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Reporte zur Charge UJ660AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
HI 1 UT 1

VAERS 2404223

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ660AA

gering
Staat
HI
Alter
-
Geschlecht
F
Eingang
08.08.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Poor quality product administered Product preparation error

Symptomtext

administered Pentacel that was mixed with Quadracel instead of the Pentacel diluent with no reported adverse event; administered Pentacel that was mixed with Quadracel instead of the Pentacel diluent with no reported adverse event; Initial information received on 01-Aug-2022 regarding an unsolicited valid non-serious case received from a physician. GMI number: 01215828 This case involves Infant female patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that was mixed with quadracel instead of the pentacel diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received Suspect Pentacel Vaccine mixed with quadracel instead of the Pentacel diluent at dose 0.5 ml once (lot UJ660AA, expiry: 25-Feb-2023) via unknown route in unknown administration site for immunization with no reported adverse event (product preparation error, poor quality product administered). Action taken: Not applicable. At time of reporting, the outcome was Unknown for both events. 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
Poor quality product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2387801

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ660AA

gering
Staat
UT
Alter
1,2
Geschlecht
F
Eingang
24.07.2022
Impfdatum
19.07.2022
Beginn
19.07.2022
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

patient was given ACTHIB and PENTACEL on the same day extra dose adminstered with no reported adverse event; Initial information received on 19-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2022SA294411 for same patient. This case involves a 14 months old female patient who experienced patient was given ACT-HIB and diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] on the same day extra dose adminstered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination. On 19-Jul-2022, the patient received a 0.5ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot UJ660AA;strength and expiry date not provided) via intramuscular route in the left thigh for prophylactic vaccination. On 19-Jul-2022 on same day it was reported patient was given acthib and pentacel on the same day extra dose adminstered with no reported adverse event (extra dose administered). Reporter asked if there were any concerns about the patient receiving two doses of HIB in the 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MMR; HEPATITIS A; VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-