Received Jul 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
broken hip; diarrhea; dehydration; fell; This serious case was reported by a physician via sales rep and described the occurrence of fractured hip in a elderly female patient who received Herpes zoster (Shingrix) suspension for injection in pre-filled syringe for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus inadequate control (currently taking insulin and no history of GLP 1 use). In JUL-2026, the patient received the 1st dose of Shingrix (unknown arm) .5 ml and PREVNAR 20 (unknown arm). In JUL-2026, 3 days after receiving Shingrix and an unknown time after receiving PREVNAR 20, the patient experienced fractured hip (Verbatim: broken hip) (serious criteria hospitalization and GSK medically significant), diarrhea (Verbatim: diarrhea), dehydration (Verbatim: dehydration) and fall (Verbatim: fell). The outcome of the fractured hip, diarrhea, dehydration and fall were not reported. It was unknown if the reporter considered the fractured hip, diarrhea, dehydration and fall to be related to Shingrix and Shingrix Pre-Filled Syringe Device. The company considered the fractured hip 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: 21-JUL-2026 The patient was approximately 85 years old. The doctor did not know if the fall and/or diarrhea and dehydration were a result of concomitant vaccine administration and/or one particular vaccine. The doctor would like to follow up from company. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Hip fracture, 3 days after vaccination with the 1st dose of Shingrix and Shingrix PRE-FILLED SYRINGE DEVICE, in an elderly female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (history of fall)
Type II diabetes mellitus inadequate control (currently taking insulin and no history of GLP 1 use)