chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Sinus headache
Clinical narrative: A non-serious report of "head is pounding sinus headache" has been received from a consumer concerning a 45 year-old female.  No medical history nor concomitant medications were provided.  The patient received FLUMIST on 18-Nov-2008.  Two hours after the dose of FLUMIST, the patient report "head was pounding; feels like a sinus headache that is extreme."  The patient was vaccinated at Air force base.  Outcome for the events was not resolved.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: A non-serious, spontaneous report of partial dose given was received from a nurse concerning a five year-old female subsequent to FLUMIST. On 19-Nov-2008 the patient received a full dose in one nostril and pulled away during the dose to the second nostril. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious, spontaneous report of "accidentally gave expired FLUMIST" was received from a physician assistant concerning an eight year-old female subsequent to FLUMIST. The patient received expired FLUMIST on 20-Nov-2008 and was not redosed; the product was expired by eight days. 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 04-Dec-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Influenza, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: A non-serious report of positive flu nasal swab, high fever, sore throat, cough, body ache, and congestion has been received from a health care professional concerning a 10-year-old male. No medical history nor concomitant medications were provided. The patient received FLUMIST on 17-Nov-2008. One day after the dose of FLUMIST, the patient developed symptoms of high fever, sore throat, cough, body ache, and congestion. The patient was tested positive for flu B via nasal swab. The treating physician prescribed TAMIFLU to the patient. The patient recovered from all of the symptoms. Additional information was received on 23-Dec-2008 and incorporated into the narrative: resolution, provider information, and treatment.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Respiratory tract congestion
Clinical narrative: A non-serious report of positive flu nasal swab, high fever, sore throat, cough, body ache, and congestion has been received from a health care professional concerning a 10-year-old male. No medical history nor concomitant medications were provided. The patient received FLUMIST on 17-Nov-2008. One day after the dose of FLUMIST, the patient developed symptoms of high fever, sore throat, cough, body ache, and congestion. The patient was tested positive for flu B via nasal swab. The treating physician prescribed TAMIFLU to the patient. The patient recovered from all of the symptoms. Additional information was received on 23-Dec-2008 and incorporated into the narrative: resolution, provider information, and treatment.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A spontaneous non-serious report of single nostril administration was received from a pharmacist concerning a 39 year old male patient. No medical history nor concomitant medications were reported. On 20-Nov-2008, the patient received FLUMIST in a pharmacy which was administered by pharmacist. The clip was off when FLUMIST was administered and the patient received the whole dose in one nostril. He said he felt drainage in the back of the throat. The pharmacist decided to administer another half-dose into the other nostril. 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 02-Dec-2008 and incorporated into the narrative. No adverse events occurred after dosing.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Anosmia, Malaise, Nasal congestion, Nasopharyngitis, Productive cough
Clinical narrative: A non-serious spontaneous report of lost sense of smell, feeling rundown, fever, sneezing, nasal congestion and productive cough was received from a consumer concerning a 39 year-old female that occurred two days after receiving FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST on 14-Nov-2008. On the 16-Nov-2008, the reporter indicated that she lost her sense of smell and had a mild fever, nasal congestion, productive cough, feeling rundown and sneezing since receiving FLUMIST. Some of the symptoms resolved in 1 to 3 days others are almost resolved. The events of fever, loss of smell and productive cough resolved; sneezing, feels rundown and nasal congestion were almost resolved as of 26-Nov-2008. The reporter states that she has acquaintances who experienced similar symptoms around the same time period of her symptoms; she thinks she had a cold.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Sneezing
Clinical narrative: A non-serious spontaneous report of lost sense of smell, feeling rundown, fever, sneezing, nasal congestion and productive cough was received from a consumer concerning a 39 year-old female that occurred two days after receiving FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST on 14-Nov-2008. On the 16-Nov-2008, the reporter indicated that she lost her sense of smell and had a mild fever, nasal congestion, productive cough, feeling rundown and sneezing since receiving FLUMIST. Some of the symptoms resolved in 1 to 3 days others are almost resolved. The events of fever, loss of smell and productive cough resolved; sneezing, feels rundown and nasal congestion were almost resolved as of 26-Nov-2008. The reporter states that she has acquaintances who experienced similar symptoms around the same time period of her symptoms; she thinks she had a cold.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a nurse concerning a six-year-old female. No medical history was provided. A nurse gave the patient FLUMIST that expired on 12-Nov-2008. There was no adverse event associated with this medication error therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up received on 02-Dec-2008 includes: patient was not re-dosed and no adverse events occurred. Additional information was received on 09-Apr-2009: Based on the results for the investigation, the root cause for the medication errors were caused by 1)customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.
Age: 57.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of "administration to a 57 year old" was received from a pharmacist concerning a 57-year-old female. The pharmacist accidentally administered FLUMIST to the patient. There was no adverse event associated with this medication error at the time of the report, nor on 19-Nov-2008; therefore, treatment and reporter/sponsor causality assessments are no applicable, and the event is considered resolved.
Age: 10.0
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 ten-year-old female. The patient received FLUMIST on 02-Dec-2008 The patient was given FLUMIST that expired in December 2007. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1)customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious report  of administration of half dose of FLUMIST was received from a consumer concerning a 31-year-old female.  No medical history was reported.  There was no adverse event associated with this medication error at the time of report, nor when follow-up was obtained;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information received 22-Dec-2008 and incorporated into the case:  No adverse event occurred and patient demographic information added.
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Ear infection, Endodontic procedure, Nasal congestion, Sinusitis
Clinical narrative: A non-serious, spontaneous report of root canal, ear infection, sinus infection and nasal congestion was received from a nurse/parent, concerning a 19 year-old male subsequent to FLUMIST.  The patient's past medical history includes IgG two deficiency, asthma, otitis infections and skin granuloma.  No concomitant medications have been reported for this patient.  The patient received a first dose of FLUMIST, intranasal for flu vaccination on 24-Oct-2008.  On 26-Oct-2008 the patient experienced nasal congestion which progressed to a sinus infection on 31-Oct-2008.  The patient was seen by a dentist on 01-Nov-2008 and was given AMOXICILLIN 500 mg for one week.  On 19-Nov-2008 the patient experienced ear infection and was given AMOXICILLIN/clavulanic acid combination 875 mg for one week.  The patient recovered from the nasal congestion, sinus infection and ear infection on 26-Nov-2008.  The patient recovered from the root canal procedure on 13-Nov-2008.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasal discomfort, Underdose
Clinical narrative: A spontaneous non-serious report of burning the nostril, hurting and administered of half dose has been received from a nurse practitioner concerning a 10 year old female patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 19-Nov-2008, the patient received one-half dose of FLUMIST in one nostril. During the administration of FLUMIST, the patient complained of the vaccine burning the nostril and burning. The patient was not able to tolerate administration in the other nostril; therefore, the patient only received a half dose of FLUMIST. At the time of the report, the patient had no symptoms. The events of burning the nostril and hurting were recovered/resolved on an unspecified date in Nov-2008.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: A non-serious spontaneous report of arthralgia has been received from a health care worker concerning a 10 year-old female, subsequent to receiving FLUMIST.  The patient's past history includes experiencing right arm pain one month after her 2007 FLUMIST dose.  No concomitant medications were reported.  The patient received FLUMIST on 18-Oct-2008, nasally for influenza prevention.  On 19-Nov-2008, the patient came to her physician's office unable to walk complaining of severe right ankle pain.  The patient was referred to an Infectious Disease (ID) specialist, due to the similar event that occurred the previous year.  The ID specialist diagnosed the event as arthralgia and was unable to determine the etiology of the event.  The event was treated with ADVIL.  The ankle pain resolved on 28-Nov-2008 at which time the patient's mother stated the patient was without fever and pain;  she was doing well and walking fine.  The site indicated they will discontinue dosing the child with FLUMIST.  The patient experienced a similar adverse reaction in 2007 one month after receiving FLUMIST.  Follow up was received on 08-Jan-2009 and incorporated into the above narrative.  Diagnosis obtained and date of resolution.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain in extremity, Sports injury
Clinical narrative: A non-serious unlabeled spontaneous report of right arm pain has been received from a health care worker concerning a nine-year-old female, subsequent to receiving FLUMIST. No past medical history or concomitant medications were reported. The patient received FLUMIST on 21-Nov-2007, nasally for influenza prevention. On 20-Dec-2007, the patient came to her physician's office with right arm pain so severe she would not allow anyone to touch her. The patient was referred to Orthopedic and neurology specialists; she was treated with orapred for 5 days, diphenhydramine, TYLENOL no. 3 and ALEVE. Around the same period of time the patient had a dodge ball injury in gym and her arm pain was attributed to the gym injury. The arm pain resolved on an unknown date.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Vaccination error
Clinical narrative: A non-serious spontaneous report of full dose of FLUMIST in one nostril has been received from a registered nurse concerning a seven year-old male. The patient received FLUMIST on 02-DEC-2008. The reporter stated that the patient received a full dose of FLUMIST in one nostril. 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: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of was received from a nurse concerning a 52-year old female. Information on FLUMIST use in ages 50 to 64 years of age was requested. 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: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: A spontaneous non-serious report of pregnancy was received from a nurse practitioner concerning a 34 year old female patient.  The mother of one of their patients was in the office and indicated that she, the mother, had received FLUMIST two weeks earlier and just found out the she was pregnant.  The mother experienced no difficulty at the time of the report.  There was no adverse event associated with this pregnancy.  Treatment and reporter/sponsor causality assessments are not applicable.  The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during this pregnancy.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST has been received from a nurse concerning a 12-year- old female. The patient's medical history included sinus problems; the patient was not taking any concomitant medications. On 04-Dec-2008, a certified medical assistant (CMA) in a community health inadvertently administered expired FLUMIST; the product was expired by nine days. The patient came into the clinic for sinus problems and the physician recommended the vaccine. Per the reporter, the CMA who administered the vaccine did not foll0w their internal clinic procedures. No adverse events have been reported since the vaccine error. 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 19-Dec-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 55.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A spontaneous non-serious report of inadvertently administered FLUMIST to a 55 year old male has been received from a nurse.  Medical history and concomitant medications were not reported.  On 05-Dec-2008, the patient received FLUMIST.  Shortly after the nurse administered FLUMIST, she discovered that the drug was not approved for the patient's age group.  The patient did not experience any apparent changes in medical/health status.  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: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: A non-serious report of fever, vomiting, chills, sore throat, and runny nose has been received from a nurse concerning a 10-year-old female, subsequent to FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST on 25-Nov-2008. On the next morning, the patient woke up with symptoms of fever, vomiting, chills, sore throat, and runny nose. Outcome for the events not reported.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash erythematous
Clinical narrative: A non-serious spontaneous report of bright red rash has been received from a nurse concerning a 48 year old female, subsequent to receiving FLUMIST.  No medical history or concomitant medication information was provided.  The patient received FLUMIST on 25-Nov-2008 nasally.  Within 4 to 6 hours after receiving FLUMIST, the patient noticed two bright red spots on her face, both on the right cheek.  One spot is 1/2 inch in diameter the other is 1 inch in diameter and the spots do not itch.  The patient reported the rash resolved by 01-Dec-2008.
Age: 46.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST has been received from a nurse concerning a 46-year-old of unknown gender. No medical history nor concomitant medications were provided. On 26-Nov-2008, the county health department inadvertently administered expired FLUMIST to 10 patients (ages 3 to 46). The product was expired by one day. The patients did not experience any adverse events and will be revaccinated in four weeks. There was no adverse event associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009: product complaint investigation results.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a male child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the agency reported that his office received a report of 30 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Myalgia, Vomiting
Clinical narrative: Neither relevant medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 28-Nov-2008, intranasal for Flu vaccination. Approximately twelve hours following administration, on 29-Nov-2008 the patient vomited twice and experienced muscle aches. The patient recovered from the episode of vomiting on 29-Nov-2008 and recovered from the muscle aches on 30-Nov-2008. The patient's physician told the parent she did not think the events were related to FLUMIST.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: A non-serious, spontaneous, report of vomiting, nausea and diarrhea was received from a consumer, concerning a nine-year-old female subsequent to FLUMIST. The patients medical history includes sensitive stomach with vomiting, and seasonal and nasal allergies. Concomitant medications include fluticasone propionate since Nov-2007 for nasal allergies. The patient received FLUMIST on 28-Nov-2008, intranasal for influenza vaccination. Approximately six hours following administration, the patient experienced nausea and began vomiting about every 20 minutes throughout the night. The next day, the patient experienced diarrhea and was taken to the pediatrician office because she could not hold down water. She was given a PEDIALYTE pop and PHENERGAN by mouth. The patient recovered from the events on 29-Nov-2008. The patient's physician told the parent she did not think the events were related to FLUMIST.
