chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Nausea, Vomiting
Clinical narrative: nausea; vomiting; Patient received an extra of MENACTRA administered; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-health care professional via Information (Reference number- 00802399) and transmitted to Sanofi on 07-Oct-2021.  This case involves a 14-year-old female patient who experienced nausea and vomiting after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (extra dose administered).  The patient's past vaccination(s) included MENACTRA on 18-SEP-2020. The patient's medical history, past medical treatment(s) and family history were not provided.  Concomitant medications included ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  On 06-Oct-2021, the patient received a second dose of 0.5 mL suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Solution for injection, lot U7140BA, expiry date 07-Oct-2022) via intramuscular route in the left arm for prophylactic vaccination.  On 07-Oct-2021, the patient developed non-serious nausea and vomiting, 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was an actual medication error due extra dose administered (latency : the same day).  At time of reporting, the outcome was unknown for the event.   It was reported "their second dose of MENACTRA in the office on 06-Oct-2021 after receiving their first dose on 18-Sep-2020.This patient received the second dose 2 years too early. Patient has had nausea and vomiting which started on 07-Oct-2021".  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: 6.0
Sex: M
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 6 year old patient was given FLUBLOK with no AE; 6 year old inadverntly got the FLUBLOK instead of Fluzone Quadrivalent with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from physician via agency (Reference number- 00802581) and transmitted to Sanofi on 07-Oct-2021.  This case involves a 6-year-old male patient who experienced 6 year old inadverntly got the flublok instead of fluzone quadrivalent (wrong product administered and product administered to patient of inappropriate age) while receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient 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 INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On 03-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered (On 03-Oct-2021) and product administered to patient of inappropriate age [Latency: on the same day].  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the 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 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: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: A 14-year-old patient received a dose of FLUBLOK no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional (Reference number- 00802604) and transmitted to Sanofi on 07-Oct-2021.  This case involves a 14-year-old female patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case an actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported "Caller states that FLUBLOK has been administered to a patient under the age of 18; the patient is 14 years of age female; caller would like to know about adverse effects to look out for and if/when the proper flu vaccine can be administered"  No other 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.
Sex: U
Vaccine: FLU3, FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: refrigerator door was left open. Products were exposed to a maximum of 57.2 degree Fahrenheit for a duration of 12 hours with no adverse event; Initial information received on 07-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves no identifiable patient and it was reported that refrigerator door was left open. products were exposed to a maximum of 57.2 degree Fahrenheit for a duration of 12 hours with no adverse event (product storage error).  Product included:  Insulin glargine [Toujeo] (batch number and expiry date unknown).   On an unknown date (latency unknown), it was reported that a refrigerator door was left open. Products were exposed to a maximum of 57.2 degree Fahrenheit for a duration of 12 hours (product storage error).  Action taken with suspect drug was not applicable.  No corrective treatment was received.  At the time of report, event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case   No further relevant information was reported
Age: 1.25
Sex: F
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: patient received the YF-VAX but the diluent that was used to reconstitute it was a sterile diluent which was taken from an MMR vaccine, with no adverse event;Initial information received on 07-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional and physician via Media Information (under reference 00803170).  This case involves a 1 years old female patient who received YELLOW FEVER VACCINE (YF-VAX) but the diluent that was used to reconstitute it was a sterile diluent which was taken from an MMR vaccine (product preparation error).  Patient received no other vaccines as concomitant medication(s).  The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided.  On 05-Oct-2021, the patient received a 0.5 mL first dose of suspect YF-VAX (Total, lot UJ386AA and expiration date: 22-AUG-2022) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to Wrong diluent used (same day latency).  It was reported "Caller states that a patient received the YF-VAX in her office on 05OCT2021 but the diluent that was used to reconstitute it was a sterile diluent which was taken from an MMR vaccine and not the diluent supplied with the YF-VAX. Caller wanted to know if that dose counted and how to proceed."  At time of reporting, 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 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: 14.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Staff member had administered expired IPOL to a patient with no reported adverse event; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via consumer via phone under (Information Inquiry Number: 00804220).  This case involves a 14-years old female patient who was administered with an expired dose of IPV (VERO) [IPOL] with no adverse event (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 05-Oct-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) lot number: R1S973M via and expiry date: 03-Oct-2021 via intramuscular route in the left arm for Prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "The caller stated that a staff member had administered expired IPOL to a patient. The caller would like to know how to proceed regarding 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 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: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was mistakenly administered to an underage patient with no adverse event; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via consumer via physician via phone (Inquiry Number: 00804698).  This case involves a 15-years old female patient who was mistakenly administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with no adverse event (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 25-Sep-2021, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number: UJ723AA and expiry date: 30-Jun-2022 via intramuscular route in the right deltoid for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "FLUBLOK was mistakenly administered to an underage patient, caller would like to know safety and how to proceed."  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: 65.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Underdose, Wrong product administered
Clinical narrative: Patient received FLUZONE QUADRIVALENT instead of FLUZONE HIGH-DOSE QUADRIVALENT/ no adverse event; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case from non-healthcare professional via call center via agency (Reference number- 00804783).  This case involves a 65 years old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered) and (underdose).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 21-Aug-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to wrong vaccine administered and vaccine underdose (latency: same day).  At the time of reporting, no adverse event reported.   It was reported "The caller states that since he turned 65 they have given him the high dose flu vaccine every year because it has more of the antigen and there is not any question that the high dose is better. He states that there was a different pharmacist there that did not administer the high dose flu vaccine to him but they were more than willing to give him a second dose but he wanted to check on getting a second dose first."  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: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old was inadvertently given a FLUZONE QUADRIVALENT with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via  (Reference number- 00804995).   This case involves a 4-month-old male patient who was inadvertently given a INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (off label use).    The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7347NA and expiry date: 30-Jun-2022] strength: standard via an intramuscular route in left thigh for prophylactic vaccination.  On 07-Oct-2021, the patient inadvertently received a dose of fluzone quadrivalent(Off label use in unapproved age group) (Latency same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were 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.
Sex: U
Vaccine: TYP
Symptoms: Needle issue, Syringe issue, Underdose
Clinical narrative: guesses the plunger was lose" and all the vaccine came out on the bottom.with no adverse event; some did get on her hand, but she washed it off immediately; Initial information was received on 8-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via regulatory authority (Information-00805079).  This case involves a patient of (unknown demographics) who was going for vaccination of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] at that time of vaccine preparation guesses the plunger was lose and all the vaccine came out on the bottom (needle issue) and some did get on her hand, but she washed it off immediately (occupational exposure to product).  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number T2A371M and expiry date 13-Apr-2022 were reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to needle leak and occupational exposure via skin contact with product (latency was on same day).   At the time of report, no adverse event reported.   Outcome of events 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.
