chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Asthma, Blood test, Breath sounds abnormal, Chest X-ray normal, Crying
Clinical narrative: In the nights immediately following the MMR vaccine patient woke inconsolable, not settling for hours. He also had a 102.1 fever, which I mentioned to Dr. when she did a follow-up call one or two days after his vaccine (do not know the exact date). Dr. said that it could in no way be related to the vaccine. Patient continued to wake up inconsolable for the next few nights at which point we brought him back to the pediatrician and saw Dr. who diagnosed him with an ear infection and prescribed amoxicillin. We gave him the antibiotic as dosed until Friday morning (1/16/15) when his lips turned blue. I immediately took him to the pediatrician and he was staring off and not responding when I called his name and his lips were in and out of a blue the whole way to the office.  When we arrived at the pediatricians office his lips went back and forth in color (his oxygen saturation was normal around 95-98 -cannot remember exactly, when checked), was given a breathing treatment and responded to it but then his lips turned blue again at which point the pediatrician we saw (do not remember her name) advised we go the Hospital. On the way to hospital his lips were in and out of color and he was staring off. Upon arrival, his oxygen saturation was once again checked and it was 83%. He was put on oxygen and given Prednisone and Albuterol. An x-ray was taken and the Dr. said his lungs looked good but sounded "like someone who had a bad chest cold". The Respiratory Specialist put something down his nose to get the mucus out (didn't get much of anything out). Blood was drawn. Patient seemed fine after all treatments and interventions aside from being tired and scared. He slept normally until 4 am when he woke crying again. Went back to sleep for a bit and then woke for the day. Took his morning nap as usual (still in the hospital). Meds were administered throughout this time. At around 11:30 AM he cried inconsolably for an hour (at around 45 min) the nurse on duty gave him Tylenol...he continued to cry and have violent fits and arch his back and when he calmed he'd stare off. We were discharged at 3 PM with no solid answer as to what caused the blue lips other than he has asthma. We left the hospital and over the 3 nights and days after being discharged (1/17-1/1) he cried and stared off and on ALL day and woke inconsolable. We took him in on 1/19 and Dr said his ear infections had not improved at which point he was given an injectable antibiotic. We refused further doses of antibiotics.
Age: 1.25
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Cyanosis, Ear infection, Fatigue, Fear, Middle insomnia
Clinical narrative: In the nights immediately following the MMR vaccine patient woke inconsolable, not settling for hours. He also had a 102.1 fever, which I mentioned to Dr. when she did a follow-up call one or two days after his vaccine (do not know the exact date). Dr. said that it could in no way be related to the vaccine. Patient continued to wake up inconsolable for the next few nights at which point we brought him back to the pediatrician and saw Dr. who diagnosed him with an ear infection and prescribed amoxicillin. We gave him the antibiotic as dosed until Friday morning (1/16/15) when his lips turned blue. I immediately took him to the pediatrician and he was staring off and not responding when I called his name and his lips were in and out of a blue the whole way to the office.  When we arrived at the pediatricians office his lips went back and forth in color (his oxygen saturation was normal around 95-98 -cannot remember exactly, when checked), was given a breathing treatment and responded to it but then his lips turned blue again at which point the pediatrician we saw (do not remember her name) advised we go the Hospital. On the way to hospital his lips were in and out of color and he was staring off. Upon arrival, his oxygen saturation was once again checked and it was 83%. He was put on oxygen and given Prednisone and Albuterol. An x-ray was taken and the Dr. said his lungs looked good but sounded "like someone who had a bad chest cold". The Respiratory Specialist put something down his nose to get the mucus out (didn't get much of anything out). Blood was drawn. Patient seemed fine after all treatments and interventions aside from being tired and scared. He slept normally until 4 am when he woke crying again. Went back to sleep for a bit and then woke for the day. Took his morning nap as usual (still in the hospital). Meds were administered throughout this time. At around 11:30 AM he cried inconsolably for an hour (at around 45 min) the nurse on duty gave him Tylenol...he continued to cry and have violent fits and arch his back and when he calmed he'd stare off. We were discharged at 3 PM with no solid answer as to what caused the blue lips other than he has asthma. We left the hospital and over the 3 nights and days after being discharged (1/17-1/1) he cried and stared off and on ALL day and woke inconsolable. We took him in on 1/19 and Dr said his ear infections had not improved at which point he was given an injectable antibiotic. We refused further doses of antibiotics.
Age: 1.25
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Opisthotonus, Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: In the nights immediately following the MMR vaccine patient woke inconsolable, not settling for hours. He also had a 102.1 fever, which I mentioned to Dr. when she did a follow-up call one or two days after his vaccine (do not know the exact date). Dr. said that it could in no way be related to the vaccine. Patient continued to wake up inconsolable for the next few nights at which point we brought him back to the pediatrician and saw Dr. who diagnosed him with an ear infection and prescribed amoxicillin. We gave him the antibiotic as dosed until Friday morning (1/16/15) when his lips turned blue. I immediately took him to the pediatrician and he was staring off and not responding when I called his name and his lips were in and out of a blue the whole way to the office.  When we arrived at the pediatricians office his lips went back and forth in color (his oxygen saturation was normal around 95-98 -cannot remember exactly, when checked), was given a breathing treatment and responded to it but then his lips turned blue again at which point the pediatrician we saw (do not remember her name) advised we go the Hospital. On the way to hospital his lips were in and out of color and he was staring off. Upon arrival, his oxygen saturation was once again checked and it was 83%. He was put on oxygen and given Prednisone and Albuterol. An x-ray was taken and the Dr. said his lungs looked good but sounded "like someone who had a bad chest cold". The Respiratory Specialist put something down his nose to get the mucus out (didn't get much of anything out). Blood was drawn. Patient seemed fine after all treatments and interventions aside from being tired and scared. He slept normally until 4 am when he woke crying again. Went back to sleep for a bit and then woke for the day. Took his morning nap as usual (still in the hospital). Meds were administered throughout this time. At around 11:30 AM he cried inconsolably for an hour (at around 45 min) the nurse on duty gave him Tylenol...he continued to cry and have violent fits and arch his back and when he calmed he'd stare off. We were discharged at 3 PM with no solid answer as to what caused the blue lips other than he has asthma. We left the hospital and over the 3 nights and days after being discharged (1/17-1/1) he cried and stared off and on ALL day and woke inconsolable. We took him in on 1/19 and Dr said his ear infections had not improved at which point he was given an injectable antibiotic. We refused further doses of antibiotics.
Age: 18.0
Sex: F
Vaccine: TYP, YF
Symptoms: Choking, Cold sweat, Convulsion, Dizziness, Dyspnoea
Clinical narrative: Patient recieved both immunizations at 1020. At 1022, the patient started feeling light-headed. After a minutes, her light headedness increased and she was placed in the shock position. Immediately after being placed in the shock position, the patient started convulsing and choking. The patient was moved to the treatment room, where she experienced shortness of breath, dizziness, clammy skin, increased heart rate and difficulty breathing.
Age: 18.0
Sex: F
Vaccine: TYP, YF
Symptoms: Heart rate increased
Clinical narrative: Patient recieved both immunizations at 1020. At 1022, the patient started feeling light-headed. After a minutes, her light headedness increased and she was placed in the shock position. Immediately after being placed in the shock position, the patient started convulsing and choking. The patient was moved to the treatment room, where she experienced shortness of breath, dizziness, clammy skin, increased heart rate and difficulty breathing.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Dizziness, Dry mouth, Eye pruritus
Clinical narrative: Pt walked in to clinic with c/o eyes itching and not feeling right.  Eyes red, swelling of eyelids, facial rash and hives.  Dizziness, weakness, dry mouth, throat feeling tight, phlegm in throat and heavy chest.  Dr. worried about impending anaphylactic reaction.  Pt received the following injections : Benadryl, Solu-Cortef, and epipen and was monitored until determined stable.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Feeling abnormal, Ocular hyperaemia, Productive cough, Rash
Clinical narrative: Pt walked in to clinic with c/o eyes itching and not feeling right.  Eyes red, swelling of eyelids, facial rash and hives.  Dizziness, weakness, dry mouth, throat feeling tight, phlegm in throat and heavy chest.  Dr. worried about impending anaphylactic reaction.  Pt received the following injections : Benadryl, Solu-Cortef, and epipen and was monitored until determined stable.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness, Urticaria
Clinical narrative: Pt walked in to clinic with c/o eyes itching and not feeling right.  Eyes red, swelling of eyelids, facial rash and hives.  Dizziness, weakness, dry mouth, throat feeling tight, phlegm in throat and heavy chest.  Dr. worried about impending anaphylactic reaction.  Pt received the following injections : Benadryl, Solu-Cortef, and epipen and was monitored until determined stable.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Crying, Diet refusal, Screaming
Clinical narrative: Constant screaming and crying. Refuses to eat. Gave infant Tylenol.
