Received Jul 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 94-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included VARICELLA ZOSTER VACCINE for prophylaxis and Shingrix for prophylaxis. The patient's past medical history included shingles (1st time years ago on side and back, no sooner healed up from that, then got on arm). Additional patient notes included gave birth to nine children. On an unknown date, the patient received the 2nd dose of Shingrix and VARICELLA ZOSTER VACCINE. On an unknown date, the patient received the 1st dose of Shingrix. In MAY-2026, more than 2 years after receiving Shingrix and an unknown time after receiving VARICELLA ZOSTER VACCINE, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The patient was treated with valaciclovir hydrochloride (Valacyclovir Hydrochloride) and gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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. Additional Information: GSK Receipt Date: 28-JUN-2026 This case was reported by a patient via interactive digital media. The patient had received the first shingles vaccine years ago. The patient received Shingrix vaccine in 2020. It had been six years since receiving Shingrix vaccine and got shingles again, which had been going on for four weeks. At times the patient thought the medication was working and at other times medications really did not know. The pain was excruciating, to say the least. She giving birth to their nine children had been less painful than this. She prayed that the pain would stop soon. The batch number was not provided and unable to contact the reporter. 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, more than 2 years after vaccination with 1st dose and 2nd dose of Shingrix and VARICELLA ZOSTER VACCINE, in a 94-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.
Medical History/Concurrent Conditions: Shingles (1st time years ago on side and back, no sooner healed up from that, then got on arm); Comments: gave birth to nine children