Sex: U
Vaccine: RV1
Symptoms: Accidental exposure to product, Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: It comes out of the patient's mouth and all over the patient and nurse; It comes out of the patient's mouth and all over the patient and nurse; It comes out of the patient's mouth and all over the patient and nurse.; Product Complaint; This non-serious case was reported by a other health professional via sales rep and described the occurrence of occupational exposure while administering product in a child patient who received Rota (Rotarix lyophilized formulation) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced occupational exposure while administering product (Verbatim: It comes out of the patient's mouth and all over the patient and nurse), inadvertent exposure to vaccine (Verbatim: It comes out of the patient's mouth and all over the patient and nurse), exposure via skin contact (Verbatim: It comes out of the patient's mouth and all over the patient and nurse.) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the occupational exposure while administering product, inadvertent exposure to vaccine, exposure via skin contact 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: 27-Jun-2023, 28-Jun-2023 and 29-Jun-2023 On 28th June 2023, the GlaxoSmithKline response center to obtain further details about product complaint. The detailed message was left with receptionist asking for a return call from the reporter. Filed product quality complaint with limited information. When reporter call back please verify all her demographics including her email address. The reporter asked that the office did require credit, if so they did buy from GlaxoSmithKline direct or vaccines for children, account number. The reporter stated that please obtain lot number and expiration date of suspect product  and also confirm if this only happened one time, the suspect product was retained so that it could be sent to GlaxoSmithKline for investigation.   Related adverse event had been filed by GlaxoSmithKline medical information (safety case number not generated yet). If possible please get patient's information for related adverse event -underdose (patient's initials, gender, and date of birth). Please clarify if any of the Rotarix got onto the reporter's bare skin. (If so, please obtain nurse's initials, gender, and date of birth), also ask the questions in the 'Leaky syringe' scenario box, if applicable and send follow up details to quality and safety. No further details were available. The medical information submitting all details as available per request form received. The reporter consented to follow-up. When they took cap off, the vaccine seems to be pressurized and begins to ooze out and it comes out of the patient's mouth and all over the patient and nurse, which led to occupational exposure while administering product, inadvertent exposure to vaccine and exposure via skin contact.