Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
she experienced flushing from her neck to waist; Increased blood pressure; sore arm; Tiredness; This serious case was reported by a consumer via call center representative and described the occurrence of flushing in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included propafenone (Rythmol). On 07-JUL-2025, the patient received the 1st dose of Shingrix. On 09-JUL-2025, 2 days after receiving Shingrix, the patient experienced flushing (Verbatim: she experienced flushing from her neck to waist) (serious criteria hospitalization) and increased blood pressure (Verbatim: Increased blood pressure) (serious criteria hospitalization). In JUL-2025, the patient experienced pain in arm (Verbatim: sore arm) and tiredness (Verbatim: Tiredness). The outcome of the flushing and increased blood pressure were unknown and the outcome of the pain in arm and tiredness were resolved. It was unknown if the reporter considered the flushing, increased blood pressure, pain in arm and tiredness to be related to Shingrix. The company considered the flushing and increased blood pressure to be unrelated to Shingrix. It was unknown if the company considered the pain in arm and tiredness to be related to Shingrix. Additional Information: GSK receipt date: 05-AUG-2025 The reporter was the patient who received her first dose of Shingrix and had a sore arm and felt tired. On Wednesday morning, she woke up with flushing from her neck to waist and an elevated blood pressure of 180/88. She went to the emergency room. She was also admitted to the hospital twice so far for flushing and high blood pressure. The first time was from 14th JUL 2025 to 18th JUL 2025 and the second was from the following Tuesday to Thursday.; Sender's Comments: A case of Blood pressure increased and Flushing, 2 days after receiving Shingrix in a 78-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (age).
RYTHMOL
Test Date: 20250709; Test Name: Increased blood pressure; Result Unstructured Data: (Test Result:Increased (180/88),Unit:unknown,Normal Low:88,Normal High:180)