Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; I had the shingles on my left side of the face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had the shingles on my left side of the face while I was in mid 70's) and post herpetic neuralgia (was excruciating). On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: I had the shingles on my left side of the face). The outcome of the vaccination failure and herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix. The company considered the vaccination failure and herpes zoster to be unrelated to Shingrix. Additional Information: GSK Receipt Date : 25-MAR-2025 This case was reported by a patient via interactive digital media. The patient gotten the shingle shot 8 years before but that did not help him/her any. Since he/she read you could got the shingles more than once he/she got the Shingrix vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix."
Medical History/Concurrent Conditions: Post herpetic neuralgia (was excruciating); Shingles (had the shingles on my left side of the face while I was in mid 70's)