Zurueck zur Suche

Reporte zur Charge UJ544AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TN 1 NC 1

VAERS 2440310

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ544AB

gering
Staat
TN
Alter
0,3
Geschlecht
M
Eingang
12.09.2022
Impfdatum
02.09.2022
Beginn
02.09.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

Pentacel dose given after expiration with no reported adverse event; Initial information received on 02-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who reported pentacel dose given after expiration with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Prophylactic vaccination. On 02-Sep-2022, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (1X) (lot UJ544AB; expiry date: 07-Aug-2022) via intramuscular route in the left thigh for prophylactic vaccination. On 02-SEP-2022 the patient reported pentacel dose given after expiration with no reported adverse event (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event (expired product administered). At time of reporting, the outcome was Unknown for the event expired product administered. 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 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 1793494

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ544AB

gering
Staat
NC
Alter
-
Geschlecht
U
Eingang
16.10.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

A dose of PENTACEL administered to a patient, but did not reconstitute no AE;Initial information regarding an unsolicited valid non-serious case was received from a nurse via consumer/non-health care professional via Medical Information (Reference number- 00807298) and transmitted to Sanofi on 11-Oct-2021. This case involves a patient (unknown demographics) who was received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] administered to a patient but did not reconstitute (product preparation issue). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ544AB, expiry 07-Aug-2022) via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day). It was reported "Nurse states they administered a dose of PENTACEL to a patient but did not reconstitute before administering. Nurse states the Diphtheria and tetanus toxoids and acellular pertussis- Inactivated Poliovirus Vaccine (DTaP-IPV) portion was administered but not the Haemophilus influenzae type b (Hib). states that she is just trying to request the proper diluent, the 0.4% sodium chloride (NaCl) saline solution for the Hib component. She was referred to the Pentacel Reconstitution Video." 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-