chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: YF
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: This situation is reported as a medication error due to giving an expired product with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who was treated with YELLOW FEVER VACCINE - [YF-VAX] and it was reported that this situation is reported as a medication error due to giving an expired product with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Aug-2022, the patient received an unknown dose of suspect YELLOW FEVER VACCINE (formulation, strength, route: unknown) lot UJ397AA, expiration date:22-Aug-2022, in unknown administration site as Immunization.  On 24-AUG-2022 this situation is reported as a medication error due to giving an expired product with no reported adverse event (expired product administered) same day following the administration of YELLOW FEVER VACCINE. Nurse manager was calling to find out if an expired dose of YF-VAX was given to a patient would that count as a valid dose? The nurse did not have any patient information available at this time.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (This situation is reported as a medication error due to giving an expired product with no reported adverse 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 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: 0.83
Sex: F
Vaccine: UNK
Symptoms: Product preparation error
Clinical narrative: only the liquid portion of PENTACEL was administered to a pt with no adverse event; only the liquid portion of PENTACEL was administered to a pt with no adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 10 months old female patient who to whom only the liquid portion of pentacel was administered with no adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(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 (dose, formulation, strength: unknown) lot U7130AA via unknown route in unknown administration site as prophylactic immunisation.  On an unknown date the patient developed a non-serious event "only the liquid portion of pentacel was administered to a pt with no adverse event" (product preparation error) (single component of a two-component product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  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 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: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Diarrhoea, Headache, Urticaria, Vomiting
Clinical narrative: hives in the chest area; vomiting; diarrhea; headache; Initial information received on 26-Aug-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 11 years old and unknown gender patient who experienced hives in the chest area, vomiting, diarrhea and headache after receiving vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine ,solution for injection (strength not reported) (lot U7299AA; Expiration 04-Aug-2024) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed hives in the chest area (urticaria), vomiting, diarrhea (diarrhoea), headache (unknown latency).  It was reported " Nurse called to report that one of their patient, an 11-year-old received MENQUADFI and after three days of immunization experienced hives in the chest area, vomiting, diarrhea and headache. Nurse just wants to know if these are adverse effects of the vaccine and if she needs to report this as clinic protocol."  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was supposed to have Tdap, but instead received Tenivac, with no reported adverse event; Initial information received on 25-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old female patient who was supposed to have tdap, but instead received tenivac, with no reported adverse event ,while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past vaccination(s) included DAPTACEL in 2013. The patient's past medical history, medical treatment(s) and family history were not provided.   On 09-Aug-2022, the patient received a total dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT( lot U7183AA and expiration date: 24-Sep-2023) at a dose of 0.5ml via unknown route at an unknown administration site for immunization.  On 09-Aug-2022 (Latency: same day), the patient was supposed to have tdap, but instead received tenivac, with no reported adverse event (wrong product administered) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken:not applicable  Outcome: 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 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: U
Vaccine: IPV
Symptoms: Product dose omission issue
Clinical narrative: inactivated Polio vaccine in the multi-dose form for an older patient that missed when he was supposed to be vaccinated with no adverse event; Initial information received on 26-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Elderly and unknown gender patient who missed dose of IPV (VERO) [IPOL] when he was supposed to be vaccinated with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient supposed to be received a dose of suspect IPV (VERO) (dose, strength, formulation, lot number : unknown) via unknown route in unknown administration site as immunisation.  On an unknown date the patient developed a non-serious event "inactivated polio vaccine in the multi-dose form for an older patient that missed when he was supposed to be vaccinated with no adverse event (product dose omission issue)" (unknown latency).  Action taken: not applicable.  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 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: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 month old patient being administered quadracel which is outside of the indicated age group with no reported adverse event; Initial information received on 26-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was being administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] which was outside of the indicated age group with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 16-Aug-2022, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength, formulation was unknown, lot C5916AA and expiry date: 06-Jul-2023) via intramuscular route in the left thigh for Immunization.  On 16-Aug-2022 the patient developed a non-serious event of 4 month old patient being administered quadracel which was outside of the indicated age group with no reported adverse event (Product administered to patient of inappropriate) (Latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. The patient was supposed to receive Dtap and polio  Action taken: not applicable.  Outcome: 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 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: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received their first dose of menacwy on 15oct2019 and booster dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] on 02aug2022 with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 years old male patient who received their first dose of menacwy on 15oct2019 and booster dose of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] on 02aug2022 with no reported adverse event   The patient's past medical treatment included MENACWY TT on 15-OCT-2019. The patient's past medical history, vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE  On 02-Aug-2022, the patient received a 0.5 ml Booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U7249AA, expiry date:  11-Mar-2024) via intramuscular route in the right deltoid as immunization.  On 02-AUG-2022 the patient developed a non-serious event "received their booster dose of menquadfi at 14 years old. they received their first dose of menacwy on 15-oct-2019 and the booster dose of menquadfi on 02-aug-2022 with no reported adverse event" (inappropriate schedule of product administration; latency: same day). No adverse reactions to report. There was no treatment.  Action taken was not applicable.  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.   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: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: MENQUADFI given orally to a 4 month old patient with no adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 4 months old male patient to whom menquadfi given orally to a 4 month old patient with no adverse event while receiving vaccine meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi].  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 Immunisation; and diphtheria vaccine toxoid, HIB vaccine conj (TET TOX), pertussis vaccine acellular 5-component, polio vaccine inact 3V (MRC 5), tetanus vaccine toxoid (Pentacel) for Immunisation.  On 26-Aug-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (formulation and strength not reported; lot U7373AA, expiry date: 06-Aug-2022) via oral route for prophylactic vaccination.  On 26-Aug-2022, (latency: same day) the patient had a non-serious menquadfi given orally to a 4 month old patient with no adverse event (incorrect route of product administration) following the administration of meningococcal A-C-Y-W135 (T conj) vaccine.  It was reported, they have with giving MENQUADFI orally to a 4 month old infant.  Action taken was not applicable.  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 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: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave a patient and expired Sanofi flu vaccine from last year by mistake with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 46 years old female patient who had expired sanofi INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE] vaccine from last year by mistake with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   It was reported that patient had an expired sanofi flu vaccine from last year (2021) by mistake with no reported adverse event (expired product administered) (latency: same day) (formulation, dose, route, administration site, batch and expiry date was unknown) for Immunization.  On 29-Aug-2022 she also received a 0.5ml 1X(once) dose of the same vaccine (strength, formulation was unknown ,lot UJ696AA and expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for Immunization No reaction was observed in the HCP (health care professional) office  Action taken : not applicable.  Outcome: 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: 7.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: patient had received one dose of ADACEL on Friday 26-Aug-2022 and then received an extra dose of ADACEL as patient came for more vaccinations on Monday (29-AUG-2022) but was given another dose of ADACEL by accident with no reported adverse event; patient had received one dose of ADACEL on Friday 26-Aug-2022 and then received an extra dose of ADACEL as patient came for more vaccinations on Monday (29-AUG-2022) but was given another dose of ADACEL by accident with no reported adverse event; consumer received ADACEL due to being behind on vaccinations and the catch-up schedule calls for ADACEL with no reported adverse event; Initial information was received on 29-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 years old female patient who had received one dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] on Friday (26-aug-2022) and then received an extra dose of Adacel as patient came for more vaccinations on Monday (29-aug-2022) but was given another dose of Adacel by accident with no reported adverse event, received Adacel due to being behind on vaccinations and the catch-up schedule calls for Adacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Aug-2022, the patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site, Further On 29-Aug-2022 patient had received a another dose of the same vaccine at the dose of 0.50 ml once (strength: standard, formulation, route, batch number and expiry date: unknown) in unknown administration site all for prophylactic vaccination.  It was reported that On 26-Aug-2022, the patient had received Adacel due to being behind on vaccinations and had the  catch-up schedule calls (Inappropriate schedule of product administration) (latency: same day). Further reported that the patient had received an extra dose of Adacel described as the patient came in for more vaccinations on 29-Aug-2022) (Monday) but was given another dose of Adacel by accident (Wrong product administered) (extra dose administered) (latency: 3 days).  No adverse event was reported.  No lab data was reported.  Action taken: not applicable  Outcome: 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 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: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: inadvertently given 0.25mL dose of FLUZONE QUADRIVALENT instead of the intended 0.5mL dose with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who was inadvertently given 0.25ml dose of fluzone quadrivalent (INFLUENZA QUADRIVAL A-B VACCINE) instead of the intended 0.5ml dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Aug-2022, the patient received a dose of 0.25 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot number:UJ879AB, expiration date: 30-Jun-2023, via intramuscular route in the left vastus lateralis as Immunization    On 26-AUG-2022 the patient was  inadvertently given 0.25ml dose of fluzone quadrivalent instead of the intended 0.5ml dose with no reported adverse event (incorrect dose administered by product) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inadvertently given 0.25mL dose of FLUZONE QUADRIVALENT instead of the intended 0.5mL dose with no reported adverse 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: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: inadvertently given 0.25mL dose of FLUZONE QUADRIVALENT instead of the intended 0.5mL dose with no reported adverse event.; Initial information received on 29-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA360543.  This case involves a 3 years old male patient who was inadvertently given 0.25ml dose of Influenza quadrival A-B vaccine [Fluzone Quadrivalent] instead of the intended 0.5ml dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Prophylactic vaccination.  On 26-Aug-2022, the patient was inadvertently given 0.25ml dose of suspect Influenza quadrival A-B vaccine, suspension for injection, (strength: unknown) (lot UJ879AB; expiration date: 30-Jun-2023) via intramuscular route in the left vastus lateralis for immunization instead of the intended 0.5ml dose with no reported adverse event (incorrect dose administered) (latency: same day).  Action taken : not applicable.  Outcome: 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 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: 4.0
