chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUN3
Symptoms: Eustachian tube obstruction
Clinical narrative: A non-serious spontaneous report of blocked eustachian tube has been received from a physician concerning an adult (year of birth is 1963) male, subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 06-Oct-2009. The patient received a total of one dose of FLUMIST before the onset of the event given on 06-Oct-2009. On 06-Oct-2009, the patient experienced blocked eustachian tube within 24 hours after FLUMIST administration. Another relevant etiological factor was that the patient had cold. The event was resolved on 07-Oct-2009.
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 55-year-old female was received from a nurse. The subject's medical history and concomitant medications were not provided. The subject received FLUMIST on 08-Oct-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessment are not
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of patient over the age of 49 was administered FLUMIST has been received from a nurse concerning a male born in 1947. Neither relevant medical history nor concomitant medications have been reported for this patient. 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: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious, spontaneous report of fever of 102 F has been received from a mother concerning her eight-year-old daughter subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 22-Sep-2009. On the evening of 26-Sep-2009, the patient started running fever of 102 degrees Fahrenheit. The outcome of the adverse event was not reported.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness, Influenza virus test positive, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of positive for influenza has been received from a physician concerning a ten-year-old male, subsequent to FLUMIST. No medical history or concomitant medication information was reported. The patient received FLUMIST on 25-Sep-2009. Three days later on 28-Sep-2009, the patient presented to his health care provider with flu-like symptoms including a fever and sore throat, he tested positive for influenza. No outcome was reported for the event of influenza.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: A non-serious spontaneous report of Flu-like symptoms has been received from a consumer/mother concerning her 10-year-old daughter, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. About two months ago in approximately September 2009, the patient received FLUMIST. The same night after the vaccine was administered, the patient experienced a fever and other mild flu-like symptoms. The event resolved within 24 hours of onset.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: A non-serious spontaneous report of Flu-like symptoms has been received from a consumer/mother concerning her 11-year-old daughter, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. About two months ago in approximately September 2009, the patient received FLUMIST. The same night after the vaccine was administered, the patient experienced a fever and other mild flu-like symptoms. The event resolved within 24 hours of onset.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: A non-serious spontaneous report of Flu-like symptoms has been received from a 33-year-old female consumer, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. About two months ago in approximately September 2009, the patient received FLUMIST. The same night after the vaccine was administered, the patient experienced a fever and other mild flu-like symptoms. The event resolved within 24 hours of onset.
Age: 65.0
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of FLUMIST to a 60-year-old" was received from a registered nurse concerning a 65-year-old patient (gender not reported). On 28-Sep-2009, the patient received FLUMIST. 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.
Age: 38.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: A non-serious spontaneous report of Flu-like symptoms has been received from a consumer concerning her husband, a 38-year-old male, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. About two months ago in approximately September 2009, the patient received FLUMIST. The same night after the vaccine was administered, the patient experienced a fever and other mild flu-like symptoms. The event resolved within 24 hours of onset.
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 consumer/husband concerning his wife, an adult female. At the time of report, 28-Sep-2009, the patient found out that she was two weeks pregnant. Two weeks prior to 28-Sep-2009 she received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessment are not applicable.
