Received Jul 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | NT357 | — |
Pemphigus foliaceus; This serious case was reported by a consumer via call center representative and described the occurrence of pemphigus foliaceus in a 50-year-old female patient who received Herpes zoster (Shingrix) suspension for injection in pre-filled syringe (batch number NT357 with expiry date 12-MAY-2028) for prophylaxis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On 15-MAY-2026, the patient received the 2nd dose of Shingrix. On 29-MAY-2026, 14 days after receiving Shingrix, the patient experienced pemphigus foliaceus (Verbatim: Pemphigus foliaceus) (serious criteria GSK medically significant). The patient was treated with prednisone. The outcome of the pemphigus foliaceus was not resolved. It was unknown if the reporter considered the pemphigus foliaceus to be related to Shingrix and Shingrix Pre-Filled Syringe Device. The company considered the pemphigus foliaceus to be unrelated to Shingrix and Shingrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-JUL-2026 The patient self-reported this case. The patient reported that after 2 weeks of 2nd dose administration, the patient noticed red spots and sores on abdomen, between breasts and back which increased and spread rapidly so the patient sought medical attention. The sores were biopsied and she was diagnosed with an autoimmune disorder called Pemphigus Foliaceus. On 1-JUL-2026 the patient was placed on 60 mg of prednisone to be tapered. The patient was currently on 20 mg prednisone and next day the patient would begin 10 mg of prednisone for 3 days and then stopping prednisone. The batch number was not provided upon follow-up with the reporter.; Sender's Comments: A case of Pemphigus, 14 days after vaccination with the 2nd dose of Shingrix and Shingrix Pre-Filled Syringe Device, in a 50-year-old female patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
SHINGRIX
Test Date: 20260701; Test Name: Biopsy; Result Unstructured Data: (Test Result:Pemphigus Foliaceus,Unit:unknown,Normal Low:,Normal High:)