Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Malaise, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 46-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4XH59, expiry date 2nd June 2018). Previously administered products included Flu vaccine with an associated reaction of no adverse event (unknown if they were FLUARIX). Concurrent medical conditions included blood pressure, Crohn's disease and headache. Concomitant products included HUMIRA and Iron Pill. On 2nd October 2017, the patient received FLUARIX QUADRIVALENT. On 2nd October 2017, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm. On 5th October 2017, the patient experienced numbness. In October 2017, the patient experienced feeling unwell, burning sensation, vomiting, driving ability disturbed, sweating and decreased activity. In October 2017, the outcome of the vomiting and sweating were recovered/resolved. On an unknown date, the outcome of the pain in arm, feeling unwell, burning sensation, driving ability disturbed and numbness were not recovered/not resolved and the outcome of the decreased activity was unknown. The reporter considered the pain in arm, burning sensation and numbness to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the feeling unwell, vomiting, sweating and decreased activity to be related to FLUARIX QUADRIVALENT. The reporter considered the driving ability disturbed to be possibly related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient's concomitant medication included antidepressant, birth control and blood pressure medications. The patient stated that the pharmacist placed a band aid looking circle on her arm area, she noted it looked like mesh material and then gave her the shot through the mesh. She noted that she had never seen this before. The patient received FLUARIX QUADRIVALENT in her upper left arm. The reporter did not know the dose she was given. The patient stated the pain, which was at the injection site, began the same day after the vaccination and as the days went on the pain had spread in the arm and gotten progressively worse. The numbness began on the 3rd day. She also experienced massive burning, numbness feeling, massive massive pain in the arm that received the injection. The patient had an appointment with her Neurologist on the Friday after the vaccine date, she had been seeing him for headaches. She mentioned the pain to him and noted he has done Computerised tomogram scan, and Nuclear magnetic resonance imaging that were all negative. She also noted having a Lyme disease test that was also negative. She has a follow up appointment with him in 4 weeks. The patient also saw her primary care physician for the events and had a follow up appointment with her next week. The patient also went to the emergency department yesterday because the pain was so excruciating, she noted it was now keeping her out of work, finding it difficult to drive and do daily activities. The emergency room physician placed her on pain medication and in an arm sling. The patient stated today she broke out in a sweat, threw up and did not feel good at all. She noted things were getting worse. She stated the emergency room doctor told her these events were all a reaction to the flu vaccine.