Reporte zur Charge N94P2

Symptomtext

because leur-lock and needle disconnected from PFS; Pharmaceutical product complaint; Underdose/did not get full dose of vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental underdose in a 4-year-old male patient who received MMR (Priorix) (batch number GX27P, expiry date 11-MAY-2024) and (batch number N94P2, expiry date 12-DEC-2025) for prophylaxis. This case was associated with a product complaint. On 31-AUG-2023, the patient received Priorix. On 31-AUG-2023, an unknown time after receiving Priorix, the patient experienced accidental underdose (Verbatim: Underdose/did not get full dose of vaccine). On an unknown date, the patient experienced syringe issue (Verbatim: because leur-lock and needle disconnected from PFS) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint).The outcome of the accidental underdose, syringe issue and pharmaceutical product complaint were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-AUG-2023 The reporter requested data on re-vaccination of Priorix after patient received an underdose of Priorix, which led to accidental underdose. PQC (Pharmaceutical product complaint) filed because leur-lock and needle disconnected from PFS as nurse was administering the Priorix dose to patient and patient did not get full dose of vaccine. The reporter consented to follow up.