Received Mar 6, 2026
| 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; Sleeping problem; 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, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and sleep problem (Verbatim: Sleeping problem). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure and shingles were not reported, and the outcome of the sleep problem was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and sleep problem to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and sleep problem to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 28-FEB-2026 and 01-MAR-2026 This case was reported by a patient via interactive digital media. The patient had received both shingles vaccine doses years earlier yet still developed shingles. When the outbreak began, the patient was prescribed valacyclovir and started the antiviral medication within hours of noticing the first symptoms. In the days leading up to the rash, the patient had experienced difficulty sleeping, along with discomfort and nerve sensitivity on the left side, including occasional shooting pains. During treatment, the patient continued to struggle with sleep, partly because the medication needed to be taken every eight hours, and they did not want to miss a dose. The patient also used additional supportive measures, including red-light therapy with a Lume box received as a gift, as well as castor oil packs on the abdomen, after reading that these methods might be helpful. At the time of the description, the rash had progressed to visible bumps but had not yet advanced further. The patient hoped the antiviral medication and possibly the protection from prior vaccination would lessen the severity of the illness. However, after hearing that someone else's case remained severe even with vaccination, the patient expressed concern, noting that the other individual continued to develop new blisters even three weeks after onset. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving the 2nd dose of Shingles vaccine, in a patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.