VAERS 1062988
SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) · Charge UJ536AA
- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 01.03.2021
- Impfdatum
- 27.10.2020
- Beginn
- 16.11.2020
- Tage bis Beginn
- 20,0
- Dosis
- UNK
- Route/Site
- OT / LA
Symptomtext
patient had recieved two doses of 0.5ml Fluzone HD Quad vaccinations, in the left deltoid on 10/27/20 and 11/16/2020 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- US-SANOFI-00479869) and transmitted to Sanofi on 17-Feb-2021 This case involves a 80 year old male patient who was administered of 0.5 ml QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ536AA,expiry date: 30-JUN-2021) via unknown route in left deltoid for prophylactic vaccination (extra dose administered) Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to extra dose administered (latency same day). The caller stated that patient PH had recieved two doses of 0.5ml Fluzone HD Quad vaccinations, in the left deltoid on 10/27/20 and 11/16/2020. Staff person had administered the last vaccination. 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. There will be no information available on the batch number for this case.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Extra dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
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