chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site mass
Clinical narrative: Little worse than the first day; Knot on left arm size of a quarter; Red spot size of half a dollar on left arm; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot/batch no: unspecified) via unspecified route of administration in the left arm as dose 2, single on 14Jul2021 14:45 PM (at the age of 57-years) for COVID-19 immunization at Facility Health Department. The patient medical history and concomitant medications were not reported. No Investigation Assessment was provided. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot/batch no: unspecified) via unspecified route of administration on an unspecified date in Jun2021 for COVID-19 immunization and had no problems. It was reported as first dose taken Three weeks before second dose (14Jul2021). No additional vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations within 4 weeks to the administration date of the suspect vaccine and no AE reported prior vaccination. Family Medical History Relevant to AE reported as None. It was reported that 30 minutes after receiving the second shot on 14Jul2021, patient experienced a knot on left arm size of a quarter developed as well as a red spot the size of half a dollar. On 15July201, reported as it was little worse than the first day. The patient asked if these complaints had been previously reported. Relevant tests done were none. Events did not require to visit Emergency Room or Physician Office. The clinical outcome for the events was not recovered except for event little worse than first day was unknown.   Information about lot/batch number is requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Deafness, Ear, nose and throat examination, Tinnitus
Clinical narrative: I lost my hearing and I have 30% left; I had the tinkering sound in my ear; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (Lot Number: EW0171), dose 2 via an unspecified route of administration on 05May2021 (at the age of 40 years old) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (Lot Number: EW0161), dose 1 via an unspecified route of administration on 14Apr2021 (at the age of 40 years old) as single dose for covid-19 immunization. The patient took last dose (second dose) on 05May2021, one months later she lost her hearing and she had 30% left and she didn't have another reason she was very healthy women and she didn't have any family problem of hearing loss. She was very active and anyway when she wake up on 25Jun2021 she had the tinkering sound in her ear she went to the specialist of ear, nose and throat (ENT) Specialist, did examine the geometry and she lost her hearing and the hearing loss was because of the shot and she couldn't find any other reason. The patient underwent lab tests and procedures which included the patient had the blood test the shot on 11May2021, ENT examination stated as 'I lost her hearing' on 25Jun2021. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Daptacel with no reported AE; Initial information regarding an unsolicited valid serious case was received from the other health professional via Medical Information (Reference number- 00694842).  This case involves a two-year-old and unknown gender patient who received an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On 23-Jul-2021, the patient received a 0.5 mL second dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Frequency: once, strength: standard, lot C5643AA, expiry date: 17-Jul-2021] via an intramuscular route at the left thigh for prophylactic vaccination (expired product administered). (Latency: on the same day)  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  It was reported that "caller states she administered expired Daptacel and would like to know if needs to be re-administered and management of adverse events and product technical complaints Pasteur adverse event (AE) reporting refunds/credits will not be issued due to adverse events".  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired IPOL was administered to a patient with no reported adverse event; Initial information received on 22-Jul-2021 regarding an unsolicited valid non-serious case from an other health professional.   This case involves an unknown age and unknown gender patient for whom it was reported, "expired ipol was administered to a patient"while receiving POLIOMYELITIS VACCINE (INACTIVATED) [IPV (VERO) [IPOL]].   The patient had no medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) [Suspension for injection,lot R1D973M and expiry date: 17-Jul-2021] via an unknown route at an unknown administration site for prophylactic vaccination.  On 22-Jul-2021, "expired IPOLwas administered to a patient" (expired product administered) (latency: on the same day) following the administration of IPV (VERO).  There were no laboratory data/results available.  It was unknown if the patient experienced any additional symptoms/events.  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Underdose
