Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Pain from the armpit to chest (same limb where Fluad was administered); Swelling from the armpit to chest (sam limb where Fluad was administered); Sort of redness from the armpit to chest (same limb where Fluad was administered); Itch from the armpit to chest (same limb where Fluad was administered); Arm was itchy at the site; Arm was red at the site; There was sort of lump; This spontaneous case was received on 08-Dec-2023 from an other non-healthcare professional (consumer) via Communications (reference number: SEQW23-04757) and concerned a 78-year-old, female patient.  The patient's medical history and concomitant medication were not reported. The patient's historical vaccines included unspecified influenza vaccines received on unspecified dates (batch numbers: not reported), all for unspecified indication. As reported, the patient never had a reaction to previous influenza vaccines.  On 20-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; anatomical location: arm; route of administration: not reported) for active immunization against influenza disease. The batch number reported was 371597 and the expiry date was 22-May-2024.  On the same date, as soon as the patient got the Fluad Quadrivalent, the arm was itchy and red at the site.  On an unspecified date in 2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed a sort of lump.  On an unspecified date in Oct-2023, the patient recovered from the events of 'vaccination site pruritus', and 'vaccination site erythema'. As reported, the events lasted for about three days. To treat the itch, the patient put some betamethasone.  On an unspecified date in 2023, the patient recovered from the event of 'vaccination site mass'. As reported, a sort of lump was there for a week.  On an unspecified date in Nov-2023, reported as four weeks after after receiving Fluad Quadrivalent, the patient experienced swelling, itch, pain, and a sort of redness from the armpit to chest (same limb where Fluad was administered).  On an unspecified date in 2023, the patient had a dermatologist's office visit, however, no further details were provided.  At the time of initial reporting, the patient had not recovered from the events of 'swelling', 'pain', 'erythema', and 'pruritus'.  The reporter did not provide a causality assessment. As reported, the patient has had other shots (other vaccines) on the other arm but experienced no reaction with those, however, the patient was still having a reaction from the armpit to the chest after the flu shot.  The case was assessed as non-serious.  Company comment: On the same date, as soon as the patient got the Fluad Quadrivalent, pruritus and erythema at vaccination site. On an unspecified date in Oct-2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed a sort of lump. The events of vaccination site erythema, vaccination site pruritus and vaccination site mass lasted for about three days. On an unspecified date in Nov-2023, reported as four weeks after after receiving Fluad Quadrivalent, the patient experienced swelling, itch, pain, and a sort of redness from the armpit to chest (same limb where Fluad was administered). The patient had a dermatologist's office visit, however, no further details were provided. Causality is assessed as possibly related for the events of vaccination site erythema, vaccination site mass and vaccination site pruritus, based on chronological and anatomical plausibility. The events of pain, swelling, erythema and pruritus are assessed as not related to the vaccine, based on biological implausibility.; Sender's Comments: On the same date, as soon as the patient got the Fluad Quadrivalent, pruritus and erythema at vaccination site. On an unspecified date in Oct-2023, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed a sort of lump. The events of vaccination site erythema, vaccination site pruritus and vaccination site mass lasted for about three days. On an unspecified date in Nov-2023, reported as four weeks after after receiving Fluad Quadrivalent, the patient experienced swelling, itch, pain, and a sort of redness from the armpit to chest (same limb where Fluad was administered). The patient had a dermatologist's office visit, however, no further details were provided. Causality is assessed as possibly related for the events of vaccination site erythema, vaccination site mass and vaccination site pruritus, based on chronological and anatomical plausibility. The events of pain, swelling, erythema and pruritus are assessed as not related to the vaccine, based on biological implausibility.