Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Product colour issue, Pruritus, Syringe issue
Clinical narrative: Little tiny blisters coming out of the skin and they itch to death like poison ivy; Arm is hurting / arm was sore / soreness in the arms and two three fingers felt sore; Itching in my right arm neck and face/Itching in addition to the pain I felt/In my arm, chest and neck bones/Back on my neck is itchy, my right side and under my side started itching, bone in my chest is also itching; The vaccine clearly was not the same as the colour was different/The vaccine was jelly-type coloured/The flu shot look "darker" than last year; This spontaneous case was received on 30-Aug-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-02550) with additional information received from Seqirus' manufacturing quality assurance department on 02-Sep-2022 and additional information received on the same day (being processed together) and concerned a 78-year-old, male patient.  The patient's concurrent conditions included diabetes and back injury. The patient's past procedures included shoulder and eye surgery. The patient's concomitant medications included Farxiga (dapagliflozin propanediol monohydrate) used for diabetes.   On 20-Aug-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. The batch number reported was 346346. The patient was suspicious regarding the appearance of the vaccine administered. The patient stated that the vaccine did not look like the shot he had last year. The vaccine clearly was not the same as the colour was different. The vaccine was jelly-type coloured, darker and thick, he felt it in his arm (explicitly coded as 'Product colour issue'). Additionally, the patient claimed the syringe looked different than the previous year. This syringe was a little smaller than the one the patient received the previous year. The patient stated that the syringe last year appeared to be wider.  On the same day, after receiving Fluad Quadrivalent, the patient's arm was hurting /sore and by nighttime it started itching in addition to the pain the patient felt. The patient could feel it in his arm in his chest and his neck bones. The patient tried taking his shirt off and slept without it to see if the itching would stop bothering him. The patient told the pharmacist who gave him the shot that the shot they gave him itched him to death. After that, the patient went to another pharmacy, and they recommended the patient took Benadryl (diphenhydramine hydrochloride) and claimed the patient's symptom were due to his nervous system. The patient added that he felt soreness in the arms and two three fingers felt sore. The back on the patient's neck was itchy, his right-side and under his jaw started itching, his bone in his chest was also itching. The patient also described the appearance of blisters as little tiny blisters coming out of his skin and they itched to death like poison ivy.   On 26-Aug-2022, after six days, the patient went to the doctor who prescribed him clobetasol propionate cream 0.05%, a steroid cream to rub on his shoulder and chest. The patient was also prescribed Benadryl (diphenhydramine hydrochloride), which the patient had at home and took to get rid of the allergy. Neither of them were working, as reported.   At the time of initial reporting, the patient had not recovered from the events. The patient still felt the symptoms described, especially the itching.  The reported assessed the event of 'itching' as related to Fluad Quadrivalent as he stated that the shot pharmacist gave him itched him to death. The reporter did not provide causality assessment for other events.   The case was assessed as non-serious.   This case has been entered onto Seqirus' database.  Company comment: A 78-year-old, male patient was vaccinated with Fluad Quadrivalent. The patient stated that the vaccine did not look like the shot he had last year. The vaccine clearly was not the same as the colour was different. The vaccine was jelly-type coloured, darker and thick, he felt it in his arm (explicitly coded as 'Product colour issue'). On the same day following vaccination, the patient experienced pain in extremity and pruritus. In addition, the patient also reported blisters. Information regarding relevant laboratory finings and diagnostic data was not provided. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility. Product colour issue is assessed as unrelated per company's conventions.; Sender's Comments: A 78-year-old, male patient was vaccinated with Fluad Quadrivalent. The patient stated that the vaccine did not look like the shot he had last year. The vaccine clearly was not the same as the colour was different. The vaccine was jelly-type coloured, darker and thick, he felt it in his arm (explicitly coded as 'Product colour issue'). On the same day following vaccination, the patient experienced pain in extremity and pruritus. In addition, the patient also reported blisters. Information regarding relevant laboratory finings and diagnostic data was not provided. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility. Product colour issue is assessed as unrelated per company's conventions.