Age: 1.2
Sex: F
Vaccine: MMR
Symptoms: Dry skin, Measles post vaccine, Pyrexia, Rash, Skin exfoliation
Clinical narrative: Broke out in a severe measles rash, got worse by 12/16/2014. Also got a low fever for one day on 12/16/2014, 101-102 degrees.  Rash subsided within a week, and dry, scaly skin present till 1/20/2015.
Age: 81.0
Sex: F
Vaccine: PNC
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Patient presented to pharmacy with a red rash at site of injection. She stated it hurt and itched.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Vomiting
Clinical narrative: The patient developed a fever with convulsions consistent with a febrile seizure. The patient had 1-2 shorter subsequent events and then vomited. We are currently monitoring him.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, RVX
Symptoms: Diarrhoea, Lethargy, Vomiting
Clinical narrative: Patient threw up about 4 times and had diarrhea and appeared lethargic.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX QUADRIVALENT (batch number FS575, expiry date 30th June 2014). On 23rd October 2014, the patient received FLURARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 18 patients were involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 10/23/14.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX QUADRIVALENT (batch number FS575, expiry date 30th June 2014). On 23rd October 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 18 pts were involved and investigation still ongoing. Called did not have pt info. Maladministration caught on 10/23/14.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Silver dollar sized erythematous/indurated area left lower and central  surface at site of injection.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity
Clinical narrative: 11 yr old female complains of right arm pain.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Full blood count normal, Postictal state, Seizure
Clinical narrative: Seizure lasting approx. 1 minutes with 5 min post ictal period within 48 hrs of vaccine administration. No fever, negative bloodwork.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Pt c/o fever after receiving injection. LD is indurated to touch and warm with redness painful all upper arm. Pt was send via ambulance to hospital.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker who refers to a group of seven patients of unkonwn age and gender. Patients' medical histories were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (doses, frequencies, indications and lot numbers were not provided, default route of administration: orally). Concomitant medication was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender who on 01-DEC-2014 was vaccinated with third dose of ROTATEQ, 2 ml, oral (lot # and expiration date were not reported) and on 15-JAN-2015, the patient received fourth dose of ROTATEQ, 2 ml, oral (lot # and expiration were not reported). The physician did not know the date when the therapy started. No adverse effect was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, Pyrexia
Clinical narrative: This spontaneous report as received from podiatrist who was also a patient's mother and refers to her 4 month old son with no drug reactions or allergies and no pertinent medical history who on 12-JAN-2015 was vaccinated with an expired dose of ROTATEQ, 2 ml, oral (lot # not reported, expiration date September 2014). There was no concomitant medication. On 12-JAN-2015, after receiving the vaccine the patient developed a fever, then on the same date the patient recovered from fever. No treatment was given for the adverse event. No laboratories diagnostic tests were performed and the patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a male patient who received FLUARIX QUADRIVALENT (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: There were 2 patients that were inadvertently administered the 0.5mL dose of FLUARIX QIV who were less than 3 YO. The nurse only had patient specific and lot specific information for only 1 of the two patients at the moment.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of 2 ml, ROTATEQ, (lot # was reported as K005396, expiration date 28-FEB-2016), (lot # J008740, expiration date 22-MAR-2015), (lot # K001935, expiration date 08-DEC-2016), (lot # was reported as K008139, expiration date 15-APR-2016), oral which were exposed to 32.5F for 2 hours. This event was considered as incorrect product storage. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX (batch number FS575, expiry date 30th June 2014). On 23rd October 2014, the patient received FLUARIX .5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 18 pts were involved and investigation still ongoing. Caller did not have pt info. Maladministration caught on 10/23/14.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Fatigue, Influenza like illness, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 61-year-old female patient who received BOOSTRIX. Concurrent medical conditions included type II Diabetes mellitus and Asthma. Concomitant products included ramipril, medication unkonwn, PROZAC and statin (NOS). On 5th January 2015 12:00, the patient received BOOSTRIX (injection) .5 ml. On 6th January 2015, 1 days after receiving BOOSTRIX, the patient experienced feeling unwell, general body pain, dry cough, Influenza-like symptoms, fever, fatigue and productive cough. On an unknown date, the outcome of the feeling unwell, general body pain, dry cough, Influenza-like symptoms, fever, fatigue and productive cough were recovering/resolving. The reporter considered the feeling unwell, general body pain, dry cough, Influenza-like symptoms, fever, fatigue and productive cough to be almost certainly related to BOOSTRIX. This was 1 of the 2 cases received from the same reporter and same family. Additional details provided: The caller reports reported that the patient felt like she had a low grade fever.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Productive cough, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 61-year-old female patient who received BOOSTRIX. Concurrent medical conditions included type II Diabetes mellitus and Asthma. Concomitant products included ramipril, medication unkonwn, PROZAC and statin (NOS). On 5th January 2015 12:00, the patient received BOOSTRIX (injection) .5 ml. On 6th January 2015, 1 days after receiving BOOSTRIX, the patient experienced feeling unwell, general body pain, dry cough, Influenza-like symptoms, fever, fatigue and productive cough. On an unknown date, the outcome of the feeling unwell, general body pain, dry cough, Influenza-like symptoms, fever, fatigue and productive cough were recovering/resolving. The reporter considered the feeling unwell, general body pain, dry cough, Influenza-like symptoms, fever, fatigue and productive cough to be almost certainly related to BOOSTRIX. This was 1 of the 2 cases received from the same reporter and same family. Additional details provided: The caller reports reported that the patient felt like she had a low grade fever.
