Age: 88.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Difficulty with daily tasks and sleeping due to the arm pain; Pain extends down the injection site; Pain in the left arm/it was painful/extremely painful when lays down at night; Not sure if this is an allergic reaction; Difficulty with daily tasks and sleeping due to the arm pain; This spontaneous case received on 24-Nov-2020 from other non-health professional (consumer) via the agency (reference number: SEQW20-05395) and concerned an 88-year-old, female patient.  The patient's concurrent conditions included high blood pressure. The patient's past medical history included stroke many years ago. The patient's concomitant medications included atenolol, Diovan (valsartan), Zocor (simvastatin), Coumadin (warfarin sodium), Lasix (furosemide), potassium, Zyrtec (cetirizine hydrochloride), vitamin B (vitamin b complex), vitamin D3, Vitamin C (ascorbic acid), CO Q 10 (ubidecarenone), Procosa (calcium ascorbate, curcumin, glucosamine hydrochloride, magnesium sulfate, manganese gluconate, potassium sulfate), calcium, all used for unreported indication.  On 17-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; anatomical location: deltoid, left arm, dose: 0.5 ml, route of administration: intramuscular) as flu prophylaxis. The batch number was not reported.  On the same day, one hour after receiving Fluad Quadrivalent, the patient experienced severe pain in the left arm which was getting worse overtime. The pain extended down the injection site and the difficulty with daily tasks and sleeping due to the arm pain. The patient stated it was extremely painful when she laid down at night and she was not sure if this was an allergic reaction. The patient had not seen a doctor but called the nurse's hotline.   On an unspecified date in 2020, the patient started treatment with Tylenol (paracetamol), ice and heat. The patient stated that the pain reduced with medication but returned and was getting worse overtime.  At the time of initial reporting on 24-Nov-2020, the patient had not recovered from the events.  The reporter did not provide causality assessment.  The event of 'loss of personal independence in daily activities' was considered to be medically significant by a Physician within Agency's Management Department.  Company comment: A 88-year-old patient was administered Fluad Quadrivalent. On the same day, one hour after receiving Fluad Quadrivalent, the patient experienced pain in extremity and pain extended down the injection site. The patient had difficulty with daily tasks and sleeping due to the arm pain. Sleep disorder and Loss of personal independence in daily activities are assessed as not related since was associated with pain. The patient was not sure if this was an allergic reaction. Due to lack of information, causality is unassessable for hypersensitivity. With information available, causality is assessed as possibly related for pain in extremity and radiating pain.; Sender's Comments: A 88-year-old patient was administered Fluad Quadrivalent. On the same day, one hour after receiving Fluad Quadrivalent, the patient experienced pain in extremity and pain extended down the injection site. The patient had difficulty with daily tasks and sleeping due to the arm pain. Sleep disorder and Loss of personal independence in daily activities are assessed as not related since was associated with pain. The patient was not sure if this was an allergic reaction. Due to lack of information, causality is unassessable for hypersensitivity. With information available, causality is assessed as possibly related for pain in extremity and radiating pain.