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Reporte zur Charge U6427AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 2

VAERS 1958099

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge U6427AA

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
17.12.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

expired Sodium Chloride Injection Diluent given with yellow fever with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from other health professional via regulatory agency (Reference number- 00892353) and transmitted to Sanofi on 10-Dec-2021. This case involves a patient (unknown demographic) receiving expired sodium chloride injection diluent given YELLOW FEVER VACCINE - US [YF-VAX] and while treated with SODIUM CHLORIDE (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US [lot U6427AA, expiry date 30-sep-2021] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient started taking SODIUM CHLORIDE [lot number and expiry date not reported] via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. (latency: same day). It was reported "expired Sodium Chloride Injection Diluent given with yellow fever." does pt need to be re- vaccinated? At time of reporting, no adverse event 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 guidelines. 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
-

VAERS 1774829

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge U6427AA

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
09.10.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

patient received expired dose of YF-VAX, no AE; Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious case from another health professional via Medical Information (Reference number- 00789201). This case involves patient (unknown demographics) who was vaccinated with the expired dose of suspect YELLOW FEVER VACCINE - US [YF-VAX], (expired product administered). The patient's medical history, past medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (vaccine lot number UJ372AA and expiry date: 22-Jul-2022, diluent lot number: U6427AA and expiry date: 20-Sep-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). It was reported "Caller reports that YF-VAX was received a few months ago and the actual product had a good expiration date but the diluent was short-dated and it expires Sep2021; caller requests replacement for diluent. Caller disconnected while on hold. caller further clarified that she spoke with Pasteur Customer Service and they sent a replacement diluent but she was sent sterile water. How purchased: Vaccine Shoppe, Number of units affected- 5 vaccines, Is dose not used or not available not used- not used, Whether product is available for return- diluent available for return o If the customer says no then advise them that if this happens again to retain the product for return to better assist in the investigation. If the customer states picture are available, ask to send us the picture. No broken vials or syringes with needles can be returned. Information to be gathered on the type of needle that was used by the end-user (e.g. gauge size)". At time of reporting, 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
-