chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: medication error/an inappropriate use  due toCaller stated they administered  FLUZONE HD to some adults under 65  and to some children as well with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA317985 (master case)  This case involves a 15-year-old male patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to a medication error during flu clinics and not paying attention, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received 0.5 ml 1x (once) Influenza USP Trival A-B high dose subvirion vaccine (strength high dose) Suspension for injection in pre-filled syringe lot:UT8473CA and expiry-30-Jun-2025 via unknown route in the right arm for Immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (latency same day).   This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well  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-2024SA318712: US-SA-2024SA318876: US-SA-2024SA313313:
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD given to 14 years old with no reported adverse event; Initial information received on 22-OCT-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to 2024SA313313.  This case involves INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] to 14 years old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  List concomitant: no other vaccine  On 04-OCT-2024, the patient received a 0.5ml high dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (once) Suspension for injection in pre-filled syringe (lot UT8473CA, expiry:30-JUN-2025) (unknown route) in the right arm for immunization was given to 14 years old with no reported adverse event (product administered to patient of inappropriate age).  Reportedly,Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well.   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-2024SA318876: US-SA-2024SA313313:02274696 US-SA-2024SA318712:
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 years female received FLUZONE HD with no adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases- US-SA-2024SA313311, US-SA-2024SA314786, US-SA-2024SA317011, US-SA-2024SA314254, US-SA-2024SA319049, US-SA-2020SA320383, US-SA-2024SA313313, US-SA-2024SA315389, US-SA-2024SA313312, US-SA-2024SA319070, US-SA-2024SA313309, US-SA-2024SA318981, US-SA-2024SA318878, US-SA-2024SA317025, US-SA-2024SA314805, US-SA-2024SA314787, US-SA-2024SA318875, US-SA-2024SA314087, US-SA-2024SA317152, US-SA-2024SA317108, US-SA-2024SA314219,  US-SA-2024SA314804, US-SA-2024SA317985  This case involves a 17 years old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received 0.5 ml 1x (once) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (strength high dose) Suspension for injection in pre-filled syringe lot UT8473CA expiry-30-Jun-2025 via unknown route in the right arm for Immunization with no adverse event (product administered to patient of inappropriate age) (latency same day).  This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well   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-2024SA317985: US-SA-2024SA318712: US-SA-2024SA313313: US-SA-2024SA313311: US-SA-2024SA314786: US-SA-2024SA317011: US-SA-2024SA314254: US-SA-2024SA319049: US-SA-2020SA320383: US-SA-2024SA315389: US-SA-2024SA313312: US-SA-2024SA319070: US-SA-2024SA318876: US-SA-2024SA313309: US-SA-2024SA318981: US-SA-2024SA318878: US-SA-2024SA317025: US-SA-2024SA314805: US-SA-2024SA314787: US-SA-2024SA318875: US-SA-2024SA314087: US-SA-2024SA317152: US-SA-2024SA317108: US-SA-2024SA314219: US-SA-2024SA318876:
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 14-years old patient received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA317985 (master case)  This case involves a 14-year-old female patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to a medication error during flu clinics and not paying attention, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received 0.5 ml 1x (once) Influenza USP Trival A-B high dose subvirion vaccine (strength high dose) Suspension for injection in pre-filled syringe lot:UT8473CA and expiry-30-Jun-2025 via unknown route in the right arm for Immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (latency same day).   This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well  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-2024SA317985:Master case US-SA-2024SA313313: US-SA-2024SA318712: US-SA-2024SA318876:
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: people under the age of 65-years received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2024SA313311 (cluster case).  This case involves a 58 years old female patient who who was under the age of 65-years received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to medication error during flu clinics and not paying attention with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   the patient received 0.5 ml of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with strength- high dose (lot UT8473CA and expiry date- 30-Jun-2025) once via unknown route in the left arm for Immunization due to medication error during flu clinics and not paying attention with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, there had been no events reported related to the administration of the vaccines.  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-2024SA313311:Cluster case US-SA-2024SA313313:
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: people under the age of 65-years received FLUZONE HD due to medication error with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2024SA313311 (cluster case).  This case involves a 49 years old female patient who was under the age of 65-years received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to medication error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2024, the patient received 0.5 ml of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with strength- high dose (lot UT8473CA and expiry date- 30-Jun-2025) once via unknown route in the left arm for Immunization due to medication error with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, vaccines were administered due to a medication error during flu clinics and not paying attention. There had been no events reported related to the administration of the vaccines.  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-2024SA313311:Master case
Age: 11.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was administered  DAPTACEL instead of ADACEL last  25Sep2024 with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to case- US-SA-2024SA314783  This case involves a 11 years old male patient who was administered  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] last  25sep2024 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 Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for Immunisation.  On 25-Sep-2024, the patient received a dose 6 of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength standard) 0.5 ml 1x (once) lot 3BA11C1 expiry-31-Dec-2025 via intramuscular route in the left deltoid for Immunization instead of adacel with no reported adverse event (wrong 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-2024SA314783:
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered FLUZONE HD to some adults under 65 and to some children as well with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old male patient who administered influenza usp trival a-b high dose subvirion vaccine [Fluzone high dose]  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2024, the patient received a 0.5 ml dose of suspect Suspension for injection in pre-filled syringe of influenza usp trival a-b high dose subvirion vaccine (lot UT8473CA, Expiry date: 30-Jun-2025, strength: high dose, frequency: once) via unknown route in the left arm as immunization (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.; Sender's Comments:  US-SA-2024SA317985:
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 35-years received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA317985 (master case)  This case involves a 35 year old female patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to a medication error during flu clinics and not paying attention, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received 0.5 ml 1x (once) Influenza USP Trival A-B high dose subvirion vaccine (strength high dose) Suspension for injection in pre-filled syringe lot UT8473CA and expiry-30-Jun-2025 via unknown route in the right arm for Immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (latency same day).   This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well  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-2024SA317985: US-SA-2024SA313313:
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 years old patient received fluzone hd with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases- US-SA-2024SA313311, US-SA-2024SA314786, US-SA-2024SA317011, US-SA-2024SA314254, US-SA-2024SA319049, US-SA-2020SA320383, US-SA-2024SA313313, US-SA-2024SA315389, US-SA-2024SA313312, US-SA-2024SA319070, US-SA-2024SA318876, US-SA-2024SA313309, US-SA-2024SA318981, US-SA-2024SA318878, US-SA-2024SA317025, US-SA-2024SA314805, US-SA- 2024SA317985, US-SA-2024SA314787, US-SA-2024SA318875, US-SA-2024SA314087, US-SA-2024SA317152, US-SA-2024SA317108, US-SA-2024SA314219, US-SA-2024SA314804  This case involves a 7 years old male patient who received 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 04-Oct-2024, the patient received 0.5 ml 1x (once) INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (strength high dose) Suspension for injection in pre-filled syringe lot UT8473CA expiry-30-JUN-2025 via unknown route in the left arm for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency same day).   This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well  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-2024SA317985: US-SA-2024SA313311: US-SA-2024SA317011: US-SA-2024SA314254: US-SA-2024SA319049: US-SA-2020SA320383: US-SA-2024SA313313: US-SA-2024SA315389: US-SA-2024SA313312: US-SA-2024SA319070: US-SA-2024SA318876: US-SA-2024SA313309: US-SA-2024SA318981: US-SA-2024SA318878: US-SA-2024SA317025: US-SA-2024SA314805: US-SA-2024SA314787: US-SA-2024SA318875: US-SA-2024SA314087: US-SA-2024SA317152: US-SA-2024SA317108: US-SA-2024SA314219: US-SA-2024SA314804:
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: people under the age of 65-years received FLUZONE HD due to a medication error during flu clinics and not paying attention with no adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2024SA313311 (cluster case).  This case involves a 6 years old male patient who who was under the age of 65-years received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to medication error during flu clinics and not paying attention with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, 0.5 ml of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with strength- high dose (lot UT8473CA and expiry date- 30-Jun-2025) once via unknown route in the left arm for Immunization due to medication error during flu clinics and not paying attention with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, there had been no events reported related to the administration of the vaccines.  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-2024SA313311:Cluster case
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5-year old received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no Adverse Event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2024SA313311 (Master case).  This case involves a 5 years old male patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] due to a medication error during flu clinics and not paying attention, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient of 5 year old received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (lot UT8473CA, Expiry: 30-Jun-2025) (Strength = high dose) via unknown route in the left arm as immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (Latency: same day).  On 04-OCT-2024 the patient developed a non-serious 5-year old received fluzone hd due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.   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-2024SA313311:Master Case
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5-yr old received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2024SA313311 (Master case).  This case involves a 5 years old female patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] due to a medication error during flu clinics and not paying attention, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient of 5 year old 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 UT8473CA, Expiry: 30-Jun-2025) (Strength = high dose) via unknown route in the left arm as immunization due to a medication error during flu clinics and not paying attention, with no 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.; Sender's Comments:  US-SA-2024SA313311:Master case
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: people under the age of 65-years received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA317985 (master case)  This case involves a 6-year-old female patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to a medication error during flu clinics and not paying attention, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received 0.5 ml 1x (once) Influenza USP Trival A-B high dose subvirion vaccine (strength high dose) Suspension for injection in pre-filled syringe lot:UT8473CA and expiry-30-Jun-2025 via unknown route in the right arm for Immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (latency same day).   This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: nurse gave FLUBLOK vaccine to a 14-year-old instead of the regular vaccine with no adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 14-year-old male patient influenza trivalent recombinant vaccine [flublok TIV] vaccine to a 14-year-old instead of the regular vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2024 the 0.5 ml of influenza trivalent recombinant vaccine Solution for injection (unknown strength and expiry date) with lot TFAA2418 via intramuscular route in the right deltoid for immunization to a 14-year-old instead of the regular vaccine (wrong product administered) (Latency same day)  Reportedly, Nurse stated they had another nurse gave a FLUBLOK vaccine to a 14-year-old instead of the regular vaccine.  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: 6.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: people under the age of 65-years received FLUZONE HD due to medication error with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case was linked to US-SA-2024SA313311 (cluster case).  This case involves a 6 years old male patient who was under the age of 65-years received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to medication error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received 0.5 ml of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with strength- high dose (lot UT8473CA and expiry date- 30-Jun-2025) once via unknown route in the left arm for Immunization due to medication error with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, vaccines were administered due to a medication error during flu clinics and not paying attention. There had been no events reported related to the administration of the vaccines.  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-2024SA317985: US-SA-2024SA313313: US-SA-2024SA318712: US-SA-2024SA318876: US-SA-2024SA313311:02274696
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 46-yr old received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2024SA313311 (Master case).  This case involves a 46 years old female patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] due to a medication error during flu clinics and not paying attention, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient of 46 year old 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 UT8473CA, Expiry: 30-Jun-2025) (Strength = high dose) via unknown route in the left arm as immunization due to a medication error during flu clinics and not paying attention, with no 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.; Sender's Comments:  US-SA-2024SA313311:Master case
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 54-years old patient received FLUZONE HD, with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2024SA313311 (Master Case).            This case involves a 54 years old female patient who received 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 04-Oct-2024, the 54 years old female patient received 0.5 mL dose of suspect  influenza usp trival a-b high dose subvirion vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) (Suspension for injection in pre-filled syringe) (Frequency: once), (strength: high dose), (lot UT8473CA and expiry date: 30-Jun-2025) via unknown route in the right arm for Immunization.  Reportedly, The clinic reported that 29 people under the age of 65-years received FLUZONE HD due to a medication error during flu clinics and not paying attention.   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-2024SA313311:Master Case
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: people under the age of 65-years received FLUZONE HD due to medication error with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case was linked to US-SA-2024SA313311 (cluster case).  This case involves a 12 years old female patient who was under the age of 65-years received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to medication error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received 0.5 ml of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with strength- high dose (lot UT8473CA and expiry date- 30-Jun-2025) once via unknown route in the left arm for Immunization due to medication error with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, vaccines were administered due to a medication error during flu clinics and not paying attention. There had been no events reported related to the administration of the vaccines.  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-2024SA317985: US-SA-2024SA313313: US-SA-2024SA318712: US-SA-2024SA318876: US-SA-2024SA313311:02274696
