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Reporte zur Charge UJ178AAB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NJ 1 IL 1 IN 1

VAERS 1349699

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ178AAB

gering
Staat
NJ
Alter
0,6
Geschlecht
F
Eingang
26.05.2021
Impfdatum
11.05.2021
Beginn
11.05.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error

Symptomtext

Patient was administered ActHib vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00598281) and transmitted to Sanofi on 12-May-2021. This case involves a 7 months old female patient who was administered with a expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ178AAB and expiry date: 04-May-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 11-May-2021. The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Immunisation. It was an actual medication error case due to expired vaccine used (latency: same day). The reporter wanted to know what to do. At the time of reporting, the patient experienced no 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
HEPATITIS B VACCINE; DTAP VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1349696

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ178AAB

gering
Staat
IL
Alter
1,3
Geschlecht
M
Eingang
26.05.2021
Impfdatum
05.05.2021
Beginn
05.05.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

A patient was given an expired ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00589040) and transmitted to Sanofi on 05-May-2021. This case involves a 15 month old male patient who received 0.5 ml dose of expired suspect HIB (PRP/T) VACCINE [ACT-HIB] vaccine (lot number: UJ178AAB; expiry date: 04-May-2021) via unknown route in the right thigh for prophylactic vaccination on 05-May-2021 (expired product administered). Medical history, medical treatment(s), past vaccination(s), and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (lot number and expiry date: not reported) for prophylactic vaccination and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) (lot number and expiry date: not reported) for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). The reporter wanted to know if they should revaccinate the patient. At the time of report, no adverse event was 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; DTAP VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1306655

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ178AAB

gering
Staat
IN
Alter
0,8
Geschlecht
F
Eingang
11.05.2021
Impfdatum
02.12.2020
Beginn
02.12.2020
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / UN
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Extra dose administered

Symptomtext

Patient had previously received two doses of HIB PRP-OMP. Patient did not need 3rd dose of HIB on 12/2/2020. Dose was given in error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-