chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of "gave expired FLUMIST" was received from a registered nurse concerning a nine-year-old male subsequent to FLUMIST therapy. On 29-Dec-2008, the patient received expired FLUMIST, which had an expiration date of 28-Dec-2008. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Subsequent contact with the initial reporter on 13-Jan-2009 confirmed no adverse event occurrence. 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. Additional information received 09-Apr-2009: product complaint investigation results.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A spontaneous non-serious report of administration of expired product has been received from a nurse practitioner concerning a 14 year old male patient subsequent to FLUMIST. Medical history and concomitant medication were not reported. On 23-Dec-2008, the patient received FLUMIST that expired on 21-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 31-Mar-2009: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the 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.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a registered nurse concerning a 15-year-old male. Neither medical history nor concomitant medications were reported. On 22-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 16-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information was received on 09-Mar-2009 that no delayed adverse events resulted from this error.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of one-half dose of expired product was received from a certified medical assistant concerning a 15-year-old male subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. On 30-Dec-2008, the reporter administered one-half of FLUMIST dosage when she noticed that the product had expiration date of 26-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the 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 20-Mar-2009: Investigation lot analysis results. Follow-up information was received on 04-May-2009: confirmation that the patient did not experience any adverse events.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a registered nurse concerning a 13-year-old female. The child was administered a FLUMIST dose that had expired 12 days earlier.  There was no adverse event associated with this inadvertent administration of expired FLUMIST; 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 15-Jan-2009 includes: DOB, FLUMIST information and no late adverse events were reported. Additional information was received on 09-Apr-2009: product Complaint Investigation results.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST administered was received from a registered nurse concerning a 17-year-old female. Neither medical history nor concomitant medications were reported. On 22-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of December 16, 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 the 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. Additional information was received on 09-Mar-2009 that no delayed adverse events resulted from this error. Additional information was received on 09-Apr-2009: product complaint investigation results.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Attention deficit/hyperactivity disorder, Contusion, Pain in extremity, Pruritus, Urticaria
Clinical narrative: A spontaneous non-serious report of hives, itching, leg pain, bruising and attention deficit/hyperactivity disorder (ADHD) has been received from manufacturer (manufacturer control number 08P-163-0479239-00) concerning a nine-year old female patient subsequent to FLUMIST use. The original reporter was a physician. Medical history included precocious puberty and no known allergies. Suspect medication included leuprolide acetate depot. Concomitant medications obetrol (ADDERALL and ADDERALL XR) 20 mg. On 24-Sep-2008, the patient received FLUMIST for flu vaccination and then her monthly dose of leuprolide acetate depot. Five minutes after receiving leuprolide acetate depot injection, the patient developed hives, itching, pain in entire leg and bruising. The bruising described as multiple red and deep purple blotches, did not originate at the site of the injection. It covered the patient's entire thigh, from top to the knee. Treatment with diphenhydramine was started for the hives and itching. On 01-Oct-2008, leuprolide acetate depot was discontinued. the patient's mother was advised to continue treatment with diphenhydramine until the reactions resolved. The events of hives, itching and bruising were resolving. The event of pain was resolved. The outcome of ADHD was unknown. The physician assessed the events of hives, itching, pain in entire leg and bruising as possibly related to leuprolide acetate depot, but the causality was questionable since the patient had been on leuprolide acetate depot since 2005. FLUMIST was also considered suspect.
Age: 19.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients ( 26 children & 3 adults) received expired FLUMIST "was received from a physician concerning a 19-year-old female. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the 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. Additional information was received on 05-Feb-2009 and incorporated into the narrative: gender and age; confirmation that there were no adverse events. Additional information received on 04/09/2009 included Product Complaint Investigative results.
Age: 29.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of expired FLUMIST given was received from a registered nurse concerning a 29-year-old male.  On 04-Dec-2008, the patient was administered expired FLUMIST (12-Nov-2008);  the product was expired by 22 days.  The reporter indicated the FLUMIST expired at the beginning of the flu season.  There was no adverse event associated with this event;  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 the 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.  Additional information received on 09-Apr-2009:  product complaint investigation results.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FLUMIST to two patients was received from a pharmacist concerning a 43-year-old female. The patient's medical history and concomitant medications were not available. On 06-Jan-2009, the patient received expired FLUMIST (expiration date 30-Dec-2008) at a Pharmacy. The pharmacist states that she did not check the expiration date prior to administration. The patient was doing well. 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 the 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. Additional information was received on 09-Apr-2009: product complaint investigation results.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired product has been received from a Registered Nurse concerning a 22-year-old female who received FLUMIST.  Medical history and concomitant medications were not reported.  On 08-Jan-2009, the patient received FLUMIST that expired on 24-Dec-2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the 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.  On 03-Feb-2009, the reporter confirmed that the patient did not experience any late-occurring adverse events.  Additional information received on 20-Mar-2009 included Product Complaint Investigative results.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administration of expired product was received from a registered nurse concerning a five year-old male subsequent to 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. 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. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a five year-old female subsequent to 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the 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. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administration of expired product was received from a nurse concerning an eight year-old female subsequent to 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. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product form the previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A spontaneous non-serious report of administration of expired product was received from a nurse concerning a twelve year-old male subsequent to 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.
Age: 5.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of "six patients received expired FLUMIST" was received from a nurse concerning a five-year-old patient (gender unknown).  The patient's medical history and concomitant medications were not available.  On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008).  The product was expired by 10 days.  There were no adverse events associated with these medications errors;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are 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.
Age: 10.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of "six patients received expired FLUMIST" was received from a nurse concerning a 10-year-old patient (gender unknown). The patient's medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are 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.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product has been received form a Registered Nurse concerning a 15 year old male who received FLUMIST. Medical history and concomitant medications were not reported. On 29-Dec-2008, this child was administered FLUMIST which expired on 28-Dec-2008. There was no adverse event associated with this error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 13-jan-2009 confirmed the child has not experienced any adverse events.  Follow-up information received on 27-Mar-2009 included Product Complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the 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.
Age: 5.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of "six patients received expired FLUMIST" was received from a nurse concerning a five-year-old patient (gender unknown).  The patient's medical history and concomitant medications were not available.  On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008).  The product was expired by 10 days.  There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are 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 resulting in some medication errors that occurred  shortly after the product expired.  Follow-up information was received on 09-Apr-2009 that included the following:  Product Complaint Investigation results.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning an 18 year old female who received FLUMIST. Medical history and concomitant medications were not reported. On 29-Dec-2008, this child was administered FLUMIST which expired on 28-Dec-2008. There was no adverse events associated with this 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 the 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. Additional information was received on 13-Jan-2009 confirmed the patient did not experience any adverse events after administration of expired product. Additional information received on 09-Apr-2009: product complaint investigation results.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered pharmacist concerning two patients (patients' demographic data not available) subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. Sometime in the last week of Dec 2008 (specific date unknown). FLUMIST which was five days past the expiration date was administered to two patients. 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. As of 23-Apr-2009, the reporter has not responded to follow-up telephone calls hence, unable to confirm any delayed occurring adverse events resulting from this error. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information received on 20-Mar-2009 included Product Complaint Investigative results.
Age: 6.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A spontaneous non-serious report of "six patients received expired FLUMIST" was received from a nurse concerning a six-year-old patient (gender unknown). The patient's medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-20098). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are 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, spontaneous report of administration of expired product was received from a registered pharmacist concerning an adult (sex unknown) subsequent to FLUMIST. On 05-Jan-2009, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and 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 the 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 with the reporter on 27-Jan-2009 revealed there were no delayed occurring adverse events related to expired FLUMIST administration. Follow-up with information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a healthcare professional concerning a five year-old female.  Patient received two doses of FLUMIST, at the time of the second dose the FLUMIST had expired.  The reporter stated that they are unable to return a partial box of FLUMIST for a refund and in order to re-dose other patients they would need to purchase a new box of FLUMIST.  The reporter asked why does the FLUMIST expire in mid-seasons.  There was no adverse event associated with this event;  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 of cause for the medication were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired.  Additional information received on 09-Apr-2009 that included the results of an investigation on medication error.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administration of expired product was received from a nurse concerning a ten year-old female subsequent to 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product form the 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. Additional information received on 09-Apr-2009: product complaint investigation results.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serous, spontaneous report of administration of expired product was received from a nurse concerning an 11 year old female patient subsequent to 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. Based on the results of the investigation, the root cause for the medications errors were caused by 1) customers not discarding product from the 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. Additional information received on 09-Apr02009: product complaint investigation results.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with the same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse events.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old female who received FLUMIST.  The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009.  Neither the patient's medical history nor concomitant medications were reported.  The patient is one of a pair of twin girls who received the FLUMIST on 02-Jan-2009, which expired on 30-Dec-2008.  All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008.  All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines.  The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients.  