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Reporte zur Charge UT7073LA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
SC 3 TX 1

VAERS 1776004

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7073LA

gering
Staat
TX
Alter
-
Geschlecht
U
Eingang
11.10.2021
Impfdatum
06.10.2021
Beginn
06.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event Product storage error

Symptomtext

Expired FLUZONE QUADRIVALENT was administered to three patients with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Regulatory authority (Reference number- 00801285) and transmitted to Sanofi on 06-Oct-2021. This case involves three patients who were received expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered). Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients were not received any other vaccine. On 06-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7073LA, expiry: 30-Jun-2021, formulation: solution for injection) via unknown 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 "Caller stated a temperature excursion on Fluzone (high dose) HD expired. Lot: UT7073LA Exp: 06/30/2021 Stated that the expired vaccine was given to 3 different patients. Pharmacist states that a box of FLUZONE QUADRIVALENT from last year's flu season was administered to 3 staff members (Nurses) today. At this time he does not have information on those individuals; identity, age, Et cetera (etc.) All 3 were given today and none of them received any other vaccines." No other 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
-

VAERS 1713145

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7073LA

gering
Staat
SC
Alter
39,0
Geschlecht
F
Eingang
18.09.2021
Impfdatum
07.09.2021
Beginn
07.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

given expired FLUZONE, with no AE; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician. This case involves a 39-year-old female patient given expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 07-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7073LA, expiry date unknown) via an intramuscular route in unknown administration site for prophylactic vaccination. It was a case of actual medication error expired vaccine used (same day). It was reported, "caller stated that she needs guidance on if they need to revaccinate a patient that was given EXPIRED FLUZONE on 07Sep2021". 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
-

VAERS 1713144

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7073LA

gering
Staat
SC
Alter
23,0
Geschlecht
F
Eingang
18.09.2021
Impfdatum
07.09.2021
Beginn
07.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

patient given expired fluzone with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Medical Information (Reference number- 00759590) and transmitted to Sanofi on 08-Sep-2021. This case involves 23-year-old female patient given expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered). Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 07-Sep-2021, the patient received 0.5ml (total, 1X(once)] dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7073LA and expiry date: 30-Jun-2021) (Frequency = once) (Strength = standard) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered). It was reported,"Caller stated that she needs guidance on if they need to revaccinate a patient, If so, what is the time frame she needs to wait?" This case was an actual medication error due to expired vaccine used (latency: same day). At the time of reporting, no adverse event. 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
-

VAERS 1713143

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7073LA

gering
Staat
SC
Alter
35,0
Geschlecht
F
Eingang
18.09.2021
Impfdatum
07.09.2021
Beginn
07.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

patient received expired fluzone; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician and non-healthcare professional via call center via Medical Information (Reference number- 00759516). This case involves a 35 years old female patient who administered expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered). The patient's medical history, past medical treatment, vaccination and family history were not provided. On 07-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7073LA and expiry date: 30-Jun-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to expired vaccine used (latency: same day). At the 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 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
-