chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, UNK
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: they administered the liquid part of PENTACEL (DTAP-IPV component) that was diluted with 0.5 ml sterile water but the lyophilized part (ACTHIB) was never given with no reported adverse event; they administered the liquid part of PENTACEL (DTAP-IPV component) that was diluted with 0.5 ml sterile water but the lyophilized part (ACTHIB) was never given with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves an unknown age and gender patient who was administered the liquid part of pentacel (dtap-ipv component) that was diluted with 0.5 ml sterile water but the lyophilized part (acthib) was never given with no reported adverse event , after  receiving vaccines HIB (PRP/T) VACCINE [ACT-HIB] and 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 once a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (U7311AA and expiration date: 09-Sep-2023) and a  dose of suspect HIB (PRP/T) VACCINE ( lot UJ757AA and expiration date: 09-Sep-2023) at an unknown dose via unknown route at unknown administration site for immunization.  On 01-Sep-2022 t(latency: same day), the patient developed a non-serious event" they administered the liquid part of pentacel (dtap-ipv component) that was diluted with 0.5 ml sterile water but the lyophilized part (acthib) was never given with no reported adverse event" (single component of a two-component product administered) (product preparation error) following the administration.   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   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: U
Vaccine: HIBV, IPV, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccines were out of range for 12 hours due to the refrigerator door being left open with a max temperature reached of 72°F with no reported adverse event.; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves no patient and reporter stated the vaccines were out of range for 12 hours due to the refrigerator door being left open with a max temperature reached of 72°f for vaccines HIB (PRP/T) VACCINE [ACT-HIB], IPV (VERO) [IPOL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  On an unknown date,  the reporter stated that the vaccines were out of range for 12 hours due to the refrigerator door being left open with a max temperature reached of 72°f with no reported adverse event. (product storage error). Vaccines have not been administered post excursion.  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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: MENACTRA at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes, with no adverse event; menactra one dose was administered post excursion, with no adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA373167, 2022SA372581 and 2022SA372123.  This case involves a 17 years old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and it was found out that menactra at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes, with no adverse event and menactra one dose was administered post excursion, with no 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  dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength: unknown) lot U7492AB, expiration date: 26-Oct-2023, via intramuscular route in the left arm as Immunisation.  On 29-AUG-2022 the menactra one dose was administered post excursion, with no adverse event (poor quality product administered) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This situation was reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard.  On an unknown date the menactra at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes, with no adverse event (product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (MENACTRA at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes, with no adverse event, menactra one dose was administered post excursion, with no adverse event).  At time of reporting, the outcome was Unknown for the all.  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: 18.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached: 1.3C Duration out of labelled range: 38 minutes with no reported adverse event; FLUZONE QUAD MDV had been administered to a patient post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who has been administered vaccine Influenza quadrival A-B multidose vaccine preserved [Fluzone quadrivalent multidose] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Temperature excursion occurred on 01-Sep-2022 for Fluzone Quad MDV (punctured and unopened) and cause is unknown. Max/low temperature reached 1.3C Duration out of labelled range: 38 minutes with no reported adverse Event (product storage error).  Other vaccines involve in temperature excursion were Daptacel, Acthib, Menquadfi, Fluzone Quad PFS (all unopened).   On 02-Sep-2022, the patient received a dose of suspect Influenza quadrival A-B multidose vaccine preserved (formulation, dose: unknown) (lot UJ879AB, Exp date: 30-Jun-2023) via unknown route in unknown administration site as Prophylactic vaccination post excursion with no reported adverse event (poor quality product administered).  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 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: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: ACTHIB at a low of negative 5.1C out of range for 12 minutes and a  low of 1.3C out of range for 10 minutes with no reported adverse event; Act HIB was administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and acthib at a low of negative 5.1c out of range for 12 minutes and a  low of 1.3c out of range for 10 minutes with no reported adverse event and act hib was administrated post excursion with no reported adverse event.  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  dose of 0. 5ml of  suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot UJ665AA, expiration date: 11-Mar-2023,via intramuscular route in the left thigh as immunization.  On an unknown date the acthib at a low of negative 5.1c out of range for 12 minutes and a  low of 1.3c out of range for 10 minutes with no reported adverse event (product storage error) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  On 30-AUG-2022 the act hib was administrated post excursion with no reported adverse event (poor quality product administered) same day following the administration of HIB (PRP/T) VACCINE. This situation was reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard. No further information provided by the reporter.