Sex: F
Vaccine: FLUC3
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Injection site is currently itchy / A lump is itchy; Injection site is currently red / I have a red lump; I have a red lump and is itchy; Consumer is concerned that the injection was delivered subcutaneously / she believes that it may not have been an intramuscular injection; This spontaneous case was received on 07-Nov-2022 from other non-healthcare professional (consumer) via regulatory authority (reference number: SEQW22-05541) concerned a female patient of an unspecified age.  The patient had no relevant medical history and was not taking any concomitant medications.  On 05-Nov-2022, on Saturday, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left arm; dose and route of administration: not reported) as influenza prophylaxis. The patient was concerned that the injection was delivered subcutaneously, she believed that it might not have been an intramuscular injection (explicitly coded as 'Inappropriate route of vaccination'). The batch number was not reported.   On the same date, after receiving Flucelvax Quadrivalent, the area at the injection site was itchy and red. There was a red lump and it was itchy. The patient stated that the injection was not in the "upside down triangle" area on the outer side of the left arm where the deltoid muscle is, instead, it seemed like the injection was more towards the back of her left arm.   At the time of initial reporting, the patient was recovering from the events. As reported, the events were still ongoing.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A female patient of an unspecified age was vaccinated with Flucelvax Quadrivalent. The patient was concerned that the injection was delivered subcutaneously, the patient believed that it might not have been an intramuscular injection (explicitly coded as 'Inappropriate route of vaccination'). On the same day following vaccination, the patient developed vaccination site pruritus, vaccination site erythema and vaccination site mass. The patient had no relevant medical history and was not taking any concomitant medications. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship. Inappropriate route of vaccination is assessed as not related per company's conventions.; Sender's Comments: A female patient of an unspecified age was vaccinated with Flucelvax Quadrivalent. The patient was concerned that the injection was delivered subcutaneously, the patient believed that it might not have been an intramuscular injection (explicitly coded as 'Inappropriate route of vaccination'). On the same day following vaccination, the patient developed vaccination site pruritus, vaccination site erythema and vaccination site mass. The patient had no relevant medical history and was not taking any concomitant medications. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship. Inappropriate route of vaccination is assessed as not related per company's conventions.