Age: 18.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Arthralgia, Muscle tightness, Neck pain
Clinical narrative: A non-serious spontaneous report of severe joint pain has been received from a consumer concerning an 18-year-old female, subsequent to FLUMIST. The patient reported no past medical history. Concomitant medications include GARDASIL. The patient received FLUMIST on 26-Sep-2009. On 28-Sep-2009, the patient experienced severe joint pain in her fingers, toes, knees, neck pain, and muscle tightness around her chest and back. On 28-Sep-2009, after consultation with her pediatrician, who suggested the possibility of Guillain-Barre Syndrome, the patient went to an urgent care facility for observation and Guillain-Barre Syndrome was ruled out. The patient received her second dose of GARDASIL the same day as FLUMIST. The outcome of the event of severe joint pain was recovering. Causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Eye haemorrhage
Clinical narrative: A non serious, spontaneous report of hemorrhage in ocular globe and epistaxis has been received from a physician concerning herself, a 43-year-old female, subsequent to FLUMIST. The patient reported no pertinent past medical history. The patient has no drug allergies and was taking calcium for prevention. The patient received FLUMIST intranasal on 28-Sep-2009 for prevention. On 28-Sep-2009 on the evening after FLUMIST the patient experienced nosebleed which was controlled. On 29-Sep-2009 the patient experienced hemorrhage in the right ocular globe. The patient recovered from the events of epistaxis and hemorrhage in the ocular globe on 29-Sep-2009. Additional information was received on 07-Oct-2009 and incorporated into the narrative: updated terms and outcome.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza virus test positive, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of positive for flu has been received from a pharmacist concerning a five-year-old female, subsequent to FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received FLUMIST on 26-Sep-2009. On Monday night, 28-Sep-2009, the patient woke up with a high fever, runny nose and sore throat. She was examined by a doctor on Tuesday 29-Sep-2009; a nasal swab was performed and was positive for flu. The outcome of the event is unknown.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Diarrhoea, Influenza virus test negative, Nausea, Vomiting
Clinical narrative: A spontaneous, non-serious report of nausea, vomiting and diarrhea has been received from a nurse practitioner, concerning a 42-year-old female patient subsequent to FLUMIST use. Medical history and concomitant medications were not reported. On 22-Sep-2009, the patient received FLUMIST. On 25-Sep-2009, the patient presented to the emergency room (ER) with nausea, vomiting and diarrhea. A rapid flu test was negative. The patient was sent home the same day and has recovered from the events. The outcome of the events, nausea, vomiting and diarrhea, was resolved. The reporter did not believe the patient's illness was related to FLUMIST.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a pregnant female was received from a pharmacist concerning a 16-year-old female. No medical or obstetrical history was reported. On 30-Sep-2009 a pregnant female received FLUMIST at a drive thru clinic, the vaccine administrator did not ask the patient if she was pregnant. There was no adverse event experienced to date. 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 pregnancy.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious, spontaneous report of fever, sore throat and cough was received from a nurse concerning a nine-year-old male patient subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 30-Sep-2009 for an unknown indication. On the morning of 02-Oct-2009 the patient experienced a fever of 101.1 degrees Fahrenheit, sore throat and cough. No additional details were provided. The outcome for the reported adverse events was not reported.
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a pregnant female was received from a consumer concerning an adult female. No medical history was reported, the patient is 39 weeks pregnant. On 30-Sep-2009 a pregnant female received FLUMIST. The patient contacted her physician who indicated "everything should be ok." There was no adverse event experienced to date 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: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: A non-serious spontaneous report of "tested positive for Flu B" has been received from a health care professional concerning an eight-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 26-Sep-2009. At the time of administration the patient had strep throat and "was sick." On 30-Sep-2009, the patient "came back sick and had normal flu symptoms", the patient tested positive for influenza B. Outcome and causality were not reported.
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to a pregnant female was received from a company representative concerning an adult female. No medical or obstetrical history or concomitant medications were reported. There was no adverse event experienced to date. 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: 20.0
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 female was received from a nurse concerning a 20-year-old female. The patient's medical history included bronchitis. No obstetrical history was provided and the patient was not taking any concomitant medications. The patient was exposed to FLUMIST on 01-Oct-2009 at 24 weeks gestation. The patient's last menstrual period was 14-Apr-2009 and the expected date of delivery was 21-Jan-2010. There was no adverse event associated with this pregnancy and after two weeks following administration. 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. Additional information was received on 07-Oct-2009 and incorporated into the narrative: patient and pregnancy information. Additional information was received on 15-Oct-2009 and incorporated into the narrative: no adverse events after two weeks of follow-up.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthma, Condition aggravated, Contraindication to vaccination
Clinical narrative: A spontaneous, non-serious event of asthma attack has been received from an office manager, concerning a five-year-old male patient subsequent to receiving FLUMIST. Medical history included asthma. Concomitant medications were not reported. On an unknown date in October 2009, the patient received FLUMIST. In the evening on the day the patient received FLUMIST, the patient experienced a severe asthma attack. The patient was not hospitalized but required nebulizer treatments for a few days. The patient was currently doing well. The outcome of the event, asthma attack, was resolved.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a physician concerning a 74 month old female subsequent to FLUMIST. Medical history and concomitant medications were not reported. The patient received a single dose of FLUMIST on 03-Oct-2009. The same day, at night, the patient ran a fever of 102. On 05-Oct-2009, the fever had decreased to 99.9. The event was resolving.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious, spontaneous report of administration of FLUMIST to a pregnant female was received from a registered nurse concerning a 32-year-old female patient. The patient's medical and obstetrical history was not provided. The patient received FLUMIST on 03-Oct-2009. There was no adverse event experienced to date. Treatment and reporter/sponsor causality assessment are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the subject experiences any adverse events during the pregnancy.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Anxiety
Clinical narrative: A non-serious, spontaneous report of anxiety attack has been received from a nurse concerning a 13-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received single dose FLUMIST on 21-Oct-2009. On 21-Oct-2009, within minutes after administration of FLUMIST, the patient experienced an anxiety attack. Paramedics were called and the patient was not hospitalized. After deep breathing exercises, the patient recovered. Anxiety attack was considered resolved 21-Oct-2009. Causality was not reported.