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (ACTHIB at a low of negative 5.1C out of range for 12 minutes and a  low of 1.3C out of range for 10 minutes with no reported adverse event, Act HIB was administrated post excursion with no reported adverse event).  At time of reporting, the outcome was Unknown for all.  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: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 year old male patient was given the quadracel in error with no reported AE; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who was given the quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE) in error with no reported ae( adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Jun-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot 65772AA, expiration date: 17-Sep-2022 via intramuscular route in the left thigh as Immunisation.  On 29-JUN-2022 the 2 year old male patient was given the quadracel in error with no reported ae (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (2 year old male patient was given the quadracel in error with no reported AE).  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: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: MENQUADFI given too early after first dose of MENACTRA on accident, with no reported adverse event; received an extra dose , with no reported AE; Initial information received on 07-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old and unknown gender patient who was given menquadfi too early after first dose of menactra on accident, with no reported adverse event and received an extra dose with no reported ae after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past vaccination(s) included MENACTRA on 22-MAR-2022 with first dose. The patient's past medical history, medical treatment(s) and family history were not provided.   On 05-Aug-2022, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U7294AC and expiration date: 23-May-2024 at a dose of 0.5ml once via intramuscular route in the left deltoid as prophylactic vaccination.  On 05-Aug-2022(latency: same day), the patient  was given menquadfi  too early after first dose of menactra on accident, with no reported adverse event (inappropriate schedule of product administration). It was also reported that the patient has received an extra dose with no reported ae (extra dose administered).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   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.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: Child was given 2nd dose of MENQUADFI in error with no repoted adverse event; was inadvertently administered an extra dose of MENQUADFI with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 11 years old female patient who reported child was given 2nd dose of menquadfi in error with no repoted adverse event and was inadvertently administered an extra dose of menquadfi with no reported 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. The patient received no concomitant vaccines on 18- Aug-2022.    On 18-Aug-2022, the patient received a  0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE once (strength, formulation, lot number not reported) via intramuscular route  in arm NOS for immunization.  On 18-AUG-2022 (latency: same day), the patient reported a non-serious events child was given 2nd dose of menquadfi in error with no repoted adverse event (wrong product administered)and inadvertently administered an extra dose of menquadfi with no reported adverse event (extra dose administered)  following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) 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: 8.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Off label use
Clinical narrative: Adacel (Tdap) as part of a catch-up immunization schedule for an 8-year-old patient with no reported adverse event; Initial information received on 07-Sep-2022 regarding an unsolicited valid non-serious case received from health professional. GMI number: 01268496.  This case involves an 8-year-old child and unknown gender patient to whom Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] (tdap) as part of a catch-up immunization schedule with no reported adverse event.  The patient has received only one dose of DTaP. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown onset and latency, the 8-year-old child patient had a prescription suspect Adacel vaccine at (formulation, strength, dose, lot number, route in unknown administration site) as part of a catch-up immunization schedule (prophylactic vaccination) with no reported adverse event (product prescribing error). Information regarding batch number requested.  It was reported that "health care professional (HCP) asked about administering ADACEL (Tdap) This situation is reported as an off label use as per local labelling due to planned use of Adacel in a patient under 10 years of age. The practice may use Adacel (Tdap) as part of a catch-up immunization schedule for an 8-year-old patient who has previously received only one dose of DTaP. Patient has not yet been administered any Adacel."  Action taken: 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: 5.0
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered PENTACEL to a patient 5 years old and 9 months with no reported adverse event; Initial information received on 07-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (vero)] to a patient 5 years old and 9 months with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received 0.5 mL of 5th dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine (lot UJ641AAA, expiry date: 28-Feb-2023) via intramuscular route in the left deltoid for prophylactic vaccination.  On 07-Sep-2022, (latency: same day) the patient was administered pentacel to a patient 5 years old and 9 months with no reported adverse event (product administered to patient of inappropriate age).  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.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 year old patient was administered QUADRACEL which is not the indicated age group with no reported adversee event; Initial information received on 07-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old female patient who was administered quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE) which is not the indicated age group 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 (HEPATITIS A).  On 06-Sep-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation, strength: unknown) lot C5851AA, expiration date: 25-Mar-2023, via intramuscular route in the right thigh as Immunization.  