Received Jul 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected Vaccination failure; Shingles was reported as worsened/outbreak of shingles; Post herpetic neuralgia; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (getting shingles since 1996 around once a year.) and post herpetic neuralgia. Previously administered products included Zostavax (in 2016). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles was reported as worsened/outbreak of shingles) and post herpetic neuralgia (Verbatim: Post herpetic neuralgia). The outcome of the vaccination failure was not reported and the outcome of the shingles and post herpetic neuralgia were not resolved. 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: 25-JUN-2025 The patient self-reported this case. He stated he had been getting shingles since 1996 around once a year. He stated he received 2 doses Shingrix in 2022, 2 to 6 months apart. He stated he was currently having an outbreak of shingles that started a few weeks ago. Shingles was reported as worsened. It was a red painful rash on left side of buttocks and outer thigh. He stated he had post herpetic neuralgia. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and 2)
Medical History/Concurrent Conditions: Post herpetic neuralgia; Shingles (getting shingles since 1996 around once a year.)