chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: were given expired pentacel vaccinations with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional and physician via medical information (Reference number- 00669898) and transmitted to Sanofi on 06-Jul-2021.  This case is linked with 2021SA225602.  This case involves an infant patient (gender not reported) who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccinations (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 05-Jul-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: UJ325AA, expiry date not reported] via an intramuscular route at right thigh for prophylactic vaccination (expired product administered) (latency: on the same day).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  It was reported that "Medical assistant calling to report that (3) patients were given expired PENTACEL vaccinations on 5Jul2021. Caller stated that all the vaccines were given intramuscularly in the right thigh. linked to case : 2021SA225602 and linked to Inquiry Number: 00669898 Case created for 2nd patient It is unknown if the patient experienced any additional symptoms/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.; Sender's Comments:  US-SA-2021SA225602:  00669898:
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: patient was given expired PENTACEL vaccinations with no reported adverse event; Initial information received on 06-Jul-2021 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2021SA225602 and inquiry number 00669898 (same reporter).  This case involves an infant patient who was given expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccinations (expired product administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On 05-Jul-2021, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ325AA and expiration date: unknown) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency: same day).  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 in 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.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menactra was given to a patient instead of Meningitis B with no reported adverse event; Initial information received on 28-Jun-2021 regarding an unsolicited valid non-serious case from other health professional via Medical Information (Reference number- 00659311).  This case involves a 15 year old female patient who received 0.5ml dose (dose 3) of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6920AA; expiry date: 15-Apr-2022) via intramuscular route in the left deltoid for prophylactic vaccination instead of MENINGOCOCCAL VACCINE B (lot number and expiry date: not reported) on 28-JUN-2021 (wrong product administered).  The patient's past medical history, medical treatment(s), concomitant medication(s), and family history were not provided.  It was an actual medication error due to wrong vaccine administered (same day).  It was not reported that the patient experienced any adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLUR4
Symptoms: Memory impairment
Clinical narrative: patient did not remember states he forgets sometimes; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (patient) via Medical Information (Reference number- 00661430) and transmitted to Sanofi on 29-Jun-2021.  This case involves a 24 year old male patient who said that he did not remember states, he forgets sometimes (Memory impairment) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date in last year the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination  On an unknown date the patient developed a non-serious patient did not remember states he forgets sometimes (memory impairment) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Additionally it was reported as Caller wants to know the side effects of tenivac and does it cause cancer or male infertility? Also wants to know about flublok hat he took last year and if it causes cancer or male infertility? Caller hasn't taken Tenivac and was given the name by the pharmacy he may get the vaccine from but has taken Flublok last year. Caller mentions he is not attempting to conceive nor has he had any symptoms but just asking the question. Caller feels testing should be done on all the vaccines for male infertility. Additional Description of event Adverse events :Caller mentions during the conversation that he didn't remember providing his email and states he forgets sometimes. Caller didn't mention any side effects of the Flublok and isn't trying to conceive. Caller mentions having the CoVid (corona virus disease) vaccine but didn't say which one.  No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was unknown for the event  There will be no information available on the batch number for this case.
Age: 0.83
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired PENTACEL was accidentally given to a 10 month old male patient/ No adverse reactions have been reported; Initial information regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00661536) and transmitted to Sanofi on 29-Jun-2021.  This case involves a 10-month-old male patient who was accidentally vaccinated with expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HEPATITIS B VACCINE for prophylactic vaccination.  On 28-Jun-2021, the patient received third dose in series of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (0.5ml standard, lot U6841AA and expiry date: 22-Jun-2021) once via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day) (expired product administered).  At the time of reporting, no adverse reactions had been reported.  The nurse stated that vaccine was later noted to have expired and asked if it is a valid dose.  Treatment reported as dose will be repeated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements 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.  Follow up information regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00661594) and transmitted to Sanofi on 29-Jun-2021.   Suspect vaccine coding, vaccination details including batch number and expiry date and concomitant medication was added and accordingly narrative was updated.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient had received an expired IMOVAX vaccination with no reported adverse event; Initial information was received on 30-Jun-2021 regarding an unsolicited valid  non-serious case from a nurse.  This case involves a 23-year-old female patient received an expired dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (expired product administered).  Medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  On 30-Jun-2021, the patient received a first dose of 1 ml suspect RABIES (HDC) VACCINE (lot R1C71) which was expired on 30-Apr-2021 via intramuscular route in the right deltoid for unknown indication (expired product administered).  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported that, nurse calling to report a patient had received an expired IMOVAX vaccination. She wants to know if she can get another IMOVAX on the same day. Upon transfer, nurse also asked if the repeat dose could be given in the left deltoid, since the expired dose was given in the right deltoid.  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 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: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Seizure
Clinical narrative: seizure; Initial information regarding an unsolicited valid serious case from a pharmacist via Regulatory Authority (Reference number- 00663747) and transmitted to Sanofi on 30-Jun-2021.  This case involves a 17-years old female patient who experienced seizure, while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported, and patient received no concomitant vaccines.  On 30-Jun-2021, the patient received 0.5 ml total (once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6828AB and expiration date: 09-Jan-2022) via intramuscular route in the left deltoid muscle for prophylactic vaccination.  On 30-Jun-2021, the patient developed a serious, seizure, same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Seriousness criteria was assessed as medically significant as per important medical event Regulatory Authority list.  It was reported "pharmacist ask about seizure as a potential side effect".  It was unknown if there were lab data/results available.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the event was unknown.; Sender's Comments: This case concerns a 17-years old female patient who had seizure same day following vaccination with MENACTRA. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, MMR
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via regulatory authority (Reference number- 00665299) and transmitted to Sanofi on 01-Jul-2021.  This case involves a 6 years old female patient who received an expired dose DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 30-Jun-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5635AA) which was expired on 08-Jun-2021 via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "reports a patient was given the DTAP/IPV combination that had expired on 18 June and wants to know if they need to revaccinate. Reporter did not know which dose in the series it was."  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: 27.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: The patient was missing the second dose, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00667193) and transmitted to Sanofi on 02-Jul-2021.  This case involves a 27-year-old female patient who missed the second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (product dose omission issue).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 23-Jun-2021, the patient received 1 mL of 1st dose of suspect RABIES (HDC) VACCINE (lot T1C66 and expiry date : 17-Jun-2022) via an unknown route in an unknown administration site for unknown indication but missed to receive the second dose on 30-Jun-2021 (product dose omission issue).  It was reported that "RPh (registered pharmacist) intern is calling to see what the scheduling for the IMOVAX vaccine is."  This was a case of actual medication error due to missed dose (latency unknown).  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: 1.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Off label use, Product preparation error
Clinical narrative: only the diluent portion of Pentacel was administered to patient, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional via Global Medical Information (GMI) (Reference number- 00667263) and transmitted to Sanofi on 02-Jul-2021 and live follow up received on 06-Jul-2021.  This case involves a 14-months old female patient who only had the diluent portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE INJECTION [PENTACEL] was administered (product preparation error) on 02-Jul-2021 (lot number: U6940BA and expiry date: 21-May-2022) at a dose of 0.5 ml via unknown route in the left thigh for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]).  It was a case of an off-label use and active ingredient not added to diluent (latency same day).  At the time of report, no adverse event was reported.  It was unknown if there were lab data/results available.  Disclaimer: 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: U
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: A 15 month-old child receive a 4th dose ADACEL instead of DAPTACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (HCP) via Medical Information (Reference number- 00667485).  This case involves a 15-month-old patient who received a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of 4th dose DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On 02-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Injection, lot C5689AA and expiry date: 10-April-2021) instead of fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) via intramuscular route in the right thigh for prophylactic vaccination (wrong product administered).  It was an actual medication error case due to wrong vaccine administered (latency: same day).  A nurse stated that today a 15-month-old child was supposed to receive a 4th dose of DAPTACEL. Instead ADACEL was administered. No adverse effects reported. Nurse states that this child is a twin and HCP initially reported that both children received the vaccine. But she was unable to find documentation of the second child's vaccination today.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: accidently received 2 doses of MENACTRA with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional (Reference number- 00667570) and transmitted to Sanofi on 02-Jul-2021.  This case involves a 12-years old male patient who received 2 doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (accidental overdose) on 01-Jul-2021 (lot number: U6878BB and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  It was a case of an off-label use and accidental overdose (latency same day).  At the time of report, no adverse event was reported.  It was reported that "patient accidently received 2 doses of MENACTRA and asked if there is any documentation regarding any adverse effects or cautions that should be considered. Warm transferred the RN to HCP. Call warm transferred from MIA. Extra Dose SRD sent"  It was unknown if there were lab data/results available.  Disclaimer: 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: 0.25
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired PENTACEL vaccine administered to a patient, No AE; Initial information was received on 06-Jul-2021 regarding an unsolicited valid non-serious case received from an other health professional (Medical assistant) via Physician (Inquiry Number: 00669898).  This case involves a three months old patient gender unknown who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 05-Jul-2021, the patients received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Formulation: Solution lot number: UJ334AA and Expiry date: 13-Jun-2021, Frequency: once, Strength: standard via intramuscular route in the right thigh for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine use (latency: same day).  It was reported "Medical assistant calling to report that three patients were given expired PENTACEL vaccinations on 5-Jul-2021. Caller stated that all the vaccines were given intramuscularly in the right thigh. Pasteur Adverse Event Reporting Refunds/ Credits will not be issued due to adverse events. Emergency Room/ Doctor visit and date 05-Jul-2021. Reporter relationship: Caregiver, Product used: Used, First time product used: No, Still using product: Yes and Was Device Used: No."  At the 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.; Sender's Comments:  US-SA-2021SA230547:
Age: 0.42
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient was vaccinated with an expired PENTACEL vaccinations 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 Medical Information  (Reference number- 00669933) and transmitted to Sanofi on 06-Jul-2021.  This case involves a 5 months old patient (unknown gender) who was vaccinated with an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines  On 05-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ325AA, expiry date: 13-Jun-2021 and strength: 0.5 ml) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day)  It was reported ''Medical assistant calling to report that (3) patients were given expired PENTACEL vaccinations on 5Jul2021''  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.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: patient was administered expired Pentacel vaccination, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (medical assistant)(Reference number- 00669947) and transmitted to Sanofi on 06-Jul-2021.  This case involves a four month old patient (gender not rpeorted) who was administered an expired dose of suspect  DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 05-Jul-2021, the patient received a 0.5 mL expired dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE  (lot number: UJ334AA; expiry date: 17-JUN-2021) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: 14 day IMOVAX RABIES dose was delayed/ NO AE; Initial information received on 06-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional via call center via Global Medical Information (GMI) (Reference number- 00670358).  This case involves a patient of (unknown demographics) whose 14th day dose was missed for RABIES (HDC) VACCINE [IMOVAX RABIES] (missed dose).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for product used for unknown indication.  It was an actual medication error case due to missed dose (latency: same day).  Caller wanting to know how to proceed for a delay in dose and The pharmacy reported that the delay in dose is due to a unusable dose of Imovax that exploded and that the consumer is due for day 14 today. Stated that he has questions on the Imovax and dosing. Pharmacy does not have the Imovax vaccine on hand.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event
Clinical narrative: a child was given PENTACEL but only given the liquid portion not the powder/ no AE; Initial information regarding an unsolicited non-valid non-serious case was received on 06-Jul-2021 from a Other healthcare professional via Medical Information (Reference number- 00670899) and transmitted to Sanofi on 06-Jul-2021.  This case involves a four-month-old male patient who while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] it was reported that child was given PENTACEL but only given the liquid portion not the powder with no adverse event (product preparation error).  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-Jul-2021, the patient received 0.5 mL (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ4400AA and expiry date 29-May-2022] via intramuscular route in left upper thigh for prophylactic vaccination.  It was a case of actual medication error due to active ingredient not added to diluent (latency was on same day).  It was reported that, "Caller stated on 7/2/21 a child was given PENTACEL but only given the liquid portion not the powder. Caller wanted to know if the child will need to be given another dose or does the child just need the HIB part. PENTACEL. Product used: Used. First time product used: Yes. Still using product: No."  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Menactra was exposed to negetive  46 degree Celsius for about 14 hours with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Physician via Global Medical Information (GMI) (Reference number- 00672178) and transmitted to Sanofi on 07-Jul-2021.  This case involves an 18 years old male patient who received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was exposed to negative 46 degree Celsius for about 14 hours (product storage error).  The patient's medical history, past medical treatment, past vaccinations and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENINGOCOCCAL VACCINE B) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 11-Jun-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6919AA and expiry date: 13-Apr-2021) via intramuscular route in the left deltoid for prophylactic vaccination that was exposed to negative 46 degree Celsius for about 14 hours (product storage error).  The reported called for guidance and confirm if revaccination is needed.  It was a potential medication error case due to product storage error temperature too low (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: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, Product storage error
Clinical narrative: Menactra exposed to - 51 Fahrenheit for about 14 hours, with no adverse event; Initial information received on 07-Jul-2021 regarding an unsolicited valid non-serious case received from a physician.   This case involves an 11 years old male patient for whom reported MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] exposed to - 51 fahrenheit for about 14 hours.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE, TETANUS VACCINE TOXOID (DIPHTHERIA TETANUS PERTUSSIS VACCINE); and HPV VACCINE.  On 18-Jun-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6919AA and expiry date: 13-Apr-2022] via an intramuscular route at left deltoid for prophylactic vaccination.  It was case of actual medication error due to product storage error [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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: a patient was administered an expired dose of Pentacel, No AE; a patient was administered an expired dose of Pentacel because the expiration date on the box was confusing, No AE; Initial information was received on 07-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician (under Global Medical Information (GMI) Inquiry Number 00672403).  This case is linked to case 2021SA226436 (same reporter sister's case).  This case involves a four months old female patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] because the expiration date on the box was confusing (Expired product administered and Product label confusion).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for prophylactic vaccination.  On 29-Jun-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number: UJ350AAA and Expiry date: 22-Jun-2021, Frequency: once, Strength : standard via intramuscular route in the left thigh for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used and expiration date format confusion (latency: same day).  It was reported "The caller declined to provide an email address, stated the office does not have one. The caller reported that two patients were administered expired Pentacel because the expiration date on the box was confusing. The caller wanted to know what they need to do now, for those patients. Caller reported that the expiration date on the box was written as 22/06/21 so the staff thought this meant it expired 21Jun2022, not 22Jun2021."  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 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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered expired Pentacel because the expiration date on the box was confusing, with no reported adverse event; Initial information was received on 07-Jul-2021 regarding an unsolicited valid non-serious case from other health professional in the (GMI Inquiry number: 00672437).  This case involves a four-month-old female patient who experienced administration of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) because the expiration date on the box was confusing (expired product administered).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation and ROTAVIRUS VACCINE for Immunisation.  On 02-Jul-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: UJ350AAA, expiry date: 22-Jun-2021] via an intramuscular route at left thigh for prophylactic vaccination.  Description: The caller reported that two patients were administered expired Pentacel because the expiration date on the box was "confusing". The caller wanted to know what they need to do now, for those patients.  It was a case of actual medication error due to expired vaccine used.  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 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.; Sender's Comments:  SAD20210707001286:
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired Adacel vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (Reference number- 00672539) and transmitted to Sanofi on 07-Jul-2021.  This case involves a 33-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 07-Jul-2021, the patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6378AA and expiry date: 04-Jul-2021) via an intramuscular route in the right deltoid for prophylactic vaccination (expired product administered).  It was reported that "Caller states that she gave an Adacel vaccine to a male patient because the patient stepped on a nail. She states that over the weekend the expired vaccines were not pulled out due to the holiday and she did not pay attention to the expiration date before vaccinating the patient. The nurse states that the patient did not experience any other AE's (adverse event) as a result of this. Pasteur AE Reporting."   There were no lab data/results available.  It 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: 59.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Expired product administered
Clinical narrative: vaccination had been given and then it was found to be 3 months expired with no reported adverse event; Initial information received on 07-Jul-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 59-year-old female patient for whom IPV (VERO) [IPOL] vaccination had been given and then it was found to be 3 months expired [expired product administered].   The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  On 02-Jul-2021, the patient received a 0.5 mL 3rd dose of suspect IPV (VERO) [lot number not reported and expiry date: 13-Mar-2021] via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to expired product administered [Latency: on the same day].  It was reported that, they realized later that this was an expired vial of Ipol they used.  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.  There will be no information available on the batch number for this case.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This case involves a 17-year old male patient who received 3 doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], not showing any adverse reactions (extra dose administered). Past vaccination(s) included MENACTRA (First dose at the age of 11 years and second dose at the age of 16 years). Medical history, past medical treatment(s), concomitant medication(s) and family history were not provided. On 01-Jul-2021, the patient received 0.5 ml third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number: U4648AA and expiration date: 25-Apr-2015 and lot number: U6951AA and expiration date: 06-Jun-2022] via intramuscular route in the left deltoid for prophylactic vaccination. It was reported as " a nurse (RN) stated a male patient received 3 doses of MENACTRA and asked if there are any concerns or anything to be aware or on the lookout for. RN stated the first MENACTRA dose was administered at the age of 11 years old; the second was administered at 16 years old and the 3rd dose was administered at the age of 17 years old. Nurse stated the patient has not shown any symptoms of adverse reactions. Nurse provided the lot & exp. dates of the first and third Menactra doses; Nurse stated there is no record of the lot/exp. date of the second dose. MIA attempted to warm transfer the nurse to a HCP. However, no HCP was available. Nurse requested a call back or an email reply tomorrow; she will be available 08:00 - 16:30. Outbound call made on 08Jul2021, 10:26 Spoke with nurse who states they thought the patient needed the second dose and when the Menactra injection was given he then presented paperwork to show he had already had the second dose. Patient Information o Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age.---SF male dob: Jul 24, 2003". It was a case of actual medication error due to extra dose administered (latency: same day). 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 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.