chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal X-ray, Abdominal pain, Diarrhoea, Stool analysis, Vomiting
Clinical narrative: A serious report of vomiting, diarrhea, and abdominal pain has been received from a physician and a consumer (patient's mother) concerning a nine-year-old male subsequent to FLUMIST. Concomitant medications included dexmethylphenidate hydrochloride for attention deficit disorder. The patient had a history of constipation. The patient was an otherwise healthy child and had no known allergies to food or medications. The patient received FLUMIST on 08-Sep-2008 for health maintenance. On 09-Sep-2008, the patient experienced vomiting, diarrhea, and abdominal pain. His symptoms were intermittent. The second episode occurred when he awoke on 13-Sep-2008 and the patient went to the physician's office. The patient's symptoms continued at least daily to every other day. He went to the doctor twice for treatment. An abdominal X-ray was normal. The physician reported stool testing was ordered but no results were available and questioned if the patient did not go for the testing. On 17-Oct-2008, the patient had another episode of vomiting, diarrhea, and abdominal pain. Three or four days after that, the patient had another episode of vomiting, diarrhea, and abdominal pain. Both times the patient had eaten something "that had egg proteins in it like a muffin" during the day and experienced the episodes in the middle of that night. The patient did not have an egg allergy. In between episodes, the patient was "fine". On 05-Nov-2008, the patient was seen by a general pediatrician in a different medical center. The pediatrician did not perform any testing because he indicated that patient previously had a normal abdominal X-ray. He also reported that the patient had a history of constipation and thought his symptoms might be related to constipation. As of 05-Nov-2008 when he saw the general pediatrician, the patient's episodes were occurring "far less frequently". The physician indicated the vomiting, diarrhea, and abdominal pain were considered serious (important medical event) due to frequent school absences. Additional information received on 14-Oct-2008 from the physician was incorporated into the above narrative and included serious criteria, event outcome, additional patient information, indication and lot number for FLUMIST, concomitant therapy and medical history. Additional information received on 27-Oct-2008 the patient's mother was incorporated into the above narrative and included event outcome and details on additional episodes of the events. Additional information received on 06-Nov-2008 from a general pediatrician was incorporated into the above narrative and included additional details regarding the event.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema, Impetigo, Scab, Skin irritation
Clinical narrative: A non-serious unlabeled spontaneous case of impetigo with redness and irritation under the nose has been received from a physician for a five-year old male, subsequent to receiving FLUMIST. The patient received one dose of FLUMIST nasally for flu vaccination on 26-Sep-2008. The reporting physician stated the patient developed irritation and redness under his nose several hours after FLUMIST administration. The patient went to his primary care physician on 02-Oct-2008 with a crusting red area under his nose that appears to be impetigo. The patient was treated with MUPIROCIN CALCIUM and CEFALEXIN. The events were considered resolved on 09-Jan-2009. The reporting physician indicated he is doubtful if FLUMIST caused the impetigo. Follow up received on the 21-Oct-2008 includes treatment for the impetigo and no outcome for the event. Follow up received on 12-Jan-2009 includes outcome of the events, patient's name and date of birth. Follow up received on 16-Jan-2009 includes general vaccine information and patient's address and county of the physician's office. The reporter also confirmed the information received on 12-Jan-2009.
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Headache
Clinical narrative: A non-serious spontaneous report of accidental exposure and headache has been received from a female medical assistant (date of birth 01-May-1969) concerning her own experience subsequent to administering FLUMIST.  Medical history included migraines.  Concomitant medications included levothyroxine, duloxetine hydrochloride, cetirizine hydrochloride, and montelukast sodium.  The patient did not take medication for her migraines.  The medical assistant never received FLUMIST.  When the medical assistant administers FLUMIST to a patient or walks into an exam room where FLUMIST was administered, she develops a headache across the top of her forehead.  She described them as mild, they "are not migraines", and the headache last until she goes outside away from where FLUMIST is being administered.  She indicated that it did not matter if she administered FLUMIST first thing in the morning or not until the middle of the afternoon, she always got a headache from it.  She experienced no other symptoms.  The medical assistant did not treat the headaches because they always resolved as soon as she went outside. Required follow-up attempts have been performed, requested information unable to be obtained.
Age: 7.5
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of hives has been received from a registered nurse concerning a 7.5-year old male patient subsequent to FLUMIST.  No medical or drug history were reported for this patient. The patient received FLUMIST into both nostrils on 06-Oct-2008.  The patient developed hives ten minutes following the administration of FLUMIST.  The hives were distributed on the patient's bilateral thighs and on the forearms.  The patient was treated with DIPHENTYDRAMINE 25 milligrams.  There were no breathing problems noted.  The patient was reportedly "calm" in approximately one hour.  The adverse event was less prominent as well.
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from a health care professional concerning a 19-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired when a nurse in the same clinic noted that the lot # of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot # of the other supply of FLUMIST with expiration date of 25-Dec-2008.  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information received on 07-Nov-2008:  Follow-up call to reporter revealed that no adverse events have occurred to date.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from a military non-commissioned officer and a health care professional an 18-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 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: 21.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 21-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. 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 Compliant Investigation results.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FluMist was received from an Air Force non-commissioned officer and a health care professional in the USA concerning a 26-year-old female. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FluMist via nasal administration by an immunization health technician. The vaccine was found to be expired (expiration date 24-Mar-2008). The expired lot of FluMist was given to 17 adult individuals including this  patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FluMist was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. 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 by1) 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: 21.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from a healthcare professional concerning a 21-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient presented at the base clinic and received FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired (expiration date 24-Mar-2008).  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  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.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 22-year-old female.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient presented at the base clinic and was given FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired (expiration date 24-Mar-2008).  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  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.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea, Upper respiratory tract congestion
Clinical narrative: A non-serious, spontaneous report of sore throat, fever, body ache, runny nose and congestion was received from  a consumer, concerning a five year-old male patient, subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on Monday, 29-Sep-2008.  On Tuesday, 30-Sep-2008 the patient experienced a sore throat, fever, body aches, runny nose and congestion, which are ongoing.  The events were ongoing as of Monday, 06-Oct-2008.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Immediate post-injection reaction, Sneezing
Clinical narrative: A non-serious labeled, spontaneous report of sneezing has been received from a nurse for a seven-year-old female, subsequent to receiving FLUMIST.  No medical history or concomitant medications were provided.  The child received one dose of FLUMIST nasally on 06-Oct-2008.  The reporter indicated that on 06-Oct-2008 the child sneezed immediately after administration of FLUMIST into the first nostril.  No sneezing or event occurred after administration into the second nostril.  The event has resolved.
Age: 21.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer/health care professional concerning a 21-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 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: 34.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer/health care professional concerning a 34-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not application, 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.
Age: 31.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 31-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. 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.
Age: 24.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer/health care professional concerning a 24-year-old-male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 07-Nov-2008 and incorporated into the narrative: No adverse events have been reported for the patient after one month of follow-up.
Age: 21.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 21-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008.  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  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.
Age: 25.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from a military non-commissioned officer and a health care professional concerning a 25-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. 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.
Age: 22.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer concerning a 22-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. The expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error at the time of the report, nor upon follow-up of the 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 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 09-Apr-2009 and incorporated into the narrative: added Product Complaint Investigation results.
Age: 37.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FluMist was received from a non-commissioned officer and a health care professional concerning a 37-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient received FluMist via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administration FluMist (expiration date 24-Mar-2008) was different from the lot# of the other supply of FluMist with expiration date of 25-Dec-2008. The expired lot of FluMist was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FluMist was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. There was no adverse event associated with this medication error at the time of the initial report, nor at the time that follow-up was obtained, 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 errors that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.
Age: 21.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 21-year-old female. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient presented herself at the base clinic for an unscheduled immunization. FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. There is no information whether the FLUMIST used on 06-Oct-2008 was taken out from the immunization clinic's refrigerator or whether it was delivered to the clinic on that day. On the same day, the immunization clinic informed the logistics office which handles storage of vaccine that expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. 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 07-Nov-2008 and incorporated into the narrative: no adverse events reported. Additional information received on 09-Apr-2009 and incorporated into the narrative: add Product Complaint Investigative results.
