Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injection site pain, Joint noise, Joint stiffness, Loss of personal independence in daily activities
Clinical narrative: Unable to move her arms from the elbow up but this was worse in the left arm/Felt paralyzed from the elbows up to the shoulders/still having problems with pulling up her pants; Shoulders went tight; Lymph nodes were swollen/swelling in her armpit, groin and base of neck; Chills; Rash in her arm pits; Some pain at the injection site; Hear a clicking sound in her shoulder joints and feels some relief afterward; This spontaneous case was received on 09-Feb-2021 reported by other non-health care professional (consumer) to Med Communications (reference number: SEQW21-00442) and concerned a 72-year-old, female patient.  The patient's concurrent conditions included thyroid issues and blood pressure problems. The patient's concomitant medications included unspecified thyroid medication and blood pressure medication.  On 23-Nov-2020, the patient was vaccinated with Seqirus influenza virus vaccine polyvalent (brand not specified; anatomical location: left arm, dose, route of administration: not reported) as influenza prophylaxis. The batch number was not reported.  On an unspecified date in 2020, about a week to ten days after receiving influenza virus vaccine polyvalent, the patient said her shoulders went tight and she had the chills, lymph nodes were swollen and she experienced some pain at the injection site. The patient also experienced swelling in her arm pits, groin and base of neck. The patient had rash in her arm pits and was unable to move her arms from the elbow up, but this was worse in the left arm. The patient felt paralyzed from the elbows up to the shoulders and could hear a clicking sound in her shoulder joints and felt some relief afterward. The patient visited her physician twice and was given prednisone and celebrex and instructed on exercises to help with shoulders.   At the time of initial reporting on 09-Feb-2021, the patient had not recovered from the event of 'vaccination site pain' since she still had problems with some pain. Also, the patient was recovering from all other events since it was reported that the medications helped and the she was better, but still had problems with pulling up her pants.  The reporter assessed the events as related to influenza virus vaccine polyvalent. The reporter stated that the patient received her first flu vaccine ever on 23-Nov-2020 and has had reactions to it.  Company comment:The patient developed mobility decreased, joint stiffness, lymphadenopathy, chills, rash, vaccination site pain and joint noise after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology seems plausible. No alternative etiology was provided. Causality for joint noise is assessed as not related as the event likely developed due to other experienced events (mobility decreased and joint stiffness). Considering all above mentioned, causal relationship for all other events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: The reporter stated the patient received her first flu vaccine ever on 23-Nov-2020 and has had reactions to it.; Sender's Comments: The patient developed mobility decreased, joint stiffness, lymphadenopathy, chills, rash, vaccination site pain and joint noise after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology seems plausible. No alternative etiology was provided. Causality for joint noise is assessed as not related as the event likely developed due to other experienced events (mobility decreased and joint stiffness). Considering all above mentioned, causal relationship for all other events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes).