Received Aug 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 3374s | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 3s354 | — |
Suspected vaccination failure; The patient was diagnosed with shingles; nerve pain from shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) (batch number 3s354, expiry date 04-JUL-2020) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number 3374s, expiry date 22-NOV-2020) for prophylaxis. The patient's past medical history included cataract (in one eye) and weight loss (lost 20 pounds due to walking). Concurrent medical conditions included fruit allergy (This caused him a vitamin c deficiency, which caused blurred vision. Once he took vitamin C the blurred vision resolved.). Additional patient notes included The patient was up to date on all vaccines and believed in vaccines. Concomitant products included acetylsalicylic acid (Aspirin) and ibuprofen. On 01-APR-2018, the patient received the 1st dose of Shingrix. On 31-JUL-2018, the patient received the 2nd 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: The patient was diagnosed with shingles) and post herpetic neuralgia (Verbatim: nerve pain from shingles). The outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not reported. 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: 23-JUL-2025 The reporter was the patient. The reporter contacted via webform. The reporter wrote that he got two shots of Shingrix April and July 2018 then today the reporter was told that he had shingles. The reporter did not have his doctor contact information in front of him but will provide this when safety sends email or letter. The patient was diagnosed with shingles but he believed he has had it off and on for the last year or so. The patient indicated that he was having pain in the lower back that has gotten worse and worse. The patient believed it is nerve pain from shingles and the pain got so extreme or bad that it hurt to push the pedal while driving. The blisters or bumps were on his buttocks (causing blood stains on his underwear) not on his back. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of TTO of an event and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1& 2).
Fruit allergy (This caused him a vitamin c deficiency, which caused blurred vision. Once he took vitamin C the blurred vision resolved.)
Medical History/Concurrent Conditions: Cataract (in one eye); Weight loss (lost 20 pounds due to walking); Comments: The patient was up to date on all vaccines and believed in vaccines
ASPIRIN; IBUPROFEN