Sex: M
Vaccine: DTAP, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administered Pentacel and the patient only needed dtap with no reported adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who had administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and the patient only needed DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]) for Prophylactic vaccination; and HIB VACCINE CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination.  On 27-Aug-2022 the patient developed a non-serious event of administered pentacle (formulation: unknown, dose: 0.5ml, 1X(once), intramuscular in Left deltoid, Batch number: UJ620AAA and expiry date: 07-Dec-2022, indication: Immunization) and the patient only needed dtap with no reported adverse event (wrong product administered, Latency: same day).   Action taken : not applicable.  Outcome: 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.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of TENIVAC was administered to a patient with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was had an expired dose of tenivac was administered to a patient with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength, dose, route and administration site not reported; lot U6669AA, expiry date: 15-May-2022) for prophylactic immunization.  On an unknown date, the patient developed a non-serious event of an expired dose of tenivac was administered to a patient with no reported adverse event (expired product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  It was reported, "an expired dose of TENIVAC was administered to a patient. The TENIVAC had expired on 15MAY2022".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received quadracel instead of the pentacel with no reported adverse event; patient received quadracel at a age of 2 years with no reported adverse event; Initial information was received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old male patient who received quadracel instead of the pentacel with no reported adverse event and patient received quadracel at age of 2 years with no reported adverse event Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/IPV (MRC5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; and HIB Vaccine CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination.  On 22-Aug-2022, the patient received 0.5 ml dose of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/IPV (MRC5) Vaccine (frequency: once; strength: standard; batch/lot number: C5862BA; expiration date: 01-Apr-2023) via intramuscular route in the left thigh for Immunization.  On 22-AUG-2022, same day, it was reported that the patient received quadracel instead of the pentacel (wrong product administered) and patient was 2 years old (product administered to patient of inappropriate age) following the administration of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/IPV (MRC5) Vaccine.  No adverse event was reported.  Seriousness criteria: non-serious  Action taken: not applicable  Outcome: unknown for both 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 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: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered with an expired dose of Tenivac with no reported adverse events; Initial information was received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center.  This case involves an 80 years old female patient who was administered with an expired dose of Tenivac with no reported adverse events while receiving vaccine Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Aug-2022, the patient was administered with an expired dose of Diphtheria-2/Tetanus-5 adsorbed toxoids no preservative adult [Tenivac] (batch/lot number: U6669AA; expiration date: 15-May-2022; formulation, strength, dose: unknown) via intramuscular route in unknown administration site (expired product administered) (latency: same day).  No adverse event was reported following expired product administered.  Seriousness criteria: non-serious  Action taken: not applicable  Outcome: 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 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: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: 18 month old patient being administered DAPATECL after the expiration date with no reported adverse event; Initial information was received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 18 months old female patient who was administered Dapatacel after the expiration date with no reported adverse event while receiving vaccine Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB Vaccine CONJ (TET TOX) (ACTHIB); Hepatitis A Vaccine (Hepatitis A) and (PCV 13).  On 29-Aug-2022, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (formulation: unknown; strength: standard; batch/lot number: C5765EA; expiration date: 28-Aug-2022; dose number: 4) once after the expiration date (expired product administered) (latency: same day) via intramuscular route in the left vastus lateralis for immunization.  No adverse event was reported after expired product administered.  Seriousness criteria: non-serious  Action taken: not applicable  Corrective treatment: not reported   Outcome: 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 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: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine) with no reported adverse event; administered the liquid component (DTAP-IPV) of vaccine without being reconstituted with the powder component (lyophilized ACTHIB vaccine) with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 months old male patient who was administered the liquid component (dtap-ipv) of vaccine without being reconstituted with the powder component (lyophilized acthib vaccine) of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Aug-2022, the patient received a 0.5 ml only the liquid component of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) (lot U7311AA, exp date: 09-Sep-2023) via intramuscular route in the left thigh as Immunization.  On 29-Aug-2022 (latency: same day), the patient developed a non-serious event of "administered the liquid component (dtap-ipv) of vaccine without being reconstituted with the powder component (lyophilized acthib vaccine) with no reported adverse event (single component of a two-component product administered" (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  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 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: 72.