Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Sensory disturbance, Vaccination site haematoma
Clinical narrative: Case number PHHY2015US061062, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 561802) website on 12 May 2015. This report refers to a 44 year old male patient. His medical history was not reported. Concomitant medication included Synthroid at a dose of 137 mcg per day. He was vaccinated with FLUVIRIN (batch number: 1412201) into left arm on 07 Oct 2014. On the same day after vaccination, he felt numbness in lower left leg, left arm and occasionally in lower left back. He had trouble sleeping and concentrating. The numbness moved around and he felt quite hot in general. He was having more frequent bowel movements. His eyes were occasionally twitching uncontrollably and he was irritable. Over the next couple of days, he began to feel disoriented, weak and tired. This was often accompanied throughout the day with sensations of numbness or a flush on his left side. Some days, he felt like he did not have any symptoms and felt very relieved. But he next day symptoms came back again. He also felt cotton mouthed sometimes. On 16 Oct 2014, the patient went to a physician and explained his symptoms. The physician ordered thyroid stimulating hormone and free T4 tests which showed normal values. On 25 Oct 2014, he went for a walk and he felt as if his left side was very heavy (a burden to move). At times, he felt disoriented (very mildly) while hiking. Despite this he played Frisbee and felt fine. He was very active and sleeping very well. On 25 Oct 2014 and 26 Oct 2014, he took only half dose of Synthroid (concomitant medication). Afterwards, he resumed the previous dose of 137 mcg per day, but he had planned to move back to half dose. On 30 Oct 2014, 3 weeks after vaccination, he noticed a deep bruise (yellow and blue) and hematoma at vaccination site. The hematoma was quite large although it never caused any pain or discomfort. After a little improvement, he again felt numbness in left leg after quite a bit of walking. On 03 Nov 2014, symptoms were slowly clearing up. He had a sort of inability to control the left side of face (as if it was flaccid) and also felt a bit numb. However, the affected area kept getting smaller. From 09 Nov 2014 to 11 Nov 2014, he felt generally fine except spells of head throbbing which distracted his concentration from everything. It was coming and going. He also experienced weakness in his muscles. He was swimming and felt that his legs were cramping up and felt reduced strength. The following month was a series of good and bad. He had head pressure coming and going accompanied with facial numbness. On 12 Dec 2014, he headed out of the country on a trip and during the first few days he felt a bit off with combination of symptoms. However, the symptoms soon dissipated and he felt very good. Upon returning, the heaviness and partial numbness in the left appeared to return, although he did not feel numbness in his skull or face. Final outcome of the events was complete recovery. The events were reported as non-serious. The consumer believed that the causality of the events might have been associated with FLUVIRIN administration.