Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Condition aggravated, Pruritus, Rash
Clinical narrative: Red, itchy bumps on her ankles that were present before she was vaccinated, but worsened after the lesion removal and vaccine; Red, itchy bumps on her ankles that were present before she was vaccinated, but worsened after the lesion removal and vaccine; Red, itchy bumps on her ankles that were present before she was vaccinated, but worsened after the lesion removal and vaccine; Itching and a rash that occurred primarily on her legs, torso, and lower back/red, itchy bumps on her ankles that were present before she was vaccinated, but worsened after the lesion removal and vaccine; Itching and a rash that occurred primarily on her legs, torso, and lower back/had a lesion removed (frozen off) from her chest and there was a rash that developed around that area as well; This spontaneous case was received on 09-Oct-2020 from other non-health professional via Health Authority (reference number: SEQW20-03337) and concerned a 76-year-old female patient.  The patient's concurrent conditions included red, itchy bumps on her ankles. The patient's past medical history included lesion that was removed (frozen off) from her chest, around the same time she received vaccine. The patient's concomitant medications were not provided. In 2016, 2017, 2018, 2019 seasons, the patient also received Fluad with no issues afterwards.  On 30-Sep-2020, the patient was vaccinated with Fluad, unknown if trivalent or quadrivalent (adjuvanted influenza vaccine, dose: 0.5 ml; route of administration: intramuscular; anatomical location: left deltoid) for protection against seasonal influenza. The batch number was not reported.  On an unknown date in Oct-2020, around 03-Oct-2020 and 04-Oct-2020, the patient experienced itching and a rash that occurred primarily on her legs, torso, and lower back. The patient stated that she had no idea what caused that and was unsure if the vaccine caused it.The patient also developed rash around the area where her lesion was removed. Red, itchy bumps on her ankles worsened after the lesion removal and vaccine. Patient was unsure if those were flea bites from her cats or due to the vaccine.   On an unknown date in Oct-2020, the patient took famotidine in the morning, Zyrtec (cetirizine hydrochloride) in the evening and used calamine lotion and that was helping.  At the time of initial reporting on 09-Oct-2020, the patient was recovering from events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious  Company comment: A 76-year-old female patient was administered Fluad vaccine, it was unknown if trivalent or quadrivalent. Approximately three days after vaccination, the patient experienced rash and pruritus, that occurred primarily on her legs, torso, and lower back. The patient's concurrent conditions included red, itchy bumps on her ankles. The patient's past medical history included lesion that was removed (frozen off) from her chest, around the same time she received vaccine. Reportedly, red, itchy bumps on her ankles worsened after vaccine administration and lesion removal. Due to lack of information regarding diagnostic findings, underlying dermatological condition, concomitant medications and medical history, causality is unassessable for all events.; Sender's Comments: A 76-year-old female patient was administered Fluad vaccine, it was unknown if trivalent or quadrivalent. Approximately three days after vaccination, the patient experienced rash and pruritus, that occurred primarily on her legs, torso, and lower back. The patient's concurrent conditions included red, itchy bumps on her ankles. The patient's past medical history included lesion that was removed (frozen off) from her chest, around the same time she received vaccine. Reportedly, red, itchy bumps on her ankles worsened after vaccine administration and lesion removal. Due to lack of information regarding diagnostic findings, underlying dermatological condition, concomitant medications and medical history, causality is unassessable for all events.