chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003857 is an initial spontaneous report received from a consumer (patient's father) on 24 FEB 2014. This report refers to a 10-year-old male child. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: unknown), intramuscularly on an unknown date in OCT 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 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 product administered to child".
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 PHEH2044US003858, is a spontaneous initial report from a pharmacist received on 21 FEB 2014 with a follow up received on 21 MAR 2014. This report refers to a 15-year-old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) which was well tolerated. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 004011A) at a dose of 0.5 ml intramuscularly into the left arm on 02 JAN 2014 at 14:40 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).    Follow up received from pharmacist on 21 MAR 2014. Updated vaccination history, vaccination time and site of vaccination of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 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: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003859, is an initial spontaneous report from a consumer received on 21 FEB 2014. This report refers to a 9-year0-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: unknown) intramuscularly on an unknown date in 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 "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 PHEH2044US003861, is a spontaneous initial report received from a pharmacist on 21 FEB 2014, with a follow up received on 21 MAR 2014. This report refers to a 15 year old female patient. Past medical history and concomitant medication were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) which was well tolerated. She was vaccinated with FLUCELVAX (batch number: 010031A) and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly into the left arm on 06 JAN 2014 at 17:00 PM. No adverse event was reported following this administration error (inappropriate age at vaccine administration).    Follow up received from pharmacist on 21 MAR 2014: Updated vaccination history, vaccination time and site of vaccination of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 MAR 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: 7.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003867 is an initial spontaneous report received from a consumer (patient's mother) on 21 FEB 2014. This report refers to a 07 year old female patient  Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: not reported), intramuscularly on an unknown date in 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 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003869 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 13 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 006031A), intramuscularly on 23 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: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003870 is an initial spontaneous report received from a pharmacist on 24 FEB 2014. This report refers to a 15-years old male patient. His medical history and concomitant medications were not reported. It was reported that his patients under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX 2013/2014 (batch number 010021A) on 19 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 24 FEB 2014: The BPI labeling of the event "inappropriate age of vaccine administration" changed from listed to unlisted and added second indication as "drug use 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 PHEH2014US003871 is an initial spontaneous report received from a consumer on 21 Feb 2014 with a follow-up received from the physician on 18 Mar 2014. Physician confirmed patient demographics therefore the case was processed as a valid case. This report refers to an 8-year-old female child who was inadvertently vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) at 0.5 ml on 06 Jan 2014. No adverse event was reported following the maladministration. Follow-up received from the physician on 18 Mar 2014: After receiving confirmation on patient identifiers, this case was databased as a valid case with four minimum criteria met. Therefore, the report type was changed from 'other' to 'spontaneous'. Patient demographics and dose and date of administration of FLUCELVAX 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 "Adult product administered to child".
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003874 is an initial spontaneous report received from a consumer (who was a nurse) on 24 Fen 2014. This report refers to a 13-years old male patient. His medical history and concomitant medications were not reported. It was reported that this patients under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) on an unknown date in 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 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: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003873 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: 004011A) intramuscularly on 14 Oct 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".
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003875 is an initial spontaneous report received from a nurse on 21 Feb 2014: This report refers to a male patient under 18-years of age who was inadvertently vaccinated with FLUCELVAX (batch number: 009021A and expiry date: Jun 2014) intramuscularly at a dose of 0.5 ml on an undetermined date. The vaccine was reported to be from the 2013/2014 season. 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: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003879 is an initial spontaneous report received form a nurse on 21 Feb 2014: This report refers to a male patient under 18-years of age who was inadvertently vaccinated with FLUCELVAX (batch number: 009021A and expiry date: Jun 2014) intramuscularly at a dose of 0.5 ml on an undetermined date. The vaccine was reported to be from he 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, 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, Product use issue
Clinical narrative: Case number PHEH2014US003882 is an initial spontnaeous report from the pharmacist received on 21 Feb 2014. This rpeot refers to a 13-year-old male patient who was accidentally vaccinated with FLUCELVAX (batch number: 009021A, expiry date: Jun 2014) at a dose of 0.5 ml intrmauscularly on an unknown date. No adverse event occurred to the patient following this medication error (inappropaite 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 use in unapproved population.
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003964 is an initial spontaneous report received from a pharmacist on 01 Apr 2014. This report refers to a 14 year old female patient. It was reported that her previous vaccinations (unspecified) were well tolerated. On 08 Jan 2014, she was accidentally vaccinated with FLUCELVAX (batch number: 004011A) at a dose of 0.5 ml intramuscularly into left deltoid. No adverse event occurred tot he patient following this medication error (inappropriate age of vaccine administration). Follow up report received from the pharmacist on 01 Apr 2014: Updated vaccination history (previous vaccines well tolerated), vaccine batch number and vaccination site (into left deltoid). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 01 Apr 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: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003925 is an initial spontaneous report received from a pharmacist on 24 FEB 2014. This report refers to a 13-years old female patient. Her medical history and concomitant medications were not reported. It was reported that this patients under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) on an unknown date in 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 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".
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003877 is an  initial spontaneous report received from a nurse on 21 FEB 2014. This report refers to a female patient under 18-years of age who was inadvertently vaccinated with FLUCELVAX (batch number 009021A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on an undetermined date. The vaccine was reported to be from the 2013/2014 season. No adverse event was reported following the 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 use in unapproved population".
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004301 is an initial spontaneous report from a pharmacist received on 27 FEB 2014. This report refers to a patient of unknown demographics. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient less than 18 years old received FLUCELVAX 2013/2014 (batch number: unknown) intramuscularly on an unknown date. No adverse event was reported following the medication error (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014 of the data received on 27 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: 8.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004359 is an initial spontaneous report received from a consumer on 28 FEB 2014. This case refers to a 08 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly in middle of 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 28 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: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004484 is an initial spontaneous report from the consumer received on 28 FEB 2014. This report refers to a 12-year-old male patient who was accidentally vaccinated with FLUCELVAX (batch number: not reported) at a dose of 0.5 ml intramuscularly on 15 AUG 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 28 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indications as "adult product administered to child".
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004488 is an initial spontaneous report from the consumer received on 28 FEB 2014. This report refers to a 13-year-old male patient who was accidentally vaccinated with FLUCELVAX (batch number: not reported) at a dose of 0.5 ml intramuscularly on 15 AUG 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, of the data received on 03 MAR 2014: It was identified th 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 added second indication off label use was added to case.
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US0004534 is an initial spontaneous report from the consumer received on 21 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: 006031A, expiry date: JUN 2014) 28 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 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indications as "adult product administered to child".
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004544 is an initial spontaneous report from a physician on  04 MAR 2014. This report refers to a patient under 18 years old who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) on an unknown date. 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 04 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indications 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 PHEH2014US004722 is an initial spontaneous report from a pharmacist  received on 05 MAR 2014. This report refers to a 12-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX 2013/2014 (batch number not reported) intramuscularly on 20 FEB 2014. No adverse event ws reported following the maladministration (inappropriate age at vaccine administration). Following an internal review on 18 AUG 2014 of the data received on 05 MAR 2014. It was identified that  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 PHEH2014US005016 is an initial spontaneous report from a healthcare professional on 07 MAR 2014. This report refers to a 11 year  old male child. His past medical history and concomitant medications were not reported. It was reported that the patient under age 18 years of age was vaccinated with FLUCELVAX (batch number: not reported) intramuscular at a dose of 0;5 ml in DEC 2013. No adverse events were 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 07 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".
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US005017 is an initial spontaneous report received from a healthcare professional on 07 MAR 2014. This report refers to an adolescent female patient whose age was not reported. Her past medical history and concomitant medications were not reported. It was reported that his patient under 18 years of age was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly at a dose of 0.5 ml in DEC 2013. No adverse events were 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 07 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: 10.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US005514 is an initial spontaneous report from a consumer received on 18 MAR 2014. This report refers to a 10-years-old female patient. Her medical history included allergy to food colors. Her concomitant medications were not reported. This patient under 18-years-of age was vaccinated with FLUCELVAX (batch number: not reported) on 06 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 18 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: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Fatigue, Headache, Product use issue
Clinical narrative: Case number PHEH2014US005986 is an initial spontaneous report from the consumer received on 24 MAR 2014. This report refers to a 13-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. On an unknown date in JAN 2014, after vaccination the patient felt more tired and experienced frequent headaches. It was reported that the reporter was unsure whether vaccine was the cause of the event or if it was because the patient was being a teenager. The final outcome of the events was unknown.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 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".
