Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Discomfort, Injection site joint movement impairment, Myositis, Pain
Clinical narrative: Based on the additional information received on 02 June 2015, this case became medically confirmed and the case 2014SA163318 was found to be a duplicate case of 2014SA163795. The 2014SA163318 was retained as reference case and all the information pertaining to case 2014SA163795 was move to case 2014SA163318. The case 2014SA163795 was deleted. Initial unsolicited report received from a non-healthcare professional on 24 November 2014. A 65-year-old female patient, whose medical history was reported as no known allergies and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE HD, (batch number: U5044BA, expiry date: 25 May 2015) and number of dose was not reported, in her left deltoid on 17-Oct-2014. On 18-Oct-2014, patient experienced pain in her arm. Illness at the time of vaccination was reported as unknown. Corrective treatment was reported as MOTRIN. Laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender: none. Follow-up information received from a non-healthcare professional on 18 February 2015. There was no other vaccination 4 weeks prior to the vaccination date and no illness at the time of vaccination. There was no pre-existing physician diagnosed allergies, birth defects, medical conditions. It was reported that normal physical examination was performed. On 14 November 2014, the patient experienced "felt to be myositis". It was reported that discomfort was much improved on an unspecified date. There was pain in the arm with movement on an unspecified date. Corrective treatment included "Heat/Rest". At the time of this report, the discomfort was much improved. The patient was recovering from the above mentioned events. Follow up information received from a non-healthcare professional on 24 April 2015. The patient details and reporters details were updated. It was reported that the patient had received 0.5 ml dose. It was also reported that the patient had recovered on an unspecified date. Follow-up information received from a healthcare professional on 02 June 2015. It was reported that patient was finding difficulty in lifting her left shoulder, myositis and had pain on 18 October 2014. Illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were reported as simvastatin and CELEXA. Patient required an ER visit. Lab investigations were reported as none. Patient was given MEDROL dose pack as a corrective treatment. At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 12 June 2015. The patient had myositis in her left shoulder. It bother her with any type of lifting and carrying. It was reported that patient had pain and discomfort now 10 to 11 months after her vaccination. Physical examination: Patient does have full range of motion and some weakness to rotator cuff activities. There is no motor or sensory deficit. She has got localized tenderness over the posterior triceps region. She has full range of motion of her elbow, wrist and hand with no evidence of instability or giving away. The patient was suggested to have an electromyography. Documents held by sender: none. Follow up information received from a physician on 14 September 2015. It was reported that, all the symptoms of patient had resolved about the first week of August and the patient was fine since that time.