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Reporte zur Charge UJ621AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
ME 2 KY 1 LA 1

VAERS 2579406

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ621AAA

gering
Staat
KY
Alter
0,2
Geschlecht
F
Eingang
10.02.2023
Impfdatum
03.02.2023
Beginn
03.02.2023
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

expired pentacel was administered with no reported adverse event; Initial information received on 06-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 2 months old female patient who was administered expired diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (VERO)/ HIB(PRP/T) vaccine [Pentacel (Vero)] 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 13V (CRM197) (Prevnar 13) for Immunisation; and rotavirus vaccine live reassort oral 5V (Rotateq) for Immunisation. On 03-Feb-2023, the patient received 0.5 mL expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection (lot: UJ621AAA; expiry date: 28-Jan-2023) via unknown route in unknown administration site with no reported adverse event (expired product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event expired pentacel was administered with no reported 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR 13; ROTATEQ
Allergien
-
Vorherige Impfungen
-

VAERS 2544176

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ621AAA

gering
Staat
ME
Alter
-
Geschlecht
F
Eingang
28.12.2022
Impfdatum
05.07.2022
Beginn
05.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

Extra dose administered; No Adverse Event; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2371879-1. The original narrative from the sender is the following: PENTACEL and VAXELIS were administered at different sites on the same day, causing an extra dose to occur with no reported adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old female patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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] were administered at different sites on the same day, causing an extra dose to occur with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Jul-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, strength unknown (lot UJ621AAA and expiry date 20-Jan-2023) via intramuscular route in the right thigh and on same day the patient received a dose of suspect 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 not produced by Sanofi Pasteur (formulation, dose, strength ,lot number and expiry date not reported) via unknown route in unknown administration site both for immunization was administered at different sites on the same day, causing an extra dose to occur with no reported adverse event (extra dose administered). 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2371879

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ621AAA

gering
Staat
ME
Alter
0,6
Geschlecht
F
Eingang
16.07.2022
Impfdatum
05.07.2022
Beginn
05.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

PENTACEL and VAXELIS were administered at different sites on the same day, causing an extra dose to occur with no reported adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old female patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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] were administered at different sites on the same day, causing an extra dose to occur with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Jul-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, strength unknown (lot UJ621AAA and expiry date 20-Jan-2023) via intramuscular route in the right thigh and on same day the patient received a dose of suspect 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 not produced by Sanofi Pasteur (formulation, dose, strength ,lot number and expiry date not reported) via unknown route in unknown administration site both for immunization was administered at different sites on the same day, causing an extra dose to occur with no reported adverse event (extra dose administered). 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2280575

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ621AAA

gering
Staat
LA
Alter
-
Geschlecht
F
Eingang
17.05.2022
Impfdatum
09.05.2022
Beginn
09.05.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error Product preparation issue

Symptomtext

mixed the ACTHIB with sterile water and administered it/ DTAP/IPV portion was never administered with no reported adverse event; Initial information received on 11-May-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 100 years old female patient and it was reported that "mixed the ACTHIB with sterile water and administered it/ DTAP/IPV portion was never administered 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 HEPATITIS B VACCINE (HEPATITIS B VACCINE); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13). On 09-May-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE , (lot : UJ621AAA ; expiry date: 28-Jan-2023) via intramuscular route in the right thigh for immunization. It was reported that on 09-May-2022, the medical assistant went to administer Pentacel to a patient and was confused because she saw the powdered ACTHIB and removed it from box and did not notice the diluent with DTAP/IPV in the box. She mixed the ACTHIB with sterile water and administered it and DTAP/IPV portion was never administered (product preparation issue) (latency: unknown). The patient did not experience any adverse event as a result of this. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS B VACCINE; ROTAVIRUS VACCINE; PREVNAR 13
Allergien
-
Vorherige Impfungen
-