Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Left arm is also restricting him from taking a bath; When the patient rotates left shoulder joint, it hurts to the point the patient can hardly reach the back of the head/significant reduction of range/everely limited range of motion; Left arm has been hurting; When the patient rotates left shoulder joint, it hurts to the point the patient can hardly reach the back of the head; The patient eceived an 0.7 ml, total dose (1x) of suspect influenza vaccine; This spontaneous initially received on 30-Apr-2024, was reported by a non health professional and concerns a 66-year-old elderly male patient.  Past medical history included COPD (chronic obstructive lung disease), Concussion which led to being on disability, Bronchitis, Bronchitis due to Covid.  At the time of the event the patient had Stomach cancer.  Concomitant medication: RSV vaccine and Spikevax (Elasomeran) vaccine, both for prophylactic vaccination.  The patient's historical vaccines included Fluzone High Dose Quadrivalent (influenza vaccine inact split 4v) received each flu season for several years, Pfizer BioNTech COVID-19 vaccine (tozinameran) received prior to 2023, Prevnar (pneumococcal vaccine conj 7v (CRM197) received on 29-Jan-2023, all for unreported indication, and influenza vaccine (brand not specified) received on 15-Sep-2022, for prophylactic vaccination.  Administration of company suspect drug(s): On 12-Sep-2023, the patient received Fluad Quadrivalent for Influenza immunization, Dose regimen: 0.7 ml (explicitly coded as 'incorrect dose administrered'), Lot number: UJ7681NA and Lot number: 370266 with expiry date 19-Apr-2024.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Left arm is also restricting him from taking a bath (Disability, outcome: Not recovered / Not resolved), When the patient rotates left shoulder joint, it hurts to the point the patient can hardly reach the back of the head / significant reduction of range to the injected arm / left shoulder joint had severely limited range of motion (Disability, outcome: Not recovered / Not resolved), Left arm has been hurting (Disability, outcome: Not recovered / Not resolved), When the patient rotates left shoulder joint, it hurts to the point the patient can hardly reach the back of the head (Disability, outcome: Not recovered / Not resolved).  On an unspecidied date, the patient had a computerised tomogram (CT) scan of that joint. However, no results were provided. A healthcare professional (HCP) prescribed meloxicam at one point, but the patient doesn't like to take pain medicine so he never took it.   Non-drug treatment/Other action taken:  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter considered the events Left arm has been hurting, Left arm is also restricting him from taking a bath, When the patient rotates left shoulder joint, it hurts to the point the patient can hardly reach the back of the head, When the patient rotates left shoulder joint, it hurts to the point the patient can hardly reach the back of the head / significant reduction of range to the injected arm / left shoulder joint had severely limited range of motion related to the administration of Fluad Quadrivalent. As reported, the shoulder symptoms may be due to the Fluad.  The case was considered as serious due to the seriousness criteria of disability.; Reporter's Comments: Causality: Considering the overall unclear chronology and the limited information provided, the causality is unassessable for the events loss of personal independence in daily activities, mobility decreased, pain in extremity and shoulder pain.