VAERS Reports UJ494AA

VAERS 1958093

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ494AA

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Staat: CT
Alter: 0,3
Geschlecht: F
Eingang: 17.12.2021
Impfdatum: 06.10.2021
Beginn: 28.10.2021
Tage bis Beginn: 22,0
Dosis: UNK
Route/Site: OT / -

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

Inappropriate schedule of product administration Medication error

Symptomtext

This case involves a 4-month-old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] 6 days earlier than due date (inappropriate schedule of product administration). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. On 06-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (injection, lot number: UJ494AA and expiry date: 09-Jul-2021) via an intramuscular route at an unknown administration site. On 28-Oct-2021 she also received a 0.5 mL dose of the same vaccine (injection, lot number: UJ494AA and expiry date: 09-Jul-2021) via a subcutaneous route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day). It was reported "Caller states that a patient received a dose of PENTACEL 6 days earlier than they were due, and would like to know what they should do next?" 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 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: Inappropriate schedule of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: ROTATEQ
Allergien: -
Vorherige Impfungen: -

VAERS 1860453

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ494AA

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Staat: AL
Alter: 0,5
Geschlecht: U
Eingang: 11.11.2021
Impfdatum: 01.11.2021
Beginn: 01.11.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Extra dose administered

Symptomtext

patient had administred Pentacel and ACT Hib on same time with no adverse event; Initial information was received on 01-Nov-2021 regarding an unsolicited valid non-serious case from an Other Health Professional via Media Information (under reference 00837120). This case involves a 6-months-old and unknown gender patient who was administered with HIB (PRP/T) VACCINE [ActHIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], which was double dose of the HIB vaccine (extra dose administered). Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination. Medical history,medical treatment, vaccination and family history were not provided. On 01-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ494AA and expiry date: not reported) (Frequency: Once) via intramuscular route in unknown administration site for prophylactic vaccination. On 01-Nov-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ522AA and expiry date: not reported) (Frequency: Once) via intramuscular route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to extra dose administered (latency on same day). It was reported that ''a child was administered ACTHIB and PENTACEL on the same date. Are there any side effects that they need to look out for?'' 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: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR
Allergien: -
Vorherige Impfungen: -

VAERS 1726440

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ494AA

gering

Staat: -
Alter: 0,2
Geschlecht: M
Eingang: 23.09.2021
Impfdatum: 22.09.2021
Beginn: 22.09.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RL

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

Incorrect dose administered Medication error

Symptomtext

Pentacel was given as the diluent only not with the additive. The lot number of the diluent is #U6945AA. Medical director notified. Diluent portion contained DTaP and IPV and is countable per Dr. Client will return for single antigen Hib.

Weitere VAERSDATA-Felder

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