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Reporte zur Charge UJ590AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
VA 2 TX 1 IN 1

VAERS 2250421

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ590AAA

mild
Staat
TX
Alter
0,3
Geschlecht
M
Eingang
25.04.2022
Impfdatum
25.04.2022
Beginn
25.04.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site swelling

Symptomtext

REDNESS AND SWELLING TO INJECTION SITE

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 2548369

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ590AAA

gering
Staat
IN
Alter
1,6
Geschlecht
F
Eingang
02.01.2023
Impfdatum
28.12.2022
Beginn
28.12.2022
Tage bis Beginn
0,0
Dosis
4
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 dose of PENTACEL was administered with no reported adverse event; Initial information received on 28-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old female patient to whom expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient's concomitant medications included hepatitis A vaccine (Hepatitis A) for Immunisation. On 28-Dec-2022, the patient received an expired 0.5 ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, suspension for injection (frequency - once, strength - standard, lot - UJ590AAA and expiry date - 18-Dec-2022), with no reported adverse event (expired product administered) (latency: same day) via intramuscular route in the left thigh for immunization. Action taken: not applicable. At time of reporting, the outcome was Unknown for the 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
HEPATITIS A
Allergien
-
Vorherige Impfungen
-

VAERS 2405546

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ590AAA

gering
Staat
VA
Alter
0,3
Geschlecht
F
Eingang
09.08.2022
Impfdatum
14.07.2022
Beginn
14.07.2022
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 Wrong technique in product usage process

Symptomtext

liquid portion of pentacel was administered without the hib portion with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who had received vaccineDIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and liquid portion of pentacel was administered without the hib 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 (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination On 14-Jul-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot UJ590AAA via intramuscular route in left thigh as immunization. On 14-JUL-2022 the liquid portion of pentacel was administered without the hib portion with no reported adverse event (product preparation issue) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (liquid portion of pentacel was administered without the hib portion with no reported adverse event). At time of reporting, the outcome was Unknown for the 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 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 2404213

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ590AAA

gering
Staat
VA
Alter
0,5
Geschlecht
F
Eingang
08.08.2022
Impfdatum
14.07.2022
Beginn
14.07.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation issue

Symptomtext

liquid portion of PENTACEL being given without the Hib portion, with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who was administered liquid portion of pentacel being given without the hib portion, 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 (PNEUMOCOCCAL VACCINE) for Immunisation; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. On 14-Jul-2022, the patient received a 2nd or 3rd dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ590AAA at a dose of 0.5ml once via intramuscular route in the left thigh for immunization. On 14-Jul-2022(latency: same day), the patient developed a non-serious event of liquid portion of pentacel being given without the hib portion, with no reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken :not applicable. It was not reported if the patient received a corrective treatment for the event 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.; Sender's Comments: 01213243:

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