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Reporte zur Charge U6214AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TX 1 GA 1 FL 1

VAERS 1653391

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6214AA

gering
Staat
TX
Alter
-
Geschlecht
F
Eingang
29.08.2021
Impfdatum
17.08.2021
Beginn
17.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error

Symptomtext

expired ADACEL was given with no reported adverse event; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional via Media information (under the reference 00728465). This case involved a 30 years old female patient who was vaccinated with an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication were given to the patient. On 17-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, total, 1X(once), 0.5ml, lot U6214AA and expiration date: 14-mar-2021) via intramuscular route in the left arm for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported, "HCP (Healthcare Professional) stated expired ADACEL was given and wanted to know what needed to be done. Attempted transfer to MIS-No answer. Placed in proxy for a call back. HCP request to be called on the mobile number on file. She would be leaving out the office in the next 25 minutes." At time of reporting, no adverse event was reported and the outcome was unknown for reported 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 1413789

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6214AA

gering
Staat
GA
Alter
-
Geschlecht
M
Eingang
21.06.2021
Impfdatum
11.06.2021
Beginn
11.06.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

patient received an expired ADACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case from a pharmacist via Medical Information (Reference number- 00638033) and transmitted to Sanofi on 11-Jun-2021. This case involves a 49-year old male patient who received an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] On 11-Jun-2021 [lot number: U6214AA and expiration date: 14-Mar-2021] via intramuscular route in the left arm for prophylactic vaccination. It was unknown if the patient had any medical history, concomitant disease or risk factor, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was an actual medication error due to expired vaccine used (latency: same day). At the time of report, no adverse event was reported. It was unknown if there were lab data/results available. Disclaimer: 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 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 1129593

SANOFI PASTEUR · TDAP (ADACEL) · Charge U6214AA

gering
Staat
FL
Alter
-
Geschlecht
U
Eingang
24.03.2021
Impfdatum
16.03.2021
Beginn
16.03.2021
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

no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Pharmacist via Agency (Reference number- 00521572) and transmitted to Sanofi on 16-MAR-2021. This case involves a patient (unknown age and gender) who was administered an expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] (lot U6214AA, expiry date: 14-Mar-2021) via unknown route in the unknown site for prophylactic vaccination on 16-Mar-2021(expired product administered) Medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of an actual medication error due to expired vaccine used (latency same day). At the time of reporting, patient had 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 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
-