chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Sleep apnoea syndrome, Tonsillitis
Clinical narrative: A serious post-marketed study report of tonsillitis and obstructive sleep apnea has been received from a study investigator concerning a four-year old female subject, patient ID 56398610, participating in a post-marketing study. 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 subject. The subject received FLUMIST on 12-Nov-2007. On 26-Nov-2007, the subject was hospitalized for tonsillitis and obstructive sleep apnea. The subject's length of hospital stay was one day. The outcome is unknown. The investigator assessed the events of tonsillitis and obstructive sleep apnea as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, MMRV
Symptoms: Chest X-ray abnormal, Computerised tomogram abnormal, Culture negative, Laboratory test normal, Pneumonia
Clinical narrative: A serious report of pneumonia has been received from a study investigator concerning post-marketing study for FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for newly indicated population of 2 to 59 months of age for FLUMIST. Medical history included no known allergies, asthma, and a positive purified protein derivate on 04-Dec-2007. Concomitant medication includes amoxicillin and albuterol. On 08-Jan-2008, the subject received FLUMIST. On the same day, the patient also received DTaP and MMR-VAR. Since 04-Dec-2007, the subject had two cases of cough, fever, and abnormal X-ray. She was diagnosed with community accuired pneumonia. Her father had recently been diagnosed with active TB so she was admitted to the hospital on 05-Feb-2008 to rule out active TB. Gastric aspirates x three were obtained for AFB smear and TB cultures. Chest CT scan was obtained to further evaluate the subject's pulmonary process. It showed no hilar LAD but two areas of infiltrated possibly consistent with resolving pneumonia. The county TB clinic indicated the contact case was pan-sensitive Mycobacterium tuberculosis but very high organism load/infectivity. Given the subject's risk and possibly abnormal pulmonary imaging, she was discharged on 07-Feb-2008 on quadruple drug therapy to be continued at least until the gastric aspirate cultures were final. On 08-Feb-2008, all three gastric aspirates were negative and the subject was doing well with no respiratory distress and was able to return to preschool. The pneumonia resolved on 11-Feb-2008. The investigator assessed the causality of the event of pneumonia to FLUMIST to be none and provided the alternative etiology of natural, viral. The severity of the event was moderate. Additional information received on 23-Oct_2008 and incorporated into narrative included concomitant therapy, medical history, and event outcome.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal X-ray, Abdominal pain, Chest X-ray normal, Crying, Dehydration
Clinical narrative: A serious report of acute gastroenteritis and viral syndrome has been received from a study investigator concerning a 43 month old female (PID 07393517) participating in a post-marketing study for FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history included urticaria and no known allergies. There were no concomitant medications. On 21-Nov-2007, the subject received FLUMIST. The patient was seen in the emergency room for abdominal pain on 06-Dec-2007, which began on 05-Dec-2007 pain improved on 06-Dec-2007 but started again on 08-Dec-2007 and caused her to cry. On the day of presentation she also had fever on 104. She received an IV fluid bolus of 20ml/kg and IV morphine. Although differential diagnosis included possibility of appendicitis, this was felt to be unlikely. She was admitted for observation and dehydration on 08-Dec-2007. Abdominal chest x-rays and urinalysis were unremarkable. White blood cell count was 8.7. Diagnoses were acute gastroenteritis and viral syndrome. The patient was discharged on 09-Dec-2007. On 10-Dec-2007 the patient's parents stated she was "feeling better this AM acting normal no fever no pain". The patience recovered on 10-Dec-2007. The investigator assessed the causality for the events  to FLUMIST as none and provided the alternative etiology of natural causes, viral. The severity of the events was mild. Additional information received on 23-Oct-2008 and incorporated into the narrative included medical history details about the hospitalization and event outcome.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Gastroenteritis, Pyrexia, Urine analysis normal, Viral infection, White blood cell count normal
Clinical narrative: A serious report of acute gastroenteritis and viral syndrome has been received from a study investigator concerning a 43 month old female (PID 07393517) participating in a post-marketing study for FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history included urticaria and no known allergies. There were no concomitant medications. On 21-Nov-2007, the subject received FLUMIST. The patient was seen in the emergency room for abdominal pain on 06-Dec-2007, which began on 05-Dec-2007 pain improved on 06-Dec-2007 but started again on 08-Dec-2007 and caused her to cry. On the day of presentation she also had fever on 104. She received an IV fluid bolus of 20ml/kg and IV morphine. Although differential diagnosis included possibility of appendicitis, this was felt to be unlikely. She was admitted for observation and dehydration on 08-Dec-2007. Abdominal chest x-rays and urinalysis were unremarkable. White blood cell count was 8.7. Diagnoses were acute gastroenteritis and viral syndrome. The patient was discharged on 09-Dec-2007. On 10-Dec-2007 the patient's parents stated she was "feeling better this AM acting normal no fever no pain". The patience recovered on 10-Dec-2007. The investigator assessed the causality for the events  to FLUMIST as none and provided the alternative etiology of natural causes, viral. The severity of the events was mild. Additional information received on 23-Oct-2008 and incorporated into the narrative included medical history details about the hospitalization and event outcome.
Age: 2.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Blood culture negative, Chest X-ray abnormal, Cough, Crepitations, Croup infectious
Clinical narrative: A serious clinical trial report of pneumonia and croup has been received from an investigator concerning a 32 month old female, subject number 28351523 who is enrolled in study. This case is submitted in accordance with 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 subject. The subject received FLUMIST on 14-Feb-2008. On 20-Mar-2008, the subject was admitted to the hospital with a one day history of cough and tachypnea. She was found to be hypoxic to the high 80's in the emergency department. Clinically with right lung inspiratory crackles, but also with a barking cough and radiographic evidence of croup (steeple sign). The subject received ceftriaxone as well as racemic epinephrine and decadron x1. The subject had a significant improvement with resolution of her tachypnea and hypoxia as well as improved air movement on the lung exam. The subject was discharged on 21-Mar-2008 with a course of amoxicillin for pneumonia. The subject's mother reported that at night following discharge, the subject seemed to be breathing harder but improved after using a humidifier. The events were considered resolved on 30-Mar-2008. The investigator assessed the pneumonia and croup as not related to FLUMIST. The sponsor assessed the relationship to FLUMIST as not related. Additional information was received on 16-Oct-2008 including: adverse onset date and resolution, rechallenge/dechallenge, suspect vaccine dose and lot#, medical and immunization history, lab and chest x-ray results.
Age: 2.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Eosinophil percentage, Haematocrit normal, Haemoglobin normal, Hypoxia, Lymphocyte percentage decreased
Clinical narrative: A serious clinical trial report of pneumonia and croup has been received from an investigator concerning a 32 month old female, subject number 28351523 who is enrolled in study. This case is submitted in accordance with 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 subject. The subject received FLUMIST on 14-Feb-2008. On 20-Mar-2008, the subject was admitted to the hospital with a one day history of cough and tachypnea. She was found to be hypoxic to the high 80's in the emergency department. Clinically with right lung inspiratory crackles, but also with a barking cough and radiographic evidence of croup (steeple sign). The subject received ceftriaxone as well as racemic epinephrine and decadron x1. The subject had a significant improvement with resolution of her tachypnea and hypoxia as well as improved air movement on the lung exam. The subject was discharged on 21-Mar-2008 with a course of amoxicillin for pneumonia. The subject's mother reported that at night following discharge, the subject seemed to be breathing harder but improved after using a humidifier. The events were considered resolved on 30-Mar-2008. The investigator assessed the pneumonia and croup as not related to FLUMIST. The sponsor assessed the relationship to FLUMIST as not related. Additional information was received on 16-Oct-2008 including: adverse onset date and resolution, rechallenge/dechallenge, suspect vaccine dose and lot#, medical and immunization history, lab and chest x-ray results.
Age: 2.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Neutrophil percentage increased, Platelet count normal, Pneumonia, Tachypnoea, White blood cell count increased
Clinical narrative: A serious clinical trial report of pneumonia and croup has been received from an investigator concerning a 32 month old female, subject number 28351523 who is enrolled in study. This case is submitted in accordance with 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 subject. The subject received FLUMIST on 14-Feb-2008. On 20-Mar-2008, the subject was admitted to the hospital with a one day history of cough and tachypnea. She was found to be hypoxic to the high 80's in the emergency department. Clinically with right lung inspiratory crackles, but also with a barking cough and radiographic evidence of croup (steeple sign). The subject received ceftriaxone as well as racemic epinephrine and decadron x1. The subject had a significant improvement with resolution of her tachypnea and hypoxia as well as improved air movement on the lung exam. The subject was discharged on 21-Mar-2008 with a course of amoxicillin for pneumonia. The subject's mother reported that at night following discharge, the subject seemed to be breathing harder but improved after using a humidifier. The events were considered resolved on 30-Mar-2008. The investigator assessed the pneumonia and croup as not related to FLUMIST. The sponsor assessed the relationship to FLUMIST as not related. Additional information was received on 16-Oct-2008 including: adverse onset date and resolution, rechallenge/dechallenge, suspect vaccine dose and lot#, medical and immunization history, lab and chest x-ray results.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Dehydration, Gastroenteritis, Pneumonia
Clinical narrative: A serious post-marketed study report of dehydration, pneumonia and acute gastroenteritis has been received from a study investigator concerning a 36-month old female subject, patient ID 43450393, participating in a post marketing study. 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 subject. The subject received FLUMIST on 14-Dec-2007. On 09-Jan-2008, the subject was hospitalized for dehydration, pneumonia and acute gastroenteritis. The outcome is unknown. The investigator assessed the events of dehydration, pneumonia and acute gastroenteritis as not related to FLUMIST. The sponsor assessed the relationship of the events of FLUMIST as not related.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Hydronephrosis, Ureteric obstruction
Clinical narrative: A serious post-marketed study report of hydronephrosis and ureteritic obstruction has been received from a study investigator concerning a four-year old male subject, patient ID 53390614, participating in a post-marketing study. 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 subject. The subject received FLUMIST on 18-Oct-2007. On 05-Nov-2007, the subject was hospitalized for hydronephrosis and ureteric obstruction. The subject's length of hospital stay was two days. The outcome is unknown. The investigator assessed the events of hydronephrosis and ureteric obstruction as not related to FLUMIST. The sponsor assessed the relationship of the events as not related to FLUMIST.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Excoriation
Clinical narrative: A non-serious spontaneous report of abrasion and nose bleed has been received from a registered nurse concerning a 46-month old female patient 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. No relevant medical and drug history were reported for this patient. The patient received FLUMIST via nasal route on 03-Oct-2008. The patient developed nose bleed after FLUMIST administration. The patient received the initial dose without any problem. The patient was reportedly moving after FLUMIST administration into the other nostril. According to the reporter, there was a possibility of an abrasion inside the second nostril from the FLUMIST syringe tip resulting in nose bleed. The outcome of the adverse events was not reported.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Body temperature increased, Fatigue, Generalised erythema, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious, spontaneous report of red skin all over, fever, fatigue and runny nose was received from a sales representative concerning a two year old female patient, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing committment 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 03-Oct-2008. On 04-Oct-2008 the child had symptoms of a fever of 104.7 F, fatigue, red skin all over and was seen by a local health provider. On 06-Oct-2008 the child was evaluated again and the fever had declined to 100.7 F, red skin had resolved and the only other symptom was a runny nose. No further information was provided.
Age: 0.5
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of inadvertent administration to six-month-old infant has been received from a Registered Nurse concerning a six-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. Medical history and concomitant medication were not reported. On 07-Oct-2008, the physician's office inadvertently gave FLUMIST to a six-month old infant. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 21-Oct-2008, 14 days after the patient received FLUMIST. indicated that there were not adverse events.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a consumer (patient's mother) concerning a 36-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. No medical or medication history was reported for this patient. The patient received FLUMIST on 29-Sep-2008. On 07-Oct-2008, the patient developed a high fever of 104.7 degrees Fahrenheit. The patient was not seen by a health care provider. The outcome of the adverse event was not reported.
Age: 0.6
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious report  of dosing error has been received from a pharmacist concerning a seven-month old infant. 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 and medication history were not reported. The patient received FLUMIST on 08-Oct-2008. There were no immediate clinical problems or adverse events noted from the dosing error. There was no immediate clinical problems or adverse events noted from the dosing error. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash pustular, Urticaria
Clinical narrative: A non-serious, spontaneous report of rash with pustule on top and hives was received from a consumer concerning a four year-old female patient 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 08-Oct-2008. After administration the child developed a rash and hives on the neck and face. The mother took the child to the pharmacist who prescribed OTC ZYRTEC. The rash and hives subsided, but the child still has two areas of small pencil head size spots with a pustule on top. The spots are located next to the eye and beside the lips.
Age: 1.8
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious report of dosing error (FLUMIST administered to 22 month infant) has been received from a Registered Nurse concerning a 22 month old male. This case is submitted in accordance with MedImmune's post-marketing committment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 13-Oct-2008, the patient was "inadvertently" administered  a half dose of FLUMIST (single nostril). When it was discovered the patient was less than 24 months old, it was decided to not administer the other half dose. The patient showed no reactivity to the half dose. The clinic planned to administer TIV at that time and the booster later since this was the first time the patient received an influenza vaccine. There was no adverse event reported with this vaccination error; therefore; treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved
Age: 0.5
Sex: M
Vaccine: FLUN3
Symptoms: Anorexia, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: A non-serious, spontaneous report of six month-old received FLUMIST, fever and loss of appetite was received from a nurse concerning a six month-old male patient, 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 11-Oct-2008. As reported on 14-Oct-2008, the child has had symptoms of fever and decreased appetite since vaccination. The outcome for the reported adverse events was not reported.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: Inappropriate dose of vaccine administered.
Sex: M
Vaccine: FLUN3
Symptoms: Ear pain, Tinnitus
Clinical narrative: A non-serious spontaneous report of "ears hurting bad" has been received from a Pharmacist concerning a male child, 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. No medical history or concomitant medications were reported. The patient received one dose of FLUMIST on 16-Oct-2008. Thirty minutes after the patient received FLUMIST he returned to the pharmacy screaming stating that his ears hurt. The child stated that his, "ears are hurting bad." The Pharmacist described the event as tinnitus. The outcome of the event was not reported. The causality of the event was not reported.
Age: 1.9
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non serious spontaneous report of administration to a 21 month-old male was received from a pediatrician's office. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 1.9
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non serious spontaneous report of "administration to a child of 1 year and 11 months of age" was received from a registered nurse concerning a 23- month old male patient. No medical history or medication history was reported for this patient. The patient received FLUMIST on 15-Oct-2008. The patient will not be turning two until 02-Nov-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 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: 0.5
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a six-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment of accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 0.8
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a nine-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. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 0.5
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a six-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. Medical history and concomitant medications were not reported. During the week of 10-Oct-2000 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 1.3
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a fifteen-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. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious report of runny nose and fever has been received from a parent of the patient concerning a 36 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. No medical history or concomitant medications were reported. The patient received FLUMIST on 13-Oct-2008. The patient received a total of one dose before onset of the events two days after their only doses of FLUMIST. The mother of the patient reported that two days after receiving FLUMIST the patient developed a runny nose on 15-Oct-2008. The following day 16-Oct-2008 the patient developed a fever. The mother reported that on 17-Oct-2008 the patient was symptoms free.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose administered. A non serious spontaneous report of dosing error (gave half of the vaccine) was received from a RN concerning a four-year old male patient. The patient has no relevant medical history. The patient was not taking any medications at the time of the event. The reporter did not remember removing the clip from the FLUMIST pre filled syringe and thinks that the only one-half dose of the vaccine was given, three times total, to a family that included a mother and her two sons. Upon follow-up, the reporter confirmed that there was no adverse event associated and the event is considered resolved. This case is submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was obtained on 30-Oct-2008 and incorporated into the narrative: Confirmation from the reporter that no adverse evens occurred from the dosing error gave half of the vaccine.
Age: 3.0
Sex: U
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A non serious spontaneous report of vomiting has been received from a registered nurse concerning a three-year old patient of unknown gender 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. No medical history or medication history was reported for this patient. The patient received FLUMIST on 21-Oct-2008. The patient vomited within a couple of hours after receiving FLUMIST. Per the reporter, approximately 600 doses were administered at the site; she does not believe "the product is bad" and does not want to return "the last five doses" at the site. The outcome of the event is unknown.
Age: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: Vomiting A non-serious spontaneous report of vomiting has been received from a registered nurse concerning a four-year old patient 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. No medical history or medication history was reported for this patient. The patient received FLUMIST on 21-Oct-2008. The patient vomited within a couple of hours after receiving FLUMIST. Per the reporter, approximately 500 doses were administered at the site; she does not believe "the product is bad" and does not want to return "the last five doses" at the site. The outcome of the event is unknown.
Sex: U
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Fever A spontaneous non-serious report of fever of less than 101 has been received from a physician in the USA concerning a child of unknown age and gender. 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. No medical history nor concomitant medications were provided. On an unknown date, the patient received a dose of FLUMIST. The physician reported the event of fever of less than 101 three days after FLUMIST. Per the reporter, the patient was a young child: no demographics were available at the time of this report. The child had no other significant symptoms. Outcome for the events was not provided by the reporter.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Irritability, Malaise, Pyrexia, Tremor
Clinical narrative: Shaking Irritability Fever Feeling unwell A non-serious report of shaking, fussiness, fever of 102, and not feeling right has been received from a pharmacist in the USA concerning his son, a three-year-old male. 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. No medical history nor concomitant medications were provided. On 15-Oct-2008, the patient received a dose of FLUMIST. Two days after the dose of FLUMIST, the patient developed a fever of 102 degrees and had symptoms of being fussy. The patient received ibuprofen and acetaminophen and the fever went away. The patient also experienced "shaking" and "not feeling right". The patient has not seen a physician for medical evaluation. The event of fever of 102 resolved on 20-Oct-2008; the events of shaking and not feeling right were still ongoing and the outcome for the event of fussiness was not provided by the reporter.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Gait disturbance, Neurological examination normal, Pyrexia, Rhinorrhoea, X-ray normal
Clinical narrative: A non-serious report of fever, runny nose, and right foot limping and dragging has been received from a physician concerning a three-year-old male. This case is submitted in accordance with MedImmune's post marketed commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST on 18-Oct-2008. On 18-Oct-2008, the patient was administered FLUMIST at a local pharmacy. On the evening of 19-Oct-2008, the patient developed symptoms of fever and runny nose. On 20-Oct-2008, the patient exhibited symptoms of limping on his right leg and dragging of his right foot. The patient did not complain of pain and was not hospitalized but was seen by a physician however, after being examined by a physician's diagnosis could not be determined. X-rays and neurological work up were performed, results were normal. The reporter confirmed that the patient did not fall or experience any incident which may have affected his leg. The patient's father, who is also a physician reported the neurological events in his son and requested additional information on the product. Per the report, his son was doing well, the event improved but was still ongoing. The causality was assessed as not related but the reporter believes that there was a temporal association.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Feeling abnormal, Pyrexia, Rhinorrhoea
Clinical narrative: Spaced out Fever Runny nose A non-serious spontaneous report of spacey, feverish and runny nose has been received from a consumer (patient's mother) concerning a 30-month-old male patient, 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 includes seasonal allergies since April 2008. No concomitant medications were reported for this patient. The patient received his first dose of FLUMIST intranasally on 08-Aug-2008. The patient was described as "feverish, spacey and had a runny nose" for the next three days after receiving FLUMIST. The patient was not evaluated by a physician for his symptoms. The patient experienced the events from 08-Aug through 11-Aug-2008. The patient did not receive another dose of FLUMIST.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose administered A non-serious spontaneous report of patient given only half a dose of FLUMIST was received from a registered nurse in the USA concerning a female child. Neither medical history nor concomitant medications have been reported. The nurse who administered the FLUMIST forgot to remove the divider clip from the plunger of the spray device and delivered only half a dose to the patient. There was no adverse event associated with this medication error: therefore, treatment and reporter/sponsor causal 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: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Inappropriate schedule of vaccine administered (Inappropriate schedule of drug administration) A non-serious spontaneous report of a second dose of FLUMIST given two weeks after the first dose to a two-year-old female child has been received from a Registered Nurse in the USA. 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 and concomitant medication were not reported. On 09-Oct-2008, the physician's office gave FLUMIST to the child and on 23-Oct-2008 a second dose of FLUMIST was given to the same child. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 13-Jan-2009 confirmed the child has not experienced any adverse events.
Age: 1.49
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Vaccination error (Medication error) A non-serious, spontaneous report of 17-month-old female was given FLUMIST was received from a pharmacist in the United States. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received 12-Nov-2008. There were no events reported for the patient since vaccination.
Age: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine used A non-serious spontaneous report of administered expired FLUMIST was received from a health care worker in the USA concerning a four-year-old child. 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. No medical history was provided. The reporter indicated that outdated FLUMIST was administered to two children on 24-Oct-2008 [expiration date 10-Jan-2008). The patient's were re-administered the flu shot. Upon follow up the reporter stated no adverse events were associated with this expired vaccine usage; therefore, treatment and causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 24-Mar-2009 included Product Complaint Investigation results.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema multiforme, Skin lesion
Clinical narrative: A non-serious spontaneous report of erythema multiforme has been received from a Registered Nurse concerning a two 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 21-Oct-2008. The patient received a total of one dose before onset of the event which occurred three days later. On 24-Oct-2008 the child was diagnosed with erythema multiforme. It was described as "raised lesions on buttocks, legs and abdomen." The event remains unresolved with the rash present.
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: Vaccination error (Medication error) A non-serious spontaneous report of patient given only half a dose of FLUMIST was received from a registered nurse in the USA concerning a male child. Neither medical history nor concomitant medications have been reported. The nurse who administered the FLUMIST forgot to remove the divider clip from the plunger of the spray device and delivered only half a dose to the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Facial palsy
Clinical narrative: A serious spontaneous report of Bell's Palsy has been received from a physician concerning a four year-old male subsequent to FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient had a recent infection in his mouth from Herpes virus. Concomitant medications were not reported. On 24-Oct-2008, the patient received FLUMIST. The lot of the vaccine came from an Air Force base. One and a half hours after FLUMIST administration, the patient experienced Bell's Palsy with symptoms of inability to close left eye, decrease in sensation on left side of face, and an "unsymmetrical" smile. As of 28-Oct-2008, the patient showed minimal improvement. The sponsor considered Bell's Palsy to be serious important medical event. The reporting physician did not thin there was a cause and effect relationship.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Accidental exposure
Clinical narrative: A non-serious spontaneous report of FLUMIST got into child's eye was received from a nurse concerning a female child.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow up: A non-serious report of FLUMIST got into child's eye was received from a nurse in the USA concerning a three year old female. There was no adverse event associated with this medication error at the time of the report, not on 07 JAN 2009 when the the reporter was contacted: 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. Additional information received on 07-Jan-2009 and incorporated into narrative: no adverse events occurred.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious, spontaneous report of hives over entire body was received from a nurse, concerning a 36-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 50 months of age for FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient received FLUMIST on 30-Oct-2008.  Within a few hours the child developed hives over his entire body.  DIPHENHYDRAMINE liquid was administered and the hives cleared.
Age: 0.8
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of FLUMIST given to a nine-month old was received from a certified medical assistant in a physician's office concerning a nine-month-old male.  The patient's medical history and concomitant medications were not reported.  On 29-Oct-2008, the patient received FLUMIST vaccine, which is only approved for patients ages 24 months to 39 years of age.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  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: Incorrect dose administered
Clinical narrative: A non-serious, spontaneous report of partial dose of FLUMIST given in a four-year old male patient was received from a pharmacist.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious, spontaneous report of partial dose of FLUMIST administered was received from a physician concerning her 32-month-old son.  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 was not reported.  The physician reported that she was not trained in FLUMIST administration hence, she did not remove the divider clip when administering FLUMIST.  She complained that the syringe did not state clear instructions on administration such as removal of clip and to use both nostrils.  There was no adverse event reported; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: A non-serious report of wheezing has been received from a nurse concerning a three-year-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.  No relevant medical history has been reported for this patient; however, the patient did not have a history of asthma, allergies of wheezing.  The patient's concomitant medications includes: TIV in 2006.  The subject received her first dose of FLUMIST on 30-Sep-2008.  On 09-Oct-2008, the mother of the three year old patient called the office indicating that the child experienced wheezing after receiving FLUMIST on 30-Sep-2008; the wheezing lasted for about 30-minutes and then resolved without reoccurrence.  The patient was doing well and the event resolved.  Per the reporter, they do not recommend that the patient receive the vaccine next year.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A non-serious report of nose bleed has been received from a nurse concerning a three-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.  No relevant medical history or concomitant medications have been reported for this patient.  The subject received a dose of FLUMIST on 09-Oct-2008.  On 09-Oct-2008, the patient experienced nose bleed after administration of FLUMIST into the the second nostril.  Per the reporter, the patient was moving about during the administration.  The outcome for this event was not reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Oedema peripheral, Pruritus generalised, Tenderness
Clinical narrative: L-ARM: SHOT GIVEN - RED, TENDERNESS, SWELLING; NOTICED THE NEXT DAY; GOT WORSE IN THE NEXT 24-36 HOURS. R-ARM: NOTHING GIVEN - BLISTERS (2) ON FOREARM HALF WAY UP; FULL BODY ITCHYNESS. PATIENT CHOSE NOT TO BE SEEN - CALL THE CLINIC TO REPORT INCIDENT.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Anxiety, Arthralgia, Depression, Fatigue
Clinical narrative: I suffered singles three days after my 2nd booster. I have since been diagnosed with a depressive disorder with memory loss and anxiety. I was extremely healthy before the vaccine and had no personal or family history of mental illness.  The following symptoms occurred after each injection; lump where the shot was given, joint aches,fatigue and headache