chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired vaccine 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 FLUMIST expired on 29-Nov-2010. On 12-Dec-2010, the patient received the 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: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non serious spontaneous report of administration of expired FLUMIST has been received from a health professional concerning a seven-year-old female patient. The patient's medical history and concomitant medication details were not provided. The product expired on 12-Dec-2010. The patient received the expired FLUMIST on 13-Dec-2010. There was no adverse event associated with this vaccination error: therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: F
Vaccine: FLUN3
Symptoms: Ageusia, Anosmia
Clinical narrative: A non-serious spontaneous report of loss of taste and smell has been received from a nurse practitioner concerning an adult female patient subsequent to receiving FLUMIST. Medical history and concomitant medications were not reported. On an unknown date five years ago, the patient received FLUMIST. After receiving FLUMIST, the subject progressively lost her sense of taste and smell. The outcome of the event is not recovered/resolved.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Pharyngeal erythema, Pyrexia, Sneezing
Clinical narrative: A non-serious spontaneous report of red throat, 104 fever, and sneezing has been received from a consumer concerning a four-year old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune 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 02-Aug-2010. On 04-Aug-2010, the patient developed symptoms of red throat, "104 fever", and sneezing. She went to the emergency room where she was treated and released. The symptoms were decreased on 05-Aug-2010. The outcome of the events was unknown; the patient's symptoms were lessening.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Influenza, Lacrimation increased, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of flu symptoms was received from a consumer involving an 47-year-old male subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST on 09-Aug-2010. On 11-Aug-2010, the patient developed watery eyes, sore throat, runny nose, fever, aches, tiredness, and headache. On 13-Aug-2010, the events resolved. The event of flu symptoms resolved on 13-Aug-2010.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of flu symptoms was received from a consumer involving an 47-year-old male subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST on 09-Aug-2010. On 11-Aug-2010, the patient developed watery eyes, sore throat, runny nose, fever, aches, tiredness, and headache. On 13-Aug-2010, the events resolved. The event of flu symptoms resolved on 13-Aug-2010.
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 patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-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 is considered resolved.
Age: 13.0
Sex: M
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 13-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. the patient received the expired FLUMIST on 21-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.
Age: 19.0
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 19-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-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 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 inadvertently administered expired FLUMIST was received from a health professional concerning a 16-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-Dec-2010. There was no adverse event associated with his medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 4.0
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 four-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-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 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: 4.0
Sex: M
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 four-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 22-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: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Influenza, Lacrimation increased, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of flu symptoms was received from a consumer involving an 18-year-old female. No medical history or concomitant medications were reported. The patient received FLUMIST on 09-Aug-2010. On 11-Aug-2010 she developed watery eyes, sore throat, runny nose, aches, tiredness, and headache. The event resolved on 13-Aug-2010.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of flu symptoms was received from a consumer involving an 18-year-old female. No medical history or concomitant medications were reported. The patient received FLUMIST on 09-Aug-2010. On 11-Aug-2010 she developed watery eyes, sore throat, runny nose, aches, tiredness, and headache. The event resolved on 13-Aug-2010.
Age: 37.0
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 consumer concerning a 37-year-old female. The patient's medical history, obstetrical history and concomitant medications were not reported. On 17-Aug-2010, the patient received FLUMIST. The patient was eight weeks pregnant. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 13.0
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 13-year-old female. On 20-Aug-2010, the patient received FLUMIST which expired in March 2010. 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: 11.0
Sex: M
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 11-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-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.
Age: 6.0
Sex: M
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 six-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-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.
Age: 19.0
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 19-year-old female. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-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.
Age: 12.0
Sex: M
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 male. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-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.
Age: 18.0
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 18-year-old female. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-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.
Age: 10.0
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 ten-year-old female. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-Dec-2010. The patient received the expired FLUMIST on 21-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.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of pregnant inadvertently received FLUMIST was received from a physician concerning herself, a 34-year-old female. The patient received FLUMIST on 24-Aug-2010 at 13 weeks gestation. The subjects last menstrual period was in Jun-2010 and the estimated date of delivery is 20-Feb-2011. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Age: 54.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered to 54-year-old was received from a health professional concerning a 54-year-old female. 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: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given expired FLUMIST was received from a health professional concerning a six-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 29-Dec-2010. The patient received the expired FLUMIST on 06-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 64.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to individual over 49 years was received from a health professional concerning a 64-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 29-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.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we administered expired FLUMIST was received from a health professional concerning an eight-year-old male patient. Neither medical history nor concomitant medications have been reported. The product expired on 20-Feb-2010. The patient received the expired FLUMIST on 22-Feb-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 08-Jun-2011 and incorporated into the narrative: The patient did not have any late occurring adverse events.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "we administered expired FLUMIST" was received from a health professional concerning a 36-month-old male patient. Neither medical history nor concomitant medications have been reported. The product expired on 20-Feb-2010. The patient received the expired FLUMIST on 22-Feb-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. Additional information was received on 08-Jun-2011 and incorporated into the narrative: The patient did not have any late occurring adverse events.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we administered expired FLUMIST was received from a health professional concerning a four-year-old female patient. Neither medical history nor concomitant medications have been reported. The product expired on 20-Feb-2010. The patient received the expired FLUMIST on 22-Feb-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. Additional information was received on 08-Jun-2011: Reporter confirmed that the patient did not experience any late occurring adverse events.
