chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Incorrect route of product administration
Clinical narrative: a new pediatric nurse administered IMOVAX subcutaneously instead of intramuscularly with no reported adverse event; Initial information received on 03-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient  and it was reported that  a new pediatric nurse administered imovax subcutaneously instead of intramuscularly with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-JUN-2022 , a new pediatric nurse administered imovax subcutaneously instead of intramuscularly with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of RABIES (HDC) VACCINE. The patient received a 1 ml dose of suspect RABIES (HDC) VACCINE, once, ( lot : U1D852M ; expiry date: 31-Aug-2023) via subcutaneous route in unknown administration site for immunization.   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: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: use of IPOL that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event; Initial information received on 03-Jun-2022 from other Health Care Professional regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves 6 patients who used ipol that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a  dose of suspect IPV (VERO) (batch lot U1A601M) (Unknown dosage, strength, formulation and expiry date ) via unknown route in unknown administration site for immunization.  On an unknown date the patients developed a non-serious event of use of ipol that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event use of ipol that experienced temperature excursion that exceeded the stability data documented in the local labelling and was due to human error with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: diluent portion of Pentacel administered without using it to reconstitute the powder portion with no reported adverse event; Initial information received on 03-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who administered diluent portion of Diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] without using it to reconstitute the powder portion 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 rotavirus vaccine live reassort oral 5v (rotateq) and pneumococcal vaccine conj 13v (crm197) (prevnar 13) both for Prophylactic vaccination.  On 03-Jun-2022, the patient received a  dose of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) (lot U7197BA; expiry date: 28-Jan-2023) (strength, dose, formulation, route: unknown) in unknown administration site for prophylactic vaccination.  On 03-JUN-2022 the patient developed a non-serious diluent portion of pentacel administered without using it to reconstitute the powder portion with no reported adverse event (Product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) 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: 4.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: administered the IPOL dose from a multi-dose vial that may have been exposed to a temperature excursion with no adverse event; Initial information received on 03-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who was administered the ipol dose from a multi-dose vial that may have been exposed to a temperature excursion with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-May-2022, the patient received a  fourth dose of 0.5 ml suspect IPV (VERO)(unknown batch lot number, dosage, strength and expiry date) injection via intramuscular route in left vastus lateralis for immunization.  On 31-May-2022 (latency :same day)the patient developed a non-serious event of administered the ipol dose from a multi-dose vial that may have been exposed to a temperature excursion outside the recommended storage guidelines with no adverse event (product storage error) following the administration of IPV (VERO).  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 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:  01131422:
Sex: U
Vaccine: YF
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered a YF-Vax for which the diluent had expired with no reported adverse event; Initial information received  on 03-Jun-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a patient of an unknown age and gender patient who was administered a YF-Vax for which the diluent had expired with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect YELLOW FEVER VACCINE , ( lot : UJ386AA ; expiry date : 22-Aug-2022) and diluent (lot: U6627AB ; expiry date: 20-May-2022)  in unknown administration site for immunization.  On an unknown date the patient was administered a YF-Vax for which the diluent had expired with no reported adverse event (expired product administered) (unknown latency). The diluent expired in May  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: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error, Wrong technique in product usage process
Clinical narrative: administered a dose of ACTHIB reconstituted with sterile water instead of provided 0.4% Sodium chloride, with no reported adverse event; Initial information received on 06-Jun-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 3 years old male patient who experienced administered a dose of acthib reconstituted with sterile water instead of provided 0.4% sodium chloride, with no reported adverse event while receiving vaccine hib (prp/t) vaccine (Act-Hib).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine polysacch (Pneumococcal Polysaccharide Vaccine).  On 27-May-2022, the patient received a dose of suspect hib (prp/t) vaccine at a dose of 0.5ml with lot UJ740AA via unknown route in unknown administration site for Immunization.  On 27-May-2022 the patient developed a non-serious administered a dose of acthib reconstituted with sterile water instead of provided 0.4% sodium chloride, with no reported adverse event (wrong technique in product usage process) following the administration of hib (prp/t) vaccine. This situation is reported as a medication error due to reconstituting with alternate diluent.   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.; Sender's Comments:  US-SA-2022SA213837:
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered a dose of ACTHIB reconstituted with sterile water instead of provided 0.4% Sodium chloride with no reported adverse event; Initial information received on 06-Jun-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 administered a dose of acthib reconstituted with sterile water instead of provided 0.4% sodium chloride with no reported adverse event , while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH.  On 27-May-2022, the patient received a  dose of 0.5 ml of  suspect HIB (PRP/T) VACCINE , (lot:  UJ740AA ; expiry date:  11-Feb-2023)  via intramuscular route in the left vastus lateralis for immunization.  It was reported that on 27-May-2022,  the patient was administered a dose of acthib reconstituted with sterile water instead of provided 0.4% sodium chloride with no reported adverse event (product preparation error), (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.; Sender's Comments:  01132906: US-SA-2022SA213022:
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pentacel was administered 4 days after the expiration date with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received from a pharmacist on 07-Jun-2022.  This case involves Infant female patient who experienced DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was administered 4 days after the expiration date with no reported adverse event.  The patient's past medical history included She was 25.4 weeks at birth (Premature baby). The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing baby is in the neonatal intensive care unit since birth (Hospitalization).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunization; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunization.  On 02-Jun-2022, the patient age <1 year received 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5ml dose once of suspect Pentacel vaccine of standard strength (lot UJ502AA, expiry date: May 29, 2022)  via intramuscular route in the right thigh for prophylactic vaccination (expired product administered, latency: same day).  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 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: UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: Medical assistant reports patient was given liquid component of PENTACEL but not powder with no adverse event; Initial information received on 07-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a patient of unknown gender and age, medical assistant reports patient was given liquid component of pentacel but not powder with no adverse event while 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), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (dose, strength, formulation, frequency: unknown) lot UJ670AA, U7256AB expiry date: 13-May-2023 via unknown route in unknown administration site as Immunization.  On an unknown date the patient developed a non-serious event medical assistant reports patient was given liquid component of pentacel but not powder with no adverse event (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (product preparation error).  At time of reporting, the outcome was Unknown for the event product preparation error.   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: F
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: administering MENACTRA to a patient after a temperature excursion where product was deemed not suitable for use with no reported adverse event.; refrigerator with vaccines previously experienced a temperature excursion that reached 37.2C with no reported adverse event.; Initial information received on 07-Jun-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 11 years old female patient who experienced administering menactra to a patient after a temperature excursion where product was deemed not suitable for use with no reported adverse event and refrigerator with vaccines previously experienced a temperature excursion that reached 37.2 Celsius with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination.  On 07-Jun-2022, the patient received a dose: 1 of 0.5 ml total once of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine lot U72688AB, 01-Jul-2023, strength: standard, via intramuscular route in left deltoid for Immunization.   On 07-Jun-2022(Latency: same day) administered menactra to a patient after a temperature excursion where product was deemed not suitable for use with no reported adverse event (Product temperature excursion issue) and refrigerator with vaccines previously experienced a temperature excursion that reached 37.2 Celsius with no reported adverse event. (product storage error).   Action taken was 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: 11.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: poor quality vaccine administered; states that their refrigerator with vaccines previously experienced a temperature excursion that reached 37.2C and the vaccines were deemed not suitable for use with no reported adverse event; Initial information received on 07-Jun-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 11 years old female patient who experienced states that their refrigerator with vaccines previously experienced a temperature excursion that reached 37.2c and the vaccines were deemed not suitable for use with no reported adverse event and poor quality vaccine administered while receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (dip tox) (menactra) for Immunisation.  On 07-Jun-2022, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U7283AA; expiry date: 02-Feb-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On 07-Jun-2022 the patient reported refrigerator with vaccines previously experienced a temperature excursion that reached 37.2c and the vaccines were deemed not suitable for use with no reported adverse event (product storage error) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine. On an unknown date the patient developed a non-serious poor quality vaccine administered (poor quality product administered) (unknown latency) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01135750:
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse administered a MENACTRA vaccine one day after the expiration date, with no adverse event; Initial information received on 08-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old female patient to whom nurse administered a MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine one day after the expiration date, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENB) for Prophylactic vaccination.  On 07-Jun-2022, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6951AA; expiry date: 06-Jun-2022, strength, expiry date: unknown) solution for injection at a dose of 0.5 ml total via intramuscular route in the deltoid as Immunization.  On 07-Jun-2022, the nurse administered a MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE one day after the expiration date, with no adverse event (expired product administered) (latency: same day). He asked if it needs to be repeated.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event nurse administered a menactra vaccine one day after the expiration date, with 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 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: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired does of daptacel with no adverse event; Initial information received on 08-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who was administered an expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine (Daptacel) with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) for Immunisation.  On 08-Jun-2022, the patient received a dose of 0.5 ml total, 1x(1 day), suspect Daptacel (form: Suspension for injection, lot C5743aa, 6-Jun-2022 via intramuscular route, administration site: right thigh, Strength = standard) for immunisation.  On 08-Jun-2022 the patient was administered an expired does of daptacel with no adverse event (expired product administered) (Latency: same day).  Action taken was 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: 2.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product use issue
Clinical narrative: 30-month-old child was given a booster injection of IPOL with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a other health professional on 08-Jun-2022.  This case involves a 30-month-old male child was given a booster injection of IPV (VERO) [IPOL] with no adverse event.    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 B) for Immunization; and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Tetanus Vaccine Toxoid (Adacel) for Immunization.  On 31-May-2022, the 30-month-old child received a second Booster dose of suspect IPV (VERO) at dose 0.5ml once (lot: V1A121M, expiry date:15-Feb-2024) via intramuscular route in the right arm for immunization (product use issue, latency same day).  Action taken: Not applicable.  At time of reporting, the outcome was Recovered on 31-May-2022 for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: received only the dtap/ipv portion of the pentacel vaccine with no adverse event; Initial information received on 08-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 patients of an unknown age and gender who  received only the dtap/ipv portion of the Pentacel vaccine with no adverse event for the 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.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 06-Jun-2022 or 07-Jun-2022, the patient received 0.5 ml  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, once ( lot: U7054AA ; expiry date: 18-Dec-2022)  via intramuscular route in left thigh for immunization.  It was reported that 2 patients received only the Dtap/Ipv portion of the Pentacel vaccine with no adverse event (single component of a two-component product administered) (onset: unknown) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. The ACT-HIB vial was not given to 2 patients  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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: given ACTHIB vaccine that was diluted with a different diluent with no reported adverse event; Initial information was received on 08-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.   This case involves a 12 months old female patient who experienced given acthib vaccine that was diluted with a different diluent with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 08-Jun-2022, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine (lot UJ635AAA, expiry-17-Nov-22) (dose, formulation, and strength: unknown) via intramuscular route in left thigh for immunisation.   On 08-Jun-2022, the patient developed a non-serious given acthib vaccine that was diluted with a different diluent with no reported adverse event (product preparation error) (latency same day) following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event given acthib vaccine that was diluted with a different diluent with no reported 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: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of DAPTACEL being administered to a patient with no reported adverse event; Initial information received on 08-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 18 months old female patient who was administered expired dose of daptacel 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 polio vaccine inact 3v (vero) (ipol [polio vaccine inact 3v (vero)]); Hepatitis A Vaccine (Hepatitis A); and Pneumococcal Vaccine Conj 13V (CRM197) (Prevnar 13) all for immunization.  On 08-Jun-2022, the patient received a 2nd, 0.5 ml dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine lot C5732AA, expiry date: 24-Apr-2022 Frequency is once, unknown strength and formulation via intramuscular route in the left thigh as immunization.  On 08-JUN-2022 the patient developed a non-serious event expired dose of daptacel being administered to a patient with no reported adverse event (expired product administered) latency: same day following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.     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: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of MENACTRA was given today with no adverse events; Initial information was received on 08-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.   This case involves a 20 years old male patient who experienced expired dose of menactra was given today with no adverse events while receiving vaccine meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 08-Jun-2022, the patient received a dose of suspect menactra (lot U6951AA) (dose, formulation, strength and expiry date: unknown) via intramuscular route in the right deltoid for immunisation.  On 08-JUN-2022 the patient developed a non-serious expired dose of menactra was given today with no adverse events (expired product administered) (latency same day) following the administration of menactra.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of menactra was given today with no adverse events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements 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: UNK
