chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered in one nostril was received from a health professional concerning an eight year-old male. No medical history was reported. FLUMIST was administered on 21-Sep-2010. There was no adverse event associated with this drug administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 57.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A health care professional reported the spontaneous non-serious event of administration to a 57-year-old male subsequent to receiving FLUMIST. Neither medical history nor concomitant medications were provided. On 14-Oct-2010, the patient received FLUMIST vaccination. The patient was reported to be healthy at the time of administration. No other 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.
Age: 1.26
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of 15-month-old received FLUMIST has been received from a health professional concerning a 15-month-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 24-Aug-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved. There were no late occurring adverse events. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: A non-serious spontaneous report of flu symptoms has been received from a consumer concerning a 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 patient's medical history and concomitant medications were not provided. The patient received FLUMIST on 08-Oct-2010. On 11-Oct-2010, the child presented with flu symptoms. No medical attention or other symptoms were reported. The outcome of the event are unknown.
Age: 20.0
Sex: M
Vaccine: FLUN3
Symptoms: Paraesthesia
Clinical narrative: An non-serious spontaneous report of tingling in nose and cheek has been received from a physician concerning a 20-year-old male, subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 15-Oct-2010. On 15-Oct-2010, two hours later FLUMIST administration, the patient experienced tingling in his nose and cheeks. The outcome of the event is unknown.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure
Clinical narrative: A health professional reported the spontaneous non-serious event of FLUMIST went into the eye and on the cheek involving a six-year-old male child. The reporter stated she administered FLUMIST to a child and he jerked his head and FLUMIST went into his eye and on his cheek. No medical attention or other 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.
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Diarrhoea
Clinical narrative: A spontaneous, non-serious report of diarrhea has been received from a nurse concerning a 33-year-old male patient which occurred one day after receiving FLUMIST. Medical history and concomitant medications were not reported. On 13-Oct-2010, the patient received FLUMIST. On 14-Oct-2010, the patient called the office and reported that he had developed diarrhea after receiving FLUMIST; the event had resolved prior to the call. The outcome for the event, diarrhea, was resolved. Additional information was received on 08-Nov-2010 and was incorporated into the narrative: diarrhea was resolved prior to the event being reported.
Age: 10.0
Sex: U
Vaccine: FLUN3
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of half dose of FLUMIST was received from a healthcare professional concerning a ten year-old. On an unreported date the nurse forgot to pull the clip off the second half of the dose and the patient only received half a dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 15.0
Sex: U
Vaccine: FLUN3
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious, spontaneous report of patient received half dose of FLUMIST was received from a health professional concerning a 15-years-old patient. When administering FLUMIST, the nurse did not remove the clip from the syringe in order to provide the second dose. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments were not applicable, and the event was considered resolved.
Age: 27.0
Sex: U
Vaccine: FLUN3
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of half dose of FLUMIST was received from a healthcare professional concerning a 27 year-old. On an unreported date the nurse forgot to pull the clip off the second half of the dose and the patient only received half a dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 9.0
Sex: U
Vaccine: FLUN3
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of half a dose of FLUMIST was received from a healthcare professional concerning a nine year-old. On an unspecified date the nurse forgot to pull the clip off the second half of the dose and the patient only received half a dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Sex: M
Vaccine: FLUN3
Symptoms: Laceration, Syringe issue
Clinical narrative: A non-serious report of "doctor cut his hand on defective sprayer during administration" has been received from a health care professional concerning an adult male who was a physician administering FLUMIST to a patient. The doctor's medical history and concomitant medications were not reported. The adverse event of "doctor cut his hand on defective sprayer during administration" occurred during FLUMIST administration to a patient. One FLUMIST sprayer broke during FLUMIST administration to a patient and cut the doctor's hand. There was no signs of damage on the outside of the product packaging or plastic molded tray. The FLUMIST sprayer which broke was the first one used from the box. The product was refrigerated at 40 Fahrenheit, and temperature was monitored twice a day. The sprayer broke after the physician had administered FLUMIST into the first nostril. The physician removed another sprayer from the package to administer the second dose. There was no injury to the patient as the sprayer had been removed from the nostril before it broke. The outcome of the event of "doctor cut his hand on defective sprayer during administration" is unknown.
Age: 1.81
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of 21-month-old received FLUMIST was received from a physician. No medical history or concomitant medications 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 to be 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: 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 administration to 54 year-old female was received from a health professional. The patient's medical history and concomitant medications were not provided. 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: 65.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered to 65-year-old was received from a consumer concerning a 65-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.
Sex: F
Vaccine: FLUN3
Symptoms: Laceration
Clinical narrative: A spontaneous, non-serious report of a cut on finger when the sprayer broke during administration of FLUMIST, concerning a female patient. On an unreported date, the nurse reported she removed the FLUMIST syringe from the package to administer to a patient and as soon as she began to push on the plunger rod, a portion of the finger flange snapped off cutting her finger. A bandaid was applied to the laceration. The outcome of the event is unknown.
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A non-serious spontaneous report of fever has been received from a non-health professional concerning a female 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 patient's past medical history and concomitant medications were not reported. The patient received one dose of FLUMIST given on 12-Oct-2010. On 14-Oct-2010, the patient experienced fever of 103 Fahrenheit. The outcome of the event of fever was unknown.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious, spontaneous report of administration to pregnant female was received from a health professional concerning a 17-year-old female, subsequent to FLUMIST. 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: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Hypoaesthesia facial, Paraesthesia oral
Clinical narrative: A non-serious spontaneous report of facial numbness, extreme dizziness and lip tingling has been received from a non-health professional concerning a 27-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 13-Oct-2010 for an unknown indication. One and one-half hours after receiving FLUMIST, the patient experienced facial numbness, extreme dizziness and lip tingling. The outcome for the reported adverse events was not reported.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: No adverse event, Underdose
Clinical narrative: A non-serious spontaneous report of administration of half dose was received from a health professional concerning a four-year-old male. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 0.92
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to an 11 month old male child was received from a physician. Neither medical history nor concomitant medication was reported for this patient. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 30.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Rectal haemorrhage
Clinical narrative: A non-serious spontaneous report of cramping and rectal bleeding has been received from a health professional concerning a 30-year-old female, subsequent to receiving FLUMIST. Medical history included ulcerative colitis. Concomitant medications included infliximab and mesalamine. On 12-Oct-2010, the patient received FLUMIST. The patient reported to her manager who relayed the information to the Director of Nursing, who then relayed this information to the reporter that on 18-Oct-2010, the patient began to have abdominal cramping. The next day she experienced rectal bleeding and called her physician. Hydrocortisone enemas were prescribed and her current dose of mesalamine was increased. The reporter did not believe that the patient was actually seen by her physician. However, the reporter indicated she has not spoken directly with the patient regarding these events. The outcome of the event was unknown.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Blister, Blood test normal, Borrelia test negative, Dyshidrosis, Hypoaesthesia facial
Clinical narrative: A non-serious spontaneous report of neuralgia of the trigeminal nerve (right side facial numbness), vertigo, dyshidrotic eczema and rosacea has been received from a consumer (registered nurse) concerning a 35-year-old female patient subsequent to FLUMIST. Medical history was included allergies. Concomitant medications were montelukast, prenatal vitamins (patient was not pregnant) and JUICE PLUS tablets. On 21-Sep-2010, the patient received FLUMIST. On 25-Sep-2010, the patient developed vertigo and two days later, 27-Sep-2010, she developed right facial numbness which was diagnosed as "neuralgia of the trigeminal nerve". She was examined by her primary care physician who subsequently sent her to see a dentist, infection disease specialist, neurologist and an ear, nose and throat specialist. An examination by the infectious disease physician revealed a deeply seated subacute vesiculation of the lateral aspects of several digits with "the right thing in our eminence". There was no evidence of secondary infection or volar wrist or dorsal hands involvement. Treatment included SA 5% fluocinonide acetonide 0.05% cream. He also noted that the patient was having none of the lancinating pain more typically associated with trigeminal neuralgia. In addition to eczema, the physician also diagnosed rosacea; she had moderate blanching erythema of the centrofacial areas of the nose, cheeks and chin with several background telangiectasias and a couple of small centrofacial pustules with no papulopustules. No evidence of ocular involvement was seen . Treatment included azelaic acid 15% gel applied to affected areas twice a day. Brain and internal auditory canal magnetic resonance imaging (MRI) scans with and without contrast were normal, multiple sclerosis (MS), Lyme's disease and multiple blood tests were negative. The event of neuralgia of the trigeminal nerve was ongoing. The events, vertigo, dyshidrotic eczema and rosacea have resolved.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain normal, Pallor, Rash pustular
Clinical narrative: A non-serious spontaneous report of neuralgia of the trigeminal nerve (right side facial numbness), vertigo, dyshidrotic eczema and rosacea has been received from a consumer (registered nurse) concerning a 35-year-old female patient subsequent to FLUMIST. Medical history was included allergies. Concomitant medications were montelukast, prenatal vitamins (patient was not pregnant) and JUICE PLUS tablets. On 21-Sep-2010, the patient received FLUMIST. On 25-Sep-2010, the patient developed vertigo and two days later, 27-Sep-2010, she developed right facial numbness which was diagnosed as "neuralgia of the trigeminal nerve". She was examined by her primary care physician who subsequently sent her to see a dentist, infection disease specialist, neurologist and an ear, nose and throat specialist. An examination by the infectious disease physician revealed a deeply seated subacute vesiculation of the lateral aspects of several digits with "the right thing in our eminence". There was no evidence of secondary infection or volar wrist or dorsal hands involvement. Treatment included SA 5% fluocinonide acetonide 0.05% cream. He also noted that the patient was having none of the lancinating pain more typically associated with trigeminal neuralgia. In addition to eczema, the physician also diagnosed rosacea; she had moderate blanching erythema of the centrofacial areas of the nose, cheeks and chin with several background telangiectasias and a couple of small centrofacial pustules with no papulopustules. No evidence of ocular involvement was seen . Treatment included azelaic acid 15% gel applied to affected areas twice a day. Brain and internal auditory canal magnetic resonance imaging (MRI) scans with and without contrast were normal, multiple sclerosis (MS), Lyme's disease and multiple blood tests were negative. The event of neuralgia of the trigeminal nerve was ongoing. The events, vertigo, dyshidrotic eczema and rosacea have resolved.
Age: 35.0
Sex: F
Vaccine: FLUN3
Symptoms: Rosacea, Scan with contrast normal, Telangiectasia, Trigeminal neuralgia, Vertigo
Clinical narrative: A non-serious spontaneous report of neuralgia of the trigeminal nerve (right side facial numbness), vertigo, dyshidrotic eczema and rosacea has been received from a consumer (registered nurse) concerning a 35-year-old female patient subsequent to FLUMIST. Medical history was included allergies. Concomitant medications were montelukast, prenatal vitamins (patient was not pregnant) and JUICE PLUS tablets. On 21-Sep-2010, the patient received FLUMIST. On 25-Sep-2010, the patient developed vertigo and two days later, 27-Sep-2010, she developed right facial numbness which was diagnosed as "neuralgia of the trigeminal nerve". She was examined by her primary care physician who subsequently sent her to see a dentist, infection disease specialist, neurologist and an ear, nose and throat specialist. An examination by the infectious disease physician revealed a deeply seated subacute vesiculation of the lateral aspects of several digits with "the right thing in our eminence". There was no evidence of secondary infection or volar wrist or dorsal hands involvement. Treatment included SA 5% fluocinonide acetonide 0.05% cream. He also noted that the patient was having none of the lancinating pain more typically associated with trigeminal neuralgia. In addition to eczema, the physician also diagnosed rosacea; she had moderate blanching erythema of the centrofacial areas of the nose, cheeks and chin with several background telangiectasias and a couple of small centrofacial pustules with no papulopustules. No evidence of ocular involvement was seen . Treatment included azelaic acid 15% gel applied to affected areas twice a day. Brain and internal auditory canal magnetic resonance imaging (MRI) scans with and without contrast were normal, multiple sclerosis (MS), Lyme's disease and multiple blood tests were negative. The event of neuralgia of the trigeminal nerve was ongoing. The events, vertigo, dyshidrotic eczema and rosacea have resolved.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error, No adverse event
Clinical narrative: A non-serious spontaneous report of half a dose of FLUMIST squirted in eyes and face was received from a registered nurse concerning an 11-year old female. No medical history or concomitant medications were reported for this patient. FLUMIST was administered on 14-Oct-2010. Upon follow up on 10-Nov-2010 there was no side effects, symptoms or anything to report after the FLUMIST sprayed in her eyes and face. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza B virus test positive, Pyrexia
Clinical narrative: A non-serious report of tested positive for influenza B with symptom of 104 fever has been received from a health professional concerning a four-year-old female 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 patient's medical history was not reported. The patient did not use any concomitant medications. The patient received FLUMIST intranasally on 19-Oct-2010. On 21-Oct-2010, the patient returned to the clinic with fever of 104 Fahrenheit and tested positive for Influenza B. The patient was treated with Oseltamivir. The events resolved on an unknown date.
Age: 82.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A health professional reported the non-serious spontaneous event of administration to patient over 49 years of age involving an 82-year-old male patient. Neither medical history nor concomitant medications were provided. FLUMIST was administered on 26-Oct-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: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: A non-serious spontaneous report of leg pain and tingling has been received from a mother/health professional concerning a eight-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on an unknown date in Oct-2010 for an unknown indication. On 26-Oct-2010, the patient began to have symptoms of leg pain and tingling. As per the reporter the symptoms did not resolve with ibuprofen. The patient had not sought medical attention at the time of report. The outcome of the events leg pain and tingling was not resolved.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of five month pregnant lady received FLUMIST was received from a health professional concerning a 22-year-old female. Neither patient's medical history nor obstetrical history reported for this patient. On 28-Oct-2010, five month pregnant female received FLUMIST. 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: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of splashed FLUMIST in 6 years-old eye was received from a nurse concerning a six-year-old male. The FLUMIST inadvertently splashed in the six year-old patient. The nurse rinsed patient's eye with water. Post rinsing, patient was fine and had no symptoms. On 27-Oct-2010, the patient received FLUMIST. 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.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Laceration, Syringe issue, Therapeutic procedure
Clinical narrative: A spontaneous, non-serious report of a cut on finger when the sprayer broke during administration of FLUMIST, concerning a 43-year-old male patient. Medical history and concomitant medications were not reported. The reporting nurse did not receive FLUMIST. On 27-Oct-2010, the patient sustained a laceration injury to his index finger when the glass flange of the base of the barrel snapped after fully depressing the plunger while administering the second half of the FLUMIST vaccine. The laceration needed to be sutured; however, he was working in a remote village so the cut was closed with medical "super glue". On 05-Nov-2010, the laceration had healed. The event resolved on 05-Nov-2010.
Sex: U
Vaccine: FLUN3
Symptoms: Laceration, Syringe issue
Clinical narrative: A non-serious spontaneous report of handle broke off of five FLUMIST syringes cutting the nurses hands has been received from a health professional concerning an adult. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient did not receive FLUMIST. On an unknown date, during the preparation of FLUMIST for administration, the handle broke off of five FLUMIST syringes and the nurses sustained a cut to their hands. Ninety percent of the handle broke off from one syringe and about 25% of the handles broke off from four other syringes. The product was not administered. There were no observed damages to the boxes or the plastic moldings and the were no product leakage. It was reported that the nurses are fine. The outcome of the reported adverse event was not reported.
Age: 56.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of 56-year-old female patient received FLUMIST was received from a healthcare professional concerning a 56-year-old female. 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: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: A non-serious, spontaneous report of four-year-old asthmatic received FLUMIST two weeks after flushot was received from a registered Pharmacist concerning a four-year-old of unknown gender. The patient's medical history included asthma and twin birth. The patient had received a flu shot two weeks before FLUMIST vaccination. On 28-Oct-2010, the patient received 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: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: No adverse event, Vaccination error
Clinical narrative: A non-serious, spontaneous report of four-year-old received FLUMIST two weeks after flushot was received from a registered Pharmacist concerning a four-year-old of unknown gender. The patient's medical history included twin birth. The patient had received a flu shot two weeks before FLUMIST vaccination. On 28-Oct-2010, the patient received 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.
Sex: F
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: A non-serious, spontaneous report of head throbbing severe headache has been received from a health professional concerning herself, a female patient, subsequent to FLUMIST. Neither medical history nor concomitant medications were reported. The patient received FLUMIST, intranasal on an unknown date. The following day the patient experienced a severe, head-throbbing headache. The patient recovered from the events on an unknown date. The reporter considered the event as related to FLUMIST.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a healthcare professional concerning a six-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 10-Feb-2010. On 28-Oct-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 0.61
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to six month-old was received from a healthcare professional concerning a seven-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Oct-2010, the patient received second dose of 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: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of sprayed in her eye while being administered was received from a consumer concerning a four-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The mother reported that her daughter received FLUMIST and it got spread in her eye while being administered. On 24-Oct-2010, the patient received FLUMIST. 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. 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: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to pregnant female was received from a registered nurse concerning a 14-year-old female. Neither relevant medical history/obstetrical history nor concomitant medications have been reported. On 01-Nov-2010, the patient received FLUMIST for an unknown indication. There was no adverse event associated with this pregnancy. Treatment and reporter 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.
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of administration of FLUMIST to a pregnant female was received from a registered nurse concerning an adult female. Neither relevant medical history/obstetrical history nor concomitant medications have been reported for this patient. On 03-Nov-2010, the patient received FLUMIST for an unknown indication. There was no adverse event associated with this medication error. Treatment and reporter 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.
Sex: F
Vaccine: FLUN3
Symptoms: Crying, Cyanosis
Clinical narrative: A non-serious spontaneous report of crying hard and turned blue has been received from a physician concerning a female infant, 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. Medical history of the patient includes that patient is a blue baby. Concomitant medications have not been reported for this patient. The patient received dose of FLUMIST on an unknown date in Apr-2010 for an unknown indication. On an unknown date in Apr-2010, the patient was crying really hard and turned blue. The pediatrician was not concerned as the patient was a blue baby. The outcome of the events was unknown.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Facial pain, Pyrexia, Toothache
Clinical narrative: A non-serious, spontaneous report of tooth pain, facial pain and low grade fever has been received from a consumer concerning an 11-year-old male, subsequent to FLUMIST. Neither medical history nor concomitant medication was reported for this patient. On 30-Oct-2010, the patient received FLUMIST for an unknown indication. Seven to eight hours later, the patient experienced tooth/facial and fever (low grade) which has continued for the past four to five days. The patient was taken to the dentist and no problems with the patient's teeth and sinuses were noted. The outcome of the events tooth pain, facial pain and low grade fever was not resolved.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Ocular hyperaemia
Clinical narrative: A non-serious spontaneous report of red eye has been received from a RN/health professional concerning an eight-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medication was reported for this patient. On 02-Nov-2010, the patient received FLUMIST. On 04-Nov-2010, two days after vaccination, the patient developed red eye. The outcome of the event red eye was unknown.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Bronchial hyperreactivity, Cough, Pneumonia streptococcal, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of strep pneumonia symptomized by fever, reactive airway disease symptomized by cough and runny nose has been received from a company representative/non-health professional concerning a six-year-old female patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received dose of FLUMIST on 01-Oct-2010 for an unknown indication. On 03-Oct-2010, the patient had runny nose, fever and cough. Symptoms developed into reactive airway disease. The patient was taking albuterol and fluticasone at the time of report. The patient was also diagnosed with strep pneumonia. The outcome of the events strep pneumonia symptomized by fever, reactive airway disease symptomized by cough and runny nose was unknown.
Age: 24.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST was administered to a pregnant female was received from a registered nurse concerning a 24-year-old female. Neither past medical history nor obstetrical history was reported for this patient. On 05-Oct-2010, patient received FLUMIST. As per the reporter, patient was in her first or second trimester of pregnancy. The reporter indicated that the patient was in good health and seemed to be doing fine. There was no adverse event associated with this pregnancy. Treatment and reporter 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: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to pregnant female was received from a nurse practitioner concerning a 27-year-old female. Neither past medical history nor obstetrical history was reported for this patient. On 04-Nov-2010, the patient received the nasal mist influenza vaccine at her family doctor. There was no adverse event associated with this pregnancy. Treatment and reporter 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: 1.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently administered to a one year old was received from a RN/health professional concerning an one-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. On 05-Nov-2010, the patient received 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: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Headache, Impaired work ability, Influenza like illness, Malaise
Clinical narrative: A non-serious, spontaneous report of flu-like symptoms manifested by nasal congestion, sores in the nostril, muscle aches, fever, congestion, cough and headache from a physician, concerning herself, a 42-year-old female, subsequent to FLUMIST. No medical history was provided for this patient, who reported she was not sick prior to receipt of FLUMIST. No concomitant medications was reported for this patient. On an unknown date in 2010, the patient received FLUMIST. Within 24 hours of receiving the FLUMIST, the patient experienced increased nasal congestion and developed sores in the nostrils. Ten to fourteen days after receiving the FLUMIST, the patient became extremely ill, beginning with 24 hours of extreme muscle aches, which quickly progressed to flu-like symptoms. The patient developed a fever < 100 degrees for 5-6 days with congestion, terrible cough, headache and muscle aches. The fever resolved after about 5-6 days, but the patient still has horrible cough and sore throat. At the time of report, the patient had been sick and out of work for about ten days. The patient was treated with albuterol inhaler, budesonide inhaler, cough syrup with codeine at night, cephalexin and benzonatate capsules. The outcome of the event flu-like symptoms was ongoing.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Myalgia, Nasal congestion, Nasal ulcer, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious, spontaneous report of flu-like symptoms manifested by nasal congestion, sores in the nostril, muscle aches, fever, congestion, cough and headache from a physician, concerning herself, a 42-year-old female, subsequent to FLUMIST. No medical history was provided for this patient, who reported she was not sick prior to receipt of FLUMIST. No concomitant medications was reported for this patient. On an unknown date in 2010, the patient received FLUMIST. Within 24 hours of receiving the FLUMIST, the patient experienced increased nasal congestion and developed sores in the nostrils. Ten to fourteen days after receiving the FLUMIST, the patient became extremely ill, beginning with 24 hours of extreme muscle aches, which quickly progressed to flu-like symptoms. The patient developed a fever < 100 degrees for 5-6 days with congestion, terrible cough, headache and muscle aches. The fever resolved after about 5-6 days, but the patient still has horrible cough and sore throat. At the time of report, the patient had been sick and out of work for about ten days. The patient was treated with albuterol inhaler, budesonide inhaler, cough syrup with codeine at night, cephalexin and benzonatate capsules. The outcome of the event flu-like symptoms was ongoing.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Respiratory tract congestion
Clinical narrative: A non-serious, spontaneous report of flu-like symptoms manifested by nasal congestion, sores in the nostril, muscle aches, fever, congestion, cough and headache from a physician, concerning herself, a 42-year-old female, subsequent to FLUMIST. No medical history was provided for this patient, who reported she was not sick prior to receipt of FLUMIST. No concomitant medications was reported for this patient. On an unknown date in 2010, the patient received FLUMIST. Within 24 hours of receiving the FLUMIST, the patient experienced increased nasal congestion and developed sores in the nostrils. Ten to fourteen days after receiving the FLUMIST, the patient became extremely ill, beginning with 24 hours of extreme muscle aches, which quickly progressed to flu-like symptoms. The patient developed a fever < 100 degrees for 5-6 days with congestion, terrible cough, headache and muscle aches. The fever resolved after about 5-6 days, but the patient still has horrible cough and sore throat. At the time of report, the patient had been sick and out of work for about ten days. The patient was treated with albuterol inhaler, budesonide inhaler, cough syrup with codeine at night, cephalexin and benzonatate capsules. The outcome of the event flu-like symptoms was ongoing.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash generalised, Rash pruritic, Streptococcus test negative
Clinical narrative: A non-serious, spontaneous report of pruritic generalized rash has been received from a physician concerning her nine-year old daughter subsequent to FLUMIST. Neither medical history nor concomitant medications were reported for the patient. The patient received FLUMIST on an unknown date in 2010. Approximately 7-10 days after receipt of FLUMIST, the patient developed an intensely pruritic generalized rash covering her whole upper body, arms and neck. The rash quickly began spreading and was unresponsive to diphenhydramine and oatmeal baths. She was taken to the pediatrician who tested her for strep throat, which was negative. The patient was referred to a dermatologist who stated the rash appeared post-viral. The rash was unresponsive to treatment at the time of reporting. The outcome of pruritic generalized rash was not resolved.
