VAERS 1301829
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ336AA
- Staat
- MD
- Alter
- 0,6
- Geschlecht
- M
- Eingang
- 10.05.2021
- Impfdatum
- 24.03.2021
- Beginn
- 24.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- OT / -
Symptomtext
the patient only received the IPV and DTAP and not the HIB portion, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (nurse) via medical information (MI) (Reference number- 00577376) and transmitted to Sanofi on 26-Apr-2021. This case involves a 7 month old male patient who only received the IPV and DTAP and not the HIB portion, while patient received a third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number: UJ336AA, expiry date and other dosing details were not reported] on 24-Mar-2021 for prophylactic vaccination (product preparation issue). Medical history, medical treatment, vaccination and family history were not reported. Concomitant vaccinations included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) (PNEUMOC 13,). It was a case of actual medication error due to inappropriate reconstitution technique. (Latency: same day) It was reported that, while doing inventory, reporter discovered an extra vial of Act HIB in a Pentacel box. It was also reported that, recently the have had vaccinated 2 children in last 2-3 weeks with Pentacel but they could not tell which child only got the IPV/DTaP vial and not the powder Act HIB vial. At the time of reporting, reporter was not sure that, the patient details reported for child that one if only IPV/DTAP portion and not the HIB portion of Pentacel or not. About lot number it was reported that, the way they document the lot for Pentacel, it was reported to her. At the time of report, 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
- Product preparation issue
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE 13V
- Allergien
- -
- Vorherige Impfungen
- -