Sex: U
Vaccine: DTAPIPV
Symptoms: Poor quality product administered
Clinical narrative: Two of the vaccines were administered; Product contamination particulate matter; had particles floating around the solution after reconstitution; This case was reported by a other health professional via call center representative and described the occurrence of poor quality vaccine administered in a patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced poor quality vaccine administered, product contamination particulate matter and pharmaceutical product complaint. On an unknown date, the outcome of the poor quality vaccine administered, product contamination particulate matter and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the healthcare Center has two boxes of vaccine that had particles floating around the solution after reconstitution and two of the vaccines were administered to the patient, which led to poor quality vaccine administered, product contamination particulate matter and pharmaceutical product complaint. The office spoke to a GSK medical scientist liaison who advised that no additional doses be administered and the patients that received the vaccine should be re vaccinated. The reporter stated that, the pictures were being emailed for the address provided. The particles were white and the size was comparable to sea salt. The shape was like a rock with pointy edges. No additional patient information was provided. The case was linked with the case US2020156615 reported by same reporter.  Follow up information was received from Quality assurance department on 29th March 2021: Conclusions of the Quality assurance statements were received as follows: Customer reported a complaint which falls within the following product technical complaint category based on the defect description. A change of scope to was made as a consequence of the Quality Control analysis of the returned samples which identified the presence of white particles. The white particles have been identified as product formulation related particles, and, therefore are considered as inherent to the vaccine. Indeed, Kinrix vaccine is formulated with aluminum salt used as antigen carrier. In some conditions, the aluminum salt can aggregate and generate some small white particles. An investigation has been conducted, including review of the reported defect trends, the returned samples, the retained samples and our production records, which has demonstrated that the subject batch was produced in compliance with the applicable procedures and met all required specifications. Moreover, the in-depth investigation performed on raw materials and at all manufacturing steps has not identified any root cause which could explain the atypical number of inherent particles observed in the syringes. Since these particles are inherent to the vaccine and based on the investigation results, data trended and safety assessment, GlaxoSmithKline was confident that there is no risk for the patient. This complaint was considered as an isolated case. Therefore, GlaxoSmithKline Biologicals considered the complaint as substantiated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156615:Same reporter