chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST was administered to a pregnant female in her first trimester was received from a pharmacist concerning a female of unknown age. The patient's medical history, obstetrical history and concomitant medication have not been reported. The patient was in her first trimester at the time of vaccination. On an unknown date in 2010, the patient received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of event vaccine exposure during pregnancy was considered to be resolved.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis, Rhinitis, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of rhinitis with symptoms of running nose with a bit of blood has been received from a nurse/health professional 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 medical history nor concomitant medication was reported for this patient. On an unknown date, the patient received FLUMIST. The patient experienced running nose with a bit of blood, diagnosed as rhinitis. The outcome of the event rhinitis was unknown.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Fatigue, Headache, Nasal discomfort, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of nose started burning, feeling very congested, tired, sore throat, headache and coughing has been received from a consumer concerning a 26-year-old female, subsequent to FLUMIST. The patient's medical history included never gotten sick from flu shots in the past. No concomitant medications reported for this patient. On 10-Nov-2010, the patient received FLUMIST. The patient had a bit of a headache, but was feeling well. When she got the shot it felt water up her nose and she started coughing. A little while later, her nose started burning, like before the start of a cold and she had congestion. Overnight, the patient was getting progressively worse. She woke up the next morning, feeling very congested, tired and had a sore throat. The outcome of events of feeling very congested, tired, sore throat was not recovered and for nose started burning, and coughing the outcome was unknown.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of nose started burning, feeling very congested, tired, sore throat, headache and coughing has been received from a consumer concerning a 26-year-old female, subsequent to FLUMIST. The patient's medical history included never gotten sick from flu shots in the past. No concomitant medications reported for this patient. On 10-Nov-2010, the patient received FLUMIST. The patient had a bit of a headache, but was feeling well. When she got the shot it felt water up her nose and she started coughing. A little while later, her nose started burning, like before the start of a cold and she had congestion. Overnight, the patient was getting progressively worse. She woke up the next morning, feeling very congested, tired and had a sore throat. The outcome of events of feeling very congested, tired, sore throat was not recovered and for nose started burning, and coughing the outcome was unknown.
Age: 50.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered FLUMIST to a 50-year-old female was received from a registered nurse/health professional. Neither medical history nor concomitant medication was reported for this patient. On an unknown date in 2010, 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 was considered resolved.
Sex: U
Vaccine: FLUN3
Symptoms: Eye irritation
Clinical narrative: A non-serious spontaneous report of burning eyes post administration of FLUMIST has been received from a company representative/non health professional concerning children of unknown gender, 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 medical history nor concomitant medication was reported for this patient. On an unknown date in Aug-2010, patient received FLUMIST. It was reported that out of 600 doses of FLUMIST, 10% of the people complained that their eyes were burning post administration of FLUMIST. The outcome of the event burning eyes post administration of FLUMIST was unknown.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of fully congested has been received from a non-health professional concerning a five-year-old male, subsequent to FLUMIST. The patient had H1N1 severe symptoms in Nov-2009. No concomitant medications were reported. The patient received 0.2ml FLUMIST nasally on 10-Nov-2010 for Influenza. The patient received FLUMIST vaccination on 10-Nov-2010 and became fully congested on 11-Nov-2010. The outcome was not recovered.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Disturbance in attention, Feeling abnormal, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of felt odd (like head in fishbowl, unable to concentrate), headache, constant runny nose, sore throat and stuffy nose/ fully congested has been received from a consumer concerning a 39-year-old female patient, subsequent to FLUMIST. The patient's past medical history includes migraine treated with cefuroxime. The patient had acquired H1N1 from her five year-old son in Nov-2009. She had experienced hallucinations, could not walk, had extreme pain in joints and was put on budesonide+formoterol for a year. The patient received 0.2 ml FLUMIST on 10-Nov-2010 nasally for Influenza. Within one hour post vaccination, the patient developed headache and took cefuroxime. The headache resolved. In the evening of 10-Nov-2010, the patient developed constant runny nose. On 11-Nov-2010, the patient had a stuffed nose and felt odd (like her head was in a fishbowl and unable to concentrate). On 12-Nov-2010, the patient woke up fully congested and with a sore throat. The symptoms were not resolved. The outcome of the events felt odd (like head in fishbowl, unable to concentrate), headache, constant runny nose, sore throat and stuffy nose/ fully congested was not recovered while the headache was resolved.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of felt odd (like head in fishbowl, unable to concentrate), headache, constant runny nose, sore throat and stuffy nose/ fully congested has been received from a consumer concerning a 39-year-old female patient, subsequent to FLUMIST. The patient's past medical history includes migraine treated with cefuroxime. The patient had acquired H1N1 from her five year-old son in Nov-2009. She had experienced hallucinations, could not walk, had extreme pain in joints and was put on budesonide+formoterol for a year. The patient received 0.2 ml FLUMIST on 10-Nov-2010 nasally for Influenza. Within one hour post vaccination, the patient developed headache and took cefuroxime. The headache resolved. In the evening of 10-Nov-2010, the patient developed constant runny nose. On 11-Nov-2010, the patient had a stuffed nose and felt odd (like her head was in a fishbowl and unable to concentrate). On 12-Nov-2010, the patient woke up fully congested and with a sore throat. The symptoms were not resolved. The outcome of the events felt odd (like head in fishbowl, unable to concentrate), headache, constant runny nose, sore throat and stuffy nose/ fully congested was not recovered while the headache was resolved.
