Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 23B54 | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | UNK | — | — |
Lack of drug effect, diagnosed her with an early onset case of shingles, suspected vaccination failure; diagnosed her with an early onset case of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25-SEP-2022) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (expiry date 25-SEP-2022) for prophylaxis and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (ZOSTAVAX) for prophylaxis. The patient's past medical history included herpes simplex (outbreak of herpes simplex on her face (right cheek) in elementary school and in her twenties.). Previously administered products included smallpox (Patient received a smallpox vaccination to stop the outbreak of herpes simplex). On 27-OCT-2020, the patient received the 2nd dose of Shingrix. On 25-AUG-2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received ZOSTAVAX. On 23-OCT-2025, 1822 days after receiving Shingrix, 1885 days after receiving Shingrix and an unknown time after receiving ZOSTAVAX, the patient experienced vaccination failure (Verbatim: Lack of drug effect, diagnosed her with an early onset case of shingles, suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed her with an early onset case of shingles). The outcome of the vaccination failure and shingles were not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and ZOSTAVAX. 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, Shingrix and ZOSTAVAX. It was unknown if the company considered the vaccination failure to be related to ZOSTAVAX. Additional Information: GSK Receipt Date: 23-OCT-2025 The patient self-reported this case for herself. Patient was unable to provide zip code for primary care physician. The batch number was not provided and a request for this information has been made. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, 1885 and 1822 days after receiving 1st and 2nd dose of Shingrix, in a 72-year-old female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Medical History/Concurrent Conditions: Herpes simplex (outbreak of herpes simplex on her face (right cheek) in elementary school and in her twenties.)