Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7zm55 | — |
diluent to contain only 0.4 ml; reconstitute two of the vaccines in the box with the same results; Product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) (batch number 7zm55, expiry date 15-NOV-2026) and (batch number 555hwztvaa) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: diluent to contain only 0.4 ml), product packaging quantity issue (Verbatim: reconstitute two of the vaccines in the box with the same results) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the incomplete dose administered, product packaging quantity issue and pharmaceutical product complaint were not applicable. Additional Information: GSK Receipt Date: 04-MAY-2025 The pharmacist reported that while reconstituting Shingrix vaccine, he/she found the diluent to contain only 0.4 ml which would not yield the 0.5 ml dose for the final vaccine which led to incomplete dose of vaccine administered and product packaging quantity issue. The pharmacist tried to reconstitute two of the vaccines in the box with the same results. The Medical Information team is submitting to safety out of abundant caution. As this potential product quality complaint (PQC) was noted during reconstitution of two doses within this box, this is being submitted as a potential near miss event. Even though the pharmacist does not provide patient details or state that the doses were administered, as the vaccine was being reconstituted, it is assumed there was a patients involved.