chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Nausea, Otitis media, Pyrexia, Rhinorrhoea, Ultrasound abdomen normal
Clinical narrative: A serious report of dehydration and constipation has been received from a study investigator concerning a four-year-old female (subject number 03402040) participating in a post marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included iron deficiency anemia. No concomitant medications were reported. On 14-Sep-2009, the subject received FLUMIST 0.25 ml per nostril. She received a total of one dose of FLUMIST before onset of the event given on 14-Sep-2009. The subject's mother reported that one week prior to hospitalization, the subject had cough and runny nose with intermittent fever of low grade. On 14-Sep-2009, the subject was diagnosed with otitis media and began taking AMOXICILLIN orally. One day prior to the hospital presentation, on 16-Sep-2009, the subject had nausea and began vomiting while febrile and could not keep down water. She was brought to emergency room, The subject was given three normal saline boluses for a total of 60 ml/kg in the emergency department, and she received ondansetron orally and intravenously. She continued to vomit and failed two oral challenges. Her white blood cell count had left shift, and urinalysis was positive for ketone. Other laboratory test results (electrolyte count, glucose and complete blood count) were normal. On 17-Sep-2009, the subject was admitted to the hospital for hydration. Due to intermittent discomfort and protracted vomiting as well as the report of low grade fevers, a KUB was done and showed no sign of obstruction but was significant for constipation. An abdominal ultrasound was obtained to rule out intussusception or an abnormal appendicitis and was normal. She continued to vomit and a non-contrast head computerised tomogram was performed, and the results ruled out intracranial abnormality as a potential cause of acute onset vomiting. The subject had fleets enema x 2 with stool output for constipation. She had persistent vomiting the day of admission which ceased overnight with return of bowel sounds. She was able to tolerate clear liquids as Jell-O and crackers with no pain or nausea, and intravenous fluids were discontinued. Follow-up electrolytes and complete blood count were normal. At discharge, the subject was tolerating diet described above with no intravenous fluid requirement, alert and active playing in the playroom. She was afebrile with normal vital signs. The events of dehydration and constipation were resolved on 18-Sep-2009. The investigator assessed the causality for the events of dehydration and constipation to FLUMIST as none. The severity of the event was mild. The alternative etiology was natural causes. The sponsor assessed the causality for the event of dehydration and constipation as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Urinary system x-ray abnormal, Urine ketone body present, Vomiting, White blood cell count abnormal
Clinical narrative: A serious report of dehydration and constipation has been received from a study investigator concerning a four-year-old female (subject number 03402040) participating in a post marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included iron deficiency anemia. No concomitant medications were reported. On 14-Sep-2009, the subject received FLUMIST 0.25 ml per nostril. She received a total of one dose of FLUMIST before onset of the event given on 14-Sep-2009. The subject's mother reported that one week prior to hospitalization, the subject had cough and runny nose with intermittent fever of low grade. On 14-Sep-2009, the subject was diagnosed with otitis media and began taking AMOXICILLIN orally. One day prior to the hospital presentation, on 16-Sep-2009, the subject had nausea and began vomiting while febrile and could not keep down water. She was brought to emergency room, The subject was given three normal saline boluses for a total of 60 ml/kg in the emergency department, and she received ondansetron orally and intravenously. She continued to vomit and failed two oral challenges. Her white blood cell count had left shift, and urinalysis was positive for ketone. Other laboratory test results (electrolyte count, glucose and complete blood count) were normal. On 17-Sep-2009, the subject was admitted to the hospital for hydration. Due to intermittent discomfort and protracted vomiting as well as the report of low grade fevers, a KUB was done and showed no sign of obstruction but was significant for constipation. An abdominal ultrasound was obtained to rule out intussusception or an abnormal appendicitis and was normal. She continued to vomit and a non-contrast head computerised tomogram was performed, and the results ruled out intracranial abnormality as a potential cause of acute onset vomiting. The subject had fleets enema x 2 with stool output for constipation. She had persistent vomiting the day of admission which ceased overnight with return of bowel sounds. She was able to tolerate clear liquids as Jell-O and crackers with no pain or nausea, and intravenous fluids were discontinued. Follow-up electrolytes and complete blood count were normal. At discharge, the subject was tolerating diet described above with no intravenous fluid requirement, alert and active playing in the playroom. She was afebrile with normal vital signs. The events of dehydration and constipation were resolved on 18-Sep-2009. The investigator assessed the causality for the events of dehydration and constipation to FLUMIST as none. The severity of the event was mild. The alternative etiology was natural causes. The sponsor assessed the causality for the event of dehydration and constipation as not related to FLUMIST.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Adenoidectomy, Dehydration, Fluid intake reduced, Tonsillectomy
