Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
loss of muscle strength; loss of nerve; Fear of falling; shooting nerve pain in my leg where the lesions were; Suspected vaccination failure; Shingles on right leg from ankle all the way to buttock; 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 15-MAR-2025, 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: Shingles on right leg from ankle all the way to buttock). On an unknown date, the patient experienced muscle weakness lower limb (Verbatim: loss of muscle strength), nerve damage (Verbatim: loss of nerve), fear of falling (Verbatim: Fear of falling) and post herpetic neuralgia (Verbatim: shooting nerve pain in my leg where the lesions were). The outcome of the vaccination failure, shingles, fear of falling and post herpetic neuralgia were not reported and the outcome of the muscle weakness lower limb and nerve damage were not resolved. It was unknown if the reporter considered the vaccination failure, shingles, muscle weakness lower limb, nerve damage, fear of falling and post herpetic neuralgia 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, muscle weakness lower limb, nerve damage, fear of falling and post herpetic neuralgia to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 10-AUG-2025 This case was reported by a patient via interactive digital media. The patient was diagnosed with shingles on my right leg from his/her ankle all the way to my buttocks on 15th March 2025 despite of having both Shingrix shots so was told it would be a mild case. About 5 months later he/she was still suffering from the loss of nerve and muscle strength which caused knee to buckle. The patient didn't dare to walk without a walker due to the fear of falling. His/her neurosurgeon said that the nerve and muscle strength would return but it would take a long time. So, patient happened to be one of the unlucky 10 percent of people who got the shot who still got shingles, and one of the unlucky 1-2 percent of people who got shingles to have nerve and muscle loss. The patient still occasionally got shooting nerve pain in leg where the lesions were. The Shingles were not fun. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix vaccine (Dose 1 & 2).