chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of gave H1N1 LAIV to person >49 years old was received from a registered nurse/healthcare professional concerning a 64-year-old male. No relevant medical history was reported for this patient. On 23-Nov-2009 the patient inadvertently received H1N1, Intranasal. 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.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of inadvertent administration of approximately 75% of H1N1 LAIV was received from a registered nurse concerning 138 children of unknown gender. No past medical history or concomitant medication was reported for these patient. On 18-Nov-2009, these patients received H1N1, Intranasal for an unknown indication. The nurse who was administering the vaccine, administered half of the dose to one nostril and then did not remove the clip before administering an additional 25% (approximately) of dose to the other nostril. There was no adverse event associated with this medication error; therefore, treatment and reported causality assessments are not applicable, and the event is considered resolved.
Age: 10.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Crying, Inappropriate affect, Miosis
Clinical narrative: A non-serious spontaneous report of uncontrollable laughter, uncontrollable crying and pupils were constricted has been received from a nurse/health professional concerning a ten-year-old male, subsequent to H1N1, Intranasal. No medical history was reported for this patient. The patient's concomitant medications included amphetamines. On 15-Dec-2009, the patient received H1N1, Intranasal for an unknown indication. On 15-Dec-2009, five minutes after vaccination the patient had an uncontrollable laughter with crying at the same time, and patient's pupils were constricted. The outcome for the reported events was unknown.
Age: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of a pregnant woman received a dose of H1N1 LAIV was received from a registered nurse/health professional concerning a 32-year-old female. The patient's medical history included anemia and back pain and obstetrical history included gravida three, para three and LMP date was 03-Jun-2009. The gestation period was 24-weeks and expected date of delivery was 10-Mar-2010. The concomitant medications taken by patient were iron tablets (oral, twice daily) and prenatal vitamins (oral, once daily). The patient was not ill at time of vaccination and no other vaccinations were given within 4 weeks of the H1N1. On 18-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. The patient delivered a female child on 18-Mar-2010. It was full term vaginal delivery with no medical complications. The newborn had a weight of 6lbs 12 oz, length of 19.5 inches and head circumference of 13 inches. The fetus had no complications with delivery. There was no adverse event associated with this pregnancy therefore, treatment and reporter causality assessments were not applicable, and the event vaccine exposure during pregnancy was considered resolved. Additional information was received on 05-Jan-2010 and incorporated into the narrative: past medical history, gestation period, EDD, LMP, gravida and para and concomitant medication. Additional information was received on 28-Apr-2010 and incorporated into the narrative: pregnancy outcome, medical history and neonatal information. Other information received was primary care physician details and patient details.
Age: 25.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Muscular weakness, Pain in extremity, Sensation of heaviness
Clinical narrative: A non-serious spontaneous report of left arm pain and left arm feeling heavy and weak has been received from a physician concerning a 25-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 16-Dec-2009 for an unknown indication. On 16-Dec-2009, shortly after the vaccine was administered the patient experienced left arm pain with arm feeling heavy and weak. Upon physical exam by the physician, arm was determined not to be weak. The outcome of left arm feeling heavy and weak was resolved whereas left arm pain was unknown.
