Age: 42.0
Sex: F
Vaccine: FLUC3
Symptoms: Syringe issue, Vaccination site extravasation
Clinical narrative: The injection site has a cellulitis reaction, three and half inches long. Redness and hot to the touch. Physician states it hurts a lot; Physician states that when pharmacist pulled out the vaccine it dripped some content out of arm; Physician states that she was given the vaccine subcutaneously or intradermally; This spontaneous case was received on 01-Oct-2021 from a physician via agency (reference number: SEQW21-03131) with additional document (being process together) received on the same date and concerned a 42-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient never had a reaction to flu vaccine.  On 30-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: subcutaneous or intradermal, anatomical location: deltoid) (explicitly coded as 'Inappropriate route od administration') for influenza prophylaxis. The batch number reported was 309613 and expiry date 25-Jun-2022.  On the same date, after the pharmacist pulled out the vaccine, it dripped some content out of arm. The patient stated she believed the vaccine was given subcutaneously or intradermally instead of intramuscularly. The vaccine was not leaking prior to administration.   On the same day, after receiving Flucelvax Quadrivalent, the patient developed a cellulitis reaction on injection site, three and half inches long which was red, hot and to the touch. Additionally, the patient stated that it hurt a lot. The patient was treated with compresses. At the time of initial reporting, it was warm to the touch.   The outcome of the events was not reported.   The reporter assessed the event of 'vaccination site cellulitis' to be related to Flucelvax Quadrivalent and did not provide causality assessment for the event of 'vaccination site extravasation'   The reporter assessed the case as non-serious.  Company Comment: A 42-year-old, female patient developed vaccination site cellulitis on the same day after vaccination with the suspect product Flucelvax Quadrivalent. Vaccination site extravasation was also reported. Vaccine was administered subcutaneously or intradermally (explicitly coded as 'Inappropriate route od administration'). Causality for this event is assessed as not related as per company specific guidelines. Causality for the remaining two events is assessed as possibly related, although confounded by inappropriate route od administration.; Sender's Comments: A 42-year-old, female patient developed vaccination site cellulitis on the same day after vaccination with the suspect product Flucelvax Quadrivalent. Vaccination site extravasation was also reported. Vaccine was administered subcutaneously or intradermally (explicitly coded as 'Inappropriate route od administration'). Causality for this event is assessed as not related as per company specific guidelines. Causality for the remaining two events is assessed as possibly related, although confounded by inappropriate route od administration.