Sex: F
Vaccine: RAB
Symptoms: Accidental exposure to product, Animal bite, Needle issue, Product administration error
Clinical narrative: The needle came out and the vaccine splashed over the patient; The needle came out and the vaccine splashed over the patient; The needle came out and the vaccine splashed over the patient; Case reference number US-BN-2022-001401 is a spontaneous case report initially received from a consumer (reference number: USBAV22-0427) on 27-Jun-2022 and concerns an elderly female patient.  The patient's medical history and concomitant medication details were not provided.  On 25-Jun-2022, the patient was vaccinated with RabAvert (Rabies Virus (Inactivated, Strain Flury LEP); batch number: YRBA841B), at an unknown dose, administered intramuscularly for post-exposure immunization; the patient was bitten by a cat. It was reported that the needle came out and that the vaccine splashed over the patient. The nurse administered another vaccine, which was approved by the doctor (explicitly coded as 'product administration error', 'needle issue' and 'accidental exposure to product').   The reporter assessed the events as related to RabAvert.  At the time of this report, it was unknown if the patient experienced any adverse event.   The product quality complaint number received for this case is QE-001571.  *Given the outcome of its investigation, GSK Biologicals considers the complaint, that is the object of this report, as unsubstantiated. An investigation has been conducted, including review of the reported defect trends, the retained samples and production records, which has demonstrated that the subject batch (batch number: YRBA841B) was produced in compliance with the applicable procedures and met all required specifications. No deviation which could be related to the reported complaint has been identified and all of applicable verifications confirmed the conformity of the batch to specifications. All tests performed were within GSK specifications. No leakage between the syringe and the needle and no abnormality were observed.*  Additional information received on 28-Jun-2022 included the local case ID and PQC reference number.  Additional information received from Manufacturer on 13-Jul-2022 included additional references and investigation report, conclusion will be provided once it done.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from Manufacturer on 17-Aug-2022: New information included complaint final investigation report.  Non significant case correction was received on 15-Sep-2022 and included reporter's e-mail.; Reporter's Comments: An elderly female patient was vaccinated with RabAvert administered intramuscularly for post-exposure; the patient was bitten by a cat. It was reported that the needle came out and that the vaccine splashed over the patient which is considered as product administration error, needle issue and accidental exposure to product. The nurse administered another vaccine, which was approved by the doctor. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. Product administration error, needle issue and accidental exposure to product are all considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. Product administration error, needle issue and accidental exposure to product are all assessed as not related to RabAvert, but to a human factor. The case is non-serious. Additionally, investigation was performed and GSK Biologicals considers the complaint, that is the object of this report, as unsubstantiated. It was also concluded that there was no leakage between the syringe and the needle and no abnormality were observed.; Sender's Comments: An elderly female patient was vaccinated with RabAvert administered intramuscularly for post-exposure; the patient was bitten by a cat. It was reported that the needle came out and that the vaccine splashed over the patient which is considered as product administration error, needle issue and accidental exposure to product. The nurse administered another vaccine, which was approved by the doctor. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. Product administration error, needle issue and accidental exposure to product are all considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. Product administration error, needle issue and accidental exposure to product are all assessed as not related to RabAvert, but to a human factor. The case is non-serious. Additionally, investigation was performed and GSK Biologicals considers the complaint, that is the object of this report, as unsubstantiated. It was also concluded that there was no leakage between the syringe and the needle and no abnormality were observed.