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: received a dose of the Fluzone High-Dose Quadrivalent before they found out that the vaccine needed to be quarantined with no reported adverse event; received a dose of the Fluzone High-Dose Quadrivalent before they found out that the vaccine needed to be quarantined with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old male patient who reported received a dose of the fluzone high-dose quadrivalent before they found out that the vaccine needed to be quarantined with no reported adverse event while receiving vaccine influenza quadrival a-b high dose hv vaccine (Fluzone High-Dose Quadrivalent).  Concomitant medications: shingles vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Aug-2022, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine via prefilled syringe at a dose of 0.7 ml with lot UJ904AB and expiry date: 30-Jun-2023 via intramuscular route in right arm for Immunization.  On 29-Aug-2022 (latency: same day) the patient developed a non-serious received a dose of the fluzone high-dose quadrivalent before they found out that the vaccine needed to be quarantined with no reported adverse event (product storage error) and (product administration error) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken: not applicable  Outcome: 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 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: 28.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient under age 65 administered Fluzone HD in error with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 28 years old female patient who was under age 65 administered fluzone hd in error with no reported adverse event ,while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJN04AA and expiration date:30-Jun-2023 at a dose of 0.7ml  via intramuscular route in the deltoid nos for immunization.  On 30-Aug-2022(latency: same day) , the patient was under age 65 administered fluzone hd in error with no reported adverse event (product administered to patient of inappropriate age) following the administration.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event .   Outcome: 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 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: RAB
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: when the Imovax was injected the needle hit her bone with no reported adverse event with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves an unknown age female patient to whom, when the RABIES (HDC) VACCINE [IMOVAX RABIES] was injected the needle hit her bone with no reported adverse event.  The patient's past medical history included Animal bite. The patient's past medical treatment included RABEGARD. The patient's past vaccination(s) included IMOVAX. The patient's past family history was not provided.  Concomitant medications included ARIPIPRAZOLE (ABILIFY) for White blood cell count increased.  On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (formulation, dose, strength, lot number: unknown) via unknown route in unknown administration site as Immunization.  On an unknown date the patient developed a non-serious event "when the imovax was injected the needle hit her bone with no reported adverse event (wrong technique in product usage process) (latency: same day) following the administration of RABIES (HDC) VACCINE.  It was reported "Caller reports when Imovax was mixed it was foaming and she questions whether she got the whole dose".  Action taken: not applicable.  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 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: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a dose of QUADRACEL was inadvertently administered to an 11 year old with no adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who was given a dose of quadracel was inadvertently with no adverse event , after receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL) for Immunisation.  On 30-Aug-2022, the patient received a  total dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE l(Lot U7526AA  and expiration date: 07-Sep-2024) at a dose of 0,.5ml via intramuscular route in the left deltoid for immunization.  On 30-Aug-2022(latency: same day ) the patient developed a non-serious event of a dose of quadracel was inadvertently administered to an 11 year old with no adverse event (product administered to patient of inappropriate age) following the administration.   Action taken :as not applicable  It was not reported if the patient received a corrective treatment for the event.   Outcome: 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 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: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: patient received part of the pentacel vaccine, the patient received the hib portion but not the polio or dtap, acthib portion of pentacel given with sterile diluent instead of provided diluent of dtap-ipv with no reported adverse event; patient received part of the pentacel vaccine, the patient received the hib portion but not the polio or dtap, acthib portion of pentacel given with sterile diluent instead of provided diluent of dtap-ipv with no reported adverse event; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received part of the pentacel vaccine, the patient received the hib portion but not the polio or dtap, acthib portion of pentacel given with sterile diluent instead of provided diluent of dtap-ipv with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2022, the patient received 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (formulation, strength and lot number not reported via intramuscular route in unknown administration site for prophylactic immunization.  On 31-Aug-2022, (latency: same day) the patient developed a non-serious patient received part of the pentacel vaccine, the patient received the hib portion but not the polio or dtap, acthib portion of pentacel given with sterile diluent instead of provided diluent of dtap-ipv with no reported adverse event (product preparation error) and (single component of a two-component product administered) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both 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 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: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered expired QUADRACEL to a 4-year-old patient with no reported ae; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4 years old male patient who was administered expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (Quadracel) with no reported adverse event(AE).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 31-Aug-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at a dose of 0.5 ml total (lot C5763AA, expiry date: 26-Aug-2022) via intramuscular route in the left deltoid for immunisation.  On 31-Aug-2022 the patient was administered expired quadracel with no reported ae (expired product administered) (same day latency).  Action taken: Not applicable.  Outcome: 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 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.