Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Mobility decreased, Muscular weakness, Musculoskeletal stiffness, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: A rheumatologist confirmed that the patient have Polymyalgia; This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 833534-1) and initially retrieved on 24-Oct-2019, concerning a 65-year-old, female patient.  The patient's medical history included high blood pressure and depression.  The patient's concomitant medications included lithium carbonate for depression, eszopiclone and olmesartan medoxomil all for unknown indications.  On 15-Jan-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, anatomical location: left arm, dose, route of administration, batch number and expiry date: not reported] for an unknown indication.  On 16-Jan-2019, one day after vaccine administration, the patient's left arm (injected arm) started to hurt a great deal all the time for 2 weeks, with stiffness beginning in her both arms.  On 25-Jan-2019, the patient woke up and was not able to lift herself up from bed and crawled to a chest of drawers to pull herself up using the knobs. The patient's hips and legs became stiff and painful.  By 31-Jan-2019 and shortly before that date, the patient had trouble walking and could only take small steps.   On 13-May-2019, the patient started treatment with prednisone at dose of 10 mg.  On unknown dates, the patient's condition improved. The patient was finally able to walk and move well. The patient performed magnetic resonance imaging (MRI), blood tests and nerve tests but the results were not provided.  On 29-Jul-2019, a rheumatologist confirmed polymyalgia.  On unknown dates, the treatment with prednisone was continued at a decreased dose of 7 mg every day, despite the patient still had symptoms, but she could get out of bed easier and walk outside a few times a week when the pain was not severe.  On 13-Sep-2019, the patient still felt a lot of pain in her arms and legs and the pain was appearing and disappearing.  The outcome of the event polymyalgia was not recovered, at the time of this report.  This case was assessed as serious and the patient did not provide causality assessment.  Company comment: The patient experienced polymyalgia rheumatica associated with Fluad (TIV). Chronology seems plausible. Concomitant drugs, here reported, may have an influence in developing reported event. More information regarding start date of concomitant drugs is needed in order to establish a propper causal relationship. Considering immunological characteristics of reported event, casuality is assessed as possibly related.; Sender's Comments: The patient experienced polymyalgia rheumatica associated with Fluad (TIV). Chronology seems plausible. Concomitant drugs, here reported, may have an influence in developing reported event. More information regarding start date of concomitant drugs is needed in order to establish a propper causal relationship. Considering immunological characteristics of reported event, casuality is assessed as possibly related.