Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Device leakage, Occupational exposure to product, Product complaint
Clinical narrative: vial leaking from the plastic stopper; product complaint; was preparing to administer a dose of SHINGRIX and upon getting to the last step and drawing up the vaccine the vial began to leak out of the edges of the bottle; This case was reported by a physician via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 46-year-old female patient who received Herpes zoster (Shingrix) (batch number DC439, expiry date 28th February 2023) and (batch number 4G94Z, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   On 8th October 2021, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 8th October 2021, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and vial adapter leak. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure while preparing product for administration, vial adapter leak and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The case was reported by patient's colleague, who was a health care professional (HCP). The age at vaccination was not applicable. HCP reported that a fellow HCP at her practice was preparing to administer a dose of Shingrix and upon getting to the last step and drawing up the vaccine the vial began to leak out of the edges of the bottle, which led to occupational exposure while preparing product for administration. Confirmation was made that all operations were performed appropriately before defect was discovered. At upon receipt during preparation and/or administration after partial use (multi pack only) at the end of the pack (multi pack only) at this stage defect was discovered and in the last step when withdrawing from the vial 2. The mixing/shaking performed after reconstitution was gently vigorously laterally upside-down Gently 3. The HCP vial was held upside down when the vaccine was being withdrawn. The product was not administered. The HCP preparing/administering vaccine was experienced user. The antigen vial component was impacted. The picture of defect was sent per HCP via email referencing the case number. The customer did not inject air from the syringe into the vial during preparation. The leak was coming from the stopper at the neck of the vial. The vial rubber stopper/metallic skirt did not detach or become loose during handling or without any manipulation. The customer removed only the plastic flip-off of the vial before handling. There was no any evidence of leakage in package or carton (ex. wet PIL or faded label). The reporter consented to follow up. Conclusions of the QA statement were received as follows A customer reported a complaint which fall within the following product technical complaint category: vial stopper integrity issue (leak around vial stopper) based on the defect description. An investigation had been conducted, including review of the reported defect trends, the retained samples, the returned sample and production records, which had demonstrated that the subject batch was produced in compliance with the applicable procedures and met all required specifications. Additionally, no deviation which could be related to the reported complaint had been identified and all of applicable verifications confirmed the conformity of the batch to specifications. Based upon the nature of the reported complaint, strict adherence to the instructions for preparation of the vaccine was of major importance and should help to minimize future occurrences of this nature. The Safety Department within GlaxoSmithKline routinely monitors safety signals (including signals potentially related to manufacturing); should a safety concern be detected, it would be managed and escalated according to processes in place. Given the outcome of its investigation, GlaxoSmithKline Biologicals considered the complaint that was the object of this report as unsubstantiated.