Clinical narrative: A serious report of tonsillitis and sleep apnea has been received from a study investigator concerning a 43-month-old male participating in a post-marketing study for FluMist, MI-MA162. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The subject's medical history included myrigotomy with tubes for acute otitis media. On 01-Oct-2009, the subject received FluMist, 0.25 ml per nostril. He received a total of one dose of FluMist before onset of the event given on 01-Oct-2009. On 17-Aug-2009, the subject was seen in pediatric clinic for complaint of sleep apnea, snoring, daytime fatigue, being congested all the time and not feeling better after taking allergy medications. He seemed to have phlegm all the time. Also, the subject had bilateral myringotomies and ventilating tube insertion previously which had since fallen out. The subject was examined well except for oral exam which showed severe hypertrophy (4+) of tonsils. Tonsillectomy and adenoidectomy was recommended. On 01-Oct-2009, preoperative examination went well and procedure was scheduled for 13-Oct-2009. On 13-Oct-2009, the subject was admitted to the hospital, and tonsillectomy and adenoidectomy procedures were performed without complications. On 14-Oct-2009, the subject recovered and was discharged from the hospital. On 15-Oct-2009, the subject's parents reported that he had not interest in drinking, popsicles, etc., and also would not take pills to help with pain and was becoming dehydrated. The subject was seen in emergency and examined well. He was discharged from the emergency room on the same day, 15-Oct-2005. The events of tonsillitis and sleep apnea resolved on 14-Oct-2009. The investigator assessed the causality for the events of tonsillitis and sleep apnea to FluMist as none. The severity of the events was mild. The alternative etiology was natural causes. The sponsor assessed the causality for the events of tonsillitis and sleep apnea as not related to FluMist.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Blood product transfusion, Gait disturbance, Grip strength decreased, Intracranial pressure increased
Clinical narrative: A serious report of transverse myelitis has been received from a study investigator concerning a 28-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment or accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included single seizure and possibly tremors. No concomitant medications were reported. On 10-Sep-2009, the subject received FLUMIST, 0.25 ml per nostril. He received a total of one dose of FLUMIST before onset of the event given on 10-Sep-2009. On 19-Oct-2009, the subject awoke with inability to grip and was complaining of arm pain. From 19-Oct-2009 to 21-Oct-2009, the subject had pediatric and neurologist visits. On 21-Oct-2009, he was hospitalized for transverse myelitis. Nuclear magnetic resonance imaging (MRI) was done and showed swelling of the cervical cord with mild mass effect. His vital signs were following: blood pressure of 89/56 mmHg, pulse of 112, and body temperature of 96.7. On 23-Oct-2009, the subject was discharged from the hospital. His treatment medications included steroids. On 24-Oct-2009, he visited a neurologist. His parents reported that he seemed fine on 23-Oct-2009 till he jumped up and down, and then he looked shocked and stopped walking well. On 24-Oct-2009, the subject was admitted to the hospital again for transverse myelitis. He started on IVIG daily for four days and continued steroid medications. A repeat MRI was done which demonstrated marked improvement of his spinal transverse myelitis with no brain involvement. The subject eventually was walking around without any signs of discomfort and was noted to have appropriate leg strength. He was discharged from the hospital in good condition on 27-Oct-2009. On 10-Nov-2009, his follow-up examination indicated that bilateral hands are still weak but have improved greatly. Forearms (for the most part) have recovered. The subject has been right handed previously. However, his left part was more involved than the right part. The outcome of the event was ongoing. The investigator assessed the causality for the event for transverse myelitis to FLUMIST as remote. The severity of the event was moderate. The alternative etiology was natural causes. The sponsor assessed the causality for the event of transverse myelitis as not related to FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Shock
Clinical narrative: A serious report of transverse myelitis has been received from a study investigator concerning a 28-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment or accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included single seizure and possibly tremors. No concomitant medications were reported. On 10-Sep-2009, the subject received FLUMIST, 0.25 ml per nostril. He received a total of one dose of FLUMIST before onset of the event given on 10-Sep-2009. On 19-Oct-2009, the subject awoke with inability to grip and was complaining of arm pain. From 19-Oct-2009 to 21-Oct-2009, the subject had pediatric and neurologist visits. On 21-Oct-2009, he was hospitalized for transverse myelitis. Nuclear magnetic resonance imaging (MRI) was done and showed swelling of the cervical cord with mild mass effect. His vital signs were following: blood pressure of 89/56 mmHg, pulse of 112, and body temperature of 96.7. On 23-Oct-2009, the subject was discharged from the hospital. His treatment medications included steroids. On 24-Oct-2009, he visited a neurologist. His parents reported that he seemed fine on 23-Oct-2009 till he jumped up and down, and then he looked shocked and stopped walking well. On 24-Oct-2009, the subject was admitted to the hospital again for transverse myelitis. He started on IVIG daily for four days and continued steroid medications. A repeat MRI was done which demonstrated marked improvement of his spinal transverse myelitis with no brain involvement. The subject eventually was walking around without any signs of discomfort and was noted to have appropriate leg strength. He was discharged from the hospital in good condition on 27-Oct-2009. On 10-Nov-2009, his follow-up examination indicated that bilateral hands are still weak but have improved greatly. Forearms (for the most part) have recovered. The subject has been right handed previously. However, his left part was more involved than the right part. The outcome of the event was ongoing. The investigator assessed the causality for the event for transverse myelitis to FLUMIST as remote. The severity of the event was moderate. The alternative etiology was natural causes. The sponsor assessed the causality for the event of transverse myelitis as not related to FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Spinal cord oedema
Clinical narrative: A serious report of transverse myelitis has been received from a study investigator concerning a 28-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment or accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included single seizure and possibly tremors. No concomitant medications were reported. On 10-Sep-2009, the subject received FLUMIST, 0.25 ml per nostril. He received a total of one dose of FLUMIST before onset of the event given on 10-Sep-2009. On 19-Oct-2009, the subject awoke with inability to grip and was complaining of arm pain. From 19-Oct-2009 to 21-Oct-2009, the subject had pediatric and neurologist visits. On 21-Oct-2009, he was hospitalized for transverse myelitis. Nuclear magnetic resonance imaging (MRI) was done and showed swelling of the cervical cord with mild mass effect. His vital signs were following: blood pressure of 89/56 mmHg, pulse of 112, and body temperature of 96.7. On 23-Oct-2009, the subject was discharged from the hospital. His treatment medications included steroids. On 24-Oct-2009, he visited a neurologist. His parents reported that he seemed fine on 23-Oct-2009 till he jumped up and down, and then he looked shocked and stopped walking well. On 24-Oct-2009, the subject was admitted to the hospital again for transverse myelitis. He started on IVIG daily for four days and continued steroid medications. A repeat MRI was done which demonstrated marked improvement of his spinal transverse myelitis with no brain involvement. The subject eventually was walking around without any signs of discomfort and was noted to have appropriate leg strength. He was discharged from the hospital in good condition on 27-Oct-2009. On 10-Nov-2009, his follow-up examination indicated that bilateral hands are still weak but have improved greatly. Forearms (for the most part) have recovered. The subject has been right handed previously. However, his left part was more involved than the right part. The outcome of the event was ongoing. The investigator assessed the causality for the event for transverse myelitis to FLUMIST as remote. The severity of the event was moderate. The alternative etiology was natural causes. The sponsor assessed the causality for the event of transverse myelitis as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Abdominal pain upper, Colonoscopy abnormal, Constipation, Diarrhoea
Clinical narrative: A serious report of proctitis has been received from a study investigator concerning a 4-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. On 10-Sep-2009, the subject received FLUMIST, 0.25 ml per nostril. She received a total of one dose of FLUMIST before onset of the event given on 10-Sep-2009. On 23-Sep-2009, the subject presented with a one-day history of blood in stool with diarrhea. At the exam, it was stated that she was without pain; however, elsewhere, it was stated that she had several months of abdominal pain prior to this event. The subject had no other symptoms. Five weeks prior to this exam, she had an episode of constipation when starting kindergarten. On 02-Oct-2009, she was examined for blood in stool although at that point passed blood with more formed stool and had occasional abdominal pain in right upper abdomen. She had no nausea or vomiting. On 08-Oct-2009, she was seen by the specialist and differential diagnosis included irritable bowel disease, polyps and Meckel's diverticulum. She was hospitalized on 14-Oct-2009 and discharged on 15-Oct-2009. Colonoscopy under sedation and MRI of the lumbar spine were done, and they were suggestive for proctitis and biopsies were clear. MRI was within normal limits. The event of proctitis was resolved on 15-Oct-2009. The investigator assessed the causality for the events to FLUMIST as none. The severity of the events were mild. The alternative etiology was natural. The sponsor assessed the causality for the event of proctitis as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Haematochezia, Proctitis
Clinical narrative: A serious report of proctitis has been received from a study investigator concerning a 4-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. On 10-Sep-2009, the subject received FLUMIST, 0.25 ml per nostril. She received a total of one dose of FLUMIST before onset of the event given on 10-Sep-2009. On 23-Sep-2009, the subject presented with a one-day history of blood in stool with diarrhea. At the exam, it was stated that she was without pain; however, elsewhere, it was stated that she had several months of abdominal pain prior to this event. The subject had no other symptoms. Five weeks prior to this exam, she had an episode of constipation when starting kindergarten. On 02-Oct-2009, she was examined for blood in stool although at that point passed blood with more formed stool and had occasional abdominal pain in right upper abdomen. She had no nausea or vomiting. On 08-Oct-2009, she was seen by the specialist and differential diagnosis included irritable bowel disease, polyps and Meckel's diverticulum. She was hospitalized on 14-Oct-2009 and discharged on 15-Oct-2009. Colonoscopy under sedation and MRI of the lumbar spine were done, and they were suggestive for proctitis and biopsies were clear. MRI was within normal limits. The event of proctitis was resolved on 15-Oct-2009. The investigator assessed the causality for the events to FLUMIST as none. The severity of the events were mild. The alternative etiology was natural. The sponsor assessed the causality for the event of proctitis as not related to FLUMIST.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Condition aggravated, Congenital anomaly, Musculoskeletal discomfort, Neck mass, Palpitations
Clinical narrative: A serious report of congenital anomaly, thyroglossal duct cyst, has been received from a study concerning a 47-month-old male participating in a post-marketing study for FLUMIST, MI-MA162. This case is submitted in accordance with manufacturer post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included thyroglossal duct cyst, peanut allergy, resolved event of heart murmur, eczema, and hypoplastic enamel in dental procedure under anesthesia. No concomitant medications were reported. On 03-Sep-2009 the subject received FLUMIST, 0.25 ml per nostril. He received a total of one dose of FLUMIST before onset of the event given on 03-Sep-2009. Prior one year to August 2009, the subject was diagnosed with midline neck mass, which has grown slowly during this time. The subject experienced mild discomfort with palpation and movement of mass. There were no dysphagia, shortness of breath, voice changes, hypo- or hyperthyroid symptoms, drainage, or infection of lesion. Ultrasound test was performed and indicated thyroglossal duct cyst. On 12-Aug-2009, it was recommended to remove the cyst. On 03-Sep-2009, the subject was cleared for surgery at preoperational exam. On 08-Sep-2009, the subject was admitted to the hospital, and surgical procedure (Sistrunk procedure) was performed under general anesthesia. After the procedure, the subject was transferred to postanesthesia care in stable condition. The subject was discharged from the hospital in stable condition. Discharge medications included acetaminophen with codeine, amoxicillin, and bacitracin-polymyxin. Pathology results were also performed and supported the diagnosis. On 15-Sept-2009, the subject was seen for follow-up exam. He was experiencing no pain. Parents reported that he was eating well, and there was no drainage from the wound. The event of congenital anomaly, thyroglossal duct cyst, was resolved on 09-Sep-2009. The investigator assessed the causality for the event of congenital anomaly, thyroglossal duct cyst to FLUMIST as none. The severity of the event was mild. The alternative etiology was congenital. The sponsor assessed the causality for the event of congenital anomaly, thyroglossal duct cyst, as not related to FLUMIST.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Thyroglossal cyst, Thyroglossal cyst excision, Ultrasound scan abnormal
Clinical narrative: A serious report of congenital anomaly, thyroglossal duct cyst, has been received from a study concerning a 47-month-old male participating in a post-marketing study for FLUMIST, MI-MA162. This case is submitted in accordance with manufacturer post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included thyroglossal duct cyst, peanut allergy, resolved event of heart murmur, eczema, and hypoplastic enamel in dental procedure under anesthesia. No concomitant medications were reported. On 03-Sep-2009 the subject received FLUMIST, 0.25 ml per nostril. He received a total of one dose of FLUMIST before onset of the event given on 03-Sep-2009. Prior one year to August 2009, the subject was diagnosed with midline neck mass, which has grown slowly during this time. The subject experienced mild discomfort with palpation and movement of mass. There were no dysphagia, shortness of breath, voice changes, hypo- or hyperthyroid symptoms, drainage, or infection of lesion. Ultrasound test was performed and indicated thyroglossal duct cyst. On 12-Aug-2009, it was recommended to remove the cyst. On 03-Sep-2009, the subject was cleared for surgery at preoperational exam. On 08-Sep-2009, the subject was admitted to the hospital, and surgical procedure (Sistrunk procedure) was performed under general anesthesia. After the procedure, the subject was transferred to postanesthesia care in stable condition. The subject was discharged from the hospital in stable condition. Discharge medications included acetaminophen with codeine, amoxicillin, and bacitracin-polymyxin. Pathology results were also performed and supported the diagnosis. On 15-Sept-2009, the subject was seen for follow-up exam. He was experiencing no pain. Parents reported that he was eating well, and there was no drainage from the wound. The event of congenital anomaly, thyroglossal duct cyst, was resolved on 09-Sep-2009. The investigator assessed the causality for the event of congenital anomaly, thyroglossal duct cyst to FLUMIST as none. The severity of the event was mild. The alternative etiology was congenital. The sponsor assessed the causality for the event of congenital anomaly, thyroglossal duct cyst, as not related to FLUMIST.
Age: 1.17
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of FluMist administered to 14 month old was received from a Licensed practical nurse concerning a 14-month-old male patient. The patient's medical history and concomitant medications were not reported. The patient received FluMist on 19-Nov-2009. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponser causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with Medimmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyspnoea, Upper airway obstruction
Clinical narrative: A non-serious spontaneous report of nasal obstruction and dyspnea has been received from a physician concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history included rhinitis. His concomitant medications included rhinitis medicine (start year of 2009 - ongoing). The patient received FLUMIST on 29-Oct-2009. On 30-Oct-2009, the patient experienced the events of nasal obstruction and dyspnea which were relieved in a few days. The outcomes of the events were unknown. The reporter assessed the events of nasal obstruction and dyspnea as possibly related to FLUMIST. Additional information was received on 24-Feb-2010 and incorporated into case: lot number.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Wrong drug administered
Clinical narrative: A non-serious spontaneous report of child received two doses of FLUMIST in the same week was received from a health professional concerning a four year old female. On 05 Oct 2009, the patient received single dose FLUMIST at school, on 09 Oct 2009, the patient received a second dose at the pediatrician's office. There is no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Angioedema, Hypersensitivity, Urticaria
Clinical narrative: A spontaneous, serious report of allergic reaction has been received from a physician concerning a four-year-old male subsequent to receiving FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history included previous flu vaccinations and concomitant medications were not reported. On an unknown date in Nov-2009, the patient received FLUMIST for the first time. Shortly after the patient received FLUMIST (date unknown), the patient presented to the emergency department with hives and angioedema. The patient was treated with steroids and H2 blockers. He was sent home and was to take diphenhydramine and oral prelone 1mg/kg divided twice a day for 3 days then 3 days at 1/2 dose at home. On 16-Nov-2009, the patient returned to the ED for persistent hives without respiratory compromise. No further information was available. The outcome of the event, allergic reaction, was unknown. The physician assessed the event of allergic reaction as related to FLUMIST. Required follow up attempts have been performed, requested information unable to be obtained.  23-Feb-2010.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: A non-serious spontaneous report of Flu-like symptoms has been received from a consumer/mother concerning her 43-month-old daughter, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history and concomitant medications were not reported. About two months ago in approximately September 2009, the patient received FLUMIST. The same night after the vaccine was administered, the patient experienced a fever and other mild flu-like symptoms. The event resolved within 24 hours of onset. Required follow up attempts have been performed, requested information unable to be obtained.  23-Feb-2010.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Decreased appetite, Influenza like illness, Oropharyngeal pain, Pain