Age: 17.0
Sex: F
Vaccine: FLUN(H1N1), HPV4, TDAP, VARCEL
Symptoms: Drug exposure during pregnancy, No adverse event, Placenta praevia
Clinical narrative: A non-serious spontaneous report of a 16 week pregnant girl got H1N1 LAIV was received from a non-health professional concerning a pregnant female. The patient's medical history included smoking, mild asthma, cardiac murmur and promiscuity. As stated by reporter, the patient had never undergone testing for asthma and cardiac murmur. The patient's obstetrical history included gravida three, para one and two spontaneous abortions which occurred in first trimester. The patient was in her 15th week gestation at the time of the vaccination (second trimester) and the estimated date of delivery was 29-May-2010. The patient was diagnosed with placenta previa (sic). The patient was a troubled teen with a criminal history. The concomitant medication included prenatal vitamins. On 08-Dec-2009, the patient was vaccinated with H1N1, Intranasal and on the same day, the patient also had taken following vaccines: varicella, combination of DTP and GARDASIL. There was no problems with the pregnancy. On 14-June-2010, patient delivered a baby boy. Baby's labs reports were fine. Patient and baby were discharged within 24 hours of delivery. 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 resolved. Additional information was received on 17-Dec-2009 and incorporated into the narrative: Details of vaccines given on same day and estimated date of delivery added. Additional information was received on 07-Jan-2010 and incorporated into the narrative: Medical history, obstetrical history and concomitant medication. Additional information was received on 09-Aug-2010 and incorporated into the narrative: Outcome of pregnancy, Reporter changed.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dyspnoea, Pruritus, Rash, Urticaria
Clinical narrative: A spontaneous report of serious event of shortness of breath, and non-serious events of "received first dose of H1N1 on 18-Nov-2009 and second dose of 15-Dec-2009", hives, itching and rash has been received from a physician concerning his seven-year-old daughter, subsequent to H1N1, Intranasal. There was no family history of drug or food allergies. The patient also had no history of drug or food allergies, no medical history, and was not taking any concomitant medications. On 18-Nov-2009, the patient received the first dose and on 15-Dec-2009, patient received the second dose of H1N1, Intranasal for an unknown indication. On 16-Dec-2009, twenty four hours after receiving the second dose of the vaccine, the patient broke out with hives, itching, rash, and shortness of breath. The patient was treated with cetirizine hydrochloride, which relieved the symptoms other than rash, which was present at the time of reporting. Over the past two weeks, the events of rash, itching, and hives returned and came back at various intervals with no temporal relationship to anything that could be new. The patient was being treated with oral diphenhydramine hydrochloride 25 mg on an as needed basis (PRN) whenever the events of rash, itching, and hives returned. The outcome of the events of shortness of breath, "received first dose of H1N1 LAIV on 18-Nov-2009 and second dose on 15-Dec-2009", was recovered, while that of rash, itching, and hives was not recovered at the time of reporting. Additional information was received on 04-Jan-2010 and incorporated into the narrative: patient's medical history; concomitant medication confirmed as none; event description and outcome of the events.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error
Clinical narrative: A non-serious spontaneous report of sprayed H1N1 LAIV in the eye was received from a registered nurse/healthcare professional concerning a female child. No relevant medical history was reported for this patient. On 22-Dec-2009 H1N1, Intranasal was sprayed in the patient's eye as she jerked her head back while the vaccine was administered. Her eye was washed out and the patient was evaluated again after 30 minutes with no symptoms. 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: 41.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Delivery, Drug exposure before pregnancy
Clinical narrative: A non-serious spontaneous report of "got H1N1 LAIV, then realized that she is pregnant" was received from a physician concerning a 41-year-old female, subsequent to H1N1, Intranasal. The patient had no medical history. The obstetrical history included gravida two and para one. The patient was not pregnant at the time of vaccination. The LMP date was reported as on or around 10-Oct-2009 whereas expected date of delivery has been reported as 17-Jul-2010. The patient was not on any concomitant medications. The patient received the vaccine during the first few days of Oct-2009 for an unknown indication. The patient delivered a baby on around16 or 17-Jul-2010. The baby was fine and there were no problems. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of vaccine exposure before pregnancy was considered resolved. Additional information received on 07-Jan-2010 and incorporated in narrative: Patient's medical and obstetrical history, concomitant medications, adverse event information. As the vaccination date is before the LMP date, coding was changed to 'vaccine exposure before pregnancy'. Other additional information received: Patient initials, date of birth and vaccination date. Additional information received on 31-Aug-2010 and incorporated in narrative: Outcome of the pregnancy. The patient delivered a baby on around 16 or 17-Jul-2010. Other additional information received: Patient's name. Corrected patient's initials.
Age: 1.42
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of a dose of H1N1 LAIV was inadvertently administered to a 17 month old was received from a physician concerning a 17-month-old female. The patient had no significant medical history and no concomitant medications was received by patient. On 22-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. Additional information was received on 5-Jan-2010 and incorporated in the narrative: Medical history and concomitant medications. Other additional information received was reporter address and phone number.
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 LAIV received from a registered nurse/health professional concerning a 43-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: 59.0
Sex: F
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 59 year old female was received from a office manager/other health professional. Neither relevant medical history nor concomitant medication have been reported. H1N1, Intranasal was administered on 14-Nov-2009. There was no adverse event associated with medication error therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Age: 13.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Blister, Oral disorder, Pyrexia, Skin lesion, Tenderness
Clinical narrative: A non-serious spontaneous report of tender vesicle lesions on fingers, tongue and inside her mouth and fever has been received from a registered nurse concerning a 13-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 13-Nov-2009 for an unknown indication. Next day on 14-Nov-2009, the patient experienced fever and tender vesicle lesions on fingers, tongue and inside her mouth. The vesicle lesions were approximately two to three millimeters on her fingers, smaller on her tongue and inside her mouth. The outcome of fever was resolved while the vesicle lesions on fingers, tongue and inside her mouth were not resolved.
Age: 42.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a nurse/health professional concerning a 42-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of 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: 57.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "administered H1N1 LAIV to 57 year old" was received from a pharmacist concerning a 57-year-old male. No relevant medical history have been reported for this patient. On 16-Nov-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: 31.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a nurse/health professional concerning a 31-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of 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: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a nurse/health professional concerning a 32-year-old female. The patient's medical history and concomitant medications was not reported. On 28-Oct-2009, the patient was inadvertently given half dose of 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: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a registered nurse/health professional concerning a 33-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of 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: 34.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a nurse/health professional concerning a 34-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of 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: 36.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a registered nurse/health professional concerning a 36-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose (0.1 ml) of 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: 61.0
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 61-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: 62.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, 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 62-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 as no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of expired product" was received from a non healthcare professional concerning a 47-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: 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 received from a registered nurse/health professional concerning a seven-year-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: 46.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of expired product" was received from a non healthcare professional concerning a 46-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: 60.0
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 60-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 were not applicable and the event was considered resolved.
Age: 31.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of expired product" was received from a non healthcare professional concerning a 31-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: 26.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of expired product" was received from a non healthcare professional concerning a 26-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 were not applicable and the event was considered resolved.
Age: 51.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, 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 51-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: 37.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration of expired product" was received from a non healthcare professional concerning a 37-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 were not applicable and the event was considered resolved.
Age: 52.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, 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 52-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. O 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: 60.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered, 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 60-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 were not applicable and the event was considered resolved.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, Pharyngitis streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: A non-serious, spontaneous report of my son got three doses of H1N1 LAIV and positive for strep throat has been received from a physician concerning a seven-year-old male, subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications were provided. The patient received H1N1, Intranasal on 21-Oct-2009, 18-Nov-2009 and 01-Dec-2009. On 01-Dec-2009 the patient mistakenly received a third dose of H1N1, Intranasal. On the evening of 01-Dec-2009 the patient experienced a fever and the next day on 02-Dec-2009 the patient tested positive for strep throat. The outcome of the events are unknown.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Incorrect dose administered, Unevaluable event
Clinical narrative: A non-serious spontaneous report of given half the dose of nasal H1N1 vaccine was received from a physician concerning approximately 40 children (between two to nine-year-old) at an urgent care clinic. The physician stated that approximately 40 children at the clinic were given half the dose of H1N1, Intranasal. A short pre-history screening was done on each child, and none of the children were on concomitant medications, and all were healthy children with no remarkable past medical history. The initial half-dosing of these children occurred between 28-Oct-2009 and 06-Nov-2009 into one nare. On an unknown date in 2009, the children were revaccinated. There were no adverse events associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 09-Dec-2009 and incorporated into the narrative: approximately age of all children, revaccination information, and period of vaccination.
Age: 0.73
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of a 8 month old got a dose of H1N1 LAIV was received from a physician concerning an eight-month-old female. The patient did not have medical history and was not taking any concomitant medications. The patient was a normal birth. On 23-Nov-2009, the patient received a dose of 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. Additional information was received on 08-Dec-2009 and incorporated into the narrative: Information about medical history and concomitant medications.
Age: 52.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of 52 year old got a dose of H1N1 LAIV was received from a consumer/non health professional concerning a 52-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 03-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: 1.63
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 19 month old was received from a registered nurse/healthcare professional concerning a 19-month-old female. The patient had no relevant medical history. The patient was not any concomitant medication. On 02-Dec-2009, the patient was administered a dose of H1N1, Intranasal. 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. Additional information was received on 17-Dec-2009 and incorporated into the narrative: Reporter's name and address and responsible physician address was changed. Additional information was received on 28-Dec-2009 and incorporated into the narrative: Patient's date of birth, gender, information on child's condition, medical history and concomitant medication.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: A non-serious spontaneous report of sprayer broke and only partial dose was given was received from a registered nurse/health professional concerning a 42-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Nov-2009, the patient received H1N1, Intranasal, for unknown indication. As per the reporter, the nurse who was giving the vaccine had no problem with the first spray, but felt resistance with the second half of the spray which broke into two pieces and the patient received a partial dose. The patient was not injured by the breakage. 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: 65.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of 65 year old patient received a dose of H1N1 LAIV was received from a pharmacist concerning a 65-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 04-Dec-2009, 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 resolved.
Age: 45.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chest pain, Immediate post-injection reaction, Laryngitis, Oropharyngeal pain, Vocal cord disorder
Clinical narrative: A non-serious spontaneous report of laryngitis, chest pain, sore throat and wheezing has been received from a physician concerning a 45-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 27-Oct-2009, the patient received H1N1, Intranasal, for unknown indication. Immediately after receiving the vaccine, the patient developed a sore throat and her voice became hoarse. The patient also experienced wheezing, chest pain and the patient vocal cords look like patient has laryngitis. The outcome of laryngitis was not resolved, however outcome of chest pain, sore throat and wheezing was resolved.
Age: 45.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Wheezing
Clinical narrative: A non-serious spontaneous report of laryngitis, chest pain, sore throat and wheezing has been received from a physician concerning a 45-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 27-Oct-2009, the patient received H1N1, Intranasal, for unknown indication. Immediately after receiving the vaccine, the patient developed a sore throat and her voice became hoarse. The patient also experienced wheezing, chest pain and the patient vocal cords look like patient has laryngitis. The outcome of laryngitis was not resolved, however outcome of chest pain, sore throat and wheezing was resolved.
Age: 0.7
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of 8 month old infant was inadvertently administered H1N1 LAIV was received from a nurse/health professional concerning an eight-month-old female. Patient was reported to have no relevant medical history and no concomitant medications were consumed. On 5-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 was considered resolved. Additional information was received on 23-Dec-2009 and incorporated into the narrative: The information regarding reporter, patient's medical history and concomitant medications was included into the narrative.
Age: 1.82
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of gave H1N1 LAIV to 22-month-old child was received from a registered nurse/health professional concerning a 21-month-old female. The patient had no any medical history and she was not on any concomitant medications. On 04-Nov-2009, the patient received first dose of H1N1, Intranasal. When she was brought back for the second dose on 08-Dec-2009, it was then they realized the medication error. At that time, she was switched to receive the H1N1 injection, and received that injectable dose. She therefore received only one dose of the intranasal vaccine. 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. Additional information received on 23-Dec-2009 and incorporated into the narrative: medical history-none, concomitant medications-none, first dose of vaccine.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, Scleral discolouration
Clinical narrative: A non-serious spontaneous report of H1N1 LAIV sprayed into eye and eye turned blue has been received from a physician concerning a child patient, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 8-Dec-2009 for an unknown indication. On 8-Dec-2009, while receiving the H1N1 vaccine inadvertently sprayed into eye. Parent reported to physician that the eye turned blue. The outcome of medication error was recovered and the outcome of the eye turned blue was unknown.
Age: 1.64
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of administration to 21 month old and runny nose was received from a public health nurse/healthcare professional concerning a 19-month-old female, subsequent to H1N1, Intranasal. The patient had no relevant medical history and no concomitant medications was administered to the patient. On 10-Nov-2009 the patient received H1N1, Intranasal for an unspecified indication. On 10-Nov-2009 after vaccination the patient developed runny nose which lasted till 13-Nov-2009. No laboratory studies and no treatments were needed for the event of runny nose. The patient was fine with no flu-like symptoms and no adverse effects from the vaccination. The outcome of the event of administration to 21 month old and runny nose was resolved. Additional information was received on 10-Dec-2009 and incorporated into the narrative: Medical history, concomitant medication, cessation date and outcome of the event, reporter's information.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Herpes simplex
Clinical narrative: A non-serious spontaneous report of herpes simplex (cutaneous and may be conjunctivitis) has been received from a physician concerning adult, subsequent to H1N1, Intranasal. Neither medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal for an unknown indication in 2009. On an unknown date the patient experienced herpes simplex (cutaneous and may be conjunctivitis). The outcome of the event was unknown.
Age: 1.98
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of H1N1 LAIV administered to patient nine days before age of two years was received from a nurse/health professional concerning a 23-month-old female. The patient had no medical history and she was not taking any concomitant medication. On 04-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are applicable, and the event was considered resolved. Additional information was received on 29-Dec-2009 and incorporated into the narrative: Medical history and concomitant medication.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a physician concerning a seven-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 03-Dec-2009, the patient developed fever of 105 F and was experiencing re-occurring fever at the time of reporting. The outcome of event was not resolved.
Age: 12.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave full dose of H1N1 LAIV in one nostril was received from a registered nurse concerning a 12-year-old female. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. 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: 13.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of gave full dose of H1N1 LAIV in one nostril was received from a registered nurse concerning a 13-year-old male. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. 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: 59.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious Spontaneous report of "patients over 49 years of age received a dose of H1N1 LAIV" was received from a Consumer/non-health professional concerning a 59-year-old Female. The relevant medical history has not been reported for this Patient. On 23-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 was considered resolved.
Age: 11.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error
Clinical narrative: A non-serious spontaneous report of gave full dose of H1N1 LAIV in one nostril was received from a registered nurse concerning a 11-year-old male. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. 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: M
Vaccine: FLUN(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of some H1N1 LAIV got into three year old's eye was received from a registered nurse/healthcare professional concerning a 36-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 20-Nov-2009, the nurse accidentally squirted some of H1N1, Intranasal into the three-year-old's eye. 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: 50.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of patients over 49 years of age received a dose of H1N1 LAIV was received from non healthcare professional concerning a 50-year-old female. The patient's medical history and concomitant medication were not reported. On 23-Nov-2009, the patient received Influenza A, 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: 53.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of patients over 49 years of age received H1N1 LAIV was received from a non healthcare professional concerning a 53-year-old female. No past medical history or concomitant medication was reported for this patient. On 23-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with the 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 "patients over 49 years of age received H1N1 LAIV" was received from a non healthcare professional concerning a 54-year-old female. No past medical history and concomitant medication was reported for this patient. On 23-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: 58.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious, spontaneous report of "patients over 49 years of age received a dose of H1N1 LAIV" was received from a non healthcare professional concerning a 58-year-old female. No past medical history and concomitant medication was reported for this patient. On 23-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: 35.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Nasal discomfort, Vaccination site pain, Vaccination site reaction
Clinical narrative: A non-serious spontaneous report of tenderness in nasal passage has been received from a registered nurse/health professional concerning a 35-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications were reported. In Nov-2009, about two weeks prior to reporting the adverse event, the patient received H1N1, Intranasal for an unknown indication. After vaccination, the patient began to experience tenderness in her nasal passage. The patient had described that her nasal passage was raw. The outcome of the reported events was not resolved.
Age: 0.8
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, Nasopharyngitis, Rhinorrhoea, Wheezing
Clinical narrative: A non-serious spontaneous report of 9 month old daughter received H1N1 LAIV  and cold which was manifested by wheezing and runny nose was received from a parent concerning her nine-month-old daughter, subsequent to H1N1, Intranasal. The relevant medical history included diagnosis of vesicoureteral reflux at three months of age, otherwise healthy. The patient's concomitant medication included trimethoprim and sulfamethoxazole liquid 1.5 ml once daily orally for treatment of vesicoureteral reflux since past six months and will continue for another three months until she is one year of age. She will be assessed for possible surgery for the repair of the defective valve. On 30-Nov-2009, the patient received H1N1, Intranasal for an unspecified indication. Eight days after the vaccination, the patient developed wheezing and a runny nose and was seen by the pediatrician who found by auscultation that child's lungs were clear and the patient was afebrile. The patient was diagnosed with a cold that both the physician and the parents felt was due to the interactions of the child in the day-care center. The cold lasted only a day or two for which no treatment received. The patient was fine ever since. She was playing, eating, drinking, and sleeping well. The outcome of vaccination error and cold was resolved.
Age: 1.3
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of H1N1, Intranasal to 15-month-old male child was received from a non-health professional. The patient had been healthy with no medical history and had not been prescribed daily medications. On 19-Nov-2009, the patient received H1N1 LAIV. 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 04-Dec-2009 and incorporated into the narrative: Medical history and concomitant medications.
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 gave H1N1 LAIV to a 54 year old female was received from a registered nurse/health professional concerning a 54-year-old female. Neither relevant medical history nor concomitant medications were reported. On 30-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.