chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Pharyngitis streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: A non-serious spontaneous report of Strep throat, fever and headache has been received from a consumer/mother concerning her eight-year-old daughter, subsequent to FLUMIST. The patient had no relevant past medical history and was not taking concomitant medications. The patient received FLUMIST on 15-Sep-2009. On 17-Sep-2009, the patient developed a fever of 100 degrees Fahrenheit and a headache. Her mother treated her with ibuprofen as needed and phoned the patient's physician. Per the patient's mother, the physician's office did not believe the events were caused by FLUMIST. On 19-Sep-2009, the fever resolved and the headache continued. On 21-Sep-2009. the patient's headache continued. Her mother took to her physician's office for evaluation. A rapid Strep test was performed and was positive. She was treated with a ten day course of amoxicillin. The headache resolved on 22-Sep-2009 and the Strep throat was considered resolved 23-Sep-2009. Additional information was received on 16-Oct-2009 and incorporated into the narrative: included clarification of the date of vaccination, onset and cessation dates of adverse events, diagnosis of Strep throat and treatment information.
Age: 81.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to individual over 49 years of age was received from a registered nurse concerning an 81-year-old male subsequent to administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 11-Sep-2009, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. On 20-Oct-2009, it was confirmed that the patient did not experience any adverse events.
Age: 66.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to individual over 49 years of age was received from a registered nurse concerning a  66-year-old female subsequent to FLUMIST. Relevant medical history and concomitant medications were not reported. On 11-Sep-2009, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. On 20-Oct-2009, it was confirmed that the patient did not experience any adverse events.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Contraindication to vaccination, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: A non-serious spontaneous report of child with asthma administered FLUMIST who experienced the following symptoms stomach pain, diarrhea, fever, tiredness, sinus congestion and appetite decreased has been received form a consumer concerning a six-year-old male, subsequent to FLUMIST. The only patient medical history reported was a history of asthma. No concomitant medications were reported. The patient received a single dose of FLUMIST around 31-AUG-2009. The patient received FLUMIST and since receiving the vaccine he has experienced stomach pain, diarrhea, fever, tiredness, sinus congestion and appetite decreased. No outcome was reported for these events.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Sinus congestion
Clinical narrative: A non-serious spontaneous report of child with asthma administered FLUMIST who experienced the following symptoms stomach pain, diarrhea, fever, tiredness, sinus congestion and appetite decreased has been received form a consumer concerning a six-year-old male, subsequent to FLUMIST. The only patient medical history reported was a history of asthma. No concomitant medications were reported. The patient received a single dose of FLUMIST around 31-AUG-2009. The patient received FLUMIST and since receiving the vaccine he has experienced stomach pain, diarrhea, fever, tiredness, sinus congestion and appetite decreased. No outcome was reported for these events.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Headache, Nausea, No reaction on previous exposure to drug
Clinical narrative: A non-serious spontaneous report of dizziness, headache, and nausea has been received from a consumer concerning herself, a 34 year old female, subsequent to FLUMIST. Medical history included hypothyroidism (diagnosed at age 19) and endometriosis (diagnosed at age 18). Concomitant medications included levothyroxine and oral contraceptives, NOS. She has received FLUMIST in previous seasons without experiencing any adverse events. The patient received a single dose of FLUMIST at 12:00 noon on 16-Sep-2009. The same day, at around 2:00 pm, she started to experienced headache, dizziness and nausea. The symptoms continued and on 17-Sep-2009 she took acetaminophen, aspirin, and caffeine, extra strength, 2 tablets, which did not help. The events did not resolve.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: A non-serious report of runny nose and nasal congestion has been received from a consumer, patient's parent, concerning a 12-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medication were not provided. The patient received FLUMIST on 10-Sep-2009. He received a total of one dose of FLUMIST before the onset of the events given on 10-Sep-2009. On 11-Sep-2009, he experienced running nose and nasal congestion. Per reporter, these symptoms were progressively getting worse. Outcome of the event was not reported.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Nausea
Clinical narrative: A non-serious, spontaneous report of nausea has been received from a patient's mother concerning her seven-year-old son subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 17-Sep-2009. On 18-Sep-2009, the patient had nausea. On the same day, the reporter's dog was also sick. The outcome of the patient's adverse event is unknown.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous case of a full dose of vaccine given in one nostril has been received from a pharmacy technician concerning a 14-year-old female, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received the entire 0.2 ml of FLUMIST in one nostril on 19-Sep-2009. The reporter indicated there were no observable changes in the patient after receiving the FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Oct-2009 and incorporated into the narrative: no adverse events observed.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administration to pregnant female (28 weeks pregnant) was received from a consumer concerning herself, a 34-year-old female. FLUMIST was administered on 17-Sep-2009. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor 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. On 16-Oct-2009, the follow-up information was received. As of 16-Oct-2009, there have been no adverse events or any side effects. The patient is currently 32 weeks pregnant and the birth is expected on 14-Dec-2009. The patient was asked to inform about any adverse events or side effects until the end of pregnancy.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administration to pregnant female (14 weeks pregnant) was received from a physician concerning herself, a 33-year-old female. FLUMIST was administered on 21-Sep-2009. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor 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: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave full dose in one nostril was received from a nurse concerning a 38-year old female. On 02-Sep-2009, the patient received the full 0.2ml dose in one nostril. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 12-Oct-2009: Follow-up received: confirmed patient had no adverse effects.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Dizziness, Vomiting
Clinical narrative: A non-serious spontaneous report of dizziness and vomiting has been received from a physician concerning a 13-year-old male subsequent to FLUMIST. The patient's past medical history and concomitant medications were not provided by the reporter. The patient received FLUMIST on 03-Sep-2009. He received a total of one dose of FLUMIST before the onset of the events given on 03-Sep-2009. The  patient developed dizziness and vomiting on 04-Sep-2009. He was not febrile and had no other symptoms. The events of dizziness and vomiting were ongoing.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion, Sneezing
Clinical narrative: A non-serious spontaneous report of stuffy nose and sneezing has been received from a registered nurse concerning herself, a 48-year-old female subsequent to FLUMIST. The patient's medical history and concomitant medication were not provided. The patient received a total of one dose of FLUMIST on 18-Sep-2009. The patient experienced stuffy nose and sneezing on 20-Sep-2009. The outcome of the events was unknown.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Pyrexia
Clinical narrative: A non-serious, spontaneous report of fever and positive flu test has been received from a physician, concerning a five-year-old female patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 06-Sep-2009. On 08-Sep-2009, the patient started running fever of 102. She tested positive for Flu B on 08-Sep-2009. The outcome of the events was not reported.
Age: 7.0
Sex: U
Vaccine: FLUN3
Symptoms: Contusion, Nasal discomfort
Clinical narrative: A non-serious, spontaneous report of sore and "bruise" on the nose has been received from a patient's mother concerning her seven-year-old child subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on an unspecified date. On 21-Sep-2009, the patient developed a sore and "bruise" on the nose. The outcome of the adverse events is unknown.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Cough, Eye swelling, Hypersensitivity, Pruritus, Sneezing
Clinical narrative: A non-serious spontaneous report of allergic reaction has been received from a Registered Nurse concerning a five-year-old male, subsequent to receiving FLUMIST. No medical history was report for this subject; concomitant medications included vaccines given the same day as FLUMIST including DTAP, Polio, MMR and Varicella. The patient received FLUMIST on 27-Aug-2009. The reporter indicated that within minutes of receiving FLUMIST the patient experienced a severe allergic reaction with excessive sneezing, coughing, eye swelling, hives and hands and feet itching. He was treated with diphenhydramine. The allergic reaction was completely resolved on 28-Aug-2009 with sneezing, coughing, hives and hand and feet itching resolved on 27-Aug-2009. The eye swelling resolved the following day.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of allergic reaction has been received from a Registered Nurse concerning a five-year-old male, subsequent to receiving FLUMIST. No medical history was report for this subject; concomitant medications included vaccines given the same day as FLUMIST including DTAP, Polio, MMR and Varicella. The patient received FLUMIST on 27-Aug-2009. The reporter indicated that within minutes of receiving FLUMIST the patient experienced a severe allergic reaction with excessive sneezing, coughing, eye swelling, hives and hands and feet itching. He was treated with diphenhydramine. The allergic reaction was completely resolved on 28-Aug-2009 with sneezing, coughing, hives and hand and feet itching resolved on 27-Aug-2009. The eye swelling resolved the following day.
Age: 10.0
Sex: U
Vaccine: FLUN3
Symptoms: Respiratory tract congestion
Clinical narrative: A non-serious, spontaneous report of congestion has been received from a patient's mother concerning her ten-year-old child subsequent to FLUMIST. The patient's medical history was not reported. The patient received FLUMIST on an unspecified date. On 21-Sep-2009, the patient developed congestion. The event resolved the same day.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: A spontaneous, non-serious event of administration of FLUMIST to a pregnant women was received from a nurse concerning an adult female patient. The patient was eight months pregnant. On 09-Sep-2009, the patient received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to report when the pregnancy has ended and report if the patient experiences any adverse events during the pregnancy.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, Eye pruritus, No reaction on previous exposure to drug, Ocular hyperaemia
Clinical narrative: A non-serious spontaneous report of vaccine administration into the right eye with resulting itching and redness has been received from a consumer concerning a 31-year-old male, subsequent to FLUMIST. No medical history was provided but he indicated that he wears contact lenses; no concomitant medication information was provided. The patient stated that he has received FLUMIST for the last two years without any adverse reactions. The consumer received a single dose of FLUMIST nasally on 07-Sep-2009 for influenza vaccination. The consumer stated that at the time of the administration of the FLUMIST, he received some in his right eye. Three days later his eye was very itchy and red. He did not seek medical attention or receive any treatment. The right eye redness and itching resolved on 12-Sep-2009. Additional information received on 30-Sep-2009 and incorporated into the narrative included: event and vaccination details and the outcome of the events.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea, Pharyngeal oedema, Urticaria
Clinical narrative: A non-serious, spontaneous report of hives, swelling of the throat and diarrhea has been received from a certified medical assistant (patient's parent) concerning a 15-year-old male, subsequent to FLUMIST. Medical history and concomitant mediations were not reported. On 05-Sep-2009, the patient received FLUMIST. On 05-Sep-2009, within 25-30 minutes after receiving FLUMIST, the patient was covered head to toe with hives, experienced swelling of the throat, and diarrhea. The events resolved.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Diarrhoea, Rash, Urticaria
Clinical narrative: A non-serious, spontaneous report of hives, rash and diarrhea has been received from a Certified Medical Assistant concerning herself, a 49-year-old female, subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 05-Sep-2009, the patient received FLUMIST. On 05-Sep-2009, within a few hours after receiving FLUMIST, the patient developed hives and a rash on her trunk, scalp, arm and leg; and diarrhea. The events resolved.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Chest pain, Cough, Hypersensitivity, Rhinorrhoea
Clinical narrative: A non-serious, spontaneous report of chest pain, runny nose, sniffles and cough has been received from a registered nurse concerning an eight-year-old patient after receiving FLUMIST. Medical history included seasonal allergies and bronchial pneumonia. Concomitant medications included oral cetirizine 2.5 mg as needed and oral diphenhydramine 12.5 mg as needed. On 04-Sep-2009, the patient received a single dose of FLUMIST. On 06-Sep-2009, the patient developed a runny nose, sniffles and cough. On 07-Sep-2009, all of the events resolved. On 08-Sep-2009, the school nurse called the patient's mother and reported that the child had chest pains while on the playground. The patient had some water and then rested. The pain improved. On 10-Sep-2009, the patient went to the pediatrician and was diagnosed with allergies not related to FLUMIST. He was prescribed oral montelukast sodium 5 mg once a day. The outcome of the events, runny nose, sniffles and cough, was resolved on 07-Sep-2009. The outcome of the event, chest pains, was not recovered/not resolved. The pediatrician assess the events, chest pain, runny nose, sniffles and cough, as not related to FLUMIST. He attributed these events of allergies.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: A spontaneous, non-serious report of fever, headache and tiredness has been received from a registered nurse concerning an 11-year-old female patient subsequent to FLUMIST use. Medical history and concomitant medications were not reported. On 08-Sep-2009, the patient received FLUMIST. After receiving FLUMIST on 08-Sep-2009, the patient developed a fever of 101 and complained of headaches and being tired. No further information was available. The outcome of the events, fever, headache and tiredness, was unknown.