Age: 4.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: received expired TYPHIM VI vaccinations with no reported adverse event;Initial information received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from a physician and consumer non health care professional via Medical Information number: 00665242.   This case involves a 4 years old male patient who who was administered an expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.    On 30-Sep-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination . It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.   It was reported "Doctor states that neither of these patients experienced any adverse events and that he was calling to find out if Sanofi had any safety or efficacy data related to expired products. Doctor also asked if the patients should be re-vaccinated. See case number 00805095 for information related to the first patient".   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: 7.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 7-year-old patient received FLUBLOK QIV vaccine with no AE; The nurse advised that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent no AE; Flublok are similar to the colors used for Fluzone Quadrivalent no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via consumer/non-health care professional via agency (Reference number- 00805127) and transmitted to Sanofi on 08-Oct-2021.  This case is linked to case 2021SA339055 (same reporter).  This case involves a 7-year-old female patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age), instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered) as FLUBLOK QIV and FLUZONE QUADRIVALENT are similar to the colors (Product appearance confusion).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2128, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  It was case of actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered and product appearance confusion (latency same day).  It was reported "Two children under the age of 18 years old were administer with Flublok. The nurse (reporter) advised the Sanofi Representative that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent. It was reported that the children's parents have been notified. Both children were administered a dose from the same lot number."  No other 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: 11.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received DAPTACEL instead of ADACEL with no reported AE; 11 year patient received DAPTACEL instead of ADACEL with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from the pharmacist via Medical Information (Reference number- 00805147) and transmitted to Sanofi on 08-Oct-2021.    This case involves a 11-year-old male patient who received 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) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for prophylactic vaccination.  On 20-Sep-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection, lot number: C5743AA, expiry date unknown) via intramuscular route in the left deltoid instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) for prophylactic vaccination.  It was case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  It was reported "patient received DAPTACEL instead of ADACEL patient was 11 years old".  At the time of this 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 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: F
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: was improperly reconstituted with sterile water instead of the supplied diluent; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from a physician via Media Information (under the reference 00806397).  This case involves a 15 months old female patient who was vaccinated with YELLOW FEVER VACCINE [YF-VAX] and STERILE WATER which improperly reconstituted with sterile water instead of the supplied diluent (product preparation error).   The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On 05-Oct-2021, the patient received a dose of suspect YF-VAX (0.5 ml, total, lot UJ386AA and expiration date: 22-aug-2022) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect STERILE WATER not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to Wrong solution used in drug reconstitution.  No adverse event reported.   It was reported "Caller wants to know if there are any issues with administering another dose. MD (Doctor of Medicine) is a pediatric infectious disease specialist, consulting as to how to manage the above situation. How do I approach properly vaccinating this child so she can go visit her family? When information was shared from the "Use of Alternate Diluents" SRD (system requirement document), he then asked, since it is a live vaccine, should there be an interval between the time of the improperly-reconstituted dose and a re-dose, such as 28 days?"  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: F
Vaccine: HIBV
Symptoms: Expired product administered, Mycobacterium tuberculosis complex test
Clinical narrative: patient had received an expired dose of ACT-HIB with no reported AE; Initial information was regarding an unsolicited valid non serious case was received from a other healthcare professional via Medical Information (MI) (Reference number- 00806513) and transmitted to Sanofi on 11-Oct-2021.  This case involves a one-month-old female patient who was vaccinated with the expired 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 DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) for Immunisation.  On an unknown date, the patient received a first dose (0.25 mL to 2 mL) of suspect HIB (PRP/T) VACCINE (lot UJ359AAA, expiry date 11-Jul-2021) via intramuscular route in the left thigh for prophylactic vaccination.  Relevant laboratory test results included: Tuberculin test - On an unknown date: Inconclusive  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported "patient had received an expired dose of ACT-HIB".  At time of reporting, 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 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: FLU4, FLU4
Symptoms: Incorrect dose administered, Medication error, Wrong product administered
Clinical narrative: The patient received FLUZONE QUADRIVALENT, but the patient was requesting Fluzone High-Dose quadrivalent no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via agency (Reference number- 00806883) and transmitted to Sanofi on 11-Oct-2021.  This case involves a patient (unknown demographics) who was received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], but the patient was requested for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry not reported, formulation: solution) via unknown route in unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  It was a case of actual medication error due to wrong vaccine administered (latency same day).  It was reported "pharmacist reporting that during a flu clinic the patient received FLUZONE QUADRIVALENT, but the patient was requesting Fluzone High-Dose (HD) quadrivalent. The pharmacist wanted to know if the same composition was in both formulations and if a person could receive more that one Fluzone inoculation to meet the Fluzone HD."  No other 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 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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Non case: No stability data available in temperature excursion case no adverse event with no medication error case
