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Reporte zur Charge UJ214AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

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

VAERS 2183962

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ214AAA

gering
Staat
FL
Alter
0,3
Geschlecht
M
Eingang
17.03.2022
Impfdatum
19.07.2021
Beginn
19.07.2021
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

Symptomtext

consumer received an expired dose of Pentacel with no adverse event; Initial information received on 14-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional. Country: This case involves a 4 months old male patient who had received an expired dose of pentacel with no 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 (pneumococcal conjugate vaccine) and rotavirus vaccine (rotavirus vaccine) for immunisation. On 19-Jul-2021, the patient received a dose 0.5 ml once a day of suspect Pentacel (lot UJ214AAA, expiry date: 02-May-2021) via intramuscular route in the right leg for immunization On 19-Jul-2021 the patient received an expired dose of pentacel with no adverse event (expired product administered) (latency: same day). Action taken: not applicable Outcome: unknown 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
PNEUMOCOCCAL CONJUGATE VACCINE; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1744255

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ214AAA

gering
Staat
FL
Alter
0,3
Geschlecht
M
Eingang
29.09.2021
Impfdatum
19.07.2021
Beginn
19.07.2021
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

Symptomtext

patient received expired vaccine PENTACEL/no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional, non-healthcare professional, physician via Medical Information (Reference number- 00778696) and transmitted to Sanofi on 21-SEP-2021. This case involves a 4 months old male patient who received expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination. On 19-Jul-2021, the patient received a 2 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ214AAA and expiry date: 02-MAY-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (on the same day). It was reported "Caller reports the patient received expired PENTACEL, the new office does not offer PENTACEL they offer Pediarix, the patient is coming in for the 6 month shots, so they need to know how to make sure the child will receive a complete series; is there any leeway with the expiration date of PENTACEL, if the expired dose is not valid how do they catch the patient up with the Pediarix vaccine instead of PENTACEL." At the time of report, the outcome was unknown for the 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
ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE
Allergien
-
Vorherige Impfungen
-