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious report of administration of expired FLUMIST was received from an Air Force non-commissioned officer and a health care professional concerning a 19-year-old male. The patient's medical history and concomitant medications were not reported. On 06-Oct-2008, the patient presented himself at the base clinic for an unscheduled immunization. FLUMIST was given via nasal administration by an immunization health technician. The vaccine was found to be expired when a nurse in the same clinic noted that the lot# of the administered FLUMIST was different from the lot# of the other supply of FLUMIST with expiration date of 25-Dec-2008. There is no information whether the FLUMIST used on 06-Oct-2008 was taken out from the immunization clinic's refrigerator or whether it was delivered to the clinic on that day. On the same day, the immunization clinic informed the logistics office which handles storage of vaccine that expired lot of FLUMIST was given to 17 adult individuals including this patient. The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal. 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. Additional information received on 07-Apr-2008 and incorporated into the narrative: no adverse events reported. Additional information received on 09-Apr-2009 and incorporated into the narrative: added Product Complaint Investigation results.
Age: 20.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administration of expired FLUMIST was received for a health care professional concerning a 20-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician.  The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008.  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  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 07-Nov-2008 and incorporated into the narrative:  no adverse events reported.  Additional information received 09-Apr-2009: product complaint investigation results.
Age: 24.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Pleurisy
Clinical narrative: A non-serious, spontaneous report of pleurisy, chest pain, shortness of breath and fever was received from a pharmacist concerning a 24 year-old female patient subsequent to FLUMIST.  The patient reported no relevant medical history.  Concomitant medications include birth control.  The patient received FLUMIST at agency on 01-Oct-2008.  On 06-Oct-2008 the patient was seen by a health care provider in the emergency room for symptoms of chest pain, shortness of breath and fever.  An electrocardiogram, chest x-ray and blood work were collected, although results were not reported.  The patient was diagnosed with pleurisy and treated with ACETAMINOPHEN, HYDROCODONE and NAPROXEN.  The patient recovered from the events on 10-Oct-2008.
Age: 24.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious, spontaneous report of pleurisy, chest pain, shortness of breath and fever was received from a pharmacist concerning a 24 year-old female patient subsequent to FLUMIST.  The patient reported no relevant medical history.  Concomitant medications include birth control.  The patient received FLUMIST at agency on 01-Oct-2008.  On 06-Oct-2008 the patient was seen by a health care provider in the emergency room for symptoms of chest pain, shortness of breath and fever.  An electrocardiogram, chest x-ray and blood work were collected, although results were not reported.  The patient was diagnosed with pleurisy and treated with ACETAMINOPHEN, HYDROCODONE and NAPROXEN.  The patient recovered from the events on 10-Oct-2008.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a consumer concerning a female greater than five-years-old. No medical history was provided. The reporter indicated that the lot number and expiration date printed on the outside of the product package had a different lot number and an expiration date than the inside of the package. The outside of the package had an expiration date of Dec-2008 and the doses inside the package had an expiration date of Jan-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 errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a consumer concerning a female greater than five-years-old. No medical history was provided. The reporter indicated that the lot number and expiration date printed on the outside of the product package had a different lot number and an expiration date than the inside to the package. The outside of the package had an expiration date of Dec-2008 and the doses inside the package had an expiration date of Jan-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) 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: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in a seventh grade, adolescent female.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose.  No adverse effects were reported; the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: One of twenty-one cases:  A nonserious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in an eighth grade, adolescent female.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip;  21 children received only half a dose.  No adverse effects were reported; the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eight grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases:  A non - serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in an eighth grade, adolescent female.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during the flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip;  21 children received only half a dose.  No adverse effects were reported; the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in an eighth grade, adolescent male.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider  clip; 21 children received only half a dose.  No adverse effects were reported;  the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse.  The event occurred in an eighth grade adolescent female.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip;  21 children received only half a dose.  No adverse effects were reported;  the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the dose had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administered the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the dose had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases: A non-serious, spontaneous event of half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the dose had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases:  A non-serious, spontaneous event of a half dose of FLUMIST administered was received fro ma registered nurse.  The event occurred in an eight grade adolescent male.  No medical or drug history was reported for this adolescent.  FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school.  The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose.  No adverse effects were reported; the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for the adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the diver clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases: A non-serious, spontaneous event of a half dose to FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. Now medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in on nostril to 21 children during a flu clinic  at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases: A non serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in on nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in and eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: One of twenty-one cases: A non-serious spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent female. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.