Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site extravasation
Clinical narrative: Pharmacist was not sure if this came from the patient's arm or the hub of the syringe/did not think it was from the hub; Part of the dose dripped down the patient's arm/ Medication leaking down arm; Part of the dose dripped down the patient's arm/ Medication leaking down arm; Pharmacist was not sure if this came from the patient's arm or the hub of the syringe/did not think it was from the hub; This spontaneous case from the  was received on 22-Oct-2020 from pharmacist via The Agency (reference number: SEQW20-04115) and concerned a 56-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 22-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, anatomical location, route of administration, dose: not reported) for flu prevention. The batch number reported was 283850, expiration date: 28-Feb-2021. When the needle was withdrawn the part of the dose dripped down the patient's arm. The medication was leaking from injection site down the patient's arm (explicitly coded as 'Incomplete dose administered' and 'Accidental exposure to product'). Pharmacist was not sure if this came from the patient's arm or the hub of the syringe, but she did not think it was from the hub (explicitly coded as 'Vaccination site extravasation' and 'Syringe leak'). No treatment measures were used.   The outcome of 'vaccination site extravasation' was not reported.  The reporter did not provide causality assessment.   The reporter assessed the case as non-serious.  Company comment: The patient was vaccinated with the suspect product, Flucelvax QIV. Reportedly, when the needle was withdrawn the part of the dose dripped down the patient's arm. The medication was leaking from injection site down the patient's arm (explicitly coded as 'Incomplete dose administered' and 'Accidental exposure to product'). Pharmacist was not sure if this came from the patient's arm or the hub of the syringe, but she did not think it was from the hub (explicitly coded as 'Vaccination site extravasation' and 'Syringe leak'). No treatment measures were used. Causal relationship for vaccination site extravasation is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes). Causality for other mentioned events is assessed as not related per company's conventions.; Sender's Comments: The patient was vaccinated with the suspect product, Flucelvax QIV. Reportedly, when the needle was withdrawn the part of the dose dripped down the patient's arm. The medication was leaking from injection site down the patient's arm (explicitly coded as 'Incomplete dose administered' and 'Accidental exposure to product'). Pharmacist was not sure if this came from the patient's arm or the hub of the syringe, but she did not think it was from the hub (explicitly coded as 'Vaccination site extravasation' and 'Syringe leak'). No treatment measures were used. Causal relationship for vaccination site extravasation is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes). Causality for other mentioned events is assessed as not related per company's conventions.