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 ther 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 werebeing 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.   Follow up information received from QA department on 27th August 2020: The reporter stated that, the healthcare center had two boxes of vaccine that had particles floating around the solution after reconstitution. Pictures were being emailed for the address provided. Two of the vaccines were administered but the office spoke to a GSK Liaison who advised that no additional doses be administered and the patients that received the vaccine should be revaccinated. No additional patient information was provided. The coordinator was contacting the healthcare provider instructing them to retain the product until they received communication from GSK concerning its retrieval. A related adverse events would be reported for the two administered vaccines. This was 1 of 2 linked cases, reported by same reporter.    Follow up information was received from QA department on 17th September 2019: Device component added for Kinrix. The complaint falls within the following product technical complaint category: vaccine appearance, based on the defect description.  A change of scope to inherent particle 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 were considered as inherent to the vaccine.  Indeed, Kinrix vaccine was formulated with aluminum salt used as antigen carrier.  In some conditions, the aluminum salt could aggregate and generate some small white particles. An investigation had been conducted, including review of the reported defect trends, the returned samples, the retained samples and our production records, which had 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 had not identified any root cause which could explain the atypical number of inherent particles observed in the syringes. Since these particles were inherent to the vaccine and based on the investigation results, data trended and safety assessment, GlaxoSmithKline was confident that there was no risk for the patient.  This complaint was considered as an isolated case. GlaxoSmithKline Biologicals considered this complaint as substantiated.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR157860:Same reporter