Age: 70.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: My arm felt weak/My arm was still weak; I had very little range of motions; My arm continued to hurt/pain; This spontaneous case was retrieved on 25-Jul-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2654772-1), reported by other non-healthcare professional (consumer), and concerned a 70-year-old, female patient.  The patient's concurrent conditions included atrial fibrillation, allergy to carvedilol, hydralazine, Aspirin (acetylsalicylic acid), Levaquin (levofloxacin), bandages and stickers. The patient's concomitant medications included losartan, Xarelto (rivaroxaban), hydrochlorothiazide, atorvastatin, Cephalexin (cefalexin) and doxazosin, all used for an unreported indication. The patient's historical vaccine included unspecified vaccine, received on an unspecified date in Oct-2012, when the patient was 60-year-old, after which the patient experienced unspecified adverse event.  On 31-Oct-2022, the patient was vaccinated with influenza vaccine (brand not specified; route of administration: injection (reported as 'SYR'); anatomical location: left arm; dose, and indication: not reported). The batch number reported was AJ3JX (batch number unable to be matched). The suspect product reported on VAERS form was Afluria Quadrivalent (influenza vaccine inact split 4v), however, the patient was unsure of what type of Influenza vaccine was given. Therefore, the suspect product was coded to an unspecified influenza vaccine.  On 02-Nov-2022, two days after receiving influenza vaccine, the patient's arm continued to hurt, and felt weak.  On an unspecified date, reported as after several weeks, the patient attended exercise class, which worked every muscle in the body, included zumba, bands, balls, and weights, hoping this would serve as rehab for arm. It didn't work. The patient's arm was still weak, the patient had very little range of motions and severe pain.  On an unspecified date in 2023, reported as six months after the injection, the patient went to the doctor, who referred the patient to Physical Therapy (PT). The pain was a bit less, but not gone. The patient's range of motion had improved 6 to 7% after six sessions of PT. The patient still had four more sessions, but the patient was very concerned that arm was not even close to back to normal.  At the time of initial reporting, the patient had not recovered from the event 'Weakness of arms' and was recovering from 'Joint range of motion decreased' and 'Pain in arm' .  The reporter did not provide a causality assessment.   This case was assessed as non-serious.  Company comment: A 70-year-old, female patient was vaccinated with influenza vaccine. Two days after vaccination, the patient experienced arm pain and felt weak. After several weeks, the patient attended exercise class, the patient's arm was still weak, and the patient had very little range of motions and severe pain. Following physical therapy, the pain was a bit less and the patient's range of motion had improved 6 to 7%. Information regarding relevant diagnostic findings was not reported. Nevertheless, causal role of the suspect vaccine is assessed as possibly related for the events pain in extremity, muscular weakness and joint range of motion decreased, with the currently available information and plausible temporal relationship.; Sender's Comments: A 70-year-old, female patient was vaccinated with influenza vaccine. Two days after vaccination, the patient experienced arm pain and felt weak. After several weeks, the patient attended exercise class, the patient's arm was still weak, and the patient had very little range of motions and severe pain. Following physical therapy, the pain was a bit less and the patient's range of motion had improved 6 to 7%. Information regarding relevant diagnostic findings was not reported. Nevertheless, causal role of the suspect vaccine is assessed as possibly related for the events pain in extremity, muscular weakness and joint range of motion decreased, with the currently available information and plausible temporal relationship.