Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Arrhythmias; Pain in arm; This serious case was reported by a consumer and described the occurrence of arrhythmia in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included trigeminal neuralgia, blood pressure, restless legs syndrome and atrial fibrillation. Concomitant products included apixaban (Eliquis), metoprolol fumarate, flecainide, rotigotine (Neupro) and gabapentin. On 02-OCT-2025, the patient received Shingrix. In OCT-2025, an unknown time after receiving Shingrix, the patient experienced arrhythmia (Verbatim: Arrhythmias) (serious criteria GSK medically significant) and pain in arm (Verbatim: Pain in arm). The outcome of the arrhythmia and pain in arm were not resolved. It was unknown if the reporter considered the arrhythmia and pain in arm to be related to Shingrix. The company considered the arrhythmia to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK receipt date:29-OCT-2025 The reporter mentioned waiting for results from heart monitor and review by electrophysiology. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Arrhythmia, an unknown time after receiving Shingrix, in a 74-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (Concurrent medical conditions included blood pressure and atrial fibrillation).
Atrial fibrillation; Blood pressure; Restless legs syndrome; Trigeminal neuralgia
ELIQUIS; METOPROLOL FUMARATE; FLECAINIDE; NEUPRO; GABAPENTIN
Comments: heart monitor and review by electrophysiology