Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
post-hepatic transplant so elevated liver labs/transient elevation in liver labs; liver transplant; This serious case was reported by a physician via sales rep and described the occurrence of elevated liver enzymes in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced elevated liver enzymes (Verbatim: post-hepatic transplant so elevated liver labs/transient elevation in liver labs) (serious criteria life threatening) and liver transplant (Verbatim: liver transplant) (serious criteria clinically significant/intervention required). The outcome of the elevated liver enzymes was resolved and the outcome of the liver transplant was not reported. The reporter considered the elevated liver enzymes to be related to Shingrix. It was unknown if the reporter considered the liver transplant to be related to Shingrix. The company considered the elevated liver enzymes and liver transplant to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 08-APR-2025 The reporter stated that the patient was post-hepatic transplant so elevated liver labs were serious, even if the elevated labs were transient.; Sender's Comments: Hepatic enzyme increased and Liver transplant are unlisted events which are considered unrelated to GSK vaccine Shingrix.