VAERS Reports U7261AA

VAERS 2666445

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7261AA

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Staat: TX
Alter: 1,0
Geschlecht: M
Eingang: 04.08.2023
Impfdatum: 31.07.2023
Beginn: 31.07.2023
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

patient inadvertently received an expired dose of acthib with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who had inadvertently received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] 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 ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) for prophylactic vaccination (Immunization). On 31-Jul-2023, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection)(Lot number- HIB: UJ679AA, DILUENT: U7261AA and expiry date: HIB: 28-May-2023, DILUENT: 07-Apr-2023) (Frequency: Once) (Strength: standard) via intramuscular route in the left thigh for Immunization. On 31-Jul-2023, the patient had inadvertently received an expired dose of ACTHIB with no reported adverse event (expired product administered) (latency: same day). 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 regulatory agency. 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 2630166

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7261AA

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Staat: MA
Alter: -
Geschlecht: U
Eingang: 11.05.2023
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 No adverse event

Symptomtext

expired diluent of ACTHIB was given at a clinic with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves unknown age and unknown gender patient who was given expired diluent of haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] at a clinic 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 0.5 ml total of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot U7261AA) (with an unknown strength and expiry date) via unknown route in unknown administration site for Immunization. On an unknown date the patient developed a non-serious event of expired diluent of haemophilus type B (HIB) (PRP/T) was given at a clinic with no reported adverse event (expired product administered) (latency- same day). Caller is inquiring if the dose is valid. 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 2626095

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7261AA

gering

Staat: IN
Alter: 1,3
Geschlecht: F
Eingang: 04.05.2023
Impfdatum: 01.05.2023
Beginn: 01.05.2023
Tage bis Beginn: 0,0
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

received a dose of ACTHIB in which the diluent is expired, with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who received a dose of HIB (PRP/T) vaccine [ACT-HIB] in which the diluent is expired, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-May-2023, the patient received 0.25 mL to 2 mL dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (Lot number = UJ677AA (carton) UJ677AA (product) U7261AA (diluent) (Expiry Date for all the Lots = JUNE 5, 2023 (product) APRIL 7, 2023 (carton and diluent) Frequency = Once, Dose = 0.1 mL for TB skin test = 0.5ml, (Strength = standard) via intramuscular route in the thigh not otherwise specified (nos) for Immunization or TB skin test. On 01-May-2023, the patient received a dose of HIB (PRP/T) vaccine in which the diluent is expired, with no reported adverse event (expired product administered) (latency: same day). 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 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 2616528

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7261AA

gering

Staat: VA
Alter: 1,3
Geschlecht: F
Eingang: 18.04.2023
Impfdatum: 11.04.2023
Beginn: 11.04.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / LL

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

Expired product administered Medication error No adverse event

Symptomtext

expired ACT-HIB was given to a patient with no reported adverse event; Initial information received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from Nurse. This case involves a 16 months old female patient to whom an expired haemophilus type B (HIB) vaccine [ACT-HIB] was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. Concomitant medications included varicella zoster vaccine (Varicella Vaccine) for immunisation. On 11-Apr-2023, the patient received 0.5 ml (dose 4) of expired haemophilus type B (HIB) vaccine, powder and solvent for solution for injection (lot U7261AA, U7261AA, expiry date: 07-Apr-0223, 05-Jun-2023) (unknown strength) via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (latency: same day). No lab data were reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for an 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 2612435

SANOFI PASTEUR · HIB (ACTHIB) · Charge u7261aa

gering

Staat: NH
Alter: 0,2
Geschlecht: M
Eingang: 10.04.2023
Impfdatum: 10.04.2023
Beginn: 10.04.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RL

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

Expired product administered

Symptomtext

We now get many of our vaccines in small amounts and the ActHib diluent expired before the vaccine. The diluent expired 3 days ago, the vaccine expires at the end of next month. Per employee we need to revaccinate which we will do tomorrow.

Weitere VAERSDATA-Felder

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

VAERS 2541550

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7261AA

gering

Staat: FL
Alter: 1,0
Geschlecht: M
Eingang: 23.12.2022
Impfdatum: 16.12.2022
Beginn: 16.12.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / RL

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

Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

patient was administered ACTHIB post excursion with no reported adverse event; Initial information received on 19-Dec-2022 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 1 years old male patient who received vaccine HIB (PRP/T) vaccine [ACT-HIB] post excursion 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 CONJ 13V (CRM197) (PREVNAR 13) ; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. On 16-Dec-2022, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine dose 4 (Powder and solvent for solution for injection) (lot U7261AA and expiry date: 07-Apr-2023) via intramuscular route in the right thigh for Immunization. On 16-Dec-2022, (latency: same day) due to a refrigerator malfunction temperature excursion occurred at a low of 31.1F for 1 day, 22 hours, and 7 minutes and patient was administered ACTHIB post excursion with no reported adverse event (poor quality product administered). 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 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: PREVNAR 13; MMR; VARICELLA VACCINE
Allergien: -
Vorherige Impfungen: -