chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
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 40-year-old female. The patients' 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: 7.0
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 seven-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 medication were reported. The patient 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 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.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received form a physician concerning a 16-year-old female. The patients' 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. Sine 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 events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received form a physician concerning a seven-year-old female. The patients' 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. Sine 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 events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
Age: 7.0
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 seven-year-old female. The patients' 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. Sine 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 events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received form a physician concerning a seven-year-old male. The patients' 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. Sine 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 events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of FLUMIST administration to pregnant female was received from a physician concerning a 27-year-old female patient. On 26-Dec-2008, FLUMIST was administered by mistake to the patient who was 16 weeks pregnant. There was no adverse event associated with this FLUMIST exposure to a pregnant female as of 13-Feb-2009. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a consumer concerning a 13-year-old female. There was no adverse event associated with this medication error 20 days after the error occurred; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Chest pain, Gastrooesophageal reflux disease, Ulcer
Clinical narrative: A  spontaneous, non-serious report of GERD and ulcer has been received from a mother concerning a nine-year-old male patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 19-Jan-2009, the patient received FLUMIST. On 26-Jan-2009, one week after receiving FLUMIST, the patient complained about chest pain when drinking something cold. He said it hurt all the way to his back. On the same day, the patient went to a physician, who diagnosed him with GERD or an ulcer. The outcome of GERD and ulcer was not reported.
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 form a physician concerning a five-year-old female. The patients' 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. Sine 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 events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
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 form a physician concerning a six-year-old female. The patients' 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. Sine 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 events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events with the medication error.
Age: 59.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A spontaneous, non-serious report of FLUMIST given to 59-year-old was received from a nurse. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 9.0
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 nine-year-old female. The patients' medical history included no history of asthma. Concomitant medication 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 associated with these medications 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.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a nurse concerning a five-year-old male. The patient's concomitant medication history included receiving a dose of FLUMIST four weeks ago. On 02-Feb-2009, the patient received a booster dose of FLUMIST, which expired on 01-Feb-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors ere 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 that included the results of an investigation regarding a medication error. Additional information was received on 09-Apr-2009 that included the results of an investigation regarding a medication error.
Age: 8.0
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 eight-year-old female. The patients' medical history included no history of asthma. Concomitant medication 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 associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
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 patients' medical history included no history of asthma. Concomitant medication 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 associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
Age: 35.0
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 35-year-old female. The patients' medical history included no history of asthma. Concomitant medication 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 associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of administration to pregnant female was received from a physician concerning a 30-year-old female who received FLUMIST.  Neither medical nor obstetrical history was provided.  FLUMIST was given to the pregnant woman by mistake.  There was no adverse event reported to date.  Treatment and reporter/sponsor causality assessments are not applicable.  The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Dizziness, Ear infection, Headache, Immediate post-injection reaction
Clinical narrative: A spontaneous, non-serious report of dizziness, lightheadedness, ear infection, sinus infection, stomach ache, fever, body aches, sore throat, congestion, headaches and malaise has been received from a patient's mother concerning an 11-year-old male patient subsequent to FLUMIST therapy. Medical history and concomitant medications were not reported. On 27-Oct-2008, the patient received FLUMIST. Since the patient received FLUMIST, he has continued to have problems. Immediately after receiving FLUMIST, the child felt dizzy an lightheaded. A couple of days later, he had a stomach ache, fever, body aches, sore throat and congestion; he also had bad headaches. The patient went to the doctor's office and was diagnosed with a sinus infection; he was ministered antibiotics (unspecified). He continued to have headaches, malaise and stomach complaints. The patient also went to see a neurologist; an MRI was normal. He continued to have ear and sinus infection with sore throat. The child was not immunocompromised. The events of sinus infection, ear infection and sore throat were ongoing. The outcome of dizziness, lightheadness, stomach ache, fever, congestion, headaches and malaise were unknown.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Malaise, Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: A spontaneous, non-serious report of dizziness, lightheadedness, ear infection, sinus infection, stomach ache, fever, body aches, sore throat, congestion, headaches and malaise has been received from a patient's mother concerning an 11-year-old male patient subsequent to FLUMIST therapy. Medical history and concomitant medications were not reported. On 27-Oct-2008, the patient received FLUMIST. Since the patient received FLUMIST, he has continued to have problems. Immediately after receiving FLUMIST, the child felt dizzy an lightheaded. A couple of days later, he had a stomach ache, fever, body aches, sore throat and congestion; he also had bad headaches. The patient went to the doctor's office and was diagnosed with a sinus infection; he was ministered antibiotics (unspecified). He continued to have headaches, malaise and stomach complaints. The patient also went to see a neurologist; an MRI was normal. He continued to have ear and sinus infection with sore throat. The child was not immunocompromised. The events of sinus infection, ear infection and sore throat were ongoing. The outcome of dizziness, lightheadness, stomach ache, fever, congestion, headaches and malaise were unknown.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Respiratory tract congestion, Sinusitis
Clinical narrative: A spontaneous, non-serious report of dizziness, lightheadedness, ear infection, sinus infection, stomach ache, fever, body aches, sore throat, congestion, headaches and malaise has been received from a patient's mother concerning an 11-year-old male patient subsequent to FLUMIST therapy. Medical history and concomitant medications were not reported. On 27-Oct-2008, the patient received FLUMIST. Since the patient received FLUMIST, he has continued to have problems. Immediately after receiving FLUMIST, the child felt dizzy an lightheaded. A couple of days later, he had a stomach ache, fever, body aches, sore throat and congestion; he also had bad headaches. The patient went to the doctor's office and was diagnosed with a sinus infection; he was ministered antibiotics (unspecified). He continued to have headaches, malaise and stomach complaints. The patient also went to see a neurologist; an MRI was normal. He continued to have ear and sinus infection with sore throat. The child was not immunocompromised. The events of sinus infection, ear infection and sore throat were ongoing. The outcome of dizziness, lightheadness, stomach ache, fever, congestion, headaches and malaise were unknown.
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A spontaneous, non-serious report of administration of expired product was received from a nurse concerning an adult female patient.  On 20-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 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 that included the results of an investigation for a medication error.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administration or expired product was received from a nurse concerning a 36 year-old female subsequent to FLUMIST. On 03-Feb02009, the patient received expired FLUMIST (expiration date 09-Jan-2009). There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information was received on 17-Feb-2009 and incorporated into the narrative: no events reported since vaccination. 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 09-Apr-2009 that included the results of investigation for medication error.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a nurse concerning a six-year-old female.  FLUMIST that expired on 08-Jan-2009 was administered on 05-Feb-2009.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  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 that included the results of an investigation for a medication error.
Age: 11.0
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 11-year-old male. The patients' medical history included no history of asthma. Concomitant medication 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 associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
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 patients' medical history included no history of asthma. Concomitant medication 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 associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "23 patients received expired FLUMIST" was received from a physician concerning a six-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 included 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: 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 patients' medical history included no history of asthma. Concomitant medication 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 associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Blister, Erythema multiforme, Oral disorder
Clinical narrative: A non-serious spontaneous report of erythema multiforme, blisters on both legs and a few on arms and sore in right nostril and upper lip has both legs and a few on arms and sore in right nostril and upper lip has been received from a physician, concerning a seven-year-old female subsequent to FLUMIST therapy.  The patient had no significant medical history.  Concomitant medication included MUPIROCIN.  The patient previously received FLUMIST via intranasal route on 09-Oct-2008 for flu prevention.  The patient's parent called the physician's office to report that one to two days after receiving FLUMIST therapy, the patient developed a sore in the right nostril and upper lip as well as blisters on both legs and a few on her arms.  On 22-Oct-2008, she was seen by her physician and diagnosed with erythema multiforme.  Pictures were taken of the lesions on her legs.  The patient had an eight-year-old brother vaccinated on the same day who did not experience any events.  The events of erythema multiforme, blisters on both legs and a few on arms and sore in right nostril and upper lip resolved on an unspecified date in Oct-2008.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza serology positive
Clinical narrative: A non-serious spontaneous report of positive influenza A test was received from a physician concerning a 14 year-old male, subsequent to FLUMIST. The, patient received FLUMIST on 01-Oct-2008. On 09-Feb-2009 the patient tested positive for influenza A. The outcome and causality of the event to FLUMIST were not reported.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administration of extra dose was received from a physician concerning a 10-year-old male who received FLUMIST. The patient received two doses of FLUMIST five months apart. No medical history was reported. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 65.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, Inappropriate schedule of drug administration
Clinical narrative: A non-serious, spontaneous report of administration of expired FLUMIST to a 65 year old was received from a nurse practitioner concerning a 65-year-old male subsequent to FLUMIST. On 19-Jan-2009 the patient received FLUMIST that expired on 13-Jan-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. 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 05-Mar-2009 and incorporated into the narrative: confirmed no adverse events were reported following vaccination. Additional information received on 31-Mar-2009 included Product Complaint Investigation results.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: 08/13/09 Non-serious, spontaneous report received from a HCP with the manufacturer regarding administration of an expired FLUMIST vaccine. DX: Medication error.  The medication error was due to the costumer not discarding the product form the previous season. The vaccine was administered shortly after the product had expired.  .  The event was considered resolved.   03/05/09 No adverse event was associated after administration of the expired vaccine.    03/31/09 Product Complaint Investigation results received.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "gave expired FLUMIST" was received from a nurse concerning an eight-year-old male. No medical history was reported. The FLUMIST was given on 19-Feb-2009 and had expired on 24-Dec-2008. 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. 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 included Product Complaint Investigative results. Follow-up information received on 28-Apr-2009 from reporter confirming no adverse events have occurred.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious, spontaneous report of sore throat and fever was received from a physician, concerning an 11 year-old male subsequent to FLUMIST. The patient's past medical history includes ADHD and behavioral problems, without diagnosis of neurologic disease. The patient also has staring episodes and was worked up for seizure disorder although no diagnosis was made. No concomitant medications have been reported for this patient. The patient received FLUMIST on 29-Oct-2008 for influenza vaccination. The patient was brought to his doctor four times in October 2008 for sore throat and fever, although no fever was documented by the physician. On 30-Oct-2008 the patient was seen for his fourth medical visit of the month for sore throat and fever. The patient recovered from the events.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "gave expired FLUMIST" was received from a nurse concerning an eight-year-old male. No medical history was reported. The FLUMIST was given  on 19-Feb-2009 and had expired on 24-Dec-2008. Based on the results of the investigation, the root cause for the medications 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. 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 included Product Complaint Investigative results. Follow-up information received on 28-Apr-2009 from reporter that confirmed no adverse events have occurred.
Age: 24.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a 24-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 17-Feb-2009 which expired on 15-Feb 2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. 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 the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 31-Mar-2009 included Product Complaint Investigative results.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "gave expired FLUMIST" was received form a nurse concerning an eight-year-old male. No medical history was reported. The FLUMIST was given on 19-Feb-2009 and had expired on 24-Dec-2008. 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 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and event is considered resolved. Follow-up information received on 31-Mar-2009 included Product Complaint Investigative results. Follow-up information received on 28-Apr-2009 from reporter that confirmed that no adverse events have occurred.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-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. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a seven-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. 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 the flu season resulting in some  medication errors that occurred shortly after the product expired. Additional information received on 31-Mar-2009 included Product Complaint Investigative results.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye pain, Headache, Myalgia, Pain, Sinus headache
Clinical narrative: A non-serious spontaneous report of eye pain, headaches, body ache, muscle ache, and sinus pain has been received from a parent concerning her 14-year-old daughter, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported. The patient received FLUMIST in January 2009. Since receiving the FLUMIST in Jan-2009, the patient has had headaches, body aches, muscle aches, sever sinus pain, and eye pain. The mother of the patient stated that the patient has been miserable everyday and has had to take ibuprofen and cetirizne hydrochloride just to be able to function. The patient has seen her physician several times and was instructed to continue taking the cetirizine hydrochloride and to call if needed, however, the patient still reports no relief. The event have not resolved.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a nine-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event  is considered resolved. 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 received on 31-Mar-2009: included Product Complaint Investigative results.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion, Snoring
Clinical narrative: A non-serious, spontaneous report of snoring and nasal congestion was received from a consumer concerning a five-year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Jan-2009 (four weeks prior to date of report). The patient began having problems with nasal congestion on 24-Feb-2009 and snoring at night after receiving FLUMIST; the patient does not have a history of snoring. The patient's pediatrician says there is not a problem. The outcome for the reported adverse event was not reported.
Age: 38.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 38-year-old male. Neither medical history nor concomitant medication were reported. On an unspecified date in Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events 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 form previous season and 20 product expiring during the peak of flu season resulting in some medical error that occurred shortly after the product expired. Additional information was received on18-Mar-2009 that indicated no adverse events were reported through the medical clinic. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administered expired products was received from a nurse concerning a six-year-old female. Subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. 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 received on 31-Mar-2009: included Product Complaint Investigative results.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a six-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause of the medication error 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 on 31-Mar-2009: included Product Complaint Investigative results.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administered expired product was received form a nurse concerning an eight-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 26-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flue season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 31-Mar-2009 included Product Complaint Investigative results.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of administered expired product was received from a nurse concerning a six-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 26-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. 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 received on 31-Mar-2009: include Product Complaint Investigative results.
Age: 11.0
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 certified medical assistant concerning an 11-year-old male patient subsequent to FLUMIST. On 13-Mar-2009, the patient received FLUMIST with an expiration date of 25-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. Additional information was received on 09-Apr-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: 19.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 19-year-old female. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-mar-2009, there were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered 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 12-may-2009: Product Complaint Investigation results.