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Reporte zur Charge UJ642AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
FL 2

VAERS 2599721

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ642AA

gering
Staat
FL
Alter
1,0
Geschlecht
M
Eingang
20.03.2023
Impfdatum
06.03.2023
Beginn
06.03.2023
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 No adverse event

Symptomtext

ACTHIB diluent was expired, and the powder was good (with no reported adverse event); Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional). This case is linked to case 2023SA087047. This case involves a 1 years old male patient and reporter reported Hib (Prp/T) Vaccine [Act-Hib] diluent was expired, and the powder was good (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 Immunization. On 06-Mar-2023, the patient received 0.5 ml Total dose of suspect Hib (Prp/T) Vaccine Powder and solvent for solution for injection (lot number: UJ642AA, Expiry date: 27-Mar-2023; Diluent) (lot number: U7247AB, Expiry date: 02-Mar-2023;Powder) (Frequency = once) (Strength = standard) via intramuscular route in the left thigh for immunization. On 06-Mar-2023, the reporter reported Hib (Prp/T) Vaccine diluent was expired, and the powder was good (with no reported adverse event) (expired product administered) (latency: same day). It was reported, It was given to two patients after the expiration date. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event acthib diluent was expired, and the powder was good (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
Allergien
-
Vorherige Impfungen
-

VAERS 2599720

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ642AA

gering
Staat
FL
Alter
1,3
Geschlecht
F
Eingang
20.03.2023
Impfdatum
14.03.2023
Beginn
14.03.2023
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

Symptomtext

An ACTHIB diluent was expired, and the powder was good. It was given to two patients after the expiration date with no reported adverse event; Initial information was received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional. This case involves 1 years old female patient who stated an acthib diluent was expired, and the powder was good. it was given to two patients after the expiration date with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB]. 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 Prophylactic vaccination. On 14-Mar-2023, the patient received 0.5 ml Total dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot: UJ642AA/U7247AB, expiry date: 27-Mar-2023/ 02-Mar-2023) (strength was unknown) via intramuscular route in Left thigh for Immunization. On 14-Mar-2023 the patient developed a non-serious event of an acthib diluent was expired, and the powder was good. it was given to two patients after the expiration date with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) vaccine. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the 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 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
-
Allergien
-
Vorherige Impfungen
-