Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
woke me every night; crying; Suspected vaccination failure; it was on my right side from my back to my ribs/pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In SEP-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: it was on my right side from my back to my ribs/pain). On an unknown date, the patient experienced sleep disorder due to a general medical condition (Verbatim: woke me every night) and crying (Verbatim: crying). The outcome of the vaccination failure was not reported and the outcome of the shingles, sleep disorder due to a general medical condition and crying were not resolved. It was unknown if the reporter considered the vaccination failure, shingles, sleep disorder due to a general medical condition and crying to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, sleep disorder due to a general medical condition and crying to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-MAR-2026 This case was reported by patient via interactive digital media. Patient stated that it was on her right side from back to her ribs she was in so much pain from September to December the pain woke her up every night crying it was hurting so bad, she was in her 60 and she got her shot. 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, unknown time after receiving Shingles vaccine, in a adult female 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.