Clinical narrative: probably 3/4 of the dose did go in. Some dripped down her (patient's) arm as I was injecting it with no adverse event; syringe cap and a tip cap. It seemed like it was leaking from underneath the syringe cap. The syringe cap seemed like it wasn't that tight with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via regulatory authority (Reference number- 00682181) and transmitted to Sanofi on 14-Jul-2021.  This case involved 19 year old female patient who administered probably 3/4 of the dose did go in and some dripped down her (patient's) arm as injecting it (underdose) due to syringe cap and a tip cap it seemed like it was leaking from underneath the syringe cap the syringe cap seemed like it wasn't that tight (device connection issue) while receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 14-Jul-2021, the patient received 1 ml dose of suspect RABIES (HDC) VACCINE (lot: T1D851M and expiry date: 26-aug-2022) via intramuscular route in the left arm for product used for unknown indication  On 14-JUL-2021 the patient administered probably 3/4 of the dose did go in and some dripped down her (patient's) arm as injecting it (underdose) due to syringe cap and a tip cap it seemed like it was leaking from underneath the syringe cap the syringe cap seemed like it wasn't that tight (device connection issue) (latency: same day, non-serious events) following the administration of RABIES (HDC) VACCINE.  It was reported that, "When she administered it leaked out where the needle attached. She stated she spoke to someone Drug information that told her to repeat vaccine. The IMOVAX leaked during injection. Yes, this occurred today. I do not know how to describe it. Let me look at the picture. I was very careful with the instructions because this seemed more complex than the usual one. I held it by the cap, not by the plunger rod or the barrel. I felt like I did everything right. I can not say exactly where it was leaking, like if it was down towards the needle or up towards the syringe. Since we do have to re-administer the shot, I would like a replacement to the pharmacy. The IMOVAX has already been discarded in the sharps container".  This case was an actual medication error case (vaccine underdose and syringe connection issue)   At the time of reporting, no adverse event
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: child was given an expired dose of PENTACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician and other health care professional via Regulatory authority (Reference number- 00683484) and transmitted to Sanofi on 15-Jul-2021.  This case involved 7 month old female patient was given an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB (PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE for Prophylactic vaccination.  On 14-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: U6842BA and UJ337AA, expiry date: 05-Jul-2021) via intramuscular route in the right thigh for prophylactic vaccination (expired product administered)  It was reported that, "Caller is wanting to know if it is a valid dose and if child needs another injection".  This case was an actual medication error case (expired vaccine used) (latency same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 18 year old male patient administered dose of Menactra instead of Bexsero with no reported avderse event; Initial information received on 15-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 18 year old male patient who was by mistake given dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV [BEXSERO].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 14-Jul-2021, the patient received a 0.5 ml third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6921AB and expiry date: 17-Apr-2022) (Frequency: once) instead of BEXSERO not produced by Sanofi Pasteur via an intramuscular route at an unknown administration site for (Wrong product administered) prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (latency on same day).  It was reported that "Nurse Practitioner stated that a gave Menactra by mistake instead of Meningococcal B it was given to 3 triplets. Is there any harm done with them getting a third Menactra vaccine. Is is alight for them to come back in to get the Meningococcal B in a few days. Nurse practitioner states triplets were given an extra dose of Menactra instead of Meningococcal B dose of Bexsero. What should they look for and can they get the Bexsero so they can go to college. Patient Information Patient age greater than one year enter as 2 month, 4 month, etc. Many pediatric vaccines need month for age. Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0.5ml, Strength: standard except for Fluzone HD-standard TB skin test-immunization. Event Information treatment- none at this time and they have spoken with the father who doesn't report any problems, dose if series-they had the first dose in childhood and one at 15-16 years and now this one by accident. They were in the clinic for school shots. Reporter relationship: HCP (health care professional) Product used: used First time product used: no still using product: no".  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Daptacel was given to a patient with no reported adverse event; Initial information received on 19-Jul-2021 regarding an unsolicited valid non-serious case from an other health professional via Media information (under reference 00688129).  This case involves a 24 months old female patient who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines/ concomitant medication(s) were given to the patient.  On 07-Jul-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (total, lot C5624AA and expiration date: 10-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  At time of reporting, the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: instead of using sodium chloride to mix YF VACCINE with they mixed the vaccine with sterile water, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00688211) and transmitted to Sanofi on 19-Jul-2021.  