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Fatigue, Headache, Product use issue
Clinical narrative: Case number PHEH014US005988, is an initial spontaneous report from a consumer on 24 MAR 2014. This report refers to a 13-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml of FLUCELVAX 2013/2014 (batch number: unknown) on an unknown date in JAN 2014. He was or tired and was experiencing frequent headaches since the vaccine was administration. Outcome of the events was unknown. No additional information was reported.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 MAR 2014. Added event "inappropriate age of vaccine administration" and 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, Product use issue
Clinical narrative: Case number PHEH2014US003974 is an initial spontaneous report received from a pharmacist on 24 FEB 2014. This report refers to a 15-years old male patient. His medical history and concomitant medications were not reported. It was reported that this patients under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) on an unknown date in 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 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: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003969, is an initial spontaneous report from a pharmacist received on 24 FEB 2014 with follow-up received on 01 APR 2014. This report refers to a 17-year-old male patient. Past medical history included congenital heart defect. He was inadvertently vaccinated with one dose of FLUCELVAX 2013/2014 (batch number: 004011A/006001A and expiry date: JUN 2014) at 0.5 ml intramuscularly on 14 JAN 2014. This was the initial application of FLUCELVAX. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).    Follow-up received from the pharmacist on 01 APR 2014: Updated medical history and information on initial application of FLUCELVAX.  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".
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003968, is an initial spontaneous report from a pharmacist received on 24 FEB 2014 and a follow up report from the pharmacist received on 01 APR 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: 004011A and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly in the left deltoid on 08 JAN 2014 at 8:30 PM.  No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow up report from the pharmacist received on 01 APR 2014. FLUCELVAX vaccination site, time and patient initials were 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".
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US007650 is an initial spontaneous report received from a pharmacist on 15 APR 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medications were not reported. On 19 NOV 2013, he was vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly. 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 15 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: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US007348, is an initial spontaneous report received from a consumer on 10 APR 2014, with a follow-up received from consumer on 29 APR 2014. This report refers to a 14-year-old female patient. Her medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was inadvertently administered a dose of FLUCELVAX (batch number: not reported) on an unknown date. She neither did not see any pediatrician nor follow up for the treatment of the FLUCELVAX she received. She did not exhibit any side effects or symptoms following the maladministration (inappropriate age at vaccine administration).   Follow up received from consumer on 29 APR 2014. Updated reporter comment (she neither did not see any pediatrician nor follow up for the treatment of the flu shot she received. She did not exhibit any side effects or symptoms following the maladministration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 29 APR 2014. Th 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 PHEH2014US006155, is an initial spontaneous report from a nurse received on 27 MAR 2014. This report refers to a 15-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) intramuscularly on an undetermined date. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction ws done for the information received on 27 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: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2044US004296 is an initial spontaneous report from the consumer received on 28 FEB 2014. This report refers to a 12-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number not reported) intramuscularly on 20 FEB 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 of the data received on 28 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: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003961 is an initial spontaneous report received from a pharmacist on 24 FEB 2014 with a follow-up received on 01 APR 2014. This report refers to a 16-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, expiry date: JUN 2014) intramuscularly into left deltoid on 08 JAN 2014 at 5 PM. No adverse event was reported following this administration error (inappropriate age at vaccine administration).    Follow-up received from a pharmacist on 01 APR 2014: Site and time of vaccination 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: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004274 is an initial spontaneous report received from a pharmacist on 27 FEB 2014. This report refers to a 12-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 01003A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 02 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 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 administration 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 PHEH2014US003962 is an initial spontaneous report from the pharmacist received on 24 FEB 2014 with a follow-up received on 01 APR 2014. This report refers to a 16-year-old male patient. His medical history included unspecified immunodeficiency and IgG disorder. His vaccination  history included administration of seasonal influenza vaccines, (manufacturer and batch number unknown) on undetermined dates, which were well tolerated. He was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: 006011A , expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly in to the right deltoid on 29 DEC 2013 at 9:00 PM. This was the first application of FLUCELVAX. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Follow up received from the pharmacist on 01 APR 2014. Updated medical history, vaccination history, batch number of FLUCELVAX and site of application.  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 PHEH2014US004272 is an initial spontaneous report received from a consumer on 27 FEB 2014. This report refers to a 16-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml on an undetermined date in DEC 2013, two weeks before Christmas. 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 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, Product use issue
