Received Jul 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
did not help; I got them about 5 weeks ago on my torso from center of stomach, left to center of my back; Open heart surgery; This serious case was reported by a consumer via interactive digital media and described the occurrence of open heart surgery in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. In DEC-2025, more than 2 years after receiving Shingrix, the patient experienced open heart surgery (Verbatim: Open heart surgery) (serious criteria clinically significant/intervention required). In MAY-2026, the patient experienced vaccination failure (Verbatim: did not help) (serious criteria GSK medically significant) and shingles (Verbatim: I got them about 5 weeks ago on my torso from center of stomach, left to center of my back). The patient was treated with gabapentin and prednisone. The outcome of the open heart surgery and vaccination failure were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the open heart surgery, vaccination failure and shingles to be related to Shingrix. The company considered the open heart surgery and vaccination failure to be unrelated to Shingrix. Additional Information: GSK Receipt date: 26-JUN-2026 This case was reported by a patient via interactive digital media. The patient stated that both doses of the Shingrix vaccine had been received six years back. The patient reported that the rash itched but was accompanied by severe pain. The patient had undergone open heart surgery in December 2025, and Shingles hurt worse than that. The symptoms began during holiday weekend, the patient reported having missed the 72-hour window for the virus vaccine. Although pain persisted, the patient stated that the condition had become significantly more manageable. The patient described shingles as a very unpleasant and difficult disease experience. The batch number was not provided, and we are unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Cardiac operation, and Vaccination failure, more than 2 years after vaccination with 1st and 2nd dose of Shingrix in a patient. For event Cardiac operation: Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. Based on the available information a possible causality that the event (Vaccination failure) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.