Received Feb 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 3X97J | — |
Gastrointestinal bleeding after first dose of Shingrix; Low A1C after first dose of Shingrix; This serious case was reported by a pharmacist via call center representative and described the occurrence of gastrointestinal bleeding in a patient who received Herpes zoster (Shingrix) (batch number 3X97J, expiry date 25-MAR-2027) for prophylaxis. The patient's past medical history included gastrointestinal bleeding. Concurrent medical conditions included hepatic cirrhosis. On 29-OCT-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced gastrointestinal bleeding (Verbatim: Gastrointestinal bleeding after first dose of Shingrix) (serious criteria GSK medically significant) and hba1c decreased (Verbatim: Low A1C after first dose of Shingrix). The patient was treated with blood, whole (Blood). The outcome of the gastrointestinal bleeding and hba1c decreased were unknown. It was unknown if the reporter considered the gastrointestinal bleeding and hba1c decreased to be related to Shingrix. The company considered the gastrointestinal bleeding to be unrelated to Shingrix. It was unknown if the company considered the hba1c decreased to be related to Shingrix. Additional Information: GSK receipt date 11-FEB-2026 The pharmacist mentioned that the patient who received blood transfusion 8 days ago. The reporter asked if patient could get second dose at the time of reporting. The patient had low A1C and had GI bleed, GI related to cirrhosis. The pharmacist mentioned that gastrointestinal bleed was a recent bleed after the first dose of Shingrix, but they did not give a specific date for the bleeding and they also mentioned that patient had had bleed once before.; Sender's Comments: A case of Gastrointestinal haemorrhage, unknown time after receiving 1st dose of Shingrix in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (past history of hepatic cirrhosis and gastrointestinal bleeding.).
Hepatic cirrhosis
Medical History/Concurrent Conditions: Gastrointestinal bleeding
Test Name: A1C; Result Unstructured Data: (Test Result:low,Unit:unknown,Normal Low:,Normal High:)