Received Jul 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Uterine bleeding the day after 2nd dose; This serious case was reported by a consumer and described the occurrence of hemorrhage uterine in a 51-year-old female patient who received Herpes zoster (Shingrix) suspension for injection in pre-filled syringe for prophylaxis. On 18-JUN-2026, the patient received the 2nd dose of Shingrix .5 ml. On 19-JUN-2026, 1 days after receiving Shingrix, the patient experienced hemorrhage uterine (Verbatim: Uterine bleeding the day after 2nd dose) (serious criteria GSK medically significant). The outcome of the hemorrhage uterine was not resolved. It was unknown if the reporter considered the hemorrhage uterine to be related to Shingrix and Shingrix Pre-Filled Syringe Device. The company considered the hemorrhage uterine to be unrelated to Shingrix and Shingrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-JUL-2026 The patient self-reported this case for herself. The reported event of uterine bleeding required intervention. No other products were received by the patient. The batch number was not provided upon follow-up with the reporter.; Sender's Comments: A case of Uterine haemorrhage, 1 day after vaccination with the 2nd dose of Shingrix and Shingrix PRE-FILLED SYRINGE DEVICE, in a 51-year-old female patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought.