Age: 19.0
Sex: F
Vaccine: FLUN3
Symptoms: Anxiety, Dizziness, Dyspnoea, Feeling abnormal, Hypersomnia
Clinical narrative: A spontaneous report has been received from a consumer concerning a 19 years old, female patient (height: between 5 feet 5 inches and 5 feet 7 inches). The patient had concomitant diseases of high blood pressure on the day of vaccine administration, cerebral palsy, attention deficit/hyperactivity disorder and occasional pain while walking, she had relevant history of flu every year, she could not sleep a day before the vaccine administration and she had headaches, fever and diarrhea from other flu vaccines previously. Her concomitant medications included alprazolam. Past drug therapy included other unspecified influenza vaccines. On an unknown date, in 2010, the patient was strapped down to a table and was forced to receive nasal FLUMIST (intranasal), unknown dose, administered once as a single dose for flu prevention. On an unknown date, in 2010, after getting FLUMIST she slept for approximately 19 hours and woke up with a fever. On unknown dates, in 2010 she had anxiety and had full blown anxiety attacks, she could not breathe, could not see and practically went blind, her heart was racing, she got dizzy and nauseous in the car, sometimes she felt fine in the house but then went out and was not fine, she felt like she was going to full on die and went numb. In 2011, she passed out twice. By the time of the report, according to the patient anxiety has pretty much became permanent, and other unspecified things and she could not leave the house. The patient recovered from the event of after getting FLUMIST slept for approximately 19 hours and woke up with a fever on an unspecified date and at the time of reporting, the events of could not see/practically went blind, full blown anxiety attacks/anxiety, heart racing, nauseous in the car, feel like I am going to full on die and numb, got dizzy and feel fine in house and then go out and I am not fine were ongoing. The outcome of the event of could not breathe and passed out twice was unknown. The company physician considered the events of after getting FLUMIST slept for approximately 19 hours and woke up with a fever, could not breathe, heart racing, passed out twice, feel like I am going to full on die and numb and feel fine in house and then go out and I am not fine to be non-serious. Instead of the reported term of could not see and practically went blind, could not see/practically went blind has been captured according to company physician with important medical event criterion. Instead of the reported term of full blown anxiety attacks and anxiety, full blown anxiety attacks/anxiety has been captured according to company physician as non-serious event. Instead of the reported term of got dizzy and nauseous in the car, the event of got dizzy and the event of nauseous in the car have been captured according to company physician as non-serious events. The company physician suggested not to capture the event of homebound. Summary of insignificant follow-up information received by AstraZeneca/MedImmune on 19-Sep-2018 from consumer: patient medical history updated, concomitant disease and relevant history added, lab data added. Narrative and PSUR updated. Sender's Comments: Blindness is not listed in company core data sheet of FLUMIST. Due to limited information on patient's relevant medical history, concurrent diseases, concomitant medication, circumstances leading to blindness, detailed diagnostic and etiologic workup (Ophthalmological workup), it is not possible to make a conclusive assessment of the causal relationship of the event with FLUMIST.