Age: 51.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: Cellulitis; Location most likely not into the deltoid; Vaccine administered subcutaneously; A 51-year-old patient received Fluad Quadrivalent; This spontaneous case was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 890741-1), reported by other health professional and concerned a 51-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 03-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: reported as 'one', route of administration: subcutaneous, anatomical location: right arm, most likely not into the deltoid and indication: not reported) (explicitly coded as Inappropriate age at vaccine administration', 'Inappropriate route of vaccination' and 'Vaccine administered at inappropriate site'). The batch number was 279803. It was reported that location of the injection was in question. Per nurse who administered the vaccine, she went four finger widths below shoulder joint, and injected with one-inch needle. Also, the vaccine was administered subcutaneously due to patient arm size and placement.   On 05-Oct-2020, two days after receiving Fluad Quadrivalent, the patient's area below "ideal" injection site that was warm, red and painful to the touch. On an unknown day in Oct-2020, the patient visited physician's office. On call provider looked at this and the patient was diagnosed with cellulitis. The patient was treated for the event with three doses of vancomycin administered intravenously.  On an unknown day in Oct-2020, the patient recovered from the event of cellulitis.  The reporter did not provide a causality assessment.  The event of cellulitis was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 51-year-old patient was administered Fluad Quadrivalent. Two days after receiving Fluad Quadrivalent, the patient's area below injection site that was warm, red and painful to the touch. The patient was diagnosed with cellulitis. Causality is assessed as possibly related. Per Brighton collaboration criteria, presented information correspond to level 2 diagnostic certainty for cellulitis at injection site (although affected area was below injection site). Vaccine was given subcutaneously, most likely not into the deltoid. Vaccine administered at inappropriate site, incorrect route of product administration and product administered to patient of inappropriate age are assessed as not related per company's conventions.; Sender's Comments: A 51-year-old patient was administered Fluad Quadrivalent. Two days after receiving Fluad Quadrivalent, the patient's area below injection site that was warm, red and painful to the touch. The patient was diagnosed with cellulitis. Causality is assessed as possibly related. Per Brighton collaboration criteria, presented information correspond to level 2 diagnostic certainty for cellulitis at injection site (although affected area was below injection site). Vaccine was given subcutaneously, most likely not into the deltoid. Vaccine administered at inappropriate site, incorrect route of product administration and product administered to patient of inappropriate age are assessed as not related per company's conventions.