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Reporte zur Charge U7198AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IL 1 CA 1 IN 1 MI 1

VAERS 2577758

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7198AA

gering
Staat
IL
Alter
1,0
Geschlecht
F
Eingang
08.02.2023
Impfdatum
03.02.2023
Beginn
03.02.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

expired dose of pentacel that was administered, with no reported adverse event; Initial information received on 03-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 1 year old female patient to whom expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that was administered, 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 PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Prophylactic vaccination. On 03-Feb-2023, the patient received Dose 3; at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation: unknown) (lot number: U7198AA and expiry date: 28-Jan-2023) in the lateral thigh for Immunization and expired dose of pentacel that was administered, with no reported adverse event (expired product administered) (latency: same day). It was reported, what should we watch for or know with respect to an expired dose of Pentacel that was administered today? She mentioned that the ink for the lot and expiry as printed on the vial is lighter in shade than the ink printed on the rest of the vial. First time product used : Yes Still using product : No. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. At time of reporting, the outcome was 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 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 2561930

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7198AA

gering
Staat
CA
Alter
5,0
Geschlecht
F
Eingang
18.01.2023
Impfdatum
03.01.2023
Beginn
03.01.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

5 year old patient was given PENTACEL because she was behind with her vaccinations with No adverse event; Initial information was received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 5 years old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] because she was behind with her vaccinations with no adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]). On 03-Jan-2023, the 5 years old patient received total 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: U7198AA, expiry date: 28-Jan-2023) via intramuscular route in the right arm for Immunization (Immunisation) because she was behind with her vaccinations with no adverse event (product administered to patient of inappropriate age) (latency: same day) No lab data reported. Action taken: not applicable. Outcome: Unknown for the event 5 year old patient was given pentacel because she was behind with her vaccinations with no 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]
Allergien
-
Vorherige Impfungen
-

VAERS 2440249

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7198AA

gering
Staat
IN
Alter
0,3
Geschlecht
M
Eingang
12.09.2022
Impfdatum
01.08.2022
Beginn
01.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error Single component of a two-component product administered

Symptomtext

reported liquid DTaP-IPV portion of PENTACEL given without the Hib component with no reported adverse event; reported liquid DTaP-IPV portion of PENTACEL given without the Hib component with no reported adverse event; Initial information received on 18-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 4 months old male patient to whom liquid dtap-ipv portion of pentacel given without the hib component 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 reassort oral 5V (Rotateq) both for Prophylactic vaccination. On 01-Aug-2022, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine at a dose of 0.5 ml total (lot U7198AA, expiry date: 28-Jan-2023) via intramuscular route in the left thigh for immunisation. On 01-Aug-2022 liquid dtap-ipv portion of pentacel given without the hib component with no reported adverse event (single component of a two-component product administered, Product preparation error) same day latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. 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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2325682

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U7198AA

gering
Staat
MI
Alter
0,3
Geschlecht
M
Eingang
21.06.2022
Impfdatum
12.05.2022
Beginn
12.05.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product preparation error

Symptomtext

THE IMMUNIZATION WAS DRAWN UP INCORRECTLY. THE 2 VIALS WERE NEVER MIXED TOGETHER SO HE DID NOT RECEIVE THE POWDER PORTION

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-