Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Based on additional information received on 06 April 2016, this case became medically confirmed. Initial unsolicited report received from a non-healthcare professional on 23-Oct-2015. This case involves an 87-year-old female patient who was vaccinated with an intramuscular dose FLUZONE HD (batch number: UI478AA, expiry date: 09-May-2016, site of administration was not reported) in left side on 07-Oct-2015. It was reported that patient had no illness at time of vaccination. Patients pre-existing medical conditions included aortic stenosis, hypertension, lung nodule, hyperlipidemia and glaucoma. Patient had no history of prior shoulder pain. It was reported that patient had no vaccination within 4 weeks. Other concomitant medications were not reported. On 07-Oct-2015, immediately after vaccination, the patient experienced that arm was painful and swollen but did not mention any erythema. It was reported that the patient experienced range of motion limited, pain with lateral raise and the patient could not lay on arm. It was reported that patient required an ER visit on 22-Oct-2015. Laboratory investigations include shoulder x-ray that showed arthritic changes and degenerative changes at rotator cuff. Left deltoid had normal appearance on examination. Corrective treatments were not reported. The outcome of all the events was reported as unknown. Documents held by sender: none. Follow-up information received from physician on 06 April 2016. The patient had received 0.5 ml dose of FLUZONE HD vaccine (expiry date- 07 October 2016) in the left deltoid. Patient had medical history included aphakic open angle glaucoma in right eye, bilateral pedophilia, blepharitis of both eyes, capsular glaucoma of left eye with pseudoexfoliation of lens, chalazion, coronary artery diseases, and dry eye syndrome of both lacrimal glands, dry eye syndrome (bilateral), herpes zoster, hypertension, shortness of breath. Patient had surgical history included hysterectomy, knee replacement and lower back surgery (laminectomy). Patient had family history included diabetes mellitus. Social history included never a smoker and never drank alcohol. The patient had penicillin allergy. Concomitant medications included Aspirin (81mg oral tablet) (daily) from 18 December 2014, hydrochlorothiazide 25 mg oral tablet (daily) from 18 December 2014, Metoprolol succinate ER 50 mg oral tablet extended release 24 hour (daily) from 10 June 2015, pravastatin sodium 40mg oral tablet from 12 August 2013 and timolol maleate 0.5 % ophthalmic solution (one drop into right eye at bedtime) from 22 November 2013. It was reported that, after vaccination (since having flu shot 2 weeks ago), the patient had experienced pain in left deltoid. On an unspecified date, immediately after vaccination, the arm became swollen and painful to move her arm. Pain was radiating down to hand and painful to lie on her arm. The patient bothered her stomach. The patient's concurrent conditions included aortic stenosis, benign essential hypertension, edema, essential familial hypercholesterolemia, hyperactivity of bladder, lung nodule, microscopic hematuria, need of prophylactic vaccination and inoculation against influenza, open angle glaucoma in the right eye, pulmonary nodule/lesions, rib pain. The patient had no acute distress, well appearing and well nourished. Laboratory data included: heart rate: systolic-82, diastolic-122. BMI: 32.01 and 1.81. Grip strength- 5/5 R, biceps: 5/5R, 4/5 L. heart rate: systolic-64, diastolic-122. X-ray of shoulder, chest two view on 19 AUGUST 2013, 09 January 2015 and chest CT scan on 13 January 2015. Corrective treatment included TYLENOL, CELEBREX (200 Mg, orally, daily) and DEPO-MEDROL- 80 mg (intramuscularly) for pain in arm. The patient was recovering from event shoulder pain.