chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired DAPTACEL being administered to a patient with no adverse event; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] being administered to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 31-Aug-2022, the patient was administered with an expired dose 4 (0.5 ml) (1x) once of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (lot C5765BA: Expiry date. 28-Aug-2022) via intramuscular route in the right vastus lateralis for immunisation with no adverse event (expired product administered) (latency: same day)  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 36.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient under age 65 administered Fluzone HD in error with no reported AE; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 36 years old female patient who was under age 65 and was administered fluzone hd in error with no reported adverse event , after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Strength: high dose) lot UJN04AA and expiration date: 30-Jun-2024 at a dose of 0.7ml via intramuscular route in the deltoid nos for immunization.  On 30-Aug-2022 (Latency: same day), the patient  was under age 65 and was administered fluzone hd in error with no reported ae (product administered to patient of inappropriate age) following the administration .   Action taken:not applicable  It was not reported if the patient received a corrective treatment for the event .   Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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:  01257338: 01258919: 01258920: 01258924: US-SA-2022SA365119:01258901
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient under age 65 administered Fluzone HD in error no adverse event; Related cases: US-SA-2022SA364394, US-SA-2022SA365006, US-SA-2022SA365119, US-SA-2022SA365883.  Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 41 years old female patient who was administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] in error no adverse event. Patient is under age 65.  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 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (formulation, strength: unknown) (lot UJN04AA, 30-Jun-2023) via intramuscular route in the deltoid NOS for immunization patient under age 65 administered fluzone hd in error no adverse event (product administered to patient of inappropriate age) (latency; Same day). Nurse reports that yesterday, they held an Employee Health Clinic and administered flu vaccines. She states that there was a "communication error" between staff, complicated by a failure to perform "triple checks". This resulted in 5 employees receiving FLUZONE HIGH-DOSE. No other vaccines were administered. QUADRIVALENT vaccine, though they were < 65 years-old.  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-2022SA365119:01258919
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they administered FLUZONE HD to employees that were not 65 and older with no reported adverse event; Related cases: US-SA-2022SA364394, US-SA-2022SA365006, US-SA-2022SA366945, US-SA-2022SA365883.  Initial information received on 31-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 30 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] long with other employees that were not 65 and older 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 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  (lot UJN04AA, 30-Jun-2023) via intramuscular route in the deltoid NOS as Immunization.  On 30-Aug-2022 the patient developed a non-serious "they administered fluzone hd to employees that were not 65 and older with no reported adverse event" (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  it was reported that Nurse reports that yesterday, they held an Employee Health Clinic and administered flu vaccines. She states that there was a "communication error" between staff, complicated by a failure to perform "triple checks". This resulted in 5 employees receiving FLUZONE HIGH-DOSE. No other vaccines were administered. QUADRIVALENT vaccine, though they were < 65 years-old.  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:  US-SA-2022SA364394:01257338 US-SA-2022SA365006:01258901 US-SA-2022SA366945:01258919 US-SA-2022SA365883:01258924
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product use issue
Clinical narrative: 48 year old patient administered fluzone high-dose vaccine, with no reported adverse event; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 48 years old female patient who was administered fluzone high-dose vaccine, with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength not reported; lot UJN04AA, expiry date: 30-Jun-2023) via intramuscular route in the deltoid nos for prophylactic immunization.  On 30-Aug-2022, (latency: same day) the 48 year old patient administered fluzone high-dose vaccine, with no reported adverse event (product use issue) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  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.; Sender's Comments:  01257338: 01258901: 01258901: 01258919: 01258920: US-SA-2022SA365119:01258924
