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Reporte zur Charge UJ648AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 2 MI 1 WV 1

VAERS 2595044

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ648AAA

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
11.03.2023
Impfdatum
07.03.2023
Beginn
07.03.2023
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 No adverse event

Symptomtext

staff found the expiration date on the PENTACEL confusing and caused them to administer the PENTACEL after it had expired with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received via consumer/non-hcp. number: 01521982. This case involves patient of unspecified demographics to whom as staff found the expiration date on the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] confusing and caused them to administer the Pentacel after it had expired with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Mar-2023, the patient received suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection at dose 0.5ml once (lot: UJ648AAA, expiry date: 25-Feb-2023) via unknown route in unknown administration site for immunization, staff found the expiration date on the Pentacel confusing and caused them to administer the Pentacel after it had expired with no reported adverse event (expired product administered) at same day latency. Action taken: Not applicable. No corrective treatment was received for the event. 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 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 2594831

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ648AAA

gering
Staat
CA
Alter
2,0
Geschlecht
F
Eingang
10.03.2023
Impfdatum
07.03.2023
Beginn
07.03.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Drug ineffective Expired product administered

Symptomtext

Patient was given a dose of expired vaccine (Dtap-IPV-Hib, Pentacel). Called manufacturer and they said the vaccine is rendered ineffective when it is past the expiration date. Manufacturer stated that vaccine should be administered to patient again to complete dose requirements. Manufacturer stated that there should be no issues with giving another dose to the patient.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Drug ineffective
Hospital-Tage
-
Labordaten
No tests or Lab results required.
Aktuelle Erkrankungen
Not disclosed
Vorgeschichte
Not disclosed
Andere Medikamente
Not Known
Allergien
No Allergies
Vorherige Impfungen
-

VAERS 2469501

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ648AAA

gering
Staat
MI
Alter
0,3
Geschlecht
F
Eingang
05.10.2022
Impfdatum
09.09.2022
Beginn
09.09.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation error

Symptomtext

4 month old patient received the acthib component of the pentacel vaccine reconstituted with sterile water instead of the dtap-ipv component with no adverse event; 4 month old patient received the acthib component of the pentacel vaccine reconstituted with sterile water instead of the dtap-ipv component with no adverse event; 4 month old patient received the acthib component of the pentacel vaccine reconstituted with sterile water instead of the dtap-ipv component with no adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who received the ACTHIB component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] reconstituted with sterile water instead of the DTaP-IPV component with no 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 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation. On 09-Sep-2022, the patient received a second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at dose of 0.5 ml once (lot UJ648AAA,exp date: 25-Feb-2023) via intramuscular route in the left thigh for Immunisation. On 09-Sep-2022 the patient received the ACTHIB component of the PENTACEL vaccine reconstituted with sterile water instead of the DTaP-IPV with no reported adverse event(product preparation error) (single component of a two-component product administered). Action taken: not applicable. At time of reporting, the outcome was Unknown for the 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
Product preparation error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2324075

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ648AAA

gering
Staat
WV
Alter
0,3
Geschlecht
M
Eingang
20.06.2022
Impfdatum
14.06.2022
Beginn
14.06.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect route of product administration No adverse event

Symptomtext

pentacel was given subcutaneous this morning in error with no adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 3 months old male patient to whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] was given subcutaneous this morning in error with no 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 13v (crm197) (Prevnar 13), Hepatitis B Vaccine and rotavirus vaccine live reassort oral 5v (Rotateq) for immunisation. On 14-Jun-2022, the patient received dose:1 of 0.5 ml total 1 day (once) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection, lot UJ648AAA expiry date: 25-Feb-2023 via subcutaneous route in the left thigh for immunization. On 14-Jun-2022 the patient was given Pentacel subcutaneous this morning in error with no adverse event (incorrect route of product administration) (Latency: same day). Action taken 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
Incorrect route of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-