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Reporte zur Charge UJ144AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
PA 1 NY 1

VAERS 1299380

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ144AAA

gering
Staat
PA
Alter
-
Geschlecht
U
Eingang
08.05.2021
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

Symptomtext

A patient received an expired diluent part, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Global Medical Information (GMI) (Reference number- 00574822) and transmitted to Sanofi on 23-Apr-2021 This case involves a patient (unknown demographics) who received an expired 0.5 mL dose of diluent part of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ144AAA and expiry date: 22-Mar-2021) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date (in between 22-Mar-2021 to 22-Apr-2021) (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. A Nurse seeking to know if ActHib would be valid if the diluent used was expired. The nurse was reporting a possible medication error occurred described as the ActHib was given after the expiration date of the diluent. The caller reported that at the time of this call the exact patients that received the vaccine are unknown due to being too early in the investigation. This was a case of actual medication error case due to expired product administered (latency same day). 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 by the regulatory authority . 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 1224954

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ144AAA

gering
Staat
NY
Alter
1,1
Geschlecht
F
Eingang
18.04.2021
Impfdatum
23.03.2021
Beginn
23.03.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error

Symptomtext

administered an expired dose of ActHIB with no reported adverse event; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case from a physician. This case involves a 13 months old female patient who was given an expired 0.5 ml fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] (Lot numbers: carton and powder: UJ144AAA liquid: U6573AA and expiration date : 22-Mar-2021 and also 28-May-2021) via intramuscular route in the left thigh for prophylactic vaccination on 23-Mar-2021 (formulation was however reported as oral solution)(expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included HEPATITIS A VACCINE for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). Reporter was with the question that what do they need to do? 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
HEPATITIS A
Allergien
-
Vorherige Impfungen
-