Received Apr 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UJ430AB | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 9472F | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | EG3A3 | IM |
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9472F, expiry date 14-OCT-2022) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number EG3A3, expiry date 10-DEC-2021) for prophylaxis and Influenza vaccine (batch number UJ430AB) for prophylaxis. On 20-MAR-2021, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 25-SEP-2020, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) and Influenza vaccine (unknown arm). On 21-MAR-2026, 1827 days after receiving Shingrix and 2003 days after receiving Shingrix and Influenza vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were unknown. 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:16-APR-2026 The patient self-reported this case. The reporter mentioned that the patient was surprised to have contracted the condition 5 years to the day of the second shot. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, 1827 days after receiving 2nd dose of Shingrix and 2003 days after receiving 1st dose of Shingrix and Influenza vaccine, in a 65-year-old 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.