chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to pregnant woman was received from a health professional concerning an adult female. Neither relevant medical history nor obstetrical history have been reported for this patient. No concomitant medications have been reported for this patient. On 02-Nov-2011, the patient received FLUMIST as she was unaware of the pregnancy. There was not adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable and the event is considered resolved. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Sex: F
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: A non-serious spontaneous report of severely ill has been received from a health professional concerning an adult female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications were reported. The patient received FLUMIST in 2010. After receiving FLUMIST, the patient became severely ill for five days in 2010. The patient was not hospitalized for the event. The outcome of the event was recovered.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST given to two children with asthma was received from a health professional concerning a nine-year-old male. The patient's medical history included asthma. No concomitant medications have been reported for this patient. On 12-Oct-2011, the patient with asthma received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST given to two children with asthma was received from a health professional concerning a 11-year-old female. The patient's medical history included asthma. No concomitant medications have been reported for this patient. On 12-Oct-2011, the patient with asthma received FLUMIST. There was on adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 75.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to a 75-year-old was received from a health professional concerning a 75-year-old female. Neither relevant past medical history nor concomitant medications were reported for this patient. The patient was given FLUMIST on 26-Sep-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 28-Oct-2011 in which reporter stated that the patient did not experience any adverse events.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: A non-serious spontaneous report of gave FLUMIST to a child with a history of asthma was received from a health professional concerning a five-year-old female. The patient's medical history included asthma. No concomitant medications have been reported for this patient. On 13-Oct-2011, the patient with history of asthma received FLUMIST. No reactions were observed from the patient following the administration of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST went into eye was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient . On 18-Oct-2011, while administering FLUMIST in the second nostril the patient jerked his head and some went into the eye. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST on face and possibly in eyes was received from a pharmacist concerning a 25-month-old female. Neither relevant medical history nor concomitant medications were reported for this patient. On 14-Oct-2011, the patient turned her head when FLUMIST was administered and some of the spray/mist got on the patient's face and may have reached the patient's eyes. The patient's eyes were flushed. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 51.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST given to person older than 49 years of age was received from a health professional concerning a 51-year-old female. On 14-Oct-2011, FLUMIST was administered to the patient who was older than 49 years of age. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Back pain, Chest pain, Immediate post-injection reaction, Pleurisy, Similar reaction on previous exposure to drug
Clinical narrative: A non-serious spontaneous report of pleurisy manifested with pain across chest and pain across back has been received from a health professional concerning an adult female, subsequent to FLUMIST. The patient's past medical history included pain across chest and pain across back two years ago in 2009 following flu injection. No concomitant medications have been reported for this patient. The patient received FLUMIST on 18-Oct-2011. On 18-Oct-2011, the patient experienced pain going straight across her back and chest immediately after FLUMIST administration. Patient stated that it felt like pleurisy. The reported stated that the reaction was not like a typical allergic reaction that she had seen in the past. No medications were given. Only monitoring the patient. The outcome of the event pleurisy was not recovered.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to pregnant female was received from a health professional concerning a 27-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Sep-2011, a pregnant female received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 0.67
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: A non-serious spontaneous report of inadvertent administration to an eight month old was received from a health professional concerning an eight-month-old female. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient inadvertently received FLUMIST on 13-Oct-2011. There was no adverse event associated with this medication error; therefore, treatment and sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently gave FLUMIST to a pregnant female was received from a health professional concerning an 18-year-old female. Neither relevant past medical history, concomitant medications nor obstetrical history were reported for this patient. The patient was inadvertently given FLUMIST on 25-Oct-2011. There was no adverse event associated with this pregnancy and the event was considered to be resolved. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Dizziness, Dyspnoea, Hypoaesthesia, Influenza
Clinical narrative: A non-serious spontaneous report of pneumonia manifested by fever, achy, shaking and shortness of breath, finger tips and toes were numb and dizzy has been received from a consumer concerning a 14-year-old male, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 26-Sep-2011, the patient received FLUMIST. Within four hours of receiving FLUMIST on 26-Sep-2011, the patient had full blown flu symptoms. The patient was taken to the hospital but not admitted. He had a fever of 104 degrees F and was diagnosed with pneumonia. The patient was given amoxicillin. The fever broke by the time he reached the hospital. The patient consistently had a high fever for ten days before going to the emergency room. The patient was taken to the hospital when the fever rose to 104 degrees F. The strep test was negative. The patient missed three weeks of his school. The outcome for the events of pneumonia manifested by fever, shaking and shortness of breath, finger tips and toes were numb and dizzy was unknown.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Pain, Pneumonia, Pyrexia, Streptococcus test negative, Tremor
Clinical narrative: A non-serious spontaneous report of pneumonia manifested by fever, achy, shaking and shortness of breath, finger tips and toes were numb and dizzy has been received from a consumer concerning a 14-year-old male, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 26-Sep-2011, the patient received FLUMIST. Within four hours of receiving FLUMIST on 26-Sep-2011, the patient had full blown flu symptoms. The patient was taken to the hospital but not admitted. He had a fever of 104 degrees F and was diagnosed with pneumonia. The patient was given amoxicillin. The fever broke by the time he reached the hospital. The patient consistently had a high fever for ten days before going to the emergency room. The patient was taken to the hospital when the fever rose to 104 degrees F. The strep test was negative. The patient missed three weeks of his school. The outcome for the events of pneumonia manifested by fever, shaking and shortness of breath, finger tips and toes were numb and dizzy was unknown.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of second dose was received from a health professional concerning a seven-year-old male. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received the first dose of FLUMIST on 11-Oct-2011 and was again inadvertently administered the second dose of FLUMIST on 18-Oct-2011. There was no adverse event associated with this medication error; therefore, treatment and sponsor causality assessments are not applicable, and the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza virus test positive, Pain
Clinical narrative: A non-serious spontaneous report of positive flu test manifested with body aches has been received from a consumer concerning a male child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 10-Sep-2011. On 19-Sep-2011, the patient tested positive for flu and then took oseltamivir and had symptoms of body aches. The outcome of event positive flu test was recovering.
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of FLUMIST to a person greater than 49 years of age was received from a health professional concerning a 52-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 19-Oct-2011. FLUMIST was inadvertently administered to a 52-year-old female. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of pregnancy was received from a health professional concerning an adult female. Neither relevant medical history nor obstetrical history have been reported for this patient. No concomitant medications have been reported for this patient. On 27-Oct-2011, the patient received FLUMIST. Later, on an unknown date, she found out that she was pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 1.67
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to 21-month-old was received from a health professional. Neither relevant past medical history no concomitant medications were reported for this patient. On 11-Oct-2011, the patient received FLUMIST. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: A non-serious report of FLUMIST administered 1 day beyond 48 hr recommended time frame of use was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 02-Nov-2011, the patient received FLUMIST vaccines exposed to 14 degree C one day beyond the 48 hour recommended time frame of use. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a 42-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Nov-2011, two patients received the expired FLUMIST. The product expired on 20-Nov-2011. On 21-Nov-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 31-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. On 20-Nov-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 20-Nov-2011. On 21-Nov-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Influenza, Influenza A virus test positive, Pain, Paranasal sinus hypersecretion
Clinical narrative: A non serious spontaneous report of faintly tested positive for influenza type A with the symptoms of cough, fever, sinus drainage and general body aches has been received from a health professional concerning an 11-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 07-Nov-2011. On 10-Nov-2011, the patient experienced cough, fever, sinus drainage and general body aches. On 16-Nov-2011, the patient was tested for nasal swab test and the result was found to be faintly tested positive for influenza type A. The outcome of the event faintly tested positive for influenza type A was unknown.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non serious spontaneous report of faintly tested positive for influenza type A with the symptoms of cough, fever, sinus drainage and general body aches has been received from a health professional concerning an 11-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 07-Nov-2011. On 10-Nov-2011, the patient experienced cough, fever, sinus drainage and general body aches. On 16-Nov-2011, the patient was tested for nasal swab test and the result was found to be faintly tested positive for influenza type A. The outcome of the event faintly tested positive for influenza type A was unknown.