Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Exposure via skin contact, Product complaint, Syringe issue, Underdose
Clinical narrative: a defected syringe of Engerix-B; Product Complaint/when administering the injection to the patient, the vaccine came out of the hub and leaked; Engerix-B under dose administered/HCP states that an AE for Engerix B was reported earlier today to a MI agent (Incomplete dose).; nurse could visibly wipe the medication from the patient's arm; nurse could visibly wipe the medication from the patient's arm; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 72-year-old female patient who received HBV (Engerix B) (batch number Y5X9T, expiry date 30-SEP-2026) for prophylaxis. This case was associated with a product complaint.   On 23-OCT-2024, the patient received the 3rd dose of Engerix B. On 23-OCT-2024, an unknown time after receiving Engerix B, the patient experienced accidental underdose (Verbatim: Engerix-B under dose administered/HCP states that an AE for Engerix B was reported earlier today to a MI agent (Incomplete dose).), inadvertent exposure to vaccine (Verbatim: nurse could visibly wipe the medication from the patient's arm) and exposure via skin contact (Verbatim: nurse could visibly wipe the medication from the patient's arm). On an unknown date, the patient experienced syringe issue (Verbatim: a defected syringe of Engerix-B) and pharmaceutical product complaint (Verbatim: Product Complaint/when administering the injection to the patient, the vaccine came out of the hub and leaked). The outcome of the accidental underdose, inadvertent exposure to vaccine, exposure via skin contact, syringe issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe issue to be related to Engerix B.     It was unknown if the company considered the syringe issue to be related to Engerix B.   Additional Information: GSK Receipt Date: 25-OCT-2024  The office Manager from doctor's office reported that one of their patient received a defected syringe of Engerix-B as a third dose but the medication splattered out everywhere outside the hub and the patient did not received a full dose of Engerix-B, which led to accidental underdose. The vaccine sprayed around the hub and the nurse could visibly wipe the medication from the patient's arm, which led to Inadvertent exposure to vaccine and exposure via skin contact. The reporter stated that there was a PQC (product quality complaint) here.  Doctor decided to wait 3 to 6 months to check immunity for hep B and determine how to proceed from there. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter stated that the nurse preparing the vaccine was an experienced user. The reporter reported that the suspect product was not available for return because the nurse discarded the vaccine syringe. When administering the injection to the patient, the vaccine came out of the hub and leaked. There was not any damage/breakage on the syringe barrel. There was no visible damage identified when the medication came spraying out. The tray and/or box/carton was not damaged. The size gauge needle was 25 gauge. The syringe was pre-assembled right before administration of the vaccine.