Received Apr 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | TL74Y | — |
started feeling dizzy then passed out after standing up; This serious case was reported by a other health professional and described the occurrence of syncope in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number TL74Y, expiry date 19-MAY-2028) for prophylaxis. The patient's past medical history included von willebrand's disease, hyperlipidemia, hypertension, celiac disease, anxiety and impaired fasting glucose. Previously administered products included Shingrix (received first dose on 25-SEP-2025). Concurrent medical conditions included cold sores. On 30-MAR-2026, the patient received the 2nd dose of Shingrix .5 ml. On 30-MAR-2026, less than a day after receiving Shingrix, the patient experienced syncope (Verbatim: started feeling dizzy then passed out after standing up) (serious criteria GSK medically significant). The patient was treated with lysine and valaciclovir hydrochloride (Valtrex). On 30-MAR-2026, the outcome of the syncope was resolved. It was unknown if the reporter considered the syncope to be related to Shingrix and Shingrix Pre-Filled Syringe Device. The company considered the syncope 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 08-APR-2026 A 56 year old male received his second Shingrix vaccine (pre filled syringe) in the morning of 30-MAR-2026. The patient reported going to dinner at a restaurant that evening, having drank 2 alcoholic beverages, started feeling dizzy then passed out after standing up. The patient was transported to the emergency room. In the emergency room, he was found to have low potassium, while all other tests and imaging were negative for acute illness or injury. His first Shingrix vaccine was administered on 25-SEP-2025 and was the original vial formulation. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Syncope, less than a day after receiving 2nd dose of Shingrix and Shingrix PRE-FILLED SYRINGE DEVICE in a 53-year-old male patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (history of anxiety).
Cold sores
Medical History/Concurrent Conditions: Anxiety; Celiac disease; Hyperlipidemia; Hypertension; Impaired fasting glucose; Von Willebrand's disease
Test Date: 20260330; Test Name: ER; Result Unstructured Data: (Test Result:low potassium,Unit:unknown,Normal Low:,Normal High:); Test Date: 20260330; Test Name: Lab test; Result Unstructured Data: (Test Result:negative for acute illness/injury,Unit:unknown,Normal Low:,Normal High:)