VAERS 1958096
SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7384LA
- Staat
- MO
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.12.2021
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Symptomtext
vaccine sprayed out between the needle and the syringe with no reported adverse event; the plastic hub attached to the syringe where the needle screws on is loose and spins, no AE; vaccine sprayed out between the needle and the syringe and into the face of the patient with no reported adverse event; Initial information was received on 07-Dec-2021 regarding an unsolicited valid non-serious case from a nurse via physician. This case involves patient (demographics unknown) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] which sprayed out between the needle and the syringe and into the face of the patient as a result of the plastic hub attached to the syringe where the needle screws on was loose and spined (underdose, needle issue and exposure via skin contact). The patient's medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7384LA, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to vaccine underdose, needle issue and exposure via skin contact (latency same day). It was reported "A medical assistant was administering this vaccine and the vaccine sprayed out between the needle and the syringe. When I looked over the needle and syringe, I noticed the plastic hub attached to the syringe where the needle screws on is loose and spins. My thoughts are when our MA tightened the needle onto the syringe the hub spun and did not allow the needle to be tightened properly. I did check the other syringes in this same box and the plastic hubs do not twist, they are fixed into place. Nurse (RN) reports that FLUZONE QIV NP syringe was used on a patient and that the hub was loose on the product and when the MA went to administer the product the fluid sprayed out between the needle and the syringe and into the face of the patient" 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
- Syringe issue
- Hospital-Tage
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- Labordaten
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- Aktuelle Erkrankungen
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- Vorgeschichte
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- Andere Medikamente
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- Allergien
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- Vorherige Impfungen
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