This case involves a 47-year-old female patient who was administered YELLOW FEVER VACCINE - US [YF-VAX] in which instead of using sodium chloride to mix, they mixed the vaccine with sterile water (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 16-Jul-2021, the patient received 0.5 mL dose of suspect YELLOW FEVER VACCINE - (lot UJ372AA and expiry date: 22-Jul-2022) via a subcutaneous route in the left arm for prophylactic vaccination in which instead of using sodium chloride to mix, they mixed the vaccine with sterile water (product preparation issue).  It was reported that "She wanted to the implications as it has already been administered. Caller transferred. Caller asking how to proceed if Yellow Fever Vaccine was given to 2 patients mixed with the diluent that is used for MMR and Varicella vaccines, it is sterile water. Caller asking why do they need to revaccinate? Do you have any specific data showing that the sterile water that they used makes the vaccine not work or stable? She asked if this is a general CDC statement or specific to YF vaccine? Does Sanofi Pasteur have actual data showing why the specific diluent is the only one that can be used? Caller said they have to investigate more and therefore this doctor is not 100% verified as the person involved in this event) medical assistant (MA) who administered vaccine. Caller came back and said she gave all this information before she checked with her medical director and she would like to wait for the medical director to make the report after they have fully investigated what happened. Medical director will be back in the office next week."  It was a actual case of medication error due to Inappropriate reconstitution technique (latency same day).  At time of reporting, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient recieved a dose of QUADRACEL that was too early with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Agency (Reference number- 00688223) and transmitted to Sanofi on 19-Jul-2021.  This case involves a one year old female patient who received a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] that was too early (inappropriate schedule of product administration).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On 19-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5951AA and expiry date: 25-May-2023) via intramuscular route in the left thigh for prophylactic vaccination (inappropriate schedule of product administration).  It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: Instead of using sodium chloride to mix the vaccine, it was mixed with sterile water and administered to a patient, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00688236) and transmitted to Sanofi on 19-Jul-2021.  This case is linked to case 2021SA241742 (same reporter).  This case involves a patient (demographics unknown) who received YELLOW FEVER VACCINE - US [YF-VAX] which was mixed with sterile water instead of using sodium chloride (Product preparation error).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE -lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Wrong diluent used (latency same day).  No adverse event was reported.  It was reported "Caller stated read instruction instead of using sodium chloride to mix YF VACCINE with they mixed the vaccine with sterile water. She wanted to the implications as it has already been administered. Caller transferred to Management Information Systems (MIS). Medical Information Anywhere (MIA) transferred caller. Caller asking how to proceed if Yellow Fever Vaccine was given to 2 patient mixed with the diluent that is used for measles, mumps, and rubella (MMR) and Varicella vaccines, it is sterile water. Caller asking why do they need to revaccinate? Do you have any specific data showing that the sterile water that they used makes the vaccine not work or stable? She asked if this is a general Centers for Disease Control and Prevention (CDC) statement or specific to YF vaccine? Does Sanofi Pasteur have actual data showing why the specific diluent is the only one that can be used? Caller said she was doing inventory and came across 2 extra vials of YF vaccine diluents and she back tracked it to a medical assistant (MA) who gave the YF vaccine with sterile water instead of the supplied diluent to patient. Caller came back on the phone after a long hold and said she would like to wait for the medical director to make the report after they have fully investigated what happened. Medical director will be back in the office next week"   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: YF
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: a dose of YF-VAX was administered today, 19Jul2021, using an expired diluent with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician.  This case involved an unknown (age and gender) patient who administered dose of YELLOW FEVER VACCINE - US [YF-VAX] was administered today 19-Jul2021using an expired diluent (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 19-Jul-2021, the patient received a dose of suspect YELLOW FEVER VACCINE - US (lot UJ371AB) (Diluent expiry date: 20Jun2021 and Vaccine expiry date: 21Jul2022) via unknown route in unknown administration site for prophylactic vaccination (expired product administered)  It was reported that, "Patient information not available. Caller with question on whether dose needs repeating. Requested HCP (health care professional) call back to provide patient data"  It was an actual medication error case (expired medical agent used) (latency same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMRV
Symptoms: Expired product administered
