Received Jan 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| VARZOS | ZOSTER LIVE (ZOSTAVAX) | MERCK & CO. INC. | UNK | UNK | — |
suspected vaccination failure; got shingles in her ear; got shingles in throat, down the side of her face, down her back and chest area; she also developed postherpetic neuralgia; Approximately a year later, she started experiencing another shingles outbreak; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Varicella zoster vaccine live (Oka/Merck) (Zostavax) for prophylaxis. On an unknown date, the patient received Shingrix and Zostavax. On an unknown date, an unknown time after receiving Shingrix and an unknown time after receiving Zostavax, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: got shingles in her ear) (serious criteria GSK medically significant), shingles (Verbatim: got shingles in throat, down the side of her face, down her back and chest area), post herpetic neuralgia (Verbatim: she also developed postherpetic neuralgia) and shingles (Verbatim: Approximately a year later, she started experiencing another shingles outbreak). The patient was treated with Antivirals. The outcome of the vaccination failure, herpes zoster otitis externa, shingles and post herpetic neuralgia were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, shingles, post herpetic neuralgia and shingles to be related to Shingrix. The reporter considered the vaccination failure, herpes zoster otitis externa, shingles, post herpetic neuralgia and shingles to be not reported if related to Zostavax. The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingrix. It was unknown if the company considered the shingles, post herpetic neuralgia and shingles to be related to Shingrix. The company considered the vaccination failure, herpes zoster otitis externa, shingles, post herpetic neuralgia and shingles to be not reported if related to Zostavax. Additional Information: GSK Receipt Date: 15-JAN-2026 This case was reported by a sister of the patient via interactive digital media. The reporter mentioned that his/her sister (patient) had received both the old and newer Shingles shots. The patient got an Antiviral medication from her physician and was hoping it kept it at bay. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Herpes zoster oticus, on an unknown time after vaccination with unknown dose of Shingrix, in a 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