VAERS Reports UJ350AAA

VAERS 1483662

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ350AAA

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Staat: WV
Alter: 0,3
Geschlecht: F
Eingang: 18.07.2021
Impfdatum: 02.07.2021
Beginn: 02.07.2021
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 Medication error No adverse event

Symptomtext

administered expired Pentacel because the expiration date on the box was confusing, with no reported adverse event; Initial information was received on 07-Jul-2021 regarding an unsolicited valid non-serious case from other health professional in the (GMI Inquiry number: 00672437). This case involves a four-month-old female patient who experienced administration of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) because the expiration date on the box was confusing (expired product administered). Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation and ROTAVIRUS VACCINE for Immunisation. On 02-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number: UJ350AAA, expiry date: 22-Jun-2021] via an intramuscular route at left thigh for prophylactic vaccination. Description: The caller reported that two patients were administered expired Pentacel because the expiration date on the box was "confusing". The caller wanted to know what they need to do now, for those patients. It was a case of actual medication error due to expired vaccine used. At the time of report, no adverse event 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 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.; Sender's Comments: SAD20210707001286:

Weitere VAERSDATA-Felder

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

VAERS 1483661

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ350AAA

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Staat: WV
Alter: 0,3
Geschlecht: F
Eingang: 18.07.2021
Impfdatum: 29.06.2021
Beginn: 29.06.2021
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 Medication error No adverse event

Symptomtext

a patient was administered an expired dose of Pentacel, No AE; a patient was administered an expired dose of Pentacel because the expiration date on the box was confusing, No AE; Initial information was received on 07-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician (under Global Medical Information (GMI) Inquiry Number 00672403). This case is linked to case 2021SA226436 (same reporter sister's case). This case involves a four months old female patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] because the expiration date on the box was confusing (Expired product administered and Product label confusion). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for prophylactic vaccination. On 29-Jun-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number: UJ350AAA and Expiry date: 22-Jun-2021, Frequency: once, Strength : standard via intramuscular route in the left thigh for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used and expiration date format confusion (latency: same day). It was reported "The caller declined to provide an email address, stated the office does not have one. The caller reported that two patients were administered expired Pentacel because the expiration date on the box was confusing. The caller wanted to know what they need to do now, for those patients. Caller reported that the expiration date on the box was written as 22/06/21 so the staff thought this meant it expired 21Jun2022, not 22Jun2021." At 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 by the regulatory authority. 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: ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)
Allergien: -
Vorherige Impfungen: -

VAERS 1459259

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ350AAA

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Staat: NH
Alter: -
Geschlecht: U
Eingang: 09.07.2021
Impfdatum: 01.07.2021
Beginn: 01.07.2021
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

a physician administered an expired Pentacel to a baby, No AE; Initial information received on 01-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional via Medical Information number: 00665242. This case involves an unknown age and gender baby who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] by a physician (Expired product administered). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On 01-Jul-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number: UJ350AAA, expiry date: 22-JUN-2021 via an unknown route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). It was reported "Medical Assistant reports she does not have patient information. She is working from home and the information was also just called in to her. Adverse Event (AE) Reporting AE event: A physician administered an expired Pentacel to a baby. Date of AE: today. Given by: Unknown, Product used". 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: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1456713

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ350AAA

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Staat: IL
Alter: -
Geschlecht: U
Eingang: 08.07.2021
Impfdatum: -
Beginn: 24.06.2021
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

an expired dose of PENTACEL was administered/ no AE; Initial information was received on 29-Jun-2021 regarding an unsolicited valid non-serious case received from a Nurse via Agency (Reference number- 00661687) and transmitted to Sanofi on 29-Jun-2021. This case involves a patient (unknown demographics) who was vaccinated 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ350AAA and expiry date 22-Jun-2021) via unknown route in unknown administration site on 24-Jun-2021 for prophylactic vaccination and reported that an expired dose of PENTACEL was administered with no adverse event (expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to expired vaccine used (latency was on same day). At the time of reporting, patient had no 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 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 1443329

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ350AAA

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Staat: NH
Alter: 4,0
Geschlecht: M
Eingang: 02.07.2021
Impfdatum: 01.07.2021
Beginn: 01.07.2021
Tage bis Beginn: 0,0
Dosis: 5
Route/Site: IM / -

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

Expired product administered

Symptomtext

Pt was given Pentacel and unfortunately, it was found later to have been an expired dose. After contacting the state, it was recommended the vaccine be re-administered. Mom was made aware at the time of the visit. We will re-administer when a dose is available.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: n/a
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: Vitamin D, Elderberry, Zyrtec (childrens)
Allergien: n.k.d.a.
Vorherige Impfungen: -

VAERS 1433624

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ350AAA

gering

Staat: MN
Alter: 0,8
Geschlecht: M
Eingang: 29.06.2021
Impfdatum: 28.06.2021
Beginn: 28.06.2021
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / LL

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

Expired product administered No adverse event

Symptomtext

Patient was given an expired vaccination. He did not have any adverse reaction to it after it was given. Provider was notified of this afterwards.

Weitere VAERSDATA-Felder

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