Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: Adjuvant dripped onto her bare hand; Adjuvant dripped onto her bare hand; All started spewing out from the stopper while needle was inside the vial; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Herpes zoster (Shingrix) (batch number 5392T, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that she called GlaxoSmithKline last week to report but did not call to the right department. The reporter wanted to report a quality control issue with Shingrix vaccine. The reporter reported that she was preparing the vaccine for administration and when she was withdrawing the diluent and it was all started spewing out from the stopper while her needle was inside the vial. Some of the liquid adjuvant was dripped onto her hand. The reporter was not wearing the gloves, The suspect vial of liquid adjuvant was not administered to a patient. The reporter used a different vial of liquid adjuvant to reconstitute the powder product. She had the suspect vial of liquid adjuvant and it will return to the GlaxoSmithKline. The GSK send the pharmacy a single dose kit of Shingrix including 1 vial of powder antigen and 1 vial of liquid adjuvant. Reporter discarded the extra powder vial.  The HCP who was preparing the dose was an experienced user, many time prepared the dose. The vial was held upside down when the liquid adjuvant was being withdrawn. The reporter stated that she flopped the lid wiped it with alcohol, inserted the needle and pushed in o.5 ml of the air and that was the time when drops of liquid started to leak down onto her hand, The reporter thinks the leak was came from stopper. The reporter stated there was no loose rubber stopper or metallic skirt detach before the handling, the patient only removed flip. The reporter stated that the box was discarded but she felt like she had noticed if there had been a water mark inside the empty box since she did remove the last two vials from the suspect box at the time of the event. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The reporter reported that while she was preparing the vaccine for administration at the time withdrawing the diluent it was all started to spewing out from the stopper and liquid adjuvant dripped on to her hand, which led to occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint.