chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, Nasal congestion
Clinical narrative: A non-serious spontaneous report of pregnancy was discovered after H1N1 LAIV given and nasal stuffiness has been received from a consumer concerning 32-year-old female, subsequent to H1N1, Intranasal vaccination. Neither relevant medical history nor concomitant medications have been reported. On 15-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. After vaccination the patient came to know that she was pregnant. On 17-Nov-2009, two days after vaccination, the patient experienced nasal stuffiness that lasted for two weeks. The reporter noted the patient seemed to be fine at the time of report. The outcome of vaccine exposure before pregnancy and nasal stuffiness was resolved.
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of portion of vaccine spritz into eye was received from a non health professional concerning a male child. Neither relevant medical history nor concomitant medications were reported. On 01-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 1.86
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Croup infectious, Inappropriate schedule of drug administration, Nasal congestion
Clinical narrative: A non-serious spontaneous report of administration to 22 month old, nose picking, mild croup and cough have been received from a physician concerning a 22-month-old female, subsequent to H1N1, Intranasal. The patient's past medical history includes diaper rash and lactose intolerance. No concomitant medications have been reported for this patient. On 14-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On the same day after vaccine administration, the patient experienced nose picking. On 03-Nov-2009, the patient was seen for mild croup and was prescribed dextromethorphan and guaifenesin. On 19-Nov-2009, the patient was examined for cough at night time but no wheeze was noted and the patient was prescribed albuterol and PHENERGAN. On 20-Nov-2009, mild croup was resolved and on 25-Nov-2009, night time cough also resolved and the patient was doing well at the time of reporting. The outcome for the event of administration to 22 month old, nose picking, mild croup and cough was resolved. Additional information was received on 24-Nov-2009 and incorporated into the narrative: medical history and concomitant medications, patient's demographics, adverse event terms and treatment. Additional information was received on 03-Dec-2009 and incorporated into the narrative: about the outcome of the reported adverse events.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of got H1N1 LAIV and developed hives on her face, neck and one of her legs has been received from a parent/consumer concerning her 11-year-old daughter, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 30-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On the same day of vaccination, five hours subsequent to vaccination, the patient developed hives on her face, neck and one of her legs. The parent had given diphenhydramine to her daughter. The outcome of the reported events was resolved.
Age: 59.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of H1N1 to 59-year-old female. The patient's medical history was not reported. On 21-Nov-2009, the patient received the expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of woman in her fifties received a dose of H1N1 LAIV was received from a physician concerning an adult female. Neither relevant medical history nor concomitant medications were reported. On 02-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 7.0
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of received half dose was received from consumer/non health professional concerning a 7-year-old patient. The patient's medical history was not reported. On 13-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 54.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of 55 year old got a dose of H1N1 LAIV was received from a registered nurse/ health professional concerning a 55-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 02-Dec-2009, the patient received H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 10.0
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of received half dose was received from a consumer/non health professional concerning a 10-year-old patient. The patient's medical history was not reported. On 13-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of most of the second dose squirted directly into the eye was received from a consumer/non health professional concerning a 5-year-old male. The patient's medical history was not reported. On 21-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 8.0
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of inadvertent administration of a partial dose only was received from a registered nurse/health professional concerning an eight-year-old child of unknown gender. Neither relevant medical history nor concomitant medications have been reported for this patient. On 09-Jan-2010, a nurse failed to remove the dose divider clip of H1N1, Intranasal and administered approximately half of the dose, divided into both nostril of the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 70.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 70 year old was received from a registered nurse/health professional concerning a 70-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 14-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 76.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 76-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV received from a registered nurse/health professional concerning a five-year-old female out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine was expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration to pregnant woman was received from a physician concerning a female of unknown age. No relevant medical and obstetrical history has been reported for this patient. The patient was eight to nine weeks pregnant at the time of vaccination. No concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 26-Jan-2010 for an unknown indication. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of vaccine exposure during pregnancy was considered resolved.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Epistaxis, Incorrect dose administered, Scratch, Underdose, Vaccination site reaction
Clinical narrative: A non-serious spontaneous report of administered half dose, scratched the inside of nose and nose bleed has been received from a registered nurse/health professional concerning a four-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 22-Jan-2010, the patient received H1N1, Intranasal via nasal route for an unknown indication. On 22-Jan-2010, after inserting the syringe tip of the H1N1 LAIV into nose, the patient jerked her head back so hard that it scratched the inside of nose and it bleed. Only half dose was administered and the other nare was not dosed. There was no symptoms at the time of report. The outcome of the administered half dose was considered to be resolved and of scratched the inside of nose and nose bleed was resolved on an unknown date of Jan-2010.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired vaccine was received from a registered nurse/health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 27-Jan-2010, the patient received expired H1N1, Intranasal, for an unknown indication. The product expired on 26-Jan-2010. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 from a registered nurse/health professional concerning a 37-month-old male out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine was expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 received from a registered nurse/health professional concerning a 42-month-old female out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 received from a registered nurse/health professional concerning a five-year-old female out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine was expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 80.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 80-year-old female out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 67.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 67-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 received from a registered nurse/health professional concerning a 42-month-old female out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine was expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 40-month-old female out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine was expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Age: 66.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of expired product" and "vaccine given to a patient" was received from a non healthcare professional concerning a 66-year-old female out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a four-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of two children were inadvertently given the field corrected expired H1N1 was received from a nurse/health professional concerning an eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 19-Jan-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a 30-month-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a 33-month-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a 47-month-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning an eight-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. The original expiry date was 12-Feb-2010 which was changed. On 20-Jan-2010, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a seven-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a four-year-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we gave expired H1N1 to several patients was received from a registered nurse/ health professional concerning a four-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. The original expiry date was 12-Feb-2010 which was changed. On 20-Jan-2010, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 14.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a 14-year-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a 39-month-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 9.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, Eye irrigation, No adverse event
Clinical narrative: A non-serious spontaneous report of "received some H1N1 LAIV liquid in her eye" was received from a registered nurse/health professional concerning an approximately nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. While receiving the vaccine, the patient jerked her head around and some H1N1 mist got into her eye. The eye was immediately flushed with water or saline. There was no adverse event associated with this medication error; therefore, reporter causality assessments are not applicable and the event was considered resolved.
Age: 56.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of we gave H1N1 to 56 year old female was received from a registered nurse/health professional concerning a 56-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 22-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Age: 0.87
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "H1N1 LAIV was administered to 10 month old" was received from a registered nurse concerning a ten-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 20-Jan-2010 for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 26-Feb-2010 and incorporated into the narrative: gender of the patient received and changed from unknown to male.
Age: 1.61
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, Nasopharyngitis
Clinical narrative: A non-serious spontaneous report of 19 month old child inadvertently received a dose of H1N1 and mild cold has been received from a health professional concerning a 19-month-old male, subsequent to H1N1, Intranasal. The patient does not have history of asthma and no relevant medical history. The patient was not taking any concomitant medication and patient is vegetarian. On 12-Jan-2010, the patient received H1N1, Intranasal, for an unknown indication. On 24-Jan-2010, at night, the patient had symptoms of mild cold. At the time of report, on 25-Jan-2010, the patient was doing well with eating and playing. The outcome of the vaccination error was considered to be resolved and the event of mild cold was resolved on the 25-Jan-2010. Additional information was received on 25-Jan-2010 and incorporated into the narrative: Added one event of mild cold and its outcome, reporter type, patient's gender and concomitant medications. Other information received are country, initials, DOB of patient and reporter's name, address and phone number.
Age: 63.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of a 63 year old female received a dose of H1N1 was received from a registered nurse/health professional concerning a 63-year-old female. Neither relevant medical history nor concomitant medication have been reported for this patient. On 12-Jan-2010 the patient received the H1N1, Intranasal an unknown indication. There was no adverse event associated with this medication error; therefore treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 37.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to immune compromised and administered the vaccine using a cotton swab was received from a wife/consumer concerning her 37-year-old husband. The patient history and concomitant medication was not reported for this patient. At the time of event the patient was immune compromised. On 09-Jan-2010, the patient received H1N1, Intranasal, for unknown indication, via nasal route. The vaccine was placed on a cotton swab and then nasally applied. There was no adverse event associated with this medication errors therefore, treatment and reporter causality assessments were not applicable, and the events were considered resolved.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: A non-serious spontaneous of tested positive for influenza A manifested with fever of 103F has been received from a registered nurse concerning a seven-year-old male, subsequent to H1N1, Intranasal. The patient's medical history included runny nose which started on unknown date in Jan-2010 and was ongoing after the vaccination on 15-Jan-2010. He also had no history of asthma. No concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 15-Jan-2010 for an unknown indication. On 18-Jan-2010, the patient experienced fever of 103F and on same day tested positive for influenza A. The outcome of the event was unknown at the time of report.
