Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product complaint, Product leakage, Product preparation error
Clinical narrative: reconstitute with remaining adjuvant and mixed with saline solution/ injected 1 adjuvant vial into another one; solution as inital volume was 0.3 ml/less than 0.5 ml/ injected 1 adjuvant vial into another one; pharmaceutical product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number K4TG5, expiry date 31-MAY-2024) 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 wrong solution used in drug reconstitution (Verbatim: reconstitute with remaining adjuvant and mixed with saline solution/ injected 1 adjuvant vial into another one), incomplete dose administered (Verbatim: solution as inital volume was 0.3 ml/less than 0.5 ml/ injected 1 adjuvant vial into another one) and pharmaceutical product complaint (Verbatim: pharmaceutical product complaint). The outcome of the wrong solution used in drug reconstitution, incomplete dose administered and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 29-Mar-2023 and 30-Mar-2023 The nurse calling because they have had 4 Shingrix adjuvant vials leak in the last week from the needle puncture in the rubber stopper and she reviewed all steps in the product Information with the reporter and the administration did not occur with 3 of the Shingrix adjuvant vials, the nurse discarded the vials but the administration did occurred with the 4th Shingrix adjuvant vial. The nurse knew she had used saline, but was not aware that this was not appropriate. The defect occurred during preparation and the adjuvant leaked during withdrawal. The reporter did not know how was the mixing/shaking performed after reconstitution, if health care professional preparing/administering vaccine was a new or experienced user, the customer injected air from the syringe into the vial during preparation. The adjuvant vials were impacted. No vial rubber stopper/metallic skirt detach or become loose during handling or without any manipulation. Just the flip-off cap of the vial was removed before handling. There were no evidence of leakage in package or carton (example wet PIL or faded label) Information for the adverse event report was collected, including vaccine information and patient information. All adjuvant vials were discarded, so there was nothing to return and no pictures can be sent of the defect.  Product quality complaint was filed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The nurse in the health care professional's office had a Shingrix adjuvant vial leak from the puncture in the rubber stopper, and she withdrew the remaining adjuvant and used it to reconstitute the Shingrix antigen vial and then withdrew the reconstituted vaccine and only had 0.3cc of Shingrix vaccine, so she added enough saline to the reconstituted 0.3cc of Shingrix to get to 0.5cc, and administered this to a patient, which led to wrong solution used in drug reconstitution and incomplete dose administered.