chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Angiogram, Blood creatinine normal, Chest X-ray normal, Chest discomfort, Chest pain
Clinical narrative: Patient received H1N1 vaccine IM 10/23/2009, 2 days later she had chest pressure and congestion. She had chest pains with cough 10/31/09. She saw her physician 11/6 and went to urgent care and then ER. CXR was negative. CT appeared negative. ECHO and EK no clinical. History of chest pain persisted till 11/8.  11/25/09 Medical records received for DOS  11/03- 11/08. Final DX; Chest pain C/O chest pain, radiates to L arm, needs deep breath. Burning pain.  Recurrent. Increasing frequency. Nausea, abd pain, constipation.   10 min episodes. Numbness hands/feet.  EKG WNL. Resolved.    ICD9 Codes: 785.50A
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Computerised tomogram normal, Cough, Electrocardiogram, Electrocardiogram T wave amplitude decreased, Full blood count normal
Clinical narrative: Patient received H1N1 vaccine IM 10/23/2009, 2 days later she had chest pressure and congestion. She had chest pains with cough 10/31/09. She saw her physician 11/6 and went to urgent care and then ER. CXR was negative. CT appeared negative. ECHO and EK no clinical. History of chest pain persisted till 11/8.  11/25/09 Medical records received for DOS  11/03- 11/08. Final DX; Chest pain C/O chest pain, radiates to L arm, needs deep breath. Burning pain.  Recurrent. Increasing frequency. Nausea, abd pain, constipation.   10 min episodes. Numbness hands/feet.  EKG WNL. Resolved.    ICD9 Codes: 785.50A
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pericarditis, Respiratory tract congestion, Troponin
Clinical narrative: Patient received H1N1 vaccine IM 10/23/2009, 2 days later she had chest pressure and congestion. She had chest pains with cough 10/31/09. She saw her physician 11/6 and went to urgent care and then ER. CXR was negative. CT appeared negative. ECHO and EK no clinical. History of chest pain persisted till 11/8.  11/25/09 Medical records received for DOS  11/03- 11/08. Final DX; Chest pain C/O chest pain, radiates to L arm, needs deep breath. Burning pain.  Recurrent. Increasing frequency. Nausea, abd pain, constipation.   10 min episodes. Numbness hands/feet.  EKG WNL. Resolved.    ICD9 Codes: 785.50A
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reported having a sore arm where injection was given - it has been over a month & it is still sore.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza like illness, Influenza serology positive, Oropharyngeal pain, Pyrexia
Clinical narrative: Influenza. A non-serious spontaneous report of influenza has been received from a MedImmune representative concerning a child, 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. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST on 26-Sep-2009. The patient received a total of one dose of FLUMIST before the onset of the event. The patient experienced the event of flu-like symptoms on 29-Sep-2009 and influenza on 30-Sep-2009. On 30-Sep-2009, the patient had a fever of 101, sore throat, and positive rapid flu test. The outcome of the event of influenza was not reported. All follow-up attempts have been completed per company SOP.  No further information is available.  19-Feb-2010.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Eyelid oedema
Clinical narrative: Swollen eyelid. A non-serious spontaneous report of swollen left eyelid 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 medical history and concomitant medications were not reported. The patient received FLUMIST on 01-Oct-2009. The patient received a total of one dose of FLUMIST before the onset of the event given on 01-Oct-2009. On 01-Oct-2009, when the patient went outside, his eyelid was swollen. The outcome of the event of swollen left eyelid was unknown.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis, Vaccination error
Clinical narrative: A non-serious spontaneous report of medication error and nose bleed has been received from a consumer 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 54 months of age for FLUMIST. No medical history or concomitant medications were provided. The patient received FLUMIST 0.2 milliliters on 01-Oct-2009, the entire dose was administrated into one nare. Two hours after receiving FLUMIST the child experienced a nose bleed. No outcome was reported for the nose bleed while the vaccination error is considered to be resolved.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Vaccination error
Clinical narrative: A non-serious, spontaneous report of jerked a little and got some i nhis eye was received from a consumer concerning a 33-month-old male. Neither medical history nor concomitant medications were reported. On 06-Oct-2009 the patient jerked during administration and the FLUMIST was sprayed in the eye. There was no adverse event associated with the medication error; therefore, treatment and reporter/sponser causality assessments are not applicable, and the event is considered resolved. All follow-ups have been completed per company.  No futher information is available. 10 Mar 2010.
Age: 0.97
Sex: M
Vaccine: FLUN3
Clinical narrative: A non-serious spontaneous report of "mistakenly administered FluMist to a one-year-old" was received from a licensed  practical nurse concerning an 11-month-old male. On 05-Oct-2009, the patient received FluMist. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 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: 1.79
Sex: F
Vaccine: FLUN3
Clinical narrative: A non-serious spontaneous report of FLUMIST given to a 21-month old female with CP was received from a registered nurse. The patient's medical history included cerebral palsy. She has no history of wheezing. The patient was administered FLUMIST on 07-Oct-2009. She is doing fine with no symptoms observed. 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: Rash generalised
Clinical narrative: Rash generalized. A non-serious, spontaneous report of full body rash has been received from a physician concerning a four year old male patient, which occurred one day after 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. The patient's medical history and concomitant medications were not provided. The patient received FLUMIST on 05-Oct-2009. On 06-Oct-2009, the patient developed a full body rash. The event outcome was not reported.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza serology positive, Pyrexia
Clinical narrative: A spontaneous, non-serious event of tested positive for Flu B has been received from a certified medical assistant, concerning a four-year-old female patient subsequent to FLUMIST use. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 54 months of age for FLUMIST. On 04-Oct-2009, the patient received FLUMIST. On 06-Oct-2009, the patient presented the doctor's office with fever. The patient tested positive for influenza B. The outcome of the event was unknown.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Influenza, Influenza like illness, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of influenza B positive had been received from a consumer concerning a 24-month-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. No medical history or concomitant medication information was provided. the patient received FLUMIST on 05-Oct-2009. On 08-Oct-2009, three days after receiving FLUMIST the patient was experiencing the following flu like symptoms: fever of 102, cough and runny nose. the patient was seen by his physician and a rapid viral flu test for A and B came back positive for influenza B.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A non-serious spontaneous report of nosebleeds has been received from a pharmacist, who is the patient's parent, concerning a 42-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 15-Sep-2009. Since 15-Sep-2009, the patient has had six nosebleeds. No other problems were reported other than nosebleeds. The outcome of the event nosebleeds was unknown.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cardiovascular evaluation, Laboratory test
Clinical narrative: see attached chart notes and letter from pt.  11/23/2009 PCP records for visits 9/16 and 9/21/2009. Patient with c/o's burning pain bilateral LE's. Tx lab studies, Cardiology w/up  11/23/09. Additional details provided per pateint. S/P vaccine fatigue, burning LE bil.  Unable to stand or sit. Later was able to walk w/assistance. Residual leg weakness x1wk.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood magnesium normal, Burning sensation, Fatigue, Laboratory test, Metabolic function test
Clinical narrative: see attached chart notes and letter from pt.  11/23/2009 PCP records for visits 9/16 and 9/21/2009. Patient with c/o's burning pain bilateral LE's. Tx lab studies, Cardiology w/up  11/23/09. Additional details provided per pateint. S/P vaccine fatigue, burning LE bil.  Unable to stand or sit. Later was able to walk w/assistance. Residual leg weakness x1wk.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Red blood cell sedimentation rate
Clinical narrative: see attached chart notes and letter from pt.  11/23/2009 PCP records for visits 9/16 and 9/21/2009. Patient with c/o's burning pain bilateral LE's. Tx lab studies, Cardiology w/up  11/23/09. Additional details provided per pateint. S/P vaccine fatigue, burning LE bil.  Unable to stand or sit. Later was able to walk w/assistance. Residual leg weakness x1wk.
Age: 2.0
Sex: M
Vaccine: FLUN3, HEPA
Symptoms: Bronchitis, Stridor
Clinical narrative: A non-serious spontaneous report of stridor and laryngeal tracheal bronchitis has been received from a nurse concerning a 24-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. The patient's past medical history included an upper respiratory tract infection the week prior to FLUMIST administration. At the time of the vaccination, the patient had a "croupy cough". On 01-Oct-2009, the patient received FLUMIST and Hepatitis A vaccination. On 01-Oct-2009, the patient developed stridor and laryngeal tracheal bronchitis. The outcome for stridor and laryngeal bronchitis was not reported. The reported indicated the events of stridor and laryngeal tracheal bronchitis were secondary to FLUMIST.  Vaccine number 1 is not a MedImmune vaccine.  Information not available. 22-Feb-2010.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Vaccination error
Clinical narrative: A non-serious spontaneous report of got full dose of FluMist in one nostril was received from a registered nurse concerning a 43-month-old male. 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 concomitant on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious report of fever and sore throat has been received from a consumer concerning a 40 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. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 06-Oct-2009. The patient received a total of one dose before onset of the event given on 06-Oct-2009 at 5:00 pm. On 09-Oct-2009, in the morning, she experienced fever of 100.5 and a sore throat. The outcome of the events of fever and sore throat were unknown.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A non-serious spontaneous report of "full dose was given in one nostril" was received from a mother concerning her four-year-old daughter subsequent to FLUMIST. On 04-Oct-2009, the patient received FLUMIST for the first time. As of 13-Oct-2009, the patient remains fine with no complaint. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated popular of 2 years to 59 months of age for FLUMIST. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Irritability, Poor quality sleep
Clinical narrative: Sleep unwell, irritable. A non-serious spontaneous report of irritable and not sleeping well has been received from a consumer concerning a 35 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 included "constant cold every other week before and after receiving FLUMIST" and teething. Concomitant medications have not been reported for this patient. The patient received FLUMIST on 20 -Sep-2009 and 20-Oct-2009. The patient received one dose prior to the onset of the events. The patient has been irritable and not sleeping well at night since receiving FLUMIST on 20-Sep-2009. The outcome of the events was not reported. Required follow-up attempts have been performed, requested information unable to be obtained.  01-Mar-2010.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Lethargy, Pyrexia
Clinical narrative: A non-serious, spontaneous report of temperature 103 degrees Fahrenheit and slightly lethargic has been received from a parent concerning a four-year-old male patient, subsequent to receiving FLUMIST. This case is submitted in accordance manufacturer post-marketing commitment or accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history included GERD as a baby, seasonal allergies, and eczema. Concomitant medications included certtirizine hydrochloride and diphenhydramine hydrochloride. The patient received FLUMIST on 19-Oct-2009. On 20-Oct-2009, the patient's temperature had been running 103 degrees F. Parent stated the patient's temperature was 102.8 F with forehead thermometer and 105 F with behind the care ear thermometer. The patient commented that the child looks perfectly fine; no symptoms other than a fever and slightly lethargic, but he does not look sick. The event outcomes ere not reported. Required follow-up attempts have been performed, requested information unable to be obtained.  01-MAR-2010. The patient was treated with ibuprofen and acetaminophen. On 22-Oct-2009, the events of fever and slightly lethargic resolved. Additional information was received on 26-Feb-2010 and incorporated into case: treatment drug and concomitant medication information, event onset/end dates and outcomes, medcial history.
Age: 1.5
Sex: M
Vaccine: FLUN3
Clinical narrative: Vaccination error. A non-serious spontaneous report of "18 month child received FLUMIST" was received from a consumer, the patient's parent concerning an 18th month old male. The patient's medical history and concomitant medications were not reported. On unknown date, the patient was administered FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Body temperature increased, Chills, Cough, Headache, Influenza
Clinical narrative: A non-serious spontaneous report of "nasal swab was taken today and was positive for influenza B" has been received from a physician concerning a 37-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 19-Oct-2009 for unknown indication. On 22-Oct-2009, the patient developed a temperature of 104 degrees, runny nose, cough, night sweats, chills, headache, achy and the patient looked "puny". Nasal swab was positive for influenza B. The patient did not receive any treatment for the event. The outcome of influenza B virus was not reported.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza serology positive, Night sweats, Pain, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of "nasal swab was taken today and was positive for influenza B" has been received from a physician concerning a 37-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 19-Oct-2009 for unknown indication. On 22-Oct-2009, the patient developed a temperature of 104 degrees, runny nose, cough, night sweats, chills, headache, achy and the patient looked "puny". Nasal swab was positive for influenza B. The patient did not receive any treatment for the event. The outcome of influenza B virus was not reported.
Age: 1.41
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of 16-month-old got FluMist was recevied from a nurse concerning a male. On 23-Oct-2009, the patient received a sing dose of FluMist. 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.  Additional information was received on 04-JUN-2010 and incorporated into the narrative: no adverse event occurred.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Incorrect dose administered
Clinical narrative: Drug administration error. Cough. A non-serious spontaneous report of got two doses of FLUMIST the same day and experienced coughing has been received from a licensed practical nurse (patient's grandmother) 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 medical history and concomitant medications included were not reported. On 27 Oct 2009, the patient received two doses of FLUMIST. The patient was inadvertently given two doses of FLUMIST by his elementary school on 27 Oct 2009. The reporter indicated a contributing factor was there were two children with the same name. He "coughed a lot" during the night. He has no other symptoms. The outcome of the medication error was considered resolved. The outcome of the coughing was not provided. The reporter stated the cough lasted for approximately one week. On 03-Nov-2009, the event of coughing resolved. The outcome of the medication error was considered resolved. On 18-Feb-2010 additional information was received and incorporated into case: event outcome for coughing. Required follow-up attempts have been performed, requested information unable to be obtained. 18-Feb-2010.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of "runny nose and low grade fever was received from a pharmacist 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. The patient's medical history and concomitant medications were not reported. The patients received FLUMIST on 23-Oct-2009. On the same same day, the patient experienced a runny nose and low grade fever. The events were ongoing. Required follow up attempts have been performed, requested information unable to be obtained.  23-Feb-2010.
Age: 0.92
Sex: U
Vaccine: FLUN3
Clinical narrative: A non-serious spontaneous report of administration of FluMist to an 11-month old was received from a pharmacist. Relevant medical history and concomitant medications were not reported. On 27-Oct-2009, the patient received FluMist. There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be 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: U
Vaccine: FLUN3
Clinical narrative: A non-serious spontaneous report of FLUMIST "administration to six month old" was received from a registered nurse concerning a six-month-old of unknown sex. The patient's medical history and concomitant medication was not reported. On 30-Oct-2009, the patient was administered FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/ sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up: Required follow-up attempts have been performed, requested information unable to be obtained.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: A non-serious report of "throwing up" and stomach ache has been received from a consumer, patient's father, concerning a four-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. The patient's medical history and concomitant medication  were not reported. The patient received FLUMIST and Hepatitis B vaccines on the same day, 27-Oct-2009. The patient received a total of one dose of FLUMIST before the onset of the events given on 27-Oct-2009. On 28-Oct-2009, the patient was "throwing up" and had a stomach ache. The outcome of the event was unknown.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Ear pain, Ocular hyperaemia
Clinical narrative: A non-serious, spontaneous report of right ear pain and bloodshot left eye has been received from a pharmacist concerning a four-year-old male patient, which occurred one day after 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. The patient has no prior medical history and was not taking concomitant medication at the time of the event. The patient received FLUMIST on 06-Oct-2009. While patient was given FLUMIST, the office staff had instructed his son to actively inhale twice after receiving the vaccine. On 07-Oct-2009, the patient developed right ear pain and blood shot left eye. The patient had no sniffle, fever or sore throat; he was active and playing. On an unknown date the right ear pain and blood shoot left eye resolved. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a parent concerning her four-year-old female 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. The patient's medical history and concomitant medications were not reported. The patient and her brother (MEDI-0009049) received FluMist on 08-Oct-2009. On 10-Oct-2009 the patient and her brother both developed a fever. The outcome of the event fever was unknown. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Muscle spasms, Pyrexia
Clinical narrative: A non-serious spontaneous report of chills, fever, and leg cramps has been received from a physician concerning a 30 month old female subsquent 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 one dose of FLUMIST intranasal on 08-Oct-2009 for influenza vaccination. The events chillds, fever, and leg cramps resolved by the date of this report per the physician
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasopharyngitis, Rhinorrhoea, Upper respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of runny nose and congestion has been received from a patient parent concerning a 30-month-old male subsequent to FluMist. This case is submitted in accordance with the manufacturer's post-marketing commitment or 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 08-Oct-2009. On 11-Oct-2009, the patient began to experience runny nose and congestion described as "cold" symptoms. The outcome of the events was not reported. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious, spontaneous report of half dose of FLUMIST administered had been received from a nurse practitioner concerning a four-year-old male patient. 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 provided. The subject received a half dose of FLUMIST in one nostril on 08-Oct-009. 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. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Decreased appetite, Feeling abnormal, Influenza, Influenza serology positive, Lethargy
Clinical narrative: A non-serious spontaneous report of positive for flu has been received from a physician concerning a 42 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. On 10-Oct-2009, the patient received FluMist. On 11-Oct-2009, at night, the patient started to feel bad and experienced symptoms that included fever, decreased appetite, and lethargy. On 12-Oct-2009, a flu test was positive for influenza B and A. No outcome was reported for this even. Required follow up attempts have been performed requested information unable to be obtained.  01-MAR-2010.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of positive for flu has been received from a physician concerning a 42 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. On 10-Oct-2009, the patient received FluMist. On 11-Oct-2009, at night, the patient started to feel bad and experienced symptoms that included fever, decreased appetite, and lethargy. On 12-Oct-2009, a flu test was positive for influenza B and A. No outcome was reported for this even. Required follow up attempts have been performed requested information unable to be obtained.  01-MAR-2010.
Age: 0.4
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Influenza, Influenza like illness, Influenza serology positive, Pyrexia
Clinical narrative: A non-serious, spontaneous report of secondary transmission and influenza A has been received from a consumer concerning a five-month-old, breastfed female patient. 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. The patient's medical history and concomitant medications were not provided. The patient's mother received FLUMIST on 12-Oct-2009. The patient did not receive FLUMIST. The patient was in close contact with her breastfeeding mother (MEDI-0009075) who received FLUMIST. On the night of 13-Oct-2009, the infant developed flu-like symptoms of fever, congestion, cough, sneezing, and runny nose. On 14-Oct-2009, she was taken to the doctor and tested positive for Influenza A. the infant also vomited after returning from the doctor's office. The mother stated that the infant is a stay at home baby and she does not think the infant could have gotten the virus from anywhere else but her since she got the live vaccine. The event of Influenza A was on going at the time of the report. Required follow-up attempts have been performed, requested information unable to be obtained. 22-Feb-2010.
Age: 0.4
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Secondary transmission, Sneezing, Upper respiratory tract congestion, Vomiting
Clinical narrative: A non-serious, spontaneous report of secondary transmission and influenza A has been received from a consumer concerning a five-month-old, breastfed female patient. 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. The patient's medical history and concomitant medications were not provided. The patient's mother received FLUMIST on 12-Oct-2009. The patient did not receive FLUMIST. The patient was in close contact with her breastfeeding mother (MEDI-0009075) who received FLUMIST. On the night of 13-Oct-2009, the infant developed flu-like symptoms of fever, congestion, cough, sneezing, and runny nose. On 14-Oct-2009, she was taken to the doctor and tested positive for Influenza A. the infant also vomited after returning from the doctor's office. The mother stated that the infant is a stay at home baby and she does not think the infant could have gotten the virus from anywhere else but her since she got the live vaccine. The event of Influenza A was on going at the time of the report. Required follow-up attempts have been performed, requested information unable to be obtained. 22-Feb-2010.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1), FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A non-serious spontaneous report of doctor gave my child a full dose of FLUMIST in one nostril and a full dose of H1N1 in the other nostril was received from a registered nurse/father in nurse USA concerning his 46-month-old daughter. On 14-Oct-2009, the patient received a full dose of FLUMIST in one nostril and a full dose of H1N1 in the other nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 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. Required follow-up attempts have been performed requested information unable to be obtained.  01-MAR-2010.
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza like illness, Pain, Pyrexia
Clinical narrative: A non-serious, spontaneous report of "developed the flu" was received from a physician's assistant, concerning a male child (age not reported) 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 an unknown date. On 12-Oct-2009 the patient developed flu-like symptoms with a high fever and aches. The reporter stated influenza had been "going around" the child's class. The outcome for the event was not reported. The reporter stated the patient "developed the flu, but not because of FLUMIST." Required follow-up attempts have been performed, requested information unable to be obtained. 22-Feb-2010.
Age: 0.8
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administration of FluMist to a Nine-month-old was received from a physician concerning a nine-month old female subsequent to the administration of 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. Relevant medical history and concomitant medications were not reported. On 15-Oct-2009, the patient was accidentally administered FluMist. There was no adverse event associated with this vaccination error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.
Age: 1.7
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccination error. A non-serious, spontaneous report of FLUMIST administered to a 20 month old has been received from a health care professional concerning a 20 month old male patient. The patient's medical history and concomitant medications was not reported. The patient received FLUMIST on 15 Oct 2009. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 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: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous case of double dose of FluMist was received from a registered nurse concerning a 38-month-old male patient. The patient received the first dose of FluMist on 14-Oct-2009 and the 15-Oct-2009, a second dose of FluMist was given. The reporter last saw that on 16-Oct-2009 at which time he was doing fine, running around, and playing. There was no adverse event associated with the vaccination error therefore, treatment and 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: Vaccination error. A non-serious spontaneous report of administration of FLUMIST to a six month old was received from a physician involving a six month old female subsequent to administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 14 Sept 2009, the patient received FLUMIST. There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be 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: 24.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered at inappropriate site, Screaming
Clinical narrative: A non-serious spontaneous report of "FluMist got in the corner of a two year old's eyes" was received from a licensed practical nurse concerning a 24-month-old male. The patient's medical history and concomitant medications were not reported. On 20-Oct-2009, the patient was administered FluMist. The patient was already screaming, and his eyes were shut when the nurse went to administer FluMist to the second nostril. Then the patient moved his head and some of the vaccine went to the corner of his eye. There was no adverse event associated with this vaccination error; therefore, treatment and submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month of age for FluMist.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Polymerase chain reaction, Pyrexia, Rash vesicular, Uveitis, Viral DNA test positive
Clinical narrative: Hospitalized 10/16/08 with one week history of fever and crops of vesicular lesions - with DFA (+) for Varicella Zoster virus; subsequent course has included multiple flares; VI dermatome and uveitis thought to be secondary varicella and only recently has vaccine strain been identified.  11/20/09:  Discharge summary and hospital records received for dates of service 10/16/09 to 10/19/09.  Dx:  Disseminated varicella.   Assessment:  Presents with fever, dried, crusted lesions on scalp, neck, arms and legs.  Placed in isolation with IV fluid hydration, started on Acyclovir, Keflex.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Viral test positive
Clinical narrative: Hospitalized 10/16/08 with one week history of fever and crops of vesicular lesions - with DFA (+) for Varicella Zoster virus; subsequent course has included multiple flares; VI dermatome and uveitis thought to be secondary varicella and only recently has vaccine strain been identified.  11/20/09:  Discharge summary and hospital records received for dates of service 10/16/09 to 10/19/09.  Dx:  Disseminated varicella.   Assessment:  Presents with fever, dried, crusted lesions on scalp, neck, arms and legs.  Placed in isolation with IV fluid hydration, started on Acyclovir, Keflex.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Feet and hands were tingling and becoming numb.  11/20/09 ED, hospital records and DC summary received, service dates 10/28/09 to 11/1/09. Assessment: Guillain-Barre syndrome, probably secondary to influenza vaccine. Acute sinusitis. Patient presented with progressive weakness of a week's duration. Flu-like illness with fever, coughing, and sore throat. Numbness in feet and hand. Teeth feel numb. Acute sinusitis with maxillary and frontal tenderness. Unable to walk up stairs. Stiffness in neck. Calf tightness. Flat affect. Sad looking. Facial weakness / paralysis. Pupils unequal. Diminished right knee reflexes.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Feet and hands were tingling and becoming numb.  11/20/09 ED, hospital records and DC summary received, service dates 10/28/09 to 11/1/09. Assessment: Guillain-Barre syndrome, probably secondary to influenza vaccine. Acute sinusitis. Patient presented with progressive weakness of a week's duration. Flu-like illness with fever, coughing, and sore throat. Numbness in feet and hand. Teeth feel numb. Acute sinusitis with maxillary and frontal tenderness. Unable to walk up stairs. Stiffness in neck. Calf tightness. Flat affect. Sad looking. Facial weakness / paralysis. Pupils unequal. Diminished right knee reflexes.
Sex: M
Vaccine: FLU(H1N1), FLUX, FLU(H1N1), FLU3
Symptoms: Blindness, Diarrhoea, Dyspnoea, Fatigue, Immediate post-injection reaction
Clinical narrative: Pallor, diaphoretic, decreased O2 sat, wheezing, SOB. Gave epi SC and O2 and neb treatment and pt recovered.
Sex: M
Vaccine: FLU(H1N1), FLUX, FLU(H1N1), FLU3
Symptoms: Pain in extremity, Pallor, Tremor
Clinical narrative: Pallor, diaphoretic, decreased O2 sat, wheezing, SOB. Gave epi SC and O2 and neb treatment and pt recovered.
Sex: M
Vaccine: FLU(H1N1), FLUX, FLU(H1N1), FLU3
Symptoms: Dyspnoea, Hyperhidrosis, Oxygen saturation decreased, Pallor, Wheezing
Clinical narrative: Pallor, diaphoretic, decreased O2 sat, wheezing, SOB. Gave epi SC and O2 and neb treatment and pt recovered.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Abnormal behaviour, Lethargy, Unresponsive to stimuli
Clinical narrative: Initial report received on 04 November 2009 from a consumer. A 4 year old female patient with no medical history and no known allergies became unresponsive and experienced behavioral changes 20 minutes after she received an intramuscular left deltoid injection of INFLUENZA A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number not provided) on 29 October 2009 at 12:15 PM. The patient was noted to have received the seasonal influenza vaccine (manufacturer and lot number not reported) in late August or early September. On 29 October 2009 the patient became unresponsive and then passed. The patient's mother noted immediate behavioral changes which was confirmed by her teacher at school. The patient seemed fidgety and had short term memory loss. The patient mixed up names while telling stories and the patient was not as "sharp or loving". She describes her daughter as a "different little girl". The patient had not recovered.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Abnormal behaviour, Amnesia, Unresponsive to stimuli
Clinical narrative: Initial report received on 04 November 2009 from a consumer. A 4 year old female patient with no medical history and no known allergies became unresponsive and experienced behavioral changes 20 minutes after she received an intramuscular left deltoid injection of INFLUENZA A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number not provided) on 29 October 2009 at 12:15 PM. The patient was noted to have received the seasonal influenza vaccine (manufacturer and lot number not reported) in late August or early September. On 29 October 2009 the patient became unresponsive and then passed. The patient's mother noted immediate behavioral changes which was confirmed by her teacher at school. The patient seemed fidgety and had short term memory loss. The patient mixed up names while telling stories and the patient was not as "sharp or loving". She describes her daughter as a "different little girl". The patient had not recovered.
Age: 41.0
Sex: M
Vaccine: FLU(H1N1), DTIPV
Symptoms: Dry mouth, Fatigue, Hyperhidrosis, Swollen tongue
Clinical narrative: My throat started to burn and felt like it was closing up. I ran a high fever and lost motion in my legs for three days..I took benedryl and slept it off. I never went to the emergency ward or back to the phisician. Two weeks later and I am coughing and my eyes are burning red. I went to the clinic at the airport in newark and was given pills to fight off a cold...
Age: 41.0
Sex: M
Vaccine: FLU(H1N1), DTIPV
Symptoms: Cough, Eye irritation, Movement disorder, Ocular hyperaemia, Pyrexia
Clinical narrative: My throat started to burn and felt like it was closing up. I ran a high fever and lost motion in my legs for three days..I took benedryl and slept it off. I never went to the emergency ward or back to the phisician. Two weeks later and I am coughing and my eyes are burning red. I went to the clinic at the airport in newark and was given pills to fight off a cold...
Age: 41.0
Sex: M
Vaccine: FLU(H1N1), DTIPV
Symptoms: Throat irritation, Throat tightness
Clinical narrative: My throat started to burn and felt like it was closing up. I ran a high fever and lost motion in my legs for three days..I took benedryl and slept it off. I never went to the emergency ward or back to the phisician. Two weeks later and I am coughing and my eyes are burning red. I went to the clinic at the airport in newark and was given pills to fight off a cold...
Age: 39.0
Sex: F
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Paraesthesia oral, Tachycardia, Throat tightness
Clinical narrative: Woke up with extreme joint pain that has not gone away after over a week. After shot had tachycardia for 2 hours and tongue and throat felt swollen and tingly.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Arthralgia, Paraesthesia, Paraesthesia oral, Sensory disturbance, Swollen tongue
Clinical narrative: Woke up with extreme joint pain that has not gone away after over a week. After shot had tachycardia for 2 hours and tongue and throat felt swollen and tingly.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Tachycardia
Clinical narrative: Woke up with extreme joint pain that has not gone away after over a week. After shot had tachycardia for 2 hours and tongue and throat felt swollen and tingly.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Small red bumps on arms, more on arm in which shot was given, still just as apparent on day 2.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1), FLUX(H1N1)
Symptoms: Erythema, Rash
Clinical narrative: Small red bumps on arms, more on arm in which shot was given, still just as apparent on day 2.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Headache
Clinical narrative: Severe headache since onset time and continues now (11:10 PM). (Headaches are extremely rare for me).
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Dyspnoea, Oropharyngeal pain, Rhinorrhoea, Wheezing
Clinical narrative: Wheezing, Coughing, Hacking, Runny Nose, Difficulty Breathing, Sore Throat
Age: 47.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nasal congestion, Pulmonary congestion, Pyrexia
Clinical narrative: Fever off and on, stuffy nose, congestion.