chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Disturbance in attention, Ear discomfort, Headache, Lacrimation increased
Clinical narrative: A non-serious spontaneous report of difficulty concentration, pressure in ear, eyes watering, headache, runny nose, sore throat, nose fully congested, cold and chills has been received from a consumer concerning a 53-year-old female, subsequent to FLUMIST. The patient did not receive Flu vaccination in years prior to this one. No concomitant medication was reported for this report. On 10-NOV-2010, the patient received 0.2ml FLUMIST nasally for influenza. Within one hour after the vaccine, the patient experienced headache and pressure in ears, soon after, got a runny nose which became fully congested the next day on 11-NOV-2010. Sore throat also started on 11-NOV-10. On 12-NOV-2010, the patient experienced chills. On 15-Nov-10, this developed into full blown cold symptoms. The patient was fully congested with eyes watering at the time of report. Only the pressure in the ear symptoms resolved on 11-Nov-10 and the chills resolved on 12-Nov-2010. All other events resolved after one week. The outcome of all the evens was resolved. Additional information was received on 02-May-2011 and incorporated into the narrative: Outcome and duration of the events.
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of difficulty concentration, pressure in ear, eyes watering, headache, runny nose, sore throat, nose fully congested, cold and chills has been received from a consumer concerning a 53-year-old female, subsequent to FLUMIST. The patient did not receive Flu vaccination in years prior to this one. No concomitant medication was reported for this report. On 10-NOV-2010, the patient received 0.2ml FLUMIST nasally for influenza. Within one hour after the vaccine, the patient experienced headache and pressure in ears, soon after, got a runny nose which became fully congested the next day on 11-NOV-2010. Sore throat also started on 11-NOV-10. On 12-NOV-2010, the patient experienced chills. On 15-Nov-10, this developed into full blown cold symptoms. The patient was fully congested with eyes watering at the time of report. Only the pressure in the ear symptoms resolved on 11-Nov-10 and the chills resolved on 12-Nov-2010. All other events resolved after one week. The outcome of all the evens was resolved. Additional information was received on 02-May-2011 and incorporated into the narrative: Outcome and duration of the events.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness, Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of flu-like symptoms with symptoms of sore throat, runny nose, stuffy nose and feels like a head cold has been received from a consumer concerning an adult female, subsequent to FLUMIST. The patient had no prior exposure to FLUMIST in the past. Concomitant medications were not reported. The patient received FLUMIST nasally on 10-NOV-2010 for Influenza prevention. On 11-Nov-2010, Thursday night at bedtime a slight sore throat was noticed. On Friday morning, 12-NOV-2010, nose was stuffy and runny. The stuffy runny nose has continued but the sore throat had gone. The patient felt like a head cold and had to take ibuprofen to get some relief at bedtime. The events resolved within four to five days from onset. Additional information was received on 02-Jan-2011 and incorporated in the narrative: outcome at the event. Other information received was: lot no, expiry date of FLUMIST.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST went into patient's eye was received from a RN/other health professional concerning a 39-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 11-Nov-2010, the patient received first half dose of FLUMIST, but while administering the second half dose vaccine the nurse slipped and the FLUMIST went into the patient's eye. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 20-Apr-2011: reporter confirmed that the patient did not experience any late occurring adverse events.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "gave patient expired FLUMIST" was received from a health professional concerning a 23-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Nov-2010. The patient received the expired FLUMIST on 29-Nov-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. There were no late occurring adverse events. Additional information was received on 04-Mar-2011 and incorporated into the narrative: updated patient's gender, no late occurring adverse events was reported.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a nine-year-old female. Neither past medical history nor concomitant medications were reported for this patient. On 30-Nov-2010, patient received expired vaccine. The product expiry date was 22-Nov-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved. Additional information was received on 07-Mar-2011: no late occurring adverse events were reported following administration of the expired FLUMIST.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a ten-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 22-Nov-2010. The patient received the expired FLUMIST on 30-Nov-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. 07-Mar-2011: Follow up call was conducted on 07-Mar-2011, no adverse events were reported following administration of the expired FLUMIST.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of "FLUMIST got into patient's eye" was received from a health professional concerning a seven-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 02-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 01-Mar-2011: Reporter confirmed that the patient did not experience any adverse events.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious, spontaneous report of administration of expired product was received from a health professional concerning a two-year-old female patient. Neither medical history nor concomitant medications were reported. The product expired on 22-Nov-2010. On 10-Dec-2010, the patient received expired product. 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 will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 24-Mar-2011 and incorporated into the narrative: no late occurring adverse event was reported.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered expired FLUMIST was received from a other health professional concerning a 16-year-old male. Neither medical history nor concomitant medications were provided. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. 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. Additional information was received on 14-Feb-2011: Reporter confirmed that there was no late occurrence of adverse events.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered expired FLUMIST was received from a other health professional concerning a 22-year-old female. Neither medical history nor concomitant medications were reported. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. 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. 14-Feb-2011: Follow up call was conducted on 14-Feb-2011, no adverse events were reported following administration of the expired FLUMIST.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered expired FLUMIST was received from a other health professional concerning a ten-year-old female. Neither medical history nor concomitant medications were provided. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. 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. Additional information was received on 14-Feb-2011: Reporter confirmed that there was no late occurrence of adverse events.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently gave two patients expired FLUMIST was received from a physician concerning a 14-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 12-Dec-2010. On 15-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 10-Mar-2011 and incorporated into case: no late occurring adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired FLUMIST was received from a nurse concerning a male pediatric patient. No medical history was provided. The product expired on 15-Dec-2010. On 21-Dec-2010, the patient received the expired product. 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 will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired FLUMIST was received from a nurse concerning a female pediatric patient. No medical history was provided. The product expired on 15-Dec-2010. On 21-Dec-2010, the patient received the expired product. 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 will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 1.81
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to two patients less than 24 months old was received from a health professional concerning a 21-month-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received the FLUMIST on 20-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of a patient received expired FLUMIST was received from a pharmacist concerning a 49-year-old female. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 30-Nov-2010. The patient received the expired FLUMIST on 10-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 23-Mar-2011: Reporter confirmed that there was no late occurrence of adverse events.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of two patients administered expired FLUMIST was received from a health professional concerning a six-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 22-Nov-2010. On 10-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of two patients administered expired FLUMIST was received from a health professional concerning a 32-month-old female. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 22-Nov-2010. On 10-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 16-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 15-Dec-2010. On 20-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 12-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 15-Dec-2010. On 20-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST to 2 males was received from a health professional concerning two 16-year-old males after receiving FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 08-Dec-2010. The patient received the expired FLUMIST on 20-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 09-Mar-2011: no late occurring adverse events.
Age: 16.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST to a female was received from a health professional concerning a 16-year-old female after receiving FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 08-Dec-2010. The patient received the expired FLUMIST on 20-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 09-Mar-2011: no late occurring adverse events.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning an 11-year-old male. Neither past medical history nor concomitant medication was reported for this patient. The product expired in 15-Dec-2010. On 20-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of two patients were administered FLUMIST was received from a health professional concerning an adult male. Neither past medical history nor concomitant medications were reported for this patient. The product expired in 22-Dec-2010. On 03-Jan-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of two patients were administered expired FLUMIST was received from a health professional concerning an adult female. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 22-Dec-2010. On 03-Jan-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of three patients received expired FLUMIST was received from a health professional concerning a seven-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The product expired in 29-Nov-2010. On 14-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Mar-2011 and incorporated into the narrative: no late occurring adverse events were reported for the this patient.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of three patients received expired FLUMIST was received from a health professional concerning a 15-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The product expired in 29-Nov-2010. On 28-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Mar-2011 and incorporated into the narrative: no late occurring adverse events were reported for the this patient.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of three patients received expired FLUMIST was received from a health professional concerning an 18-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The product expired in 29-Nov-2010. On 28-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and report causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Mar-2011 and incorporated into the narrative: no late occurring adverse events were reported for the this patient.
Sex: U
Vaccine: FLUN3
Symptoms: Asthenia, Headache, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of sore throat, headache and weakness has been received from a registered nurse concerning an unreported number of Public Health Nurses, subsequent to administering FLUMIST. No concomitant medications or medical history was provided. The patients did not receive FLUMIST. The patients experienced the events of sore throat, headache and weakness after administering 50 to 70 doses of FLUMIST over a four to six hour period. The reporter stated wearing a surgical mask while administering FLUMIST immunizations seems to prevent the symptoms. The sore throat, headache and weakness lasted for 24 hours and then resolved.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administration to a pregnant female was received from a MedImmune Representative concerning a 30-year-old female. The patient's medical history, obstetrical history and concomitant medications were not reported. On 01-Jan-2006, the patient received FLUMIST. She was in her first trimester of pregnancy, however she was unaware that she was pregnant when she received FLUMIST. On an unknown date, she delivered a healthy, full-term, female. According to the reporter, no adverse events occurred.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, Adverse event
Clinical narrative: A non-serious spontaneous report of "that went into my eye" has been received from a registered nurse concerning a 13-year-old male, subsequent to FLUMIST Vaccine. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST vaccine on 10-Sep-2010. The patient backed up while receiving FLUMIST and stated that, "went into my eye." The reporter stated that the syringe was still in the patient's nose when the patient stated that it went into his eye. There was no leak or crack on the FLUMIST syringe used on the patient. The reporter has not received any report of untoward reaction experienced by the patient and the adverse event has resolved. The patient recovered from the event. Additional information was received on 23-Sep-2010 and incorporated into the narrative: no contributory factors to cause the adverse event were found.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: A non-serious spontaneous report of fever, headache, chills, body aches and vomiting has been received from a registered nurse concerning an eight-year-old female subsequent to receiving FLUMIST. The patient experienced the same reaction of fever, headaches, chills, body aches and vomiting in 2009 after receiving FLUMIST, however she did not have any other medical history and was not taking any concomitant medication. On 27-Aug-2010, the patient received one dose of FLUMIST, intranasally. Within 24 hours of vaccine administration, the patient was awake all night with a fever of 100 to 103 degrees Fahrenheit. She also experienced headaches, chills, body aches, and she vomited once. The fever lasted for 48 hours. Treatment with TAMIFLU was initiated on 31-Aug-2010. The events of fever, headaches, chills, body aches and vomiting resolved on 01-Sep-2010.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A non-serious spontaneous report of fever, headache, chills, body aches and vomiting has been received from a registered nurse concerning an eight-year-old female subsequent to receiving FLUMIST. The patient experienced the same reaction of fever, headaches, chills, body aches and vomiting in 2009 after receiving FLUMIST, however she did not have any other medical history and was not taking any concomitant medication. On 27-Aug-2010, the patient received one dose of FLUMIST, intranasally. Within 24 hours of vaccine administration, the patient was awake all night with a fever of 100 to 103 degrees Fahrenheit. She also experienced headaches, chills, body aches, and she vomited once. The fever lasted for 48 hours. Treatment with TAMIFLU was initiated on 31-Aug-2010. The events of fever, headaches, chills, body aches and vomiting resolved on 01-Sep-2010.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Application site scab, Nasal discomfort
Clinical narrative: A non-serious spontaneous report of burning nose and developed a scab in the nose has been received from a registered nurse concerning an eight year-old male, subsequent to receiving FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST nasally on 21-Sep-2009 for flu vaccination. On 21-Sep-2009, after receiving FLUMIST the patient developed burning in the nose and a scab in the nose. No other symptoms were reported. At a medical visit on 17-Sep-2010, to obtain this years flu vaccine, the 2009 events were reported and the reporter indicated the patient had received no medical attention for the events and the events were resolved. On 17-Sep-2010, the patient was administered the injectable flu vaccine.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Application site scab, Nasal discomfort
Clinical narrative: A non-serious spontaneous report of burning nose and developed a scab in the nose has been received from a registered nurse concerning a five-year-old female, subsequent to receiving FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST nasally on 21-Sep-2009. On 21-Sep-2009, after receiving FLUMIST the patient developed burning in the nose and a scab in the nose. No other symptoms were reported. At a medical visit on 17-Sep-2010, to obtain this years flu vaccine, the 2009 events were reported and the reporter indicated the patient had received no medical attention for the events and the events were resolved.
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Dyspnoea, Headache, Nasal congestion, Nasopharyngitis
Clinical narrative: A non-serious spontaneous report of "slight shortness of breath, nasal congestion, runny nose, coughing, rash on arms, rash on palms, slight headache and sneezing" has been received from a consumer concerning himself, a 42-year-old male, subsequent to FLUMIST. The patient's medical history included seasonal allergies in spring (started in 2003), FLUMIST administration in 2009, experiencing cold symptoms in 2009, and no known food or drug allergies. The patient was treated with fluticasone/salmeterol for asthma symptoms for a month in 2003 and takes fluticasone propionate in April/May every year. The patient received one dose of FLUMIST on 11-Sep-2010 at 11:15 am. On 12-Sep-2010, in the evening, the patient experienced slight headache and nasal congestion. On 14-Sep-2010, he had an abrupt nasal congestion, coughing, rash on palms and arms which went away in approximately two hours. On 14-Sep-2010, around noon, he started sneezing repeatedly. There was a lot of clear nasal discharge, and he was not able to breathe through the nose. It was followed by coughing and slight shortness of breath. The patient also developed rash on the inside his palms and on upper arms. He took some nasal decongestant phenylephrine hydrochloride, 5 mg two times a day, and the symptoms subsided within two hours. He also used diphenhydramine later on the same day. All cold symptoms disappeared by 16-Sep-2010. The patient visited an allergy specialist and in his opinion, the reaction was not allergic in nature but rather a severe manifestation of cold symptoms. All events resolved.
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash, Rhinorrhoea, Sneezing
Clinical narrative: A non-serious spontaneous report of "slight shortness of breath, nasal congestion, runny nose, coughing, rash on arms, rash on palms, slight headache and sneezing" has been received from a consumer concerning himself, a 42-year-old male, subsequent to FLUMIST. The patient's medical history included seasonal allergies in spring (started in 2003), FLUMIST administration in 2009, experiencing cold symptoms in 2009, and no known food or drug allergies. The patient was treated with fluticasone/salmeterol for asthma symptoms for a month in 2003 and takes fluticasone propionate in April/May every year. The patient received one dose of FLUMIST on 11-Sep-2010 at 11:15 am. On 12-Sep-2010, in the evening, the patient experienced slight headache and nasal congestion. On 14-Sep-2010, he had an abrupt nasal congestion, coughing, rash on palms and arms which went away in approximately two hours. On 14-Sep-2010, around noon, he started sneezing repeatedly. There was a lot of clear nasal discharge, and he was not able to breathe through the nose. It was followed by coughing and slight shortness of breath. The patient also developed rash on the inside his palms and on upper arms. He took some nasal decongestant phenylephrine hydrochloride, 5 mg two times a day, and the symptoms subsided within two hours. He also used diphenhydramine later on the same day. All cold symptoms disappeared by 16-Sep-2010. The patient visited an allergy specialist and in his opinion, the reaction was not allergic in nature but rather a severe manifestation of cold symptoms. All events resolved.
Age: 63.0
Sex: F
Vaccine: FLUN3
Symptoms: Back pain, Drug administered to patient of inappropriate age
Clinical narrative: A non-serious, spontaneous report of administration to a 63-year-old and lower back pain has been received from a health care professional concerning a 63-year-old female patient, subsequent to receiving FLUMIST. No concomitant medications or medical history were provided. The patient received FLUMIST on 15-Sep-2010. On 15-Sep-2010, the patient experienced lower back pain. No medical attention or other symptoms were reported. The event was ongoing at the time of the report.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Chills, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of sore throat, headache and weakness has been received from a registered nurse concerning a seven-year-old female subsequent to receiving FLUMIST. The patient did not have any other medical history and was not taking any concomitant medication. In November 2009, the patient received one dose of FLUMIST, intranasally. Within 24 hours of vaccine administration, the patient experienced fever, headaches, chills, body aches, and vomiting. Treatment with TAMIFLU was initiated. The events of fever, headaches, chills, body aches and vomiting resolved.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A non-serious spontaneous report of sore throat, headache and weakness has been received from a registered nurse concerning a seven-year-old female subsequent to receiving FLUMIST. The patient did not have any other medical history and was not taking any concomitant medication. In November 2009, the patient received one dose of FLUMIST, intranasally. Within 24 hours of vaccine administration, the patient experienced fever, headaches, chills, body aches, and vomiting. Treatment with TAMIFLU was initiated. The events of fever, headaches, chills, body aches and vomiting resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Sneezing
Clinical narrative: A non-serious, spontaneous report of sneezing has been received from a consumer concerning a male patient, subsequent to receiving FLUMIST. No concomitant medications or medical history was provided. The patient received FLUMIST on 17-Sep-2010. On 18-Sep-2010, the patient experienced sneezing. The event of sneezing was ongoing at the time of the report.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: A non-serious, spontaneous report of fever and rash that caused itching has been received from a consumer concerning a five-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 17-Sep-2010. On 18-Sep-2010 the patient experienced a high fever of 105 degrees Fahrenheit and a rash that caused itching. The fever was treated with acetaminophen and ibuprofen although the fever did not resolve and the patient was taken to the emergency room on 22-Sep-2010. In the emergency room the patient was treated with oral diphenhydramine and hydroxyzine for itching and intravenous saline. The subject was discharged home and on 23-Sep-2010 the patient was prescribed a cream for the rash. The event of fever resolved on 24-Sep-2010, although the event of rash that caused itching was ongoing.
Age: 69.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Fatigue
Clinical narrative: A non-serious spontaneous report of administration to a 69-year-old and fatigue has been received from an other health professional concerning a 69-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 23-Sep-2010 for an unknown indication. On 23-Sep-2010, the patient experienced fatigue. Treatment information was not provided. The event of vaccination error resolved. The outcome for the event of fatigue was not reported.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Influenza, Lethargy, Pain, Pyrexia
Clinical narrative: A non-serious, spontaneous report of flu and fever of 104 has been received from a physician concerning her six-year-old female daughter, one day subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. The patient received FLUMIST on the afternoon of 29-Sep-2010. Around 7:30 PM on 30-Sep-2010 the patient experienced symptoms of influenza including fever of 104, chills, body aches and lethargy. On 01-0ct-2010 all reported symptoms resolved.
Age: 1.02
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of "administration to a 13-month-old" was received from a registered nurse involving a 12-month-old female subsequent to the administration of FLUMIST. No prior medical history or concomitant medications were reported. On 01-Oct-2010, 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 to be resolved.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Feeling abnormal, Headache, Lethargy, Oropharyngeal pain
Clinical narrative: A spontaneous, non-serious report of sinus drainage, headache, lethargy, sore throat and cough has been received from a consumer concerning herself, a 45-year-old female patient subsequent to FLUMIST administration. Medical history included penicillin and doxycycline allergies, ear surgery for cholesteatoma of the left ear (3 times), non-smoker and occasional alcohol use. She received FLUMIST last year. Concomitant medications included oral contraceptive (norethindrone and ethinyl estradiol combination). On 25-Sep-2010, the patient received FLUMIST. Prior to receiving FLUMIST, the subject felt that she was "trying to catch a cold" but had not become ill. On 27-Sep-2010, she began to feel "a little under the weather". On 28-Sep-2010, the patient developed a serious headache and lethargy. On the evening of that day, she also developed sinus drainage and a sore throat; she developed a cough on 30-Sep-2010. On 30-Sep-2010, the patient went to see her physician. She was prescribed a phenylephrine, chlorpheniramine and dextromethorphan-containing cough syrup and azithromycin. On 04-Oct-2010, the patient returned to see her physician. She was told to continue her medications and was told that she could take cetirizine at night. On 09-Oct-2010, sinus drainage, headache, lethargy and sore throat were resolved; on 05-Nov-2010 her cough resolved. On 09-Oct-2010, the events of sinus drainage, headache, lethargy, sore throat were resolved; On 05-Nov-2010, cough was resolved. Additional information was received on 09-Nov-2010 and incorporated into the narrative; resolution date for cough was 05-Nov-2010.
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Sinus disorder
Clinical narrative: A spontaneous, non-serious report of sinus drainage, headache, lethargy, sore throat and cough has been received from a consumer concerning herself, a 45-year-old female patient subsequent to FLUMIST administration. Medical history included penicillin and doxycycline allergies, ear surgery for cholesteatoma of the left ear (3 times), non-smoker and occasional alcohol use. She received FLUMIST last year. Concomitant medications included oral contraceptive (norethindrone and ethinyl estradiol combination). On 25-Sep-2010, the patient received FLUMIST. Prior to receiving FLUMIST, the subject felt that she was "trying to catch a cold" but had not become ill. On 27-Sep-2010, she began to feel "a little under the weather". On 28-Sep-2010, the patient developed a serious headache and lethargy. On the evening of that day, she also developed sinus drainage and a sore throat; she developed a cough on 30-Sep-2010. On 30-Sep-2010, the patient went to see her physician. She was prescribed a phenylephrine, chlorpheniramine and dextromethorphan-containing cough syrup and azithromycin. On 04-Oct-2010, the patient returned to see her physician. She was told to continue her medications and was told that she could take cetirizine at night. On 09-Oct-2010, sinus drainage, headache, lethargy and sore throat were resolved; on 05-Nov-2010 her cough resolved. On 09-Oct-2010, the events of sinus drainage, headache, lethargy, sore throat were resolved; On 05-Nov-2010, cough was resolved. Additional information was received on 09-Nov-2010 and incorporated into the narrative; resolution date for cough was 05-Nov-2010.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered full dose of FLUMIST into one nostril was received from a health professional concerning a two-year-old female. Neither medical history nor concomitant medications were reported. On 03-Oct-2010, the patient received a full dose in one 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 will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered full dose of FLUMIST to one nostril was received from a health professional concerning a six-year-old female. Medical history and concomitant medications were not reported. On 03-Oct-2010, the patient received a full dose of FLUMIST into one 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.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious, spontaneous report of second dose administered 12 days after first dose was received from a nurse concerning a 4-year-old female patient. Medical history and concomitant medications were not reported. On 24-Sep-2010 and 06-Oct-2010, the patient received a dose of 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 resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received in 08-Nov-2010 and incorporated into the narrative: the patient did not have an adverse event.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Immediate post-injection reaction
Clinical narrative: A non-serious spontaneous report of bloody nose has been received from a registered nurse concerning an eight-year-old female, subsequent to FLUMIST Vaccine. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST vaccine on 06-Oct-2010. Immediately after FLUMIST was administered, the child had a bloody nose. The outcome of the event was not reported.
Age: 65.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious, spontaneous report of gave FLUMIST to a 65-year-old female patient was received from a nurse, subsequent to FLUMIST. Medical history and concomitant medications were not reported. On an unknown date, 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 resolved.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Eyelid oedema, Pyrexia, Swelling face
Clinical narrative: A non-serious spontaneous report of fever, puffy face and eyes has been received from a health professional concerning a 47-month-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 28-Sep-2010 for an unknown indication. On 02-Nov-2010, the patient developed a fever. On 07-Oct-2010, the patient's face and eyes were puffy. Treatment for the events was not provided. The outcome for the reported adverse events was not reported.
Age: 1.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious, spontaneous report of inadvertently gave FLUMIST to a 1-year-old was received from a health professional concerning a 12-month-old female. Neither medical history nor concomitant medication was reported for this patient. The patient received FLUMIST on an unknown date. 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 will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 0.7
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious, spontaneous report of gave FLUMIST to a nine-month-old was received from a health professional concerning an eight-month-old male. Neither medical history nor concomitant medication was reported for this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently sprayed into eye was received from a Physician concerning a male child. Neither medical history nor concomitant medications were provided. Per the reporter, FLUMIST was inadvertently sprayed into a child's eye during administration. There were no symptoms to report. 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: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache, Influenza, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of flu, runny nose, stuffy nose, fever of 102 and headache has been received from a consumer concerning an eight-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 08-Oct-2010 for an unknown indication. On 09-Oct-2010, the patient experienced runny nose, stuffy nose, fever of 102 and headache. On 11-Oct-2010, the patient experienced flu. Treatment for the events was not provided. The outcome for the reported adverse events was ongoing.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: A non-serious, spontaneous report of administration to Asthmatic was received from a physician concerning a 41-year-old female patient. Medical history included asthma. On 08-Oct-2010, the patient received FLUMIST before disclosure to the physician that she had a history of asthma. 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. Additional information was received on 09-Nov-2010 and incorporated into the narrative: The patient did not experience any late occurring adverse events.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious, spontaneous report of a three-year-old received full dose of FLUMIST in one nostril was received from a health professional concerning a three-year-old female. Neither medical history nor concomitant medications were reported. On 13-Oct-2010, the patient received a full dose in one nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.