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered FLUMIST to a pregnant woman was received from a registered nurse concerning an adult female. Medical history and concomitant medications were not reported. The patient's obstetrical history included one full-term delivery. 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 experienced any adverse events during the pregnancy. Additional information was received on 05-Nov-2009 and incorporated into the narrative: included number of full-term deliveries.
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of A 52-year-old female who got FLUMIST was received from a registered nurse concerning a 52-year-old female subsequent to administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 02-AUG-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.
Age: 66.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of gave FLUMIST to a person > 49 years of age was received from a nurse concerning a 66-year old male. Medical history and concomitant medications were not reported. On 11-Nov-2009, the patient was inadvertently administered 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.
Sex: U
Vaccine: FLUN3
Symptoms: Drug administration error, Incorrect dose administered, No adverse event
Clinical narrative: A non-serious, spontaneous report of "patients got a full dose of FLUMIST in each nare" was received from a nurse practitioner concerning 16-20 adult patients. The nurse practitioner discovered that an office assistant was administering two doses of FLUMIST per patient, one in each nostril. The patients received the doses from 24-Sep-2009 through 16-Oct-2009. There were no adverse events associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Nasal congestion
Clinical narrative: A non-serious, spontaneous report of "patient got a full dose of FLUMIST in each nare" and nasal stuffiness was received from a nurse practitioner concerning a female adult patient. Sometime between 24-Sep-2009 and 16-Oct-2009, the patient received two doses of FLUMIST at one time, one full dose given into each nostril. After receiving FLUMIST, the patient developed nasal stuffiness. The outcome of the events, "patient got a full dose of FLUMIST in each nare" and nasal stuffiness, was resolved.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza A virus test positive, Influenza like illness, Pyrexia
Clinical narrative: A non-serious spontaneous report of tested positive for influenza A has been received from a certified medical assistant concerning a six-year-old male, subsequent to FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received FLUMIST on 30-Oct-2009. On 31-Oct-2009, the patient developed a fever of 104 degrees Fahrenheit and flu-like symptoms. On the same day, he tested positive for influenza A and was treated with oseltamivir. The outcome of the event was not provided.
