VAERS 1824732
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ458AB
- Staat
- CO
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 28.10.2021
- Impfdatum
- 08.10.2021
- Beginn
- 08.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RA
Symptomtext
Patient received quadracel instead of pentacel with no adverse event; Initial information regarding an unsolicited valid non serious case was received from other health professional and physician via Medical Information (MI) (Reference number: 00812771) and transmitted to Sanofi on 14-Oct-2021. This case involves a four-year-old male patient received quadracel instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered). The patient medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Prophylactic vaccination. On 08-Oct-2021, the patient received a o.5 mL total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5ml, Strength: standard except for Fluzone, dosage form: solution, lot UJ458AB, expiry date: 21-May-2022] via an intramuscular route in the right deltoid for Prophylactic vaccination. It was an actual medication error case due to wrong vaccine administered (latency: same day). It was reported "medical assistant states pentacel was given to a patient accidently when quadracel was the vaccine they were trying to administer." At the time of reporting, no adverse event was reported. This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- PROQUAD
- Allergien
- -
- Vorherige Impfungen
- -