Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; Shingles/ Shingles entered the spine; stroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles/ Shingles entered the spine) (serious criteria other: serious as per reporter) and stroke (Verbatim: stroke) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the shingles and stroke were resolving. It was unknown if the reporter considered the vaccination failure, shingles and stroke to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, shingles and stroke to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 21-JUN-2025 This case was reported by a patient via interactive digital media. After both vaccines that the facility thought the patient needed, Shingles raised its ugly head. The blisters were few some on left elbow and left hand on the palm. The patient never had shingles before. A few days after, the patient couldn't remember driving home. A trip to the emergency room and they diagnosed a stroke after many tests and finally after a lumbar puncture it was seen that the shingles had entered the spine. The doctors said only 0.03% experiences this. The patient spent the next year in a wheelchair, then a walker and cane, today the patient could walk 2 miles a day. There was some progress and maybe 90% recovery. The Shingles was serious. This case was considered as suspected vaccination failure as details regarding time to onset for shingles was 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 Shingles vaccine (dose 1 and 2) Herpes zoster and Cerebrovascular accident are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Test Name: laboratory test; Result Unstructured Data: (Test Result:Stroke,Unit:unknown,Normal Low:,Normal High:); Test Name: Lumbar puncture; Result Unstructured Data: (Test Result:shingles had entered the spine,Unit:unknown,Normal Low:,Normal High:)