VAERS 1528279
SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ358AAB
- Staat
- CA
- Alter
- 1,3
- Geschlecht
- M
- Eingang
- 05.08.2021
- Impfdatum
- 28.07.2021
- Beginn
- 28.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RL
Symptomtext
A patient received a expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00701286) and transmitted to Sanofi on 28-Jul-2021. This case involves a 16-month-old male patient who received an expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 28-Jul-2021, the patient received 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE (lot UJ358AAB and expiry date: 27-Jul-2021) via an intramuscular route in the right thigh for prophylactic vaccination (expired product administered). This was a case of actual medication error due to Expired vaccine used (latency same day). At time of reporting, no adverse events were 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- DAPTACEL; PREVNAR 13
- Allergien
- -
- Vorherige Impfungen
- -