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Reporte zur Charge UJ399AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
UT 1 AR 1

VAERS 1531175

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ399AA

gering
Staat
UT
Alter
-
Geschlecht
M
Eingang
06.08.2021
Impfdatum
27.07.2021
Beginn
27.07.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

ACTHIB was mixed with sterile water instead of ACTHIB diluent and administered to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Medical Information (MI) (Reference number- 00700661) and transmitted to Sanofi on 28-Jul-2021. This case involves a one-year-old male patient who was administered with HIB (PRP/T) VACCINE [ACT-HIB] which was mixed with sterile water instead of Act-Hib diluent (wrong diluent used). The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination. On 27-Jul-2021, the patient received third dose of 0.5ml suspect HIB (PRP/T) VACCINE (lot UJ399AA and expiry date: 02-Oct-2021) via an intramuscular route in the left thigh for prophylactic vaccination. The reporter "asking for further guidance." It was a case of an actual medication error due to wrong diluent used (latency: same day). At time of reporting 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 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
VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1299392

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ399AA

gering
Staat
AR
Alter
0,2
Geschlecht
F
Eingang
08.05.2021
Impfdatum
28.04.2021
Beginn
-
Tage bis Beginn
-
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

2 month old was administered Act-HIB and Pentacel/no AE; Initial information was received on 28-Apr-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office manager). This case involves a 2 month-old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] (extra dose administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for prophylactic vaccination. On 28-Apr-2021, the patient received first dose 0.5 mL(once) of suspect HIB (PRP/T) VACCINE (lot UJ399AA and expiry date 02-OCT-2021) via an intramuscular route at the right thigh for prophylactic vaccination and a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at unknown administration site for prophylactic vaccination. It was a case of actual medication error due to extra dose administered (latency was on same day). At the time of report, no adverse event 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. There will be no information available on batch number for Pentacel

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
ROTAVIRUS VACCINE; PREVENAR 13
Allergien
-
Vorherige Impfungen
-