Age: 10.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rash papular, Rash pruritic
Clinical narrative: A non-serious, spontaneous report of papular itchy rash over his trunk was received from a nurse practitioner concerning a ten-year-old male subsequent to FLUMIST and H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 24-Sep-2009 and H1N1, Intranasal on 06-Nov-2009. On the evening of 09-Nov-2009 the patient experienced a fine papular rash over his trunk. The rash was described as mildly itchy. The outcome for the event of papular rash and itchy rash was not reported.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Nasal congestion
Clinical narrative: A non-serious, spontaneous report of "patients got a full dose of FLUMIST in each nare" and nasal stuffiness was received from a nurse practitioner concerning a female adult patient. Sometime between 24-Sep-2009 and 16-Oct-2009, the patient received two doses of FLUMIST at one time, one full dose given into each nostril. After receiving FLUMIST, the patient developed nasal stuffiness. The outcome of the events, "patient got a full dose of FLUMIST in each nare" and nasal stuffiness, was resolved.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Arthralgia, Chills, Cough, Dizziness
Clinical narrative: A non-serious, spontaneous report of muscle strain, dizziness, paleness, flu like symptoms, chills, sore throat and pain in the abdomen, runny nose, cough, fatigue and cold extremities was received from a consumer concerning a seven-year-old female subsequent to FLUMIST. The patient's past medical history included H1N1 influenza in Aug-2009 and lymphadenopathy in left side of the neck following influenza since 2006. The patient was not taking any concomitant medications. The patient received FLUMIST on 23-Oct-2009 for flu vaccination. On 23-Oct-2009 following the vaccination the patient experienced flu-like-symptoms including dizziness, paleness, chills, sore throat, pain in the abdomen, runny nose, cough, fatigue and cold extremities. On 30-Oct-2009 the patient experienced left hip pain and was seen by physician on 04-Nov-2009 and diagnosed with a muscle strain. The patient participates in gymnastics. The patient recovered from the events of dizziness, paleness, flu like symptoms, chills, sore throat and pain in the abdomen, runny nose, cough, fatigue and cold extremities on 28-Oct-2009. The event of muscle strain improved although was ongoing.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Influenza like illness, Muscle strain, Oropharyngeal pain, Pallor
Clinical narrative: A non-serious, spontaneous report of muscle strain, dizziness, paleness, flu like symptoms, chills, sore throat and pain in the abdomen, runny nose, cough, fatigue and cold extremities was received from a consumer concerning a seven-year-old female subsequent to FLUMIST. The patient's past medical history included H1N1 influenza in Aug-2009 and lymphadenopathy in left side of the neck following influenza since 2006. The patient was not taking any concomitant medications. The patient received FLUMIST on 23-Oct-2009 for flu vaccination. On 23-Oct-2009 following the vaccination the patient experienced flu-like-symptoms including dizziness, paleness, chills, sore throat, pain in the abdomen, runny nose, cough, fatigue and cold extremities. On 30-Oct-2009 the patient experienced left hip pain and was seen by physician on 04-Nov-2009 and diagnosed with a muscle strain. The patient participates in gymnastics. The patient recovered from the events of dizziness, paleness, flu like symptoms, chills, sore throat and pain in the abdomen, runny nose, cough, fatigue and cold extremities on 28-Oct-2009. The event of muscle strain improved although was ongoing.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Peripheral coldness, Rhinorrhoea
Clinical narrative: A non-serious, spontaneous report of muscle strain, dizziness, paleness, flu like symptoms, chills, sore throat and pain in the abdomen, runny nose, cough, fatigue and cold extremities was received from a consumer concerning a seven-year-old female subsequent to FLUMIST. The patient's past medical history included H1N1 influenza in Aug-2009 and lymphadenopathy in left side of the neck following influenza since 2006. The patient was not taking any concomitant medications. The patient received FLUMIST on 23-Oct-2009 for flu vaccination. On 23-Oct-2009 following the vaccination the patient experienced flu-like-symptoms including dizziness, paleness, chills, sore throat, pain in the abdomen, runny nose, cough, fatigue and cold extremities. On 30-Oct-2009 the patient experienced left hip pain and was seen by physician on 04-Nov-2009 and diagnosed with a muscle strain. The patient participates in gymnastics. The patient recovered from the events of dizziness, paleness, flu like symptoms, chills, sore throat and pain in the abdomen, runny nose, cough, fatigue and cold extremities on 28-Oct-2009. The event of muscle strain improved although was ongoing.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of two doses one day apart was received from a physician concerning a nine-year-old male. On 19-Nov-2009 the patient received a second dose of FLUMIST after they received a dose the previous day. 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: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: A non-serious spontaneous report of headache has been received from a consumer, the patient's wife, concerning an 33-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received FLUMIST on 27-Oct-2009. He received a total of one dose of FLUMIST before the onset of the event. After FLUMIST administration on 27-Oct-2009, the patient experienced a headache. The event resolved within one day on 27-Oct-2009.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of the full FLUMIST dose in one nostril was received from a pharmacist concerning a five-year-old female subsequent to the administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 18-Nov-2009, the patient received a full dose of FLUMIST into one nostril. 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: F
Vaccine: FLUN3
Symptoms: Influenza like illness
