chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired dose of MENACTRA not realizing it was expired on 30-Jul-2021 with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (Reference number- 00710629) and transmitted to Sanofi on 04-Aug-2021.  This case involves a 18 year old female patient who experienced patient was administered expired dose of menactra not realizing it was expired on 30-Jul-2021 (expired product administered) while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient past medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 04-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6641AB and expiry date: 30-Jul-2021] via an intramuscular route in the right arm for prophylactic vaccination.  It was case of actual medication error due to expired product administered. (Latency: on the same day).  Details of laboratory data not 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: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Temperature excursion at maximum 11.5  Celsius for total excursion of 6 hours and 16 minutes, 11.4 Celsius for total excursion of 8 hours, and 12.3 Celsius for total excursion of 17 hours and 8 minutes/ NOAE; This case was considered as non-case as temperature excursion reported without stability data.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: the vaccine MENACTRA had expired on 31-Jul-2021 and was administered with no reported adverse event;Initial information regarding an unsolicited valid non-serious case from a consumer/ non-health care professional via Medical Information (Reference number- 00711805) and transmitted to Sanofi on 05-Aug-2021 and live follow up received on 03-Aug-2021.  This case was linked with GMI ID 00707969 and ARTEMIS ID SAD20210803001152.  This case involves a 12-year-old female patient for whom it was reported that the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, solution for injection [MENACTRA] had expired on 31-Jul-2021 and was administered (expired product administered) (lot number: U6641AB) at 0.5 ml dose via unknown route in an unknown site for prophylactic vaccination on 02-Aug-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used (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.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal behaviour, Delirium, Hallucination, Memory impairment, Vomiting
Clinical narrative: delirium; does not remember anything from that time; she was talking to her father who had died 10 years before; vomited while she was on her couch; Initial information received on 05-Aug-2021 regarding an unsolicited valid serious case received from a consumer/non-Healthcare professional via Medical Information (Reference number 00711987).  This case involves 81-year-old female patient who experienced delirium, vomited while she was on her couch (vomiting), does not remember anything from that time (memory impairment) and she was talking to her father who had died 10 years before (abnormal behaviour) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included FLUZONE HIGH-DOSE QUADRIVALENT and experienced no issues.  The patient's medical history included urticaria.  The patient's past medical treatment(s) and family history were not provided.  Concomitant medications included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Urticaria.  On 29-Sep-2020, the patient received dose of 0.7ml suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ483AA and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On 29-Sep-2020, the patient developed a serious delirium (lasted two days) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  On 29-Sep-2020, the patient developed a non-serious vomited while she was on her couch (vomiting), does not remember anything from that time (memory impairment) and she was talking to her father who had died 10 years before (abnormal behaviour) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that, patient had a reaction to last year's (2020-2021) Fluzone High-Dose Quadrivalent vaccine, and wanted to know the ingredients so that patient and her doctor could compare them to the ingredients in the Covid-19 vaccine.  Relevant laboratory tests were not reported.  It was not reported if the patient received any corrective treatment for all the events.  At time of reporting, the outcome was resolved on an unknown date for the events.; Sender's Comments: This case involves an 81-year-old female patient who had delirium, vomiting, memory impairment and abnormal behavior after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. There is no further information regarding patient's medical condition at time of vaccination, history and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: injection site pain for about 10 days afterwards; Patient reports that she was given ADACEL by a nurse last week; reports the nurse administered it in her triceps rather than her deltoid; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (patient) via Global Medical Information (Reference number- 00711995) and transmitted to Sanofi on 05-Aug-2021.  This case involved an unknown age female patient was given DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] by a nurse last week reports the nurse administered it in her triceps rather than her deltoid (product administered at inappropriate site) and experienced injection site pain for about 10 days afterwards (vaccination site pain)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 28-Jul-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6964AA) (Frequency: once) (total) via intramuscular route in right triceps for prophylactic vaccination (product administered at inappropriate site)  On 28-JUL-2021 the patient developed a non-serious injection site pain for about 10 days afterwards (injection site pain) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported that, "Patient asking if this dose is still effective or if she should get another dose of ADACEL and reports injection site pain has started to subside".  This vaccine administered at inappropriate site event was an actual medication error (latency same day)  Patient did not receive treatment  At time of reporting, the outcome was Resolving for vaccination site pain  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: 0.58
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACT HIB was administered with no adverse event; Initial information received 05-Aug-2021regarding an unsolicited valid non-serious case from the other health professional via Global Medical Information (Reference number- 00712064).  This case involves a seven-month-old male patient who was vaccinated with the expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 24-Jul-2021, the patient received a third dose of suspect HIB (PRP/T) VACCINE (lot number: UJ359AA and expiry date: 11 Jun 2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was also reported that, "expired ACTHIB was administered and wanted to know if it's safe for the consumer. Should the consumer be re-vaccinated?"  At 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: 1.17
