Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | HA5HL | — |
Product Complaint; Injection hurt; bubbles like a soda/it was too bubbly; pharmacist did not shake the vial, it was gently swirled; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number 4H79Y, expiry date 13-NOV-2026) and (batch number HA5HL) for prophylaxis. This case was associated with a product complaint. On 03-FEB-2025, the patient received Shingrix. On 03-FEB-2025, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection hurt), poor quality vaccine administered (Verbatim: bubbles like a soda/it was too bubbly) and wrong technique in drug usage process (Verbatim: pharmacist did not shake the vial, it was gently swirled). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain was unknown and the outcome of the poor quality vaccine administered, wrong technique in drug usage process and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK Receipt Date: 04-FEB-2025 The pharmacist reported that during and after reconstitution, the Shingrix solution bubbles like a soda. The pharmacist floats to other pharmacies and had noticed this lately when reconstituting Shingrix, confirmed that the pharmacist did not shake the vial, it was gently swirled which led to wrong technique in drug usage process. The pharmacist reported, 2 doses day before reporting were from lot 4H79Y (adjuvant HA5HL) that was very bubbly which led to poor quality vaccine administered. The pharmacist had to discard one dose because she was unable to withdraw a full dose because it was too bubbly (was only able to withdraw 0.2 to 0.3 milliliters). The other she was able to eliminate most of bubbles from the syringe and administer a full dose. However, the patient complained that the injection hurt because the pharmacist left one small bubble. The defect was discovered during preparation for administration; after half way through the multipack. One dose was discarded (not administered), the other was administered. There was no visible damage present on the vial. There were no temperature excursions during storage. Bak Snap, 25 gauge, 1 inch needle was used. The particle observed when the adjuvant was introduced into the antigen vial.