VAERS Reports UJ661AAA

VAERS 2409558

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ661AAA

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Staat: KS
Alter: -
Geschlecht: F
Eingang: 12.08.2022
Impfdatum: 04.08.2022
Beginn: 04.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RA

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

Expired product administered

Symptomtext

expired ACT-HIB was inadvertently given with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old female patient to whom expired HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently given with no reported adverse event. The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had some other health issues (ill-defined disorders) On 04-Aug-2022, the patient received 0.25 ml dose of suspect HIB (PRP/T) VACCINE, with an unknown formulation and strength, (frequency: once) ( lot: UJ661AAA ; expiry date: 06-May-2022) via intramuscular route in the right arm for immunization. It was reported that an expired Act-hib was inadvertently given with no reported adverse event (expired product administered) (onset date: 04-Aug-2022) (latency: same day). No other vaccines were given 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: Medical History/Concurrent Conditions: Ill-defined disorder
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2309793

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ661AAA

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Staat: IL
Alter: 1,3
Geschlecht: M
Eingang: 06.06.2022
Impfdatum: 23.05.2022
Beginn: 23.05.2022
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 No adverse event

Symptomtext

patient received an expired dose of ACT-HIB with no reported adverse event; Initial information was received on 23-May-2022 regarding an unsolicited valid non-serious case from a pharmacist via call center. This case involves a 15 months old male patient who received an expired dose of act-hib 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) and Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination. On 23-May-2022, the patient received 0.5 ml dose of suspect HIB (PRP/T) Vaccine once (batch/lot number: UJ661AAA, expiration date: 06-May-2022, strength: standard) via intramuscular route in the thigh nos for immunization (formulation: unknown). On 23-May-2022, it was reported that the patient received an expired dose of act-hib with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) Vaccine. Action taken: not applicable At time of reporting, the outcome was Unknown for the event (expired product administered). 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 2309789

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ661AAA

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Staat: MI
Alter: 3,0
Geschlecht: F
Eingang: 06.06.2022
Impfdatum: 20.05.2022
Beginn: 20.05.2022
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 No adverse event

Symptomtext

patient who was given expired dose of ACTHIB (14 days after it has been expired) with no reported adverse event.; Initial information received on 20-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 years old female patient who was given expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (14 days after it has been expired) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-May-2022, the patient received expired dose of 0.5 ml suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection (lot UJ661AAA, Expiration date: 06-May-2022) via unknown route in unknown administration site for immunization 14 days after it has been expired with no reported adverse event (expired product administered). It was asked "what are the side effects, what to look for and what to do to a patient who was given expired dose of ACTHIB (14 days after it has been expired)" Action taken : not applicable. At time of reporting, the outcome was Unknown for the event patient who was given expired dose of acthib (14 days after it has been expired) 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 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 2290269

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ661AAA

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Staat: MI
Alter: 1,0
Geschlecht: M
Eingang: 23.05.2022
Impfdatum: 16.05.2022
Beginn: 16.05.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / -

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

Expired product administered

Symptomtext

HIB vaccine expired on 5/6/2022 and administered on 5/16/2022 ; will need to be repeated.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: NONE
Vorgeschichte: -
Andere Medikamente: NONE
Allergien: NONE
Vorherige Impfungen: -

VAERS 2289157

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ661AAA

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Staat: CO
Alter: 1,0
Geschlecht: F
Eingang: 21.05.2022
Impfdatum: 11.05.2022
Beginn: 11.05.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / RL

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

Expired product administered

Symptomtext

ACTHIB expired and administered to a patient; Initial information received on 11-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered expired vaccine with no AE with 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination; pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination; hepatitis a vaccine for Prophylactic vaccination; and diphtheria vaccine toxoid, hib vaccine conj (TET TOX), pertussis vaccine acellular 5-component, polio vaccine inact 3v (MRC 5), tetanus vaccine toxoid (Pentacel) for Prophylactic vaccination. On 11-May-2022, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE unknown formulation and strength lot UJ661AAA expiry date 06-May-2022 via intramuscular route in the right thigh for prophylactic vaccination. ACTHIB was expired and administered to a patient (expired product administered). Medical assistant wants to know how soon the dose should be repeated. Action taken: Not applicable. Corrective treatment: Not reported 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 1713162

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ661AAA

gering

Staat: NY
Alter: -
Geschlecht: U
Eingang: 18.09.2021
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: - / -

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

Product storage error

Symptomtext

vaccine were exposed to 19.8 Fahrenheit and were out of range for 2 hour and 16 minutes/no ae; Initial information received on 10-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care professional via under Medical Information Inquiry Number: 00764523. This case is linked to case US-SA-2021SA303376(CLUSTER). This case was considered as non-valid due to no involvement of patient. This case involved vaccines IPV (VERO) (lot number: R1F973M and expiry date: 10-MAR-2021), (lot number: T1E871M and expiry date: 10-OCT-2022), (lot number: T1D482M and expiry date: 25-FEB-2022), (lot number: R1F97 and expiry date: 10-MAR-2021), (lot number: T1E87 and expiry date: 10-OCT-2022) HIB (PRP/T) VACCINE (lot number: UJ661AAA and expiry date: 05-JUN-2022), (lot number: UJ526AAA and expiry date: 06-MAR-2022), (lot number: CC5788BA and expiry date: 14-OCT-2022) DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number C5829BA and expiry date: 03-JAN-2031) DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ528AAA and expiry date: 07-OCT-2022), (lot number: UJ435AAA and expiry date: 17-MAY-2022), (lot number: UJ421AAA and expiry date: 03-AUG-2022) DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: CC5788BA and expiry date: 07-OCT-2022) MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6951AA and expiry date: 06-JUN-2022) that were exposed to negative 19.8 degrees Fahrenheit degree for an undetermined period (product storage error). It was potential medication error case due to product storage error temperature too low. It was reported "Caller stated they had a temperature excursion of unknown cause". At the time of reporting, no 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: Product storage error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -