VAERS 1653308
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ415AAA
- Staat
- IL
- Alter
- 0,2
- Geschlecht
- M
- Eingang
- 29.08.2021
- Impfdatum
- 30.07.2021
- Beginn
- 30.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Symptomtext
Patient was given PENTACEL as well as ACT-HIB on the same day/ no AE; Initial information was received on 30-Jul-2021 regarding an unsolicited valid non-serious case received from a Nurse via Global Medical Information (GMI) (Reference number- 00704764) and transmitted to Sanofi on 30-Jul-2021. This case involves a two-month-old male patient reported that patient was given HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on the same day (extra dose administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for prophylactic vaccination, HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]) for prophylactic vaccination and INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for prophylactic vaccination. On 30-Jul-2021, the patient received 0.5 ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ415AAA and expiry date 12-May-2022] via intramuscular route in unknown administration site for prophylactic vaccination and a dose of suspect HIB (PRP/T) VACCINE [lot UJ426AAA and expiry date 28-May-2022] via unknown route in unknown administration site for prophylactic vaccination. It was reported that, "Nurse stated 2 month old child was given PENTACEL as well as ACT-HIB today. Caller is requesting to know if child will be ok and what to do". It was a case of actual medication error due to extra dose administered (latency was on same day). At the time of reporting, patient had 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 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
- ROTAVIRUS VACCINE; PNEUMOCOCCAL CONJUGATE VACCINE; HEP [HEPATITIS B VACCINE]; FLUZONE HIGH DOSE
- Allergien
- -
- Vorherige Impfungen
- -