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Reporte zur Charge UJ651AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 2 NM 1 NC 1

VAERS 2608855

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ651AAA

gering
Staat
CA
Alter
0,3
Geschlecht
M
Eingang
04.04.2023
Impfdatum
16.03.2023
Beginn
16.03.2023
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

expired pentacel vaccine was administered,with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case from other health professional. This case is linked to case 2023SA102456. This case involves a 4 months old male patient to whom expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] 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 rotavirus vaccine pneumococcal vaccine CONJ 15V (CRM197) (vaxneuvance) and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (VAXELIS) all for Immunisation. On 16-Mar-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine suspension for injection at a dose of 0.5 ml once (lot UJ651AAA, expiry date: 25-Feb-2023) via intramuscular route in the left thigh for immunization. On 16-Mar-2023, expired pentacel vaccine was administered,with no reported adverse event (expired product administered, latency: same day). It was reported that an expired PENTACEL vaccine was administered to 3 patients, she then after investigating stated it was only 2 patients. 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
ROTAVIRUS VACCINE; VAXNEUVANCE; VAXELIS
Allergien
-
Vorherige Impfungen
-

VAERS 2608854

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ651AAA

gering
Staat
CA
Alter
0,5
Geschlecht
F
Eingang
04.04.2023
Impfdatum
23.03.2023
Beginn
23.03.2023
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

an expired PENTACEL vaccine was administered with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient and reporter reported an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] 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 Rotavirus Vaccine (Rotavirus Vaccine) for Prophylactic vaccination; and Pneumococcal Vaccine Conj 15v (Crm197) (Vaxneuvance) for Prophylactic vaccination. On 23-Mar-2023, the patient received 0.5 ml Total (1X) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (Frequency- once; Strength-standard) (with an unknown dose number) (lot number: UJ651AAA, Expiry date: 25-Feb-2023) via intramuscular route in the left thigh for Immunisation. On 23-Mar-2023, the reporter reported an expired of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine was administered with no reported adverse event (expired product administered) (Latency: same day). It was reported, Medical assistant reporting that an expired PENTACEL vaccine was administered to 3 patients, she then after investigating stated it was only 2 patients. This situation is reported as a medication error due to the administration of an expired 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 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; VAXNEUVANCE
Allergien
-
Vorherige Impfungen
-

VAERS 2595043

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ651AAA

gering
Staat
NM
Alter
1,0
Geschlecht
M
Eingang
11.03.2023
Impfdatum
03.03.2023
Beginn
03.03.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error Product preparation error Single component of a two-component product administered

Symptomtext

administered pentacel but it was expired with no reported adverse event; administered pentacel but it was expired and also was only administered to component part of the vaccine with no reported adverse event; liquid portion of PENTACEL was administered, it was not reconstituted with the ACTHIB portion, with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 1-year-old male patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] but it was expired, administered pentacel but it was expired and also was only administered to component part of the vaccine and liquid portion of pentacel was administered, it was not reconstituted with the acthib portion, 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 and HEPATITIS B VACCINE for Prophylactic vaccination. On 03-Mar-2023, the patient received dose 2 at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (Strength: standard) (lot number: UJ651AAA, expiry date: 25-Feb-2023) via intramuscular route in the left thigh (leg) for Immunization and on the same day the patient was administered pentacel but it was expired with no reported adverse event (expired product administered), pentacel but it was expired and also was only administered to component part of the vaccine with no reported adverse event (single component of a two-component product administered) and liquid portion of pentacel was administered, it was not reconstituted with the acthib portion, with no reported adverse event (product preparation error). It was reported, medical assistant (MA) calling for guidance moving forward. The caller noted that the liquid vaccine component that was administered was expired. The caller is not aware of any adverse reactions, or any treatment. The liquid vaccine portion expired on 25FEB2023. However, they misread the expiration date. Caller also requested information for when the DTAP-IPV liquid portion and ACTHIB portion of PENTACEL are administered separately when both are used prior to their expiration date. The caller requested this information for future reference should these be administered separately without being reconstituted. This situation is reported as a medication error due to the inappropriate administration of an expired product to a patient and for not reconstituting the product as outlined in the prescribing information. It was determined that this was also a product technical complaint (PTC). Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable. At time of reporting, the outcome was Unknown for all 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 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 VACCINE; HEPATITIS B VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2440248

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ651AAA

gering
Staat
NC
Alter
4,0
Geschlecht
F
Eingang
12.09.2022
Impfdatum
18.08.2022
Beginn
18.08.2022
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 Wrong product administered

Symptomtext

patient received an unnecessary hib dose as well as an extra IPV dose; patient was inadvertently given PENTACEL instead of the ordered DAPTACEL; Initial information received on 18-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old female patient who experienced patient was inadvertently given pentacel instead of the ordered daptacel and patient received an unnecessary hib dose as well as an extra ipv dose 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA ZOSTER VACCINE) for Immunisation. On 18-Aug-2022, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE once (lot UJ651AAA; expiry date: 25-Feb-2023) via intramuscular route in the left thigh for prophylactic vaccination. On 18-AUG-2022 the patient reported patient was inadvertently given pentacel instead of the ordered daptacel (wrong product administered) and received an unnecessary hib dose as well as an extra ipv dose (extra dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event wrong product administered and extra dose 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MMR; VARICELLA ZOSTER VACCINE
Allergien
-
Vorherige Impfungen
-