Age: 3.0
Sex: M
Vaccine: FLUN3, PPV
Symptoms: Cough, Malaise, Oedema peripheral, Pruritus, Pyrexia
Clinical narrative: A non-serious spontaneous report of arm swollen, hives, very ill, rash, fever and cough has been received from a consumer/mother 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. The patient has history of seasonal allergies. The patient received FLUMIST first time this season; received injections before. The patient received pneumococcal vaccine on same day of his first dose of FLUMIST. On 11-Nov-2010, the patient received his first dose of FLUMIST and on 28-Dec-2010, the patient received his second dose of FLUMIST. The patient's arm was very swollen after the pneumococcal injection. It was treated with warm compress. On 18-Nov-2010, one week after the first dose, the patient had fever of 101-102 degrees F on every other day with a rash on his neck and face and cough for about two weeks. On 31-Dec-2010, three days after his second dose, the patient had hives all over his body. He was taken to the physician and physician did not think that the symptoms were related to FLUMIST. On 01-Jan-2011, the patient was seen by a nurse practitioner at pediatrician's office. The patient was currently prescribed loratadine 1tsp daily for his history of seasonal allergies. The nurse recommended that the dose be increased to 2 tsp for the treatment of current symptoms. The patient was also received diphenhydramine and was bathed in oatmeal baths to reduced itching. The outcome of the events arm swollen, hives, very ill, rash, fever and cough was resolved. Additional information was received on 10-Jan-2011 and incorporated into the narrative: received updates on adverse events, patient history, concomitant medication, treatment medication and outcome of the events.
Age: 3.0
Sex: M
Vaccine: FLUN3, PPV
Symptoms: Rash, Urticaria
Clinical narrative: A non-serious spontaneous report of arm swollen, hives, very ill, rash, fever and cough has been received from a consumer/mother 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. The patient has history of seasonal allergies. The patient received FLUMIST first time this season; received injections before. The patient received pneumococcal vaccine on same day of his first dose of FLUMIST. On 11-Nov-2010, the patient received his first dose of FLUMIST and on 28-Dec-2010, the patient received his second dose of FLUMIST. The patient's arm was very swollen after the pneumococcal injection. It was treated with warm compress. On 18-Nov-2010, one week after the first dose, the patient had fever of 101-102 degrees F on every other day with a rash on his neck and face and cough for about two weeks. On 31-Dec-2010, three days after his second dose, the patient had hives all over his body. He was taken to the physician and physician did not think that the symptoms were related to FLUMIST. On 01-Jan-2011, the patient was seen by a nurse practitioner at pediatrician's office. The patient was currently prescribed loratadine 1tsp daily for his history of seasonal allergies. The nurse recommended that the dose be increased to 2 tsp for the treatment of current symptoms. The patient was also received diphenhydramine and was bathed in oatmeal baths to reduced itching. The outcome of the events arm swollen, hives, very ill, rash, fever and cough was resolved. Additional information was received on 10-Jan-2011 and incorporated into the narrative: received updates on adverse events, patient history, concomitant medication, treatment medication and outcome of the events.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a 13-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 02-Jan-2011. On 05-Jan-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.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered one dose of expired FLUMIST was received from a health professional concerning a 13-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 29-Dec-2010. On 30-Dec-2010, 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: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired FLUMIST has been received from a registered nurse concerning a 30-month-old female patient. The patient's medical history and concomitant medication details were not provided. The product expired on 02-Jan-2011. The patient received the expired FLUMIST on 03-Jan-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. Additional information received on 08-Apr-2011 and incorporated into case: no late occurring adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: A non-serious spontaneous report of several patients received expired FLUMIST was received from a health professional concerning female children ages 2-years-old to 18-years-old. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 06-Dec-2010. The patients received expired FLUMIST from 07-Dec-2010 through 03-Jan-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: 6.0
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 six-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 02-Jan-2011. On 04-Jan-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.