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 52-yr old received FLUZONE HD due to a medication error during flu clinics and not paying attention, with no adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to 2024SA317985 (master case)  This case involves a 52-year-old female patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] due to a medication error during flu clinics and not paying attention, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2024, the patient received 0.5 ml 1x (once) Influenza USP Trival A-B high dose subvirion vaccine (strength high dose) Suspension for injection in pre-filled syringe lot UT8473CA  expiry-30-Jun-2025 via unknown route in the left arm for Immunization due to a medication error during flu clinics and not paying attention, with no adverse event (product administered to patient of inappropriate age) (latency same day).   This situation is pre-assessed as a medication error/an inappropriate use due to Caller stated they administered FLUZONE HD to some adults under 65 and to some children as well  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-2024SA317985:
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose of FLUZONE QIV NP to a patient.; Initial information received on 22-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 had administration of an expired dose of influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE).  On 21-Oct-2024, the patient received expired 0.5 ml dose of suspect influenza quadrival a-b vaccine (lot UT8144JA, Expiry date: 30-Jun-2024, frequency: once, strength: standard) via intramuscular route in the left deltoid as immunization from last year's flu season (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: 4.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was administered by MA to 4-year-old patient with no adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was administered Influenza Trivalent Recombinant Vaccine [Flublok Tiv] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2024, the 4 year old patient received once a 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (lot TFAA2444, Expiry: 30-Jun-2025) (strength: standard) via intramuscular route in the left deltoid as Immunization (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.; Sender's Comments:  US-SA-2024SA318719:
Age: 50.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Injection site pain
Clinical narrative: injection site burning; Initial information received on 22-Oct-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 50 years old female patient who had injection site burning after receiving Rabies Vaccine Inact (Chick Embryo) (Rabavert) And Rabies (Hdc) Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Oct-2024, the patient received a dose 1 of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection via intramuscular route in unknown administration site for post exposure prophylaxis (Immunisation) (strength, dose, batch and expiry date unknown).  On 18-OCT-2024 the patient had injection site burning (injection site pain) (latency same day) ater receiving dose 1 of imovax rabies.  On 21-Oct-2024, the patient received a dose 2  of suspect Rabavert not produced by Sanofi Pasteur (form unknown) via intramuscular route in unknown administration site for post exposure prophylaxis (Immunisation) (strength, dose, batch and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Reportedly, they administered 2 doses post exposure prophylaxis to a patient. The HCP stated that the 1st dose was pink in color, maybe translucid pink and yesterday, the vaccine looked clear. At the time of the call, they thought that both vaccines were Rabavert. They just realized that only the 2nd shot was Rabavert because of the lot number. The patient expressed concern in receiving different color on the 1st vaccine she received in comparison to the 2nd vaccine she received. On the follow up, the patient stated that she experienced burning at the injection site during the injection on 18-Oct-2024, and no pain or burning on the injection received 21-Oct-2024  Action taken; not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: product administered to patient of inappropriate age; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was administered Influenza Trivalent Recombinant Vaccine [Flublok TIV] with no adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2024 at 10:30, the patient received once a 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (lot TFAA2444, Expiry: 30-Jun-2025) (strength: standard) via intramuscular route in the right deltoid for Immunization (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.; Sender's Comments:  US-SA-2024SA313815:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: getting 2 FLUZONE HD vaccinations at the same time, with no reported adverse event; Initial information received on 22-Oct-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 65 years old female patient who got 2 influenza USP trival A-B high dose subvirion [Fluzone HD] vaccinations at the same time, with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines   On 22-Oct-2024 at the same time, the patient received twice a dose (dose 1 on the left arm and dose 2 on the right arm) of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot U8524CA , Expiry : 30-Jun-2025, strength: high) via intramuscular route for Influenza, with no reported adverse event (extra dose administered) (Latency: same day).  Reportedly, Pharmacist was not sure if that happened but he believed it might have. Pharmacist said that he already looked it up online and found out that it was really not harmful but would like to ask what adverse event to look out 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.