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient mistakenly received an injection of quadracel instead of pentacel with no adverse event;Initial information regarding an unsolicited valid non-serious case was received from the physician via Medical Information (Reference number- 00712491) and transmitted to Sanofi on 05-Aug-2021.  This case involves a one-year-old male patient who mistakenly received an injection of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no adverse event (Wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 02-Aug-2021, "the patient received a 0.5 ml (dose 4) dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number: C5763AA; expiry date: 26-Aug-2022) via intramuscular route in the left upper thigh for prophylactic vaccination instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported)."  It was case of actual medication error due to wrong vaccine administered (latency: same day).  It was reported, "Doctor stated that a patient mistakenly received an injection of QUADRACEL on 02AUG2021 instead of PENTACEL. Doctor asked if QUADRACEL and PENTACEL contained the same amount of DTAP-IPV antigens and if so, whether she could just administer ACTHIB to the patient instead of administering PENTACEL."  At the 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.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired dose of ACTHIB was given to a patient with no adverse event; Initial information received on 05-Aug-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (Reference number- 00712752).  This case involves a one years old female patient who was vaccinated with the expired dose of suspect vaccine HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.   Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR] for immunisation.  On 05-Aug-2021, the patient received a 0.5ml fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ327AAC and expiry date: 28-Jun-2021) (oral solution) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  The reporter "asking if patient will need to be revaccinated."  At 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave an expired pentacel to a patient today, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse via Global Medical Information (Reference number- 00712774) and transmitted to Sanofi on 05-Aug-2021.  This case involved 4-month-old female patient gave an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] to a patient today (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Nurse reports that the patient also received injection of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) on the other side and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) via oral route for prophylactic vaccination   On 05-Aug-2021, the patient received first 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ347AAA and expiry date: 30-Jul-2021) (Strength : standard) (Drug Interval Dosage : once)  (Form: Suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered)  It was reported that, "Nurse would like to know what are the next step? Is re-vaccination necessary and how soon"?  This was an actual medication error due to 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: 0.75
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was given first dose on 30Jul2021 and second dose on 02Aug 2021, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Global Medical Information (Reference number- 00714095) and transmitted to Sanofi on 06-Aug-2021.  This case involves a 9-month-old male patient who had 2 doses of RABIES (HDC) VACCINE [IMOVAX RABIES] 3 days apart instead of recommended 7 days apart (Inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO) for prophylactic vaccination.  On 30-Jul-2021, the patient received a first dose of the suspect RABIES (HDC) VACCINE (lot T1C662M) via unknown route in the left thigh for Pre-exposure immunisation.   On 02-Aug-2021, the patient received a second dose of the suspect RABIES (HDC) VACCINE (lot T1C662M) via unknown route in the left deltoid for Pre-exposure immunisation.  It was a case of an actual medication error due to inappropriate schedule of vaccine administered (latency: same day of 2nd dose)  It was reported that "Pharmacist reports that a 9 month old baby was advised to get pre-exposed vaccine for rabies for travelling purposes. Patient received it 3 days apart instead of recommended 7 days apart and caller needs information to proceed. Pharmacist from a travel clinic states the child was given first dose on 30Jul2021 and second dose on 02Aug 2021. States they had the child coming back in today for the next dose and were going to count this as 7 days from the dose on 30Jul2021 because everything they have read says not to count an early dose. Caller wants to know if this is correct and to get the child back on the 7 day apart schedule and give them a 4th dose or will they give 3 doses total. IF they give 3 doses total for the pre-exposure when would be the next dose? They travel out of the country on 25Aug2021"  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: 12.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: DAPTACEL was given to a 12-year-old patient instead of Adacel with no reported adverse event; DAPTACEL was given to a 12-year-old patient instead of ADACEL With No Reported Adverse Event; Initial information was received on 06-Aug-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (Reference number- 00714231).  This case involves a 12 years old male patient who administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of ADACEL with no reported adverse event (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 06-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (frequency: once, strength: standard, lot number and expiry date not reported) via an intramuscular route in the deltoid not otherwise specified (NOS) for prophylactic vaccination.  It was of actual medication error due to wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event reported.  It was reported as Caller stated that she had a nurse give DTap instead of a Tdap and she need to know the correct interval before she can give the correct vaccine. Caller states that they need to know the interval for when they can safely give the Adacel.   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.  There will be no information available on the batch number for this case.