Age: 71.0
Sex: F
Vaccine: FLUC3
Symptoms: Skin exfoliation
Clinical narrative: Red lump on injection arm; Rash appeared on the same arm/Red streaking rash then spread all over my body/Rash developed 4-5 inches from injection site / The rash eventually spread all over her body; Extreme itching at the injection site/ itch at injection site; Scaliness; Red streaks that fade away and come back; Blotches that come and go; This spontaneous case was received on 10-Jan-2023 from other non-healthcare professional (consumer) via Communications (reference number SEQW22-00140) and concerned a 71-year-old, female patient. At the time of initial reporting, the patient was 74-year-old.  The patient's concurrent conditions included high blood pressure and acid reflux. The patient's concomitant medications included irbesartan and pantoprazole, both used for an unreported indication.  On 14-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration, anatomical location: not reported) for prevent influenza. The batch number reported was 276547, and the expiry date was 27-Jun-2021.  On the same day, immediately after receiving Flucelvax Quadrivalent vaccine, the patient experienced extreme itching at the injection site.   On 19-Oct-2022, five days later, a rash appeared on the same arm, four to five inches of injection site and the rash eventually spread all over her body. The red streaking rash then spread all over patient's body, rash appeared and disappeared. Also, the patient developed a red lump on injection arm.  On an unspecified date in Oct-2020, an unreported amount of time after receiving Flucelvax Quadrivalent, the patient developed blotches that came and went. The patient also developed scaliness and red streaks that fade away and come back. The patient had biopsies, blood work drawn and saw several doctors who couldn't diagnose what was wrong.  At the time of initial reporting, the patient had not recovered from the events. As reported, after two years the patient still had symptoms.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 74-year-old patient experienced vaccination site pruritus immediately after receiving the suspect product Flucelvax Quadrivalent vaccine. The patient also developed erythematous rash and erythematous nodule five days after vaccination. The patient developed skin exfoliation, erythema, and macular rash an unknown amount of time after vaccination. Reportedly, the patient had biopsies, blood work drawn and saw several doctors who were unable to make a diagnosis. Based on suggestive temporal relationship, anatomic plausibility, and the absence of confounders, causality for the event vaccination site pruritus is assessed as probably related. Causality for the events erythematous rash and erythematous nodule is assessed as possibly related, based on chronological plausibility. Due to lack of information and unclear temporal relationship, causality for the events skin exfoliation, erythema, and macular rash is unassessable.; Sender's Comments: A 74-year-old patient experienced vaccination site pruritus immediately after receiving the suspect product Flucelvax Quadrivalent vaccine. The patient also developed erythematous rash and erythematous nodule five days after vaccination. The patient developed skin exfoliation, erythema, and macular rash an unknown amount of time after vaccination. Reportedly, the patient had biopsies, blood work drawn and saw several doctors who were unable to make a diagnosis. Based on suggestive temporal relationship, anatomic plausibility, and the absence of confounders, causality for the event vaccination site pruritus is assessed as probably related. Causality for the events erythematous rash and erythematous nodule is assessed as possibly related, based on chronological plausibility. Due to lack of information and unclear temporal relationship, causality for the events skin exfoliation, erythema, and macular rash is unassessable.