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received one and one-half doses of FLUMIST was received from a health professional concerning a 12-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. On 18-Nov-2011, the patient received FLUMIST, one side of which came out as stream and ran out of the nose. The nurse gave another half dose in that nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a 16-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Nov-2011, two patients received the expired FLUMIST. The product expired on 20-Nov-2011. On 21-Nov-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of four patients were administered one half FLUMIST dose was received from an other health professional concerning four children. Neither relevant medical history nor concomitant medications have been reported for this patient. The patients received one-half dose of FLUMIST in one nostril on 05-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of a patient who received expired FLUMIST was received from a health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Nov-2011, the nurse administered FLUMIST to the patient; she did not realize that the FLUMIST had been expired. The product had expired on 02-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered 1 day beyond 48 hrs recommended time frame of use was received from a health professional concerning a seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 01-Nov-2011, the patient received FLUMIST vaccines exposed to 14 degrees C one day beyond the 48 hour recommended time frame of use. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a two-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Nov-2011, the nurse did not realize that the FLUMIST had expired before administering it to the patient and the patient received expired FLUMIST. The product expired on 02-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of a child inadvertently receiving two doses of FLUMIST one month apart was received from a physician concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient required one dose of FLUMIST but inadvertently received two doses of FLUMIST one month apart. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of hives has been received from a consumer concerning a six-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Nov-2011, the patient received FLUMIST. The patient developed huge hives all over his body within five hours of receiving FLUMIST. The outcome of the event hives was unknown.
Age: 1.58
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration by mistake to child 1 yr and 7 months old was received from a health professional concerning a 19-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 08-Nov-2011, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 1.94
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to a child less than two year was received from a health professional concerning a 23-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 01-Nov-2011, FLUMIST was administered to the patient less than two years of age. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Headache
Clinical narrative: A non serious spontaneous report of blinding headaches during FLUMIST administration has been received from a health professional concerning an adult female nurse who administers FLUMIST. Medical history included an immunocompromised status. Concomitant medication included long-term steroid therapy. The event was reported to occur in the nurse responsible for the administration of FLUMIST and after she administers the vaccine to patients. The nurse complains of immediate blinding headaches after administration of any dose of FLUMIST. She wears a mask and does not have any splash back or part of the dose getting into her eye. The headaches resolve once she is done giving the doses. She normally does not give FLUMIST except when there is no one else in the clinic who can administer it. The outcome of the events is resolved.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of gave FLUMIST that expired in April 2011 was received from a health professional concerning a ten-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 12-Nov-2011, the patient received expired FLUMIST. The product expired on 12-Apr-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently gave FLUMIST into one nostril was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 07-Oct-2011, the patient inadvertently received the entire content of the FLUMIST sprayer unit in one (single) nostril. The patient did not experienced any observable changes. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST was administered was received from a pharmacist concerning a 33-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received expired FLUMIST. The product expired on 27-Nov-2011. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a pharmacist concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 08-Dec-2011, the patient received expired FLUMIST. The product expired on 27-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Henoch-Schonlein purpura
Clinical narrative: A non-serious spontaneous report of Henoch-Schonlein purpura after FLUMIST has been received from a physician concerning an eight-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 22-Aug-2011. On 10-Oct-2011, the patient was diagnosed with Henoch-Schonlein purpura about six weeks after receiving FLUMIST. The outcome of the event, Henoch-Schonlein purpura after FLUMIST was not recovered.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 11-Dec-2011. On 12-Dec-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a 46-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 11-Dec-2011. On 12-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: A non-serious spontaneous report of itchy scalp, palm and feet, red palms, red feet and hives on forearms, legs, ears and trunk has been received from a consumer concerning a 40-year-old female, subsequent to FLUMIST. The patient's past medical history included mild reaction to cat dander. No concomitant medications have been reported for this patient. The patient received FLUMIST on 15-Sep-2011. On 17-Sep-2011, the patient experienced itchy scalp. Days later patient had very itchy and red palms and feet, which lasted a week. It stopped for one day. Then patient had red and itchy hives on forearms, legs, ears and trunk of the body. The outcome of events red palms and red feet were recovered and the outcome of events itchy scalp, palm and feet and hives on forearms, legs, ears and trunk was unknown.