Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
Suspected vaccination failure; she received the 2-dose series of Shingrix in 2017 and has had several flare ups of Shingles since that time; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). 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) and shingles (Verbatim: she received the 2-dose series of Shingrix in 2017 and has had several flare ups of Shingles since that time). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles 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 to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 11-MAR-2025 The patient reported that she had received the 2-dose series of Shingrix in 2017 and had several flare ups of Shingles since that time. She had a case right now that affects under her right arm and to comes and goes with no warning. The batch lot number of Shingles vaccine she could not remember. The expiry date of Shingles vaccine was unknown. She was going to the doctor on Thursday, 13th March 2025. This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory confirmation of 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).