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Reporte zur Charge U6187AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
ND 1 NY 1 OK 1 OH 1 TX 1

VAERS 1775082

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6187AA

gering
Staat
ND
Alter
64,0
Geschlecht
M
Eingang
09.10.2021
Impfdatum
06.10.2021
Beginn
06.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered No adverse event

Symptomtext

TENIVAC LOT U6187AA WAS EXPIRED ON 2/6/21 AND GIVEN TO PATIENT ON 10-6-21. NO ADVERSE EVENTS. REPEATED DOSE

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1412611

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6187AA

gering
Staat
NY
Alter
14,0
Geschlecht
F
Eingang
19.06.2021
Impfdatum
10.06.2021
Beginn
10.06.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

expired Tenivac was accidentally administered to a patient, with no reported adverse event; Initial information received on 10-Jun-2021 regarding an unsolicited valid non-serious case from a nurse practitioner (under reference id 00636554). This case involves a 14 years old female patient who was accidentally administered with 0.5 ml expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (booster, lot number U6187AA and expiration date: 06-Feb-2021) via an unknown route in the right deltoid for prophylactic vaccination on 10-Jun-2021 at 13:15 (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given to the patient. It was a case of an actual medication error due to expired vaccine used (same day latency). Reported that caller would like to find out about next steps. 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 1406215

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6187AA

gering
Staat
OK
Alter
29,0
Geschlecht
M
Eingang
17.06.2021
Impfdatum
01.06.2021
Beginn
01.06.2021
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

29 year old male patient received expired dose of Tenivac with no adverse event; Initial and additional information regarding an unsolicited valid non-serious case was received on 04-Jun-2021 and 7-Jun-2021 from a pharmacist via Agency (Reference number- 00628884). This case involves a 29-year-old male patient who was vaccinated with 0.5 mL (standard) expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6187AA, expiry date: 06-Feb-2021] via intramuscular route at left deltoid for prophylactic vaccination (expired product administered). Caller with question on whether dose needs repeating and whether they had any safety data to provide regarding expired dose. The patient's medical history, past medical treatments, and family history were not provided. No concomitant therapy was given. It was a case of an actual medication error due to expired vaccine used (latency was on same day). 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 1227984

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6187AA

gering
Staat
OH
Alter
72,0
Geschlecht
M
Eingang
19.04.2021
Impfdatum
29.03.2021
Beginn
29.03.2021
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 No adverse event

Symptomtext

expired dose of TENIVAC was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Agency (Reference number- 00541423) and transmitted to Sanofi on 30-Mar-2021. This case involves a 72 years old male patient who experienced expired 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6187AA and expiration date 06-Feb-2021) via intramuscular route in an unknown administration site for prophylactic vaccination(Expired product administered) on 29-Mar-2021. The patient's medical history, past medical treatment(s), vaccination(s), family history, risk factor and concomitant medication were not provided. It was an actual medication error due to expired vaccine used (same day latency). It was not reported that the patient experienced any 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 1080357

SANOFI PASTEUR · TD ADSORBED (TENIVAC) · Charge U6187AA

gering
Staat
TX
Alter
55,0
Geschlecht
M
Eingang
08.03.2021
Impfdatum
21.02.2021
Beginn
21.02.2021
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 Medication error No adverse event

Symptomtext

expired Tenivac was given to a patient with no adverse event; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a Nurse Practitioner via Agency (Reference number- 00495304). This case involves a 55 years old male patient who received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] batch number: U6187AA, expiry date: 06-FEB-2021 via unknown route and administration site on 21-Feb-2021 for prophylactic vaccination (expired product administered). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error due to expired vaccine used (latency same day). Reporter causality: not reported. Reporter can be contacted by Sanofi: Yes. Potential product technical complaint (PTC): No. Description: Nurse Practitioner would like to know how to proceed. Does the patient need to be re-vaccinated and are there any health risks. Reviewed case and did not speak with the caller as the caller requested a response via email. Product used. At the 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 holders 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
-