On 06-SEP-2022 the 7 year old patient was administered quadracel which is not the indicated age group with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (7 year old patient was administered QUADRACEL which is not the indicated age group 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.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally gave a patient expired typhim vi with no reported adverse event; Initial information received on 07-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter stated that accidentally gave a patient expired TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] 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 an unknown date, the patient received an unknown dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (strength, formulation, lot number was unknown and expiry date: 03-Sep-2022) not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event of accidentally gave a patient expired typhim vi with no reported adverse event (expired product administered) (latency: unknown) following the administration of TYPHOID VI POLYSACCHARIDE 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 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: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: have received an expired FLUZONE QIV vaccine with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (Healthcare professional).  This case is linked to case 2022SA375602(CLUSTER).  This case involves a 80 years old female patient who received an expired Influenza quadrival A-B vaccine [Fluzone QIV] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Sep-2022, the patient received first dose, 0.5 ml of suspect Influenza quadrival A-B vaccine, pre-filled syringes (lot UT7411JA 30-Jun-2022) via intramuscular route in the deltoid NOS (not otherwise specified) as Immunization.  On 08-Sep-2022 (latency: same day), the patient has received an expired Fluzone QIV vaccine with no reported adverse event (expired product administered).  One of the boxes of Fluzone QIV NP pre-filled syringes that was received on 01-Sep-2022 contained multiple lot numbers and that up to 10 pre-filled syringes had already expired on 30-Jun-2022. Also, as many as 6 other patients may have received expired Fluzone QIV NP vaccines earlier in the week.   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: 0.17
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product formulation issue, Single component of a two-component product administered
Clinical narrative: DTaP-IPV component of PENTACEL given without the Hib component with no reported adverse event.; Initial information received  on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old female patient was given dtap-ipv component of pentacel given without the hib component with no reported 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. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 08-Sep-2022, the patient received a total dose number 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6970BA and expiration date:  31-Jan-2023) at a dose of 0.5ml via intramuscular route in the right thigh for immunization.  On 08-Sep-2022 (Latency: same day),the patient was given dtap-ipv component of pentacel given without the hib component with no reported adverse event(Product ingredient issue) 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.
Age: 0.75
Sex: M
Vaccine: YF
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: YF-VAX had an excursion and were administered to a patient, with no reported adverse event; YF-VAX had an excursion and were administered to a patient, with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a nurse. GMI number: 01270287  This case involves a 9-month-old male patient who had YELLOW FEVER VACCINE - [YF-VAX] after excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, nurse reported yf-vax had an excursion (product storage error).  On 07-Sep-2022, the patient received suspect YF-VAX vaccine post excursion at dose 0.5 ml once via subcutaneous route in the left leg (lot UJ563AA, expiry date: 23-May-2023) for prophylactic vaccination with no reported adverse event (poor quality product administered) same day latency. It was not the first time of product use. At time of report, product was not in use.  It was reported that "Nurse called to report that her YF-VAX had an excursion and were administered to a patient. Nurse also wants to know if they need to revaccinate and if they could return or reimburse the vaccines. Nurse also confirmed stability information just to make sure she has right info. Agent advised nurse to contact customer service with regards to replacement and reimbursement. Agent provided contact details."  Action taken: Not applicable.  At time of reporting, the outcome was 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.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: an extra dose (third dose) of menactra was inadvertently administered to a patient,with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case via health professional. Agency number: 01270356  This case involves a 17-year-old male patient who experienced an extra dose (third dose) of Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] was inadvertently administered to a patient with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Oct-2016, patient received 1st dose of suspect Menactra at 1 dosage form at (unknown: formulation, strength, batch number, route, administration site for immunization and second dose on 29-Jul-2021.  On 07-Sep-2022, patient received an extra dose 3rd dose of suspect Menactra at dose 0.5ml once via intramuscular route in the left deltoid (lot: U7211AB, expiry date: 14-MAR-2023) for immunization was inadvertently administered with no reported adverse event (extra dose administered) 5 years 10 months 18 days following first dose and same day following last vaccination.  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: 3.0
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: had an excursion and were administered to a patient with no reported adverse event; had an excursion and were administered to a patient with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who  were administered vaccine post excursion with no reported adverse event , after receiving vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received a  dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot U2A471M  and expiration date: 02-Nov-2023) at a dose of 0.5ml total dose via intramuscular route in the left arm for vaccination.  On 07-Sep-2022, the patient developed a non-serious had an excursion and were administered to a patient with no reported adverse event (poor quality product administered)(latency: same day) (product storage error).  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   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: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: inadvertently administered YF-VAX intramuscularly rather than subcutaneously with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient of unknown demographics who was inadvertently administered yf-vax(YELLOW FEVER VACCINE) intramuscularly rather than subcutaneously with no reported 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 received a dose of 0.25 mL to 2 mL of suspect YELLOW FEVER VACCINE- (formulation, strength: unknown) lot number not reported via intramuscular route in unknown administration site as Immunization. Lot number was requested.  On an unknown date the patient was inadvertently administered yf-vax intramuscularly rather than subcutaneously with no reported adverse event (incorrect route of product administration) same day following the administration of YELLOW FEVER VACCINE. Caller asked if there was any guidance on what they should do, asked if it was necessary to revaccinate the patient with YF-VAX via the subcutaneous route?  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inadvertently administered YF-VAX intramuscularly rather than subcutaneously 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: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a patient was mistakenly given Daptacel in the right deltoid instead of a Tdap vaccine with no reported AE; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced a patient was mistakenly given daptacel in the right deltoid instead of a tdap vaccine with no reported ae 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 MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 03-Aug-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE once (lot C5829BA; 01-Mar-2023)  via unknown route in the right deltoid for immunization.  On 03-AUG-2022 the patient reported a non-serious event a patient was mistakenly given daptacel in the right deltoid instead of a tdap vaccine with no reported ae (wrong product administered) 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 wrong 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 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: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Temperature excursion at 31.3 degrees Fahrenheit / Below 0 degrees Celsius to 46.4 degrees Fahrenheit/ 8 degrees Celsius for 1 hour and 30 minutes with no reported adverse event; vaccine administered post excursion with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA377654(CLUSTER), 2022SA378232(CLUSTER) and 2022SA377972(CLUSTER).  This case involves an unknown age and unknown gender patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] post temperature excursion at 31.3 degrees Fahrenheit / below 0 degrees Celsius to 46.4 degrees Fahrenheit/ 8 degrees Celsius for 1 hour and 30 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE was exposed to a temperature excursion at 31.3 degrees Fahrenheit / below 0 degrees Celsius to 46.4 degrees Fahrenheit/ 8 degrees Celsius for 1 hour and 30 minutes with no reported adverse event (product storage error).  On 07-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ882AE and expiry date: 30-Jun-2023; strength, formulation, dose, route and administration site not reported) for prophylactic vaccination.  On 07-Sep-2022, (latency: same day) the patient was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE post excursion with no reported adverse event (poor quality product administered).  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 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:  01268516: 01270405: 01270731: 01270733: 01270734: 01270737: 01270744:
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion "over the weekend" with no adverse event; 1 dose of FLUZONE QUAD was administered with no adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA374787, 2022SA375305, 2022SA377972, 2022SA377654, 2022SA378232, 2022SA377654, 2022SA376599 and 2022SA378232.  This case involves an unknown age and unknown gender patient where temperature excursion "over the weekend" with no adverse event and 1 dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 07-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at an unknown dose (lot UJ882AE, expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunisation.  On an unknown date there was temperature excursion "over the weekend" with no adverse event (product storage error) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On 07-Sep-2022, 1 dose of fluzone quad was administered with no adverse event (poor quality product administered) same day latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported that the refrigerator reached the lowest temperature of 31.3 degrees F for 1 and a half hours before returning to recommended storage conditions. The pharmacist reported that he had called yesterday to obtain stability information and was calling back to gather additional stability information. Alternate temperatures were initially reported therefore the pharmacist confirmed the following temperature readings with the system for verification: MAXIMUM TEMP REACHED: 46.4 degrees F/ 8 degrees C MINIMUM TEMP REACHED: 31.3 degrees F / Below 0 degrees C MAXIMUM TIME PERIOD EXPOSED: 1 hour and 30.  Action taken: Not applicable.  Outcome: 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.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: maximum temp reached 46.4 degrees F/ 8 degrees C minimum temp reached: 31.3 degrees F / Below 0 degrees C maximum time period exposed: 1 hour and 30 minutes and FLUZONE HIGH DOSE were administered with no adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2022SA374787, 2022SA375305, 2022SA376599, 2022SA377972, 2022SA378232 and 2022SA379755.  This case involves an unknown age and unknown gender patient who was given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after maximum temp reached 46.4 degrees F/ 8 degrees C minimum temp reached 31.3 degrees f / below 0 degrees c maximum time period exposed 1 hour and 30 minutes with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ882AE Exp date: 30-Jun-2023) via unknown route in unknown administration site for Immunization.  On 07-Sep-2022 (same day), the patient developed a non-serious maximum temp reached 46.4 degrees f/ 8 degrees c minimum temp reached: 31.3 degrees f / below 0 degrees c maximum time period exposed: 1 hour and 30 minutes and fluzone high dose were administered with no adverse event (poor quality product administered).  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.