Received Mar 13, 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; reoccurrence now and may need the vaccination again; irritating; intensity of the pain; spot on her skin; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female 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 (painful episode of shingles over ten years ago (prior to Shingrix dose 1) in 2011 or 2012) and pain. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: reoccurrence now and may need the vaccination again), feeling irritated (Verbatim: irritating), pain (Verbatim: intensity of the pain) and rash (Verbatim: spot on her skin). The outcome of the vaccination failure and shingles were not resolved and the outcome of the feeling irritated, pain and rash were not reported. It was unknown if the reporter considered the vaccination failure, shingles, feeling irritated, pain and rash 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, feeling irritated, pain and rash to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 07-MAR-2025 The patient had a reoccurrence of shingles at the time of reporting and might need the vaccination again. She did not know the exact dates of the Shingrix shots, but she said that she got both shots about 5 years ago from reporting. The pharmacy where she got the shots did not have the injection dates on file. Limited information collected due to the lack of information (and the length of time since the shots were given) as well as a bad or noisy phone connection. She indicated she would call GlaxoSmithKline back if she was able to acquire the dates or lot numbers of the Shingrix shots she received. The patient indicated that her physician did not think she has a current shingles outbreak, but the patient think shingles because something was irritating. The intensity of the pain was similar to what she experienced in the past when she had shingles over ten years ago. The patient mentioned a little spot on her skin (that her physician could not saw). The pharmacy where the Shingrix vaccine was given did not maintain the information for more than 2 years. The physician office did not keep that type of record beyond 5 years. The patient asking how long have to wait in between vaccinations. The patient attributes this outbreak of shingles to have been triggered by family stress. 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 provided about the laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
Medical History/Concurrent Conditions: Pain; Shingles (painful episode of shingles over ten years ago (prior to Shingrix dose 1) in 2011 or 2012)