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in an infant patient who received FLUARIX Quadrivalent 2014-2015).  On an unknown date, the patient received FLUARIX Quadrivalent 2014/2015 season .5ml. On an unknown date, an unknown time after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration.  On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the wrong vaccine administered and inappropriate age at vaccine administration to be related to FLUARIX Quadrivalent 2014-2015 season.   Additional information received: There were 2 patients that were inadvertently administered the 0.5 ml dose of FLUARIX QIV who were less than 3 yo. The nurse only had patient specific and lot specific information for ony 1 of the two patients at the moment.
Age: 10.0
Sex: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003837 is an initial spontaneous report received from a nurse on 21 Feb 2014: This report refers to a 10-year-old patient of unknown gender who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) 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 Adult product administered to child.
Age: 9.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003815 is an initial spontaneous report received from a pharmacist on 21 Feb 2014: This report refers to a 9-year-old female patient who was inadvertently vaccinated with FLUCELAX (batch number: 004011A and expiry date: Jun 2014) intramuscularly at a dose of 0.5 ml on 06 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 administered" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003816 is an initial spontaneous report received from a pharmacist on 21 Feb 2014: This report refers to a 14-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006031A and expiry date: Jun 2014) intramuscularly at a dose of 0.5 ml on 09 Nov 2013. No adverse event was reporting 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 used in unapproved population".
Age: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003817, is an initial spontaneous report from a pharmacist received on 24 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: 010021A) intramuscularly on 23 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 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 an unapproved population".
Age: 12.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003819 is an initial spontaneous report received from a pharmacist on 21 Feb 2014 with a follow-up received on 07 Apr 2014: This report refers to a 12-year-old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006031A and expiry date: Jun 2014) intramuscularly at a dose of 0.5 ml on 27 Dec 2013 at 2.51 pm. This was the initial application of FLUCELVAX. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Follow-up received from the pharmacist on 07 Apr 2014: Updated time of vaccination and batch number of FLUCELVAX. Following an interval review on 18 Aug 2014, a significant correction was done for the information received on 07 April 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: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003821, is an initial spontaneous report from a pharmacist received on 24 FEB 2014. This report refers to an 11-year-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: unknown) at a dose of 0.5 ml intramuscularly on 11 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 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: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PH#H2014US003823 is an initial spontaneous report received from a pharmacist on 21 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 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: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2044US003824 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 15-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011A, expiry date: 30 JUN 2014) at a dose of 0.5 ml intramuscularly in the left arm on 13 DEC 2013. 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: FLUCELVAX vaccination date, batch number, expiry date, dose 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".