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Feeling abnormal, Influenza virus test negative, Oropharyngeal pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of feeling bad, fever and sore throat has been received from a physician concerning an 18-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medication was reported for this patient. On 31-Oct-2010, the patient received FLUMIST. On 05-Nov-2010, five days after vaccination, the patient started feeling bad. On 07-Nov-2010, the patient experienced fever and sore throat. The outcome of the events feeling bad, fever and sore throat was unknown.
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to a pregnant female was received from a physician concerning an adult female. Neither past medical history nor obstetrical history were reported for this patient. On 08-Nov-2010, patient received FLUMIST. As per the reporter, they inadvertently gave FLUMIST to a pregnant woman. There was no adverse event associated with this pregnancy. Treatment and reporter 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: 57.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST given to patients greater than 49-years-old was received from a physician concerning a 57-year-old female. As per the reporter, there was inadvertent administration of FLUMIST to two patients who were more than 49-years-old. On 03-Nov-2010, the patient received FLUMIST. 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.
Age: 50.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST given to patients greater than 49-years-old was received from a physician concerning a 50-year-old female. As per the reporter, there was inadvertent administration of FLUMIST to two patients who were more than 49-years-old. On 05-Nov-2010, the patient received FLUMIST. 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.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test negative, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever and flu symptoms has been received from a nurse concerning an eight-year-old male patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 27-Oct-2010, the patient received FLUMIST. On 08-Nov-2010, the patient developed a fever of 104 degrees and flu symptoms. On 09-Nov-2010, the patient was examined by his physician. A flu swab test was negative. The events, fever and flu symptoms, were ongoing.
Sex: U
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A non-serious spontaneous report of nose bleeds has been received from a non-healthcare professional concerning a patient, subsequent to FLUMIST. Neither medical history no concomitant medication was reported for this patient. On an unknown date, the patient received FLUMIST. The patient experienced nose bleeds after receiving FLUMIST. The outcome of the event of nose bleeds was unknown.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza like illness, Influenza virus test negative
Clinical narrative: A non-serious spontaneous report of positive rapid influenza diagnostic test manifested by flu-like symptoms has been received from a LPN/health professional concerning a seven-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a dose of FLUMIST on 04-Nov-2010. On 05-Nov-2010, the patient started getting flu like symptoms. On 09-Nov-2010, the patient was given a rapid influenza diagnostic test, which was positive. The symptoms were carried on through at the time of report. The outcome of the events positive rapid influenza diagnostic test was not recovered.
Age: 24.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza like illness, Nasal congestion
Clinical narrative: A non-serious spontaneous report of flu-like symptoms and nasal congestion has been received from a consumer concerning a 24-year-old female, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. On 05-Nov-2010, patient received FLUMIST. On 08-Nov-2010, patient started having flu-like symptoms and nasal congestion. The outcome of events flu-like symptoms and nasal congestion was considered unknown.
Age: 51.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertently given FLUMIST to a 51-year-old female patient was received from a registered nurse/health professional. Neither relevant medical history nor concomitant medications have been reported for this patient. On 08-Nov-2010, the patient received a dose of 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.