name: eosinophils; Test Result: 3.2 %; Test Name: haemoglobin; Result Unstructured Data: (Test Result:11.7,Unit:g/dL,Normal Low:,Normal High:); Test Name: immunological evaluation; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: INR; Result Unstructured Data: (Test Result:supratherapeutic,Unit:unknown,Normal Low:,Normal High:); Test Name: lymphocytes; Test Result: 13.9 %; Test Name: monocytes; Test Result: 1.4 %; Test Name: neutrophils; Test Result: 81 %; Test Name: platelet count; Result Unstructured Data: (Test Result:92000,Unit:/uL,Normal Low:,Normal High:); Test Name: erythrocyte sedimentation rate; Result Unstructured Data: (Test Result:elevated at 38,Unit:mm/h,Normal Low:,Normal High:); Test Name: white blood cell count; Result Unstructured Data: (Test Result:3300,Unit:/uL,Normal Low:,Normal High:); Comments: On admission, physical examination revealed numerous tender, erythematous papules and vesicles with central necrosis distributed across the trunk and bilateral lower extremities, along with oral mucosal ulcers and perineal mucositis. On an unknown date Skin biopsy was performed. On an unknown date histopathological examination showed erosive folliculitis with neutrophilic inflammation, squamous hyperplasia, increased mitotic activity, and perifollicular abscess formation, findings consistent with a vaccine-induced inflammatory reaction. On an unknown date a broad infectious work-up, including testing for herpesvirus reactivation, was negative.