Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, Product colour issue, Product physical issue
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 Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: 11449211A, Route of administration: intramuscular, Dose: 0.5 ml. AFLURIA was stored at 41 degrees Fahrenheit 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. No additional drugs suspected. On an unspecified date, the patient received an intramuscular dose of AFLURIA that may have contained a black particle floating in the vaccine (small protein-like particles), The particle was 1 mm T-shaped suspended in the solution (did not dissolve when shaken for a few seconds), described as looking like a 'piece of pepper'. The AFLURIA vial with PharmaJet device was punctured once with the adaptor cap. The particulate/foreign matter did not appear to be a piece of rubber stopper. After the pharmacist saw the black particle, he started to inspect the other vials. He could see 'white matter suspended in the solution, they look like proteins'. They appear as red shapes but some looked like 'flakes'. Some appeared big and some are small, but they did not float. It was very hard to see and only visible when a piece of paper was held 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. Reporter's assessment: non-serious. Reported the terms 'Medication error' and 'Quality defect'. 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 Election Microscopy) and EDS (Energy-Dispersive X-Ray Spectroscopy) was performed and determined the composition of the particle to bot be similar to the vial stopper. The bulk reference sample 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 (dispensed from the same bulk). 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-Mar-2016): AE 1 and 2 re-coded to better terms and AE 3 was deleted.