Received Mar 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; I have shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia. Concomitant products included valaciclovir (Valacyclovir). On 15-OCT-2025, the patient received Shingrix 50 mcg/mg. On 24-FEB-2026, 132 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles). The outcome of the vaccination failure was not reported, and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 02-MAR-2026 The patient self-reported this case for herself. The patient reported that she was diagnosed with Chronic Lymphocytic Leukemia (CLL) in June 2025 and was recommended to get vaccines while healthy. She expected Shingrix to prevent shingles outbreak, not activate the virus. The patient reported, she was CLL treatment naive patient with excellent red blood cells (RBC) and platelet counts. Then four and a half months after receiving Shingrix, she had shingles. Concomitant medication includes Vacyclovir for shingles, started from 27-FEB-2026 This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Vaccination failure, 132 days after receiving Shingrix, in a 60-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Chronic lymphocytic leukemia
VALACYCLOVIR