chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004075 is an initial spontaneous report received from a pharmacist on 25 FEB 2014. This report refers to a 09-year-old male child.  He had a pre-existing medical history of autism. His concomitant medications were not reported. On an unknown date in JAN 2014, he was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly. No adverse event was reported following this administration error (inappropriate age at vaccine administration). However upon insisting by this pharmacist the child's pediatrician has been contacted about this incident.  Following an internal review on 18 AUG 2014 of the data received on 25 FEB 2013, it ws identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003950 is an initial spontaneous report from the consumer received on 21 FEB 2014. This report refers to a 11-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) as a dose of 0.5 ml intramuscularly on 24 JAN 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Non significant follow up received on 25 MAR 2014: Updated  physician information only.  Following an internal review on 18 AUG 2014 of the data received on 25 MAR 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 16.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004074 is an initial spontaneous report received from a pharmacist on 25 FEB 2014. This report refers to a 16-year-old patient of unknown gender. The medical history and concomitant medication of the patient was not reported. On an unknown date in FEB 2014, the patient was vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly at a dose of 0.5 ml. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 26 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 10.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003952 is an initial spontaneous report from the consumer received on 21 FEB 2014. This report refers to a 08 year old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly at a dose of 0.5 ml on 24 JAN 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).  Non significant follow up report received on 25 MAR 2014: Updated physician information only.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 15.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHEH2014US004070 is an initial spontaneous report received from a pharmacist on 26 FEB 2014. This report refers to a 15-year-old patient of unknown gender. The medical history and concomitant medication of the patient was not reported. On an unknown date in FEB 2014 (two weeks ago), the patient was vaccinated with FLUCELVAX (batch number 004011A) intramuscularly at a dose of 0.5 ml. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014 of the date received on 26 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004043 is an initial spontaneous report received from a nurse on 25 FEB 2014. This report refers to a 14 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: unknown), intramuscularly on 08 JAN 2014. No adverse event was reported following this administration error. Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 25 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 11.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003955 is an initial spontaneous report received from a pharmacist on 24 FEB 2014. This report refers to an 11 years-old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. It was reported that this patient under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) on an unknown date. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult provide administered to child".
Age: 11.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHEH2014US004026 is an initial spontaneous report received from a physician on 24 FEB 2014. This report refers to an 11 year old patient of unknown gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported), at dose of 0.5 ml intramuscularly on an unknown date. No adverse event was reported following this administration error.    Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration "  was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003956 is an initial spontaneous report received from a nurse on 24 FEB 2014. This report refers to an 11-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on 21 FEB 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 7.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004025 is an initial spontaneous report received from a physician on 24 FEB 2014. This report refers to a 07 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: not reported), at dose of 0.5 ml intramuscularly on an unknown date. No adverse event was reported following this administration error.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult provide administered to child".
Age: 8.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003957 is an initial spontaneous report received from a nurse on 24 FEB 2014. This report refers to an 8-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on 21 FEB 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult provide administered to child".
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003958 is an initial spontaneous reprot received from a pharmacist on 24 FEB 2014 with a follow-up received on 01 APR 2014. This report refers to a 14-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with 0.5 ml of FLUCELVAX (batch number: 004011A/006001A, expiry date JUN 2014) intramuscularly into left deltoid on 31 DEC 2013 at 6:40 PM. No adverse event ws reported following this administration error (inappropriate age at vaccine administration).   Follow-up received from a pharmacist on 01 APR 2014. Site and time of vaccinatiion updated.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003773, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 16 year old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with one dose of FLUCELVAX 2013/2014 (batch number: unknown) at a dose of 0.5 ml intramuscularly on 01 DEC 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug use in unapproved population".