Age: 30.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a 30-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired product was received from a non health professional concerning a eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The labeled expiration date was 12-Feb-2010; the re-assigned expiration date was 15-Jan-2010. On 18-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Age: 24.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of "we gave H1N1 LAIV to a woman who is pregnant" was received from a registered nurse concerning a 24-year-old pregnant female. The patient had no past medical history. The patient's concomitant medications included prenatal vitamins, Rho(D) immune globulin, vitamin C and iron during the pregnancy. The obstetrical history included gravida two and para one. Gestation period at the time of vaccination was 15 weeks and four days. She was in her second trimester of pregnancy with the estimated date of delivery as 10-Jul-2010. On 20-Jan-2010, the patient received the H1N1, Intranasal for an unknown indication. On 16-June-2010 at 39 weeks gestation, the patient vaginally delivered a female infant. The infant weighed seven lbs & four ozs; apgar at one minute was eight and at five mins was nine. There were no complications at delivery for mother or the infant. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments were not applicable. The outcome of vaccine exposure during pregnancy was considered resolved. This case is linked to MEDI-0011481. Additional information was received on 12-Feb-2010 and incorporated in narrative: Patient history, concomitant medications, obstetrical history, LMP date and expected delivery date received. Other additional information received: Reporter title and address. Additional information received on 16-Aug-2010 and incorporated in narrative: Pregnancy outcome, concomitant medications and infant information. Other additional information received was Reporter information, patient name, responsible physician information.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired product was received from a non-health professional concerning a 26-month-old female, subsequent to H1N1,  Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The product's labeled expiration date was 12-Feb-2010. The re-assigned expiration date was 15-Jan-2010 due to Field Correction Notice. The patient received the vaccine on 18-Jan-2010 for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of two children were inadvertently given the field corrected expired H1N1 LAIV was received from a nurse/health professional concerning a 33-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 19-Jan-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a 11-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. The original expiry date was 12-Feb-2010 which was changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional in concerning a 36-month-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 43.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Asthma, Condition aggravated
Clinical narrative: A non-serious spontaneous report of "an employee who also has a history of asthma, inadvertently received H1N1 LAIV" and "patients asthma is worse after she got H1N1 LAIV" has been received from a pharmacist, concerning a 43-year-old female subsequent to H1N1, Intranasal. The patient had a history of asthma. No concomitant medications have been reported for this patient. On 06-Nov-2009, the patient received H1N1, Intranasal for unknown indication. In Nov-2009, starting next week after the vaccine administration, the patient noticed that her asthma progressively got worsened and it was resolving after antibiotics and steroids were given, at the time of report. The outcome of the event of "employee who also has a history of asthma, inadvertently received H1N1 LAIV" was considered as recovered, while that of "patients asthma is worse after she got H1N1 LAIV" was recovering at the time of reporting.
Age: 28.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a 28-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a 40-month-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a 6-year-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received  from a registered nurse/health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1 vaccine, intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a seven-year-old male. Neither relevant medical history now concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010, On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of only half dose of H1N1 LAIV was given to son was received from a mother/consumer concerning her 29-month-old son. Neither relevant medical history nor concomitant medications have been reported for this patient. In 2009, the patient received the first dose of H1N1 LAIV. On 23-Dec-2009, the patient received only half dose of (0.1ml) H1N1, Intranasal via nasal route for an unknown indication. This dose was his booster dose of H1N1 LAIV. There was no adverse event associated with medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved on 23-Dec-2009.
Age: 19.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Headache, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever and extreme headache has been received from a mother/consumer concerning a 19-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 24-Dec-2009, the patient received H1N1, Intranasal for an unknown indication. On 24-Dec-2009, 12 hours after vaccination the patient experienced fever and severe headache. The outcome of the reported events was unknown.
Age: 62.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 62-year-old was received from a health professional concerning a 62-year-old male. The patient's medical history was not provided. On 30-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable. The outcome of the event was considered recovered.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "eight year old received first dose of H1N1 03 Dec 2009 and second dose was administered on 23 Dec 2009" was received from a registered nurse/health care professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 03-Dec-2009, the patient received first dose of H1N1, Intranasal. After 20 days, on 23-Dec-2009, the patient received second dose. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 22.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of patient inadvertently received a full dose of H1N1 LAIV in one nostril was received from a pharmacist/health professional concerning a 22-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error therefore treatment and reporter causality assessments were not applicable and the event was considered as resolved.
Age: 57.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration to 57 year old was received from a registered nurse concerning a 57-year-old female. The relevant medical history was not reported for this patient. On 30-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter's causality assessments are not applicable and the event was considered resolved.