Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered at inappropriate site
Clinical narrative: Pain in shoulder; The vaccine was given in the bursa from the patient's description of the pain; She was experiencing pain in activities of daily living (ADL); She was experiencing pain in activities of daily living (ADL); This spontaneous case was retrieved on 11-Jan-2021 from Vaccine Adverse Event Reporting System (VAERS), reported by other health professional and concerned a 66-year-old, female patient.  The patient's medical and concomitant medications were not reported.  On 29-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location: left arm, route of administration: intramuscular, dose: one as reported and indication: not reported). The batch number reported was 282539.  On 30-Oct-2020, one day after receiving Fluad Quadrivalent, the patient experienced severe pain in her shoulder.   On an unspecified date in Nov-2020, after a few days as reported, the patient visited her doctor who indicated that vaccine was given in the bursa (explicitly coded as 'Product administered at inappropriate site') from her description of the pain. The patient was treated with unspecified oral steroids which did not help to alleviate the pain.   On an unspecified date in 2020, over the time as reported, the pain was subsiding, however, the patient was still experiencing pain in activities of daily living (ADL). The patient was consulting with a kinesiologist to aid in movement therapy.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The event of 'activities of daily living impaired' was considered to be medical significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Additional information received on 22-Jan-2021 via Product Technical Complaint (PTC) group: After batch number mapping, suspect product was re-coded from Fluad (TIV) to Fluad Quadrivalent. The narrative was amended accordingly.  Company comment: The patient developed all events after receiving Fluad Quadrivalent. Chronology is plausible. Reportedly, the vaccine was given in the bursa from the patient's description of the pain. The patient's medical and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes). Vaccine administered at inappropriate site is assessed as not related based on company's conventions.; Sender's Comments: The patient developed all events after receiving Fluad Quadrivalent. Chronology is plausible. Reportedly, the vaccine was given in the bursa from the patient's description of the pain. The patient's medical and concomitant medications were not reported. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes). Vaccine administered at inappropriate site is assessed as not related based on company's conventions.