Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 48 year old female patient who had a medical history of latex allergy, pre-diabetes, hyperlipidaemia, GERD (Gastroesophageal Reflux Disease), exercise-induced asthma and right shoulder pain. As of the 07-Oct-2014, the patient saw the PCP (Primary Care Physician) in regards to a ten month history of right shoulder pain with radiculopathy. An MRI (Magnetic Resonance Imaging) of the cervical spine done on the 13-Jan-2014 showed multilevel degenerative disc disease which was worse at C5/C6 with mild to moderate bilateral neural foraminal narrowing. The right shoulder pain was treated with gabapentin tid (three times daily), a neck pillow and PT (Physical Therapy). Concomitant medications included metformin, gabapentin, esomeprazole, ranitidine, baclofen, atorvastatin, montelukast, loratadine, mometasone, albuterol and fluticasone/salmeterol. The patient had no acute illness and was in a normal state of health at the time of vaccination. The patient was left-hand dominant. On the 02-Oct-2014 in the morning, the patient received AFLURIA injection (batch number T59406) via the intramuscular route in the left upper arm. Both the patient and the vaccinator were standing. On the 02-Oct-2014, the patient immediately noted that something felt different in that the vaccination site hurt more than usual. She noted a stinging/burning pain (6 out of 10) in her left upper arm while waiting in the clinic during the 15 minute period observation. The patient took 800mg ibuprofen later in the day without improvement. Over the next 72 hours, the patient noted intermittent soreness (6 out of 10) of her left upper and left shoulder [sic]. This pain increased with writing, driving and was worse in the arm and at night while sleeping with some improvement during the course of the day. The patient denied having numbness, tingling of the shoulder/arm/hands/fingers, decreased ROM (range of motion) or weakness of her left upper extremity. On the 07-Oct-2014, the patient was seen by her PCP for her over ten month history of right shoulder pain with radiculopathy. At this time, the patient continued to have intermittent pain in her left upper arm/shoulder which was worse when writing, driving and sleeping but she did not mention this at the appointment. On the 12-Nov-2014, the patient was seen by her PCM (Primary Care Manager) for complaints of left shoulder and left upper arm pain, decreased strength and decreased ROM. The patient stated that she had pain and difficulty with lifting her arm above her head, washing her hair and internal rotation such as hooking her bra. The patient denied a history of trauma to her left shoulder or neck. Labs were drawn for CRP (C-Reactive Protein), CK (Creatine Kinase) which were both normal, and ESR (Erythrocyte Sedimentation Rate) which was slightly elevated at 28. The patient was prescribed lidocaine patches which did improve the pain. Physical Therapy (PT) was ordered at the appointment but was not started until the 09-Jan-2015. Prior to the first PT appointment, the patient had noted improvement in her ROM and she was able to reach above her head. At the time of her appointment, the patient reported much improvement (pain was zero-one out of ten) and she could drive and wash/comb her hair without left arm/shoulder pain. She was experiencing minimal discomfort with writing and she was able to hook/unhook her bra with some discomfort. On the 12-Nov-2014, laboratory tests were completed. CRP was 8.1 mg/L, CK was 79 U/L, ESR was 28 (U) mm/hr and a procedure of MRI of the C spine without contrast was completed. On the 13-Jan-2014, an unenhanced MRI of the cervical spine found that the vertebral bodies of the cervical spine had normal height and alignment. There was no evidence of a fracture and intervertebral disks had normal spacing. There was no abnormal signal within the spinal cord. The visualized portion of the base of the brain was unremarkable as were the paravertebral soft tissues of the neck and lung apices. C2/C3 intervertebral disk was normal. There was no spinal canal stenosis or neural foraminal narrowing. C3/C4 had a minimal disk/spu [sic]. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported that the patient went to the Emergency Room. The regulator reported the terms of 'asthenia', 'blood creatine phosphokinase normal', 'C-reactive protein normal', 'Immediate post-injection reaction', 'nuclear magnetic resonance imaging spinal abnormal'.