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: DAPTACEL was given to a 12 year old with no reported adverse event; Initial information received on 31-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 12 years old female patient who was given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] to a 12 year old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccines included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation; and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  On 12-Aug-2022, the patient received a 0.5 ml once, 6th dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown), (lot C828AA, exp date: 30-Mar-2023) via intramuscular route in the right deltoid as immunization.  On 12-Aug-2022 (latency: same day),  the patient developed a non-serious event of "Daptacel was given to a 12 year old with no reported adverse event" (product administered to patient of inappropriate age) 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 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: 19.0
Sex: F
Vaccine: YF
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: red dots on neck hands and arms; developed random red bumps not at the injection site but on neck. They went away and got some on arms and hands; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 19 years old female patient who experienced red dots on neck hands and arms and developed random red bumps not at the injection site but on neck. they went away and got some on arms and hands, after 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 22-Aug-2022, the patient received a dose number 2 of suspect YELLOW FEVER VACCINE -   injection(lot UJ602AA and expiration date: 13-Jul-2023)at a dose of 0.5ml total via subcutaneous route in the left arm  for immunization.  In AUG-2022 (latency: approximately a week) , it has been over a week since the patient her yellow fever vaccine and she developed random red bumps not at the injection site but on her neck (rash papular).They went away and she got some on her arms and her hands (rash erythematous). The bumps do not hurt or itch they are just there and she wanted to know if it is associated with the vaccine. It was also reported the first injection the patient received the syringe was a faulty syringe and started leaking as soon as the syringe was injected  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events .   Outcome: unknown for both events
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: an expired ACTHIB was given to patient with no reported adverse event; Initial information received from on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 6 months old female patient to whom an expired HIB (PRP/T) VACCINE [ACT-HIB] was given with no reported adverse event.  Concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) ; POLIO VACCINE (POLIO) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) all for Immunisation.  On 31-Aug-2022, the patient received an expired dose 3 (0.5ml) of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection, (Strength; Unknown) (lot UJ521AAA: expiry date 11-Jul-2022)  via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (latency: same day). Reporter wants to know if they need to revaccinate and if there are adverse effects that they should look out for.  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: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Quadracel given by mistake instead of the age-appropriate vaccine no adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 months old and unknown gender patient to whom diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] given by mistake instead of the age-appropriate vaccine no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5ml dose once (1X) of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (lot number and expiry date not reported) via unknown route in unknown administration site for immunization given by mistake instead of the age-appropriate vaccine no adverse event (product administered to patient of inappropriate age) (unknown latency). The dose was given about a week ago. It was asked that is there any consequences or potential adverse risk to a 10-month old who received Quadracel instead of the age-appropriate 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: 8.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: stated Daptacel administered instead of ADACEL for 8 years old patient with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old female patient where it was reported that daptacel (DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE) administered instead of adacel for 8 years old patient 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 POLIO VACCINE (POLIO VACCINE) for Immunisation.  On 01-Sep-2022, the patient received a third dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot C5829BA, expiration date: 01-Mar-2023, via unknown route in unknown administration site as Immunization.  On 01-SEP-2022 the daptacel was administered instead of adacel for 8 years old patient with no reported adverse event (wrong product administered) 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 (stated Daptacel administered instead of ADACEL for 8 years old patient 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: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: extra dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient to whom extra dose of acthib was administered 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 01-Sep-2022, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (formulation and strength not reported; lot U7260AA, expiry date: 30-Mar-2023) via intramuscular route in the left vastus lateralis for prophylactic immunization.  