Sex: M
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: reconstituted vaccine a significant portion of the substance sprayed from the stopper; reconstituted vaccine a significant portion of the substance sprayed from the stopper into face; reconstituted vaccine a significant portion of the substance sprayed from the stopper into eyes; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a adult male patient who received Herpes zoster (Shingrix) 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 occupational exposure while preparing product for administration (Verbatim: reconstituted vaccine a significant portion of the substance sprayed from the stopper), exposure via skin contact (Verbatim: reconstituted vaccine a significant portion of the substance sprayed from the stopper into face), exposure via eye contact (Verbatim: reconstituted vaccine a significant portion of the substance sprayed from the stopper into eyes) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the occupational exposure while preparing product for administration, exposure via skin contact, exposure via eye contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter reported that a leaky vial of Shingrix lyophilized antigen component vial.  The reporter confirmed that all operations were performed appropriately before defect was discovered.  The step was the defect discovered during reconstitution. The mixing/shaking was performed after reconstitution that was gently and while swirling the vial. The reporter stated that when this occurred it sprayed him in the face and eyes.  The vial was held upside-down when the vaccine is being withdrawn. Never able to withdraw vaccine. The product was not administered or partially administered. The healthcare professional preparing/administering vaccine was an experienced user. The lyophilized antigen component vial. The customer did not inject air from the syringe into the vial during preparation. The leak was coming from the rubber stopper. The vial rubber stopper/metallic skirt not detached or became loosen during handling or without any manipulation. The customer only removed the plastic flip-off before handling. There was no any evidence of leakage in package or carton (e.g., wet PIL or faded label). The agent requested return of both the adjuvant and antigen vial for each dose related to the product complaint and the original packaging without further manipulation/handling.  The reporter did not consent to follow-up. During reconstitution of Shingrix, while gently swirling the vial containing the reconstituted vaccine a significant portion of the substance sprayed from the stopper, which led to occupational exposure while preparing product for administration, exposure via skin contact and exposure via eye contact.