VAERS 1893348
SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE) · Charge UJ477AA
- Staat
- IL
- Alter
- -
- Geschlecht
- F
- Eingang
- 23.11.2021
- Impfdatum
- 28.10.2021
- Beginn
- 28.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Symptomtext
Patient received a FLUZONE QUADRIVALENT that was later noted to have expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Global Medical Information (Reference number- 00855893) and transmitted to Sanofi on 12-Nov-2021. This case involves a female patient (age unknown) who had received an expired INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (expired product administered). The patient's medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided. On 28-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED produced by Sanofi Pasteur (lot number: UJ477AA and expiry date: 30-Jun-2021) via intramuscular 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 "Staffer is calling back to provide name of an expired vaccine June 2021, that was given to another staffer on October 28. The staffer wants to know if she needs to get another shot. She is unsure if it was with or without preservatives. health care professional (HCP) states that on 10/28/2021, an employee at one of their sites received a FLUZONE QUADRIVALENT vaccine that was later noted to have expired. Caller states that she was not present, does not know if vaccine was from a multi-dose vial or single dose presentation. She also does not know the national drug code (NDC) or the injection site. Telephone connection was very bad, incomplete patient specifics collected. Treatment-will be repeated". 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
- -