chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003694 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 14-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 27  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: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003693, 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 vaccinated with FLUCELVAX 2013/2014 (batch number: not provided) at a dose of 0.5 ml intramuscularly on 12 NOV 2013. It was reported that she did not experience any adverse reactions since 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: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2044US003692, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 12-year-old male patient. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years was vaccinated with 0.5 ml of FLUCELVAX (batch number: unknown) intramuscularly on 02 DEC 2013. No adverse event was reported following the medication error.  Following an internal review on 18 AUG 2013 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".
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003639 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 this patient under 18-uears of age was vaccinated with a dose of FLUCELVAX 2013/2014 (batch number: 006031A) 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: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2044Us003643 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with follow-up received on 25 MAR 2014. This case refers to a 13 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 009031SA and expiry date: JUN 2014) at dose of 0.5 ml intramuscularly on 04 NOV 2013 at 7:30 PM.  No adverse event was reported following this administration error.  Follow-up received from a pharmacist on 25 MAR 2014. Time of vaccinated was updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information receive don 25 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed form 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, Product use issue
Clinical narrative: Case number PHEH2044US003645 is an initial spontaneous report from the pharmacist receive don 21 FEB 2014. This report refers to a 16-year-old male 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 11 JAN 2014. No adverse event reported following the 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: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003647 is an initial spontaneous report from the pharmacist received on 21 FEB 2014 with a follow-up received on 25 MAR 2014. This report refers to a 12-year-old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: 003031A, expiry date; JUN 2014) at a dose of 0.5 ml intramuscularly on 01 JAN 2014. No adverse event reported following this medication error (inappropriate age of vaccine administration).  Follow-up from pharmacist received on 25 MAR 2014: Batch number amended.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 25 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: 11.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2044US003650 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with a follow-up received on 25 MAR 2014. This case refers to an 11 years old female patient. She had no know drug allergies. Concomitant medication included clonidine. She was vaccinated with FLUCELVAX (batch number: 009031A and expiry date: JUN 2014), at a dose of 0.5 ml intramuscularly on 04 NOV 2013 at 7:30 PM. No adverse event was reported following this administration error.  Follow-up from pharmacist received on 25 MAR 2014. Concomitant medication and time of vaccination was updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 25 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003652 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This case refers to a 13 years old female patient. Past medical history and concomitant medication were not reported.She was vaccinated with FLUCELVAX (batch number: 010021A and expiry date: JUN 2014) at dose of 0.5 ml intramuscularly on 22 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 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 PHEH2014US003655 is an initial spontaneous report from the nurse (also patient's mother) 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) intramuscularly on an unknown date in DEC 2013. No adverse event reported 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003658 is an initial spontaneous report from the pharmacist received on 21 FEB 2014 with a follow up information received from a pharmacist on 13 MAR 2014. This report refers to a 13-year-old female patient who was accidentally vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly on 20  NOV 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration). Upon follow up receipt on 13 MAR 2014, it was reported that the reporter called the patient and was not able to get in touch with her or patient's family. Reporter also had no information about patient's physician and since the reporter could not get in contact with the patient, she was not able to obtain her physician's information. The reporter did not have any further information to provide.  Follow up information received from a pharmacist on 13 MAR 2014. Reporter did not have any information to provide.   Following an internal review on 18 AUG 2014 of the data received on 13 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.
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003638 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. It was reported that this patient under 13-years-of age was vaccinated with a dose of 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2044US003621 is an initial spontaneous report received from a physician on 21 FEB 2014. This report refers to a 13 year old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on an undetermined date in DEC 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Non significant follow up report received from physician on 21 MAR 2014. No medical information was available.  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 use in unapproved population".
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003623 is an initial spontaneous report received from a consumer (patient's parent) on 21 FEB 2014. This report refers to a 13-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number unknown) intramuscularly on an undetermined date in JAN 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 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: 10.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003624 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 10-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on 26 DEC 2013. 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 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: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003636 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011A) intramuscularly at a dose of 0.5 ml on 27  NOV 2013. 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 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: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003628 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 13-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on 28 DEC 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  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.
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003630 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a female patient under the age of 18 years, was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on an undetermined date. 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 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".
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003633 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. It was reported that the patient under 18-years of age was vaccinated with a dose of FLUCELVAV 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 form listed to unlisted and added second indication as "drug used in unapproved population".
