chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. 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 was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Urticaria
Clinical narrative: A non-serious, spontaneous report of fever of 104 and hives was received from a consumer, 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 30-Oct-2008. On 01-Nov-2008 the child experienced fever of 104 F and hives on her feet and lower back. On 02-Nov-2008 the reporter called their pediatrician and on 02-Nov-2008 was instructed to administer diphenhydramine. As of 03-Nov-2008 the fever is no longer present and the hives have subsided somewhat.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FluMist administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FluMist vaccine.  The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter / sponsor causality assessment are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient.  Neither medical history nor concomitant medications have been reported.  On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine.  The vaccine had an expiration date of March 2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after product expired.  Follow-up information was received on 09-Apr-2009:  Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy patients, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient.  Neither medical history nor concomitant medications have been reported.  On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine.  The vaccine had an expiration date of March 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.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication that occurred shortly after the product expired.  Follow-up information was received on 09-APR-2009:  Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peat of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient received expired FLUMIST vaccine. The vaccine had an expiration date of March 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. Bases on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient received expired FLUMIST vaccine. The vaccine had an expiration date of March 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-used report of expired FluMist administered was received from  a patient. Neither medical history nor concomitant medication have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FluMist vaccine. The vaccine had an expiration date of March 2009. There was no adverse event associated with this medication error; treatment and reporter / sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors occurred shortly after the product expired. Follow up information was received on 09-Apr-2009: Product complaint Investigation results.
Age: 24.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: A non-serious spontaneous report of administration to a pregnant female was received from a nurse practitioner concerning a 24-year old female. The patient was unaware of her pregnancy at two weeks gestation (estimated calculation obtained using the patient's last menstrual period) at the time of FLUMIST administration. The patient's obstetrical history included one pregnancy and one full-term delivery; the patient has no history of premature delivery, spontaneous abortion, elective termination, treatment for infertility, pregnancy complications and fetal/neonatal complications. The patient's second cousin reportedly has a history of retardation. There is no relevant information from the father in relation to this pregnancy. The pregnancy is ongoing at the time of this report. Treatment and reporter/sponsor causality assessments are not applicable.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Pain
Clinical narrative: A non-serious, spontaneous report of achiness and joint pain was received from a physician concerning a 27 year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 21-Oct-2008. Within a few hours after administration the patient had symptoms of achiness and joint pain on the left side of the body. As of 05-Nov-2008 the symptoms persist.
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Cough, Fatigue, Headache, Pyrexia
Clinical narrative: A non-serious spontaneous report of accidental exposure, influenza, fever exhaustion, coughing, headache and sneezing was received from a female adult consumer, who is a nurse, subsequent to FLUMIST. The patient administered FLUMIST "years ago". The reporter stated that, "twice I gave FLUMIST years ago and twice I contracted influenza. The reporter stated she was in bed for one week with exhaustion, a fever of 104, sneezing coughing and severe headache. The outcome of the events was not reported.  All follow up attemps completed.  Information not available 11-11-2009.
Sex: F
Vaccine: FLUN3
Symptoms: Sneezing
Clinical narrative: A non-serious spontaneous report of accidental exposure, influenza, fever exhaustion, coughing, headache and sneezing was received from a female adult consumer, who is a nurse, subsequent to FLUMIST. The patient administered FLUMIST "years ago". The reporter stated that, "twice I gave FLUMIST years ago and twice I contracted influenza. The reporter stated she was in bed for one week with exhaustion, a fever of 104, sneezing coughing and severe headache. The outcome of the events was not reported.  All follow up attemps completed.  Information not available 11-11-2009.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Abdominal pain upper, Nausea, Pain in extremity, Pyrexia
Clinical narrative: A non-serious, spontaneous report of pain in leg, stomach pain, fever and nausea was received from a nurse, concerning an 11 year-old female subsequent to FLUMIST. There was no relevant medical history reported for the patient. Concomitant therapy include GARDASIL vaccination given on 04-Nov-2008. The patient received FLUMIST, nasal, on 04-Nov-2008 for Flu vaccination. Six hours after administration the child had symptoms of stomach pain. On the morning of 05-Nov-2008 the patient still had stomach pains along with a fever of 101F, some nausea and hurting in the legs. The health department nurse referred the child to a local medical doctor for evaluation and the patient was seen by the physician on 05-Nov-2008 for the reported symptoms. By the time the patient was seen by the physician the symptoms had gone away and per the patients mother, the daughter "was all better". The treating physician informed the patient's mother events were likely related to stomach gas.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Migraine
Clinical narrative: A non-serious spontaneous report of migraine headaches and abdominal pain was received from a medical assistant in a physician's office concerning an 11-year-old female, subsequent to FLUMIST. The patient received FLUMIST ON 03-Nov-2008. Within several hours after the dose of FLUMIST the patient developed a migraine headache and abdominal pain. The events remained unresolved at the time of the report.
Sex: F
Vaccine: FLUN3
Symptoms: Skin laceration
Clinical narrative: A non-serious spontaneous report of FLUMIST syringe portion broke and caused town cuts on finger was received from a Registered Nurse in concerning a female adult of unknown age. Medical history and concomitant medications were not reported. On 04-Nov-2008, a nurse was administering FLUMIST to a patient. After removing the divider clip and depressing the plunger to the stopping point, the flange (flare) portion at the top of the barrel broke (shattered) leaving a jagged edge. The jagged edge ripped the nurse's gloves and caused two cuts on her finger. The nurse was concerned that the FLUMIST liquid went into the cuts although there was no liquid on the cuts, and inquired whether there were any safety concerns. The entire contents of the syringe was administered to the patient. The event is considered resolved.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash pruritic
Clinical narrative: A non-serious spontaneous report of itchy rash has been received from a certified medical assistant concerning an eight-year old male patient subsequent to FLUMIST. No relevant medical and medication history were reported for this patient. The patient received FLUMIST via nasal route at a private doctor's office during a Flu Clinic on 05-Nov-2008. Two hours after FLUMIST administration, the patient developed a rash which was described as extremely itchy. The patient recovered on the same day.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: A non-serious, spontaneous report of rash on forehead and upper half of face was received from a pharmacist, concerning a seven-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. On 05-Nov-2008, the patient received FLUMIST vaccine. The following morning on 06-Nov-2008, the patient developed rash on her forehead and upper half of face. The outcome of the event was not reported.
Age: 54.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administration to a 54 year-old was received from a 54 year-old female consumer subsequent to FLUMIST. The patient received FLUMIST (date not reported). The consumer reported that she received FLUMIT at her church and later discovered that FLUMIST was only indicated up to age 49 years of age. 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: F
Vaccine: FLUN3
Symptoms: Malaise, Oral herpes, Rhinorrhoea
Clinical narrative: A non-serious, spontaneous report of fever blister on the lip, "felt bad" and runny nose was received from a nurse concerning an adult female, subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. The patient received FLUMIST vaccine on 31-Oct-2008. Immediately after receiving FLUMIST, the patient began having a runny nose and just "felt bad". Two days later she woke up with a large fever blister on she lip and felt terrible. The following day, she was seen by a doctor, who agreed that her symptoms were caused by FLUMIST. The outcome of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious, spontaneous report of hives all over her body was received from a nurse, a 41 year-old female subsequent to FluMist. The patient's past medical history includes hives of unknown etiology and trips to the emergency room for IV treatment. Concomitant medications or therapies are unknown. The patient received FluMist , nasal on 04-Nov-2008 for flu vaccination. On the evening of 04-Nov-2009 the patient experienced hives all over her body. The patient went to the emergency room for treatment and received an unknown IV. The patient was not admitted. No additional reactions or descriptions of the reaction were reported of available. The patient recovered from the same night and did not consider the event a "big deal".
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of sore throat, body aches and low grade temperature has been received from a consumer concerning a 43 year-old female, subsequent to FLUMIST. No medical history or concomitant medication information was provided. The patient received FLUMIST on 5-Nov-2008. Less than 24 hours after receiving FLUMIST, the patient reported developing symptoms of sore throat, body aches and low grade temperature. The outcome of these events was not reported. The causality was not reported.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Malaise, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from the mother of the patient concerning a seven year-old male, subsequent to FLUMIST. The patient received FLUMIST on 07-Nov-2008. The patient received FLUMIST on a Friday and the mother reported that her son was sick all weekend with a fever up to 103. On 10-Nov-2008 the fever was 101.2. The patietn had not recovered
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal discomfort, Chills, Headache
Clinical narrative: A non-serious spontaneous report of headache, chills, and stomach upset has been received from a Doctor of Pharmacy concerning a 17-year-old female subsequent to FLUMIST. Medical history included headaches. The patient was not taking any concomitant medications. On 08-Nov-2008, the patient received FLUMIST, nasal administration for flu immunization. The patient had never received FLUMIST before. On 11-Nov-2008, the patient experienced a severe headache, chills with no fever, and stomach upset. The pharmacist did not know the location or type of headache. The patient was treated with ibuprofen and calcium carbonate. After 12 hours, the patient fully recovered.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 30 children ages range from five to seven years-old who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following patient demographics and outcome of the event.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of half the total dose of FLUMIST was received from a physician concerning a female child subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 30 children ages ranging form five to seven years-old who received half the total dose of FLUMIST in one nostril. The other half was discarded. 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: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 30 children ages ranged from to seven who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  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: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 30 children ranging in age from five to seven who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. Three 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST 06-Nov-2008. A physician reported that his office received a report of 30 children ranging in age from five to seven years who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  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 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: Inappropriate dose of vaccine administered (Incorrect dose administered). A non-serious spontaneous report gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician form CDC reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that one of the children experienced adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 30 children ranging in age from five to seven who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 31 children ranging in age from five to seven who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received form a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from CDC reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medications error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that one of the children experienced adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  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 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  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 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008. A physician from CDC reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. 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 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Age: 35.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A non-serious, spontaneous report of "gave it unknowingly to a pregnant women in her 3rd trimester" was received from a physician concerning a 35 year-old female. The patient's medical history included hypothyroidism, gestational diabetes, asthma and gastroesophageal reflux disease. Concomitant medications include levothyroxine since Feb-2008, glyburide since Nov-2008 and prenatal vitamins since May-2008. (Reference MEDI-0007555). The patient received FLUMIST for flu vaccination on 28-Oct-2008 during her 3rd trimester of pregnancy. The pregnancy was completed 2-Feb-2009 at full term via C-section. There were no complications with delivery and there were no adverse events, congenital anomalies or neonatal illness reported. Additional information was received on 27-Feb-2009 and incorporated into the narrative: pregnancy outcome.
Age: 35.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Diarrhoea, Drug exposure during pregnancy, Vomiting
Clinical narrative: A non-serious, spontaneous report of "gave it unknowingly to a pregnant women in her 3rd trimester" was received from a physician concerning a 35 year-old female. The patient's medical history included hypothyroidism, gestational diabetes, asthma and gastroesophageal reflux disease. Concomitant medications include levothyroxine since Feb-2008, glyburide since Nov-2008 and prenatal vitamins since May-2008. (Reference MEDI-0007555). The patient received FLUMIST for flu vaccination on 28-Oct-2008 during her 3rd trimester of pregnancy. The pregnancy was completed 2-Feb-2009 at full term via C-section. There were no complications with delivery and there were no adverse events, congenital anomalies or neonatal illness reported. Additional information was received on 27-Feb-2009 and incorporated into the narrative: pregnancy outcome.
Age: 35.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A non-serious, spontaneous report of vomiting and diarrhea was received from a consumer, concerning a 35 year-old female subsequent to FLUMIST. The patient's past medical history includes asthma, gestational diabetes, hypothyroidism and gastroesophageal reflux disease. The patient is currently in her third trimester of pregnancy with an expected due date of 10-Feb-2009 via caesarean section. Concomitant medications include SYNTHROID since Feb-2008. The patient received FLUMIST, nasal on 28-Oct-2008 for Flu Vaccination. That evening the patient experienced vomiting and diarrhea lasting for five days. The patient recovered from the events.
Age: 35.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Diarrhoea, Drug exposure during pregnancy, Vomiting
Clinical narrative: A non-serious, spontaneous report of vomiting and diarrhea was received from a consumer, concerning a 35 year-old female subsequent to FLUMIST. The patient's past medical history includes asthma, gestational diabetes, hypothyroidism and gastroesophageal reflux disease. The patient is currently in her third trimester of pregnancy with an expected due date of 10-Feb-2009 via caesarean section. Concomitant medications include SYNTHROID since Feb-2008. The patient received FLUMIST, nasal on 28-Oct-2008 for Flu Vaccination. That evening the patient experienced vomiting and diarrhea lasting for five days. The patient recovered from the events.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: A non-serious spontaneous report of runny nose and sneezing was received from the consumer concerning an eight year-old female, subsequent to FLUMIST.  The patient received FLUMIST on 11-Nov-2008.  The mother of the child reported that on 13-Nov-2008 the child was sent home with a runny nose and sneezing a lot.  The outcome was not reported.
Sex: F
Vaccine: FLUN3
Symptoms: Device breakage, Skin laceration
Clinical narrative: A non-serious spontaneous report "middle and index finger cuts" was received from a nurse concerning an adult female, subsequent to FLUMIST administration.  Neither medical history nor concomitant medications have been reported.  The reporter administered FLUMIST to another person.  As she was placing the syringe into the sharps container, she noticed blood on her hand.  After removing her glove, she found two small but deep cuts on her middle and index fingers that were bleeding.  She inspected the glove and noted three small puncture marks.  She then inspected the syringe and noticed that the finger flange was chipped.  She stated that the only way she could see this happening was due to the product packaging somehow being compressed or jostled enough to cause pressure during transport.  She was not sure if she did any compressing or jostling on the packages either.  The outcome of the event is unknown.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Influenza, Influenza serology positive, Pyrexia, Vomiting
Clinical narrative: A non-serious spontaneous report of tested positive for influenza, fever, vomiting and headache was received from a nurse concerning a six year-old male subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 13-Nov-2008. The next day the patient's mother reported the patient experienced fever, vomiting and headache. The child also later tested positive for influenza. The events of fever, vomiting and headache lasted for two days and then resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  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 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A non-serious, spontaneous report of administration to a pregnant women was received from a consumer, concerning a 39 year-old female.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on 24-OCT-2008, "around the time of conception."  No adverse events have been reported in the patient.  The outcome for the pregnancy is not yet available.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a 17-year old pregnant female was received from a nurse practitioner concerning a 17-year old female patient. The patient received a single dose of FLUMIST on 22-Oct-2008. The reporter's clinic was not aware of the pregnancy until 18-Nov-2008. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable.