chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
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 36-month-old male. Neither relevant medical history nor 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. 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: 3.0
Sex: M
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 37-month-old male after receiving FLUMIST. 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 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. 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: 5.0
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 health professional concerning a five-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 22-Nov-2011. The patient received the expired FLUMIST on 16-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 04-Apr-2011: The patient did not have any late occurring adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Nasal discomfort, Sneezing, Throat irritation
Clinical narrative: A non-serious spontaneous report of irritated nose, irritated throat and sneezing has been received from a non-health professional concerning a female patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date, the patient received FLUMIST. The next morning of receiving FLUMIST, the patient experienced irritated nose and throat, and sneezing which lasted for six hours. The outcome of the events irritated nose, irritated throat and sneezing was resolved. Additional information was added on 31-Jan-2011: A correction was made in the narrative to correct an error in the country where the reporter was located.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a five-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 29-Nov-2010. On 29-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 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 38-month-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 29-Nov-2010. On 07-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 commitment for the indicated population of 2 years to 59 months of age. 09-Mar-2011: Follow up call was conducted on 09-Mar-2011, no adverse events were reported following administration of the expired FLUMIST.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 14-year-old male. Neither medical history not concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 08-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. Additional information received on 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a seven-year-old male. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 13-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 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Age: 5.0
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 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 25-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: 17.0
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 17-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 was considered resolved.
Age: 5.0
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 five-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: 11.0
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 11-year-old male. Neither relevant medical history nor 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: 6.0
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 six-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 was considered resolved.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 14-year-old male. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 28-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 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 44-month-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 29-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. Additional information received on 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 12-year-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 29-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 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning an eight-year-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 29-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 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 14-year-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-2010. On 14-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 09-Mar-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 expired FLUMIST administered was received from a health professional concerning a six-year-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-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. 09-Mar-2011: Follow up call was conducted on 09-Mar-2011, no adverse events were reported following administration of the expired FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a four-year-old female. Neither medical history nor concomitant medication was reported for this patient. The FLUMIST expired on 29-Nov-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. 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: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 13-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 29-Nov-2010. The patient received the expired FLUMIST on 23-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. 09-Mar-2011: Follow up call was conducted on 09-Mar-2011, no adverse events were reported following administration of the expired FLUMIST.
Age: 8.0
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 eight-year-old male patient. Neither relevant medial history nor concomitant medications have been reported for this patient. The vaccine expired on 06-Dec-2010. The patient received the expired FLUMIST on 23-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: 10.0
Sex: U
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 patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 06-Dec-2010. The patient received the expired FLUMIST on 23-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: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: A non-serious spontaneous report of a patient received expired FLUMIST and flu-like symptoms has been received from a health professional concerning an 11-year-old male, subsequent to FLUMIST. The patient's medical history included flu-like symptoms in the past with flu shots. No concomitant medications were reported. The patient received the expired FLUMIST on 27-Dec-2010. The vaccine expired on 06-Dec-2010. The mother stated that she was sure that the FLUMIST was effective because the patient developed flu-like symptoms as he did with past flu shots. The reporter offered to revaccinate the patient; however the mom seemed convinced that the dose he received was effective and did not want him to develop flu-like symptoms again. The patient was seen at subsequent visits and no longer had the symptoms. The outcome of both the events was resolved. Additional information was received on 24-Mar-2011 incorporated in the narrative: patient's medical history, adverse events and the outcome.
Age: 13.0
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 13-year-old male, subsequent to receiving FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 02-Jan-2011. The patient received the expired FLUMIST on 13-Jan-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. Additional information was received on 23-Mar-2011: Reporter confirmed that there was no late occurrence of adverse events.
Age: 13.0
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 registered nurse concerning a 13-years-old male. The patient's medical history and concomitant medications were not reported. The product expired on 05-Jan-2011. The patient received the expired FLUMIST on 14-Jan-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. Additional information received on 08-Apr-2011 and incorporated into case: no late occurring adverse events.
Age: 6.0
Sex: U
Vaccine: FLUN3
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: A non-serious spontaneous report of product left at room temperature for 20 days was received from a Consumer or other non health professional concerning a 6 year-old. The father had purchased FLUMIST over the counter and was not advised or counseled to refrigerate. The father did not read to packaging and stored at room temperature. The FLUMIST was left at room temperature for 20 days and then administered on 10-Jan-2011. 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: U
Vaccine: FLUN3
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: A non-serious spontaneous report of product left at room temperature for 20 days was received from a Consumer or other non health professional concerning an eight year-old. The father had purchased FLUMIST over the counter and was not advised or counseled to refrigerate. The father did not read the packaging and stored at room temperature. The FLUMIST was left at room temperature for 20 days and then administered on 10-Jan-2011. 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: 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 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 25-Feb-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. 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: 17.0
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 17-year-old female. Neither the patient's past medical medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 02-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: 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 24-month-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 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 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: 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 02-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: 7.0
Sex: M
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 seven-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 25-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: 8.0
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 an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 02-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: 6.0
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 six-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.
Age: 15.0
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 15-year-old female. Neither relevant medical history nor concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 02-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: 8.0
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 an eight-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 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.
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: A non-serious spontaneous report of product left at room temperature for 20 days was received from a Consumer or other non health professional concerning an adult female. The spouse had purchased FLUMIST over the counter and was not advised or counseled to refrigerate. The spouse did not read the packaging and stored at room temperature. The FLUMIST was left at room temperature for 20 days and then administered on 10-Jan-2011. 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: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired dose of FLUMIST given was received from a health professional concerning a seven-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 09-Jan-2011. The patient received the expired FLUMIST on 18-Jan-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. Additional information was received on 05-Apr-2011 which confirmed that the patient did not experience any adverse events following administration of expired FLUMIST. This information was incorporated into the narrative.
Age: 10.0
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 10-year-old Female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Feb-2011. On 28-Feb-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 was considered resolved.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of expired dose of FLUMIST given was received from a health professional concerning a seven-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 09-Jan-2011. The patient received the expired FLUMIST on 18-Jan-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. Additional information was received on 05-Apr-2011 which confirmed that the patient did not experience any adverse events following administration of expired FLUMIST. This information was incorporated into the narrative.
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 physician concerning a 30-month-old female subsequent to receiving FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 12-Dec-2010. On 17-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. 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: 19.0
Sex: U
Vaccine: FLUN3
Symptoms: Dizziness
Clinical narrative: A non-serious spontaneous report of dizziness has been received from a physician concerning a 19-year-old patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date, the patient received FLUMIST. On an unknown date in 2010, the patient experienced dizziness. The outcome of the event of dizziness was unknown.
Age: 19.0
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 health professional concerning a 19-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 22-Dec-2010. On 19-Jan-2011, 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. Additional information was received on 10-Jun-2011: The patient did not have any late occurring adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Nasal discomfort
Clinical narrative: A non-serious spontaneous report of nose burning after receiving FLUMIST has been received from a health professional concerning an adult female, subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on an unknown date. The patient felt burning in her nose after FLUMIST administration. No medical attention or other symptoms were reported. The reporter stated that the patient no longer worked at the office; so no follow-up information was available. The outcome of the event was unknown. Additional information was received on 23-Mar-2011 and incorporated into the narrative: reporter details.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of we gave a dose of expired FLUMIST was received from a health professional concerning a nine-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 02-Jan-2011. On 18-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. Additional information was received on 10-Jun-2011: 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 two patients were administered expired FLUMIST was received from a health professional concerning a four-year-old female. 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 24-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. 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. 04-Mar-2011: Follow up call was conducted on 03-Mar-2011, no adverse events were reported following administration of the expired FLUMIST.
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 administered 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 23-Jan-2011. The patient received the expired FLUMIST on 24-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 03-Mar-2011: Reporter confirmed that neither of the two patients experienced any adverse events after receiving the expired FLUMIST.
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 28-month-old female. Neither the patient's past medical history nor the concomitant medications were reported. The FLUMIST expired on 09-Jan-2011. The patient received the expired FLUMIST on 10-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. 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 11-Mar-2011: Reporter confirmed that there was no late occurrence of adverse events.
Age: 4.0
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 four-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 09-Jan-2011. The patient received the expired FLUMIST on 10-Jan-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. 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 11-Mar-2011 and incorporated into the narrative: There were no late occurrence of 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 product 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 09-Jan-2011. The patient received the expired FLUMIST on 10-Jan-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. Additional information was received on 11-Mar-2011: The reporter confirmed that there was no late occurrence of 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 health professional concerning a nine-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 02-Jan-2011. The patient received the expired FLUMIST on 03-Jan-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. Additional information was received on 11-Mar-2011: The reporter confirmed that there was no late occurrence of adverse events.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza virus test positive
Clinical narrative: A non-serious spontaneous report of tested positive for influenza has been received from a health professional concerning a four-year-old female patient, 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 18-Jan-2011, the patient received FLUMIST. On 26-Jan-2011, the patient tested positive for influenza using the rapid diagnostic test. The outcome of the event tested positive for influenza was unknown.
Age: 1.92
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of a patient less than 2 years of age received FLUMIST was received from a health professional concerning a 23-month-old male. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 21-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. 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. 08-Mar-2011: Follow up call was conducted on 08-Mar-2011, no adverse events were reported following administration of the FLUMIST.