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Body temperature, Cough, Fatigue, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of sore throat, temperature, fatigue, cough, runny nose and wheezing has been received from a consumer concerning a 10-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Sep-2011. On 29-Sep-2011, the patient experienced temperature, fatigue, cough and runny nose, where coughing went to chest. The patient went to emergency room for wheezing, cough and sore throat and prescribed antibiotics and inhalers. Rest of the family also have similar symptoms. The outcome of events of sore throat, temperature, fatigue, cough, runny nose and wheezing was resolving.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: A non-serious spontaneous report of sore throat, temperature, fatigue, cough, runny nose and wheezing has been received from a consumer concerning a 10-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Sep-2011. On 29-Sep-2011, the patient experienced temperature, fatigue, cough and runny nose, where coughing went to chest. The patient went to emergency room for wheezing, cough and sore throat and prescribed antibiotics and inhalers. Rest of the family also have similar symptoms. The outcome of events of sore throat, temperature, fatigue, cough, runny nose and wheezing was resolving.
Age: 22.0
Sex: M
Vaccine: FLUN3
Symptoms: Immediate post-injection reaction, Oedema mouth, Sneezing
Clinical narrative: This is a verbatim narrative as reported on web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported from on Dec 27, 2007. Male patient, 22 years of age, was vaccinated with FLUMIST on Dec 27, 2007. "pt had no previous history of influenza vaccine. He stated that he never received flu shot before ever." Immediate oral swelling, sneezing, unlabored respiration, alert and oriented x 3. Seen in ER and was discharged with prednisone, CLARITIN and BENADRYL." None. None. Patient recovered."
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of received half dose of FLUMIST was received from a consumer concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Oct-2011, the patient received FLUMIST then the patient moved and did not receive the second half of dose into the second nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of individual over 49 year old received FLUMIST was received from a health professional concerning a 52-year-old female. Neither relevant past medical history nor concomitant medications were reported for this patient. The patient who was over 49 years of age received FLUMIST on 11-Oct-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment are not applicable, and the event is considered resolved.
Age: 1.74
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of "FLUMIST administration to a 21-month-old" was received from a physician concerning a 20-month-old female. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient accidentally received FLUMIST on 29-Sep-2011,. There was no adverse event associated with this medication error; therefore, treatment and sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 65.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Nasal congestion, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of administration to 65 year old, stuffy nose and runny nose has been received from a consumer concerning herself, a 65-year-old female, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 20-Oct-2011, the patient received FLUMIST. On 22-Oct-2011, the patient had stuffy nose and runny nose. The events of stuffy nose and runny nose was not recovered and the event of administration to 65 year old was recovered.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration during pregnancy was received from a health professional concerning a 16-year-old female. Neither relevant medical history nor obstetrical history have been reported for this patient. No concomitant medications have been reported for this patient. On 27-Oct-2011, the patient received FLUMIST. On 28-Oct-2011, the patient found out that she is pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of sore throat has been received from a consumer concerning an adult female herself, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 06-Oct-2011, the patient's received FLUMIST. After receiving FLUMIST, the patient had sore throat which lasted for four days. The patient also had a son, who too received FLUMIST on the same day. He had a non-productive cough in his chest for four days. The outcome of the event sore throat was recovered.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Abnormal behaviour, Agitation, Depressed mood, Emotional distress
Clinical narrative: A non-serious spontaneous report of acting different, unhappy, upset and agitated has been received from a physician concerning an eight-year-old male, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 20-Oct-2011, the patient received FLUMIST. About one hour after receiving FLUMIST, the patient became very agitated, unhappy, upset and was acting very different. The patient's behavior became normal by bedtime. The symptoms subsided in less than 24 hours. The events acting different, unhappy, upset and agitated recovered.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of fever of 100.8 F and runny nose has been received from a health professional concerning a six-year-old female, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on 20-Oct-2011. On 23-Oct-2011, the patient developed fever of 100.8F and runny nose. The outcome of the events fever of 100.8F and runny nose was unknown.
