VAERS 1071185
SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ184AA
- Staat
- DC
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.03.2021
- Impfdatum
- 23.02.2021
- Beginn
- 23.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Symptomtext
inadvertently administered expired ACTHIB to a patient because the diluent was still in date but the powered portion was expired; with no reported AE; Initial information was received on 23-Feb-2021 regarding an unsolicited valid non-serious case from a other healthcare professional in the United States. This case involves child patient (age and gender unknown) who inadvertently administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lyophilized powder: lot number: UJ184AA, expiration date: 15-Feb-2021) via an unknown route at an unknown administration site on 23-Feb-2021 for prophylactic vaccination (expired product administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was reported that this occurred because diluent was still in date but the powered portion was expired [diluent: lot number: U6723AA, expiration date: 17-Sep-2021]. The agent asked caller if she can answer additional questions for a safety report. Caller stated that she cannot but if safety wants to send her the questions via email she can follow up that way. It was an actual medication error due to expired vaccine used (latency: same day). 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 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
- -