VAERS 1776004
SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7073LA
- Staat
- TX
- Alter
- -
- Geschlecht
- U
- Eingang
- 11.10.2021
- Impfdatum
- 06.10.2021
- Beginn
- 06.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Symptomtext
Expired FLUZONE QUADRIVALENT was administered to three patients with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Regulatory authority (Reference number- 00801285) and transmitted to Sanofi on 06-Oct-2021. This case involves three patients who were received expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered). Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients were not received any other vaccine. On 06-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7073LA, expiry: 30-Jun-2021, formulation: solution for injection) via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). It was reported "Caller stated a temperature excursion on Fluzone (high dose) HD expired. Lot: UT7073LA Exp: 06/30/2021 Stated that the expired vaccine was given to 3 different patients. Pharmacist states that a box of FLUZONE QUADRIVALENT from last year's flu season was administered to 3 staff members (Nurses) today. At this time he does not have information on those individuals; identity, age, Et cetera (etc.) All 3 were given today and none of them received any other vaccines." No other 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -