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Reporte zur Charge UJ862AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
GA 2 TX 1

VAERS 2728368

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ862AA

gering
Staat
TX
Alter
1,0
Geschlecht
F
Eingang
28.12.2023
Impfdatum
01.12.2023
Beginn
01.12.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

Nurse states a patient only received the diluent portion of the ACTHIB vaccine instead of the reconstituted product with no reported adverse event; Initial information received on 20-Dec-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old female patient for whom nurse states a patient only received the diluent portion of the HIB (PRP/T) vaccine [ACT-HIB] vaccine instead of the reconstituted product 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR): VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation. On 01-Dec-2023, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (strength not reported) (Lot # diluent UJ862AA; EXP: 24-May-2024 ? Lot # aCTHIB UJ855AA; EXP: 22-Mar-2024) via unknown route in the thigh nos (not otherwise specified) for Immunization nurse states a patient only received the diluent portion of the acthib vaccine instead of the reconstituted product with no reported adverse event (product preparation error) (on same day). 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
MMR; VARICELLA VACCINE; INFLUENZA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2724629

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ862AA

gering
Staat
GA
Alter
1,0
Geschlecht
M
Eingang
15.12.2023
Impfdatum
08.12.2023
Beginn
08.12.2023
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 issue

Symptomtext

patient may have been administered a dose of ACTHIB that was inadvertently reconstituted with sterile water instead of the provided ACTHIB diluent with no reported adverse event; Initial information received from RA on 11-Dec-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 1 years old male patient who experienced patient may have been administered a dose of HIB (PRP/T) vaccine [ACT-HIB] that was inadvertently reconstituted with sterile water instead of the provided acthib diluent 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (daptacel), measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (proquad) and hepatitis a vaccine inact (vaqta). On 08-Dec-2023, the patient received 0.5 ml (TOTAL) dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot- UJ862AA and expiration date- 24-Mar-2024) via intramuscular route in the right thigh (strength: not provided) for Immunisation (product preparation error) (latency- same day). 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
DAPTACEL; PROQUAD; VAQTA
Allergien
-
Vorherige Impfungen
-

VAERS 2722799

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ862AA

gering
Staat
GA
Alter
1,3
Geschlecht
M
Eingang
11.12.2023
Impfdatum
08.12.2023
Beginn
11.12.2023
Tage bis Beginn
3,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation error

Symptomtext

staff member mixed the acthib with sterile water instead of the sodium chloride solution that comes with the kit for reconstitution then injected patient.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
n/a
Allergien
no known allergies
Vorherige Impfungen
-