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003635 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a female patient whose age was not reported. 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) 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 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".
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003636 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a male patient whose age was not reported. His 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) at a doser 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 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: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2044US003618, is an initial spontaneous report from a pharmacist received on 21 FEB 2014 and a follow up report received from the pharmacist on 18 MAR 2014. This report refers to a 17-year-old male patient. The patient's medical history and concomitant medications were not reported. The patient had no known drug allergies. This patient under the age of 18 years was vaccinated with 0.5 ml of FLUCELVAX (batch number: unknown) intramuscularly in the right deltoid on 20 JAN 2014. No adverse event was reported following the medication error. No further information was provided.  Follow up report received from the pharmacist on 18 MAR 2014. Information related to patient's medical history and vaccination site were updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 18  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: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003620, is an initial spontaneous report from a pharmacist received on 21 Feb 2014 and a follow up report from the pharmacist received on 18 Mar 2014. This report refers to a 14-year-old male patient. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years was vaccinated with 0.5 ml of FLUCELVAX (batch number: 010021A, expiry date: Jun 2014) intramuscularly in the right arm on 08 Dec 2013. No adverse event was reported following the medication error. No further information was provided. Follow up report from the pharmacist received on 18 mar 2014: The vaccination site was updated. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 18 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: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US001232 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 15-year-old female adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 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 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: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US001233 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 14-year-old male adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 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 13 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: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US001235 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 17-year-old female adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 Jan 2014. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, significant correction was 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US001238 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 13-year-old female adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 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 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: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US001240 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 15-year-old male adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 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 27 Jan 2014: The 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 PHEH2014US001289 is an initial spontaneous repot received from a pharamcist on 14 jan 2014 with the follow-up received on 10 Feb 2014. This report refers to a 14-year-old female adolescent who was inadvertently vaccainted with 0.5 ml dose og FLUCELVAX (batch number: 006031A) intramuscular on 07 Jan 2014 at 02:51 pm. No adverse event was reproted following this administration error. Follow-up received from a pharamcist on 10 Feb 2014: Dose and time of vaccination updated. Following an intermal review on 18 Aug 2014, a significant correction was done for the information received on 10 Feb 2014: 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 PHEH2014US001305 is an initial spontaneous report received from a pharmacist on 14 Jan 2014 with the follow-up received on 08 Feb 2014. This report refers to a 12-year-old male patient. His current condition included egg allergy. Concomitant medications were not reported. This patient under 18-years of age was vaccinated with FLUCELVAX (batch number: 009031A, expiry date: Jun 2014) into left deltoid at a dose of 0.5 ml intramuscularly on 08 Jan 2014. No adverse event was reported following the inadvertent administration. Follow-up received from a pharmacist on 08 Feb 2014: Concurrent condition and site of vaccination was updated. Following an internal review on 18 Au 2014, a significant correction as done for the information received on 08 Feb 2014: The 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: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US001600 is an initial spontaneous report from the pharmacist received on 16 Jan 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: not reported) intramuscularly on 10 Dec 2013. No adverse event reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 16 Jan 2014: The 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 PHEH2014US001601 is an initial spontaneous report from the pharmacist received on 16 Jan 2014. This report refers to a 16-year-old female patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: not reported) intramuscularly on 13 Jan 2014. No adverse event reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 16 Jan 2014: The 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 PHEH2014US001602 is an initial spontaneous report from the pharmacist received on 16 Jan 2014. This report refers to a 15-year-old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: not reported) intramuscularly on 13 Jan 2014. No adverse event reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 16 Jan 2014: The 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 PHEH2014US001603 is an initial spontaneous report from the pharmacist received on 16 Jan 2014. This report refers to a 14-year-old male patient who was accidentally vaccinated with 0.5 ml of FLUCELVAX (batch number: not reported) intramuscularly on 11 Jan 2014. No adverse event reported following this medication error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 16 Jan 2014: The 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: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: case number PHEH2014US002103 is an initial spontaneous report received from a pharmacist on 27 Jan 2014. This report refers to a 16-year-old patient of an unknown gender who was accidentally vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 23 Jan 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 27 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: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003591 is an initial spontaneous report received from a pharmacist on 20 Feb 2014. This report refers to a 13 year old adolescent male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly on 27 Nov 2013. No adverse event was reported following this medication error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was 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 use 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 PHEH2014US003593 is an initial spontaneous report received from a pharmacist on 21 Feb 2014. This report refers to a 16 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly on 11 Jan 2014. No adverse event was reported following this medication error (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 use 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 PHEH2014US003591 is an initial spontaneous report received from a pharmacist on 21 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 0.5 ml of FLUCELVAX (batch number: unknown) intramuscularly on 29 Nov 2013. 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 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 use in unapproved population".
Age: 17.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003680 is an initial spontaneous report received from a pharmacist on 20 Feb 2014. This report refers to a 17-year-old patient of unknown gender. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years might have vaccinated with 0.5 ml of FLUCELVAX (batch number: unknown) intramuscularly on unknown date in Nov 2013. 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 was 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 use in unapproved population".
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003594, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a 15-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly on 23 NOV 2013. It was reported that she did not experience any adverse reactions due to the maladministration (inappropriate age at vaccine administration).  Following an internal review on AUG 2014, a significant correction was 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: 16.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003678, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a 16-year-old patient of unknown gender. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 might have vaccinated with 0.5 ml of FLUCELVAX (batch number: unknown) intramuscularly on an unknown date in NOV 2013. No adverse event was reported following the medication error. No further information was provided.  Following an internal review on 18 AUG 2014, a significant correction was 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: 7.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003677 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 7-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 FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly at a dose of 0.5 ml on 13 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 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: 10.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003675, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a 10-year-old patient of unknown gender. The patient's medical history and concomitant medications were not reported. This patient under the age of 18 years might have vaccinated with 0.5 ml of FLUCELVAX (batch number: unknown) intramuscularly on an unknown date in NOV 2013. No adverse event was reported following the medication error. No further information was provided.  Following an internal review on 18 AUG 2014, a significant correction was 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003671 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 13-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011) intramuscularly on 15 JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  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.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003670 is an initial spontaneous report from the consumer 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 an unknown dale in  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".
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003668, is an initial spontaneous report from a pharmacist received on 20 FEB 2014. This report refers to a patient of unknown demographics. 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: unknown) intramuscularly on 20 FEB 2014. No adverse event was reported following the medication error. No further information was provided.  Following an internal review on 18 AUG 2014, a significant correction was 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: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003667 is an initial spontaneous report from the consumer 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 an unknown date in 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: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003662, is an initial spontaneous report from a pharmacist received on 21 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: unknown) intramuscularly on an unknown date in NOV 2013. No adverse event was reported following the medication error. No further information was provided.  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 use in unapproved population".
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003617, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to an 11-year-old male patient. His concurrent condition included egg allergy. Concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 004011A) intramuscularly on 22 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 "adult product administered to child".
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003616, is an initial spontaneous report from a pharmacist received on 21 FEB 2014 and follow up report received from the pharmacist on 18 MAR 2014. This report refers to a 15-year-old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010021A, expiration date: JUNE 2014) at a dose of 0.5 ml intramuscularly in the right arm on 06 DEC 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow up report received from the pharmacist on 18 MAR 2014. The vaccination site of FLUCELVAX was updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 18 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: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003614 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 and a follow up report from the pharmacist received on 18 MAR 2014. This report refers to a 16-year-old male patient. His medical history and concomitant medications were not reported. On 06 DEC 2014, he was vaccinated with FLUCELVAX (batch number: 010021A, expiry date: JUN 2014) intramuscularly in the left deltoid at a dose of 0.5 ml. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Follow up report from the pharmacist received on 18 MAR 2014: The vaccination site was updated.  Following an internal review on 18 AUG 2014 of the data received on 18 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: 9.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2044US003613 in an initial spontaneous report received from a consumer on 21 FEB 2014. This report refers to a 09-year-old child of unknown gender. The medical history and concomitant medication of the child was not reported. On an unknown date the child was vaccinated with FLUCELVAX (batch number not reported). 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 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: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2044US003612 is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 16-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A) intramuscularly on 19 NOV 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: 14.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003610 is an initial spontaneous report received from a consumer on 21 FEB 2014. This report refers to a 14-year-old patient of unknown gender. The medical history and concomitant medication of the patient was not reported. On an unknown date, the patient was vaccinated with FLUCELVAX (batch number: unknown). 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 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".