Sex: U
Vaccine: FLU3
Symptoms: Liquid product physical issue, No adverse event
Clinical narrative: This spontaneous case was initially received on 29-Sep-2015. Follow up information received on 30-Sep-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on unknown dates, batch no: 11449211A, Route of administration: intramuscular, dose: 0.5 ml. AFLURIA was stored at 41 degrees Farenheit and was not exposed to any temperature excursions. It was monitored with a digital thermometer between 38-44 degrees Fahrenheit and the alarm sounds if the temperature exceeded this range. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unspecified date, the patient received an intramuscular dose of AFLURIA that may have contained a black particle floating in the vaccine. The particle was 1 mm T-shaped suspended in the solution, described as looking like a 'piece of pepper'. The ALFURIA vial with Pharmajet device was punctured once with the adaptor started to inspect the other vials. He could see 'white matter suspended in the solution, they look like proteins'. They appear as rod visible when a piece of paper was help up to the vial. It was noticed after removal from carton. No adverse reaction since receiving the vaccine. The pharmacist had quarantined the vaccine. No additional information was available. The outcome was not reported. Action taken: #Details manually to be entered#, Event treatment: #Details manually to be entered#, Rechallenge/Dechallenge information: #Details manually to be entered#. For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate# Reporter's assessment: non-serious. Reported the terms 'Medication error' and 'Quality defect'. Quality assurance investigation of AFLURIA MDV batch 11449211A: As part of the investigation undertaken for this complaint, description testing was performed for the returned sample. The description testing confirmed the reported complaint. Further analysis by FTIR and SEM (scanning electron microscopy) and EDS (energy-dispersive x-ray spectroscopy) was performed and determined the composition of the particle to not be similar to the vial stopper. The bulk reference samples were inspected and found to be of normal appearance for the vaccine and the retention sample inspection also met the standard description of AFLURIA vaccine. The analysis of the particle shows the dimensions as approximately 665 x 610 microns. Given these dimensions, it would not have been possible for the particle to have passed through any of the filtration steps listed above. There have been no other complaints reported for this batch. Also, to date, there have been no reported complaints for particles in the sister batch. In conclusion, the investigation demonstrates that the particle was most likely introduced into the vial from an unidentified external source after the stopper had been pierced. ***Case correction (31-Mmar-2016): AE 1 and 2 re-coded to better terms and AE # was deleted.