Clinical narrative: A non-serious spontaneous report of flu-like symptoms has been received from a consumer concerning her friend's five-year-old daughter, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not provided. The patient received FLUMIST via nasal route on an unspecified date in Oct-2008. Two days after FLUMIST vaccination, the patient experienced flu-like symptoms. She was evaluated by her physician. No medications were provided. The event resolved five days after onset. Per the reporter, the patient's physician was not sure if the symptoms were caused by FLUMIST.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious report of pregnancy was received from a registered nurse concerning a 36-year-old female patient. The patient's medical history and obstetrical history was not reported. On 29-Sep-2009, the patient received FLUMIST. On an unspecified date after receiving FLUMIST, she found out that she was pregnant. The patient's last menstrual period, estimated date of delivery, and number of weeks gestation was not reported. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Influenza A virus test positive, Influenza like illness, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious, spontaneous report of flu-like symptoms and Influenza A has been received from a licensed practiced nurse concerning a six-year-old female patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 16-Oct-2009. On 16-Oct-2009, the patient experienced flu-like symptoms manifested as a fever of 103.1F, cough, sore throat, a runny nose. On an unknown date, the patient tested positive for Influenza A. On an unknown date, the events of flu-like symptoms and Influenza A resolved.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious, spontaneous report of flu-like symptoms and Influenza A has been received from a licensed practiced nurse concerning a six-year-old female patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 16-Oct-2009. On 16-Oct-2009, the patient experienced flu-like symptoms manifested as a fever of 103.1F, cough, sore throat, a runny nose. On an unknown date, the patient tested positive for Influenza A. On an unknown date, the events of flu-like symptoms and Influenza A resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of a girl got FLUMIST and then found out pregnancy was received from a registered nurse concerning a teenage (16 or 17-years-old) female. The patient's medical and obstetrical history were not reported. On an unknown date, the patient received FLUMIST at her school and later found out that she was pregnant. Laboratory test, date of last menstrual period, estimated date of delivery and number of weeks gestation were not reported. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable.
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 nurse concerning an adult female. On 10-Nov-2009, the patient received FLUMIST. The patient's obstetrical history included that she was in her second trimester. 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: 64.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report expired FLUMIST administered to a patient who is older than 49 years was received from a consumer concerning a 64-year-old female. The patient's medical history was not reported. The product expired on 01-Jan-2009. On 30-Oct-2009, the patient received expired FLUMIST. On 04-Nov-2009, the patient was revaccinated with a current FLUMIST. There was no adverse event associated with the vaccination error or expired vaccine used; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 56.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "a 56 year old received FLUMIST" was received from a nurse concerning a 56-year old male. On 11-Nov-2009, the patient was inadvertently administered FLUMIST. 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.
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: A non-serious spontaneous report of "staff person > 49 years of age received FLUMIST" was received from a nurse concerning a 53-year old female. On 13-Nov-2009, the patient inadvertently received FLUMIST. 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.
Sex: M
Vaccine: FLUN3, HEPAB, YF
Symptoms: Anaphylactic reaction
Clinical narrative: A serious spontaneous report of anaphylactic reaction has been received from a registered nurse concerning an adult male of unknown age, subsequent to FLUMIST along with Yellow Fever vaccine and TWINRIX vaccine. The patient's medical history and concomitant medication were not reported. The patient received FLUMIST along with Yellow Fever vaccine and TWINRIX vaccine on an unknown date. The patient received a total of one dose of FLUMIST before the onset of the event. The patient experienced the event of anaphylactic reaction, hives, wheezing and bradycardia, within 20 minutes after FLUMIST, Yellow Fever vaccine and TWINRIX vaccination administration. He was treated with two doses of epinephrine. The outcome of the event of anaphylactic reaction was recovered. The reporter assessed the event of anaphylactic reaction as related to FLUMIST, Yellow Fever vaccine and TWINRIX vaccine. On 30-Sep-2009, additional information was received from the reporter: she submitted a VAERS report to the Center of Disease Control.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Fatigue, Headache, Influenza virus test negative, Mononucleosis heterophile test negative
Clinical narrative: A non-serious spontaneous report of dizzy, sore throat, headache and extreme fatigue has been received from a consumer concerning a 16-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 25-Sep-2009 for unreported indication. Three weeks after receiving FLUMIST, the patient developed sore throat, headache, extreme fatigue and was dizzy. Laboratory findings were negative for mononucleosis and swine flu. Treatment for the events was not reported. The outcome for the reported adverse events is considered ongoing.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of dizzy, sore throat, headache and extreme fatigue has been received from a consumer concerning a 16-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 25-Sep-2009 for unreported indication. Three weeks after receiving FLUMIST, the patient developed sore throat, headache, extreme fatigue and was dizzy. Laboratory findings were negative for mononucleosis and swine flu. Treatment for the events was not reported. The outcome for the reported adverse events is considered ongoing.