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: vaccine was given to  patient that was supposedly expired with no reported adverse event; Initial information received on 06-Aug-2021 regarding an unsolicited valid  non-serious case received from a other health professional via Global Media Information (under the reference 00714462).  This case involved a 11 years old female patient who was given an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] that was supposedly expired (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE (lot and expiration date not reported) via unknown route in an unknown site for prophylactic vaccination..  On 29-Sep-2017, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, lot U5654AA and EXP: 04/27/2017) via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine use (same day latency).  It was reported that "patient was administered Adacel intramuscularly into the right lower thigh on 29 Sep 2017. The lot number for the Adacel was U5654AA. The expiration date that was recorded was 27 Apr 2017, which, if correct, would mean that the patient had received an expired dose of Adacel. However, the reporter thinks that the expiration date may have been recorded incorrectly, and the Adacel might actually have had a later expiration date. Reporter was calling to check and see what the expiration date is for Adacel given lot".  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 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: 11.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A patient administered the DAPTACEL instead of Adacel, no AE; A 11 year old patient administered Daptacel , no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00714481) and transmitted to Sanofi on 06-Aug-2021.  This case involves a 11-year-old male patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 28-Jul-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5765BA and expiry date: 28-Aug-2021) via an intramuscular route in the left deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  It was reported that "Will there be any harm related to this or will the patient require revaccination?"  This was a case of actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered (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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation error
Clinical narrative: they only gave the dtap/polio part of the PENTACEL because it was not mixed with ACTHIB with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00715707) and transmitted to Sanofi on 09-Aug-2021.  This case involves a 5 month old female patient for whom they only gave the dtap/polio part of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] because it was not mixed with ACTHIB  (product preparation issue).  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 06-Aug-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot U6940BA and expiry date: not reported] via an unknown route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to product preparation issue (Latency: on the same day).  It was reported that, Caller stated they only gave the dtap/polio part of the PENTACEL because it was not mixed with ACT-HIB. AE symptoms or no AE (adverse event). ActHIB lot: UJ472AA expiry date: 21-May-2022.  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.  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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of ACTHIB with no AE; Initial information received on 09-Aug-2021 regarding an unsolicited valid non-serious case from an other health professional and consumer/ non health care professional via Global Media information (under reference 00715879).  This case involves a 1 years old male patient who received an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) [expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) [lot number and expiration date] via unknown route in an unknown site for prophylactic vaccination.  On 09-Aug-2021, the patient received a 0.5 mL dose of suspect ACT-HIB (total, lot UJ324AA and expiration date: 14-JUN-2021] via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported that "The caller would like to know if they must revaccinate the patient as well as other instructions on how to proceed to care for the patient".  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 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: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: some of the dose did not go into the patient's arm and leaked out, no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist (Reference number- 00715961) and transmitted on 09-Aug-2021.  This case involves a 54-year-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] from which some of the dose did not go into the patient's arm and leaked out (underdose).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 09-Aug-2021, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ686AA and expiry date: 30-Jun-2022) via an intramuscular route in the arm for prophylactic vaccination from which some of the dose did not go into the patient's arm and leaked out (underdose).  It was reported that "Pharmacist wanted to know what the protocol should be."  This was a case of actual medication error due to vaccine underdose (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.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, Medication error
Clinical narrative: five year old female patient received doses of Ipol,and Kinrix vaccines  with no reported adverse event; Initial information received on 09-Aug-2021 regarding an unsolicited valid non-serious case from a pharmacist via Global Medical Information (Reference number- 00716202).  This case involves a five year old female patient who received vaccines IPV (VERO) [IPOL] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [KINRIX], which was double dose of the polio vaccine (extra dose administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 09-Aug-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot number and expiry date: not reported) (Frequency: Once) via an unknown route at an unknown administration site for prophylactic vaccination.  On 09-Aug-2021, the patient received a 0.5 ml dose of suspect KINRIX not produced by Sanofi Pasteur (lot number and expiry date: not reported) (Frequency: Once) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  It was reported that "she asks what to do about the patient receiving a double dose of the polio vaccine and what side effects that a 5 year old patient might expect. Unable to find this information in the standards or PI (prescription information)".  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.  There will be no information available on the batch number for this case.
