Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concomitant products included upadacitinib (Rinvoq). On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and the 1st dose of Shingrix (intramuscular) .5 ml. In JAN-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Linked case(s) involving the same patient: US2026AMR013622 Additional Information: GSK receipt date: 26-JAN-2026 The patient had previously received two doses of the Shingrix vaccine when it first came out, around 2018 and did not remember where the vaccines were given or the lot/expiration details. The patient was taking an immune-suppressing medication called Rinvoq (upadacitinib). The patient stated that despite having completed the Shingrix series, he ended up getting shingles around JAN-2024. The patient inquired about when he should get another shingles vaccine. No other issues or events were reported. The patient did not recall if the vaccines were administered at a local pharmacy or at his health care processional's medical facility. This case considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was not reported. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Vaccination failure, more than 2 years after receiving 1st and 2nd dose of Shingrix, in a 81-year-old male patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
RINVOQ