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of mild congestion has been received from consumer concerning a 42-year-old male patient, subsequent to receiving FLUMIST and H1N1. The patient's medical history and concomitant medications were not reported. On 13-Oct-2009, the patient received H1N1 and on 23-Oct-2009, the patient received FLUMIST. On 24-Oct-2009, the patient experienced mild congestion. The reporter stated that the event of mild congestion resolved on 25-Oct-2009.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of FLUMIST to a 9-year-old with asthma was received from a registered nurse. The patient's medical history included asthma. Concomitant medications included the Flu Shot given 22-Sep-2009. 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: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administration to a pregnant 33-year-old female was received from a registered pharmacist. FLUMIST was administered on 15-Sep-2009. The patient's expected date of delivery was May 2010. 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: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest discomfort, Pruritus, Urticaria
Clinical narrative: A non-serious spontaneous report of chest tightness, itching, and head to toe hives has been received from a MedImmune Sales Representative concerning a 46-year-old female, subsequent to FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received her first dose of FLUMIST on 23-Oct-2009. Within five hours of receiving FLUMIST, the patient experienced head to toe hives, chest tightness and itching. She was treated with steroids. The outcome of the events was not provided.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: A non-serious, spontaneous report of "inadvertently gave FLUMIST that had been exposed to room temperature for 48 hours" has been received from a registered nurse concerning a 39-year-old female. On 22-Oct-2009, the patient was "inadvertently given FLUMIST that had been exposed to room temperature for 48 hours." 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: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "14-year-old patient at the clinic received two doses of FLUMIST by mistake" was received from a medical assistant concerning a 14-year-old female. No relevant medical history or concomitant medications have been reported for this patient. On 27-Oct-2009, the patient inadvertently received two doses of FLUMIST from two different nurses at the clinic on the same day. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Vomiting
Clinical narrative: A non-serious, spontaneous report of headaches and vomiting has been received from a nurse concerning a 22-year-old female patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 15-Oct-2009. On 15-Oct-2009, the patient developed a headache that lasted for two days and vomiting. Approximately one and a half weeks later, the patient experienced similar headaches and vomiting. The events of headaches and vomiting are ongoing.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of we gave the full dose of FLUMIST (0.2 ML) into one nostril was received from a nurse concerning a five-year-old female. No medical history nor concomitant medications were reported. On 22-Oct-2009, the patient received the entire 0.2ml FLUMIST dose in one nostril. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 56.0
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Vaccination error
Clinical narrative: A non-serious, spontaneous report of FLUMIST administered to a 56-year-old, has been received from a nurse concerning a 56-year-old female patient. The patient's medical history and concomitant medications was not reported. The patient received FLUMIST on 26-Oct-2009. The patient requested to have FLUMIST and informed the clinic during screening that she was "healthy." The administrator of the FLUMIST stated she failed to check age on consent form prior to giving FLUMIST. No adverse events were observed. 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: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness
Clinical narrative: A non-serious spontaneous report of flu-like symptoms has been received from a physician concerning a 15-year-old female patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 22-Oct-2009. On 23-Oct-2009, the patient got sick and experienced classic flu-like symptoms. On 27-Oct-2009, she tested positive for Influenza A. The outcome of the event was not reported.