Age: 13.0
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 13-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 02-Jan-2011. On 04-Jan-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.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a pharmacist concerning a nine-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 02-Jan-2011. On 05-Jan-2011, the patient received the 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.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a pharmacist concerning a five-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 02-Jan-2011. On 05-Jan-2011, the patient received the 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. Additional information was received on 24-Mar-2011 which confirmed that the patient did not report any adverse events following administration of expired FLUMIST. This information was incorporated into the narrative.
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Myalgia, Nasopharyngitis, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of head cold, runny nose and muscle aches all over the body has been received from a non health professional concerning a 29-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medication was reported for this patient. On 10-Nov-2010, the patient received FLUMIST. On 11-Nov-2010, the patient experienced symptoms of cold; head cold, runny nose and muscle aches all over the body. The outcome of the events head cold, runny nose and muscle aches all over the body was not resolved.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Petechiae, Pyrexia
Clinical narrative: A non-serious spontaneous report of petechial rash and fever has been received from a physician concerning a 33-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 past medical history nor concomitant medications were reported for this patient. On 03-Jan-2011, the patient received FLUMIST. On 05-Jan-2011, the patient developed a fever of 103 F and 104 F. The patient also developed a petechial rash on the arm. The outcome of the events petechial rash and fever was unknown.
Sex: F
Vaccine: FLUN3
Symptoms: Ear discomfort, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of ears blocked, head cold and sore throat has been received from a non-health professional concerning an adult female, subsequent to FLUMIST. Neither the patient's past medical history nor concomitant medications were reported. The patient received FLUMIST on an unknown date. The patient experienced ears blocked, head cold and sore throat after receiving FLUMIST. The outcome of ears blocked, head cold and sore throat was unknown.
Age: 1.65
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Hypophagia
Clinical narrative: A non-serious spontaneous report of 19 month old patient was administered FLUMIST, not eating as much and not drinking as much has been received from a health professional concerning a 19-month-old female, subsequent to receiving 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 the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 05-Jan-2011. The patient's mother reported that the child was not eating and drinking as much as she normally did. The outcome of the event of 19 month old patient was administered FLUMIST was considered resolved while the outcome of not eating as much and not drinking as much was unknown.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Thirst
Clinical narrative: A non-serious spontaneous report of thirsty and rash has been received from a health professional concerning a five-year-old female, subsequent to FLUMIST. The patient did not have a hypersensitivity history to eggs or egg proteins. Concomitant medications were not reported. On 12-Nov-2010, the patient received 0.2ml FLUMIST nasally for flu vaccination. The patient had rash on forehead, neck, cheek and chest and was thirsty with no fever. The outcome of all the events was unknown. The reporter assessed the event of rash as possibly related to FLUMIST as it started a few hours of vaccination.
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion, Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of fever, runny nose, stuffy nose and feels like a cold has been received from a non-health professional concerning an adult female, subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST nasally on 10-Nov-2010 for Influenza prevention. By Thursday, on 11-Nov-2010, the patient experienced a fever that lasted one day and nose was stuffy and running. The stuffy runny nose had continued and she felt like a cold. The outcome of fever was resolved, while that of stuffy nose, runny nose and feels like a cold was not recovered.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A non-serious spontaneous report of bloody nose has been received from a non-health professional concerning an eight-year-old male, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. On unknown date, patient received FLUMIST. An eight year old patient reported bloody nose after receiving FLUMIST. Nurse who administered the vaccine believes that it was because the child was not cooperating with her. The outcome of event bloody nose was unknown.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired dose of FLUMIST was received from a health professional concerning a child older than five years of age. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 19-Jan-2010. On 15-Nov-2010, the patient received the expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal discomfort, Dyspnoea, Rash, Swelling face, Tremor
Clinical narrative: A serious spontaneous report of short of breath and swelling of face and non-serious events of shaky, stomach upset and rash have been received from a consumer concerning herself, a 35-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medication was reported for this patient. On 13-Oct-2010, the patient received FLUMIST. On 16-Oct-2010, the patient experienced short of breath, shaky, swelling of face, stomach upset and rash. The outcome of the events short of breath, shaky, swelling of face, stomach upset and rash was not resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Myalgia, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of cold-like symptoms with manifestation of congestion, headaches, fatigue and muscle pain has been received from a consumer concerning an adult female, subsequent to receiving FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on an unknown date. The patient reported experiencing cold-like symptoms (congestion, headaches, fatigue, and muscle pain), coming on quite suddenly the day after taking FLUMIST. The outcome of was unknown.
Sex: F
Vaccine: FLUN3
Symptoms: Hypersensitivity, Lip pain, Lip swelling
Clinical narrative: A non-serious spontaneous report of allergic reaction with symptoms of swelling and pain of lips has been received from a physician concerning an adult female subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 03-Nov-2010. On 08-Nov-2010, the patient developed swelling and pain of her lips. The reporter was doubtful that an allergic reaction could develop five days later. The outcome of the event was unknown.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Decreased appetite, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of sore throat, fever of 102 F, low appetite and didn't seem to feel well has been received from a non-healthcare professional concerning a 46-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 the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 15-Nov-2010 in the evening. After receiving FLUMIST, the patient had low appetite and didn't seem to feel well. On 16-Nov-2010, the patient complained of a sore throat and on 18-Nov-2010 had fever of 102 F. The outcome of all the events was unknown.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of runny nose and fever has been received from a consumer concerning a 39-month-old female patient, 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 a dose of FLUMIST on 19-Nov-2010. On 21-Nov-2010, the patient began running a fever (102F) and had a runny nose two days after receiving FLUMIST. The patient was taken to emergency care and was given oseltamivir phosphate. The outcome of the event was unknown.
Age: 2.0
Sex: U
Vaccine: FLUN3
Symptoms: Influenza like illness, Influenza virus test positive
Clinical narrative: A non-serious spontaneous report of flu-like symptoms has been received from a non-health professional concerning a 24-month-old patient, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for indicated population of 2 years to 59 months of age. Neither medical history nor concomitant medication was reported for this patient. On 19-Nov-2010, the patient received FLUMIST. On 21-Nov-2010, two days after vaccination, the patient went to the emergency room with flu-like symptoms and tested positive for influenza. The outcome of the event, flu-like symptoms, was unknown.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: A non-serious spontaneous report of vomiting and 103F fever has been received from a non-health professional concerning a four-year-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 past medical history nor concomitant medications were reported for this patient. On 18-Nov-2010, patient received FLUMIST. On 18-Nov-2010, the patient experienced vomiting all night after receiving FLUMIST, and on 19-Nov-2010, developed a fever of 103F. The outcome of the events of vomiting and fever was not resolved.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive, Pyrexia
Clinical narrative: A non-serious spontaneous report of positive influenza test with a symptom of fever of 102'F has been received from a health professional concerning a 39-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 the patient's past medical history nor the comcomitant medications were reported. The patient received FLUMIST on 19-Nov-2010. On 21-Nov-2010, the patient was taken to an urgent care clinic with a fever of 102'F. She tested positive for Influenza with the nasal swab diagnostic test. The outcome of the event was unknown.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Cough, Nausea, Pain, Paraesthesia
Clinical narrative: A non-serious spontaneous report of tingling in right hand, fever, runny nose, cough, aches, chills and nausea has been received from a consumer concerning an eight-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a dose of FLUMIST on 17-Nov-2010. On 20-Nov-2010, the patient experienced adverse symptoms of fever, runny nose, cough, aches, chills, nausea and tingling in right hand. The outcome of the events fever, runny nose, cough, aches, chills, nausea and tingling in right hand was unknown.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of tingling in right hand, fever, runny nose, cough, aches, chills and nausea has been received from a consumer concerning an eight-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a dose of FLUMIST on 17-Nov-2010. On 20-Nov-2010, the patient experienced adverse symptoms of fever, runny nose, cough, aches, chills, nausea and tingling in right hand. The outcome of the events fever, runny nose, cough, aches, chills, nausea and tingling in right hand was unknown.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion
Clinical narrative: A non-serious spontaneous report of stuffy nose has been received from a non-health professional concerning a 34-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 the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 16-Nov-2010. On 17-Nov-2010, one day after vaccination, the child developed a stuffy nose. The outcome of the event was unknown.
Age: 52.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 52-year-old was received from a non-health professional concerning a 52-year-old male. On 22-Nov-2010, the patient inadvertently received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Sex: U
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: A non-serious spontaneous report of administration of product exposed to temperature way outside allowance was received from a non-health professional concerning 60 adult patients. Neither the patients' past medical history nor the concomitant medications were reported. The patients received FLUMIST on 22-Nov-2010. FLUMIST was administered to the patients even though their TempTale was alarmed and the product was exposed to temperatures outside of the allowance. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Face oedema, Swelling face
Clinical narrative: A non-serious spontaneous report of facial edema has been received from a physician concerning a 17-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a dose of FLUMIST on 27-Oct-2010. On 07-Nov-2010, the patient developed facial edema. The patient had been seen in the physicians office on 09-Nov-2010 and 12-Nov-2010 for the facial swelling. The outcome of the event facial edema was unknown.
Age: 65.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 65 year old was received from a health professional concerning a 65-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 24-Nov-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
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 female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 22-Nov-2010. On 23-Nov-2010, 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.
Age: 37.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a 37-year-old female. Neither past medical history nor concomitant medications were reported for this patient. On 30-Nov-2010, patient received expired vaccine. The product expiry date was 29-Nov-2010. 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: 54.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Eye discharge, Eye pruritus, Ocular hyperaemia
Clinical narrative: A non-serious spontaneous report of FLUMIST accidentally squirted in eye, which became red, itchy, and oozing eye has been received from a health professional concerning herself, 54-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Nov-2010, the patient was administering the vaccine which squirted in her eye. The patient did not receive FLUMIST herself. On 30-Nov-2010, the FLUMIST squirted in her eye. The medication came out from the plunger and hit the patient's eye. The eye became red, itchy and oozing. The outcome of the event FLUMIST accidentally squirted in eye was recovered while the outcome of the events red eye, itchy eye and oozing eye was not recovered.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Headache, Pyrexia
Clinical narrative: A non-serious spontaneous report of headache and fever has been received from a non-health professional concerning an eight-year-old male, subsequent to FLUMIST. The past medical history includes asthma and the patient was recovering from cold and had a cough (typical of his asthma). No concomitant medication was reported for this patient. On 20-Nov-2010, the patient received FLUMIST. On morning of 23-Nov-2010, the patient complained of headache and had a fever of 100 degree F. He had no other symptoms and given acetaminophen and by evening of 24-Nov-2010, the symptoms had gone away. The outcome of the events headache and fever was resolved.
Age: 8.0
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 an eight-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 22-Nov-2010. The patient received the expired FLUMIST on 30-Nov-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a ten-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 04-Apr-2011 which confirmed that the patient did not report any adverse events following administration of expired FLUMIST. This information was incorporated into the narrative.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a nine-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a six-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "inadvertently gave expired FLUMIST" was received from a health professional concerning a 16-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 29-Nov-2010. On 30-Nov-2010, 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.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a ten-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information received on 04-Apr-2011 and incorporated into case: no late occurring adverse events.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a ten-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive, Polymerase chain reaction
Clinical narrative: A non-serious spontaneous report of influenza has been received from a healthcare professional concerning a six-year-old female, subsequent to receiving FLUMIST. The patient's past medical history included being a twin and concomitant medications included varicella vaccination two days prior to FLUMIST. The patient received FLUMIST on 22-Oct-2010. After receipt of FLUMIST the patient developed influenza. PCR was positive for influenza. The outcome of the event was not reported.
