Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Stroke mimic; This serious case was reported by a consumer via call center representative and described the occurrence of stroke mimic in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced stroke mimic (Verbatim: Stroke mimic) (serious criteria hospitalization and GSK medically significant). The outcome of the stroke mimic was unknown. It was unknown if the reporter considered the stroke mimic to be related to Shingrix. The company considered the stroke mimic to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 14-MAR-2025 The case was reported by patient's daughter. Patient had a severe episode which led him to the ER (emergency room) and resulted in his admission to the hospital. They ran all their tests to check for a stroke since it resembled a stroke or TIA (transient ischemic attack). They performed EEG (electroencephalogram) and an echocardiogram. Reporter mentioned to the staff that he had the shingles vaccine, but none of them followed up on that. Reporter's father was not inclined to follow up on that. She had read in the package insert about the syncope warning and had asked, what was the time frame (number of days) in which syncope had been recorded after shingrix so that he could acknowledge that perhaps it was related, because if he went and received the second shot, he might have had a worse reaction, which was hard to imagine. Patient stayed in the hospital for about 24 hours.; Sender's Comments: Pseudostroke is an unlisted event which is considered unrelated to GSK drug Shingrix.
Test Name: echocardiogram; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:); Test Name: electroencephalogram; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:); Comments: They did EEG (electroencephalogram) and an echocardiogram.