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: patient is two days late for their second dose of pre-exposure prophylaxis with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was two days late for their second dose of pre-exposure prophylaxis with no reported adverse event while receiving vaccine IPV (VERO) [IMOVAX].  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 IPV (VERO) lot number not reported via unknown route in unknown administration site for prophylactic vaccination  On an unknown date the was two days late for their second dose of pre-exposure prophylaxis with no reported adverse event (inappropriate schedule of product administration) (unknown latency). It was asked "how to proceed with the second dose"  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event patient is two days late for their second dose of pre-exposure prophylaxis with no reported 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 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: YF
Symptoms: Incorrect route of product administration
Clinical narrative: patient was given YF VAX intramuscularly instead of subcutaneously; Initial information received on 09-Jun-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who was given yellow fever vaccine [YF-VAX] intramuscularly instead of subcutaneously.   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 yellow fever vaccine (lot number, expiry date, form, route, administration site: unknown) for immunization.   On an unknown date the patient was given yellow fever vaccine intramuscularly instead of subcutaneously (incorrect route of product administration) (latency: same day).   Action taken was not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 70.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: received a Tenivac immunization that was later noted to have already expired with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 70 years old female patient who experienced received a tenivac immunization that was later noted to have already expired 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 09-Jun-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, once ( lot: U6669AA ; Expiry date: 15-May-2022)  via intramuscular route in the right deltoid for immunization.  Medical assistant reported that the patient  received a Tenivac immunization that was later noted to have already expired with no reported adverse event (expired product administered) (onset date: 09-Jun-2022; 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: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired DAPTACEL vaccine that was given , Vaccine was Administered on 5/1/2022 but it expired 4/24/2022 with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 5 years old female patient who got expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].vaccine that was given on 01-May-2022 but it expired 24-Apr-2022 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 HEPATITIS A VACCINE INACT (HEP A IN VAC) for Immunisation.  On 01-May-2022, the patient received 0.5 ml total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) (lot C5732AA, Exp date: 24-Apr-2022) via intramuscular route in the right deltoid for immunization.  On 01-MAY-2022 the patient developed a non-serious event of expired daptacel vaccine that was given , vaccine was administered on 5/1/2022 but it expired 4/24/2022 with no reported adverse event (expired product administered) (latency: same day ) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: temperature excursion due to refrigerator data logger malfunction low of 15.22 F 47 min with no ae; product being administered not suitable to use post temperature excursion with no adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 9-month-old female patient who reported HIB (PRP/T) VACCINE [ACT-HIB] product being administered not suitable to use post temperature excursion with no adverse event and temperature excursion due to refrigerator data logger malfunction low of 15.22 f 47 min with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) for Immunization; Polio Vaccine Inactive (IPV) for Immunization; and Hepatitis B Vaccine (Hepatitis B Vaccine) for Immunization.  On an unknown date, it was reported that temperature excursion occurred due to refrigerator data logger malfunction low temperature of 15.22 Fahrenheit and time 47 min with no ae (product storage error).  On 08-Jun-2022, the patient received suspect ACT-HIB vaccine post temperature excursion at dose 0.5ml once intramuscular (lot uj633aaa, expiry date: 30-Nov-2022) via intramuscular route in unknown administration site for prophylactic vaccination (poor quality product administered, latency: same day).  Action taken: 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: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administering Menactra after expiration with no reported adverse event; Initial information received  on 09-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 20 years old female patient who experienced administering menactra after expiration with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 09-Jun-2022, the patient received a  0.5 ml dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (lot U6921AA; expiry date: 07-Apr-2022)  (strength, formulation: unknown) via intramuscular route in the left deltoid for immunization.  On 09-JUN-2022 the patient reported administering Meningococcal A-C-Y-W135 (D CONJ) vaccine (Menactra) after expiration with no reported adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event (expired product administered).  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.