Sex: F
Vaccine: VARZOS
Symptoms: Device leakage
Clinical narrative: vial of adjuvant of Shingrix leaked during withdrawal and leaked on her hand; vial of adjuvant of Shingrix leaked during withdrawal and leaked on her hand; after partial use of the pack and was not administered or partially administered to a patient; leak from the stopper at the neck of the vial/vial rubber stopper became loose during handling; vial leak; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inadvertent exposure to vaccine in a female patient who received Herpes zoster (Shingrix) (batch number FJ9A7, expiry date 16-JUL-2026) 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 inadvertent exposure to vaccine (Verbatim: vial of adjuvant of Shingrix leaked during withdrawal and leaked on her hand), exposure via skin contact (Verbatim: vial of adjuvant of Shingrix leaked during withdrawal and leaked on her hand), accidental underdose (Verbatim: after partial use of the pack and was not administered or partially administered to a patient), vial stopper damage (Verbatim: leak from the stopper at the neck of the vial/vial rubber stopper became loose during handling), product container leak (Verbatim: vial leak) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the inadvertent exposure to vaccine, exposure via skin contact, accidental underdose, vial stopper damage, product container leak and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 04-NOV-2024 The pharmacist reported that the vial of adjuvant of Shingrix was leaked during withdrawal and leaked on her hand (accidental exposure), which led to inadvertent exposure to vaccine and exposure via skin contact. The defect was noticed after partial use of the pack and was not administered or partially administered to a patient, which led to accidental underdose.  The consumer injected 0.5 ml air from the syringe into the vial during preparation and at the step before withdrawal of adjuvant. The leak was coming from the stopper at the neck of the vial and the vial rubber stopper became loose during handling and she only noticed the stopper was loose after the leakage.  The customer removed only the plastic flip-off. There was no any evidence of leakage in package or box or carton (e.g. wet PIL or faded label). The suspect product was not available for return as the vials were disposed of.   Follow-up information received on 21-NOV-2024 Executive summary and conclusions of the QA statement was received as follows. GSK has completed its investigation for the quality defect that was reported. The investigation included a review of the defect trends, a testing of the retained samples and a review of the related production records, all of which demonstrated that the reported batch was produced in compliance with the applicable procedures and met all required specifications. Nothing atypical was identified while the product was under GSK control which would explain the reported quality defect. To properly handle Shingrix doses, the HCP must follow the steps described in the US PIL (refer to below figure) and in the instructional video available on GSK website which should avoid recurrence of the reported issue. The Safety Department within GSK routinely monitors safety signals (including signals potentially related to manufacturing); should a safety concern be detected, it will be managed and escalated according to processes in place.  Given the outcome of its investigation, GSK considered the complaint that was the object of this report as unsubstantiated.  Summary of changes: Product details (Batch and lot tested and found within specifications ticked) and narrative was updated.