There was no adverse event associated with this medication error as of 15-Jan-2009;  therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.  Additional information received on 15-Jan-2009 and incorporated into the narrative:  patient's demographics and outcome of adverse  event.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a five-year-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history concomitant medications were reported. The patient is one of a pair of twin girls who received the FLUMIST on 02-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot # delivered to the clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associate with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non serious spontaneous report of administration of expired product was received from a registered nurse concerning a seven-year-old male subsequent to FLUMIST. The patient is one of the 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medial history nor concomitant medications were reported. The patient received the FLUMIST on 02-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable,and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a six-year-old female who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of siblings who received the FLUMIST on 05-Jan-2009, which expired on 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with the same lot# delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a nurse practitioner concerning a 9-year-old female subsequent to FLUMIST.  Neither medical history nor concomitant medications were reported.  On 06-Jan-2009, FLUMIST which expired on 28-Dec-2008 was administered to the 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.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the 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.  Additional information was received on 09-Apr-2009: product complaint investigation results.  Additional information was received on 24-Apr-2009:  route of administration of suspect FLUMIST, where the patient was vaccinated and that no delayed adverse events resulted from this error.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A spontaneous non-serious report of administration to a pregnant female was received from a physician concerning a 26 year old female patient. On 19-Dec-2008, FLUMIST was unknowingly administered to a woman that was two weeks pregnant. Past obstetrical history included: Para 1, Gravida 1, Premature 0, Spontaneous Abortion:0, Elective termination:0. The patient's last menstrual period was 19-Nov-2008. The estimated date of delivery was 26-Aug-2009. The pregnancy was ongoing. There was no adverse event associated with this pregnancy at the time of the report. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to report when the pregnancy ended and if the patient experienced any adverse events during pregnancy.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Feeling abnormal, Nasopharyngitis
Clinical narrative: A non-serious spontaneous report of cold like symptoms has been received from a consumer concerning a 12-year-old female, subsequent to FLUMIST.  No past medical history nor concomitant medications were reported.  The patient received FLUMIST on 06-Jan-2009.  The patient began to experience cold like symptoms approximately five days receiving FLUMIST, and was reportedly feeling "pretty bad" on 13-Jan-2009.  The outcome was not reported.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST to two patients was received from a pharmacist concerning a nine-year-old female.  The patient's medical history and concomitant medications were not available.  On 06-Jan-2009, the patient received expired FLUMIST (expiration date 30-Dec-2008) at a Pharmacy.  The pharmacist states that she did not check the expiration date prior to administration.  The patient was doing well.  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 expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 09-Apr-2009:  product complaint investigation results.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Asthma, Condition aggravated
Clinical narrative: A non-serious spontaneous report of asthma attack and accidental exposure has been received from a Registered Nurse concerning a 33-year-old female. Medical history included asthma (since childhood) and colitis. The patient (nurse) takes azathioprine for her colitis and salbutamol for her asthma. The reporter is a RN who works in a community health center and administers FLUMIST. The nurse did not receive FLUMIST herself. The nurse reported she has an asthma attack after she administers FLUMIST to a patient. She clarified that she has had 15 asthma attacks this flu season beginning in 2008. These attacks have occurred about 5-10 minutes after she administers the FLUMIST. The nurse has had to increase her asthma medication, and on occasion had to use a nebulizer (as well as her salbutamol inhaler). No attack has resulted in a hospitalization. Per the reporter "after treatment she recovers but the event always returns."
Age: 20.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Nasal congestion, Pyrexia, Sneezing
Clinical narrative: A non-serious spontaneous report of fever, fatigue, nasal congestion, and sneezing has been received from a nurse concerning a 20-year-old female patient subsequent to FLUMIST.  No past medical history nor concomitant medications were reported.  The patient received FLUMIST on 14-Jan-2009 for the first time.  Within 48 hours after receiving FLUMIST, the patient developed a fever, fatigue, nasal congestion, and sneezing.  The patient did not recall being in close proximity to anyone with similar symptoms during the week prior to onset of the symptoms.  The patient  recovered from the events on 22-Jan-2009.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 13-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-2009. Neither the patient's medical history nor concomitant medications were reported. The patient received the FLUMIST on 05-Jan-2009, which expired 30-Dec-2008. All the expired FLUMIST vaccines were part of the 300 units with same lot # delivered to the pediatric clinic on 21-oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic an only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day expired FLUMIST were given to the 16 patients. There was no adverse event associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a six-year-old male. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: 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.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a five-year-old female. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: 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.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a five-year-old male. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: 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.