Received Mar 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; 6 months later dealing with post herpetic neuralgia; 15 years later got a triple dose of shingles; 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 (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (twice). On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), post herpetic neuralgia (Verbatim: 6 months later dealing with post herpetic neuralgia) and extra dose administered (Verbatim: 15 years later got a triple dose of shingles). The outcome of the vaccination failure and post herpetic neuralgia were not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the vaccination failure and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she had shingles twice, got the vaccine, 15 years later got a triple dose of Shingles and 6 months later dealing with post herpetic neuralgia and it was horrendous. The reporter further stated, the physician said she wanted his/her body healed for a full year and then get the new vaccine and the booster shot. Patient received a triple dose of Shingles vaccine, which led to an extra dose administered. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding post herpetic neuralgia were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles, insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1, Dose 2 and extradose)
Medical History/Concurrent Conditions: Shingles (twice)