chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: all affected products were administered to patients with no reported adverse event; Initial information received on 06-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 3 patients of age between one year of age to 8 years old, IPV (Vero) [IPOL] products were administered to patients 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 patients received a unknown dose of suspect IPV (VERO) suspension for injection (strength: unknown, expiry date: 09-Aug-2025 and lot W1A101M) via unknown route in unknown administration site as prophylactic vaccination (immunization) and all affected products were administered to patients with no reported adverse event (poor quality product administered) (same day latency).  Reportedly: - From 24-Aug-2024 to 05-Sep-2024 vaccine that was involved in a temperature excursion resulting in below 0 temperature exposure was given to 3 patients.  All patients involved in this administration range were one year of age to 8 years old.  Per guidelines this inactivated doses and all patients have been informed and offered a no cost revaccination.   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.   Additional information received on 24-Sep-2024 following changes were updated: Base upon information received case type was updated to valid from non-valid and patient detail, batch lot detail were updated text amended accordingly.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 50-year-old patient was inadvertently administered a dose of FLUZONE HD, with no reported adverse event; Initial information received on 07-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 50 years old female patient was inadvertently administered a dose of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD], 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 Varicella zoster vaccine rgE (CHO) (Shingrix) for Immunisation.  On 07-Oct-2024, the patient received a dose of 0.5 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) lot UT8463AA, Expiry date: 30-Jun-2025, strength was unknown via intramuscular route in the left arm for Immunization and 50-year-old patient was inadvertently administered a dose of fluzone hd, with no reported adverse event (product administered to patient of inappropriate age) (latency : same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administration of FLUZONE HD to a patient whose age is not within the approved product labeling."  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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered PENTACEL in which only the diluent/ DTAP/IPV portion was administered, with no reported adverse event; Initial information received on 07-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] in which only the diluent/ dtap/ipv portion was 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 Rotavirus vaccine, Hepatitis b vaccine and PNEUMOCOCCAL VACCINE all for Immunisation.  On 07-Oct-2024, the patient received 0.5 l (dose 1)  dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (lot UJ971AA; Expiration date:  05-NOV-2024) via intramuscular route in the right thigh for Immunization in which only the diluent/ dtap/ipv portion was administered, with no reported adverse event (single component of a two-component product administered) (latency: same day).    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: 16.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally administered flublok to a patient who is 16 years old with no reported adverse event; Initial information received on 07-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 16 years old and unknown gender patient who was accidentally administered influenza quadrivalent recombinant vaccine [Flublok] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Oct-2024, a 16 year old patient received 0.5 ml of influenza quadrivalent recombinant vaccine with standard strength (formulation- unknown, lot TFAA2404 and expiry date- 01-Apr-2025) once via intramuscular route in the right deltoid for Inluenza Vaccination with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, there was no other vaccines and no ER (emergency room)/Dr (doctor) visit.  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: 15.0
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK TRIVALENT being administered to a 15-year-old, with no reported adverse event; Initial information received on 07-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15-year-old and unknown gender patient whom influenza trivalent recombinant vaccine [Flublok TIV] being administered 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 15-year-old patient received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  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: No adverse event, Product preparation issue
Clinical narrative: patient who was given with a partial dose of PENTACEL vaccine DTAP-IPV liquid portion was given but it was not mixed with the powdered component (ACTHIB) with no reported adverse event; Initial information received on 08-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who who was given with a partial dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and DTAP-IPV liquid portion was given but it was not mixed with the powdered component (ACTHIB) 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 (Pneumococcal vaccine) for Immunisation; Polio vaccine (Polio vaccine) for Immunisation; and Rotavirus vaccine (Rotavirus vaccine) for Immunisation.  On 12-Sep-2024, the patient was given with a partial dose (dose 2) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UK019AA; Expiration Date: 30-Jun-2025) via intramuscular route in the left arm for Immunization as dtap-ipv liquid portion was given but it was not mixed with the powdered component (acthib) with no reported adverse event (single component of a two-component product administered) (latency: same day).   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: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: received fluzone qiv np last year and after a few days develop shingles; Initial information received on 08-Oct-2024 regarding an unsolicited valid  non-serious case received from a consumer/Non-Healthcare Professional.  This case involves a 78 years old female patient who received Influenza quadrival A-B vaccine [Fluzone Quadrivalent] last year and after a few days develop shingles.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2023 the patient received unknown dose of suspect Influenza quadrival A-B vaccine, Suspension for injection (strength, lot number and expiry date not reported) via unknown route in unknown administration site for Immunization. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date in 2023 after a few days patient develop shingles (herpes zoster).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (received fluzone qiv np last year and after a few days develop shingles).  At time of reporting, the outcome was Unknown for the event received fluzone qiv np last year and after a few days develop shingles.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: administering MENQUADFI vaccines that are no longer suitable to patients because of a temperature excursion with no ae; administering menquadfi vaccines that are no longer suitable to patients because of a temperature excursion with no ae; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  The case is linked to US-SA-2024SA306025.  This case involves a 17 years old female patient who was administering Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] vaccines that are no longer suitable to patients because of a temperature excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) , Concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (solution for injection) lot UJ975AA, Expiry date : 23-NOV-2024, strength was unknown via unknown route in unknown administration site for Immunization and administering menquadfi vaccines that are no longer suitable to patients because of a temperature excursion with no ae (product storage error) (unknown latency) and (poor quality product administered) (latency: same day).   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-2024SA306025:Cluster case
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: had a temperature excursion/patient administered with the MENQUADFI post-excursion, with no reported adverse event; had a temperature excursion/patient administered with the MENQUADFI post-excursion, with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who had a temperature excursion/patient administered with the MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] post-excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) lot UJ975AA, Expiry date: 23-Nov-2025, strength was unknown via unknown route in unknown administration site for Immunization and had a temperature excursion/patient administered with the menquadfi post-excursion, with no reported adverse event (product storage error) (unknown latency) and (poor quality product administered) (latency: same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administering MENQUADFI vaccines that are no longer suitable to patients because of a temperature excursion."   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-2024SA305074:
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: patient administered with MENQUADFI post excursion with no reported AE; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2024SA306481 (cluster case).  This case involves a 16 years old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] 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 an unknown date, the patient received an unknown dose of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection with standard strength (lot UJ975AA and expiry date- 23-NOV-2024) via unknown route in unknown administration site for immunization post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Caller stated that they had a temperature excursion on vaccines. She had already used the online stability calculator to determine they were no longer viable. Nurse confirmed that there are 12 patients administered with MENQUADFI post excursion.   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-2024SA306481:Cluster case
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: menquadfi vaccines that are no longer suitable to patients because of a temperature excursion with no reported ae; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2024SA304909 (Master case).  This case involves 17 years old male patient who was given a dose of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] 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 an unknown date, the patient received a standard dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (strength: standard, lot U7996BB and expiry date: 30-Apr-2026) (with an unknown dose) via unknown route in unknown administration site for Immunization; post excursion with no reported adverse event (poor quality product administered) (latency- same day).   Reportedly: " She has already used the online stability calculator to determine they are no longer viable, but they have already administered a MENQUADFI and a PENTACEL after the excursion. Nurse confirmed that there are 12 patients administered with MENQUADFI post excursion. This case is for patient 10 that was given a dose of MENQUADFI post excursion."  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-2024SA304909:Master case
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion with no reported adverse event; administered a MENQUADFI  after the excursion with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to 2024SA305074.  This case involves a 16-year-old female patient who was administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] post temperature 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, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot U7996BB, expiry: 30-APR-2026) (unknown route, administration site, strength and dosage) for prophylactic vaccination post temperature excursion with no reported adverse event (product temperature excursion issue) and (poor quality product administered) (unknown latency).  Reportedly,Caller states they had a temperature excursion on some Sanofi vaccines. She has already used the online stability calculator to determine they are no longer viable.  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-2024SA305074:
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: given a dose of MENQUADFI post-excursion, with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2024SA304909 (Master case).  This case involves 16 years old female patient who was given a dose of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] 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 an unknown date, the patient received a standard dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection (lot U7996BB, expiry date- 30-APR-2026) via unknown route in unknown administration site for Immunization; post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Caller states they had a temperature excursion on some Sanofi vaccines. She had already used the online stability calculator to determine they were no longer viable, but they had already administered a menquadfi and a pentacel after the excursion. She was asking if those vaccines need to be repeated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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-2024SA304909:master case US-SA-2024SA305074:
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: physician prescribing vaccines, including the Hib, to an adult patient  with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 36 years old female patient who was prescribed, HIB (PRP/T) VACCINE [ACT-HIB] by physician with no adverse event.  The patient's past medical history included Bone marrow transplant.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received was prescribed with suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (dose, strength, lot, route and expiry: unknown) (product prescribing error) (latency same day) in unknown administration site for immunization.  Reportedly:- The physician prescribed the Hib vaccine and she has pre-ordered everything for the patient's vaccination tomorrow. However, the primary care office only carries the ACTHIB and the nurse read it's indicated up to 5 years of age only. Nurse asked whether the adult patient can use the ACTHIB. Nurse added that he knows there are other Hib vaccines that exist. The ACTHIB hasn't been given to the patient post-transplant.   Product used: 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: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of fluzone post-expiry with no reported adverse event; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 49 years old female patient where reporter reported inappropriate use due to administration of Influenza usp trival a-b subvirion no preservative vaccine [Fluzone] post-expiry with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Sep-2024, the patient received 1 DF (dosage form) dose of suspect Influenza usp trival a-b subvirion no preservative vaccine Suspension for injection (strength- standard) (lot- U8435AA and expiration date- 30-JUN-2024) via intramuscular route in the left deltoid for Immunisation and inappropriate use due to administration of Fluzone post-expiry with no reported adverse event (expired product administered) (latency- same day).  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: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: nurse practitioner at their practice administered a fluzone hd vaccine to a patient who is only 48 years old with no ae; Initial information received on 09-Oct-2024 regarding an unsolicited valid non-serious case received from Other Health Care Professional.  This case involves a 48 years old and unknown gender patient, reporter reported a Nurse practitioner at their practice administered a Influenza Usp Trival A-B High Dose Subvirion Vaccine [FluzoneHD] vaccine to a patient who is only 48 years old with no ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, nurse practitioner at their practice administered the Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe 0.5 ml x1 (once) via unknown route in unknown administration site for Immunization (strength, batch and expiry date unknown) to patient only 48 years old with no ae (product administered to patient of inappropriate age) (same day latency).  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Reportedly, asked what precautions they need to take and any side effects they need to be on the lookout for.  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: FLU3
Symptoms: Exposure via skin contact, No adverse event
Clinical narrative: vaccine ran down the patient's arm and onto the arm of the chair with no reported adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient reportedly vaccine ran down the patient's arm and onto the arm of the chair with no reported adverse event while receiving  Influenza USP trival A-B high dose subvirion vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot UT8409CA; expiry date unknown) ran down the patient's arm and onto the arm of the chair with no reported adverse event (accidental exposure to product) (same day latency).   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: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administer a FLUZONE HD to a patient who is only 61 years old with no reported adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 61 years old female patient who got administered Influenza USP Trival A-B high dose subvirion vaccine [Fluzone HD] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2024, the patient received 0.5 ml dose of suspect Influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot- U8515CA and expiration date- 30-JUN-2025) via unknown route in the left deltoid (route, strength: not provided) for Immunisation and administered a Fluzone hd to a patient who is only 61 years old with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  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: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child who is less than 6 months old inadvertently received FLUZONE, with no reported adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old and unknown gender patient who stated that child who is less than 6 months old inadvertently received Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 02-Oct-2024, the patient received a dose of 0.5 ml 1 X Suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine  (Suspension for injection) strength, expiry date, lot number not reported via intramuscular route in unknown administration site for Influenza and child who is less than 6 months old inadvertently received fluzone, with no reported adverse event (product administered to patient of inappropriate age) (unknown latency). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  Reportedly "This situation is pre-assessed as an off-label use as per local labelling due to infant receiving FLUZONE NP below the recommended age. Batch/lot number requested, not available at the time of call. Follow-up with caller possible. Nurse and quality director stated that they had a baby that is two months old receive FLUZONE. She was searching some resources/information on anybody who had this incident happen so she could share it with the provider and the parent."  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: No adverse event, Product preparation issue