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST has been received from a nurse concerning a 42-year old male.  The patient's medical history and concomitant medications were not reported.  On 05-Dec-2008, the patient was inadvertently administered expired FLUMIST;  the product was expired by 10 months (February 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 31-Mar-2009 that included the results of a Lot Investigation. Eased on the results of the investigation, the root 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: F
Vaccine: FLUN3
Symptoms: Acarodermatitis
Clinical narrative: A spontaneous non-serious report of scabies was received form a nurse concerning a six year old female patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 18-Nov-2008 the patient received FLUMIST. On 27-Nov-2008, nine days after receiving FLUMIST, the mother took the patient and her brother, who also received FLUMIST, to the emergency room (ER) with rash on their arms and body that started on or shortly after the day the patient received FLUMIST. Treatment included BENADRYL, and acyclovir. The attending physician in the ER  diagnosed the patient with scabies and not an allergic reaction. At the time of the report, the event of scabies was ongoing and may be worsening.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Acarodermatitis, Rash
Clinical narrative: A spontaneous non-serious report of scabies was received from a nurse concerning a nine year old male patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 18-Nov-2008 the patient received FLUMIST. On 27-Nov-2008, nine days after receiving FLUMIST, the mother took the patient and his sister, who also receive FLUMIST, to the emergency room (ER) with rash on their arms and body that started on or shortly after the day the patient received FLUMIST. Treatment included BENADRYL and acyclovir. The attending physician in the ER diagnosed the patient with scabies and not an allergic reaction. At the time of the report, the event of scabies was ongoing and may be worsening.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Henoch-Schonlein purpura, Upper respiratory tract infection
Clinical narrative: A non-serious spontaneous report of Henoch-Schoenlein purpura and upper respiratory infection was received from a physician concerning a 6 year-old male, subsequent to receiving FLUMIST.  At the time of FLUMIST administration the patient had a mild skin rash that the physician diagnosed as a fungal infection.  No concomitant medications were reported.  The patient received FLUMIST on 26-Nov-2008.  Around 01-Dec-2008 the patient experienced a mild upper respiratory infection that was resolving on 04-Dec-2008 at the time the patient was seen due to Henoch-Schoenlein purpura (HSP).  No treatment was given for the HSP, the patient was monitored.  The HSP resolved later in Dec-2008.
Age: 9.0
Sex: U
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A non-serious spontaneous report of vomiting was received from a consumer concerning a nine year-old (gender not reported), subsequent to FLUMIST. The patient received FLUMIST on 29-Nov-2008. The mother of the child stated that 6 to 12 hours after administration of FLUMIST the child started to vomit. The outcome of the vomiting was not reported.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a seven-year-old male who received FLUMIST on 15-Nov-2008. FLUMIST expired on 12-Nov-2008. Medical history and concomitant medications were not reported. There was no adverse event reported with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. On 05-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events reported.
Age: 54.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious, spontaneous report of gave FLUMIST to a 54 year-old was received from a pharmacist, concerning a 54 year-old female subsequent to FLUMIST. There was no adverse even associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Urticaria
Clinical narrative: A spontaneous non-serious report of coughing and hives has been received from a patient's father concerning a five year old female patient subsequent to FLUMIST. The patient has no relevant medical history and no concomitant medications. On an unknown date in October 2008, the patient received FLUMIST. The patient received FLUMIST and started coughing immediately after administration. A day or two after dosing, the patient broke out in hives. She was referred to an allergist, who treated her with "medication with steroid". A skin test was not performed; it was though that she may be allergic to red dye #3. She continued to take oral BENADRYL every morning; however, one day she did not take BENADRYL, her hives broke out. The patient's father had not taken the patient to a physician for further follow-up; the family was looking for a new allergist. As of 12-Dec-2008, she continued to break out in hives, which resolved with BENADRYL. The patient's cough was ongoing. Additional information was received on 12-Dec-2008 and incorporated into the narrative: medical history, siblings, event details and outcome.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of FLUMIST given to a pregnant female has been received from a Registered Nurse concerning a 26-year-old female. Medical history included asthma, smoking, bipolar disorder and allergies to codeine and aspirin. Obstetrical history included eight previous pregnancies (four full-term deliveries, three spontaneous abortions and one delivery of twins at 24 weeks, the twins died shortly after birth). The patient continued to smoke throughout this pregnancy. Concomitant therapy included albuterol and prenatal vitamins. The father's medical history included "borderline" retardation/was "slightly retarded'> On 02-Oct-2008, the patient received FLUMIST at a county health department. When filling out her paperwork to receive FLUMIST, she indicated that she was not pregnant. The patient's obstetrician/gynecologist contacted the reporting nurse to indicate that the patient was pregnant. Gestation at the time of exposure was 13 weeks. Last menstrual period was 13-Jun-2008 and the patient's estimated date of delivery was 24-Mar-2009. On 26-Mar-2009, the patient gave birth to a normal baby boy (eight pounds, one ounce; 19.25 inches) via vaginal birth at 40+ weeks gestation. Apgar scores at one minute was nine and at five minutes was nine. The patient had no complications during her pregnancy and no complications with the delivery. There were no adverse events reported. Additional information received on 11-Dec-2008 was incorporated into the narrative and included patient demographics, vaccine information, medical history, concomitant medications and pregnancy information. Additional information received on 21-Apr-2009 and incorporated into the narrative included the outcome of the pregnancy and the labor and delivery summary.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of expired FLUMIST given was received from a registered nurse concerning a 49 year-old female, It was discovered 21 days after dosing that the patient was given expired FLUMIST. The reporter indicated the FLUMIST expired at the beginning of the flu season. 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 error that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye discharge, Eye disorder, Nasal congestion, Ocular hyperaemia
Clinical narrative: A spontaneous non-serious report of "glassy looking eyes, red eyes, eye discharge and nasal congestion has been received from a consumer concerning a six year old female patient subsequent to FLUMIST.  Medical history and concomitant medications were not reported.  On 11-Dec-2008, the patient received FLUMIST.  Within 24 hours of administration, the patient developed nasal congestion which progressed to "glassy looking eyes", red eyes and discharge from eyes.  These symptoms were not associated with itching or burning of the eyes.  The patient's mother was going to take her to the doctor's office;  however, the symptoms began to clear on 14-Dec-2008 with no discharge and only mild redness of the eyes.  The events of "glassy looking eyes", red eyes, discharge and nasal congestion from eyes was recovering/resolving.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure
Clinical narrative: A non-serious spontaneous report of FLUMIST sprayed in the eye was received from a registered pharmacist concerning a 22-year-old female.  Medical history and concomitant medications were not reported.  On 13-Dec-2008, the patient received FLUMIST.  FLUMIST was sprayed in the eye during administration.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved.  Additional information received on 29-Dec-2008 was incorporated into the narrative and included the patient's gender and the lot number of FLUMIST.  The pharmacist confirmed that there were no late-occurring adverse events reported.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy. A spontaneous non-serious report of administration to pregnant female was received from a nurse concerning a 23 year old female patient. On 30-Sep-2008, FLUMIST was administered to the patient at the health department. The patient was two to three weeks pregnant. In November 2008, the patient discovered she was pregnant. She had no symptoms or problems at the time of the report. There was no adverse event associated with this FLUMIST exposure to a pregnant female. 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/subject experiences any adverse events during the pregnancy.
Age: 6.0
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 6-year 11 month old male. Neither medical history nor concomitant medications were reported. On 29-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 23-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 10-Mar-2009. The reporter confirmed that no delayed adverse events resulted from this error. Additional information was received on 09-Apr-2009: product complaint investigation results.