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Headache, Influenza like illness, Joint stiffness, Oral pain, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of stiff jaw and flu like symptoms manifested by sore throat, headache, body ache and mouth sore has been received from a health professional concerning an adult female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 18-Oct-2011. On 20-Oct-2011, the patient had flu like symptoms which included sore throat, headaches, mouth sores, body aches and stiff jaw. The outcome of the events were resolving.
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Pain
Clinical narrative: A non-serious spontaneous report of stiff jaw and flu like symptoms manifested by sore throat, headache, body ache and mouth sore has been received from a health professional concerning an adult female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 18-Oct-2011. On 20-Oct-2011, the patient had flu like symptoms which included sore throat, headaches, mouth sores, body aches and stiff jaw. The outcome of the events were resolving.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to patient with thyroid disease was received from a pharmacist concerning a 33-year-old female. Medical history included thyroid disease. No concomitant medications had been reported for this patient. On 20-Oct-2011, the patient received FLUMIST. The reporter stated that she did not realize that the patient's medical history included thyroid disease. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Ataxia, Confusional state
Clinical narrative: A non-serious spontaneous report of ataxia and mental confusion has been received from a health professional concerning a 32-year-old female, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received FLUMIST on mid Sep-2011. After 15 minutes of receiving FLUMIST, the patient experienced ataxia and mental confusion which for lasted three hours. The outcome of the events ataxia and mental confusion was recovered.
Age: 54.0
Sex: U
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to a 54 year old patient was received from a pharmacist concerning a 54-year-old patient. Neither relevant medical history nor concomitant medications had been reported for this patient. An adverse event was reported regarding a 54-year-old patient receiving FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough
Clinical narrative: A non-serious spontaneous report of non-productive cough has been received from a consumer concerning her son, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 06-Oct-2011, the patient received FLUMIST. After receiving FLUMIST, the patient had non-productive cough for four days. The outcome of the event non-productive cough was recovered.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received half dose in one nostril was received from a health professional concerning a 12-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. After receiving FLUMIST in one nostril, the patient did not receive more. The patient only received one half in one nostril on 20-Oct-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: A non-serious spontaneous report of severely ill has been received from a health professional concerning a five-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST in 2010. In 2010, the patient ended up severely ill for three days after receiving FLUMIST. The patient was not hospitalized. The outcome of event severely ill was resolved.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever of 105F has been received from a consumer concerning a 37-month-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 12-Oct-2011. On 14-Oct-2011, the patient woke up with a fever of 105 degrees F. The outcome of the event fever of 105F was unknown.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of chest congestion, fever and cough has been received from a consumer concerning a 36-month-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 05-Oct-2011, the patient received FLUMIST. After receiving FLUMIST, the patient had chest congestion with cough. The patient first had fever but not anymore. The symptoms lasted for 20 days. The outcome of the event fever was recovered and the events chest congestion and cough was not recovered.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis, Immediate post-injection reaction
Clinical narrative: A non-serious spontaneous report of nosebleed has been received from a health professional concerning a three-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's past medical history includes nosebleeds. No concomitant medications were reported. The patient received FLUMIST on 04-Aug-2011. Immediately after administration of FLUMIST to the left nostril, patient had a nosebleed for a couple of seconds. Then the nosebleed quit. No further nosebleed. The outcome of the event was resolved.
Sex: U
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: A non-serious spontaneous report of wheezing has been received from a non-health professional concerning a child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST last flu season in 2010-2011. The patient developed wheezing after receiving FLUMIST. The patient went to hospital but not admitted. The outcome of the event was unknown.