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003776, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with one dose of FLUCELVAX 2013/2014 (batch number: unknown) at 0.5 ml intramuscularly on 30 NOV 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003777 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 17-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 30 DEC 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003779 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 17-year-old male patient who was accidentally vaccinated with FLUCELVAXZ 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 23 DEC 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).    Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003781 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 16-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 06 DEC 2013. No adverse event occurred to the patient following this medication  error (inappropriate age of vaccinae administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population"
Age: 11.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014YS003782 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 11-year-old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 NOV 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003784 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 17-year-old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 03 JAN 2014. No adverse event occurred to the patient showing following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003786 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 16-year-old  male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 22 NOV 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003787 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 23 DEC 2013. No adverse event occurred to the  patient following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003789, is an initial spontaneous report from a consumer received on 24 FEB 2014 and a follow up report from the nurse received on 26 FEB 2014. This report refers to a 12-year-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010021A) intramuscularly on 27 DEC 2013. No adverse event was reported following the maladministration (inappropriate age of vaccine administration. Upon follow-up, the nurse confirmed the maladministration.  Follow up report from the nurse received on 26 FEB 2014: Nurse confirmation regarding the maladministration was updated in the narrative.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 26 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003791 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 16-year-old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number 006031A, expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly on 14 JAN 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003793 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16-year-old male patient. His medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A, expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly on 04 JAN 2014. No adverse events were reported following the maladministration.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 8.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003795 is an initial spontaneous report received from a consumer on 21 FEB 2014. This report refers to an 8-years -old female patient. Her medical history and concomitant medications were not reported. This patient under 18-years of age was vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003799 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. It was reported that his patient under 18-years of age was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: 006031A, expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 08 NOV 2013. No adverse events were reported following the maladministration.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003800 is an initial spontaneous report received from a consumer on 21 FEB 2014. This report refers to a 16-years-old female patient. Her medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly at a dose of 0.5 ml on an unknown date. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2043US025228, is an initial spontaneous report received from a nurse on 03 DEC 2013. This report refers to a 15-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 009031A and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly on 20 NOV 2013. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 03 DEC 2013. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003801, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 14-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) at a dose of 0.5 ml intramuscularly on 08 JAN 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003802, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly on 23 OCT 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003804 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 14 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014), at dose of 0.5 ml intramuscularly on 08 JAN 2014 in a flu clinic. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 4.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US026087 is an initial spontaneous report received from a health care professional on 17 DEC 2013. This report refers to an 04 year old male child. His current condition included asthma and concomitant medication was not reported. He was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: 005021A) intramuscularly on 17 DEC 2013. No adverse reaction occurred following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 17 DEC 2013. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003805, is an initial spontaneous report from a pharmacist received on 24 FEB 2013 with a follow up information received from a pharmacist on 21 MAR 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with first dose of FLUCELVAX (batch number: 004011A, expiry date: JUN 2014) at a dose of 0.5  ml intramuscularly in the left deltoid on 11 JAN 2014 approximately at 5 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow up information received from a pharmacist on 21 MAR 2014: Updated reporter information, dose number, batch number, expiry date, dose and site of administration of suspect vaccine).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 31 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US026644 is an initial spontaneous report received from a pharmacist on 30 DEC 2013. The case refers to a 12-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014) intramuscularly at dose of 0.5 ml on 30 DEC 2013. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 30 DEC 2013. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000800 is a combined initial and follow up spontaneous report received from a pharmacist on 07 JAN 2014. This report refers to a 15 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX 2013/2014 (batch number: 010031A) intramuscularly on 07 JAN 2014. No adverse event was reported following this medication error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 07 JAN 2014, it was identified that the  BPI labeling of the event "inappropriate age at vaccine administration " was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000812 an initial spontaneous report received from a pharmacist on 07 JAN 2014. This report refers to a 13 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: 010011A) intramuscularly on 03 JAN 2014. No adverse event was reported following this medication error. No additional information was available.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 07 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 8.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000823 an initial spontaneous report received from a pharmacist on 07 JAN 2014 with the follow-up received on 26 JAN 2014. This report refers to a 08 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUCELVAX 2013/2014 (batch number: 004011A) intramuscularly on 07 JAN 2014 at 19:15. No adverse event was reported following this medication error.  Follow-up received from a pharmacist on 26 JAN 2014: Dosage and time of vaccination was updated.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 26 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US026643 is an initial spontaneous report received from a pharmacist on 30 DEC 2013. This case refers to a 14-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 30 DEC 2013. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 30 DEC 2013. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000912 is an initial spontaneous report received from a pharmacist on 08 JAN 2014. This report refers to a 14-years-old male patient. His medical history and concomitant medications were not reported. He was erroneously vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly on 07 JAN 2014. No adverse event was reported following the inadvertent administration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 08 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000914 is an initial spontaneous report from the pharmacist received on 08 JAN 2014 with a follow-up received on 02 FEB 2014. This report refers to a 12-year old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: 010011A, expiry date: JUN 2014) intramuscularly in to the left deltoid on 07 JAN 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Follow-up received from the pharmacist on 02 FEB 2014: Updated site of FLUCELVAX.  Non-significant follow-up received from Vaccine Adverse Event Reporting System (VAERS ID: 518888) website on 06 MAR 2014. Updated VAERS ID only.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 02 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000917 is an initial spontaneous report from the pharmacist received on 08 JAN 2014 with a follow-up received on 22 JAN 2014. This report refers to a 16-year-old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: 010011A and expiry date: JUN 2014) intramuscularly in to the left deltoid, on 07 JAN 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Follow-up received from the pharmacist on 22 JAN 2014. Updated site of vaccination as left deltoid.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 22 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025315 is an initial spontaneous report received from a pharmacist on 04 DEC 2013 and a follow up report received from the pharmacist on 21 DEC 2013. This report refers to a 14-year-old female patient. She tolerated her previous vaccinations. She was vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly in the left deltoid on 04 DEC 2013 (at 5:00 PM). No adverse event was reported following this medication error (inappropriate age at vaccine administration).  Follow up report received from the pharmacist on 21 DEC 2013: Vaccination history added. Updated: FLUCELVAX vaccination site and time.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 31 DEC 2013. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 12.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000918 is an initial spontaneous report from the pharmacist received on 08 JAN 2014 with a follow-up received on 02 FEB 2014. This report refers to a 12-year-old female patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: 010011A, expiry date: JUN 2014) intramuscularly in to the left deltoid on 07 JAN 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Follow-up received from the pharmacist on 02 FEB 2014: Updated site of administration of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 02 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US000919 is an initial spontaneous report from the pharmacist received on 08 JAN 2014 with a follow-up received on 02 FEB 2014. This reprot refers to a 14-year-old female patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: 010011A, expiry date: JUN 2014) intramuscularly in to the left deltoid on 07 JAN 2014. No adverse event reported following this medication error (inappropriate age at vaccine administration).  Follow-up received from the pharmacist on 02 FEB 2014: updated site of administration of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 02 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 63.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case  number PHEH2014US021302 is an initial spontaneous report received from a consumer on 20 OCT 2014. This report refers to a 63 year old female patient. Her past medical history and concomitant mediations were not reported. On an unspecified date, she was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly. On 18 OCT 2014, her shoulder through elbow seemed to be radiating pain and was very stiff. She was unable to lift her arm up. The outcome of the events was not reported. The seriousness and causality of the events was not reported.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025954 is an initial spontaneous report received from a nurse on 16 DEC 2013. This report refers to a 13-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on 16 DEC 2013. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 16 DEC 2013: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US001217 is an initial spontaneous report received from a health care professional on 13 JAN 2014. This case refers to a 14-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 004031A) intramuscularly on 11 JAN 2014. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 13 JAN 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003768, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with one dose of FLUCELVAX 2013/2014 (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 JAN 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003756 is an initial spontaneous report received from a pharmacist on 20 FEB 2014. This report refers to 17 years old female patient. Past medical history and concomitant medication were not reported. She vaccinated with FLUCELVAX (batch number: 004001A) intramuscularly on 07 NOV 2013. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 20 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 11.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003754, is an initial spontaneous report received from a pharmacist on 20 FEB 2014 with a follow-up received on 16 MAR 2014 with the follow-up received on 20 MAR 2014. This report refers to a 14-year-old female patient who was inadvertently vaccinated with one dose of FLUCELVAX (batch number: 004011A) at 0.5 ml, intramuscularly in to the left deltoid on 20 JAN 2014 at 16:00 PM. This was an initial application of FLUCELVAX. No adverse event was reported following his administration error.  Follow-up received from the pharmacist on 16 MAR 2014: Updated patient gender and batch number and site of application of FLUCELVAX.  Follow-up received from the pharmacist on 20 MAR 2014: Updated vaccination time.  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 20 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration"  was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003751, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a 16-year-old female patient. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years was vaccinated with FLUCELVAX (batch number: 010031A) intramuscularly on an unknown date in DEC 2014. No adverse event was reported following this medication error. No further information was provided.  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 20 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 11.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003749 is an initial spontaneous report from a pharmacist received on 20 FEB 2014 with a follow up information received from a pharmacist on 16 MAR 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. This patient under the age of 18 years was vaccinated with an initial dose of 0.5 ml of FLUCELVAX (batch number: 004011A) intramuscularly in the left deltoid on 20 JAN 2014. No adverse event was reported following the medication error. No further information was provided.  Follow up information received from a pharmacist on 16 MAR 2014. Patient demographics (date of birth, age and gender) batch number of suspect vaccine and site of administration updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 16 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 9.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use
Clinical narrative: Case number PHEH2014US003713, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 09-year-old female patient. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years was vaccinated with FLUCELVAX (batch number: 009031A) intramuscularly on 15 JAN 2014. No adverse event was reported following the medication error. No further information was provided.  Following an internal review on 18 AUG 2014 of the data received on 21 FEB 2014, it was identified that the BPI labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.