Received Feb 26, 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; got it a year after the Shingrex shots/ It was the worst outbreak ever; Post herpetic neurologic pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 (He/ she got in his/her early 20's, twice in his/her 50's). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got it a year after the Shingrex shots/ It was the worst outbreak ever) and post herpetic neuralgia (Verbatim: Post herpetic neurologic pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was resolved (duration 3 months). 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: 11-FEB-2025 The patient self-reported this case for himself/herself. This case was reported by a patient via (Facebook) interactive digital media. Patient had gotten it in his/her early 20s, twice in my 50s, and finally received the 2-shot Shingrix in his/her 60s. Then he/she got it a year after the Shingrix shots. It was the worst outbreak ever. The post-herpetic neurologic pain had been unbearable for 3 months. He/she had been told the vaccine was not 100 percent. 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 about the laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
Medical History/Concurrent Conditions: Shingles (He/ she got in his/her early 20's, twice in his/her 50's)