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A non-serious spontaneous report of positive for influenza B has been received from a consumer and a physician 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 FLUMIST on 09-Sep-2009. On 14-Sep-2009 the patient tested positive for Type B Influenza. Outcome and causality were not reported. Additional information was received on 14-Sep-2009 from the patient's physician that included the following: reporter information and event onset.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Influenza virus test positive, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: A spontaneous, non-serious report of fever, stomach ache, runny nose and achy all over has been received from a physician concerning a 14 year-old female patient subsequent to receiving FLUMIST. Medical history and concomitant medications were not reported. On 26-Aug-2009, the patient received FLUMIST. On 29-Aug-2009, the patient developed a fever, stomach ache, runny nose and achy all over. A rapid flu test was positive. No further information was reported. The outcome of the events fever, stomach ache, runny nose and achy all over were not reported.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza B virus test positive, Influenza like illness, Pyrexia
Clinical narrative: A non-serious, spontaneous report of positive B strain, flu like symptoms and fever has been received from a registered nurse concerning an eight-year-old female patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 24-Aug-2009. On 26-Aug-2009, the patient presented with flu-like symptoms including fever. She was tested for flu which came back B positive. The outcome of the events was not reported.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious, spontaneous report of administration to pregnant female was received from a Registered Nurse concerning a 40-year-old female. The patient's medical history and obstetrical history were not reported. There was no adverse event experienced to date. 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: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Influenza B virus test positive, Lymphadenopathy, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious, spontaneous report of swollen glands, fever, chills, runny nose and positive B flu has been received from a registered nurse concerning a 12-year-old female patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 27-Aug-2009. On 31-Aug-2009, the patient presented with fever of 102.5 degrees for two to three days, swollen glands, chills and runny nose. She tested positive for B flu. The outcome of the events was not reported.
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 nursing assistant in a private doctor's office concerning an eight-year-old female. The patient's medical history and concomitant medications were not reported. The product expired in Dec-2008. On 24-Aug-2009, the patient received expired FLUMIST. On 11-Sep-2009, the reporter confirmed that there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. The customer reported that they thought all expired FLUMIST was removed from inventory at the end of the 2008-2009 season. The product was missed and inadvertently used. Additional information was received on 11-Sep-2009 and 16-Sep-2009 and incorporated into the narrative: included confirmation from reporter that no adverse events were associated with this medication error and product complaint information. Additional information was received on 14-Oct-2009: included patient's date of birth.
Age: 6.0
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 nursing assistant in a private doctor's office concerning a six-year-old male. The patient's medical history and concomitant medications were not reported. The product expired in Dec-2008. On 24-Aug-2009, the patient received expired FLUMIST. On 11-Sep-2009, the reporter confirmed that there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. The customer reported that they thought all expired FLUMIST was removed from inventory at the end of the 2008-2009 season. The product was missed and inadvertently used. Additional information was received on 11-Sep-2009 and 16-Sep-2009 and incorporated into the narrative: included confirmation from reporter that no adverse events were associated with this medication error and product complaint information. Additional information was received on 14-Oct-2009: included patient's date of birth.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: A non serious spontaneous report of rash has been received from a physician concerning a seven-year-old male, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received a single dose of FLUMIST on 22-Sep-2009. An hour after receiving FLUMIST he had a rash on his chest of tiny raised bumps. There was no itching or other signs or symptoms. The following day the reporter indicated the event had resolved.