Clinical narrative: expired dose of ACTHIB was inadvertently administered/ no AE; Initial information was received on 20-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Regulatory authority (Reference number- 00689723) and transmitted to Sanofi on 20-Jul-2021.  This case involves a four-year-old female patient who inadvertently administered expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for prophylactic vaccination and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  On 19-Jul-2021, the patient received 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ264AA expiry date 04-Jun-2021] via intramuscular route in right thigh for prophylactic vaccination.  It was reported that, "Caller with question on whether dose needs repeating".  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received PedVaxHIB (Merck product) instead of the intended vaccine, MENACTRA with no adverse event; Initial information regarding an unsolicited valid non-serious case from a nurse via Agency (Reference number- 00689735) and transmitted to Sanofi on 20-Jul-2021.  This case involves a 16-year old female patient received HIB VACCINE CONJ (OMPC) (PEDVAXHIB) (merck product) (lot number: S023646 and expiration date: 31-Mar-2022) at first dose of 0.5 ml via intramuscular route in the right deltoid instead of the intended vaccine, MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: unknown and expiration date: unknown) (wrong product administered) for prophylactic vaccination on 19-Jul-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported, "The caller would like to know if it's okay to give the MENACTRA today? The nurse has the patient coming in today. I checked the SRDs and PI and did not see any warnings or precautions about giving Menactra with other vaccines but the nurse wanted to escalate to double check."  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV, MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: This case involves an unknown age and unknown gender patient for whom reported "temperature excursion for menactra & ipol (opened) that reached -0.43 Celsius for 3.5 hours in the fridge" while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and POLIOMYELITIS VACCINE (INACTIVATED) [IPV (VERO) [IPOL]]. The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (VERO) [Lot: T1D481M and expiry date: 25-Jul-2022] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date: not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date the, patient developed a non-serious event "temperature excursion for menactra & ipol (opened) that reached -0.43 Celsius for 3.5 hours in the fridge" (product storage error) (latency: on the same day) following the administration of IPV (VERO) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was reported that, "the temperature excursion was occurred due to unknown reason and this occurred a couple of months ago. Caller stated to disregard the freezer temperatures of 17.52 Celsius for 7.5 hours". Laboratory data was not reported. At the time of report no adverse event was reported. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HPVX, MNQ
Symptoms: Pyrexia
Clinical narrative: fever; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Regulatory authority (Reference number- 00690450) and transmitted to Sanofi on 20-Jul-2021.  This case involves a 16 year old male patient who had fever (pyrexia) after receiving MENINGOCOCCAL VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV (Human papillomavirus) VACCINE [HPV VACCINE].  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot number: AMAA521A4 and expiry date: not reported) by unknown route, in an unknown administration site for prophylactic vaccination .  On an unknown date the patient developed a non-serious fever (pyrexia) (unknown latency) following the administration of MENINGOCOCCAL VACCINE.  It was reported, "Caller has had a fever for 6 days. Caller wanted to know if that was normal after taking Vaccine. Caller did not want to provide demographics. Caller was warm transferred to ask about a fever for 6 days after getting Menactra. Explained the side effects on the package insert to him and when obtaining the lot number he states that he received a meningitis vaccine but was not sure which one he received at the pharmacy. Explained to him that his pharmacy would know which brand he received if he called them. Caller states he also received the HPV vaccine the same day."  No laboratory data was received.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Age: 11.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: ACTHIB was administered to an 11 year old patient/ no AE; Initial information was received on 21-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Regulatory authority (Reference number- 00691458) and transmitted to Sanofi on 21-Jul-2021.  This case involves a 11-year-old male patient reported that HIB (PRP/T) VACCINE [ACT-HIB] was administered to an 11-year-old patient with no adverse event (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 20-Jul-2021, the patient received 0.5 ml (total) second dose of suspect HIB (PRP/T) VACCINE [lot UJ404AA and expiry date 04-Oct-2021] via intramuscular route in right deltoid for prophylactic vaccination.  It was reported that, "1st one was in 2010. Product used: Used. First time product used: No".  It was a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 8 year old female patient was given expired dose of IPOL vaccine, with no reported adverse event; Initial information received on 21-Jul-2021 regarding an unsolicited valid non-serious case from a other health professional via physician via Agency (Reference number- 00691611).  This case involves a 8 year old female patient who was vaccinated with the expired dose of suspect IPV (VERO) [IPOL]. Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 19-Jul-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot R1D973M and expiry date: 17-Jul-2021) (Frequency: once) via an intramuscular route in the right arm (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: got injected expired Adacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Agency (Reference number- 00692200) and transmitted to Sanofi on 21-Jul-2021.  This case involve a 31-year-old female patient who was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of got injected expired adacel (Expired product administered).   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was reported as 05-Jan-2021.  The estimated due date is 12-Oct-2021.  The patient past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 19-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [prefilled syringes, lot U6273AA and expiry: 24-Apr-2021] via an intramuscular route in the left deltoid for prophylactic vaccination (Fetus prevention of whooping cough).  It was reported that, "The patient was given the Adacel because she is 28 weeks pregnant to protect the fetus against Whooping cough". The expired box of Adacel, but is believed that one of the expired Adacel prefilled syringes got accidentally put in a new Adacel box.  It was as actual medication error due to expired product administered (latency: on the same day)  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was unknown for the event got injected expired adacel.  Additionally, at time of reporting, the pregnancy is still ongoing.  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TYP
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: Typhim was administered to a 13 month old child with no reported adverse event; Initial information received on 21-Jul-2021 regarding an unsolicited valid  non-serious case from an other health professional and physician via Agency (under reference number 00692273).  This case involves a 13 months old (unknown gender) patient who was given TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included YELLOW FEVER VACCINE LIVE (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date.  On 20-Jul-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (Total, lot T1A671M and expiration date : 17-Feb-022) via intramuscular route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration (same day latency).  It was reported that " She reports that the child tolerated the immunizations well and no adverse events have been reported. Case placed in proxy for callback or email, call came in just before 6pm, not able to transfer. Nurse says that Typhim was administered to a 13 month old child. She wants to find out what side effects they should look out for.  Outbound call made at 1:33pm on 22jul2021. Caller was in a meeting. Voicemail left with contact and case number."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was inadvertently vaccinated with an expired dose of Typhim Vi with no AE; Initial information was received on 22-Jul-2021 regarding an unsolicited valid non-serious case from pharmacist via call center via Regulatory authority (Reference number- 00693193).  This case involves a 57-year-old female patient who vaccinated with an expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  The patient's past medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 21-Jul-2021, the patient received a 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number : R2A252M and expiry date : 11-May-2021) via an intramuscular route in the right deltoid for prophylactic vaccination (expired product administered).  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported that, "pharmacist reported that She requested guidance on how to proceed. the pharmacist stated that she will re-vaccinate the patient."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient accidentally received an expired dose of DAPTACEL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (health care professional and nurse) via medical information (Reference number- 00693201).  This case involves a five-year-old patient (gender unspecified) who accidentally received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  List of concomitants was reported as no other vaccines.  On 21-Jun-2021, the patient received a 0.5 mL fifth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Injection, frequency: once, strength: standard, lot C5624AA, expiry date: 10-Jun-2021] via an intramuscular route at the left thigh for prophylactic vaccination (expired product administered). (Latency: on the same day)  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  It was reported that "nurse states that on 21-Jun-2021, a five-year-old child received a DAPTACEL vaccine that had expired on 10-Jun-2021 and HCP (Healthcare Professional) wanted to know when the consumer can be re-vaccinated with DAPTACEL that is not expired".  It was also reported that treatment- will be repeated  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired vaccine to patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 22-JUL-2021 from a Physician and other healthcare professional (Reference number- 00693284) and transmitted to Sanofi on 22-Jul-2021.  This case involves a 6-month-old female patient who was vaccinated with an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 09-Jul-2021, the patient received a 0.5ml of third dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (lot number: UJ327AA and expiry date: 28-Jun-2021 was reported) via intramuscular route at the left thigh for prophylactic vaccination.  It was also reported that "if there was a grace period if an expired product was administered".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.