Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Chest discomfort, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse, subject) and described the occurrence of sore arm (injection site) in a 61-year-old female subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). The subject's medical history included gallbladder attack and gallbladder exeresis. Concurrent medications included Vitamin D, Calcium salt (Calcium) and Oestradiol (Estradiol patch). On 31 October 2013 the subject received 1st dose of FLULAVAL TETRA 2013-2014 (unknown details, left arm). The subject reported that she was required to receive the vaccination as part of her employment. She also reported that she "would have to use a face mask with her interactions with patients in the hospital." On 31 October 2013, within "a few hours" of vaccination with FLULAVAL TETRA 2013-2014, the subject experienced sore arm (injection site), injection site reaction (difficulty in moving arm). The subject reported that she could "barely life her arm." On 31 October 2013, within the same day as vaccination with FLULAVAL TETRA 2013-2014, the subject experienced chest tightness and headache. In 2013, within weeks of vaccination with FLULAVAL TETRA 2013-2014, the subject experienced runny nose, watering eyes and decreased in thinking of words to say. The subject reported that she had "some difficulty with saying words and speaking, due to her not being able to think about what she wants to say". At the time of reporting the events of sore arm (injection site), injection site reaction (difficulty in moving arm), and decreased in thinking of words to say were resolved on an unknown date. The reporter documented that the chest tightness had improved. The reporter stated that events of runny nose, watering eyes, and headache were not resolved at the time of reporting. The healthcare professional considered the events of sore arm (injection site), injection site reaction (difficulty in moving arm), and chest tightness were probably related to vaccination with FLULAVAL TETRA. The nurse did not document causality with the other events. Follow-up information was received on 09 December 2013 via healthcare professional (nurse), who is also the subject. The subject had not received FLULAVAL TETRA previously. The subject reported the events occurred on 31 October 2013 and are unresolved (different from initial report). The reporter did not consider the events to be serious. She did not attribute the events to medical history/concurrent illness, lack of efficacy or suspected transmission of infectious agent via medicinal product. Follow-up information received on 08 January 2014 via physician who reported the events started shortly after the subject received the flu shot and have since resolved. The physician did not attribute the events to medical history/concurrent illness. The physician reported the subject "came to see me one and half after the vaccine was given at her work. She doesn't want to receive flu shot again. Her symptoms had resolved by time she presented to me." At the time of the report no other information was provided.