VAERS 2722608
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ858AA
- Staat
- NH
- Alter
- 0,6
- Geschlecht
- M
- Eingang
- 11.12.2023
- Impfdatum
- 24.11.2023
- Beginn
- 24.11.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LL
Symptomtext
PENTACEL and Pediarix are given at the same time, with no reported adverse event; Initial information received from Regulatory Authority on 29-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old male patient to whom Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] and pediarix are given at the same time, 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) for Prophylactic vaccination. On 24-Nov-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ858AA, strength and expiry date not reported) via intramuscular route in the left thigh as Immunization and at the same time patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number, strength, form, dose, expiry date not reported) via unknown route in unknown administration site as Prophylactic vaccination with no reported adverse event (contraindicated 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
- Contraindicated product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
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- Allergien
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- Vorherige Impfungen
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