Received Oct 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
Suspected vaccination failure; diagnosed with shingles/ outbreak encompassed her trigeminal area and mandibular area.; 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) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (when she was in her 20's she was diagnosed with shingles.). Previously administered products included aveeno (Aveeno to treat the rash.). On 26-DEC-2020, the patient received the 2nd dose of Shingrix (unknown arm). In OCT-2020, the patient received the 1st dose of Shingrix (intramuscular). On 06-OCT-2025, 1745 days after receiving Shingrix and more than a year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: diagnosed with shingles/ outbreak encompassed her trigeminal area and mandibular area.). The patient was treated with valaciclovir (Valacyclovir) and pregabalin (Lyrica). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster was not reported. It was unknown if the reporter considered the vaccination failure and herpes zoster 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 herpes zoster to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 16-OCT-2025 Consumer was the reporter. Consumer stated she was received both doses of SHINGRIX in2020. Consumer stated her second dose was administered on 26 DEC 2020, was an injection but does not remember which arm the injection was administered. Consumer stated she believes her first dose was administered 2 months prior to her second dose; however, she was unable to provide the date of administration for the first dose. Consumer states on 6-OCT-2025 she broke out in a rash and on 8-OCT- 2025 she went to her doctor and was diagnosed with shingles. Consumer stated shingles rash was present on the left side of her face, neck, chin, left ear, and chest area. Consumer did go to an eye doctor and was told she did not have ocular shingles. The eye doctor told the consumer the outbreak encompassed her trigeminal area and mandibular area. Consumer stated this bout of shingles had caused her an extreme amount of fatigue. Consumer stated the rash was itchy, red, and raised. Consumer described the rash as puffy. The rash was burning and tingling. Consumer was provided medication to take on 8-OCT-2025. Medication prescribed was valacyclovir 1gm take three times daily and Lyrica 75mg take twice daily. No further information was provided/obtained. This case was considered as suspected vaccination failure as details regarding laboratory test confirming 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 a year and 1745 days after receiving Shingrix (Dose 1 and Dose 2) in a 65-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (h/o shingles and laboratory confirmation test unknown).
Medical History/Concurrent Conditions: Shingles (when she was in her 20's she was diagnosed with shingles.)