VAERS Reports UJ739AB

VAERS 2677355

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ739AB

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Staat: OH
Alter: 0,2
Geschlecht: U
Eingang: 28.08.2023
Impfdatum: 23.08.2023
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: ID / -

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

Expired product administered No adverse event

Symptomtext

given a vaccine on 8/23/23 that had expored on 8/10/23 No complications at this time

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: Oral thrush
Vorgeschichte: N/A
Andere Medikamente: diflucan 10mg oral suspension
Allergien: N/A
Vorherige Impfungen: -

VAERS 2677300

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ739AB

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Staat: OH
Alter: 0,2
Geschlecht: M
Eingang: 28.08.2023
Impfdatum: 23.08.2023
Beginn: 23.08.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: OT / RL

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

Expired product administered Medication error No adverse event

Symptomtext

administered ActHIB 13 days after expiry with no reported adverse event; Initial information was received on 23-Aug-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 months old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] 13 days after expiry 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 diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), pertussis vaccine acellular 3-component, polio vaccine inact 3V (VERO), tetanus vaccine toxoid (PEDIARIX), pneumococcal vaccine conj 7V (CRM197) (PREVNAR) and rotavirus vaccine live reassort oral 5V (ROTATEQ) for Prophylactic vaccination. On 23-Aug-2023, the patient received a 0.5 ml dose (dose 1) (once) of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot:UJ739AB, expiry date: 10-Aug-2023, strength: standard) via intramuscular route in the right thigh for Immunisation and was administered acthib 13 days after expiry with no reported adverse event (expired product administered) (Latency: same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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 2676332

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ739AB

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Staat: CA
Alter: 0,5
Geschlecht: M
Eingang: 24.08.2023
Impfdatum: 16.08.2023
Beginn: 16.08.2023
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: OT / LL

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

Expired product administered

Symptomtext

administering an expired vaccine to a patient with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient to whom an expired Hib (Prp/T) Vaccine [Act-Hib] 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine, Tetanus Vaccine Toxoid (Dtp); Rotavirus Vaccine (Rotavirus Vaccine); Polio Vaccine Inact (Ipv); And Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination. On 16-Aug-2023, the patient received expired dose 3 at a dose of 0.5 ml of suspect Hib (Prp/T) Vaccine (Frequency: once, strength: standard, expiry date: 10-Aug-2023 and lot UJ739AB) via intramuscular route in the left thigh for immunization (expired product administered) (latency: same day). It was reported "Medical assistant called saying she has questions on a vaccine that was administered but has already expired. She said that ACT-HIB which expired on 10Aug2023 was administered to a patient on 16Aug2023. She asked what are the guidance regarding this or what are the next steps following the situation? She also asked if they should re-administer the dose and where can they report the situation? This situation is reported as a medication error due to administering an expired vaccine to a patient." Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: DTP; ROTAVIRUS VACCINE; IPV; PNEUMOCOCCAL CONJUGATE VACCINE
Allergien: -
Vorherige Impfungen: -