VAERS 2723384
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ791AB
- Staat
- PA
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 12.12.2023
- Impfdatum
- 05.12.2023
- Beginn
- 05.12.2023
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Symptomtext
expired PENTACEL was administered with no reported adverse event; Initial information received on 05-Dec-2023 regarding an unsolicited valid non-serious case received via physician. This case involves a 2-month-old male patient who and expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) and rotavirus vaccine for Prophylactic vaccination. On 05-Dec-2023, the patient received a dose 1 of 0.5 ml dose of suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ791AB, expiry date: 10-Oct-2023) via intramuscular route in thigh unknown if left or right for immunization and expired pentacel was administered with no reported adverse event (expired product administered) (latency: same day). 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
- -