Received Apr 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
the nerve pain affects his ribcage under his heart/PHN; had the first dose administered and then one year later the second dose administered; Suspected vaccination failure/Lack of drug effect; diagnosed with Shingles/ has been having little outbreaks since July 2024; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood pressure high. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JUL-2024, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/Lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with Shingles/ has been having little outbreaks since July 2024). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: the nerve pain affects his ribcage under his heart/PHN) and drug dose administration interval too long (Verbatim: had the first dose administered and then one year later the second dose administered). The patient was treated with gabapentin. The outcome of the vaccination failure was unknown, and the outcome of the shingles and post herpetic neuralgia were not reported and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia 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 and post herpetic neuralgia to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 21-APR-2026 The patient reported that he completed both series of shingles vaccine, however, stated he had the first dose administered and then one year later the second dose administered (Inappropriate schedule of vaccine administered). The patient was diagnosed with shingles in JUL-2024, and he was prescribed Gabapentin for post herpetic neuralgia (PHN). The nerve pain affected his ribcage under his heart. The patient stated he has been having little outbreaks since JUL-2024. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, on an unknown time after vaccination with the 2nd dose of Shingrix and the 1st dose of Shingrix, in an elderly 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.
Blood pressure high