VAERS Reports UJ585AAA

VAERS 2648516

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ585AAA

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Staat: TX
Alter: 1,3
Geschlecht: F
Eingang: 22.06.2023
Impfdatum: 02.11.2022
Beginn: 02.11.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered No adverse event

Symptomtext

patient was administered expired ACTHIB with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid non-serious case from other health professional. This case involves a 15-month-old female patient who was administered expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past vaccination(s) included diphtheria vaccine toxoid,HIB vaccine CONJ (TET TOX), pertussis vaccine acellular 5-component,polio vaccine INACT 3V (MRC 5),tetanus vaccine toxoid (Pentacel) and was given 3 doses of same. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and influenza vaccine INACT SPLIT 4V (Fluzone Quadrivalent) both for Immunisation. On 02-Nov-2022, the patient received suspect HIB (PRP/T) vaccine at a dose of 0.5 ml (lot UJ585AAA, expiry date: 16-Oct-2022) via intramuscular route in the left thigh for immunization. On 02-Nov-2022 the patient was administered expired acthib with no reported adverse event (expired product administered, same day latency). Action taken: Not applicable. Outcome: Unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2573891

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ585AAA

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Staat: PA
Alter: 0,8
Geschlecht: F
Eingang: 02.02.2023
Impfdatum: 31.01.2023
Beginn: 31.01.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered No adverse event

Symptomtext

expired dose of ACTHIB was administered to a patient with no reported AE; Initial information received on 31-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 months old female patient to whom expired dose of HIB (PRP/T) vaccine [ACT-HIB] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On 31-Jan-2023, the patient received a dose 3 at dosage 0.5 mL of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection, at once (lot number: UJ585AAA; expiry date: 16-Oct-2022) via intramuscular route in the thigh nos along with diluent (lot number: U7146AB) for prophylactic vaccination (immunization) with no reported ae (expired product administered) (latency: same day). No lab data was reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2502864

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ585AAA

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Staat: OH
Alter: 2,0
Geschlecht: M
Eingang: 09.11.2022
Impfdatum: 24.10.2022
Beginn: 24.10.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered Medication error No adverse event

Symptomtext

administered a dose of ActHIB that was 8 days past its expiration when it was given with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old male patient who was administered a dose of acthib that was 8 days past its expiration when it was given with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation. On 24-Oct-2022, the patient received 0.5 ml total of dose 4 of suspect HIB (PRP/T) VACCINE (formulation and strength not reported; lot UJ585AAA and expiry date: 16-Oct-2022) via unknown route in unknown administration site for prophylactic vaccination. On 24-Oct-2022, (latency: same day) the patient was administered a dose of acthib that was 8 days past its expiration when it was given with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE. It was reported, a patient was administered a dose of ActHIB that was 8 days past its expiration when it was given. A patient was given ActHIB in an unknown injection site on 24Oct2022. The ActHib vaccine that was administered had expired on 16Oct2022. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: INFLUENZA VACCINE; DAPTACEL
Allergien: -
Vorherige Impfungen: -

VAERS 1941971

SANOFI PASTEUR · DTAP (DAPTACEL) · Charge UJ585AAA

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Staat: FL
Alter: 0,1
Geschlecht: M
Eingang: 11.12.2021
Impfdatum: 08.11.2021
Beginn: 08.11.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

A four week old patient received Daptacel no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via a consumer/non-health care professional via Medical Information (MI) (Reference number- 00878868) and transmitted to Sanofi on 30-Nov-2021. This case involves a 4 week old male patient who was received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (product administered to patient of inappropriate age). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination. On 08-Nov-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot UJ585AAA, expiry not reported) via intramuscular route in the right thigh for prophylactic vaccination. It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day). It was reported "A four week old patient received Daptacel and not Adacel, Ipol, and ActHIB and she would like to know how to proceed with the patient. She states that e-mail is fine." No other adverse event was reported. 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.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: ROTAVIRUS VACCINE; PREVNAR
Allergien: -
Vorherige Impfungen: -