VAERS 1653340
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ347AAA
- Staat
- CO
- Alter
- 0,3
- Geschlecht
- F
- Eingang
- 29.08.2021
- Impfdatum
- 05.08.2021
- Beginn
- 05.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Symptomtext
gave an expired pentacel to a patient today, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse via Global Medical Information (Reference number- 00712774) and transmitted to Sanofi on 05-Aug-2021. This case involved 4-month-old female patient gave an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] to a patient today (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Nurse reports that the patient also received injection of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) on the other side and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) via oral route for prophylactic vaccination On 05-Aug-2021, the patient received first 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ347AAA and expiry date: 30-Jul-2021) (Strength : standard) (Drug Interval Dosage : once) (Form: Suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered) It was reported that, "Nurse would like to know what are the next step? Is re-vaccination necessary and how soon"? This was an actual medication error due to expired vaccine used (latency: same day) At the time of reporting, 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 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
- PREVENAR 13; ROTAVIRUS VACCINE
- Allergien
- -
- Vorherige Impfungen
- -