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Reporte zur Charge UJ266AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
PA 1 NY 1 MI 1

VAERS 1653414

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ266AA

gering
Staat
PA
Alter
0,2
Geschlecht
M
Eingang
29.08.2021
Impfdatum
23.08.2021
Beginn
23.08.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

Expired dose had been administered, no AE; Initial information received on 23-Aug-2021 regarding an unsolicited valid non-serious case from a nurse and physician via Media Information (under the reference 00735979). This case involved a 2 month old male patient who was given an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant medication was given to the patient. On 23-Aug-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (0.5 ml, once in total, lot UJ266AA and expiration date: 05-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported "Nurse called to report that an expired dose of ACTHIB had been administered to a patient. The caller would like to know whether the dose is valid and if it should be repeated." No treatment was required. At time of reporting, it was unknown where the patient had any adverse event or not and the outcome was unknown for the reported 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
-

VAERS 1449799

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ266AA

gering
Staat
NY
Alter
1,0
Geschlecht
F
Eingang
06.07.2021
Impfdatum
11.06.2021
Beginn
11.06.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

expired ACT-HIB was administered to a patient/no AE; Initial information was received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from a physician via MI (Medical Information- 00657177). This case involves a 1 year-old female patient who was vaccinated with expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination. On 11-Jun-2021, the patient received fourth dose 0.5 mL (once) fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ266AA and expiry date 05-Jun-2021) via an intramuscular route at the right deltoid for prophylactic vaccination. It was a case of an actual medication error due to expired product administered (latency was on same day). At the time of report, no adverse event reported. Result of assessment was not reported. 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 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
Allergien
-
Vorherige Impfungen
-

VAERS 1183988

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ266AA

gering
Staat
MI
Alter
-
Geschlecht
U
Eingang
09.04.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product preparation issue

Symptomtext

found a leftover saline diluent that was supposed to be mixed in with the HIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a other health care professional via Medical Information (Reference number- 00522974) and transmitted to Sanofi on 17-Mar-2021. This case involves a patient of unknown age for whom it was reported found a leftover saline diluent that was supposed to be mixed in with the HIB (PRP/T) VACCINE [ACT-HIB] (product preparation error) (lot number: UJ266AA and expiration date: unknown] via an unknown route at an unknown administration site for prophylactic vaccination. Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was also reported that that it was probably another sterile diluent that they use for their other vaccines. Caller asking if the dose needs to be repeated. Caller asking if the dose can be repeated at any time. It was an actual medication error due to wrong diluent used (latency: unknown). At the time of report, no adverse event was reported. It was not reported if the patient received a corrective treatment. Disclaimer: 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 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
-
Allergien
-
Vorherige Impfungen
-