On 01-Sep-2022, (latency: same day) the patient had extra dose of acthib was administered to a patient with no reported adverse event (extra dose administered) following the administration of HIB (PRP/T) VACCINE.  It was reported, "An extra dose of ACTHIB was administered to a 6 month old male patient. This was ACTHIB dose number four in the series. The patient received their third dose of ACTHIB on 11Aug2022".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 4 year old patient was administered DAPTACEL after the expiration date with no adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 4 years old and unknown gender patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] 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.  On 01-Sep-2022, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (dose, strength, formulation: unknown), (lot C5765BA, 28-Aug-2022) via unknown route in unknown administration site as Immunization.  On 01-Sep-2022 (latency: same day), the patient developed a non-serious event "a 4 year old patient was administered daptacel after the expiration date with no adverse event" (expired 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.   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: 25.0
Sex: U
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gave TDAP designed for a 4 to 6 week old to a 25 year old accidentally with no reported adverse event.; Initial information received on 01-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 25 years old and unknown gender patient who was given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] designed for a 4 to 6 week old with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Sep-2022, the patient received a 0.5 ml total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5828AA, 30-Mar-2023) via intramuscular route in the left deltoid as Immunization   .  On 01-Sep-2022 (latency: same day), the patient developed a non-serious "gave tdap designed for a 4 to 6 week old to a 25 year old accidentally with no reported adverse event" (product administered to patient of inappropriate age) 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: pentacel was not mixed with no reported adverse event; patient received the Dtap and Ipol portion but not the ACTHIB portion with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient for whom pentacel was not mixed with no reported adverse event and patient received the dtap and ipol portion but not the acthib portion with no reported adverse event after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date pentacel was not mixed with no reported adverse event (product preparation error) (same day latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  On an unknown date the patient received the dtap and ipol portion but not the acthib portion with no reported adverse event (single component of a two-component product administered) (same day latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  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.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: patient mistakenly received a fluzone qiv np vaccine instead of a fluzone high-dose quadrivalent vaccine with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 71 years old female patient who mistakenly received a Influenza quadrival A-B vaccine (Fluzone QIV NP) instead of a Fluzone high-dose quadrivalent vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2022, the patient mistakenly received 0.5 ml  dose 1 of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7681NA; expiry date: 30-JUN-2023) via intramuscular route in the left deltoid for immunization instead of a fluzone high-dose quadrivalent vaccine with no reported adverse event (wrong product administered) (latency: same day) Pharmacist initially stated that the patient had received a FLUBLOK vaccine but clarified that they did receive a FLUZONE QIV NP vaccine from pre-filled syringe during the visit after reviewing the case. Pharmacist asked how to proceed and whether or not the patient should be re-vaccinated with FLUZONE HIGH-DOSE QUADRIVALENT.  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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Pentacel dose given after expiration 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 a 4 months old male patient who reported pentacel dose given after expiration with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Prophylactic vaccination.  On 02-Sep-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (1X) (lot UJ544AB; expiry date: 07-Aug-2022) via intramuscular route in the left thigh for prophylactic vaccination.  On 02-SEP-2022 the patient reported pentacel dose given after expiration with no reported adverse event (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Accidental dose given to 3 year 8 month and 3 day 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 a 3 year 8 month and 3 day old male patient was accidentally given a dose of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] 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) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 15-Aug-2022, the patient received accidentally 0.5 ml dose (5th dose of Dtap and 4th Dose of Polio) of suspect  diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (lot C5862BA: Expiration Date; 01-Apr-2023) via unknown route in the left vastus lateralis for Immunization with no reported adverse event (inappropriate schedule of product administration) (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.
Age: 25.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error, Wrong product administered
Clinical narrative: adacel was supposed to be given, however daptacel was given in error,with no reported adverse event; DAPTACEL indicated for 4 weeks to 6 years that had been given to a woman in her 20s with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 25 years old female patient to whom adacel was supposed to be given, however daptacel was given in error,with no reported adverse event and daptacel indicated for 4 weeks to 6 years that had been given to a woman in her 20s with no reported adverse event while receiving vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 01-Sep-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml (lot C582844, expiry date: 30-Mar-2023) via intramuscular route in the left deltoid for immunisation.  On 01-Sep-2022 the patient to whom adacel was supposed to be given, however daptacel was given in error,with no reported adverse event (wrong product administered) and daptacel indicated for 4 weeks to 6 years that had been given to a woman in her 20s with no reported adverse event (product administered to patient of inappropriate age) same day latency following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  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: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 4 patients received IPOL from the opened multi-dose vial after it was punctured  with no reported adverse event; several cold temperature excursions occurred.The total excursion time was for 20 hours and the lowest temperature reached was 0.7C with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves  4 patient of unknown age and gender who received IPV (VERO) [IPOL] from the opened multi-dose vial after it was punctured  with no reported adverse event and several cold temperature excursions occurred. the total excursion time was for 20 hours and the lowest temperature reached was 0.7c with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  It was reported that there was a several cold temperature excursion occurred between 29-Apr-2022 and 27-May-2022. The total excursion time was for 20 hours and the lowest temperature reached was 0.7c with no reported adverse event (product storage error) involving IPV (VERO). Reporter was not sure of the cause of the excursions because they all occurred overnight while the facility was closed and believes that it may have been due to a fluctuation in electricity. The products involved were one punctured multi-dose vial of IPOL that was punctured on 03-May-2022. This situation was reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data  On 03-May-2022, the patient received a 0.5ml dose of suspect IPV (VERO) (strength, formulation was unknown, lot V1A121M and expiry date: 15-FEB-2024) via unknown route in unknown administration site for Immunization.  On 03-May-2022 the patient developed a non-serious event of 4 patients received ipol from the opened multi-dose vial after it was punctured  with no reported adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  No further information provided by the reporter  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: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2 years old and given all 5 doses( 5th dose is given only after 4.5 year with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 2 years old female patient who was given all 5 doses ( 5th dose is given only after 4.5 year) of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE 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 suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (dose, formulation, brand name, batch lot : unknown) produced by unknown manufacturer via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious event of "2 years old and given all 5 doses( 5th dose is given only after 4.5 year) with no reported adverse event (inappropriate schedule of product administration) (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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: under dose administration of quadracel due to the child moving during administration with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 years old female patient who had under dose administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] due to the child moving during administration 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 MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On 02-Sep-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at a dose of 0.5 ml lot U7526AA via intramuscular route in the left deltoid for immunisation.  On 02-Sep-2022 the patient had under dose administration of quadracel due to the child moving during administration with no reported adverse event (underdose).  Action taken: Not applicable.  Outcome: Unknown.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: adcel given intradermally instead of intramuscular, with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 43 years old female patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was given intradermally instead of intramuscular 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 0.5ml once (1X) as  booster dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot C5963AA; expiry date: 18-Jan-2024) via intradermal route in the left forearm for immunization instead of intramuscular, with no reported adverse event (incorrect route of product administration) (unknown latency).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, Medication error
Clinical narrative: extra dose of menactra 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 and unknown gender patient who was administered extra dose of menactra 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.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength, dose, route, administration site and lot number not reported) for prophylactic vaccination.  On an unknown date, (unknown latency) the patient was administered an extra dose of menactra with no reported adverse event (extra dose administered).  It was reported, "Patient was administered a 3rd dose 1 year after the patient's 2nd dose by mistake".  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: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired dose of acthib administered 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 years old male patient to whom experienced expired dose of HIB (PRP/T) VACCINE [ACT-HIB] administered 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 PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 03-Sep-2022, the patient received a 0.5 ml total, 4th dose of suspect HIB (PRP/T) VACCINE, unknown formulation, (lot UJ661AA, exp date: 06-May-2022) via intramuscular route in the left thigh as Immunization.  On 03-Sep-2022 the patient got expired dose of acthib administered with no reported adverse event (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: DTAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: one dose of DAPTACEL was administrated 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 involves an unknown age and unknown gender patient whom one dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administrated post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administrated one dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (lot number and expiry date not reported) via unknown route in unknown administration site for immunization post excursion with no adverse event (poor quality product administered) (unknown latency).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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:  01266903: 01266768: 01266921: 01266924: 01266780: 01266792: 01266974: 01266976: 01266978: 01266980: 01266982: 01266983: 01266985: US-SA-2022SA372080: