Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; I have lost sight in my eye; lost hearing in my right ear; still have them/feel like it killing me from the inside out/shingles never came out but stay on inside instead of shingles; got nerve damage bad; i can't work anymore or do things with my kids or grandkids; Sickness; Tiredness; Weakness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis. 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), loss of vision (Verbatim: I have lost sight in my eye) (serious criteria GSK medically significant), hearing loss unilateral (Verbatim: lost hearing in my right ear) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: still have them/feel like it killing me from the inside out/shingles never came out but stay on inside instead of shingles), nerve damage (Verbatim: got nerve damage bad), activities of daily living impaired (Verbatim: i can't work anymore or do things with my kids or grandkids), sickness (Verbatim: Sickness), tiredness (Verbatim: Tiredness) and weakness (Verbatim: Weakness). The outcome of the vaccination failure, loss of vision, hearing loss unilateral, nerve damage, activities of daily living impaired, sickness, tiredness and weakness were not reported and the outcome of the zoster sine herpete was not resolved. It was unknown if the reporter considered the vaccination failure, loss of vision, hearing loss unilateral, zoster sine herpete, nerve damage, activities of daily living impaired, sickness, tiredness and weakness to be related to Shingrix. The company considered the vaccination failure, loss of vision and hearing loss unilateral to be unrelated to Shingrix. It was unknown if the company considered the zoster sine herpete, nerve damage, activities of daily living impaired, sickness, tiredness and weakness to be related to Shingrix. Additional Information: GSK Receipt Date:12-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that his/her friend told to get the vaccine, and did shingles never came out but stay on inside. The patient mentioned that had gone thru five years of hell and still had them. He had also lost sight in eye and lost hearing in right ear to and now doctors say he got nerve damage bad plus the shot made so sick. The patient thought was going died now just felt like it killing him from the inside out and could not work anymore or do things with kids or grandkids and mentioned so tired and weak and he was fine before the shot patient mentioned wish to god and never got the vaccine. The patient also mentioned after his close friend developed shingles, he saw how painful it could really be, live a full life, and mentioned did not want shingles to get in the way. Here's story on why the patient was started a conversation with doctor about the shingles risk. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Blindness and Deafness unilateral are unlisted events which are considered unrelated to GSK Shingrix."