Age: 55.0
Sex: M
Vaccine: FLUN3
Symptoms: Oedema peripheral, Rash erythematous, Rash macular, Urticaria
Clinical narrative: A non-serious spontaneous report of hives, red blotchy skin/redness, both hands swelled and 55-year-old administered FLUMIST has been received from the patient, as 55-year-old male. The patient had no relevant medical history nor concomitant medications. On 08-Oct-2008, the patient received FLUMIST via intranasal administration as a flu vaccine. Within 18 hours on that date, the patient developed hives on his buttocks and ribs and both hands swelled (not his feet). This peaked at 24 hours then diminished in the next 24 hours. At that time, he had just red blotchy skin/redness where the hives were. The patient did not see a physician. He self-treated with fexofenadine hydrochloride 24 hours after his FLUMIST dose. On 11-Oct-2008, the patient recovered. Additional information received on 13-Jan-2009 and incorporate into the above narrative included therapy dates, treatment medications, additional events and outcome dates.
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a female employee "in her 20's" who received FluMist.  Medical history and concomitant medications were not reported.  On 15-Dec-2008, the patient was administered FLUMIST which expired on 12-Nov-2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information received on 29-Dec-2008 and incorporated into the narrative included patient demographics and lot number of FLUMIST.  The reporter confirmed there were no late-occurring adverse events.  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 administration of expired product has been received from a Registered Nurse concerning a 6 year old female who received FLUMIST. Medical history and concomitant medications were not reported. On 16-Dec-2008, this child was administered FLUMIST which expired on 15-Dec-2008. There was no adverse event associated with this error; therefore; treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 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 of into the cause of medication error.
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a female employee "in her 20's" who received FLUMIST. Medical history and concomitant medications were not reported. On 15-Dec-2008, the patient was administered FLUMIST which expired on 12-Nov-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 cased 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 29-Dec-2008 and incorporated into the narrative included patient demographics and lot number of FLUMIST. The reporter confirmed there were no late-occurring adverse events. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 24.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of administration to a pregnant female was received from a consumer concerning a 24-year-old female. The patient's medical history and concomitant medications were not reported. The patient was administered FLUMIST but did not know that she was pregnant. 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: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A spontaneous non-serious report of administration of extra dose has been received from a nurse practitioner concerning a five year old male patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 15-Dec-2008, the patient received one dose of FLUMIST and on 17-Dec-2008, the patient received FLUMIST again. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 28.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A spontaneous non-serious report of administration to pregnant female has been received from a health care professional concerning 28 year old female subsequent to FLUMIST. Medical history and concomitant medications were not reported. No obstetrical history was available. On 07-Nov-2008, the patient received FLUMIST and subsequently discovered she was pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product has been received from a Registered Nurse concerning a female employee "in her 20's" who received FLUMIST. Medical history and concomitant medications were not reported. On 15-Dec-2008, the patient was administered FLUMIST which expired on 12-Nov-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 29-Dec-2008 and incorporated into the narrative included patient demographics and lot number of FLUMIST. The reporter confirmed there were no late-occurring adverse events. 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 expired FLUMIST given to this patient was received from a certified medical assistant concerning a six-year-old female. Neither medical history nor concomitant medications were reported. On 26-Dec-2008, the patient and her brother received expired FLUMIST vaccine. The vaccine had 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 03-Feb: reporter confirmed no delayed occurring adverse events related to being given expired FLUMIST. Follow-up information received on 27-Mar-2009 included Product Complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired.
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administration of expired product to a 52-year-old was received from a Nurse concerning a 52-year-old female. The patient's medical history and concomitant medications were not reported. On 22-Dec-2008, the patient received expired FLUMIST (expiration date 21-Dec-2008). The reporter inquired about dosing with expired product and information in patient over 49 years of age. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a Registered Nurse concerning a 14 year-old-male. FLUMIST, which expired on 25-Dec-2008, was administered on 29-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of gave expired FLUMIST to an 11-year old was received from a Nurse Manager concerning a 11-year-old male. The patient's medical history and concomitant medications were not available. On 29-Dec-2008, the patient received expired FLUMIST (expiration date 24-Dec-2008) at an immunization clinic. 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 07-Jan-2009 that no delayed adverse events resulted from this error. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administered expired FLUMIST was received from a Registered Nurse concerning a seven-year-old male.  Medical history and concomitant medications were not reported.  On 22-Dec-2008, the patient received FLUMIST that expired on 10-Dec-2008.  The physician decided not to redose with 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.  On 08-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events.  Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.