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 71-year-old female was given Adacel as a tetanus booster that was out of the age range, with no reported adverse event; Initial information was received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a nurse via consumer via physician (under Medical Information (MI) Inquiry Number: 00807107).  This case involves a 71- years old female patient who was administered with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] as a tetanus booster with no reported adverse event (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   On 02-Apr-2021, the patient received a 0.5 ml booster dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: U6807BB and expiry date: 10-Sep-2022 via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, 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 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: FLU3, FLU4
Symptoms: Wrong product administered
Clinical narrative: patient had received fluzone quadrivalent instead of fluzone hd, with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a pharmacist via agency(Reference number- 00807239) and transmitted to Sanofi on 11-Oct-2021.  This case involves an unknown demographic patient (unknown age and unknown gender) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 11-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong product administered (latency: same day).  It was reported patient came in today to receive FLUZONE HD, but received FLUZONE QUADRIVALENT (prefilled syringe) instead.  At time of reporting, 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 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: 11.0
Sex: M
Vaccine: DTAPIPVHIB, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old patient was given pentacel instead of adacel, with no reported adverse event; Initial information was received on 11-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional (under Medical Information (MI) Inquiry Number:00807251).  This case involves a 11- years old male patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]with no adverse event (wrong product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 08-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number: UJ542AA and expiry date: 10-Jul-2022 via intramuscular route in the left deltoid for prophylactic vaccination.  It was of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  It was reported "Do they still need ADACEL. When should they receive it."  At the time of reporting, 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 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: MNQ
Symptoms: Expired product administered, Medication error
Clinical narrative: patient accidentally received expired dose of MENACTRA vaccine with no reported AE; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional Medical Information (Reference number- 00807259).  This case involves a patient (unknown demographics) who was accidentally vaccinated with the expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, medical treatment, vaccination and family history were not provided.  On 08-Oct-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6745AB and expiry date: 06-Oct-2021) (Frequency: once) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Caller reported accidentally administering a MENACTRA vaccine on 08OCT2021 to a patient that expired on 06OCT2021 (2 days expired vaccine). Caller is asking about the efficacy of this vaccine and where to go from here".   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 guidelines. 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: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age, Syringe issue
Clinical narrative: pharmacist administered MENACTRA to a 73 yrs old female patient per the pts request with no reported adverse event; Menactra was administered the syringe needle was not secure and there was leakage between the needle and the syringe; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist and consumer non health care professional via Medical Information number: 00807265.  . This case involves a 73 years old female patient who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (product administered to patient of inappropriate age) (syringe issue).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number and expiry number not reported via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to inappropriate age at vaccine administration and syringe leak (latency: 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: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Medication error
Clinical narrative: Patient was administered an expired vaccine with no reported A/E; Initial information was received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a physician via consumer (Regulatory authority Inquiry Number: 00807266).  This case involves a 74- years old male patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (expired product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On 08-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ469AA and expiry date: 2021 via unknown route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "There are no side effects but since it's a different formulation, do we advise to give the 21-22 version. How long should we wait. The nurse who administered the vaccine wrote the expiration down and put expired next to it, and then proceeded to administer the vaccine. The physician stated that her facility would be documenting the event as an incident report. The patient is fine."  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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: A dose of PENTACEL administered to a patient, but did not reconstitute no AE;Initial information regarding an unsolicited valid non-serious case was received from a nurse via consumer/non-health care professional via Medical Information (Reference number- 00807298) and transmitted to Sanofi on 11-Oct-2021.   This case involves a patient (unknown demographics) who was received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] administered to a patient but did not reconstitute (product preparation issue).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ544AB, expiry 07-Aug-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  It was reported "Nurse states they administered a dose of PENTACEL to a patient but did not reconstitute before administering. Nurse states the Diphtheria and tetanus toxoids and acellular pertussis- Inactivated Poliovirus Vaccine (DTaP-IPV) portion was administered but not the Haemophilus influenzae type b (Hib). states that she is just trying to request the proper diluent, the 0.4% sodium chloride (NaCl) saline solution for the Hib component. She was referred to the Pentacel Reconstitution Video."  No other 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.