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Reporte zur Charge UJ856AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CO 1 GA 1

VAERS 2718867

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ856AB

gering
Staat
CO
Alter
1,3
Geschlecht
M
Eingang
29.11.2023
Impfdatum
17.11.2023
Beginn
17.11.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

reconstituting ACT-HIB with a sterile water and administering the reconstituted dose to a patient with no adverse event; Initial information received on 22-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 15 months old male patient who was administered the reconstituted dose after reconstituting HIB (PRP/T) VACCINE [ACT-HIB] with a sterile water with no 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) for Immunisation; and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Immunisation. On 17-Nov-2023, the patient received 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UJ856AB; Expiration Date : 25-MAR-2024) via intramuscular route in the right thigh for Immunization after reconstituting with a sterile water with no adverse event (product preparation error) (Latency: on same day). Site manager calling from a medical center stated that one of their nurses gave the ACT-HIB to a patient but she didn't use the supplied vial of sodium chloride to reconstitute the lyophilized powder. 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 and Regulatory Authority 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
DAPTACEL; VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]
Allergien
-
Vorherige Impfungen
-

VAERS 2690935

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ856AB

gering
Staat
GA
Alter
1,3
Geschlecht
M
Eingang
04.10.2023
Impfdatum
19.09.2023
Beginn
19.09.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error Single component of a two-component product administered

Symptomtext

medical technician administered a patient with only the diluent part of acthib and the incident has been found 4 days after with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient to whom medical technician administered only the diluent part of HIB (PRP/T) vaccine [ACT-HIB] and the incident has been found 4 days after with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Sep-2023, the patient received an unknown dose (Booster dose, once) of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ856AB expiry date, strength: unknown) via intramuscular route in unknown administration site for Immunization and was administered only the diluent part of acthib and the incident has been found 4 days after with no reported adverse event (Product preparation error) (Latency: same day). 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-