Age: 20.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: A non-serious, report of pregnancy was received from a registered nurse concerning a 20-year-old female. On 17-Nov-2009, the patient received FLUMIST. Neither relevant medical history nor obstetrical history have been reported for this patient. The patient tested positive for pregnancy on 20-Nov-2009. Treatment and reporter causality assessments are not applicable.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Lip swelling, Rash, Swollen tongue
Clinical narrative: A non-serious spontaneous report of swelling of tongue, swelling of lips and rash on nose around the mouth and cheeks has been received from a registered nurse concerning a 30-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 23-Nov-2009 for an unreported indication. One day after receiving FLUMIST, the patient developed rash on her nose, around her mouth and cheeks which later progressed to swelling of lips and tongue. On 27-Nov-2009, the patient sought treatment and was given a prescription for prednisone. The outcome for the reported adverse events was not reported.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: A spontaneous, non-serious report of rash was received from a nurse concerning a nine-year-old female patient subsequent to FLUMIST administration. Medical history and concomitant medications were not reported. On 25-Nov-2009, the patient received FLUMIST. On 26-Nov-2009, the patient developed a rash localized to her "belly" that looked like a "splotchy sunburn". The outcome of the event, rash, was not reported.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash pruritic
Clinical narrative: A spontaneous, non-serious report of rash was received from a nurse concerning a six-year-old female patient subsequent to FLUMIST administration. Medical history and concomitant medications were not reported. On 25-Nov-2009, the patient received FLUMIST. On 26-Nov-2009, the patient developed a rash around her neck, which presented as little tiny bumps that were very itchy. The rash spread from the lower portion of her neck down to her torso. The outcome of the event, rash, was not reported.
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a 53-year-old female was received from a patient/consumer. Neither relevant medical history nor concomitant medications have been reported for this patient. There was no adverse event associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of "FLUMIST administered to a pregnant woman at week 17" was received from a physician concerning a female patient. On 13-Dec-2009, FLUMIST was administered to the patient who is 17-weeks pregnant. The nurse in the physician's office reported that they are in contact with the patient to follow-up her condition but they do not have any additional information as of 15-Dec-2009. The patient's medical history and concomitant medications are unknown. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor 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: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a consumer concerning a six-year-old female, subsequent to FLUMIST. The patient was healthy at the time of vaccination. Concomitant medication was not reported. The patient received FLUMIST intranasally on 13-Dec-2009. On 16-Dec-2009, the patient developed fever of 38.8. The patient had not returned to the doctor. The outcome of the event was not reported.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthma, Contraindication to vaccination, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of FLUMIST to a person with asthma was received from a physician concerning an 11 year old male subsequent to the administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 02-Nov-2009, the patient received FLUMIST inadvertently. There was no adverse event associated with this vaccination error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Influenza B virus test positive, Pyrexia
Clinical narrative: A non-serious spontaneous report of positive flu strain B and fever was received from a health professional concerning a 61 month old female. Medical history and concomitant medications were not reported. On 24-Aug-2009 the patient received FLUMIST. On 27-Aug-2009, the patient tested positive for Flu B and had a temperature of 104 Fahrenheit. The outcome of the events flu strain B and fever was not reported.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye irritation, Oropharyngeal pain, Pain, Rhinorrhoea, Sneezing
Clinical narrative: A non-serious, spontaneous report of eyes burning, achy, nose running, sore throat and sneezing was received from a consumer concerning a 14-year-old female patient subsequent to FLUMIST. The patient's past medical history includes asthma. No concomitant medications have been reported for this patient. The patient received FLUMIST on 21-Aug-2009 for an unknown indication. On the evening of 21-Aug-2009 the patient experienced eyes burning, achy, nose running, sore throat and sneezing. The physician knew the patient had asthma before administering FLUMIST. The events were ongoing as of 26-Aug-2009.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Hallucination
Clinical narrative: A non-serious spontaneous report of hallucinations was received from a physician concerning a five-year-old female subsequent to FLUMIST. No known medical history or concomitant medications were reported. The patient received FLUMIST on 14-Aug-2009. It was reported that about 24 to 30 hours after FLUMIST administration the patient complained of having spiders on her and started grabbing things out of her hair. According to the parents it seemed like she had nightmares while awake which lasted about two hours. There was no report of fever, new medications or head trauma. The event lasted for two hours.
Age: 12.0
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 12 year-old female. The patient's medical history was not reported. On 18 Aug 2009, the patient inadvertently received FLUMIST that expired on 05 Apr 2009. There was no adverse event associated with this medication; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of accidental exposure and sore throat has been received from a MedImmune representative concerning an adult female. Medical history and concomitant medications were not reported. On an unspecified date last year, the reporter stated a nurse reported after each flu clinic with FLUMIST last year, the nurse experienced a sore throat for a day. The events accidental exposure during administration and sore throat resolved.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Malaise, Oropharyngeal pain
Clinical narrative: A spontaneous, non-serious report of headache and sore throat has been received from a consumer concerning a 12-year-old female patient subsequent to FLUMIST use. Medical history and concomitant medications were not reported. On 04-Sep-2009, the patient received FLUMIST. On 05-Sep-2009, the patient developed a headache, sore throat without fever over the weekend. The patient still did not feel well, so she was sent home from school. No further information was available. The outcome of the events of headache and sore throat were ongoing.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A spontaneous, non-serious report of administration of expired FLUMIST has been received from a physician concerning a nine-year-old male patient. Medical history and concomitant medications were not reported. On 08-Sep-2009, the patient received expired FLUMIST (expiration date 12-Dec-2008). There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Lethargy, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of lethargic, stomach ache, high fever, and sore throat has been received from a nurse 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 on 02-Sep-2009. The patient received a single dose before onset of the events. On 03-Sep-2009, the patient developed lethargy, stomach ache, high fever, and sore throat. The outcome and causality were not reported.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza virus test positive, Malaise, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: A non-serious, spontaneous report of positive flu test, sore throat, fever, and vomiting has been received from a registered nurse concerning a 13-year-old female subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 01-Sep-2009. On 02-Sep-2009, the patient experienced a sore throat and on 04-Sep-2009 was feeling horrible and tested positive for the flu, had a fever of 102.1 and vomiting. At the time of the report, the events were ongoing.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: A non-serious report of positive B strain test has been received from a nurse practitioner concerning a five-year-old male subsequent to FLUMIST. The patient's past medical history and concomitant medications are not provided. The patient received FLUMIST on 25-Aug-2009. On 31-Aug-2009, the patient tested positive for B strain of influenza. Outcome of the event was unknown. Reported causality assessment was not provided.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A spontaneous, non-serious event of administration of expired FLUMIST was reported by a nurse concerning a 23-year-old male patient. Medical history and concomitant medications were not reported. On 24-Aug-2009, the subject received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 15-Oct-2009 and 16-Oct-2009: the patient has not experienced any adverse event and was revaccinated for the flu.
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST to a 52 year old female was received from a health professional concerning a 52-year-old female subsequent to administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 24-Aug-2009, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. Additional information was received on 15-Oct-2009 and incorporated into the narrative: confirmed the patient did not experience any adverse events associated with the medication error and the patient was re-vaccinated with FLUMIST.
Age: 55.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST and administration of FLUMIST to 55-year-old female was received from a registered nurse. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 31-Aug-2009 or 01-Sep-2009. The product expired in Apr-2009. The patient was re-vaccinated with the "flu shot" on an unspecified date. On 15-Oct-2009, the reporter confirmed there was no adverse event associated with the medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. Additional information was received on  15-Oct-2009 and incorporated into the narrative: confirmed the patient did not experience any adverse events associated with the medication error and the patient was re-vaccinated with the "flu shot."
Age: 11.0
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 registered nurse concerning an 11-year-old female patient. Neither relevant medical history nor concomitant medications were reported. On 01-Sep-2009, the patient received FLUMIST that expired in April 2009. Follow-up with the reporter on 15-Oct-2009 showed "the patient was doing fine with no problems after taking the expired FLUMIST. She has been re-vaccinated for the flu and had no problems or reaction of any kind. The patient is doing great". There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Oct-1009 and incorporated in the narrative: outcome of the adverse event.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever, body ache, chills, and sore throat has been received from a nurse concerning a 14-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 29-Aug-2009. On 30-Aug-2009, the patient developed fever of 102, body ache, chills, and sore throat. The outcome of fever, body ache, chills, and sore throat was not reported.
