Sex: F
Vaccine: FLUR4
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: Flublok vaccine on her skin as patient was preparing 3 Flublok prefilled syringes on three separate occasions/ leaking onto the hands of the person administering the vaccine with no AE; Vaccine was leaking from the base of several Flublok syringes with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- 00461599) and transmitted to Sanofi on 04-Feb-2021.  This case involves a female patient who experienced  leakage of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2035 and expiration date: 30-Jun-2021)on her skin while preparing the syringes on three separate occasions/ leaking onto the hands while administering the vaccine (occupational exposure to product) and vaccine was leaking from the base of medical device FLUBLOK QUADRIVALENT PRE-FILLED SYRINGE (syringe issue) on an unknown date.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of potential medication error due to occupational exposure to product (latency on the same day). It was also a case of Syringe issue.  Reporter had reported 2 issues regarding the Flublok vaccine and that there was an issue with multiple Flublok syringes. The reporter also stated that they have been charged for a shipment of Flublok that was not delivered. Raised refund request regarding 3 Flublok syringes. Warm transferred back to Sanofi Pasteur Customer Service regarding an invoice for Flublok that was not received by the facility.  It was reported that fluid was leaking from the base of several Flublok syringes, leaking onto the hands of the person administering the vaccine. The reporter also stated that the fluid never flowed through the needle. In addition, reported that they have been charged for a shipment of Flublok that was never received. LOT: QFAA2035. The reporter has been in touch with Sanofi on several occasions without resolution. Some of her contact includes: 19Oct2020 spoke with staff  11Nov2020 spoke with Sanofi and was told it would takes 6 to 8 weeks for resolution 22Dec2020 spoke with staff who was checking with the credit department 29Dec2020 spoke with staff Description of complaint (as much information as possible) A physician's assistant, got Flublok vaccine on her skin as she was preparing 3 Flublok prefilled syringes on three separate occasions. The syringes never touched a patient. The event happened when the PA was attaching the needles to the syringes and the vaccine leaked out of the necks of all 3 syringes. At first the reporter stated the leaking occurred when the vaccine was being drawn into the syringe, but then it was pointed out that the syringes were prefilled, and then she said it was when the needles were being put on, and the syringe drawn. The syringes were put aside, and new ones were used for the patients.   It was not reported whether the vaccine was administered to the patient and patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.