VAERS Reports UJ584AAA

VAERS 2574702

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ584AAA

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Staat: CA
Alter: 15,0
Geschlecht: F
Eingang: 03.02.2023
Impfdatum: 27.01.2023
Beginn: 27.01.2023
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

dose of acthib was given past the expiration date with no adverse event; Initial information was received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional. This case involves 15 months old female patient who stated dose of acthib was given past the expiration date with no adverse event after receiving haemophilus type B (HIB) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (Daptacel). On 27-Jan-2023, the patient received 0.5 ml dose of suspect haemophilus type B (HIB) vaccine Powder and solvent for solution for injection (lot UJ584AAA, expiration date: 16-Oct-2022) (strength, frequency was unknown) via intramuscular route on left thigh for Immunization. On 27-Jan-2023 the patient developed a non-serious event dose of acthib was given past the expiration date with no adverse event (expired product administered) same day following the administration of hib (prp/t) vaccine. 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 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: PREVNAR 13; DAPTACEL
Allergien: -
Vorherige Impfungen: -

VAERS 2505317

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ584AAA

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Staat: CA
Alter: -
Geschlecht: U
Eingang: 11.11.2022
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Expired product administered Medication error No adverse event

Symptomtext

inappropriate administration of ACTHIB to a patient after it had expired with no reported adverse event; Initial information was received on 01-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who reported inappropriate administration of hib (prp/t) vaccine [ACT-HIB] after it had expired 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 hib (prp/t) vaccine powder and solvent for solution for injection (lot UJ584AAA, expiry date - 16-Oct-2022) via unknown route in unknown administration site (strength, dose, frequency: unknown) for Immunization. On an unknown date the patient reported a non-serious event of inappropriate administration of hib (prp/t) vaccine after it had expired with no reported adverse event (expired product administered) (unknown latency) following the administration of hib (prp/t) vaccine. Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

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

VAERS 2487137

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ584AAA

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Staat: AZ
Alter: 2,0
Geschlecht: F
Eingang: 24.10.2022
Impfdatum: 21.10.2022
Beginn: 21.10.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / RL

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

Expired product administered No adverse event

Symptomtext

PT HASNT REPORTED ANY SIGNS OF ADVERSE EVENTS. REPORT BEING MADE BECAUSE VACCINE ADMINISTERED EXPIRED ON 10/16/2022.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: loratadine 5 mg/5 mL syrup 5ml ORALLY EVERY DAY
Allergien: none
Vorherige Impfungen: -

VAERS 2204607

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ584AAA

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Staat: OR
Alter: 1,3
Geschlecht: M
Eingang: 29.03.2022
Impfdatum: 17.03.2022
Beginn: 17.03.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Product administered to patient of inappropriate age Wrong product administered

Symptomtext

there were no Adverse reactions it's just that The Tdap was given to a 15mos old not recommended until age 7yrs and older it should have been Dtap given. The MA who gave the vaccine realized she had given the wrong vaccine and notified the Provider and the Provider looked into it and stated that it's not recommended but it will be ok and the child will just need it again at the time needed per the vaccine schedule. Mother was notified as well and I contacted program and got this info back : As long as the Tdap was given as dose # 4 or 5 of the DTaP series it can be counted as part of the DTaP series. The child still needs a dose of DTaP at age 4 years and yes, it will go into system correctly. Please let me know if you have any other questions.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product administered to patient of inappropriate age
Hospital-Tage: -
Labordaten: n/a
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 2037704

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ584AAA

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Staat: UT
Alter: 1,0
Geschlecht: M
Eingang: 15.01.2022
Impfdatum: 05.01.2022
Beginn: 05.01.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

Incorrect product formulation administered

Symptomtext

she mixed ACTHIB with the wrong diluent and administered it to a patient WITH NO REPORTED ADVERSE EVENT; Initial information received on 06-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 months old male patient who experienced she mixed acthib with the wrong diluent and administered it to a patient 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 HEPATITIS A VACCINE (HEPATITIS A VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE). On 05-Jan-2022, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UJ584AAA via unknown route in the right thigh for prophylactic vaccination. On 05-JAN-2022 the patient developed a non-serious event "she mixed acthib with the wrong diluent and administered it to a patient with no reported adverse event" (incorrect product formulation administered) following the administration of HIB (PRP/T) VACCINE. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. It was not reported if the patient received a corrective treatment for the event (she mixed ACTHIB with the wrong diluent and administered it to a patient WITH NO REPORTED ADVERSE EVENT). At time of reporting, the outcome was Unknown for the event she mixed acthib with the wrong diluent and administered it to a patient with no reported adverse 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: Incorrect product formulation administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -