Age: 74.0
Sex: F
Vaccine: FLUA4
Symptoms: Neck pain, Pain in extremity, Product administered at inappropriate site, Urticaria
Clinical narrative: Cellulitis; Hives; Welts at the injection area; Flu vaccination being given too low on the arm; This spontaneous case was retrieved on 21-Dec-2020 from VAERS (reference number: 896357-1), reported by other health professional and concerned a 74-year-old female patient.  The patient's concurrent conditions included bladder infection, asthma, codeine and sulfa allergy. The patient's concomitant medications included Levaquin (levofloxacin), levothyroxine, folic acid, Coreg (carvedilol), Lasix (furosemide), KCl (potassium chloride), Cholestyramine light (colestyramine) and oxybutynin, all for unreported indication. The patient's historical vaccine included influenza virus vaccine in 2017 after which the patient developed severe flu symptoms and was under a lot of stress at the time (see case 202009088).   On 07-Nov-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, anatomical location: right arm, dose and indication: not reported). The batch number reported was 279796.  On 08-Nov-2020, one day after receiving Fluad Quadrivalent, the patient experienced hives, welts at the injection area (red, sore, hot to touch area about size of a hand), pain from elbow to shoulder. She had no fever; body temperature was 98 degrees Fahrenheit. Size of redness increased over time and pain progressed to wrist and to top of the neck.   On 10-Nov-2020 in the evening, the patient went to urgent care and was given a prescription for cephalexin for 10 days and told she had cellulitis from the flu vaccination being given too low on the arm (explicitly coded as 'Vaccine administered at inappropriate site').  On 11-Nov-2020, the next morning, the patient saw primary care physician (PCP) and would follow up with PCP after finishing course of antibiotics.   At the time of initial reporting, the patient had not recovered from the events, as she had taken two doses of cephalexin and symptoms remained.   The reporter did not provide a causality assessment, but the urgent care stated that the cellulitis was from flu vaccination.   The event of 'cellulitis' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  The case is linked to the case 202009088 (the same patient).  Company comment: A 74-year-old patient was administered Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient experienced hives, welts at the injection area (red, sore, hot to touch area about size of a hand), pain from elbow to shoulder. The patient went to urgent care and was given a prescription for cephalexin for 10 days and told she had cellulitis from the flu vaccination being given too low on the arm. Vaccine administered at inappropriate site is assessed as not related per company's conventions. Causality is assessed as possibly related for vaccination site urticaria, urticaria and cellulitis. Per Brighton collaboration criteria, presented information correspond to level 2 diagnostic certainty for cellulitis at injection site.; Reporter's Comments: The urgent care stated that the cellulitis was from flu vaccination.; Sender's Comments: A 74-year-old patient was administered Fluad Quadrivalent. One day after receiving Fluad Quadrivalent, the patient experienced hives, welts at the injection area (red, sore, hot to touch area about size of a hand), pain from elbow to shoulder. The patient went to urgent care and was given a prescription for cephalexin for 10 days and told she had cellulitis from the flu vaccination being given too low on the arm. Vaccine administered at inappropriate site is assessed as not related per company's conventions. Causality is assessed as possibly related for vaccination site urticaria, urticaria and cellulitis. Per Brighton collaboration criteria, presented information correspond to level 2 diagnostic certainty for cellulitis at injection site.