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003826 is an initial spontaneous report from a pharmacist received on 21 FEB 2014 with a follow up report received from a health care professional on 19 MAR 2014. This report refers to a 12 year old male patient. His past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number 0041211A) at a dose of 0.5 ml intramuscularly into his right deltoid on 04 JAN 2014 at 16:15 hours. It was reported that he did not experience any adverse reactions since the maladministration (inappropriate age at vaccine administration).   Follow up report received from a health care professional on 19 MAR 2014: Reporter information , date of vaccination, dose and anatomical location of the vaccination were updated.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 19 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: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003829, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 15-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A, expiry date: June 2014) at a dose of 0.5 ml intramuscularly on 05 JAN 2014. It was reported that he 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: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003831 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 17 year old male patient. Past medical history and concomitant medication were not reported. He vaccinated with FLUCELVAX (batch number: 005021A and expiry date: JUN 2014), at dose of 0.5 intramuscularly on 20 NOV 2013. No adverse event was reported following this administration error.   Following an internal review on 18 AUG 2014, a signficant 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 inidcation as Drug use 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 PHEH2014US003832 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 18 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: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003834 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16 year old male patient. Past medical history and concomitant medication were not reported. He vaccinated with FLUCELVAX (batch number: 010021A and expiry date: JUN 2014), at dose of 0.5 ml intramuscularly on 01 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 "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 PHEH2014US003835 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 16-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown)) at a dose of 0.5 ml 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 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: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003836 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: unknown) intramuscularly at a dose of 0.5 ml 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: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003807 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 14 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014), at a dose of 0.5 ml intramuscularly on 16 JAN 2014 in the flu clinic. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indications 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 PHEH2014US003808 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with a follow up report received from the pharmacist on 24 MAR 2014. This report refers to an 11 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 010021A and expiry date: JUN 2014), at dose of 0.5 ml intramuscularly into his right deltoid on 23 NOV 2013 at 15:14. No adverse event was reported following this administration error. NO additional information was available.     Follow report received from the pharmacist on 24 MAR 2014: The anatomical site, date and time of vaccination were updated.  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 "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 PHEH2014US003809 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 004011A and expiry date: JUN 2014), at dose of 0.5 ml intramuscularly on an unknown date in DEC 2013. No adverse event was reported following this administration error. No additional 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 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 PHEH2014US003812 is an initial spontaneous report received from a consumer (parents) on 21 FEB 2014. This report refers to a 14 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: unknown), 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 "drug used 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 PHEH2014US003813 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to an 11-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 004011A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 06 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 Adult product administered to child.
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003839 is an initial spontaneous report received from a consumer (patient's parent) on 24 FEB 2014: This report refers to a 16-year-old male 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).  Following an internal review on 18 AUG 2014 of the data received on 24 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: U
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003840 is an initial spontaneous report received from a nurse on 21 FEB 2014. This report refers to a 15-year-old patient of unknown gender who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) 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 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 PHEH2014US003841 is an initial spontaneous report received from a nurse on 21 FEB 2014. This report refers to a 17-year-old patient of unknown gender who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) on an undetermined date. The vaccination 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".
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003846 is an initial spontaneous report received from a consumer on 24 Feb 2014: This report refers to a 16-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. 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 24 Feb 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003847 is an initial spontaneous report received from a pharmacist on 21 Feb 2014 with a follow-up received on 21 Mar 2014: This report refers to a 16-year-old male patient. He was vaccinated with seasonal influenza vaccines (manufacturer and batch number: unknown) on undetermined dates in the past which were well tolerated. he was inadvertently vaccinated with FLUCELVAX (batch number: 004011A) intramuscular in to the left arm at a dose of 0.5 ml on 02 Jan 2014. This vaccination with FLUCELVAX was an initial application of the vaccine. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Follow-up information received from the pharmacist in 21 Mar 2014: Updated information about application, vaccination history and batch number and site of administration of FLUCELVAX.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003848 is an initial spontaneous report received from a consumer on 23 Feb 2014: This report refers to a 17-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscular 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 23 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: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2044US003853 is an initial spontaneous report received from a pharmacist on 21 FEB 2014 with a follow up report received from the pharmacist on 21 MAR 2014. This report refers to a 15 year old female patient. Her past vaccination history included seasonal influenza with was well tolerated. She was inadvertently vaccinated with FLUCELVAX (batch number: 01003A and expiry date: JUN 2014) intramuscularly into her left arm at a dose of 0.5 ml on 02 JAN 2014 at 15:57 hours. No adverse event was reported following this administration error (inappropriate age at vaccine administration).   Follow up report was received from the pharmacist on 21 MAR 2014. The anatomical site of vaccination, vaccination history, time of vaccination and the reporter's details were updated.  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: 15.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHEH2014US003854 is an initial spontaneous 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. She was vaccinated with seasonal influenza vaccines (manufacturer and batch number: unknown) on undetermined dates in the past which were well tolerated. She was inadvertently vaccinated with FLUCELVAX (batch number: 01003A and expiry date: JUN 2014) intramuscularly in to the left arm at a dose of 0.5 ml on 09 JAN 2014. This vaccination with FLUCELVAX was an initial application of the vaccine. No adverse event was reported following this administration error (inappropriate age at vaccine administration).   Follow-up information received from the pharmacist in 21 MAR 2014. Updated information about application, vaccination history and site of administration 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".