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Reporte zur Charge UJ334AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

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

VAERS 1483656

SANOFI PASTEUR · DTAP + IPV (QUADRACEL) · Charge UJ334AA

gering
Staat
FL
Alter
0,3
Geschlecht
U
Eingang
18.07.2021
Impfdatum
05.07.2021
Beginn
05.07.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

patient was administered expired Pentacel vaccination, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (medical assistant)(Reference number- 00669947) and transmitted to Sanofi on 06-Jul-2021. This case involves a four month old patient (gender not rpeorted) who was administered an expired dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 05-Jul-2021, the patient received a 0.5 mL expired dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number: UJ334AA; expiry date: 17-JUN-2021) via intramuscular route in the right thigh for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). 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 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 1483654

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ334AA

gering
Staat
FL
Alter
0,3
Geschlecht
U
Eingang
18.07.2021
Impfdatum
05.07.2021
Beginn
05.07.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

expired PENTACEL vaccine administered to a patient, No AE; Initial information was received on 06-Jul-2021 regarding an unsolicited valid non-serious case received from an other health professional (Medical assistant) via Physician (Inquiry Number: 00669898). This case involves a three months old patient gender unknown who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On 05-Jul-2021, the patients received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Formulation: Solution lot number: UJ334AA and Expiry date: 13-Jun-2021, Frequency: once, Strength: standard via intramuscular route in the right thigh for prophylactic vaccination. It was case of an actual medication error due to expired vaccine use (latency: same day). It was reported "Medical assistant calling to report that three patients were given expired PENTACEL vaccinations on 5-Jul-2021. Caller stated that all the vaccines were given intramuscularly in the right thigh. Pasteur Adverse Event Reporting Refunds/ Credits will not be issued due to adverse events. Emergency Room/ Doctor visit and date 05-Jul-2021. Reporter relationship: Caregiver, Product used: Used, First time product used: No, Still using product: Yes and Was Device Used: No." At the 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.; Sender's Comments: US-SA-2021SA230547:

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