Clinical narrative: Case number PHEH2014US003963 is an initial spontaneous report from the pharmacist received on 24 FEB 2014 with a follow-up received on 01 APR 2014. This report refers to a 14-year-old male patient. His vaccination history included administration seasonal influenza vaccine (manufacturer and batch number: unknown) on undetermined dates, which were well tolerated. He was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: 006011A, expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly in to the left deltoid on 06 JAN 2014 at 8:00 PM. This was the first application of FLUCELVAX. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Follow-up received from the pharmacist on 01 APR 2014: Updated vaccination history and batch number time, site of application of FLUCELVAX.  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: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2044US004271 is an initial spontaneous report received from a consumer on 27 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 an undetermined date in DEC 2013, two weeks before holiday. 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 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: 9.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US004270 is an initial spontaneous report received from a pharmacist on 27 FEB 2014. This report refers to a 9-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 01003A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 02 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 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 PHEH2014US004180 is an initial spontaneous report received from a nurse on 27 FEB 2014. This report refers to an 11-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on 21 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 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 PHEH2014US004177 is an initial spontaneous report received from a nurse on 26 FEB 2014 with a follow up report received from the nurse on 24 MAR 2014. This report refers to a 16 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 006031A) intramuscularly on 15 JAN 2014. No adverse event was reported following this administration error. No seriousness criteria were ticked.     Non significant follow up report received from the nurse on 24 MAR 2014: Updated patient demographics (height and weight).  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: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003965 is an initial spontaneous report received from a pharmacist on 24 FEB 2014 with a follow up report received from the pharmacist on 01 APR 2014. This report refers to a 16 year old male patient. It was reported that his previous vaccinations (unspecified) were well tolerated. On 31 DEC 2013 at 06:40 AM, he was accidentally vaccinated , for the first time, with FLUCELVAX 2013/2014 (batch number: 006001, expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly into left deltoid. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).  Follow up report received from the pharmacist on 01 APR 2014: Updated vaccination history (previous vaccine well tolerated), vaccine batch number and vaccination site (into left deltoid).  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: 10.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US004156 is an initial spontaneous report received from a consumer on 27 FEB 2014. This case refers to a 10 year old male patient whose medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was intramuscularly vaccinated with FLUCELVAX (batch number: not reported) on an unknown date in early 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 27 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, Product use issue
Clinical narrative: Case number PHEH2014US003967, is an initial spontaneous report from a pharmacist received on 24 FEB 2014 and a follow up received from a pharmacist on 01 APR 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not reported. Her vaccination history included administration of seasonal influenza vaccine (manufacturer unknown and batch number: not reported) which she tolerated well. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 004011A, and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly into the right deltoid on 07 JAN 2014 at 16:45 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow up received from pharmacist on 01 APR 2014: Updarted vaccination history, time and site of vaccination.  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: 18.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003878 is an initial spontaneous report received from a nurse on 21 FEB 2014. This report refers to a male patient under 18-years of age who was inadvertently vaccinated with FLUCELVAX (batch number: 009021A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on an undetermined date. The vaccine was reported to be from the 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration).Case number PHEH2014US003967, is an initial spontaneous report from a pharmacist received on 24 FEB 2014 and a follow up received from a pharmacist on 01 APR 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not reported. Her vaccination history included administration of seasonal influenza vaccine (manufacturer unknown and batch number: not reported) which she tolerated well. She was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 004011A, and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly into the right deltoid on 07 JAN 2014 at 16:45 PM. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Follow up received from pharmacist on 01 APR 2014: Updated vaccination history, time and site of vaccination.  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 PHEH2014US004151 is a combined initial and follow up spontaneous report from the pharmacist received on 27 FEB 2014 and on 28 FEB 2014. This report refers to a male child who was accidently vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on 10 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 27 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.