Received May 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure/ Lack of drug effect; has had total of 2 shingles outbreaks since being vaccinated first episode of shingles in 2020; could not eat; she could not drink; Fever; has had total of 2 shingles outbreaks since being vaccinated her second outbreak in Jan 2026; shingles on right ear/ left ear; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included asthma (Asthma) and immune disorder (nos) (Immune disorder (NOS)). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JAN-2026, more than 2 years after receiving Shingrix and Shingrix, the patient experienced herpes zoster otitis externa (Verbatim: shingles on right ear/ left ear) (serious criteria GSK medically significant) and shingles (Verbatim: has had total of 2 shingles outbreaks since being vaccinated her second outbreak in Jan 2026). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ Lack of drug effect) (serious criteria GSK medically significant), shingles (Verbatim: has had total of 2 shingles outbreaks since being vaccinated first episode of shingles in 2020), appetite absent (Verbatim: could not eat), ill-defined disorder (Verbatim: she could not drink) and fever (Verbatim: Fever). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure, appetite absent, ill-defined disorder and fever were unknown and the outcome of the herpes zoster otitis externa, shingles and shingles were not reported. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles, shingles, appetite absent, ill-defined disorder and fever to be related to Shingrix and Shingrix. The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, shingles, appetite absent, ill-defined disorder and fever to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 27-APR-2026 The patient received 2 doses of Shingrix in 2019 and had first episode of shingles in 2020 and has had total of 2 shingles outbreaks since being vaccinated. Patient stated she had her second outbreak in Jan-2026 and both bouts of shingles had started on her face. She described the second bout the worse case of shingles. The shingles started on her right ear, which was swollen, red, and painful. The shingles moved onto her right cheek and almost her entire scalp and forehead. She reported she was prescribed acyclovir (dose/strength not disclosed) almost immediately after diagnosis. However, the shingles moved onto her left ear, which was also red, swollen and painful. Consumer states she could not eat or drink and had a fever. The patient stated both vaccines were administered within the recommended vaccine schedule. 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. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure more than 2 years after vaccination with the 2nd dose of Shingrix and More than a year after vaccination with the 1st dose of Shingrix; and Herpes zoster oticus more than 2 years after vaccination with the 2nd and the 1st dose of Shingrix in an elderly female patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.
Asthma (Asthma); Immune disorder (NOS) (Immune disorder (NOS))