Clinical narrative: only the liquid portion of pentacel was administered to a patient with no reported adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered only the liquid portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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 only the liquid portion of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (strength, expiry date, lot number - not reported) via unknown route in unknown administration site for Immunization; with no reported adverse event (single component of a two-component product administered) (latency- same day).  Information on the batch number cannot be requested corresponding to the one at time of event occurrence.  Reporter cannot be contacted by Sanofi  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: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inappropriate use due to FLUZONE HD being administered twice to a patient with no adverse event; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 69 years old female patient with inappropriate use due to INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] being administered twice to a patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Aug-2024, the patient received a dose 1 of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe dose 0.7 ml via intramuscular route in unknown administration site. On 10-Sep-2024 she also received dose 2 of same vaccine administered twice dose- 0.7 ml batch -U8429AA expiry-30-Jun-2025 via intramuscular route in the left deltoid for influenza (Influenza immunisation) with no adverse event (extra dose administered) (latency same day).  Reportedly, the patient forgot that she already received a FLUZONE HD shot from a physician's office and consequently because they forgot, they've got another one in their pharmacy. She remarked that the patient did not feel any peculiarities or unwellness.   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: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: left arm swelled from her deltoid down to her elbow; it was extremely warm; Initial information received on 10-Oct-2024 regarding an unsolicited valid non-serious case received from  Patient.  This case involves a 70 years old female patient who experienced left arm swelled from her deltoid down to her elbow and it was extremely warm after receiving Influenza USP TRIVAL A-B HIGH DOSE Subvirion vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date 2024, the patient received a dose of suspect Influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via intramuscular route in the left arm (dose, strength, lot/batch number and expiration date: not provided) for Influenza immunization.  On an unknown date 2024, the patient developed left arm swelled from her deltoid down to her elbow (peripheral swelling) and it was extremely warm (vaccination site warmth) (unknown latency).  Reportedly, HD shot last year and her left arm swelled from her deltoid down to her elbow. She said it was extremely warm and it was bad. It lasted for about 2 weeks. Therapy Date: Either 30Sep2024 or 01Oct2024.  Action taken- not applicable.  The patient was treated with Hydrocortisone, witch hazel and cold compresses as an corrective treatment was received for the events.  At time of reporting, the outcome was Recovered / Resolved in 2024 for both the events.
Age: 6.0
Sex: F
Vaccine: MEN, MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was inadvertently administered a third dose of MENQUADFI instead of BEXSERO, with no reported adverse event; Initial information received on 11-Oct-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 6 years and 6 months old female patient and reporter stated that patient was inadvertently administered a third dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] instead of Meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero), 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 27-SEP-2024 the patient developed a non-serious patient was inadvertently administered standard third dose of 0.5 ml of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection once with lot U8361AA and expiry date 31-Mar-2028 via unknown route in the left deltoid for immunization instead of Meningococcal vaccine B RFHBP/NADA/NHBA OMV, with no reported adverse event (wrong product administered) (Latency same day).  Reportedly, The patient was inadvertently administered a third dose of menquadfi instead of bexsero on September 27th.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.75
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: inadvertently gave the second dose of fluzone np a little too early with no adverse event; Initial information received on 11-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 9-month-old and unknown gender patient who was inadvertently administered the second dose of Influenza Quadrival A-B Intradermal Vaccine [Fluzone]a little too early 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 received was inadvertently given 0.5ml (dose 2) of suspect Influenza Quadrival A-B Intradermal Vaccine Solution for injection in pre-filled syringe (unknown lot number, expiry date and route) in unknown administration site for Influenza a little too early with no adverse event (inappropriate schedule of product administration) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence.  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: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Fluzone HD was administered via subcutaneous rather than the IM route, with no reported adverse event; Initial information received on 11-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 68 years old female patient who was administered the influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] via subcutaneous rather than the im route, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2024, the patient received a 0.5 ml dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot UT8425AA, Expiry date: 30-Jun-2025, strength: high) once via subcutaneous route rather than the intramuscular route in the left arm as Immunization (incorrect route of product administration, latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inappropriate use due to administration to age range it is not indicated for with no reported adverse event; Initial information received on 14-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 59 years old male patient and the reporter reported an inappropriate use due to administration of influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] to age range it is not indicated for with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2024, the patient received 0.7 ml dose of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with strength- high dose (lot U8499DA and expiry date- 30-Jun-2025) once via intramuscular route in the left deltoid as immunization which was inappropriate use due to administration to age range it is not indicated for with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  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.