Clinical narrative: A non-serious spontaneous report of flu-like symptoms, vomited once or twice, fever (maximum of 105.3 F), and macular rash has been received from a physician (also the patient's parent) concerning a four-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient's older sister had recently recovered from a viral respiratory infection. The patient received a single dose FLUMIST the evening of 28-Sep-2009. On19-Sep-2009, the patient experienced flu-like symptoms of aching, sore throat, cough, congestion, and decreased appetite. During the next six and half days, the patient also experienced vomiting once of twice, fever (maximum was 105.3 F) and a macular rash on 25-sept-2009. All events resolved by 26-Sep-2009. The reporter assessed the flu-like symptoms, vomited once or twice (maximum of 105.3 F), and macular rash as not related to FLUMIST, but rather to the combination of viral exposure in the home environment and then the vaccine. Additional information received on 22-Feb-2010 and incorpaorted into case: lot number.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rash macular, Upper respiratory tract congestion, Vomiting
Clinical narrative: A non-serious spontaneous report of flu-like symptoms, vomited once or twice, fever (maximum of 105.3 F), and macular rash has been received from a physician (also the patient's parent) concerning a four-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient's older sister had recently recovered from a viral respiratory infection. The patient received a single dose FLUMIST the evening of 28-Sep-2009. On19-Sep-2009, the patient experienced flu-like symptoms of aching, sore throat, cough, congestion, and decreased appetite. During the next six and half days, the patient also experienced vomiting once of twice, fever (maximum was 105.3 F) and a macular rash on 25-sept-2009. All events resolved by 26-Sep-2009. The reporter assessed the flu-like symptoms, vomited once or twice (maximum of 105.3 F), and macular rash as not related to FLUMIST, but rather to the combination of viral exposure in the home environment and then the vaccine. Additional information received on 22-Feb-2010 and incorpaorted into case: lot number.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Lethargy, Neck pain, Pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of neck pain, glandular pain, lethargic, high fever, body aches, and chills has been received from a consumer, patient's father, concerning a 26-month-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 04-Nov-2009. On 07-Nov-2009, the patient experienced neck pain, lethargic, high fever of 100.5, body aches and chills. The reported stated the patient was "feeling better". Required follow up attempts have been performed, requested information unable to be obtained.  23-Feb-2010.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Lethargy, Neck pain, Pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of neck pain, glandular pain, lethargic, high fever, body aches, and child has been received from a consumer, patient's father, concerning a four year old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient received FLUMIST on 04 Nov 2009. The patient received a total of one dose of FLUMIST before onset of the event given on 04 Nov 2009. On 06 Nov 2009, the patient experienced neck pain, glandular pain, lethargic, high fever of 100.5, body aches, and chills. The patient was feeling better. Required follow up attempts have been performed, requested information unable to be obtained.  19-Feb-2010.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Breath sounds abnormal, Cough, Decreased appetite, Flushing, Headache
Clinical narrative: A non-serious spontaneous report of pale, flushed, "breaths sounds like a rattle in her nose", fever, headache, loss of appetite, rash on cheeks and cough has been received from a parent of a child concerning a 34-month-old female subsequent to FLUMIST and H1N1 MONOVALENT vaccine, Intranasal. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST on 27-Oct-2009 and H1N1 MONOVALENT vaccine, Intranasal on 16-Oct-2009. On 29-Oct-2009 the patient stated daughter became ill with fever, headache, loss of appetite and pale. When the parent called to report the event on 04-Nov-2009 she stated her daughter is now flushed. The parent also stated the daughter has a little rash on her cheeks, has a cough due to a tickle in her throat and when she breaths it sounds like there is a rattle in her nose. The outcome of the event of pale did not resolve but the other events are all not recovered since the mother stated her daughter was still not feeling well. Required follow-up attempts have been performed, requested information unable to be obtained. 18-Feb-2010.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Pallor, Pyrexia, Rash, Throat irritation
Clinical narrative: A non-serious spontaneous report of pale, flushed, "breaths sounds like a rattle in her nose", fever, headache, loss of appetite, rash on cheeks and cough has been received from a parent of a child concerning a 34-month-old female subsequent to FLUMIST and H1N1 MONOVALENT vaccine, Intranasal. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST on 27-Oct-2009 and H1N1 MONOVALENT vaccine, Intranasal on 16-Oct-2009. On 29-Oct-2009 the patient stated daughter became ill with fever, headache, loss of appetite and pale. When the parent called to report the event on 04-Nov-2009 she stated her daughter is now flushed. The parent also stated the daughter has a little rash on her cheeks, has a cough due to a tickle in her throat and when she breaths it sounds like there is a rattle in her nose. The outcome of the event of pale did not resolve but the other events are all not recovered since the mother stated her daughter was still not feeling well. Required follow-up attempts have been performed, requested information unable to be obtained. 18-Feb-2010.
Sex: U
Vaccine: FLUN3
Symptoms: Cough, Influenza, Influenza like illness, Influenza serology negative, Influenza serology positive
Clinical narrative: A non serious, spontaneous report of flu-like symptoms and Influenza A has been received from a licensed practical nurse concerning three children of unconfirmed age, subsequent to receiving FluMist. This case is subscribed in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 50 months of age for FluMist. The patients' medical history and concomitant medications were not reported. On an unknown date, the patients received FluMist. On an unknown date, within three to seven days subsequent to receiving FluMist, the patients experienced flu-like symptoms manifested as high fever, cough, sore throat and runny nose and also tested positive for Influenza A. The events resolved. Required follow-up attmepts have been performed, requested information unable to be obtained. 18-Feb-2010.
Sex: U
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A non serious, spontaneous report of flu-like symptoms and Influenza A has been received from a licensed practical nurse concerning three children of unconfirmed age, subsequent to receiving FluMist. This case is subscribed in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 50 months of age for FluMist. The patients' medical history and concomitant medications were not reported. On an unknown date, the patients received FluMist. On an unknown date, within three to seven days subsequent to receiving FluMist, the patients experienced flu-like symptoms manifested as high fever, cough, sore throat and runny nose and also tested positive for Influenza A. The events resolved. Required follow-up attmepts have been performed, requested information unable to be obtained. 18-Feb-2010.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Contraindication to vaccination
Clinical narrative: A non-serious spontaneous report of gave FLUMIST to a child with asthma was received from a health professional concerning a 41-month-old male. Medical history included mild asthma. On 04-Nov-2009, the patient inadvertently received FLUMIST. The doctor's office was informed the patient had asthma after FLUMIST was given. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash pruritic
Clinical narrative: A non-serious spontaneous report of rash has been received from a consumer, patent's mother, concerning a 42-month-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on acceleration reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received one dose of FLUMIST on 29-Oct-2009. The patient received a total of one dose of FLUMIST before the onset of the event given on 29-Oct-2009. On 30-Oct-2009, the patient "broke out in a severe rash." The rash had persisted, and the patient's physician prescribed steroids. The reporter stated that the rash was fading and then coming back. It had extended from the patient's head to his toes. The rash was itchy and did not look as prominent as "it did upon initial presentation". Last season the patient received FLUMIST and did not have any adverse events. The outcome of the event of rash was ongoing. The event of rash was resolved on 08-Nov-2009. On 09-Dec-2009, follow-up information was received and incorporated into the narrative: the outcome of the event and resolution date. on 19-Feb-2010, follow-up information was received and incorporated into the case: lot number.
Age: 1.5
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to an 18-month-old was received from a registered nurse in a country concerning an 18-month-old subsequent to the administration of FLUMIST. This case is submitted accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Relevant medical history and concomitant medications were not reported. On 02-Nov-2009, the patient was administered FLUMIST. There was no adverse event associated with this vaccination administration at an inappropriate age, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. Required follow-up attempts have been performed, requested information unable to be obtained.  18-Feb-2010.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of sore throat and fever has been received from a nurse concerning a 47-month-old female, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FluMist on 26-Oct-2009. On 01-Nov-2009, the patient developed sore throat and fever. The outcomes ere not reported for these events.
Age: 0.6
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "I gave a 7 month-old FluMist" was received from a nurse subsequent to FluMist. Neither relevant medical history have not been reported for this patient. On 26-Oct-2009, a nurse inadvertently administered FluMist to the 7 month-old patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months for FluMist. Required follow up attempts have been performed, requested information unable to be obtained.  23-Feb-2010.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test normal, Pulmonary thrombosis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no known medical history and no known previous illness on 21-AUG-2007 was vaccinated with the fourth dose of GARDASIL (Lot # 654741/1208F) IM into the right arm. It was reported that on 12-APR-2009 the patient had blood clot in lung and would have to be on blood thinners the rest of her life. She was on 15 mg of "warfarin" daily to keep her blood thinned between 2-3 INR. The patient was hospitalized for 5 days, and they ran all the relevant tests for blood clots. Then the patient went to the clinic, and they ran numerous tests related to blood clots and the patient did not have any risk factors associated with blood clotting. The listing indicated that one or more of the events required hospitalization, was considered to be disabling and was considered to be immediately life-threatening. It was reported that the event required ER visit. The event was serious. The original reporting source was not provided. The VAERS ID # is 357350. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Pulmonary thrombosis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with no known medical history and no known previous illness on 21-AUG-2007 was vaccinated with the fourth dose of GARDASIL (Lot # 654741/1208F) IM into the right arm. It was reported that on 12-APR-2009 the patient had blood clot in lung and would have to be on blood thinners the rest of her life. She was on 15 mg of "warfarin" daily to keep her blood thinned between 2-3 INR. The patient was hospitalized for 5 days, and they ran all the relevant tests for blood clots. Then the patient went to the clinic, and they ran numerous tests related to blood clots and the patient did not have any risk factors associated with blood clotting. The listing indicated that one or more of the events required hospitalization, was considered to be disabling and was considered to be immediately life-threatening. It was reported that the event required ER visit. The event was serious. The original reporting source was not provided. The VAERS ID # is 357350. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Dizziness, Injection site warmth, Rash pruritic
Clinical narrative: Received H1N1 by injection app 2 hours had generalized rash over torso, head and neck. Took BENADRYL and went to doctor. Told her she was having an allergic reaction and take BENADRYL - She did - ran subsided by next day.
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Dizziness, Pruritus
Clinical narrative: Received H1N1 by injection app 2 hours had generalized rash over torso, head and neck. Took BENADRYL and went to doctor. Told her she was having an allergic reaction and take BENADRYL - She did - ran subsided by next day.
Age: 38.0
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Hypersensitivity, Rash generalised
Clinical narrative: Received H1N1 by injection app 2 hours had generalized rash over torso, head and neck. Took BENADRYL and went to doctor. Told her she was having an allergic reaction and take BENADRYL - She did - ran subsided by next day.
Age: 24.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Fatigue, Gait disturbance, Tremor
Clinical narrative: Woke up having "seizures".  Taken to ER, diagnosed as tremors, sent home.  Since onset, has seen primary care 3 times, 3 ER visits with the last visit admitted.  No answers yet.
Age: 24.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Blood test, Computerised tomogram, Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Woke up having "seizures".  Taken to ER, diagnosed as tremors, sent home.  Since onset, has seen primary care 3 times, 3 ER visits with the last visit admitted.  No answers yet.
Age: 24.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Tremor, X-ray
Clinical narrative: Woke up having "seizures".  Taken to ER, diagnosed as tremors, sent home.  Since onset, has seen primary care 3 times, 3 ER visits with the last visit admitted.  No answers yet.
Age: 27.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Facial pain, Facial palsy, Hordeolum, Swelling
Clinical narrative: Left side face pain for 3 days  Bells Palsy Referred to ENT 12/8/09
Age: 27.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Facial pain, Facial palsy
Clinical narrative: Left side face pain for 3 days  Bells Palsy Referred to ENT 12/8/09