Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Asthenia, Chest discomfort, Chest pain, Contraindicated product administered
Clinical narrative: Tightness in chest; Difficulty breathing/ breathing issues; The patient started feeling like she had the flu/like she had a case of an awful flu; All over itching; Rash all over/rash on face, head and trunk and itched; Rash all over/rash on face, head and trunk and itched; Fluad Quadrivalent contained neomycin and hydrocortisone - two ingredients that the patient has a severe allergy to; This spontaneous case was received on 17-Sep-2020 from a pharmacist via agency (reference number: SEQW20-01883) with additional information (reference number: SEQW20-02245) on 23-Sep-2020 (being processed together) and concerned a 76-year-old, female patient.   The patient's current conditions included long list of allergies (some severe) including allergy to steroid, neomycin, yellow dye and hydrocortisone. The patient's concomitant medications were not reported.  On 08-Sep-2020, the patient was vaccinated with Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid] (explicitly coded as 'Contraindicated drug administered') as protection against seasonal influenza. The batch number was 279790, expiry date: 25-May-2021.  On the same day, at the evening, the patient started feeling like she had the flu and was all over itching. She had tightness in her chest, severe symptoms such as rash all over and difficulty breathing. The rash was primarily on her face, head and trunk and itched severely. The patient experienced pain all over her body and in her joints, experienced severe fatigue, felt weak all over and had chest pain. Upon examining the ingredients, after the reaction occurred, the patient realized that Fluad Quadrivalent contained neomycin and hydrocortisone, two ingredients that the patient had a severe allergy to.  On 09-Sep-2020, the patient went to health clinic  and was given Tylenol (paracetamol) for the pain, Albuterol (salbutamol) inhaler for difficulty breathing and Atarax (alprazolam) for itching.  On 23-Sep-2020, She was still using a nebulizer for her breathing issues and the chest pain and was in a lot of pain all over. The patient also reported that her head and face still had a rash and itch from time to time, and that she was still experiencing an overall weakness, like she had a case of an awful flu.  At the time of initial reporting on 23-Sep-2020, the patient had not recovered from the events.  The reporter assessed the event to be related to Fluad Quadrivalent. Patient wanted to know if there were any tests they could run to see if she was still having an immune reaction to the vaccine she had received.  Case updated on 10-Nov-2020: Correction made to information received on 17-Sep-2020: Vaccine indication recoded from 'flu prophylaxis' to 'influenza immunization'. Narrative was amended.  Company comment: Chest discomfort, dyspnoea, influenza-like illness, pruritus, rash and pruritic rash were associated with the use of the suspect product Fluad Quadrivalent. The events occurred on the same day after vaccination (in the evening) making chronology suggestive. Reportedly, upon examining the ingredients, after the reaction occurred, the patient realized that Fluad Quadrivalent contained neomycin and hydrocortisone, two ingredients that the patient had a severe allergy to which was captured as contraindication. The patient's current conditions included long list of allergies (some severe) including allergy to steroid, neomycin, yellow dye and hydrocortisone while concomitant medications were not reported. With information presented, causality is assessed as possibly related for all events. Contraindication is assessed as unrelated per company conventions.; Reporter's Comments: Patient wanted to know if there were any tests they could run to see if she was still having an immune reaction to the vaccine she had received.; Sender's Comments: Chest discomfort, dyspnoea, influenza-like illness, pruritus, rash and pruritic rash were associated with the use of the suspect product Fluad Quadrivalent. The events occurred on the same day after vaccination (in the evening) making chronology suggestive. Reportedly, upon examining the ingredients, after the reaction occurred, the patient realized that Fluad Quadrivalent contained neomycin and hydrocortisone, two ingredients that the patient had a severe allergy to which was captured as contraindication. The patient's current conditions included long list of allergies (some severe) including allergy to steroid, neomycin, yellow dye and hydrocortisone while concomitant medications were not reported. With information presented, causality is assessed as possibly related for all events. Contraindication is assessed as unrelated per company conventions.