VAERS 1931711
SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7058JA
- Staat
- PA
- Alter
- 29,0
- Geschlecht
- F
- Eingang
- 08.12.2021
- Impfdatum
- 24.11.2021
- Beginn
- 24.11.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Symptomtext
expired dose of FLUZONE QUADRIVALENT was administered inadvertently, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via physician via Agency (Reference number- 00877775) and transmitted to Sanofi on 30-Nov-2021. This case involves a 29 year old female patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] inadvertently (Expired product administered). The patient's medical history, medical treatment(s), past vaccination(s) and family history were not provided. She had no other vaccines. On 24-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE produced by Sanofi Pasteur (lot number: UT7058JA and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency same day). It was reported "Nurse reported that an expired dose of FLUZONE QUADRIVALENT was administered inadvertently to a patient by a medical assistant on 24NOV2021. The FLUZONE QUADRIVALENT expired on 30JUN2021. The caller would like to know if this is a valid dose and how to proceed. Product: FLUZONE QUARIVALENT (pre-filled syringe (PFS)). Caller stated that the patient did not have any adverse reactions and did not require Doctor or emergency room (ER) visit post administration" 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 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
- -