Sex: F
Vaccine: FLUN4
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Sputum discoloured, Vomiting, Weight decreased
Clinical narrative: FLU; POSSIBLY BEEN A REACTION TO THE PRESERVATIVES IN FLUMIST; COULD HARDLY STAND UP; TIGHTNESS ACROSS HER CHEST; COUGHING /CONGESTION WITH PHLEGM; FEVER; VOMITING; LOST WEIGHT; NAUSEA; SICK; NOSE BLEEDS; COVID-19; A spontaneous report has been received from a consumer. The report concerns a female patient (age 59 years, height 67 in, weight 120 lb).    The patients past and current medical history included hysterectomy (dates not reported). No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number Unknown) 0.2 ml once/single administration, via nasal route, for prevention of influenza on an unknown date, probably 5 years ago. She reported that she was sick in bed for 10 days after getting the dose, she thought that she was going to die, it was horrible and she was sicker than she was when she previously had the Flu (preferred term: Influenza).      She reported that she had Flu and chronic nose bleeds(preferred term: Epistaxis). She stated that within an hour of receiving the dose her nose started bleeding from her left nostril and she stuck a Kleenex in it and the bleeding stopped. She also stated that she thought blood was running down her throat because she started to feel nauseated (preferred term: Nausea) and was nauseated for the 10 days after she took the dose.  Two hours after the bleeding stopped in her left nostril she started to bleed from the right nostril.     She later had chronic bleeding from both nostrils and it was during this time that it was so hard to manage. The nose kept bleeding and on day 5 after getting the dose the bleeding was at the worst and the bleeding slowed down after day 7 when she started to feel better. Her HCP is aware and told her that it could have possibly been a reaction to the preservatives in Flumist (preferred term: Reaction to preservatives). The nose bleed and the nausea stopped about the same time, exact date is unknown.     She stated that she could hardly stand up (preferred term: Gait inability). She also stated that she had tightness across her chest (preferred term: Chest discomfort), started coughing and had congestion with phlegm (preferred term: Cough) and she was spitting up green stuff, start date was day 2 after taking the dose and by day 4 or 5 it was worst.     She had a hard time sitting up but it was the only way that she could breath but when she sat up her nose bleed would start. She also stated that in the past she has had fever (preferred term: Pyrexia) of 105 degrees Fahrenheit and after she got the dose she had a fever of 104 degrees Fahrenheit for 2 days . HCP told her to take Ibuprofen for the fever. The fever came back down to 102 degrees Fahrenheit.      She also stated that she was really sick (preferred term: Malaise) for 3 days after she took the dose  and she gradually got better. She also stated that she was actively vomiting (preferred term: Vomiting) for 4 days. She started throwing up on day 2 after taking the dose and she lost 12 pounds (preferred term: Weight decreased) in those 10 days after taking the dose. She also stated that she had Covid 19 (preferred term: covid-19), start date was 09-Mar-2020. She did not get tested because there was no test available at that time. She stated that she only felt bad with Covid 19 for 5 days and she recovered.      She recovered from the nose bleeds, covid-19, flu, possibly been a reaction to the preservatives in flumist, could hardly stand up, tightness across her chest, coughing /congestion with phlegm, fever, vomiting, lost weight, nausea and sick on an unknown date. Exact start dates for the events are unknown.     Company physician suggested not to capture event hard time sitting up.    Company physician suggested to club events coughing and congestion with phlegm.    The company physician assessed following events to be serious due to important medical event: nose bleeds. The reporter assessed following events to be non-serious: covid-19, flu, possibly been a reaction to the preservatives in flumist, could hardly stand up, tightness across her chest, fever, vomiting, lost weight, nausea and sick. The company physician assessed following events to be non-serious: coughing /congestion with phlegm.    Device Information:     Product As Reported: FLUMIST QUADRIVALENT  Product Role: Suspect  Operator of device: Health Professional