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious, spontaneous report of nurse offered without asking whether she was pregnant was received from a physician concerning an adult female. Neither past medical history nor concomitant medications were reported for this patient. The patient was six weeks pregnant when she received FLUMIST. On an unknown date, 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.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: A non-serious spontaneous report of headache has been received from a non-health professional concerning a nine-year-old male subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST in 2010. The patient developed a headache in the beginning of Nov-2010 after receiving FLUMIST. The outcome was unknown.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Influenza, Influenza A virus test positive, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of influenza A with symptoms of nasal drainage, cough, sore throat and fever up to 103 has been received from a health professional concerning a six-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received 0.2 ml FLUMIST, nasally, on 01-Dec-2010 for protection against Influenza. On 04-Feb-2011, the patient presented to the doctor's office with reports of nasal drainage, cough, sore throat and fever up to 103 which started in the evening on 03-Feb-2011. She tested positive for influenza at the office. The sample was sent to the State lab. The patient was treated with oseltamivir 45 mg twice a day for five days, acetaminophen+chlorpheniramine+dextromethorphan+pseudoephedrine and ibuprofen+pseudoephedrine+chlorpheniramine. The event resolved on 06-Feb-2011.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of influenza A with symptoms of nasal drainage, cough, sore throat and fever up to 103 has been received from a health professional concerning a six-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received 0.2 ml FLUMIST, nasally, on 01-Dec-2010 for protection against Influenza. On 04-Feb-2011, the patient presented to the doctor's office with reports of nasal drainage, cough, sore throat and fever up to 103 which started in the evening on 03-Feb-2011. She tested positive for influenza at the office. The sample was sent to the State lab. The patient was treated with oseltamivir 45 mg twice a day for five days, acetaminophen+chlorpheniramine+dextromethorphan+pseudoephedrine and ibuprofen+pseudoephedrine+chlorpheniramine. The event resolved on 06-Feb-2011.
Sex: F
Vaccine: FLUN3
Symptoms: Condition aggravated, Epistaxis
Clinical narrative: A non-serious spontaneous report of nose bleed has been received from a health professional concerning an female older than five years of age, subsequent to FLUMIST. Medical history includes nose bleed. No concomitant medication was reported for this patient. On an unknown date in Nov-2010, the patient received FLUMIST for Flu prevention via intranasal route. Some time during the night on the same day of FLUMIST vaccination, the patient experienced nose bleed twice. The outcome of the event nose bleed was resolved.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Influenza, Influenza B virus test positive, Influenza virus test positive, Pyrexia
Clinical narrative: A non-serious spontaneous report of influenza B with symptoms of fever and cough has been received from a health professional concerning a 31-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. The patient's medical history included gestation period of 41 weeks. Concomitant medications were not reported. The patient received 0.2ml FLUMIST nasally on 09-Nov-2010 for protection against flu. The patient started with fever and cough in the evening of 18-Jan-2011. He tested positive for influenza at the doctor's office on 20-Jan-2011. The sample was sent to the stat lab and it came back B positive. The patient was treated with oseltamivir 45 mg twice daily for five days from 20-Jan-2011 to 23-Jan-2011 and ibuprofen 100 mg one tsp from 18-Jan-2011 to 23-Jan-2011 for fever. The events resolved on 22-Jan-2011.
Sex: M
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 an adult male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Nov-2010. On 01-Dec-2010, the patient received the expired FLUMIST vaccine. 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: Cough, Headache, Influenza, Influenza A virus test positive, Influenza virus test positive
Clinical narrative: A non-serious spontaneous report of influenza A, subtype H3 manifested by cough, fever (101.5 degrees Fahrenheit), headache and sore throat has been received from a health professional concerning a seven-year-old male, subsequent to FLUMIST. The patient's past medical history included a left femur fracture in July 2005. No concomitant medications were reported. On 10-Nov-2010, patient received FLUMIST. On 30-Jan-2011, the patient started with cough, fever of 101.5 degrees Fahrenheit, headache and a sore throat. On 31-Jan-2011, the patient's influenza test was positive and he was diagnosed with influenza A, subtype H3. The patient was treated with oral oseltamivir 4 ml twice/day for five days. The outcome of event was resolved.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of influenza A, subtype H3 manifested by cough, fever (101.5 degrees Fahrenheit), headache and sore throat has been received from a health professional concerning a seven-year-old male, subsequent to FLUMIST. The patient's past medical history included a left femur fracture in July 2005. No concomitant medications were reported. On 10-Nov-2010, patient received FLUMIST. On 30-Jan-2011, the patient started with cough, fever of 101.5 degrees Fahrenheit, headache and a sore throat. On 31-Jan-2011, the patient's influenza test was positive and he was diagnosed with influenza A, subtype H3. The patient was treated with oral oseltamivir 4 ml twice/day for five days. The outcome of event was resolved.