Age: 18.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 18 year old male patient administered an expired dose of IPOL vaccine with no reported adverse event; Initial information received on 09-Aug-2021 regarding an unsolicited valid non-serious case from a other health care professional via Global Medical Information (Reference number- 00716235).  This case involves an 18 year old male patient who was vaccinated with the expired dose of suspect IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 09-Aug-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 left deltoid for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At 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: 12.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 12 year old patient was vaccinated with Quadracel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (GMI) (Reference number- 00718133) and transmitted to Sanofi on 10-Aug-2020.  This case involves a 12-year-old female patient who was administrated DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] [Product administered to patient of inappropriate age].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot U693588 and expiry date: 26-May-2023) via unknown route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  It was reported, "I gave a Quadracel injection to a 12 year old who didn't need it. Are there any concerns?"  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 by the regulatory authority. 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
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Autoimmune thyroid disorder, Condition aggravated, Fatigue, Pain
Clinical narrative: exacerbation of her thyroid autoimmune condition; exacerbation of her thyroid autoimmune condition; fatigue; aches; weakness; Initial information received on 10-Aug-2021 regarding an unsolicited valid serious case from a consumer via Agency (Reference number- 00718199).  This case is linked to case 2021SA269884.  This case involves a 47 year old female patient who experienced exacerbation of her thyroid autoimmune condition (autoimmune thyroid disorder) and (condition aggravated), fatigue, aches (pain) and weakness (asthenia), while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing Autoimmune thyroid disorder.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious fatigue, aches (pain), weakness (asthenia) and exacerbation of her thyroid autoimmune condition (autoimmune thyroid disorder) and (condition aggravated), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. These events were assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a 47 year old female patient who had autoimmune thyroid disorder, condition aggravated, fatigue, pain and asthenia, after receiving ADACEL. The time to onset is unknown. At the time of the event, the patient had ongoing autoimmune thyroid disorder. Additional information regarding patient's medical history, condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 12.0
Sex: F
Vaccine: DTAPIPVHIB, MEN
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: 12 year old patient was given pentacel instead of meningococcal vaccine with no reported adverse event; 12 year old patient was given pentacel instead of meningococcal vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via global medical information (GMI) (Reference number- 00718276) and transmitted to Sanofi on 10-Aug-2021.  This case involves a 12-year-old female patient was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of MENINGOCOCCAL VACCINE (product administered to patient of inappropriate age and wrong product administered).  Medical history, medical treatment, vaccination and family history were not provided.  On 05-Aug-2021, the patient received DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE (HPV VACCINE) as a concomitant medication.  On 05-Aug-2021, the patient received a 48 ug dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ436AAA, expiry date: 17-May-2022, vaccine presentation/ national drug code (NDC): 49281-051005] via an intramuscular route at the left deltoid for prophylactic vaccination instead of MENINGOCOCCAL VACCINE (not produced by Sanofi Pasteur) [lot number, expiry date and other dosing details not applicable] (product administered to patient of inappropriate age wrong product administered).  It was a case of actual medication error due inappropriate age at vaccine administration and wrong vaccine administered. (Latency: on the same day).  It was reported that, "caller asks how to proceed, caller states she also received Tdap and HPV vaccines on the same day and received meningococcal vaccine a day later".  At the time of report, no adverse event 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 by the regulatory authority. 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: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error
Clinical narrative: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare professional via Medical Information (Reference number- 00718286) and transmitted to Sanofi on 10-Aug-2021.  This case involves a 11-year-old male patient who received an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received an expired dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5660AA and expiry date: 06-Aug-2021) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "Office manager called to confirm guidance because a consumer received an expired dose of Adacel. The office manager she does not have the patient information at the time of the call so limited information was obtained."  This was a case of actual medication error due to expired vaccine used (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.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of ACTHIB with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Global Medical Information (GMI) (Reference number- 00718295) and transmitted to Sanofi on 10-Aug-2021.  This case involves a 12-month-old male patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for immunization.  On 10-Aug-2021, the patient received a third 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot UJ357AAA and expiry date: 26-Jul-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was reported that "Caller states her son went in for 12 month checkup and immunizations and they gave him expired ACTHIB. Patient received "4 sticks" in total."  It was an actual medication error case due to expired vaccine used (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 by the regulatory authority. 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.