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever, cough and nasal congestion has been received from a consumer concerning herself, an adult patient, subsequent to FLUMIST. The medical history included: patient did not have any concurrent illness nor did she receive any other vaccines within 30 days of receiving FLUMIST. No concomitant medications have been reported for this patient. On an unknown date, the patient received FLUMIST. On an unknown date, the patient experienced fever, cough and nasal congestion. The events fever, cough and nasal congestion resolved without treatment. Additional information was received on 25-Apr-2011 and incorporated into the narrative: outcome of adverse events as resolved and medical history.
Sex: U
Vaccine: FLUN3
Symptoms: Cough, Nasal congestion, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever, cough and nasal congestion has been received from a consumer concerning her 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 relevant medical history nor concomitant medications have been reported for the patient. On an unknown date, the patient received FLUMIST. On an unknown date, the patient experienced fever, cough and nasal congestion. The outcome of the events of fever, cough and nasal congestion was resolved. Additional information was received on 15-Apr-2011 and incorporated into the narrative: Outcome of the events, reporter confirmed that the patient did not experience any late occurring adverse events.
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Influenza, Influenza A virus test positive, Nasal congestion, Pyrexia
Clinical narrative: A non-serious spontaneous report of Influenza Type A manifested by fever, cough and nasal congestion has been received from a consumer concerning her 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. The medical history includes patient did not have any concurrent illness nor did she receive any other vaccines within 30 days of receiving FLUMIST. No concomitant medications have been reported for this patient. On 11-Sep-2010, the patient received FLUMIST. On an unknown date, the patient experienced fever, cough and nasal congestion and went to ER. He was tested positive for Influenza Type A. The event Influenza Type A manifested by fever, cough and nasal congestion resolved without treatment. Additional information was received on 25-Apr-2011 and incorporated into the narrative: The outcome of adverse event was resolved and medical history.
Age: 39.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash generalised, Tachycardia
Clinical narrative: A non-serious spontaneous report of tachycardia and generalized rash has been received from a physician concerning a 38-year-old female, subsequent to receiving FLUMIST. Medical history included allergy to ampicillin, penicillin and acetaminophen. Concomitant medications were not reported for this patient. On 20-Jan-2011, the patient received one dose of FLUMIST intranasal for flu vaccination. A few minutes after receiving the vaccination, the patient experienced tachycardia and a generalized rash. The outcome of the events was unknown.
Age: 30.0
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 30-year-old female subsequent to receiving FLUMIST. Neither relevant medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 02-Jan-2011. The patient received the expired vaccine on 28-Jan-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. There were no late occurring adverse events. Additional information received on 25-Apr-2011 and incorporated into case: no late occurring adverse events.
Age: 31.0
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 31-year-old male patient after receiving FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 30-Jan-2011. The patient received the expired FLUMIST on 20-Feb-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.
Age: 8.0
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 eight-year-old female patient. Medical history of the patient includes that patient was involved in a study. Concomitant medications have not been reported for this patient. The patient received the expired FLUMIST on 04-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: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "received expired product" was received from a health professional concerning a 14-year-old male patient, subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported. The product expired on 02-Feb-2010. The patient received the expired FLUMIST on 03-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.
Sex: F
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: A non-serious spontaneous report of nurse went to school to administer FLUMIST and developed rash on index finger has been received from a health professional concerning herself, an adult female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient did not receive FLUMIST. The patient was a public health nurse who went into a school to administer FLUMIST. She administered FLUMIST throughout the months of November and December 2010 and developed a rash on her index finger in November. The patient stated that the rash recently returned and she had not dispensed FLUMIST. The outcome of the nurse went to school to administer FLUMIST and developed rash on index finger was resolved. The reported assessed the event of rash as probably not related to FLUMIST. Additional information was received on 23-Mar-2011 and incorporated into the narrative: reporter information, outcome of the event rash and reporter causality.
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 health professional concerning a nine/ten-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 02-Feb-2011. The patient received the expired FLUMIST on 04-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. Additional information was received on 23-Mar-2011: Reporter confirmed that there was no late occurrence of adverse events.
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: A non-serious spontaneous report of nurse administering FLUMIST to students experienced adverse events, breathing difficulty, chest discomfort, dizziness, sore throat and headache has been received from a health professional concerning two adult female nurses, subsequent to administering FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient did not receive FLUMIST. The reporter indicated that two registered nurses who worked in an area remote to the facility, called and reported that on specific days that these nurses were involved in adminstering FLUMIST to 30 or more students at school vaccination clinics, these same RN's experienced sore throat, dizziness, headache and chest discomfort that resulted in breathing difficulty. They both indicated that these events resolved about an hour after they left the school. The reporter also indicated that these schools have been flooded in the past. The reporter considered the possibility that these events may be a result of exposure to mold that may have developed in these schools. The outcome of all the events was resolved.