Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
Suspected vaccination failure; Shingles; Inappropriate schedule of vaccine administered/ received 1st shot of Shingrix in OCT-2020, received 2nd dose in OCT-2021; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 58-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 (had 3 times in her life). In OCT-2021, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. In OCT-2020, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. In OCT-2021, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered/ received 1st shot of Shingrix in OCT-2020, received 2nd dose in OCT-2021). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the drug dose administration interval too long was not applicable. 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. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 14-NOV-2025 The patient self-reported this case for herself. The patient received concomitant medication included an Antiviral medication. She reported that she received the 1st shot of Shingrix vaccine and did not get the 2nd dose right away which led to an inappropriate schedule of vaccine. The patient further reported that she received both vaccines at a local pharmacy and 4 years after, in 2025 she had the first episode of shingles. No additional event was reported. The batch number was not provided and a request for this information had been made. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingrix (dose 1 and dose 2), in a 58-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. The company has assessed that it is unlikely that event Inappropriate schedule of product administration, was caused by vaccine Shingrix.
Medical History/Concurrent Conditions: Shingles (had 3 times in her life)