Age: 20.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST exposure during pregnancy was received from a registered pharmacist concerning a 20-year-old female patient. The patient's medical history and concomitant medications were not reported. On an unknown date in Oct-2009, the patient received FLUMIST. The patient was 28 weeks pregnant at the time of FLUMIST administration. There was no reported adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: A non-serious spontaneous report of headache has been received from a registered nurse, concerning a 13-year-old male, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST on 23-Oct-2009. On the same day of vaccination, the patient got a headache. He complained of noise in the classroom and reported to the school nurse that he has does not get headaches. The patient was sent home. The adverse event resolved. The patient was back in class on 26-Oct-2009.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: A non-serious spontaneous report of headache has been received from a registered nurse, concerning a 14-year-old female, subsequent to FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST nasally on 23-Oct-2009. On the same day the vaccination, the patient got a headache. The adverse event resolved. The patient was back in class on 26-Oct-2009.
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Erythema, Heart rate increased, Muscle tightness
Clinical narrative: A non-serious spontaneous report of felt as if she was going to pass-out, mouth and jaw became tight, increased heart rate, and face and neck red has been received from a nurse concerning an adult female (age unknown), subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. History of allergies was not reported. The patient received FLUMIST on 29-Oct-2009. Approximately two hours after receiving FLUMIST, the patient's mouth and jaw became tight, she felt as if she was going to pass-out, and her face and neck were red. The patient was transported to the emergency room (ER). Her heart rate was increased while at the ER. The patient's symptoms subsided somewhat after a couple of hours, and she was sent home with orders to take diphenhydramine for four days.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Blood creatine phosphokinase increased, Grip strength decreased, Laboratory test normal, Pain in extremity
Clinical narrative: A spontaneous, non-serious event of muscle aches was received from a pharmacist (who was the patient) concerning a 39-year-old patient subsequent to FLUMIST administration. Medical history included that the patient "works out" a lot. Concomitant medications were not reported. On 28-Sep-2009, the patient received FLUMIST. This was the first time he had received FLUMIST. On 26-Oct-2009, the patient awoke during the night in response to achiness; his forearms "really hurt". The next night, 27-Oct-2009, the patient's legs began to hurt. On 28-Oct-2009, the pain continued. The patient also reported that it was difficult to grab and squeeze things; he said that he had difficulty pumping gas on 29-Oct-2009. Treatment included ibuprofen. He went to the doctor on 29-Oct-2009; laboratory tests were done and most of the tests were normal; however creatine kinase was "a little elevated". His physician prescribed diazepam and the patient took a dose that night to relieve the pain. The outcome of the event was not reported.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Sleep disorder
Clinical narrative: A spontaneous, non-serious event of muscle aches was received from a pharmacist (who was the patient) concerning a 39-year-old patient subsequent to FLUMIST administration. Medical history included that the patient "works out" a lot. Concomitant medications were not reported. On 28-Sep-2009, the patient received FLUMIST. This was the first time he had received FLUMIST. On 26-Oct-2009, the patient awoke during the night in response to achiness; his forearms "really hurt". The next night, 27-Oct-2009, the patient's legs began to hurt. On 28-Oct-2009, the pain continued. The patient also reported that it was difficult to grab and squeeze things; he said that he had difficulty pumping gas on 29-Oct-2009. Treatment included ibuprofen. He went to the doctor on 29-Oct-2009; laboratory tests were done and most of the tests were normal; however creatine kinase was "a little elevated". His physician prescribed diazepam and the patient took a dose that night to relieve the pain. The outcome of the event was not reported.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: No adverse event, Screaming, Vaccination error
Clinical narrative: A non-serious spontaneous report of "FLUMIST got in the corner of a two year old's eye" was from a licensed practical nurse concerning a 24-month-old male. The patient's medical history and concomitant medications were not reported. On 20-Oct-2009, the patient was administered FLUMIST. The patient was already screaming, and his eyes were shut when the nurse went to administer FLUMIST to the second nostril. Then the patient moved his head and some of the vaccine went to the corner of his eye. 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. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza like illness, Influenza virus test positive
Clinical narrative: A non-serious spontaneous report of positive influenza test has been received from a registered nurse concerning a seven-year-old male child, subsequent to FLUMIST. No medical history or concomitant medications were reported for this child. The patient received a single dose of FLUMIST on 12-Sep-2009. On 17-Sep-2009 the patient presented with flu like symptoms, an influenza test was positive. No outcome has been reported.