Age: 51.0
Sex: M
Vaccine: FLUC3
Symptoms: Accidental exposure to product, Incorrect dose administered, Injection site swelling
Clinical narrative: Patient had a swollen spot near injection site; Gave an injection of Flucelvax to an employee and part of the injection ran down patient's arm. Administered another vaccine; Gave an injection of Flucelvax to an employee and part of the injection ran down patient's arm. Administered another vaccine; This spontaneous case  was received on 05-Oct-2022 from other health care professional (nurse) via Agency (reference number: SEQW22-04073) with additional information received on 07-Oct-2022 from Seqirus' manufacturing quality assurance department (being processed together), and concerned a 51-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 01-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration: intramuscular; anatomical location: not reported) for influenza prophylaxis. The batch number reported was 348368 and the expiry date was 30-Jun-2023. The nurse gave an injection of Flucelvax to an employee, and part of the injection ran down patient's arm (explicitly coded as 'accidental exposure while administering drug'). The nurse  administered another vaccine to the patient (explicitly coded as 'incorrect dose administered'). The nurse stated that she attached the needle to some pre-filled syringe (PFS) prior to administration and when she was administrating the vaccine she didn't check the needle again.   On 03-Oct-2022, two days after receiving Flucelvax Quadrivalent, the patient experienced a swollen spot near injection site.  On 05-Oct-2022, the patient recovered from the event of vaccination site swelling.   The reporter assessed the event of fluid leak as not related to the Luer Lok Syringe. As reported, nurse did not want to report a product complaint because she thinks that the problem is from the needles and not from Seqirus syringes. She stated that when she changed the needle brand to BD needles the problem didn't happen again.  The case was assessed as non-serious.  This case has been entered onto Seqirus's manufacturing quality assurance tracking database and allocated reference number 1111212.  Company comment: The event of vaccination site swelling is assessed as possibly related to Flucelvax Quadrivalent due to a plausible temporal relationship. The events of accidental exposure while administering drug and incorrect dose administered are assessed as not related to Flucelvax Quadrivalent as per company conventions.; Reporter's Comments: The reporter assessed the event of fluid leak as not related to the Luer Lok Syringe. As reported, nurse did not want to report a product complaint because she thinks that the problem is from the needles and not from Seqirus syringes. She stated that when she changed the needle brand to BD needles the problem didn't happen again.; Sender's Comments: The event of vaccination site swelling is assessed as possibly related to Flucelvax Quadrivalent due to a plausible temporal relationship. The events of accidental exposure while administering drug and incorrect dose administered are assessed as not related to Flucelvax Quadrivalent as per company conventions.