Age: 64.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a 64-year-old female was received from a health professional. Neither relevant medical history nor concomitant medications have been reported for this patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of hives has been received from a nurse concerning an eight-year-old female, subsequent of FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST in Feb-2009. The patient received a total of two doses before onset of the event. One week after the second dose of FLUMIST, the patient experienced hives. The event of hives was reported as resolved. Causality was not reported.
Age: 73.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to individual over 49 years of age was received from a registered nurse involving a 73-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 11-Sep-2009, the patient received FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. On 20-Oct-2009, it was confirmed that the patient did not experience any adverse events.
Age: 77.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to an individual over 49 years of age was received from a registered nurse involving a 77-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 11-Sep-2009, the patient received FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. On 20-Oct-2009, it was confirmed that the patient did not experience any adverse events.
Age: 69.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a female greater that 49 years old was received from a licensed practical nurse concerning a 69-year-old female. Relevant medical history and concomitant medications were not reported. On 11-Sep-2009, the patient received FLUMIST. There were no adverse events associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. Follow-up obtained on 0-Oct-2009 verified no adverse events occurred.
Age: 55.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a patient over 50 years old was received from a nurse concerning a 55-year-old female. There were no observable changes in the patient following dosing with FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 06-Oct-2009 confirmed that no adverse event was associated with this medication error.
Age: 63.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST given to a female greater than 49 years of age was received from a licensed practical nurse concerning a 63-year-old female. On 11-Sep-2009, the patient received FLUMIST. On 06-Oct-2009, the reporter confirmed that the subject did not experience any adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 06-Oct-2009 and incorporated into the narrative: included confirmation that the patient did not experience any adverse events associated with the vaccination error.
Age: 61.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Nasal congestion
Clinical narrative: A non-serious, spontaneous report of administered FLUMIST to a person over 49 years of age and slightly stuffy nose has been received from a nurse concerning a 61-year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 11-Sep-2009. The only observable change in the patient following FLUMIST was a slightly stuffy nose. The patient recovered from the event of slightly stuffy nose on 14-Sep-2009. Additional information was received on 06-Oct-2009 and incorporated into the narrative: updated outcome.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Fatigue, Influenza, Pyrexia, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of influenza and vomiting was received from a consumer concerning a seven-year-old male, subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on 17-Aug-2009.  On 13-Sep-2009, the patient developed fever of 100.8.  On 14-Sep-2009, temperature was 103.  The patient also experienced some coughing, sneezing, with some congestion.  On 14-Sep-2009, the patient tested positive for Influenza A and seemed tired.  The patient was treated with oseltamivir, which resulted in vomiting.  Outcome and causality were not reported.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Sneezing, Vomiting
Clinical narrative: A non-serious spontaneous report of influenza and vomiting was received from a consumer concerning a seven-year-old male, subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on 17-Aug-2009.  On 13-Sep-2009, the patient developed fever of 100.8.  On 14-Sep-2009, temperature was 103.  The patient also experienced some coughing, sneezing, with some congestion.  On 14-Sep-2009, the patient tested positive for Influenza A and seemed tired.  The patient was treated with oseltamivir, which resulted in vomiting.  Outcome and causality were not reported.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of gave expired FLUMIST was received from a nurse concerning a 10-year old female. On 03-Feb-2010, the patient received FLUMIST that expired on 02-Feb-2010. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 11-May-2010, and incorporated into the narrative: there were no associated adverse events.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired vaccine has been received from a registered nurse concerning a 38-year old female. On 03-Feb-2010, the patient received FLUMIST that expired on 02-Feb-2010. The patient was instructed to call or follow-up with the reporter if she had any symptoms/adverse events after receiving FLUMIST. As of 11-May-2010, she did not report any adverse events. There were no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. On 11-May-2010, follow-up information (no adverse events were associated with this medication error), was received and incorporated into the narrative.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of gave expired FLUMIST was received from a nurse concerning a 14-year-old male. On 03-Feb-2010, the patient received FLUMIST that expired on 02-Feb-2010. There were no subsequent adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 11-May-2010 and incorporated into the case: there were no associated adverse events.