Age: 9.0
Sex: M
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 nine-year-old male, subsequent to FLUMIST. Neither the patient's past medical history nor concomitant medications were reported. The product expired on 23-Jan-2011. The patient received the expired FLUMIST on 16-Feb-2011. 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: no late occurring adverse events were reported.
Age: 5.0
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 five-year-old female, subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 23-Jan-2011. The patient received the expired FLUMIST on 02-Feb-2011. 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. 04-Mar-2011: Follow up call was conducted on 04-Mar-2011, no adverse events were reported following administration of the expired FLUMIST.
Age: 12.0
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 12-year-old female, subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 23-Jan-2011. The patient received the expired FLUMIST on 25-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 04-Mar-2011: Reporter confirmed that there was no late occurrence of adverse events.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of administration of partial dose was received from a health professional concerning a six-year-old female patient. Neither patient history nor concomitant medication have been reported for this patient. On 22-Feb-2011, the patient received FLUMIST. While receiving FLUMIST in first nostril, the patient moved her head and did not get full dose. There were no problems while administrating FLUMIST in the second nostril. 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: Influenza, Influenza A virus test positive
Clinical narrative: A non-serious spontaneous report of tested positive for Influenza A has been received from a health professional concerning a seven-year-old male child, subsequent to receiving FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 04-Nov-2010, the patient received FLUMIST. On 07-Jan-2011, the patient was tested positive for Influenza A. The outcome of the event was unknown.
Age: 37.0
Sex: M
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 health professional concerning a 37-year-old male patient. The product expired on 23-Feb-2011. On 25-Feb-2011, the patient received FLUMIST. Neither relevant medical history nor concomitant medications have been 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.
Age: 18.0
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 health professional concerning an 18-year-old male. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 09-Jan-2011. On 25-Feb-2011, 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 04-Apr-2011 and incorporated into case: no late occurring adverse events.
Age: 28.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a 28-year-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 02-Jan-2011. On 28-Feb-2011, 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 04-Apr-2011 and incorporated into case: no late occurring adverse events.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A non-serious spontaneous report of influenza has been received from a health professional concerning a five-year-old female, subsequent to FLUMIST. The patient has no significant medical history and does not have any concomitant medications. The patient did not receive any other vaccination on the day that FLUMIST was administered. The patient received FLUMIST on 15-Oct-2010. The patient tested positive for influenza on 28-Feb-2011, 136 days after receiving FLUMIST. The outcome was resolved. Additional information was received on 09-May-2011 and incorporated into the narrative: Reporter information, outcome of the event, medical history and concomitant medication.
Age: 14.0
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 registered nurse concerning a 14-year-old female. The patient's medical history and concomitant medications were not included. The patient received a dose of expired FLUMIST. The product expired on 20-Feb-2011. On 26-Feb-2011, 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 received on 05-May-2011 and incorporated into case: no late occurring adverse events.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient was given expired FLUMIST was received from a health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 23-Feb-2011. On 25-Feb-2011, 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 was received on 19-May-2011: Reporter confirmed that there was no late occurrence of adverse events and the patient decided not to revaccinate.
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a health professional concerning a male child. Neither medical history nor concomitant medication was reported for this patient. The product expired on 16-Jan-2011. On 26-Jan-2011, 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 concomitment for the indicated population of 2 years to 59 months of age.
Age: 11.0
Sex: M
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 11-year-old male. 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.
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 product was received from a registered nurse concerning a nine-year-old female. The patient's medical history and concomitant medications were not reported. The FLUMIST expired on 27-Feb-2011. On 28-Feb-2011, the patient received the expired FLUMIST, no symptoms were reported. 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 received on 05-May-2011 and incorporated into case: no late occurring adverse events.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non serious spontaneous report of administration of expired FLUMIST has been received from a health professional concerning a 6-year-old male patient. The patient's medical history and concomitant medication details were not provided. The product expired on 12-Dec-2010. The patient received the expired FLUMIST on 14-Dec-2010. On 21-Dec-2010, the patient was administered another dose of FLUMIST as the previous administered dose was expired. 05-Jan-2011, the reporting nurse reported that the patient did not experience any adverse events after receiving either of the FLUMIST doses. Since there was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 05-Jan-2011 and incorporated into the narrative.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired vaccine was received from a physician concerning a six-year-old female. Neither past medical history nor concomitant medications were reported for this patient. On 17-Nov-2010, the patient received the first dose of FLUMIST. On 12-Dec-2010, the product expired. The patient received the expired FLUMIST on 15-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. Additional information was received on 06-Jan-2011: No adverse events were reported.
Age: 8.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of two children administered expired FLUMIST was received from a health professional concerning an eight-year-old patient. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 08-Dec-2010. The patient received the expired FLUMIST on 14-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 received on 01-Mar-2011: no late occurring adverse events.
Age: 9.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of two children administered expired FLUMIST was received from a health professional concerning a nine-year-old patient. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 08-Dec-2010. The patient received the expired FLUMIST on 14-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 received on 01-Mar-2011: no late occurring adverse events.
Age: 33.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a pharmacist concerning a 33-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 15-Dec-2010. On 17-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.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered expired FLUMIST was received from a health professional concerning three children. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 28-Nov-2010 or 29-Nov-2010. On 20-Dec-2010, the patient received expired product. There were 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: Asthma
Clinical narrative: A serious spontaneous report of asthma attack has been received from a health professional concerning a male child, 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 medical history nor concomitant medication was reported for this patient. On an unknown date in Dec-2010, the patient received FLUMIST. On 21-Dec-2010, two weeks after FLUMIST vaccination, the patient experienced an asthma attack that caused him to go to the hospital. The outcome of the event asthma attack was unknown.
Sex: F
Vaccine: FLUN3
Symptoms: Device breakage, Laceration
Clinical narrative: A non-serious spontaneous report of divider clip broke off and cut the nurses' hand has been received from a health professional concerning herself, and adult female, subsequent to administering FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient did not receive FLUMIST. The dose divider clip broke off and cut the nurses' hand when the nurse tried to removed it to deliver the second half of FLUMIST. The second half was administered to the patient and no other issues were reported. There was no damage noted with the packaging or the other doses. The nurse has already discarded the sprayer. The nurse stated that when she went to pinch the dose divider clip to remove it from the plunger rod the dose divider clip broke right in half and a small piece scratched her hand. The nurse received only a small cut that did not require any medical attention and there were no reactions or symptoms to report. The outcome of both the events was resolved.
Age: 2.0
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 health professional concerning a 28-month-old female. Neither relevant medical history nor concomitant medication have been reported for this patient. The product expired on 19-Jan-2011. On 09-Mar-2011, 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. Additional information received on 22-Apr-2011 and incorporated into case: no late occurring adverse events.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Decreased appetite, Influenza, Influenza virus test positive, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a seven-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 16-Sep-2010, the patient received FLUMIST. On 22-Feb-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a seven-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 16-Sep-2010, the patient received FLUMIST. On 22-Feb-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A non-serious spontaneous report of tested positive for Influenza A has been received from a health professional concerning a 14-year-old female child, subsequent to receiving FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 20-Nov-2010, the patient received FLUMIST. On 01-Dec-2010, the patient tested positive for Influenza A. The outcome of the event was unknown.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Decreased appetite, Influenza, Influenza virus test positive, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a ten-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Aug-2010, the patient received FLUMIST. On 15-Feb-2011, a rapid flu test performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a ten-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Aug-2010, the patient received FLUMIST. On 15-Feb-2011, a rapid flu test performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Decreased appetite, Influenza, Influenza virus test positive, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a seven-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Aug-2010, the patient received FLUMIST. On 15-Feb-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a seven-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Aug-2010, the patient received FLUMIST. On 15-Feb-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Decreased appetite, Influenza, Influenza virus test positive, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a six-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Dec-2010, the patient received FLUMIST. On 03-Mar-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a six-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Dec-2010, the patient received FLUMIST. On 03-Mar-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A non-serious spontaneous report of tested positive for Influenza A has been received from a health professional concerning a nine-year-old female child, subsequent to receiving FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 05-Aug-2010, the patient received FLUMIST. On 03-Jan-2011, the patient tested positive for Influenza A. The outcome of the event was unknown.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Decreased appetite, Influenza, Influenza virus test positive, Respiratory tract congestion
Clinical narrative: A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a 16-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Oct-2010, the patient received FLUMIST. On 25-Feb-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a 16-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Oct-2010, the patient received FLUMIST. On 25-Feb-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a two-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Feb-2011. On 25-Feb-2011, 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 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.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a 15-year-old male. Neither the patient's past medical nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a 12-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of two patients were given expired FLUMIST was received from a health professional concerning a five-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 29-Dec-2010. On 05-Jan-2011, the patient received the 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: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a ten-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning an 18-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a five-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 01-Mar-2011. 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.