Received May 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
suspected vaccination failure; possible shingles; painful skin; blood sugar increased; spot on the abdomen; injection site pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included chickenpox (as a child) and shingles. Concurrent medical conditions included diabetes. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In MAY-2026, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: possible shingles), skin pain (Verbatim: painful skin), blood sugar increased (Verbatim: blood sugar increased) and skin disorder (Verbatim: spot on the abdomen). On an unknown date, the patient experienced injection site pain (Verbatim: injection site pain). The outcome of the vaccination failure was not reported and the outcome of the shingles, skin pain, blood sugar increased and skin disorder were not resolved, and the outcome of the injection site pain was resolved (duration 1 week). It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, skin pain, blood sugar increased and skin disorder 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, injection site pain, skin pain, blood sugar increased and skin disorder to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 12-MAY-2026 The reporter was the patient. The patient experienced injection-site pain that felt like needles after receiving Shingrix in 2017 at that time. About four or five days earlier, in May 2026, the patient developed a painful spot on her abdominal skin that was persisting. The area was painful when clothing touched it. There were no visible dermal effects. The patient was concerned that the pain might be shingles. The patient had not yet seen her physician. The patient also noticed that her blood sugars were elevated after using her usual dose of mealtime insulin. Nothing else had been reported. Insulin NOS values were not considered as concomitant The batch number was not provided upon follow up with the reporter. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, more than 2 years after vaccination with 1st and 2nd doses of Shingrix, in a 85-year-old female 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.
Diabetes
Medical History/Concurrent Conditions: Chickenpox (as a child); Shingles
Test Date: 202605; Test Name: blood sugar; Result Unstructured Data: (Test Result:Elevated,Unit:unknown,Normal Low:,Normal High:)